Time Check: Developing New Therapeutics
Hello! I’m delighted to pen my inaugural blog post here as Cytel’s Chief Medical Officer. In this series, we’ll explore current topics pertinent to us here at Cytel and the global community interested in developing new therapeutics. It’s an exciting space where science, technology, computation, software, statistics, medicine, and clinical trials all interact to help bring forward new products that improve people’s lives. Let’s begin with a bird’s eye perspective on where things are at the moment and where we are headed.
What a time it is now in the world. Several crises fight for our attention: a simmering global pandemic, economic volatility, and an international conflict that recently erupted. Information and disinformation abound with television, computers, and mobile phones carrying content streams of every kind. Digital interconnectedness is the new normal – email, texting, tweeting, TikTok, Zoom, Teams, WebEx. Despite the wealth of information and connectivity, people can feel isolated and there is a constant struggle to filter good information from bad so that we can constructively interact with our friends, colleagues, and fellow global citizens.
What a time it is for medicine. The advent of mRNA vaccines for SARS-Cov2/COVID-19 has showcased the enormous potential benefits of new medicines. The global pandemic lockdowns set the stage for a riveting reality show watching several sponsors race to develop new medicinal agents to, quite literally, save the world. Talented colleagues at Astra Zeneca (AZ), Janssen, Moderna, and Pfizer/BioNTech (among others) worked tirelessly to deliver vaccines and antivirals. Ultimately, Spikevax (Moderna) and Comirnaty (Pfizer/BioNTech) have emerged as two of the most safe and effective vaccines in history, and Paxlovid (Pfizer) is efficacious oral antiviral. These medicines were developed on unprecedented timelines (for mRNA vaccines, <1 year from inception to emergency authorization) and have already had a hugely positive impact on the world.
What a time it is for new therapeutics. As I write this piece, there are over 1000 biotech companies in Boston alone. There has never been a more dynamic time to develop new technologies and medicines – scientific innovation, appetite for investment, and opportunities to bring products to market are abundant. But challenges also abound, and recent headlines around biotech failures are a sobering reminder that science and drug development are hard.
One specific challenge common to us in the therapeutics space is how to best generate and understand data. I joined Cytel because this company specializes in addressing that challenge. From our broad capabilities in real world data and advanced analytics to our core strengths in biometric services to our groundbreaking software like LiveSLR® for systematic literature review and SolaraTM for digital-age clinical trial design, Cytel is ideally positioned to help collaborators develop new therapies for patients by generating data optimally and understanding it well. The SolaraTM team in particular has some great things in store for this first-in-class digital development platform that helps teams chart the best path for their clinical trial, much like a GPS navigation app. As teams are designing their studies, SolaraTM helps visualize and account for scenarios they might encounter during execution and choose the best design for their goals. Stay tuned for more on this topic.
We have also reframed the mission of our strategic design consulting group to provide quantitative thought leadership around design, statistical methods, and decision-making during therapeutic product development. Building on our industry leading statistical design capabilities (e.g., the TOGETHER trial, Bhatt and Mehta NEJM), we are expanding our vision to move beyond statistics and approach therapeutic development more holistically so that we can bring all of Cytel’s tools to bear for our partners.
I am truly excited to be here and help with Cytel’s mission to transform how therapeutics are developed in this rapidly evolving new age of science and technology. To the point made earlier about people feeling isolated despite being connected electronically, I am a firm believer in the value of a real conversation (above and beyond exchanging words electronically) and look forward to interacting that way with many of you out there in the days and months to come. Together, we have a lot to contribute.
About Albert Kim
Albert Kim, MD, PhD, is the Chief Medical Officer at Cytel. Dr Kim has rich expertise in cardiovascular disease, translational medicine, and drug development. After receiving degrees from Harvard and UCLA, completing residency at Brigham and Women's Hospital, and undertaking further specialty training at Mass General Hospital and UCSF, he achieved board certification in internal medicine, cardiology, and clinical cardiac electrophysiology.
Most recently, he was Vice President, Clinical Research Head for Pfizer’s Internal Medicine Research Unit. His roles at Pfizer and at Novartis saw him lead early and late phase programs for common and rare diseases. Dr Kim has contributed to development efforts for several candidate medicines utilizing different therapeutic modalities and has authored a body of work including numerous publications in leading medical journals. He was also a medical reviewer in the Division of Cardiac Devices at the FDA.