Our industry continues working to build a more resilient, affordable and equitable health care system. I recently had the opportunity to connect with William Pao, M.D., Ph.D., Chief Development Officer and Executive Vice President for Pfizer, a PhRMA member company.
Rich Moscicki (RM): Obviously, Pfizer has been working hard over the past two and a half years to combat COVID-19, both in terms of finding vaccines to protect patients from severe disease, but also to find treatments for those who do end up getting the virus. As you take on your new role as Pfizer’s Chief Development Officer, what lessons from the pandemic do you plan to apply to future drug development?
William Pao (WP):
Like many, I watched Pfizer defy conventions established in the industry, bringing a safe and effective vaccine and an oral antiviral at record speed when the world needed them most. That ability to move at the speed of science is one of the reasons I joined this company with the hopes of applying that same agile mindset, scientific prowess and innovative approach to other therapeutic areas. Within the walls of Pfizer, we refer to this streamlined approach as “lightspeed.” And while we recognize that we cannot deliver all future breakthroughs at such pace, there are certainly durable lessons from COVID-19 trials that we are carrying through to all our programs.
One of those lessons includes fully embracing digital throughout the development process. During COVID-19, with everyone in lockdowns, we had to rely on technology and remote monitoring to continue our trials and we did so with great success. Incorporating technology into clinical trials is critical for speeding up many aspects of development and also improving participants’ experiences.
Another lesson involves enhancing scientific dialogue between regulators and sponsors. The COVID-19 pandemic has pressure-tested how we interact with regulatory systems like never before. Regulators took a pragmatic approach to regulatory requirements to expedite development without compromising patient safety. These process enhancements and real-time reviews should be made permanent, at least for seriously debilitating and life-threatening conditions where every minute counts, to routinely facilitate faster scientific exchanges, and accelerate the safe development of medicines and vaccines.
Lastly, we need to improve access to and awareness about clinical trials. One of the key factors that contributed to the speed of clinical development for COVID-19 vaccines and treatments was quick patient enrollment. Many courageous volunteers around the world raised their hands and believed that science could win. We need to seize this moment and unprecedented interest in science to continue to engage the public in medical research and make it easier for potential participants from all backgrounds to find, learn more about and ultimately participate in medical research. Pfizer is committed to doing its part to make trials more accessible and equitable.
RM: It’s quite an exciting time to be in the industry, where we’re seeing these incredible new vaccines and treatments being developed. What do you think is on the horizon for the future of medicine?
WP:
These are indeed exciting times in drug and vaccine development. Pfizer has a rich pipeline with 60 programs currently in phase 2 and 3 development to address various patient needs spanning oncology, inflammation & immunology, rare diseases, internal medicine, vaccines and hospital products. We are investing in areas where we see the greatest opportunity, where the science is mature for drug and vaccine development, and where we believe we can deliver the best value for patients and society.
One area of science that Pfizer is really excited about is mRNA technology. The swift delivery of the world’s first mRNA-based vaccine made its promise clear, but we are only beginning to tap the potential of this technology for both vaccines and therapeutics that could unleash the next wave of scientific innovations. Pfizer is taking multiple steps and making investments to harness the power of mRNA and bring the full potential of this platform forward. For example, we are expanding our mRNA portfolio to other key infectious diseases with prophylactic vaccines against seasonal flu and shingles as well as advancing mRNA research and development into new therapeutic areas, such as mRNA for gene editing in rare disease.
For patients with rare disease, gene therapy also holds great promise and Pfizer is working to unlock its potential with several development programs in this area, including clinical trials in Duchene Muscular Dystrophy (DMD) and hemophilia. We are also looking at what’s next in oncology, such as novel T-cell engaging therapies, other novel immunotherapies, and small molecules designed to overcome resistance to existing therapies.
Another exciting area is the use of artificial intelligence across medicine development. Pfizer is utilizing AI, analytics, data and digital technology in our efforts to advance understanding of disease and risk, improve outcomes and speed analysis in the R&D process, and more quickly discover new approaches to prevent, cure, and treat disease for patients in need.
RM: Our industry has had many lessons learned in drug development throughout the pandemic, including how we hope to conduct and recruit in clinical trials. For instance, during COVID-19, we saw a shift toward decentralized clinical trials that can help strengthen diversity in clinical trials. How can we continue improving health equity and establishing trust in this area?
WP:
At Pfizer, equity is a core value and we believe that diversity in trials is a matter of both equity and good science. We recognize that people respond to medicines and vaccines differently and factors like race, ethnicity, age and gender can contribute to these differences. We believe that all patients, regardless of background, should have the opportunity to receive the latest breakthrough treatments and that starts with equitable access to clinical trials.
Unfortunately, some communities have not always been accurately represented in clinical trials for numerous reasons, either because of lack of trust, financial challenges, limited awareness of trials that are taking place or inability to get to the trial site.
By giving participants the option to participate in the trial remotely, decentralized trials help address some of these issues and certainly have the potential to broaden access to trials for those who otherwise couldn’t participate. We recognize the role of decentralized trials and I’m proud to say that many of our trials now offer decentralized elements, making it easier for participants.
But Pfizer is also focused on addressing other barriers and we believe partnerships are critical to ensuring equitable trials. We partner across the ecosystem from helping to build awareness to making it easier to access our trials to ensuring diverse investigators. For example, recently we partnered with Columbia University on a multi-year initiative to address clinical trial diversity and we are working with them on many different aspects from increasing community engagement to broadening the pool of investigators who conduct trials.
We are also making investments to embed our commitment internally—from training our colleagues who manage the operations of clinical trials to building an epidemiology library to implementing an interactive dashboard that enables real-time diversity enrollment analytics in our trials—to ensure our organization is fully equipped to achieve diverse representation in clinical trials.
Pfizer made a commitment to having all its clinical trials reflect the racial and ethnic demographics of the countries and communities in which we conduct our trials. We are determined to achieve that.
You can stay up to date with the work the biopharmaceutical industry is doing to build a better health care system here.
