Translating complex data into actionable insights, to create big value for smaller biotech companies
20 Feb 2024
Lisa Benincosa is senior vice president of clinical pharmacology strategy at the specialized Clinical Research Organization (CRO), Allucent. Here she discusses how she and her team leverage the power of data to help sponsors optimize decision-making and create efficiencies across the drug development continuum – to drive value for their small and mid-sized biotech partners, and ultimately, help get medicines to patients faster.
What inspired you to pursue a career in clinical pharmacology?
After earning my pharmacy degree and PhD, I started my career at SmithKline Beecham (prior to the GSK merger). There, I spent 10 years focused on drug metabolism and pharmacokinetics (DMPK) before continuing my career with three other large pharmaceutical companies where I held executive leadership positions in translational medicine, clinical pharmacology, DMPK, and bioanalytics. My 25+-years working in big pharma allowed me to hone specialized expertise in early-stage drug development and translational medicine, and gain extensive experience working on global programs and with various regulatory agencies around the world.
I think what appealed to me about this work initially is what continues to motivate me to this day. Namely, the power that data holds to help guide difficult decision-making with objectivity – which is particularly important in drug development where so much is riding on making informed choices. There will always be pain points in drug development. But, understanding the critical questions and then examining the data that exists and/or determining what additional information we can collect to solve those things is hugely rewarding. Getting feedback from a sponsor that those data-driven insights helped guide a difficult decision, or from a regulatory body that they shed light on a key question – that’s a big part of what drives me.
Why did you decide to transition from working in-house at big pharma to a CRO focused on the smaller biotech sector?
After working in big pharma for so long I was drawn to Allucent for a number of reasons. Perhaps most notably, coming here gave me the unique opportunity to continue working across a wide array of indications and modalities on a global scale, but with a diverse assortment of smaller biotech companies. At Allucent I’m able to apply the breadth and depth of my experience to help deliver innovative strategies, which are just as informative as traditional approaches but leverage data to improve efficiencies, for example by delivering essential information more quickly with less costs. All in all, being at Allucent allows me to work where I can have the greatest impact. It’s really gratifying to be able to apply my expertise to help small and mid-sized companies working across an expansive array of cutting edge-science so that they can propel their pipelines forward with confidence.
Where and how can you and your team have the greatest impact(s) on smaller biotech companies’ drug development programs?
By translating complex data into insights that inform dosing, study designs, therapeutic index, and more, we help our biotech partners foresee and address difficult clinical challenges head on, moving them toward critical milestones faster and mitigating risks along the way. For example, starting at the preclinical stage our team uses data to help expedite a compound’s transition to clinical development and optimize first-in-human protocols – and to select the right molecules, useful biomarkers, and dosing frequency. Those are just a few examples. We provide end-to-end clinical pharmacology strategy and services based on each client’s unique needs to accelerate development at every stage, enabling informed decisions, reducing risks, and saving sponsors valuable time and resources. All in all, clinical pharmacology is really helping to reshape the future of drug development – for the benefit of sponsors and the patients we all serve.
What are some current trends in drug development, and how does the field of clinical pharmacology help meet these needs?
Today’s drug development landscape is rapidly evolving, with new and diverse modalities – such as cell and gene therapies (CGT) and new approaches to address the complexities in rare diseases – that hold extreme promise. In this environment, drug development has to keep up with the unprecedented pace of science, and applying clinical pharmacology principles to a rapidly changing and diverse landscape is an important way to do just that. There are also a number of new and emerging trends to consider within today’s drug development ecosystem where clinical pharmacology is instrumental. As one example, there’s a lot of important work being done to increase diversity and inclusion in clinical trials, in order to better understand the safety and efficacy of a given compound across the diversity of patients who will be using the medicine. Of course, there are many factors that go into this, but the field of clinical pharmacology plays a crucial role. For instance, examining questions such as who will be using the product, what characteristics of that population are likely to affect their response, and how will data be collected to ensure proper representation of the target population are all fundamental to designing a protocol that can help achieve this goal.
Furthermore, conducting PK (pharmacokinetic)/PD (pharmacodynamic) studies in various patient populations can provide highly valuable insights into how diverse populations metabolize and respond to drugs, enabling more precise tailoring of drug dosages based on specific characteristics such as age, sex, race, and ethnicity to help ensure a medication is both effective and safe across the intended populations.
As another example, we’re currently seeing a profound shift in oncology drug development. Specifically, last year the U.S. Food and Drug Administration (FDA) released guidance on dose optimization for cancer drugs and biologics to help sponsors identify the optimal dosage(s) in order to maximize not just efficacy, but also safety and tolerability. In the past, with the modalities being developed for oncology you couldn’t separate safety and efficacy. Therefore, the philosophy up until very recently was that a higher dose was always better in order to achieve the maximum response. But now, we’re able to separate those curves, and the Agency is looking for sponsors to provide data that shows they’re achieving efficacy without bringing in higher, unneeded toxicity. So, we’re working with our partners to change the design of early clinical trials and develop effective dose finding strategies. This is what we do across other therapeutic areas, but it’s cutting-edge in oncology and an area where we’re helping sponsors effectively and efficiently navigate a rapid paradigm shift.
Overall, it’s a highly dynamic and very exciting time in drug development. I’m humbled to be able to use my experience and expertise to help guide our partners through it - to bring meaningful benefits to their journey and help deliver essential medicines to the patients who need them around the world.
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