Focusing On The Total Cost Of PharmD E-Discovery Review

Prescription drug E-Discovey matching requirements for protocols and procedures via http://www.HaystackID.com:

The Dynamics of Agency Investigations:
A Second Request Update 

An Industry Education Webcast from HaystackID+ Date: Wednesday, October 14, 2020
+ Time: 12:00 PM ET (11:00 AM CT/9:00 AM PT)
+ One Step Registration (Click Here)

HSR Act-driven Second Request responses require an uncommon balance of understanding, expertise, and experience to successfully deliver certified compliant responses. Recent FTC and DOJ updates, coupled with the increasing velocity of requests, make current expertise more crucial than ever in this unique discovery area.

In this presentation, expert investigation, eDiscovery, and M&A panelists will present updates and considerations for managing Second Request responses to include tactics, techniques, and lessons learned from fourteen recent responses. 

Webcast Highlights

+ Defining Second Requests: The Requirement and Task
+ Context for Consideration: The Prevalence of Requests Over Time
+ A Different Type of Discovery: Characteristics of a Second Request
+ Recent DOJ and FTC Updates: From the Practical to the Tactical
+ Managing Second Requests: A Provider’s Perspective

Presenting Experts

+ Michael Sarlo, EnCE, CBE, CCLO, RCA, CCPA – Michael is a Partner and Senior EVP of eDiscovery and Digital Forensics for HaystackID.

+ Mike Quartararo – Mike currently serves as the President of ACEDS, which provides training and certification in eDiscovery and related disciplines to law firms, corporate legal, and the broader the legal community.

+ John Wilson, ACE, AME, CBE – As CISO and President of Forensics at HaystackID, John is a certified forensic examiner, licensed private investigator, and IT veteran with more than two decades of experience.

+ Anya Korolyov – A Senior Consultant with HaystackID, Anya has 12 years of experience in eDiscovery with extensive expertise with Second Requests as an attorney and senior consultant.

+ Seth Curt Schechtman – As Senior Managing Director of Review Services for HaystackID, Seth has extensive legal review experience, including class actions, MDLs, and Second Requests.

+ Young Yu – As Director of Client Service with HaystackID, Young is the primary strategic and operational advisor to clients in matters relating to eDiscovery.
 Register Now for this Educational Webcast

https://haystackid.com/webcast-transcript-hatch-waxman-matters-and-ediscovery-turbo-charging-pharma-collections-and-reviews/

Editor’s Note: On September 16, 2020, HaystackID shared an educational webcast designed to inform and update legal and data discovery professionals on the complexities of eDiscovery support in pharmaceutical industry matters through the lens of the Hatch-Waxman Act. While the full recorded presentation is available for on-demand viewing via the HaystackID website, provided below is a transcript of the presentation as well as a PDF version of the accompanying slides for your review and use.

Hatch-Waxman Matters and eDiscovery: Turbo-Charging Pharma Collections and Reviews

Navigating Hatch-Waxman legislation can be complex and challenging from legal, regulatory, and eDiscovery perspectives. The stakes are high for both brand name and generic pharmaceutical manufacturers as timing and ability to act swiftly in application submissions and responses many times mean the difference between market success or undesired outcomes.

In this presentation, expert eDiscovery technologists and authorities will share information, insight, and proven best practices for planning and supporting time-sensitive pharmaceutical collections and reviews so Hatch-Waxman requirements are your ally and not your adversary on the road to legal and business success.

Webcast Highlights

+ NDA and ANDA Processes Through the Lens of Hatch-Waxman
+ ECTD Filing Format Overview For FDA (NDA/ANDA Submissions)
+ Information Governance and Collections Under Hatch-Waxman
+ Dealing with Proprietary Data Types and Document Management Systems at Life Sciences Companies
+ Streamlining the Understanding of Specific Medical Abbreviations and Terminology
+ Best Practices and Proprietary Technology for Document Review in Pharmaceutical Litigation

Presenting Experts

Michael Sarlo, EnCE, CBE, CCLO, RCA, CCPA – Michael is a Partner and Sr. EVP of eDiscovery and Digital Forensics for HaystackID.

John Wilson, ACE, AME, CBE – As CISO and President of Forensics at HaystackID, John is a certified forensic examiner, licensed private investigator, and infotech veteran with more than two decades of experience.

Albert Barsocchini, Esq. – As Director of Strategic Consulting for NightOwl Global, Albert brings more than 25 years of legal and technology experience in discovery, digital investigations, and compliance.

Vazantha Meyers, Esq. – As VP of Managed Review for HaystackID, Vazantha has extensive experience in advising and helping customers achieve their legal document review objectives.


Presentation Transcript

Introduction

Hello, and I hope you’re having a great week. My name is Rob Robinson. On behalf of the entire team at HaystackID, I’d like to thank you for attending today’s webcast titled Hatch-Waxman Matters and eDiscovery, Turbo-Charging Pharma Collections and Reviews. Today’s webcast is part of HaystackID’s monthly series of educational presentations conducted on the BrightTALK, and designed to ensure listeners are proactively prepared to achieve their computer forensics, eDiscovery, and legal review objectives during investigations and litigation, and our expert presenters for today’s webcast include four of the industry’s foremost subject matter experts and authorities on eDiscovery, all with extensive experience in pharmaceutical matters. 

Our first presenter that I’d like to introduce you to is Michael Sarlo. Michael is a Partner and Senior Executive Vice President of eDiscovery and Digital Forensics for HaystackID. In this role, Michael facilitates all operations related to eDiscovery, digital forensics, and litigation strategy both in the US and abroad for a HaystackID. 

Our second presenter is digital forensics and cybersecurity expert John Wilson. As Chief Information Security Officer and President of Forensics at HaystackID, John’s a certified forensic examiner, licensed private investigator, and information technology veteran of more than two decades of experience working with the US government in both public and private companies. 

Our next presenting expert, Vazantha Meyers serves, as Vice President of Discovery for HaystackID, and Vazantha has extensive experience in advising and helping customers achieve their legal document review objectives. She’s recognized as an expert in all aspects of traditional and technology-assisted review. Additionally, Vazantha graduated from Purdue University and obtained her JD from Valparaiso University School of Law. 

Our final presenting expert is Albert Barsocchini. As Director of Strategic Consulting for NightOwl Global, newly merged with HaystackID, Albert brings more than 25 years of legal and technology experience in discovery, digital investigations, and compliance to his work supporting clients in all things eDiscovery. 

Today’s presentation will be recorded and provided for future viewing and a copy of the presentation materials are available for all attendees, and in fact, you can access those materials directly beneath the presentation viewing window on your screen by selecting the Attachments tab on the far left of the toolbar beneath the viewing window, and also a recorded version of this presentation will be available directly from the HaystackID and BrightTALK network websites upon completion of today’s presentation, and a full transcript will be available via the HaystackID blog. At this time, with no further ado, I’d like to turn the microphone over to our expert presenters, led by Mike Sarlo, for their comments and considerations on the Hatch-Waxman Matters and eDiscovery presentation. Mike? 

Michael Sarlo

Thanks for the introduction, Rob, and thank you all for joining our monthly webinar series. We’re going to be covering a broad array of topics around pharmaceutical litigation in general, the types of data types, in particular around Electronic Common Technical Documents (eCTDs), which we’ll learn more about. We’re going to start out with really looking at Hatch-Waxman as a whole and new drug application and ANDA processes related to Hatch-Waxman. We’re going to get into those eCTDs and why those are important for pharmaceutical-related matters on a global scale. I’m going to start to talk about more information governance and strategies around really building a data map, which is also more of a data map that is a fact map. These matters have very long timelines when you start to look at really just the overall lifecycle of an original patent of a new drug going through a regulatory process, and then actually hitting market and then having that patent expire. We’ll learn more about that, then we’re going to get into some of the nitty-gritties of really how we enhance document reviews at HaystackID for pharmaceutical matters and scientific matters in general, and then finish off with some best practices and just a brief overview of our proprietary testing mechanism and placement platform ReviewRight. 

So, without further ado, I’m going to kick it off to Albert. 

Albert Barsocchini

Thank you very much, Michael. So, I’m going to start off with a 30,000-foot level view of Hatch-Waxman, and I always like to start off with a caveat any time I’m talking about pharma related matters. Pharma is a very complex process, complex laws, and very nuanced, and especially Hatch-Waxman. So, my goal today is really just to give you the basic things you need to know about Hatch-Waxman, and it’s very interesting. In fact, in 1984, generic drugs accounted for 19% of retail prescriptions, and in 2018, they accounted for 90% and that’s because of Hatch-Waxman. In a recent report, the President’s cancer panel found that the US generic drug market saved the US healthcare system an estimated $253 billion overall in 2018, including $10 billion in savings for cancer drugs. So, Hatch-Waxman really has been very important to the generic drug market and to us, in public, for being able to get drugs at an affordable price. 

So, how did Hatch-Waxman start? And it started with a case called Roche v. Bolar. So, Roche made a drug, it was a sleeping pill, Dalmane, I don’t know if anybody’s taken it, I haven’t. Anyway, it was very popular, it made them literally millions and billions of dollars, and so what, and normally they have a certain patent term, and what a generic drug company likes to do is to make a bioequivalent of that, and to do that, they want to try to be timed, so at the termination of a patent, the generic drugs can start marketing their product. So, in this case, Bolar started the research and development before the Roche patent expired, and because of that, they were per se infringing on the Roche patent, and so a lawsuit pursued and Bolar lost. 

Now, a couple of terms that I think are important, and I’m going to throw them out now just because there are so many nuanced pharma terms. One is branded biologic, and biosimilar generic, and then there’s branded synthetic, and bioequivalent generic. Now, branded drugs are either synthetic, meaning they’re made from a chemical process or biological, meaning they’re made from a living source. We’re going to be talking today about synthetics and what is important is that synthetic branded drugs can be exactly replicated into more affordable generic versions, bioequivalents, but because biologics involve large complex molecules, because they’re talking about living sources, that’s where biosimilar comes in. So, today, we’re going to just focus on the bioequivalents, on synthetic drugs, and just as another point, there was a… in signing the law by President Obama, I think it was around 2010, the Biosimilar Act became law, which is another law very similar to the Hatch-Waxman. So, anyway, because of the Roche case, we came out in 1983 with the Hatch-Waxman Act, and the reason they wanted this was because what was happening is since a generic company could not start to research and development until after a patent expired, this in essence gave the new drug application additional years of patent, and which means millions of more dollars, and so Congress came in, and they thought this wasn’t fair, and so they decided that they were going to allow generic companies to start the research and development process before the patent expired, and this prevented that from happening in terms of giving the original patent holder more years on the patent, and also allowed generics to get on the market quicker and get to the public at cheaper prices, and that’s just trying to strike a balance, and as you can see, between the pharmaceutical formulations, the original patents, and the new generic versions, and so it’s a delicate balance, but they seem to have achieved it because of the fact that generics are now so prevalent in the market. 

And one thing about this act, generic drug companies are not required to conduct their own independent clinical trials to prove safety and efficacy but can instead rely on research of the pioneer pharmaceutical companies, and they can start development before the original patent expires. So, that’s already a headstart because they don’t have to produce their own data, they can rely on the data of the original patent holder, and that allowed this exploration in the patent process for generic drugs. 

So, one of the important areas that is part of this whole act is the so-called “Orange Book”. So, before you can have an abbreviated new drug application, called ANDA, for approving that generic drug, you must first have a new drug application or an NDA. Now the NDA is a pioneering brand name drugs company seeking to manufacture a new drug, and they must prepare, file, and have approved its drug by the FDA. Additionally, as part of this new drug application process, the pioneering drug company submits the information on the new drug safety and efficacy [obtained] from the trials. Now, the NDA applicant must also identify all patents that could reasonably be asserted, if a person not licensed by the owner engaged in the manufacture, use, or sell the drug, and the patents covering approved drugs, or use thereof, are published in what’s called the “Orange Book”. So, a generic company will be going to this “Orange Book”, which is like a pharma bible, to see what patents are in effect, and this helps them target certain patents they want to create a generic version of, so it’s a very important starting point and this process can start while the original patent hasn’t even gone to market. 

And so, you can see things start to heat up pretty early, and one of the things that we notice in this whole process is that when a patent is filed, the clock ticks on the patent, and so it may be another six years before that patent goes to market, and so because of that, there is a… it can be very unfair, and so there’s a lot of extensions that occur for the patent holder. 

Now, what happens in this particular situation with an ANDA is that we’re going to have a Paragraph IV certification, and briefly, in making a Paragraph IV certification, the generic drugmaker says the patent is at least one of the following. It’s either invalid, not infringed, or unenforceable, and that’s really the Reader’s Digest version on their Paragraph IV certification after the story gets much more complicated and adversarial, and that’s why I always give the warning that this is a very complex dance that’s occurring with Hatch-Waxman, but ANDA really is a very, I would say, important piece of this whole puzzle, and once the ANDA information is put together, it’s filed by what’s called the Electronic Common Technical Document, eCTD, and it’s a standard format for submitting application amendments, supplements, and reports and we’re going to talk about this a little later on in the presentation. Very similar to electronic court filings, but there’s a lot more to it, but it is something that is part of the process when you start the whole process. 

Now the patent owner, their patents and a pharma patent is good for about 20 years after the drug’s invention, and the Hatch-Waxman Act gave patent extensions to name-brand drug companies to account for delays in the approval process, and that is taken into the fact that, as pointed out earlier, that when the patent is filed, research is still in development, and it may be another six years, so realizing that, they decided to extend the 20-year patent and so it can be extended for another five years, and there are also other extensions that can occur during this time. So, with that, the patent owner is also concerned about these generic drug companies and so they’re always looking over their shoulder and looking for where there may be threats to their patent, and so once a patent owner files an action for infringement, in other words, we have the ANDA, we have the certification, it’s published, and then the patent owner has a certain amount of time, within 45 days of receiving notice of the Paragraph IV certification, to file their infringement action. At that point, there’s a 30-month period that protects the patent owner from the harm that could otherwise ensue from the FDA granting marketing approval to the potentially infringing product. 

But that’s really the start of where the race begins, and it’s very important to realize that during this race, what’s going to happen is that there could be other types of generic drug applicants that want to get in on it and they want to get in on it for a very specific reason because if their certification is granted, they get a 180-day exclusivity, which means that they could go to market for their generic product, and in countries like Europe and other countries, this can be worth hundreds of millions of dollars, this exclusivity. So, you’re going to have this 45-day period where the original patent holder will file their response to it, and then everything gets locked down for 30 months, and then there’s a lot of information that has to be exchanged from all the data during the research process, and all these certifications, and so it’s a very compressed time period. 

And what Michael is going to show in these next couple slides is that compressed time period means that you have to have your ducks in order, you have to have robust collection planning, you have to have legal review teams using the latest technology, and trying to digest this patent information that has a lot of terms that can be very difficult to assimilate, and for anybody that’s not familiar with patent litigation. HaystackID has been through a lot of this, so we have a good, solid basis and understanding of this whole process, and a very interesting process that we specifically designed for Hatch-Waxman. 

So, without further ado, I’m going to hand this over to Michael, and he’s going to go through it just to show you some of that compressed timelines and then get into the whole electronic filing process. Michael? 

Michael Sarlo

Thanks for that. Appreciate it. Thank you, Albert. That was a great overview. So, as Albert mentioned, really the timeline and lifecycle of a new drug is incredibly long. Really, the drug discovery itself, finding a compound that may have some clinical efficacy, that can take anywhere from three to six years, and at that same time you’re doing testing and you’re preparing to then file an IND, which is an investigational new drug application, so a lengthy process from an administrative standpoint, and really, as we get toward litigation, the lifecycle of litigation oftentimes begins at year zero, and if an IND is approved, you’ll get into Phase I, II, and III clinical studies. At that point, assuming you’re meeting your target metrics for the IND and the study’s end goals, you can choose to submit an NDA, and that review of an NDA can take quite some time, years often, and at the end of that process, the FDA might come back and say, well, we actually want some more information and wants you to go do this or do that, which is usually pretty devastating for organizations. It really can add on years of timeframe, and if they do accept it, then you’re at a point where it’s approved and you can start to go to market and the marketing process is highly regulated, and there are specific verticals you could market, and actually, marketing would be attended to oftentimes an NDA. 

So, right here alone, we have several different data points that might all be relevant for a Hatch-Waxman matter. On the flip side, a generic manufacturer has a much shorter timeframe, and they’re much less invested from a time standpoint. Typically speaking, they’re looking at a couple of years to develop something, to do some testing, they file an NDA, and then there’s this marketing period where they get 18 to 36 months before the marketplace becomes so crowded just due to so many generics, and at that point, usually, they move on or there’s this big stockpile, and all this is important because as we start to talk about these different applications and abbreviations, it’s important to understand the mechanisms, since most people here are on this presentation for eDiscovery purposes, of how this data is organized, and really, it started out with what’s called the Common Technical Document format, which is really a set of specifications for an application dossier for the registration of medicines designed to be used across Europe, Japan, and the United States. This was the paper format version. So, really, there are many other countries who also would adhere to the modern eCTD Common Technical Document, and really what’s the goal here, is that you can choose to streamline the regulatory approval process for any application so that the application itself can adhere to many different regulatory requirements, and these cost a lot of money, millions of dollars to put these together, millions of dollars to assemble these. You’re talking tens of thousands of pages, and these have a long lifecycle, and on January 1, 2008, actually, there was more of a scanning format for submitting an eCTD to the FDA, and at that point, they actually mandated a certain format, which became the eCTD format for these submissions. 

These are broken up into five different modules, and we’ll get into that, but the prevalence and rise of the eCTD format really began in 2008, and as you can see in the above graphic, on the right here, they became highly prevalent around 2017/2018. That’s really all there is, and that’s because as of 2017, NDAs, the FDA required that they would all be in eCTD format. The same thing for ANDAs, and then also, BLAs, and then INDs in 2018 – that actually got a little bit pushed, but we don’t need to get into that here. What’s important is that all subsequent submissions to these applications, including any amendments, supplements, reports, they need to be in digital format. This is important because a common strategy when you’re trying to… I’m a large pharmaceutical company, I’m trying to get all the value I possibly can out of my invention, this drug, we’ve spent probably millions, hundreds of millions of dollars on going to market, and something that could be making us billions of dollars, is oftentimes to really go through these, more of these NDA like processes for off label uses, for new populations that were outside the original study groups that the drug was approved for, and this is where it becomes incredibly complex, and there’s this concept of exclusivity around new novel treatments relating to use of a previous compound, and this is one of the major components of that of the Hatch-Waxman dance, how big pharma really has found many different mechanisms to extend these patents beyond their term life. 

It’s also important to note that master files, Trial Master Files, these are all of your trial data, human clinical trials, all that stuff actually would get appended to these files, and just in general you think about how fast we’re approving vaccines for coronavirus, you can see why there’s concern, that our system isn’t doing due diligence when you realize that these lifecycles of any normal drug is oftentimes 15 years. Trial Master Files, we commonly handle them the same way as an eCTD package, but there is actually a new format that more international standards are trying to move to, which is the electronic Trial Master File and having more set defined specifications regarding what the structure of that looks like is something that’s going on. 

What an eCTD is, is a collection of files. So, when we think eDiscovery, we often… we do production, let’s say now, in today’s world, it’s usually a Concordance load file, and you get an Opticon and DAT file. The eCTD file, you have to think about it very much in the same way. There’s an XML transform file, think about that more like your DATs, your load files. This is going to basically have all of the metadata. It’s going to contain all the structure of the application. It’s going to have more metadata about folders. It’s also going to track when additions and changes for when documents were removed from any eCTD and this is very important. So, there’s a whole industry that services creating these. It’s very much like where someone in a niche industry and eDiscovery, everything related to drug development from a technology standpoint has very similar functions that almost cross-correlate to eDiscovery. You have your folks who are supporting the scientists as they build out these applications, and one thing is these platforms are calibrated, and they’re calibrated by a third party. It’s very important that timing and timestamps as far as when something was touched, when it was looked at, and when it was deleted, so that metadata can be incredibly important. Outside the context of Hatch-Waxman, thinking about maybe a shareholder lawsuit against some executives at a pharmaceutical company who might have been accused of having access to a failed trial prior to the general public, you see these accusations quite a bit in small pharma companies, and they dump some shares and there’s an investigation, and you can see now why this type of information of who accessed what, when, and when something was added or removed might be important. 

The same thing goes for trial data itself. It’s highly audited, who accessed it, when. That type of data is really highly confidential, even to the company that is conducting the trial. It’s usually a third party that’s handling that, and so all this history is in there, and we have metadata about each module, and you’ll see here on the right-hand side, we have a structure here. 

It looks pretty basic. There are folders, there are files. There are also more stylesheet files, schema files that are similar to XML that will more control the formatting and should be thought of as extended metadata. Likewise, we’re also going to see files and folders, PDFs, Word docs, scientific data, big databases like Tableau, things like that. So, as you start getting into all of the extra stuff that goes with an application, these can become massive, and this is usually something that spans both paper sources and digital sources, so it’s really important to basically work on these to parse them appropriately for eDiscovery purposes. 

It should be something you have a lookout for if you ever see these modules, these little “Ms” in a folder structure that you get from your client; you should stop and say, wait a minute, this looks like it has some structure, what is this, and you’ll see it’s an eCTD, and oftentimes, because of their interlinked nature between what can be a paper file that was just scanned and thrown in a folder, and/or a digital file, and then all of these additions and adds, and these are also something that these filings go back and forth between the regulators and the organization that’s putting through an application. So, they might submit something, they say, okay, we want to see more of this or that, or we want more information here. They add it to the existing eCTD. So, in that way, you can also get a separate revision history that oftentimes wraps around the discourse between the regulator and the drug company. HaystackID deals with these often and is first to market in eDiscovery to have a solution to view, parse, review, and produce eCTDs or files from eCTDs right out of Relativity, and we’d be happy to do a demo for anybody. Just shoot us an email and it’s highly useful and has been really impactful in several large cases for us where we dealt with a lot of NDAs or INDs. 

We’ll say one thing, too, here is it’s important to realize that many different organizations may be a part of this process. 

So, now, here’s a screenshot as well for you. You see a little Relativity tree over here where we break out and parse everything. We also give you full metadata, both for your eDiscovery files, your PDFs, your Word docs, all of that, that may not be contained in the eCTD. So, this is important to note too. You can’t just load this as a load file and then not actually process the data. The data needs to be processed and it needs to be linked at the same time. And here in this application, a really unique feature is your ability to sort, filter, and search based on revisions and changes. So, if we have a case, we’re just interested in the final eCTD that resulted in an approval, we can get right to that, maybe cutting out 50% of the application. If we have a case where we’re interested about the actual approval process and the application process, then we can start to look at that and look at anything that was deleted, anything that was changed – a highly useful tool. 

Right, I’m going to kick it off to my colleague, John Wilson. I probably will jump in and cut him off a few times as well, because that’s what I do, then we’re going to talk more about information governance for these matters that have an incredibly long lifecycle, like legal hold and just preparing to respond to a Paragraph IV notice as more of a large pharmaceutical organization. 

John Wilson

Thanks, Mike. So, as Mike just said, there is a significant timeline involved with these projects, and the other side of the coin is you have a short time fuse for actually responding to requests and doing the appropriate activities. So, those two things are fighting each other because you’ve got this long history of information that you’ve got to deal with, and so, as soon as you receive the Paragraph IV acknowledgment letter, you should definitely have triggered your legal hold process. There are very short timeframes for receiving and acknowledging that letter, as well as the opposing sides have typically 45 days to take action and then decide if they’re going to sue or get involved. 

So, again, short timeframes, a lot of data, and data that spans a lot of different systems because you’re talking about a lot of historical information. The pharmaceutical companies need to be prepared to challenge all their generic manufacturers ahead of the patent expirations, because that is their – if that is their prerogative because waiting until it’s filed, you’re going to have a hard getting it all together in that short order. The INDs, the NDAs, the timelines, again, you have 20 years on the patent and the timelines of when the original work was done when the IND and the NDA were filed can be over 15 years and you’ve got to deal with paper documents, you’ve got to deal with lab notebooks and digital documents across a lot of different spectrums. A lot of the information may not even be documents. A lot of it may be logging data from your clinical trials that’s in a database system, and lab notebooks that are actual physical notebooks and they’re very fragile and you can have hundreds and hundreds of them. So, how do you identify them, find them? Where are they located? Get them all brought into your legal hold. There’s a lot of challenges around that. 

So, be prepared. Preparedness is certainly the key here. Also, because you’re talking about a lot of disparate data types, how do you parse all that properly into a review so that you can actually find the information you need and action your review. So, you’ve got to actually take a lot of preparation, you’ve got to plan out and create a data map. There’s a lot of historical data systems here involved, typically, so you’ve got to really understand your fact timeline in relation with your data maps. So, lab notebooks, how were they kept 15-20 years ago, how are they kept today? Clinical trials, how is that data stored? Is it in a database? Is it in log sheets or is it in a ticker tape that’s been clipped and put into the lab notebooks? Understanding all of those different aspects is why the timeline becomes really important. You’ve got to be able to tie that whole timeline back to all the different data sources at the relevant timeframes. 

So, always assume you’re going to have a mix of paper and digital when you’re dealing in these requests, because so much of the data is so much older and the timelines go far back. It’s really important that you identify who your key players in the drug developments are, the key milestones within the timeline, because your benchmark points through your process, when did you go to clinical trials? When did you file your IND? When did you file your NDA? All of those key milestones are going to be really important because you may have a lot of key people that you may have to deal with that may no longer be around because these things happened 15 years ago, 20 years ago, so understanding who those individuals are, who the inventors are, and what files they may have, how you’re going to track those, how you’re going to get those produced for your requests. 

Also, in a lot of these matters, a smaller pharmaceutical company may have gone out and used five, six, 10 other companies that were supporting distribution or packaging, all sorts of different aspects relative to that pharmaceutical, so how are you going to get the information from those companies. What if they don’t exist anymore? Do you have retention of your own information around it? There are a lot of moving parts. Really, that fact timeline data map becomes really critical to make sure that you’ve addressed all of that. 

Then like the lab notebooks, not only are they, a lot of times, paper, they can be very fragile. You have a lot of information. Sometimes it’s old logs off thermal printers that have been cut out and pasted into the lab notebooks. Sometimes those lab notebooks are on rice paper and very think and fragile, so understanding how those are all going to be handled and that they have to be handled with care, how you’re going to get them, how you’re going to get them all scanned. They can be very challenging to actually scan a lot of that content. 

Michael Sarlo

Let me actually say one thing too is that some organizations will not let those lab notebooks out of their sight. They’re considered the absolute crown jewels, like [hyperbaric states], and big pharmaceutical companies have a strong line and track on this stuff, so they are managing it, so if you’re a third party, you’re a law firm, you’re a vendor, you may be under some heavy constraints as it relates to getting access to those lab notebooks, scanning them or even taking photos. as John said, usually they’re very old. Then actually having to track down, in some cases, people who kept their own notes and these can be dead people with how long these go on for. 

Just something to keep in mind there. Go ahead, John. 

John Wilson

Then the last part is document management systems, pharmaceutical health sciences companies have used document management systems for a long time. A lot of those documents management systems are very dated. Some of them have been updated, but you may have to span five different document management systems, because the information may be across all of them, and understanding how that specific system functions, how you’re going to get the data, how you’re going to correlate the data and load it into a review, they’re very typically non-typical data repositories, very frequently not typically. They are very frequently specialized systems that house all that data. 

So, really just driving home the last point is really the collection planning becomes very critical to support these investigations and you can wind up with all sorts of data types. A lot of them don’t get thought about until too late to properly address, like voicemail and faxes and things of those natures, or items that are in other document management or document control systems within the organization that are more data-driven and become much harder to find your relative sources in a typical review type format. 

Also, backup tapes, do you have to go into archives? Do you have to get into backup tapes for some of the data, because that may be the only place some of it’s stored, or offsite storage facilities like an Iron Mountain or places of that nature where you’ve got to go into a warehouse with 8,000 boxes and find the six boxes for this particular product. How are you going to get those documents? How are you going to get them scanned? How are you going to get them identified when you’ve got a 45-day window and you’ve got 8,000 boxes that you need six of? All of those things have to go into the larger-scale collection plan and data map to help support these investigations. 

Really, the last comment is, keeping in mind, a lot of these investigations are global. You have a company that was doing R&D here in the US and they might have been doing manufacturing in India or Norway or Germany, a lot of different places. They may have been doing clinical trials somewhere else, so you’ve got to take into consideration all these global locations and global access points for all of this data. 

From there, I will turn it back over to Mike and the rest of the team. 

Michael Sarlo

Thanks, John. Really, the name of the game here is don’t get caught unawares. Just have a strong sense of where data is, what relates to drugs that might be expiring. HaystackID with our information governance offering does a lot of work in this domain to help organizations organize all of their fringe data and really building out a data retrieval plan, when we start to get historical documents, like [inaudible] long timelines that we’re preparing for. 

I’m going to kick it off to Vazantha Meyers, Vee for short, who is going to talk about all of the document review magic that we bring to every [support opportunity].

Vazantha Meyers

Thank you, Mike. So, let me set the stage before I go into the next few slides. Mike and Albert and John have described the process, and all of that information from the timeline to the terms that are being used, to what were the goals that were being accomplished, the data sources and the milestones, and the key players have to be conveyed to a team so that they can then take that data and categorize it. 

So, all of what they’ve talked about has to be taught to the team and usually, that’s done through protocols, towards framing sessions, and a protocol that the reviewers can reference in order to make decisions on that document. The other thing that we’re asking reviewers to do is understand the data. What documents are they looking at and what’s in the document? 

So, one of the things that we understand about these particular Hatch-Waxman reviews and pharmaceutical reviews, in general, is that they contain a lot of medical terms and abbreviations that’s difficult for the industry. A lot of the drugs have long names, the protocols have long names, the projects have long names, and in order to efficiently communicate about those drugs, processes, and protocols, internally/externally, medical terms are used, and abbreviations are used across the board, internally and externally. 

One of the things that is important for a reviewer to do, in addition to understanding the process in terms of the goal of the process and the timeline and the key players, is understanding those terms in the documents. They cannot make a coding decision if they don’t understand the words that are coming out of the mouth, to quote a movie phrase. So, they have to understand the words on the paper, and so we want to make sure that that is being taught to the reviewers, and we also want to make sure that we’re being accountable for this timeframe and that we can do this teaching. So, we want to streamline that process. 

One of the ways that we can do that is by a few of the things I’m going to talk about in this next slide. So, one of the things that we do is that we make sure, in addition, is to review the protocol, the bible of the review. This is how the drug was developed, here are the timelines, the key players, the milestones, all of the information you know about the particular process in which the drug was developed. We also want to share with them background information, and that background information will be the terminology, the key phrases, the abbreviations, the project code names, etc. that we know about. A lot of times, that is shared information that comes from the client or the counsel, and it’s given to the reviewer. The other thing that we can do is take that shared resource, we mean the background information that’s available to the review team, and create a library. So, that library is everything that we’ve talked about in terms of terms, abbreviations, protocol names, project names, code names etc, and then we make that available not just on the particular project, but across several reviews for that same client, so it’s a library of terms that the reviewers have access to for every project that they work on for pharmaceutical clients, including these Hatch-Waxman reviews that have very truncated timelines. 

The other thing that we do in terms of making sure that we’re taking advantage of best knowledge is that we create client teams, so the same way that we have taken shared resources and created a library that can go across particular reviews for pharmaceutical clients, we take client teams and have review managers, key reviewers and first-level reviewers who have worked with the client, and we put them on the same – put on projects with the same clients, so that they can take that knowledge that they gained on the first few projects they work on and take that through the last project they work continuously, and they’re building their information, they’re sharing that information, which means team members go across projects, sometimes even with new counsel. And that’s a way of sharing information, sort of the library of review teams, for lack of a better way of phrasing that. 

The other thing that is available is public sources. There are public sources out there that have information about medical terms, abbreviations that’s sort of common in the industry. I will also encourage folks if they’re using that [inaudible] the one thing that we found, and this is true for every single thing that’s listed on this slide, is that these are living organisms, meaning you have background information, you have these libraries, and you have this vested team, but they are always learning new information as they’re going through the documents, and then they’re feeding that information back into the resources, meaning if I have some background information that has protocol names or medical terms or abbreviations and I go through the documents and I learn a few, I want to make sure I’m giving that information back to whoever created that shared resource, so they can update it. The same with the library, if I’m updating the shared resource, I want to make sure I’m updating the library. And the client team – and we’re going to talk about this a little bit later – client teams are always learning more information and they need to share that amongst themselves and also take that into the next review. The same with public resources, if you find that there’s something in that public resources that are lacking, please inform them and build that resource, because it benefits all of us. 

The other thing that happens in terms of a review, and I know you guys are familiar with this in terms of the day-to-day [inaudible] and communication with the review is that reviewers have a lot of questions, or they’re finding information as they go through the documents and we’ve talked about giving that back to those resources, but also we want to make sure that the reviewers are able to ask about that information in real-time. So, we use a chat room, and this is a secure chat room, but it allows the reviewers to ask questions to their whole team in real-time, meaning I have this information, I think this might be an acronym that will affect all of what we’re reviewing, can I get some clarification, can I inform you guys of this information in real-time. Everyone sees it, the QC reviewers, and the project managers, and the team leads can opine on that, they can escalate those questions, and get information back to the team in real-time. It’s really important, especially for fast-moving reviews, that reviewers are able to ask questions and get answers in real-time or give information and validate their understanding in real-time. And so, the chat room allows us to do that. 

And so, now having said that, all the information that’s pertinent that needs to go the library, go these other shared resources, or even to these public resources, it sort of needs to be documented and it needs to be [inaudible] issue logs documentation of anything that we think is impactful to the review. All of the terminology, the medical terms, the validations, the understandings, the clarifications that impact how reviewers categorize documents. We then do categorize that information in the issue log, particular to that review, and then we share that information and update our resources, these living things, these living resources I talked about after that fact. 

So, I’ve talked about… before I get into the next few slides, I’ve talked about these client teams, so one of the things that’s important for all review, but particularly reviews that have this need to understand the background information, is we select the team appropriately. So, I’m going to talk about a little bit about the selection of teams, generally, and then specifically for these particular types of review. 

So, one of the things that we have at HaystackID is we have the ability, we have our proprietary ReviewRight software that gives us the ability to gather a ton of information about reviewers and then match that reviewer to the project that is best suited for them, or at least match the project to the reviewers that are best suited for that. We do this through a qualification process, an identification process, a framing process, and then a ratings and certification process. 

In terms of qualification, we test the reviewers and we give them a 15-part test that goes through – across the review, issue coding, [prevalence review], and what we’re looking for is to see which is the best reviewer, who is going to sit up in this top right quadrant in terms of speed and accuracy and recall, who are the best reviewers technically. That doesn’t tell us if they’re better on this particular project, but it does tell us who has the best skills in terms of a reviewer. So, that’s the first assessment that we make on reviewer. 

The second thing that we’re doing is we’re looking to see what their background qualifications are, so we ask them questions about what reviews they’ve worked on, how many reviews they’ve worked on, what foreign languages do they have, skills in either fluent or reading or native etc, we want to know what practice areas they’ve worked in. Also, what tools they’ve worked on, and in particular what their scientific and their school background. What have they worked on outside of the legal field? We collect all of that information during the onboarding process. We want to be sure that we are selecting reviewers who are suitable for these Hatch-Waxman reviews. This list that I have here – you can see on the slide – we are looking for reviewers, and this is a list in ranking. 

First, we want to see what reviewers – if we’re selecting them for this particular type of review – do you have experience on Hatch-Waxman reviews. Do you have experience with this particular pharmaceutical client? Have you worked on projects with them before and are you familiar with their data, terms, and terminologies that they use in their data and communicating? Do you have experience in this industry? So, maybe you haven’t worked with this client specifically, but have you worked with other pharmaceutical clients similar to the one that we’re staffing for. Do you have patent experience? Do you understand the process, the timeline etc, the terminologies used and even that process? Then lastly, do you have at least a science or a chemistry background? 

A lot of times, reviewers will have all of these or some of these, but this is for me the [inaudible], and this is what we’re looking for and we collect that information during the onboarding process, so that we can match the reviewer to the project at hand when we’re staffing, which is particularly important, because like we talked about earlier, it’s very specific in terms of the terminology, the abbreviations, the processes being used and we’re assessing. We want to make sure that reviewers can look at a document and understand what they’re looking at. 

And then I’m not going to go through this slide in-depth, but we do a background check. Security is also very key. And we have some security information about our environment, so since we’re talking about reviewers, we do a background check. We do a general background check. We look to make sure their license is verified and we do a conflict of interest screening, so we check whether or not they have a conflict of interest-based on the employment information they’ve given us, and we also ask the reviewer to attest that they don’t have a conflict based on the parties of a particular project that we’re working on, and that’s for every project that we work on. 

So, the other goal… and I have five minutes, so I’m going to go pretty fast, so that I won’t hold you guys up. But the overall goal for managed review project is to get through the documents in a timely manner, efficiently, meaning you’re not going to cost the client any unnecessary money, accurately so you won’t make a mistake, and then defensibly so that you’re doing it according to prescribed standards. 

One of the things that we do is we want to optimize the workflow. We want to reduce the review count and then we want to optimize the workflow. Reducing the review count is interesting, when it comes to Hatch-Waxman reviews, because there’s targeted pools, so we’re looking at rich data sets. There’s not a whole lot to call [inaudible], but typically they have, and this is true for a lot of the pharmaceutical projects, they have a higher responsive rate, so their targeted pools, we understand what drug we’re looking at, this isn’t a data dump. And so, we have a higher review rate, a lower cull range, we want to go through the process and make sure that you’re optimizing your workflow. 

So, how do you that? It’s typical for a lot of reviews, so you want to make sure that you’re analyzing your search terms and that you are testing them, and that can be done pre-linear review or pre-analytical review, whichever one you’re using, and then there’s this decision on whether or not to use analytical review or linear review. 

Now, I found that with pharmaceutical clients, it’s a mixed set of data, and that data works well with certain workflows. For instance, spreadsheets and image files don’t really work that well with TAR, so 2.0 or 1.0, so continuous active learning or predictive coding. But the other documents do, like emails and regular Word documents do work well with TAR. What we’ve done for other clients is we’ve split that data set, so we have the data that works well with TAR, it goes through that process and then we pool adaptive data that doesn’t work well with TAR and put it through more of a linear process. The idea is that we’re optimizing the workflow for the data that we have, as opposed to making a decision for the overall project, so we’re being adaptive and that’s what you kind of are going to have to do with the data that we’re getting. We use custom de-duping, we make sure that we are culling out non-responsive documents as we identify them, either by similar documents or filenames, or we know that we have a newsletter that’s coming in and we want to make sure we call that out, even though it wasn’t called out at the search term level. We want to make sure we’re doing single instance review of search term hits, we’re using propagation. Particularly with redaction, most of folks who have been involved with managed review, you know that redaction can slow down the review and increase costs, so we want to make sure that we’re using the methodology available as to reduce that cost and clean up the review, and propagation happens to be one of them, as well as negotiating the use of using example redaction documents. 

Then there’s quality control, which is key for every review that you’re working on. So, I’m going to go through this, again, pretty quickly. We have a gauge analysis, and this is similar to what we’ve talked about in terms of testing reviewers as they come into our system. We test them as they come onto review, and so this allows us to give to the reviewers the same set of documents across the board. We have 10 reviewers; all 10 reviewers are looking at the same 50 documents. Outside counsel is looking at the same 50 documents as with someone in-house that’s managing the review who has been a part of the QC process. They can look at those same documents too. Everyone is coding those documents at the same time, and what that allows us to do is test understanding and instruction. 

We give the documents back [inaudible] for the reviewer and we get information about how well they do in terms of coding the documents and how well we do in terms of instructing them about how to code the documents. The solution to any low score is retraining, rewriting the protocol, or replacing reviewers, etc. So, we want to know that information upfront because it sets us off the right pace, everyone is on the same place with the review, and what that does and how it circles back to these particular reviews is that we’re on a staff timeline and we want to make sure that you’re catching any issues upfront, so it might be like a day that you have to do this gauge analysis, but it saves you so much time and additionals you see down the road because you’re making everyone should be on the same page, and all of the instructions that are given to the team should be given to the team, so it’s a really good [inaudible] go forward. 

We do traditional sampling, and targeted QC for sampling is looking at a percentage of what the reviewers have coded, looking for mistakes, and then the targeted QC would be [inaudible] in the data set and cleaning them up and that should be a typical part of most reviews. 

The other thing that we do, which is a quality control tool is event handlers, so event handlers prevent reviewers from making obvious mistakes. For instance, if I know I have a responsive document and every responsive document has to have a privileged coding or issue coding or a confidentiality coding, the event handler will trigger if the reviewer tries to save that document without making some of the necessary coding. So, if it has to have a responsive coding, the event handler will not let the reviewer save that document until it makes a privileged call or the confidentiality call or issue call. Event handlers are handlers that eliminate mistakes that we have to find later. However, for all of the systems that we can’t control, cleaning up the bottom is really important, so we want to make sure that we’re doing clean-ups and [inaudible] and conformity and consistency searches. One of the tools talked about already, if you know you have a mistake that you found with sampling or someone has told you about a mistake that you are aware of, you want to make sure that you’re going through and finding those mistakes as [inaudible] the data set so that mistake doesn’t exist, we also want to make sure that the documents are coded consistently and that redactions and very important privileged coding is very important, so you can check that in several ways. You can do hashtag searches, you can look for near dupes, and we can look for similar text and similar filenames, to make sure to clean up those documents. 

This has to be proactive and continuous. So, proactive in that you’re making sure that you are aware of mistakes that can happen with the event handlers, you’re looking at making sure everyone is on the same page in terms of the coding, and then you’re continuously looking for mistakes and [inaudible] to process. It has to happen in real-time, because we just don’t have time to clean it up after the review is over. And so, it’s really important on all reviews, it’s particularly important [inaudible] that we process that because we just don’t have the time to go back and fix it later. It’s a truncated timeline. 

With that, I apologize for breezing through these slides, but if you have any questions, please let us know. I will turn this back over to Mike Sarlo. 

Michael Sarlo

Thanks for that, Vee, really appreciate it, and I know all of our clients do as well. We have a question here and thank you all for joining. Here we go. “what is the best way to collect and especially produce the regulatory data? I assume this means the eCTD files, the NDAs, and those things. This has caused some issues in the past with respect to pages and pages of blank sheets when producing these types of documents.” 

First, that would be to understand if there’s an active eCTD management system behind the organization’s firewall or if they’ve used a cloud solution, if it is a newer matter where maybe the whole thing is digital. At that point, you would want to handle it just like any kind of unknown repository. We would test and triage it and get a repeatable outcome as we export data out from and audit it to make sure it’s the way that we think it should be. 

If these are just historical files that are sitting on a CD somewhere, that can be a process where we can scan for blank pages and things like that using some custom scripts based on pixel content or file size and look for those, but I would say that, typically speaking, you’re going to want to go back to whoever gave you the data and understand where it came from and how it was gathered, or bring in an expert company like HaystackID to work with you. 

It doesn’t cost a lot to do this right, but there can be so many systems involved and so many point of handoff, so to speak, from an eCTD becoming relevant to a matter and somebody else makes a call internally to somebody else and yada-yada-yada, it’s important to really audit that process so that you know that you have everything.

Then as far as produce it, it can then be uploaded through our tool in Relativity, where it can be acted on and tested and converted and thrown out like any regular production document. I’ve seen organizations try to produce the entire file. We’ve had them come to us with these types of issues. 

So, once we get the eCTD, handling the production is really easy. 

Any other questions? 

Great, well, thank you all for joining us today. We look forward to having you guys every month. We see a lot of the same names and faces, so we really appreciate the support. I will hand it back to Rob Robinson to close out. Any questions that pop up, please feel free to email us. You have access to these slides. We also post these on our learning section on our website. 

Go ahead, Rob. Thank you, guys. 

Closing

Thank you so much, Mike, we appreciate it. Thank you, John, Vee, and Albert for the excellent information and insight. We also want to thank each of you who took time out of your schedule to attend today. We know how valuable that time is, and we don’t take for granted you sharing it with us, so we appreciate that. 

Additional, we hope you have an opportunity to attend our next monthly webcast, and that’s scheduled for 14 October, Wednesday at 12 p.m. Eastern Time, and that will be on the topic of the Dynamics of Antitrust Investigations, and that presentation, which will be led by Michael, again will include some recent updates on FTC and DOJ practices and procedures regarding Second Requests, so please take the opportunity to attend. You can find a detailed description of that on our website and also register there. 

Again, thank you for attending. Have a great rest of the day and this formally concludes today’s webcast. 


CLICK HERE TO DOWNLOAD THE PRESENTATION SLIDESPage 1 / 45Zoom 100%


Learn More About HaystackID Electronic Common Technical Document (eCTD) SupportPage 1 / 2Zoom 100%


CLICK HERE FOR THE ON-DEMAND PRESENTATION (BrightTalk)

Avatar
Marketing Team

Editor’s Note: On September 16, 2020, HaystackID shared an educational webcast designed to inform and update legal and data discovery professionals on the complexities of eDiscovery support in pharmaceutical industry matters through the lens of the Hatch-Waxman Act. While the full recorded presentation is available for on-demand viewing via the HaystackID website, provided below is a transcript of the presentation as well as a PDF version of the accompanying slides for your review and use.

Hatch-Waxman Matters and eDiscovery: Turbo-Charging Pharma Collections and Reviews

Navigating Hatch-Waxman legislation can be complex and challenging from legal, regulatory, and eDiscovery perspectives. The stakes are high for both brand name and generic pharmaceutical manufacturers as timing and ability to act swiftly in application submissions and responses many times mean the difference between market success or undesired outcomes.

In this presentation, expert eDiscovery technologists and authorities will share information, insight, and proven best practices for planning and supporting time-sensitive pharmaceutical collections and reviews so Hatch-Waxman requirements are your ally and not your adversary on the road to legal and business success.

Webcast Highlights

+ NDA and ANDA Processes Through the Lens of Hatch-Waxman
+ ECTD Filing Format Overview For FDA (NDA/ANDA Submissions)
+ Information Governance and Collections Under Hatch-Waxman
+ Dealing with Proprietary Data Types and Document Management Systems at Life Sciences Companies
+ Streamlining the Understanding of Specific Medical Abbreviations and Terminology
+ Best Practices and Proprietary Technology for Document Review in Pharmaceutical Litigation

Presenting Experts

Michael Sarlo, EnCE, CBE, CCLO, RCA, CCPA – Michael is a Partner and Sr. EVP of eDiscovery and Digital Forensics for HaystackID.

John Wilson, ACE, AME, CBE – As CISO and President of Forensics at HaystackID, John is a certified forensic examiner, licensed private investigator, and infotech veteran with more than two decades of experience.

Albert Barsocchini, Esq. – As Director of Strategic Consulting for NightOwl Global, Albert brings more than 25 years of legal and technology experience in discovery, digital investigations, and compliance.

Vazantha Meyers, Esq. – As VP of Managed Review for HaystackID, Vazantha has extensive experience in advising and helping customers achieve their legal document review objectives.


Presentation Transcript

Introduction

Hello, and I hope you’re having a great week. My name is Rob Robinson. On behalf of the entire team at HaystackID, I’d like to thank you for attending today’s webcast titled Hatch-Waxman Matters and eDiscovery, Turbo-Charging Pharma Collections and Reviews. Today’s webcast is part of HaystackID’s monthly series of educational presentations conducted on the BrightTALK, and designed to ensure listeners are proactively prepared to achieve their computer forensics, eDiscovery, and legal review objectives during investigations and litigation, and our expert presenters for today’s webcast include four of the industry’s foremost subject matter experts and authorities on eDiscovery, all with extensive experience in pharmaceutical matters. 

Our first presenter that I’d like to introduce you to is Michael Sarlo. Michael is a Partner and Senior Executive Vice President of eDiscovery and Digital Forensics for HaystackID. In this role, Michael facilitates all operations related to eDiscovery, digital forensics, and litigation strategy both in the US and abroad for a HaystackID. 

Our second presenter is digital forensics and cybersecurity expert John Wilson. As Chief Information Security Officer and President of Forensics at HaystackID, John’s a certified forensic examiner, licensed private investigator, and information technology veteran of more than two decades of experience working with the US government in both public and private companies. 

Our next presenting expert, Vazantha Meyers serves, as Vice President of Discovery for HaystackID, and Vazantha has extensive experience in advising and helping customers achieve their legal document review objectives. She’s recognized as an expert in all aspects of traditional and technology-assisted review. Additionally, Vazantha graduated from Purdue University and obtained her JD from Valparaiso University School of Law. 

Our final presenting expert is Albert Barsocchini. As Director of Strategic Consulting for NightOwl Global, newly merged with HaystackID, Albert brings more than 25 years of legal and technology experience in discovery, digital investigations, and compliance to his work supporting clients in all things eDiscovery. 

Today’s presentation will be recorded and provided for future viewing and a copy of the presentation materials are available for all attendees, and in fact, you can access those materials directly beneath the presentation viewing window on your screen by selecting the Attachments tab on the far left of the toolbar beneath the viewing window, and also a recorded version of this presentation will be available directly from the HaystackID and BrightTALK network websites upon completion of today’s presentation, and a full transcript will be available via the HaystackID blog. At this time, with no further ado, I’d like to turn the microphone over to our expert presenters, led by Mike Sarlo, for their comments and considerations on the Hatch-Waxman Matters and eDiscovery presentation. Mike? 

Michael Sarlo

Thanks for the introduction, Rob, and thank you all for joining our monthly webinar series. We’re going to be covering a broad array of topics around pharmaceutical litigation in general, the types of data types, in particular around Electronic Common Technical Documents (eCTDs), which we’ll learn more about. We’re going to start out with really looking at Hatch-Waxman as a whole and new drug application and ANDA processes related to Hatch-Waxman. We’re going to get into those eCTDs and why those are important for pharmaceutical-related matters on a global scale. I’m going to start to talk about more information governance and strategies around really building a data map, which is also more of a data map that is a fact map. These matters have very long timelines when you start to look at really just the overall lifecycle of an original patent of a new drug going through a regulatory process, and then actually hitting market and then having that patent expire. We’ll learn more about that, then we’re going to get into some of the nitty-gritties of really how we enhance document reviews at HaystackID for pharmaceutical matters and scientific matters in general, and then finish off with some best practices and just a brief overview of our proprietary testing mechanism and placement platform ReviewRight. 

So, without further ado, I’m going to kick it off to Albert. 

Albert Barsocchini

Thank you very much, Michael. So, I’m going to start off with a 30,000-foot level view of Hatch-Waxman, and I always like to start off with a caveat any time I’m talking about pharma related matters. Pharma is a very complex process, complex laws, and very nuanced, and especially Hatch-Waxman. So, my goal today is really just to give you the basic things you need to know about Hatch-Waxman, and it’s very interesting. In fact, in 1984, generic drugs accounted for 19% of retail prescriptions, and in 2018, they accounted for 90% and that’s because of Hatch-Waxman. In a recent report, the President’s cancer panel found that the US generic drug market saved the US healthcare system an estimated $253 billion overall in 2018, including $10 billion in savings for cancer drugs. So, Hatch-Waxman really has been very important to the generic drug market and to us, in public, for being able to get drugs at an affordable price. 

So, how did Hatch-Waxman start? And it started with a case called Roche v. Bolar. So, Roche made a drug, it was a sleeping pill, Dalmane, I don’t know if anybody’s taken it, I haven’t. Anyway, it was very popular, it made them literally millions and billions of dollars, and so what, and normally they have a certain patent term, and what a generic drug company likes to do is to make a bioequivalent of that, and to do that, they want to try to be timed, so at the termination of a patent, the generic drugs can start marketing their product. So, in this case, Bolar started the research and development before the Roche patent expired, and because of that, they were per se infringing on the Roche patent, and so a lawsuit pursued and Bolar lost. 

Now, a couple of terms that I think are important, and I’m going to throw them out now just because there are so many nuanced pharma terms. One is branded biologic, and biosimilar generic, and then there’s branded synthetic, and bioequivalent generic. Now, branded drugs are either synthetic, meaning they’re made from a chemical process or biological, meaning they’re made from a living source. We’re going to be talking today about synthetics and what is important is that synthetic branded drugs can be exactly replicated into more affordable generic versions, bioequivalents, but because biologics involve large complex molecules, because they’re talking about living sources, that’s where biosimilar comes in. So, today, we’re going to just focus on the bioequivalents, on synthetic drugs, and just as another point, there was a… in signing the law by President Obama, I think it was around 2010, the Biosimilar Act became law, which is another law very similar to the Hatch-Waxman. So, anyway, because of the Roche case, we came out in 1983 with the Hatch-Waxman Act, and the reason they wanted this was because what was happening is since a generic company could not start to research and development until after a patent expired, this in essence gave the new drug application additional years of patent, and which means millions of more dollars, and so Congress came in, and they thought this wasn’t fair, and so they decided that they were going to allow generic companies to start the research and development process before the patent expired, and this prevented that from happening in terms of giving the original patent holder more years on the patent, and also allowed generics to get on the market quicker and get to the public at cheaper prices, and that’s just trying to strike a balance, and as you can see, between the pharmaceutical formulations, the original patents, and the new generic versions, and so it’s a delicate balance, but they seem to have achieved it because of the fact that generics are now so prevalent in the market. 

And one thing about this act, generic drug companies are not required to conduct their own independent clinical trials to prove safety and efficacy but can instead rely on research of the pioneer pharmaceutical companies, and they can start development before the original patent expires. So, that’s already a headstart because they don’t have to produce their own data, they can rely on the data of the original patent holder, and that allowed this exploration in the patent process for generic drugs. 

So, one of the important areas that is part of this whole act is the so-called “Orange Book”. So, before you can have an abbreviated new drug application, called ANDA, for approving that generic drug, you must first have a new drug application or an NDA. Now the NDA is a pioneering brand name drugs company seeking to manufacture a new drug, and they must prepare, file, and have approved its drug by the FDA. Additionally, as part of this new drug application process, the pioneering drug company submits the information on the new drug safety and efficacy [obtained] from the trials. Now, the NDA applicant must also identify all patents that could reasonably be asserted, if a person not licensed by the owner engaged in the manufacture, use, or sell the drug, and the patents covering approved drugs, or use thereof, are published in what’s called the “Orange Book”. So, a generic company will be going to this “Orange Book”, which is like a pharma bible, to see what patents are in effect, and this helps them target certain patents they want to create a generic version of, so it’s a very important starting point and this process can start while the original patent hasn’t even gone to market. 

And so, you can see things start to heat up pretty early, and one of the things that we notice in this whole process is that when a patent is filed, the clock ticks on the patent, and so it may be another six years before that patent goes to market, and so because of that, there is a… it can be very unfair, and so there’s a lot of extensions that occur for the patent holder. 

Now, what happens in this particular situation with an ANDA is that we’re going to have a Paragraph IV certification, and briefly, in making a Paragraph IV certification, the generic drugmaker says the patent is at least one of the following. It’s either invalid, not infringed, or unenforceable, and that’s really the Reader’s Digest version on their Paragraph IV certification after the story gets much more complicated and adversarial, and that’s why I always give the warning that this is a very complex dance that’s occurring with Hatch-Waxman, but ANDA really is a very, I would say, important piece of this whole puzzle, and once the ANDA information is put together, it’s filed by what’s called the Electronic Common Technical Document, eCTD, and it’s a standard format for submitting application amendments, supplements, and reports and we’re going to talk about this a little later on in the presentation. Very similar to electronic court filings, but there’s a lot more to it, but it is something that is part of the process when you start the whole process. 

Now the patent owner, their patents and a pharma patent is good for about 20 years after the drug’s invention, and the Hatch-Waxman Act gave patent extensions to name-brand drug companies to account for delays in the approval process, and that is taken into the fact that, as pointed out earlier, that when the patent is filed, research is still in development, and it may be another six years, so realizing that, they decided to extend the 20-year patent and so it can be extended for another five years, and there are also other extensions that can occur during this time. So, with that, the patent owner is also concerned about these generic drug companies and so they’re always looking over their shoulder and looking for where there may be threats to their patent, and so once a patent owner files an action for infringement, in other words, we have the ANDA, we have the certification, it’s published, and then the patent owner has a certain amount of time, within 45 days of receiving notice of the Paragraph IV certification, to file their infringement action. At that point, there’s a 30-month period that protects the patent owner from the harm that could otherwise ensue from the FDA granting marketing approval to the potentially infringing product. 

But that’s really the start of where the race begins, and it’s very important to realize that during this race, what’s going to happen is that there could be other types of generic drug applicants that want to get in on it and they want to get in on it for a very specific reason because if their certification is granted, they get a 180-day exclusivity, which means that they could go to market for their generic product, and in countries like Europe and other countries, this can be worth hundreds of millions of dollars, this exclusivity. So, you’re going to have this 45-day period where the original patent holder will file their response to it, and then everything gets locked down for 30 months, and then there’s a lot of information that has to be exchanged from all the data during the research process, and all these certifications, and so it’s a very compressed time period. 

And what Michael is going to show in these next couple slides is that compressed time period means that you have to have your ducks in order, you have to have robust collection planning, you have to have legal review teams using the latest technology, and trying to digest this patent information that has a lot of terms that can be very difficult to assimilate, and for anybody that’s not familiar with patent litigation. HaystackID has been through a lot of this, so we have a good, solid basis and understanding of this whole process, and a very interesting process that we specifically designed for Hatch-Waxman. 

So, without further ado, I’m going to hand this over to Michael, and he’s going to go through it just to show you some of that compressed timelines and then get into the whole electronic filing process. Michael? 

Michael Sarlo

Thanks for that. Appreciate it. Thank you, Albert. That was a great overview. So, as Albert mentioned, really the timeline and lifecycle of a new drug is incredibly long. Really, the drug discovery itself, finding a compound that may have some clinical efficacy, that can take anywhere from three to six years, and at that same time you’re doing testing and you’re preparing to then file an IND, which is an investigational new drug application, so a lengthy process from an administrative standpoint, and really, as we get toward litigation, the lifecycle of litigation oftentimes begins at year zero, and if an IND is approved, you’ll get into Phase I, II, and III clinical studies. At that point, assuming you’re meeting your target metrics for the IND and the study’s end goals, you can choose to submit an NDA, and that review of an NDA can take quite some time, years often, and at the end of that process, the FDA might come back and say, well, we actually want some more information and wants you to go do this or do that, which is usually pretty devastating for organizations. It really can add on years of timeframe, and if they do accept it, then you’re at a point where it’s approved and you can start to go to market and the marketing process is highly regulated, and there are specific verticals you could market, and actually, marketing would be attended to oftentimes an NDA. 

So, right here alone, we have several different data points that might all be relevant for a Hatch-Waxman matter. On the flip side, a generic manufacturer has a much shorter timeframe, and they’re much less invested from a time standpoint. Typically speaking, they’re looking at a couple of years to develop something, to do some testing, they file an NDA, and then there’s this marketing period where they get 18 to 36 months before the marketplace becomes so crowded just due to so many generics, and at that point, usually, they move on or there’s this big stockpile, and all this is important because as we start to talk about these different applications and abbreviations, it’s important to understand the mechanisms, since most people here are on this presentation for eDiscovery purposes, of how this data is organized, and really, it started out with what’s called the Common Technical Document format, which is really a set of specifications for an application dossier for the registration of medicines designed to be used across Europe, Japan, and the United States. This was the paper format version. So, really, there are many other countries who also would adhere to the modern eCTD Common Technical Document, and really what’s the goal here, is that you can choose to streamline the regulatory approval process for any application so that the application itself can adhere to many different regulatory requirements, and these cost a lot of money, millions of dollars to put these together, millions of dollars to assemble these. You’re talking tens of thousands of pages, and these have a long lifecycle, and on January 1, 2008, actually, there was more of a scanning format for submitting an eCTD to the FDA, and at that point, they actually mandated a certain format, which became the eCTD format for these submissions. 

These are broken up into five different modules, and we’ll get into that, but the prevalence and rise of the eCTD format really began in 2008, and as you can see in the above graphic, on the right here, they became highly prevalent around 2017/2018. That’s really all there is, and that’s because as of 2017, NDAs, the FDA required that they would all be in eCTD format. The same thing for ANDAs, and then also, BLAs, and then INDs in 2018 – that actually got a little bit pushed, but we don’t need to get into that here. What’s important is that all subsequent submissions to these applications, including any amendments, supplements, reports, they need to be in digital format. This is important because a common strategy when you’re trying to… I’m a large pharmaceutical company, I’m trying to get all the value I possibly can out of my invention, this drug, we’ve spent probably millions, hundreds of millions of dollars on going to market, and something that could be making us billions of dollars, is oftentimes to really go through these, more of these NDA like processes for off label uses, for new populations that were outside the original study groups that the drug was approved for, and this is where it becomes incredibly complex, and there’s this concept of exclusivity around new novel treatments relating to use of a previous compound, and this is one of the major components of that of the Hatch-Waxman dance, how big pharma really has found many different mechanisms to extend these patents beyond their term life. 

It’s also important to note that master files, Trial Master Files, these are all of your trial data, human clinical trials, all that stuff actually would get appended to these files, and just in general you think about how fast we’re approving vaccines for coronavirus, you can see why there’s concern, that our system isn’t doing due diligence when you realize that these lifecycles of any normal drug is oftentimes 15 years. Trial Master Files, we commonly handle them the same way as an eCTD package, but there is actually a new format that more international standards are trying to move to, which is the electronic Trial Master File and having more set defined specifications regarding what the structure of that looks like is something that’s going on. 

What an eCTD is, is a collection of files. So, when we think eDiscovery, we often… we do production, let’s say now, in today’s world, it’s usually a Concordance load file, and you get an Opticon and DAT file. The eCTD file, you have to think about it very much in the same way. There’s an XML transform file, think about that more like your DATs, your load files. This is going to basically have all of the metadata. It’s going to contain all the structure of the application. It’s going to have more metadata about folders. It’s also going to track when additions and changes for when documents were removed from any eCTD and this is very important. So, there’s a whole industry that services creating these. It’s very much like where someone in a niche industry and eDiscovery, everything related to drug development from a technology standpoint has very similar functions that almost cross-correlate to eDiscovery. You have your folks who are supporting the scientists as they build out these applications, and one thing is these platforms are calibrated, and they’re calibrated by a third party. It’s very important that timing and timestamps as far as when something was touched, when it was looked at, and when it was deleted, so that metadata can be incredibly important. Outside the context of Hatch-Waxman, thinking about maybe a shareholder lawsuit against some executives at a pharmaceutical company who might have been accused of having access to a failed trial prior to the general public, you see these accusations quite a bit in small pharma companies, and they dump some shares and there’s an investigation, and you can see now why this type of information of who accessed what, when, and when something was added or removed might be important. 

The same thing goes for trial data itself. It’s highly audited, who accessed it, when. That type of data is really highly confidential, even to the company that is conducting the trial. It’s usually a third party that’s handling that, and so all this history is in there, and we have metadata about each module, and you’ll see here on the right-hand side, we have a structure here. 

It looks pretty basic. There are folders, there are files. There are also more stylesheet files, schema files that are similar to XML that will more control the formatting and should be thought of as extended metadata. Likewise, we’re also going to see files and folders, PDFs, Word docs, scientific data, big databases like Tableau, things like that. So, as you start getting into all of the extra stuff that goes with an application, these can become massive, and this is usually something that spans both paper sources and digital sources, so it’s really important to basically work on these to parse them appropriately for eDiscovery purposes. 

It should be something you have a lookout for if you ever see these modules, these little “Ms” in a folder structure that you get from your client; you should stop and say, wait a minute, this looks like it has some structure, what is this, and you’ll see it’s an eCTD, and oftentimes, because of their interlinked nature between what can be a paper file that was just scanned and thrown in a folder, and/or a digital file, and then all of these additions and adds, and these are also something that these filings go back and forth between the regulators and the organization that’s putting through an application. So, they might submit something, they say, okay, we want to see more of this or that, or we want more information here. They add it to the existing eCTD. So, in that way, you can also get a separate revision history that oftentimes wraps around the discourse between the regulator and the drug company. HaystackID deals with these often and is first to market in eDiscovery to have a solution to view, parse, review, and produce eCTDs or files from eCTDs right out of Relativity, and we’d be happy to do a demo for anybody. Just shoot us an email and it’s highly useful and has been really impactful in several large cases for us where we dealt with a lot of NDAs or INDs. 

We’ll say one thing, too, here is it’s important to realize that many different organizations may be a part of this process. 

So, now, here’s a screenshot as well for you. You see a little Relativity tree over here where we break out and parse everything. We also give you full metadata, both for your eDiscovery files, your PDFs, your Word docs, all of that, that may not be contained in the eCTD. So, this is important to note too. You can’t just load this as a load file and then not actually process the data. The data needs to be processed and it needs to be linked at the same time. And here in this application, a really unique feature is your ability to sort, filter, and search based on revisions and changes. So, if we have a case, we’re just interested in the final eCTD that resulted in an approval, we can get right to that, maybe cutting out 50% of the application. If we have a case where we’re interested about the actual approval process and the application process, then we can start to look at that and look at anything that was deleted, anything that was changed – a highly useful tool. 

Right, I’m going to kick it off to my colleague, John Wilson. I probably will jump in and cut him off a few times as well, because that’s what I do, then we’re going to talk more about information governance for these matters that have an incredibly long lifecycle, like legal hold and just preparing to respond to a Paragraph IV notice as more of a large pharmaceutical organization. 

John Wilson

Thanks, Mike. So, as Mike just said, there is a significant timeline involved with these projects, and the other side of the coin is you have a short time fuse for actually responding to requests and doing the appropriate activities. So, those two things are fighting each other because you’ve got this long history of information that you’ve got to deal with, and so, as soon as you receive the Paragraph IV acknowledgment letter, you should definitely have triggered your legal hold process. There are very short timeframes for receiving and acknowledging that letter, as well as the opposing sides have typically 45 days to take action and then decide if they’re going to sue or get involved. 

So, again, short timeframes, a lot of data, and data that spans a lot of different systems because you’re talking about a lot of historical information. The pharmaceutical companies need to be prepared to challenge all their generic manufacturers ahead of the patent expirations, because that is their – if that is their prerogative because waiting until it’s filed, you’re going to have a hard getting it all together in that short order. The INDs, the NDAs, the timelines, again, you have 20 years on the patent and the timelines of when the original work was done when the IND and the NDA were filed can be over 15 years and you’ve got to deal with paper documents, you’ve got to deal with lab notebooks and digital documents across a lot of different spectrums. A lot of the information may not even be documents. A lot of it may be logging data from your clinical trials that’s in a database system, and lab notebooks that are actual physical notebooks and they’re very fragile and you can have hundreds and hundreds of them. So, how do you identify them, find them? Where are they located? Get them all brought into your legal hold. There’s a lot of challenges around that. 

So, be prepared. Preparedness is certainly the key here. Also, because you’re talking about a lot of disparate data types, how do you parse all that properly into a review so that you can actually find the information you need and action your review. So, you’ve got to actually take a lot of preparation, you’ve got to plan out and create a data map. There’s a lot of historical data systems here involved, typically, so you’ve got to really understand your fact timeline in relation with your data maps. So, lab notebooks, how were they kept 15-20 years ago, how are they kept today? Clinical trials, how is that data stored? Is it in a database? Is it in log sheets or is it in a ticker tape that’s been clipped and put into the lab notebooks? Understanding all of those different aspects is why the timeline becomes really important. You’ve got to be able to tie that whole timeline back to all the different data sources at the relevant timeframes. 

So, always assume you’re going to have a mix of paper and digital when you’re dealing in these requests, because so much of the data is so much older and the timelines go far back. It’s really important that you identify who your key players in the drug developments are, the key milestones within the timeline, because your benchmark points through your process, when did you go to clinical trials? When did you file your IND? When did you file your NDA? All of those key milestones are going to be really important because you may have a lot of key people that you may have to deal with that may no longer be around because these things happened 15 years ago, 20 years ago, so understanding who those individuals are, who the inventors are, and what files they may have, how you’re going to track those, how you’re going to get those produced for your requests. 

Also, in a lot of these matters, a smaller pharmaceutical company may have gone out and used five, six, 10 other companies that were supporting distribution or packaging, all sorts of different aspects relative to that pharmaceutical, so how are you going to get the information from those companies. What if they don’t exist anymore? Do you have retention of your own information around it? There are a lot of moving parts. Really, that fact timeline data map becomes really critical to make sure that you’ve addressed all of that. 

Then like the lab notebooks, not only are they, a lot of times, paper, they can be very fragile. You have a lot of information. Sometimes it’s old logs off thermal printers that have been cut out and pasted into the lab notebooks. Sometimes those lab notebooks are on rice paper and very think and fragile, so understanding how those are all going to be handled and that they have to be handled with care, how you’re going to get them, how you’re going to get them all scanned. They can be very challenging to actually scan a lot of that content. 

Michael Sarlo

Let me actually say one thing too is that some organizations will not let those lab notebooks out of their sight. They’re considered the absolute crown jewels, like [hyperbaric states], and big pharmaceutical companies have a strong line and track on this stuff, so they are managing it, so if you’re a third party, you’re a law firm, you’re a vendor, you may be under some heavy constraints as it relates to getting access to those lab notebooks, scanning them or even taking photos. as John said, usually they’re very old. Then actually having to track down, in some cases, people who kept their own notes and these can be dead people with how long these go on for. 

Just something to keep in mind there. Go ahead, John. 

John Wilson

Then the last part is document management systems, pharmaceutical health sciences companies have used document management systems for a long time. A lot of those documents management systems are very dated. Some of them have been updated, but you may have to span five different document management systems, because the information may be across all of them, and understanding how that specific system functions, how you’re going to get the data, how you’re going to correlate the data and load it into a review, they’re very typically non-typical data repositories, very frequently not typically. They are very frequently specialized systems that house all that data. 

So, really just driving home the last point is really the collection planning becomes very critical to support these investigations and you can wind up with all sorts of data types. A lot of them don’t get thought about until too late to properly address, like voicemail and faxes and things of those natures, or items that are in other document management or document control systems within the organization that are more data-driven and become much harder to find your relative sources in a typical review type format. 

Also, backup tapes, do you have to go into archives? Do you have to get into backup tapes for some of the data, because that may be the only place some of it’s stored, or offsite storage facilities like an Iron Mountain or places of that nature where you’ve got to go into a warehouse with 8,000 boxes and find the six boxes for this particular product. How are you going to get those documents? How are you going to get them scanned? How are you going to get them identified when you’ve got a 45-day window and you’ve got 8,000 boxes that you need six of? All of those things have to go into the larger-scale collection plan and data map to help support these investigations. 

Really, the last comment is, keeping in mind, a lot of these investigations are global. You have a company that was doing R&D here in the US and they might have been doing manufacturing in India or Norway or Germany, a lot of different places. They may have been doing clinical trials somewhere else, so you’ve got to take into consideration all these global locations and global access points for all of this data. 

From there, I will turn it back over to Mike and the rest of the team. 

Michael Sarlo

Thanks, John. Really, the name of the game here is don’t get caught unawares. Just have a strong sense of where data is, what relates to drugs that might be expiring. HaystackID with our information governance offering does a lot of work in this domain to help organizations organize all of their fringe data and really building out a data retrieval plan, when we start to get historical documents, like [inaudible] long timelines that we’re preparing for. 

I’m going to kick it off to Vazantha Meyers, Vee for short, who is going to talk about all of the document review magic that we bring to every [support opportunity].

Vazantha Meyers

Thank you, Mike. So, let me set the stage before I go into the next few slides. Mike and Albert and John have described the process, and all of that information from the timeline to the terms that are being used, to what were the goals that were being accomplished, the data sources and the milestones, and the key players have to be conveyed to a team so that they can then take that data and categorize it. 

So, all of what they’ve talked about has to be taught to the team and usually, that’s done through protocols, towards framing sessions, and a protocol that the reviewers can reference in order to make decisions on that document. The other thing that we’re asking reviewers to do is understand the data. What documents are they looking at and what’s in the document? 

So, one of the things that we understand about these particular Hatch-Waxman reviews and pharmaceutical reviews, in general, is that they contain a lot of medical terms and abbreviations that’s difficult for the industry. A lot of the drugs have long names, the protocols have long names, the projects have long names, and in order to efficiently communicate about those drugs, processes, and protocols, internally/externally, medical terms are used, and abbreviations are used across the board, internally and externally. 

One of the things that is important for a reviewer to do, in addition to understanding the process in terms of the goal of the process and the timeline and the key players, is understanding those terms in the documents. They cannot make a coding decision if they don’t understand the words that are coming out of the mouth, to quote a movie phrase. So, they have to understand the words on the paper, and so we want to make sure that that is being taught to the reviewers, and we also want to make sure that we’re being accountable for this timeframe and that we can do this teaching. So, we want to streamline that process. 

One of the ways that we can do that is by a few of the things I’m going to talk about in this next slide. So, one of the things that we do is that we make sure, in addition, is to review the protocol, the bible of the review. This is how the drug was developed, here are the timelines, the key players, the milestones, all of the information you know about the particular process in which the drug was developed. We also want to share with them background information, and that background information will be the terminology, the key phrases, the abbreviations, the project code names, etc. that we know about. A lot of times, that is shared information that comes from the client or the counsel, and it’s given to the reviewer. The other thing that we can do is take that shared resource, we mean the background information that’s available to the review team, and create a library. So, that library is everything that we’ve talked about in terms of terms, abbreviations, protocol names, project names, code names etc, and then we make that available not just on the particular project, but across several reviews for that same client, so it’s a library of terms that the reviewers have access to for every project that they work on for pharmaceutical clients, including these Hatch-Waxman reviews that have very truncated timelines. 

The other thing that we do in terms of making sure that we’re taking advantage of best knowledge is that we create client teams, so the same way that we have taken shared resources and created a library that can go across particular reviews for pharmaceutical clients, we take client teams and have review managers, key reviewers and first-level reviewers who have worked with the client, and we put them on the same – put on projects with the same clients, so that they can take that knowledge that they gained on the first few projects they work on and take that through the last project they work continuously, and they’re building their information, they’re sharing that information, which means team members go across projects, sometimes even with new counsel. And that’s a way of sharing information, sort of the library of review teams, for lack of a better way of phrasing that. 

The other thing that is available is public sources. There are public sources out there that have information about medical terms, abbreviations that’s sort of common in the industry. I will also encourage folks if they’re using that [inaudible] the one thing that we found, and this is true for every single thing that’s listed on this slide, is that these are living organisms, meaning you have background information, you have these libraries, and you have this vested team, but they are always learning new information as they’re going through the documents, and then they’re feeding that information back into the resources, meaning if I have some background information that has protocol names or medical terms or abbreviations and I go through the documents and I learn a few, I want to make sure I’m giving that information back to whoever created that shared resource, so they can update it. The same with the library, if I’m updating the shared resource, I want to make sure I’m updating the library. And the client team – and we’re going to talk about this a little bit later – client teams are always learning more information and they need to share that amongst themselves and also take that into the next review. The same with public resources, if you find that there’s something in that public resources that are lacking, please inform them and build that resource, because it benefits all of us. 

The other thing that happens in terms of a review, and I know you guys are familiar with this in terms of the day-to-day [inaudible] and communication with the review is that reviewers have a lot of questions, or they’re finding information as they go through the documents and we’ve talked about giving that back to those resources, but also we want to make sure that the reviewers are able to ask about that information in real-time. So, we use a chat room, and this is a secure chat room, but it allows the reviewers to ask questions to their whole team in real-time, meaning I have this information, I think this might be an acronym that will affect all of what we’re reviewing, can I get some clarification, can I inform you guys of this information in real-time. Everyone sees it, the QC reviewers, and the project managers, and the team leads can opine on that, they can escalate those questions, and get information back to the team in real-time. It’s really important, especially for fast-moving reviews, that reviewers are able to ask questions and get answers in real-time or give information and validate their understanding in real-time. And so, the chat room allows us to do that. 

And so, now having said that, all the information that’s pertinent that needs to go the library, go these other shared resources, or even to these public resources, it sort of needs to be documented and it needs to be [inaudible] issue logs documentation of anything that we think is impactful to the review. All of the terminology, the medical terms, the validations, the understandings, the clarifications that impact how reviewers categorize documents. We then do categorize that information in the issue log, particular to that review, and then we share that information and update our resources, these living things, these living resources I talked about after that fact. 

So, I’ve talked about… before I get into the next few slides, I’ve talked about these client teams, so one of the things that’s important for all review, but particularly reviews that have this need to understand the background information, is we select the team appropriately. So, I’m going to talk about a little bit about the selection of teams, generally, and then specifically for these particular types of review. 

So, one of the things that we have at HaystackID is we have the ability, we have our proprietary ReviewRight software that gives us the ability to gather a ton of information about reviewers and then match that reviewer to the project that is best suited for them, or at least match the project to the reviewers that are best suited for that. We do this through a qualification process, an identification process, a framing process, and then a ratings and certification process. 

In terms of qualification, we test the reviewers and we give them a 15-part test that goes through – across the review, issue coding, [prevalence review], and what we’re looking for is to see which is the best reviewer, who is going to sit up in this top right quadrant in terms of speed and accuracy and recall, who are the best reviewers technically. That doesn’t tell us if they’re better on this particular project, but it does tell us who has the best skills in terms of a reviewer. So, that’s the first assessment that we make on reviewer. 

The second thing that we’re doing is we’re looking to see what their background qualifications are, so we ask them questions about what reviews they’ve worked on, how many reviews they’ve worked on, what foreign languages do they have, skills in either fluent or reading or native etc, we want to know what practice areas they’ve worked in. Also, what tools they’ve worked on, and in particular what their scientific and their school background. What have they worked on outside of the legal field? We collect all of that information during the onboarding process. We want to be sure that we are selecting reviewers who are suitable for these Hatch-Waxman reviews. This list that I have here – you can see on the slide – we are looking for reviewers, and this is a list in ranking. 

First, we want to see what reviewers – if we’re selecting them for this particular type of review – do you have experience on Hatch-Waxman reviews. Do you have experience with this particular pharmaceutical client? Have you worked on projects with them before and are you familiar with their data, terms, and terminologies that they use in their data and communicating? Do you have experience in this industry? So, maybe you haven’t worked with this client specifically, but have you worked with other pharmaceutical clients similar to the one that we’re staffing for. Do you have patent experience? Do you understand the process, the timeline etc, the terminologies used and even that process? Then lastly, do you have at least a science or a chemistry background? 

A lot of times, reviewers will have all of these or some of these, but this is for me the [inaudible], and this is what we’re looking for and we collect that information during the onboarding process, so that we can match the reviewer to the project at hand when we’re staffing, which is particularly important, because like we talked about earlier, it’s very specific in terms of the terminology, the abbreviations, the processes being used and we’re assessing. We want to make sure that reviewers can look at a document and understand what they’re looking at. 

And then I’m not going to go through this slide in-depth, but we do a background check. Security is also very key. And we have some security information about our environment, so since we’re talking about reviewers, we do a background check. We do a general background check. We look to make sure their license is verified and we do a conflict of interest screening, so we check whether or not they have a conflict of interest-based on the employment information they’ve given us, and we also ask the reviewer to attest that they don’t have a conflict based on the parties of a particular project that we’re working on, and that’s for every project that we work on. 

So, the other goal… and I have five minutes, so I’m going to go pretty fast, so that I won’t hold you guys up. But the overall goal for managed review project is to get through the documents in a timely manner, efficiently, meaning you’re not going to cost the client any unnecessary money, accurately so you won’t make a mistake, and then defensibly so that you’re doing it according to prescribed standards. 

One of the things that we do is we want to optimize the workflow. We want to reduce the review count and then we want to optimize the workflow. Reducing the review count is interesting, when it comes to Hatch-Waxman reviews, because there’s targeted pools, so we’re looking at rich data sets. There’s not a whole lot to call [inaudible], but typically they have, and this is true for a lot of the pharmaceutical projects, they have a higher responsive rate, so their targeted pools, we understand what drug we’re looking at, this isn’t a data dump. And so, we have a higher review rate, a lower cull range, we want to go through the process and make sure that you’re optimizing your workflow. 

So, how do you that? It’s typical for a lot of reviews, so you want to make sure that you’re analyzing your search terms and that you are testing them, and that can be done pre-linear review or pre-analytical review, whichever one you’re using, and then there’s this decision on whether or not to use analytical review or linear review. 

Now, I found that with pharmaceutical clients, it’s a mixed set of data, and that data works well with certain workflows. For instance, spreadsheets and image files don’t really work that well with TAR, so 2.0 or 1.0, so continuous active learning or predictive coding. But the other documents do, like emails and regular Word documents do work well with TAR. What we’ve done for other clients is we’ve split that data set, so we have the data that works well with TAR, it goes through that process and then we pool adaptive data that doesn’t work well with TAR and put it through more of a linear process. The idea is that we’re optimizing the workflow for the data that we have, as opposed to making a decision for the overall project, so we’re being adaptive and that’s what you kind of are going to have to do with the data that we’re getting. We use custom de-duping, we make sure that we are culling out non-responsive documents as we identify them, either by similar documents or filenames, or we know that we have a newsletter that’s coming in and we want to make sure we call that out, even though it wasn’t called out at the search term level. We want to make sure we’re doing single instance review of search term hits, we’re using propagation. Particularly with redaction, most of folks who have been involved with managed review, you know that redaction can slow down the review and increase costs, so we want to make sure that we’re using the methodology available as to reduce that cost and clean up the review, and propagation happens to be one of them, as well as negotiating the use of using example redaction documents. 

Then there’s quality control, which is key for every review that you’re working on. So, I’m going to go through this, again, pretty quickly. We have a gauge analysis, and this is similar to what we’ve talked about in terms of testing reviewers as they come into our system. We test them as they come onto review, and so this allows us to give to the reviewers the same set of documents across the board. We have 10 reviewers; all 10 reviewers are looking at the same 50 documents. Outside counsel is looking at the same 50 documents as with someone in-house that’s managing the review who has been a part of the QC process. They can look at those same documents too. Everyone is coding those documents at the same time, and what that allows us to do is test understanding and instruction. 

We give the documents back [inaudible] for the reviewer and we get information about how well they do in terms of coding the documents and how well we do in terms of instructing them about how to code the documents. The solution to any low score is retraining, rewriting the protocol, or replacing reviewers, etc. So, we want to know that information upfront because it sets us off the right pace, everyone is on the same place with the review, and what that does and how it circles back to these particular reviews is that we’re on a staff timeline and we want to make sure that you’re catching any issues upfront, so it might be like a day that you have to do this gauge analysis, but it saves you so much time and additionals you see down the road because you’re making everyone should be on the same page, and all of the instructions that are given to the team should be given to the team, so it’s a really good [inaudible] go forward. 

We do traditional sampling, and targeted QC for sampling is looking at a percentage of what the reviewers have coded, looking for mistakes, and then the targeted QC would be [inaudible] in the data set and cleaning them up and that should be a typical part of most reviews. 

The other thing that we do, which is a quality control tool is event handlers, so event handlers prevent reviewers from making obvious mistakes. For instance, if I know I have a responsive document and every responsive document has to have a privileged coding or issue coding or a confidentiality coding, the event handler will trigger if the reviewer tries to save that document without making some of the necessary coding. So, if it has to have a responsive coding, the event handler will not let the reviewer save that document until it makes a privileged call or the confidentiality call or issue call. Event handlers are handlers that eliminate mistakes that we have to find later. However, for all of the systems that we can’t control, cleaning up the bottom is really important, so we want to make sure that we’re doing clean-ups and [inaudible] and conformity and consistency searches. One of the tools talked about already, if you know you have a mistake that you found with sampling or someone has told you about a mistake that you are aware of, you want to make sure that you’re going through and finding those mistakes as [inaudible] the data set so that mistake doesn’t exist, we also want to make sure that the documents are coded consistently and that redactions and very important privileged coding is very important, so you can check that in several ways. You can do hashtag searches, you can look for near dupes, and we can look for similar text and similar filenames, to make sure to clean up those documents. 

This has to be proactive and continuous. So, proactive in that you’re making sure that you are aware of mistakes that can happen with the event handlers, you’re looking at making sure everyone is on the same page in terms of the coding, and then you’re continuously looking for mistakes and [inaudible] to process. It has to happen in real-time, because we just don’t have time to clean it up after the review is over. And so, it’s really important on all reviews, it’s particularly important [inaudible] that we process that because we just don’t have the time to go back and fix it later. It’s a truncated timeline. 

With that, I apologize for breezing through these slides, but if you have any questions, please let us know. I will turn this back over to Mike Sarlo. 

Michael Sarlo

Thanks for that, Vee, really appreciate it, and I know all of our clients do as well. We have a question here and thank you all for joining. Here we go. “what is the best way to collect and especially produce the regulatory data? I assume this means the eCTD files, the NDAs, and those things. This has caused some issues in the past with respect to pages and pages of blank sheets when producing these types of documents.” 

First, that would be to understand if there’s an active eCTD management system behind the organization’s firewall or if they’ve used a cloud solution, if it is a newer matter where maybe the whole thing is digital. At that point, you would want to handle it just like any kind of unknown repository. We would test and triage it and get a repeatable outcome as we export data out from and audit it to make sure it’s the way that we think it should be. 

If these are just historical files that are sitting on a CD somewhere, that can be a process where we can scan for blank pages and things like that using some custom scripts based on pixel content or file size and look for those, but I would say that, typically speaking, you’re going to want to go back to whoever gave you the data and understand where it came from and how it was gathered, or bring in an expert company like HaystackID to work with you. 

It doesn’t cost a lot to do this right, but there can be so many systems involved and so many point of handoff, so to speak, from an eCTD becoming relevant to a matter and somebody else makes a call internally to somebody else and yada-yada-yada, it’s important to really audit that process so that you know that you have everything.

Then as far as produce it, it can then be uploaded through our tool in Relativity, where it can be acted on and tested and converted and thrown out like any regular production document. I’ve seen organizations try to produce the entire file. We’ve had them come to us with these types of issues. 

So, once we get the eCTD, handling the production is really easy. 

Any other questions? 

Great, well, thank you all for joining us today. We look forward to having you guys every month. We see a lot of the same names and faces, so we really appreciate the support. I will hand it back to Rob Robinson to close out. Any questions that pop up, please feel free to email us. You have access to these slides. We also post these on our learning section on our website. 

Go ahead, Rob. Thank you, guys. 

Closing

Thank you so much, Mike, we appreciate it. Thank you, John, Vee, and Albert for the excellent information and insight. We also want to thank each of you who took time out of your schedule to attend today. We know how valuable that time is, and we don’t take for granted you sharing it with us, so we appreciate that. 

Additional, we hope you have an opportunity to attend our next monthly webcast, and that’s scheduled for 14 October, Wednesday at 12 p.m. Eastern Time, and that will be on the topic of the Dynamics of Antitrust Investigations, and that presentation, which will be led by Michael, again will include some recent updates on FTC and DOJ practices and procedures regarding Second Requests, so please take the opportunity to attend. You can find a detailed description of that on our website and also register there. 

Again, thank you for attending. Have a great rest of the day and this formally concludes today’s webcast. 


CLICK HERE TO DOWNLOAD THE PRESENTATION SLIDESPage 1 / 45Zoom 100%


Learn More About HaystackID Electronic Common Technical Document (eCTD) SupportPage 1 / 2Zoom 100%


CLICK HERE FOR THE ON-DEMAND PRESENTATION (BrightTalk)

Avatar
Marketing Team

https://haystackid.com/webcast-transcript-hatch-waxman-matters-and-ediscovery-turbo-charging-pharma-collections-and-reviews/

Universally Recognized Principles via Advocatetanmoy Law Library

Global Forensic Science Test 1st Set via Advocatetanmoy Law Library

1- Dying declaration is to be preferably recorded by

(A) Doctor

(B) Police

(C) Magistrate

(D) Jury Member

Answer: (C)

2. Murder cases are tried in the following courts

(A) Chief Judicial Magistrate’s Court

(B) 1st Class Metropolitan Magistrate’s Court

(C) Sessions Court

(D) High Court

Answer: (C)

3. Police inquest is conducted under section

(A) 174 CrPC

(B) 174 IPC

(C) 176 CrPC

(D) 176 IPC

Answer: (A)

4. Assertion (A): Blood stains on cloth should be collected after drying in shade under room heater.

Reason (R): It causes disintegration of blood stains.

(A) Both (A) and (R) are correct.

(B) Both (A) and (R) are incorrect.

(C) (A) is correct, but (R) is incorrect.

(D) (A) is incorrect, but (R) is correct.

Answer: (D)

5. Preservation of footprint on snow can be done by

(A) Plaster of Paris Cast

(B) Sulphur Casting

(C) Tracing

(D) Wax Casting

Answer: (B)

6. Light that has all its waves pulsating in unison is called

(A) Maser

(B) Laser

(C) Monochromatic light

(D) Polychromatic light

Answer: (B)

7. Hollow Cathode Lamp (HCL) is used in the following:

(A) Atomic Absorption Spectrometer

(B) Atomic Emission Spectrometer

(C) Infra Red Spectrometer

(D) X-ray Fluorescence Spectrometer

Answer: (A)

8. Deviations from Beer’s Law fall into which categories?

(A) Real

(B) Instrumental

(C) Chemical

(D) All of the above

Answer: (D)

9. One of the following is not the component of Kastle-Meyer Test

(A) Phenolphthalein

(B) Glacial Acetic Acid

(C) Zinc dust

(D) Potassium Hydroxide

Answer: (B)

10. Confirmation of menstrual blood stain is done by the following method:

(A) Isoenzyme marker

(B) Fibrin Degradation Product (FDP)

(C) Protein Marker

(D) Restriction enzymes

Answer: (B)

11. The complementary base pairs among four nucleotides (A, T, G, C) are as

(A) A= G and T = C

(B) A = C and G = T

(C) A = T and G = C

(D) All of the above

Answer: (C)

12. Seminal fluid is a gelatinous material produced in males by seminal vesicles, prostate and

(A) Adrenal gland

(B) Pituitary gland

(C) Cowper’s gland

(D) Thyroid gland

Answer: (C)

13. The level of toxicity of Datura plant on the basis of increasing level is

(A) Root, Seeds, Fruit, Leaf

(B) Leaf, Root, Fruit, Seeds

(C) Fruit, Root, Seeds, Leaf

(D) Seeds, Leaf, Root, Fruit

Answer: (B)

14. Sodium and Potassium hydroxides are strongly corrosive due towww.netugc.com

(A) Their solvent action on protein material

(B) Their saponifying action on the lipids

(C) Their ability to extract water from the tissues

(D) All of above

Answer: (D)

15. In case of carbon monoxide poisoning which preservative is recommended for the preservation of blood samples

(A) Sodium Chloride

(B) Sodium Fluoride

(C) Sodium Carbonate

(D) No preservative

Answer: (D)

16. Free sulphuric acid is rarely found in stomach contents in acid poisoning cases because

(A) It may be vomited out

(B) May be neutralised by alkalies given as antidotes

(C) May combine chemically with the tissue with which it comes in contact

(D) All the above

Answer: (D)

17. Arrange the following firearms in the proper chronological order:

(i) Flint lock

(ii) Wheel lock

(iii) Match lock

(iv) Percussion cap lock

Codes:

(A) (ii) (iii) (iv) (i)

(B) (iii) (i) (ii) (iv)

(C) (iv) (ii) (i) (iii)

(D) (i) (iv) (iii) (ii)

Answer: (B)

18. The Indian Arms Act was enforced in

(A) 1955

(B) 1959

(C) 1961

(D) 1964

Answer: (B)

19. The bore of the 12 bore gun is

(A) 0.723″

(B) 0.727″

(C) 0.729″

(D) 0.731″

Answer: (C)

21. The diameter of SG pellet in 12 bore gun cartridge is

(A) 8.43 mm

(B) 7.77 mm

(C) 6.83 mm

(D) 5.16 mm

Answer: (A)

22. Faeces stains are identified from odour, presence of indigested matter, vegetable fibres and

(A) Stercobilin

(B) Dark brown crystals of choline iodide

(C) Rhombic crystals

(D) All of the above

Answer: (A)

23. Assertion (A): Hair has paramount importance to establish the link between suspect and victim and linking both with the scene of occurrence.

Reason (R): As per Locards principle of exchange.

Codes:

(A) (A) is correct, but (R) is incorrect.

(B) Both (A) and (R) are incorrect.

(C) (R) is correct, but (A) is incorrect.

(D) Both (A) and (R) are correct.

Answer: (D)

24. The direction of a wound can be ascertained from which of the following injuries:

(A) Chop wound

(B) Contusion

(C) Incised wound

(D) Laceration

Answer: (C)

25. Lanugo hairs are

(A) Pigmented

(B) Thin and soft

(C) Medullated

(D) Scale pattern is complex

Answer: (B)

26. The following method is used for determining the age of an ink by tracking the degradation of certain dyes.

(A) Thin layer chromatography (TLC)

(B) Gas chromatography (GC)

(C) Laser desorption mass spectrometry (LDMS)

(D) High Performance Liquid Chromatography (HPLC)

Answer: (C)

27. LSD is derived from which of the following plant?

(A) Cannabis sp.

(B) Papaver Somniferum

(C) Erthroxylum sp.

(D) Clavicepspurpurea

Answer: (D)

28. Linseed, Safflower and Cottonseed are used for

(A) Paint pigments

(B) Paint oils

(C) Paint solvents

(D) Paint binders

Answer: (B)

29. Assertion (A): As the rhodamine ‘B’ in ballpoint pen ink degrades, it loses the ethyl groups.

Reason (R): The ethyl groups are replaced by hydrogen atoms.

Codes:

(A) Both (A) and (R) are true.

(B) Both (A) and (R) are false.

(C) (A) is true, but (R) is false.

(D) (A) is false, but (R) is true.

Answer: (A)

30. For hardening of plaster of paris cast of foot prints, following substance is added:

(A) Sodium chloride

(B) Sodium carbonate

(C) Talcum powder

(D) Sodium sulphate

Answer: (B)

31. When the temperature of a liquid is raised

(A) Its refractive index increases

(B) Its refractive index decreases

(C) Its refractive index disappears

(D) Its refractive index doesn’t change

Answer: (B)

32. The skid marks on the road in a vehicular accident may give an indication of

(A) Make of the vehicle

(B) Speed of the vehicle

(C) Weight of the vehicle

(D) Height of the vehicle

Answer: (B)

33. Chemical etching is a method for restoration of erased marks on

(A) Wood

(B) Leather

(C) Metal

(D) Plastic

Answer: (C)

34. Scales are found on the following fibre:

(A) Wool

(B) Cotton

(C) Linen

(D) Silk

Answer: (A)

35. Fractures due to heat are

(A) Radial

(B) Spiral

(C) Hackle marks

(D) Wavy

Answer: (D)

36. Which of the following type of abrasions are associated in sexual assault over the thigh of a woman?

(A) Graze

(B) Imprint

(C) Pressure

(D) Scratch

Answer: (D)

37. The chromosome pattern in Turner’s syndrome is

(A) XXY

(B) XO

(C) XXX

(D) XYY

Answer: (B)

38. Cusp of Carabelli is found on

(A) Incisors Central

(B) Canines

(C) Bicuspids

(D) Tricuspids

Answer: (D)www.netugc.com

39. ABO grouping is based on

(A) Red cell surface antigen

(B) Plasma proteins

(C) Red cell enzyme

(D) Nuclear chromatin

Answer: (A)

40. The total number of bones in the human skeleton in an adult is

(A) 208

(B) 308

(C) 408

(D) 508

Answer: (A)

41. In handwriting comparison the crossing in ‘t’ and the dots in ‘i’ and ‘j’ are known as

(A) Connective signs

(B) Diacrytic signs

(C) Loop signs

(D) Shoulder signs

Answer: (D)

42. Which of the following disease affects handwriting?

(A) Chronic Leukaemia

(B) Chronic Malaria

(C) Parkinsonism

(D) Thalassemia

Answer: (C)

43. The following is a sign of forgery:

(A) Retouching

(B) Connecting strokes

(C) Pen lifts

(D) All of the above

Answer: (D)

44.The most suitable solvent system for thin layer chromatography/paper chromatography of inks is

(A) N-butanol: pyridine: water (3: 1: 1.5)

(B) Amyl alcohol: acetic acid: chloroform (6: 1: 2)

(C) Ethanol: Acetone: acetic acid (4: 1: 5)

(D) Amyl alcohol: acetic acid: pyridine (6: 1: 2)

Answer: (A)

45. The following is the most acceptable method for revealing indented writing:

(A) Oblique lighting

(B) Intense lighting

(C) Rubbing with a pencil lead

(D) ESDA

Answer: (D)

46. Cadaveric spasm indicates

(A) Suicide

(B) Homicide

(C) Natural death

(D) Last act of a person before death

Answer: (D)

47. The sequence of post-mortem changes in a cadaver includes

(A) Rigor mortis, primary flaccidity, secondary flaccidity, marbling

(B) Primary flaccidity, secondary flaccidity, rigor mortis, marbling

(C) Marbling, secondary flaccidity, primary flaccidity, rigor mortis

(D) Primary flaccidity, rigor mortis, secondary flaccidity, marbling

Answer: (B)

48. “Taches Noire Scleroitiques” is a post-mortem feature seen in

(A) Eyes

(B) Nostrils

(C) Ears

(D) Mouth

Answer: (A)

49. The following are examples of unnatural sexual offences

(i) Sodomy

(ii) Incest

(iii) Buccal coitus

(iv) Bestiality

Codes:

(A) (i), (ii) and (iii) are correct.

(B) (ii) and (iv) are correct.

(C) (i), (ii) and (iv) are correct.

(D) (i), (iii) and (iv) are correct.

Answer: (D)www.netugc.com

50. The criminal responsibility of a mentally ill person is stated under the following section of Indian law?

(A) CrPC 84

(B) CrPC 80

(C) IPC 84

(D) IPC 80

Answer: (C)

1- Dying declaration is to be preferably recorded by (A) Doctor (B) Police (C) Magistrate (D) Jury Member Answer: (C)

Solved Objective Question(MCQs)-Forensic Science-1st Set — Advocatetanmoy Law Library

Principles of Forensic Science

Sources:A Closer Look On Forensic Science written by Archana Singh

laws.pngLaws and Principles of Forensic Science

Introduction

Forensic Science is the science which has developed its own Laws and Principles. The Laws and Principles of all the natural sciences are the bases of Forensic Science.

Every object, natural or man-made, has an individuality which is not duplicated in any other object.

1. Law of Individuality

Anything and everything involved in a crime, has an individuality. If the same is established, it connects the crime and the criminal.

This principle at first sight appears to be contrary to common beliefs and observations. The grains of sand or common salt, seeds of plants or twins look exactly alike.

2. Principle of exchange

Contact exchange traces is principle of exchange. It was first enunciated by the French scientist, Edmond Locard. Commonly known as Edmond Locard’s maxim on Interchange.

According to the principle, when a criminal or his instruments of crime come in contact with the victim or the objects surrounding him, they leave traces. Likewise, the criminal or his instruments pick up traces from the same contact.

3. Law of progressive change

“Change is inevitable” , this also applies to object. Different types of objects may take different time spans.

The criminal undergoes progressive changes. If he is not apprehended in time, he becomes unrecognizable.

The scene of occurrence undergoes rapid changes. The weather, the vegetable growth, and the living beings make extensive changes in comparatively short periods.

Samples degrade with time, Bodies decompose, tire tracks & bite marks fade, the firearm barrel loosen, metal objects rust, etc.

4. Principle of comparison

“Only the likes can be compared” is the principle of comparison.

It emphasize the necessity of providing like samples and specimens for comparisons with the questioned items.

A questioned hair can only be compared to another hair sample, same with tool marks, bite marks, tire marks, etc.

For example

A specimen obtained by writing on the same wall, at the same height and with the same instrument and then photographed. It can be matched.

Once handwriting available on a photograph allegedly written on a wall was compared with the specimen written on paper. It did not give worthwhile results.

5. Principle of analysis

The Analysis can be no better than the sample analyzed.

Improper sampling and contamination render the best analysis useless.

The principle emphasizes the necessity of correct sampling and correct packing for effective use of experts.

6. Law of probability

All identification, definite or indefinite, are made, consciously or unconsciously, on the basis of probability.

Probability is mostly misunderstood. If we say that according to probability a particular fingerprint has come from the given source, but it is not a definite opinion.

Probability is a mathematical concept. It determines the chances of occurrence of a particular event in a particular way.

If “P” represents probability, “Ns” the number of ways in which the event can successfully occur (with equal facility) and “Nf” the number of ways in which it can fail ( with equal facility) , the probability of success is given by the formula:

7. Law Of Circumstantial Facts

“facts do not lie, men can and do”

Evidences given by eye witnesses or victims may not always be accurate.

Sometimes victims may intentionally lie or sometimes because of poor senses (such as low sight, unclear hearing), exaggeration & assumptions.

According to Karl Marx “True belief only becomes knowledge when backed by some kind of investigation and evidence”.

Watch it🤳, share it ✌and subscribe it 👇 : –

Laws & Principles of Forensic Science

Know More Details of Laws and Principles of Forensic Science; Read

“A Closer Look On Forensic Science”

  • Share
  • 17Comments

 

Forensic Science is the science which has developed its own Laws and Principles. The Laws and Principles of all the natural sciences are the bases of Forensic Science…READ MORE….

via Laws and Principles of Forensic Science — Forensic’s blog

Forensic Expert via The Forensic Science Public Desk, India

Who is an Expert?

I am an expert in doing sketches. How? I am passionate about sketching and drawing since my childhood and still, I practice it. I take a very short time to do any kind of sketch within few minutes compared to the capability of any other common human. Hence, It can be said as he has expertise in the art of sketching and he has knowledge on sketching where he can form an opinion or comment on other work whether it is authentic, truly hard work, commendable work or possibilities and what were the possible ingredients used to make a certain sketch.

So that was an example which gives us a better understanding of who is an expert.

A person who has special knowledge and skill in a particular branch of learning and thus qualified to give his opinion, whereas, an ordinary person is not competent to do so.

Thus, Doctors, artists, engineers, surveyors, engravers, mechanics, artisans, and the diverse classes of specifically skilled workmen would all be experts within the meaning of the expert, of course, each in his walk of life.

How can you be one? 

Crimes are associated with the number of evidence like blood, bullet or a dead body. Identification or classifying any of this would easy due to definite science which is available as the experience of individuals working with a field like serologists, Ballistic experts or Doctors. This particular aspect can be learnt and it can apply to

Section 45 in The Indian Evidence Act, 1872

Opinions of experts.—When the Court has to form an opinion upon a point of foreign law or science or art.

What is foreign law or science or art? Means, Court is represented by personnel’s dealing with law and justice enforced for public welfare. I pursuit of justice there are certain aspects which are also involved like science. Representatives of court, that is judges or law Practitioners are not aware of these particular sciences like serology or physics or medicine nor they can complete the degree in few days nor they can be unethical by justifying anything on their own. They are knowledgeable personnel’s in enacting law and justice for public welfare but not to justify truth hidden within the scientific evidence like nature of injury on the body or striation marks on the bullet.

Hence, the Court needs to rely on expert opinion to understand the significant scientific evidence role of any kind of case dealt with in the court.

Examples

Doctor: As to ascertain the cause of death or time since death

Chemical examiner: identification of a questioned substance by conducting chemical examination which approved by scientific statutory bodies.

Ballistics expert: identification of alleged firearm by comparing test-fired bullet and questioned bullet.

Court believes science-based literature, research held and scientific principles or laws developed during a search of the reality behind happenings of many unknown things to mankind.

Whom will you handover the evidence to?

Just imagine if you are having an Evidence which is a “Document with disputed signature, questioned age of ink in the signature and contents on the questioned document” Whom will you handover the evidence to?

One who has just completed Masters in Forensic Science – has experience practice with demo samples or simulated samples or experience while in internship or project under the supervision of an expert. The court cannot rely on you leaving behind qualified experts but you should be having the capability to convince the court in the science subject matter thus makes you an expert. Anybody one who can prove or involve in the scientific examination of the evidence on the grounds of being intellectual in scientific principles and law which are in current practice by many of the recognized scientists can be referred and can be used to prove the truth hidden with evidence. This can be regarded as the private practice of forensic consultancy.

According to IEA 45, an opinion formed by an expert is based on recognized principles regulating the scientific study. The opinion so formed by a person having the necessary special skill in the subject is, therefore, the opinion of an expert in that branch of the science. Such an opinion is the opinion of an expert in a branch of science which is admissible in evidence under Section 45 of the Indian Evidence Act. (or)

One who has 10 years of experience dealing with similar types of cases as an expert – Similar kind of cases here means, there is plenty of complications involved in dealing with crime evidence. Hence, Experience will be vast and much expertise in nature. Many of the times experts may fail to form an opinion and where by the court will justify such conflict by itself being expert by considering other circumstantial evidence and facts of the case. Under section 73 IEA.

Though Section 73 deals with Comparison of signature, writing or seal with others admitted or proved. It has also relevance with the explanation given for court expertise.

Patna High Court State (Through Cbi) vs S.J. Choudhary on 13 February, 1996

Are there any designated experts recognized by the court?

Yes, Forensic Science Laboratories personnel’s under section 293 says Reports of certain Government scientific experts. Subsection 4 applies to the Government scientific experts, namely:-

(a) any Chemical Examiner or Assistant Chemical Examiner to Government; of Forensic Science Laboratories or Govt. Chemical Examiners Laboratory.

(b) the Chief Inspector of- Explosives; current position is Joint Chief Controller of Explosives (HOD) of Petroleum & Explosives Safety Organization (PESO).

(c) the Director of the Finger Print Bureau; both state level and central level.

(d) the Director, Haffkeine Institute, Bombay; as a bacteriology research Centre called the “Plague Research Laboratory”. It now offers various basic and applied biomedical science services.

(e) Director, Deputy Director or Assistant Director] of a Central Forensic Science Laboratory or a State Forensic Science Laboratory;

(f) the Serologist to the Government. Head of Institute of Serology that is Serologist & Chemical examiner or Assistant serologists.

So these people are regarded as experts in the court officially or they can also appoint assistants working with case actually under subsection 3 of Cr.P.C 293

 

This article will help to understand forensic expertise, the role of an expert in criminal justice system by providing suitable examples accordingly Indian Evidence Act Sections 45 & 73 and also gives a glance on government scientific experts under section 293 of Criminal Procedure Code.

via Forensic Expert — Forensic Science Public Desk, India

Arson Investigation Dogs Can Detect Traces of Gasoline as small as 1 Billionth of a Teaspoon via Crime Scene to Court 

Arson Canine  East  Texas Nina Lab ATF
ATF ADC, Nina
Photo: Mark Moore; Gregg County, Texas Fire Marshal

New research out of the University of Alberta – Canada, finds that dogs can detect gasoline in quantities as small as one billionth of a teaspoon.

Daisy, an accelerant detection canine from Westchester County, New York works with her partner Detective John V. Peters.
Photo: US Fire Administration

Canines have been used in arson investigations for about 30 years, beginning when the US ATF partnered up with the Connecticut State Police in 1986 to train an accelerant detecting canine (ADC) named Mattie.

Mattie was a Labrador Retriever, working for the Connecticut State Police, and she was trained to alert to 17 different ignitable liquids. We all know that Mattie and her kind have an incredible sense of smell, but just how sensitive, is amazing.

Dogs typically have about 200 million receptor cells in their noses that help them identify scents and odors, compared to about 5 million cells in a human nose. Further increasing their sense of smell is an organ located in the roof of their mouths that allows them to basically “taste” a smell.

Mando the Chihuahua
Mando

Just like a human, a dog can smell an odor that comes directly from an item, and like us, they can smell an odor left on a surface after the source of the odor has been removed, the difference is that a dog’s sense of smell eclipses ours, and it even beats electronic equipment designed for hydrocarbon detection.

In fact, man made odor detecting devices detect hydrocarbon components in the neighborhood of parts per million, where dogs an detect amounts as small as .01 micro liters. And if that wasn’t enough to favor the dog, a dog pinpoints the area of the source odor, where a man made instrument cannot.

Lastly, a dog can actually differentiate between true accelerants and similar gases that an instrument cannot do.

K9’s are often used in arson investigation, allowing investigators to locate items and debri that presumptively contains accelerants. These areas shown as “hits” by the dog will be collected, and sent to a lab for scientific analysis.

Click the link below for more info on accelerant detecting K9’s.

 

via Arson Investigation Dogs Can Detect Traces of Gasoline Down to 1 Billionth of a Teaspoon — Crime Scene to Court 

How to Catch a Liar via Brainwave Science

According to Brainwave Science an average person hears about 200 lies every day. It is no surprise as we learn how to lie in our early development stages and by the time we become adults, we get pro at lying! The only catch here is the question, ‘how to catch a liar?’

Technological advancements in different fields of crime scene investigation have drastically changed the landscape. Today, law enforcement can use technology to detect and solve criminal activity happening at the moment. The approach is more proactive than reactive. Forensic Science has completely changed the way crimes are investigated, prosecuted, and adjudicated.

Biometrics work very well to confirm the identity of the person. They are being utilized in ID cards, bank cards, phones, and other technological devices and come in various forms such as fingerprints, irises, voice patterns, and the spatial geometry of the faces, etc. Biometric systems must be able to accommodate changes to the biometric over time which may be caused by aging, illness, or injury.  Let us not forget though that external subject identification via its Automated Biometrics Identification System aims to ensure national security and public safety. It can only, however, identify the person’s identity externally, but not the mind and schemes of the person.

Brain Fingerprinting – This technique is quite ideal for discovering if a piece of information is collected in a person’s brain through EEG. It correctly measures the electric brainwaves science which helps us tap into the person’s familiarity with the crime scene. The major challenge in using this technique is the need for extensive training and the cumbersome nature of software and hardware application needs specialized neuroscientists to administer tests that may not be learned by investigators. It is more of a service-based model where the expert is needed to constantly conduct testing.

iCognative technology is the only available neuroscience-based forensic technology that is over 99.9% accurate, applicable in almost all investigations, is based on proven P300 science, has been used in over 100 real-life cases, and is virtually unbeatable. Today many countries and intelligence agencies in the world are already reaping the benefits afforded by it. To top it all it supports human rights and eliminates torture.

iCognative technology:

  • identifies criminals from innocents, detects presence or absence or information in the brain
  • specifically screens privileged information holders, specific training like IED/EOD bomb-making
  • helps apprehend terrorism and crime supporters and sympathizers
  • helps identify foot soldiers from kingpins in organized crimes
  • successfully detects intent to harm and cause violence

distinguishes between witness and perpetrator

DNA and Fingerprints are the first go-to methods for all investigations. They are accepted as a piece of evidence in the court of law. However, the issue with them is that the crime scene must remain uncorrupted and the collection of evidence must be done properly to eliminate cross-contamination. Preservation of these evidence is also a labor-intensive task that must be conducted by professionals who have been extensively trained in this field.

Lie Detector/Polygraphs are not accepted as evidence but are extensively used by law enforcement agencies to eliminate innocents from the suspects. The accuracy rates of Lie detectors or Polygraph has been hotly debated. People are able to beat them, and the interpretation of results is done subjectively by the examiner. Most psychologists agree that there is little evidence that polygraph tests can accurately detect lies – American psychological Association (APA)

 

Did you know that an average person hears about 200 lies every day? It is no surprise as we learn how to lie in our early development stages and by the time we become adults, we get pro at lying! The only catch here is the question, ‘how to catch a liar?’ Technol

Maggot Analysis with Mass Spectrometry via Locard’s Lab

A new proof-of-concept study by researchers at the University at Albany in New York has developed a mass spectrometry-based technique for the rapid species prediction of blow fly larvae for use in forensic investigations.

Entomological evidence (evidence relating to insects) has proven invaluable to forensic investigations for decades, particularly in the estimation of time since death. Insects which feed on decomposing remains, known as necrophagous insects, will colonise a body in a reasonably predictable pattern, with different insects arriving at different stages throughout the decomposition process. Different species of flies, beetles and mites are commonly encountered. Blow flies in particular will often arrive at the scene within minutes of death to lay eggs on the body. As these eggs hatch, larvae (or maggots) emerge to feed on the decomposing remains. By studying the type and age of insects present at a scene, it may be possible to estimate the time since death, or postmortem interval.

The ability to achieve this hinges on the correct identification of insect species, which is unfortunately not always straightforward. The larvae of different species of blow fly are visually very similar, thus difficult to distinguish by eye. For this reason, maggots are often reared to maturity for species identification, with adult blow flies exhibiting more distinguishing physical differences. Inevitably the rearing of maggots to adulthood is a time-consuming process that requires the expertise of a forensic entomologist.

In recent years, researchers have tried to develop more rapid approaches to insect species identification, particularly using chemical analysis. Researchers at the University at Albany in New York have been applying direct analysis in real time mass spectrometry (DART-MS) to the analysis of insect evidence to provide a rapid species identification tool. In DART-MS, the sample is placed between the DART ion source and the inlet of the mass spectrometer, allowing chemical components in the sample to be ionised and drawn into the MS for direct analysis. DART-MS requires minimal or no sample preparation and results can be obtained almost instantly. Using this technique, Rabi Musah and her team have already demonstrated the ability to determine the species of larvae, pupae and adult flies, highlighting a promising new tool in rapid species identification in forensic entomology.

However, until now this research has focused on the analysis of individual species. In a real-world scenario, maggots present on the body may consist of multiple different species, therefore any techniques developed for rapid species identification of larvae must be able to work with mixed samples. In a recent study, the team have taken the method one step further by examining the potential to identify larvae from mixed species.

Blow flies of various species were collected from Manhattan, New York. Maggots were submerged in 70% ethanol and the solution exposed to the ion source of the DART-MS to produce chemical signatures of both individual species and combinations of species. Mixtures of two, three, four, fix and six different species were analysed. Using the chemical profiles produced, a predictive model was constructed for the subsequent identification of unknown insect samples. Using this model, maggot species could be established with an accuracy of up to 94% and a confidence interval of 80-95%. Individual insect species are readily differentiated, with different species producing distinct chemical profiles. Similarly, mixtures of two different species could also be differentiated. As might be expected, samples containing a higher number of species were more difficult to differentiate.

Although only a proof-of-concept study and further validation is required, the study demonstrates that DART-MS could offer a way of rapidly determining the species of blowfly larvae, thus allowing investigators to establish which insects are present at the scene of a death and work out postmortem interval faster.

 

Beyramysoltan, S. Ventura, M. I. Rosati, J. Y. Giffen, J. E. Musah, R. A. Identification of the Species Constituents of Maggot Populations Feeding on Decomposing Remains—Facilitation of the Determination of Post Mortem Interval and Time Since Tissue Infestation through Application of Machine Learning and Direct Analysis in Real Time-Mass Spectrometry. Analytical Chem, 2020, In Press. 

A new proof-of-concept study by researchers at the University at Albany in New York has developed a mass spectrometry-based technique for the rapid species prediction of blow fly larvae for use in forensic investigations. Entomological evidence (evidence relating to insects) has proven invaluable to forensic investigations for decades, particularly in the estimation of time since […]

via Maggot Analysis with Mass Spectrometry — Locard’s Lab

4 alternative ways to analyze personality via Inspiring enlightened living

“Why am I as I am? To understand that of any person, his whole life, from birth must be reviewed. All of our experiences fuse into our personality. Everything that ever happened to us is an ingredient.” ― Malcolm X, The Autobiography of Malcolm The dawning of a new year brings a fresh opportunity to […]

via 4 alternative ways to analyse personality — Inspiring enlightened living

#Forensics: Contextual bias influences jury outcomes via CSIDDS

When police lab results are weak or ambiguous, juries commonly use non science circumstances to increase its value. https://phys.org/news/2019-10-csi-current-impact-bias-crime.html

via #Forensics: Contextual bias influences and weak forensic testing results leads to jury overestimation of guilt — FORENSICS and LAW in FOCUS @ CSIDDS | News and Trends