Published on Oct 02, 2024
An interview with our newest speaker, Dmitriy Kosarikov, who is speaking on the upcoming ‘Navigating Regulatory Compliance Whilst Developing and Distributing PCR-Based IVD Tests’ happening on the 14th November 2024.
A: Almost by accident, actually. I've been interested in understanding how life works for almost as long as I can remember and naturally got into life sciences as I grew up. That said, I was mostly into physics and chemistry early on. My first master’s degree was in Chemical Physics – yes, there is such a branch in science, and it is different from physical chemistry (every Chemistry undergraduate's worst nightmare!) – but while it was fun, I quickly realized how far removed it was from applied research.
I was also longing for something that would allow me to contribute to bettering human health and so my next Master's was in Biochemistry. That happened after I immigrated to the United States and after I was fortunate to get some experience working in biomedical research at Stanford and a pharmaceutical start-up in Bay Area. I had my eyes set on continuing in pharma, when my graduate school lab mate mentioned that Roche Diagnostics had an R&D facility in the same town my wife and I just moved to for a completely unrelated reason. Back in those days you'd simply walk up to the reception desk, leave a paper copy of your resume and then hope for the best.
Three months later I was about to accept an offer from Bayer Pharmaceutical when Roche called and asked if I cared to come in for an interview. Maybe because I already had that job offer or maybe for other reasons, the interview went well and while Roche's offer was lower, I was too curious about diagnostics (and I could actually walk to work!) so I couldn't resist. The rest – as they say – is history. During the next 20 plus years I grew from a bench scientist to senior manager to senior director and time flew by just like that!
A: Definitely, yes and I wholeheartedly agree with people who say that military service is an "accelerated life schooling”. The inner discipline, the sense of honour, duty and loyalty that are inherent to military service are fully applicable to any industry. They are especially important in the IVD industry because the way we act and the products we make have a profound impact on people's lives. Just think how a result from a diagnostic test could change the treatment for a cancer patient or prevent a viral infection from being transmitted through a blood donation. The stakes are high and teaching how to live in a world of high stakes is what the military service is best at!
I used to shy away from mentioning my military experience because I thought it was "in the wrong army" (the much-feared Soviet Army!)...until one day when I was at the memorial service for a fallen soldier who was a brother of my co-worker at Roche. This was soon after the 9-11 and in conversation with members of his unit who were at the service I mentioned my "wrong army" background and how it was only by accident that I did not end up serving in Afghanistan myself. It was there and then that all of the green berets present stood up, saluted and told me that anyone who ever put on a uniform to honourably serve their country was their soulmate – no matter what army they served in.
A: This may sound a bit odd, but I actually grew fond of working with regulators from all types of national (FDA, Health Canada, TGA, CMDE) and supranational bodies (WHO, BSI) as well as NGOs. Despite popular belief, most of them are anything but a bunch of bureaucrats scheming to make industry's life miserable. Sure, they have to follow the rules and navigate complicated procedures for review, registration and post-approval oversight mandated by the law of the land they operate in. Sure, they may get confused and/or have strong opinions at times...because they are humans – just like us in the industry. At the end of the day though, it is about understanding the incentives and the dialogue. There is nothing wrong with regulators acting as guardians of public health and public interests, just like there is nothing wrong with industry's desire to deliver and maintain new product for profit. Achieving the balance between those two is what we all strive for!
A: I'd be hard pressed to choose between two and therefore will mention both. In 2009, I was fortunate to be part of the team that developed and launched the first PCR-based HPV tests which achieved the primary screening claim for cervical cancer a few years later. It was quite a journey and actually just a beginning of a fundamental paradigm shift in cervical cancer screening which continues to this day. What we launched back may ultimately lead to making the third most common cancer in women to become almost an extreme rarity. There is still much to be done before we get there, but having something to do with making it possible will be one of my fondest memories. I would be remiss if I didn't mention serving as a product development lead for that very first high throughput PCR test for SARS-CoV-2 in 2020. We made an impossible happen by compressing a typical 18-months product development cycle into mere 37 days and it was all for a cause – those test kits were literally flying off the production line to testing labs and the difference it made in people's lives was palpable. There will be books written and deeper research done on how we (as a collective human "We") handled the pandemic, whether or not the testing was excessive and/or restrictions were appropriate...But to me personally, it is the very fact that when all the chips were down, we could still turn on a dime and make the needed tools available in record time that made it all worth the efforts.
A: It was actually much longer than most folks realize, and I was fortunate enough to see it almost from the start. A little-known fact is that Roche had been supplying the very first non-commercial line-blot PCR-based assay for HPV genotyping to academic researchers in the field for quite a while in late 19th and early 20th century. Then, there was the first commercial PCR assay for HPV based on an antiquated endpoint microwell plate technology which was met by rather cold reception by KOLs and regulators worldwide. Those were disappointing and tough times, but also the great lessons and if it weren't for the perseverance of some great scientists and business leaders at Rocher, the first medically and commercially successful PCR test for HPV may not have been developed for many more years (and just as likely – not by Roche) . I can't take credit for any of the decisions that ultimately triggered the development of that first successful HPV test, but I was lucky to be part of the team that actually made it happen. What was even more remarkable -–we did it in just over 2 years while also developing an entire platform (instruments, software, generic reagents) which is amazingly is still in use around the world.
A: I truly believe that the greatest achievement of that crazy period was not the product itself, but the collaboration and the confluence of human spirit. It went beyond the walls of Roche and I witnessed some amazing examples of selflessness on the parts of all stakeholders including some of the bitterest rivals. I remember the FDA asking us daily about the progress on test development and asking how they could help – almost to the point where it felt like too much pressure. That was until one of particularly challenging days when it looked like no airline was willing to fly a vial of inactivated virus from our lab in US to our BSL-3 facility in Switzerland for testing that we had to do. I half-jokingly asked if perhaps the US military would be up for the task. Next thing I knew - we got a word from the agency that the CO of the local military base was on standby to get instructions from us. The vial was at the airline shipping warehouse by that time and ultimately got to where we needed it to go on a cargo plane, but the memory stuck in my mind. I also remember talking to the fellow representatives of the rival diagnostics company and agreeing that for the sake of making as many collection devices as possible available to everyone, we'd share the results of our explorations into the stability of the virus in different solutions instead of making each and every one repeat the studies in our own labs.
A: I'm looking forward to sharing my expertise and everything I learned about IVD product development, registration and post-market support with the wider industry community, startups, regulators and educational institutions like IPI. This is why I started D&L Consulting, Education and Services LLC – a new consulting firm specializing in molecular diagnostics, medical devices and all things IVD. It is dedicated to providing expert guidance and operational solutions tailored to meet the evolving needs of the medical diagnostics industry. Whether you are a startup navigating complex regulatory pathways or an established company seeking advice on your product portfolio and R&D structure, D&L Consulting, Education and Services LLC will be there to support you every step of the way.
A: This course is designed to equip participants with comprehensive knowledge and practical insights into navigating the regulatory and quality landscapes in the United States (US) and the European Union (EU) specifically tailored for PCR-based diagnostic tests. Participants will delve into the intricacies of regulatory frameworks governing PCR-based diagnostic tests in both regions, including but not limited to:
The course will also address quality management systems essential for compliance with regulatory standards, such as ISO 13485 and Good Manufacturing Practice (GMP) guidelines. Regulatory expectations for quality control, risk management, cybersecurity and documentation will be covered to ensure participants gain a holistic understanding of designing, verifying and validating PCR-based tests for quality and regulatory compliance throughout the product lifecycle.
Published on Oct 02, 2024 by Ella Thomas