Mario Rocci’s new book, “Regulated Bioanalysis: Fundamentals and Practice,” places the foundation of bioanalytical science in the context of its current practice, its challenges, and ongoing developments.
In collaboration with leaders at Pfizer, Roche, Merck, Bristol-Myers Squibb, GlaxoSmithKline, and other contract laboratories, this first-of-its-kind book, confronts the sweeping changes ahead for bioanalytical laboratories in clinical development and outlines a framework that is intended to guide the next generation of scientists in this field to success.
Rocci is a former president of the American Association of Pharmaceutical Scientists and the American Society for Clinical Pharmacology & Therapeutics. He is a thought leader in ICON’s bioanalytical sciences practice and the broader global pharmaceutical sciences community.
Q: What challenges are bioanalytical laboratories facing today, specifically with regard to their role in drug development?
A. There are many ongoing challenges and shifting trends that are being embraced in today’s bioanalytical laboratories. As with most facets of drug development, there is considerable pressure to significantly reduce the costs associated with bringing a new drug to market. This can be difficult in a regulated, scientific setting given the need to maintain the highest quality standards.
Another concern for bioanalytical laboratories is the progression of using “wet biomarkers” as measures of drug efficacy during drug development. Now labs are facing the challenge of how to measure very low concentrations of endogenous compounds for which there may not be a reference standard available.
Moreover, in the area of immunogenicity testing, regulators in certain instances are requiring the use of neutralising antibody assessments that are cell-based, which can be less robust, more expensive and time-consuming to employ when compared to their plate-based counterparts.
Additionally, as mass spectrometry technology advances, using LC/MS versus conventional ligand binding assays (LBAs) to measure select proteins has increased.
Q: How must bioanalytical laboratories evolve to cope with these challenges?
A. The field’s future is changing in many ways, and my co-authors in this book are all on the cutting-edge of these changes. At a macro level, the lab must help contain the rising cost of drug development. That means delivering smarter data faster so that development decisions can be made at earlier points in time, thereby generating greater value.
For example, bioanalytical laboratories are beginning to introduce a higher degree of automated laboratory instrumentation interfaced to flexible LIMS systems, thereby enabling laboratory staff to accomplish more at a reduced cost. They are also continually examining emerging technologies for more efficient ways of operating.
To solve challenges associated with the measurement of low-level endogenous biomarkers, bioanalytical laboratories are evaluating many new platforms including some that use “single molecule detection.” In the near future, this will provide a technological runway for ultra-sensitive analysis. Furthermore, the qualification and use of reference material will continue to evolve through scientific meetings, published white papers, good scientific practice and regulatory guidance related to the appropriate validation and use of biomarker assays.
Despite the drawbacks that can be associated with the use of cell-based neutralising antibody assessments, many bioanalytical groups are gearing up their laboratories to meet the increasing regulatory requirement for such assays, while performing plate-based neutralizing antibody assessments whenever they can be justified.
Finally, the use of LC/MS to support the bioanalysis of protein therapeutics is growing substantially based on its prevalence in journal publications and presentations at scientific conferences. Many companies are using LC/MS whenever possible during a compound’s early phase development. We see this trend continuing, and while it is hard to imagine that LC/MS will supplant LBAs in the future, it will be a technology of choice for the bioanalysis of proteins.
Q: How does your book guide sponsors and laboratories through these shifts in bioanalysis during clinical development?
A. To my knowledge, there is no other book that provides the fundamental science and best practices underpinning small and large molecule bioanalysis, along with the roots and evolution of regulatory guidance of the field. While a myriad of journal publications exists, the information is scattered widely, and until now, a single resource that complied all the basic information required did not exist.
Furthermore, there are no focused programs of study at the college/university level in regulated bioanalysis, so newly minted graduates need to “find their way” into the field.
Our text discusses the origins of bioanalysis, the regulations that govern it, and the elements of good science required to perform this work. Also, the book discusses the often-untaught nuances of assays – for example, how to efficiently surmount the potential problems one may encounter with so many ELISA formats.
We also discuss new and future technology platforms, and the challenges associated with some of them. The book shares insights missing from current literature that can help laboratories as they expand to meet growing demands.
Q: How is ICON evolving its bioanalytical laboratories to meet future needs?
In the last five years, we’ve seen explosive growth as sponsors shift work from in-house laboratories to CROs such as ICON. We’ve recently doubled capacity to meet the future needs of sponsors and added new technologies that are highly automated, including the Gyrolab™ platform for supporting pharmacokinetic assessments of protein therapeutics.
In fact, we believe we were the first laboratory to be audited by the FDA in a pre-approval inspection for a biosimilar that employed this technology. This year we’re looking at single-molecule detection technologies such as the Singulex® SMC and the Quanterix™ Samoa.
Q: What do you see as the future of bioanalytical laboratories over the next 5 to 10 years?
A. The next 5-10 years will be an exciting time for the regulated bioanalysis field. On the journey towards more sensitive and specific bioanalytical platforms, we will witness continued automation of our laboratories, as well as further improvements in instrumental technology. Advancing the ability to measure and use biomarkers will be a major driver in paving the way toward a precision medicine approach to therapeutics.
It is our hope that this book will help those in our discipline embrace this exciting future!
Thanks, Mario, for your time.
Read a preview of Rocci’s book on the publisher’s website. To talk with Mario Rocci and ICON’s Bioanalysis Laboratory team about how you can overcome challenges in your bioanalytical work, use ICON’s contact form.