![]() ![]() The key is to be able to cherry pick the winners early, which they do using a framework called, “Signal of Clinical Activity.” While in small patient studies, the development teams look for big signals that show the risk is worth taking. “We work with colleagues in the more business intrapreneurial aspect of trying to understand how could the world embrace such a new innovation. ![]() “We start with a very integrated approach in looking at what area may have science starting to show signs of maturity to be transformative,” Dr. To do so, he revitalized the company’s passion for biomedical science and its focus on medical breakthroughs. Dolsten has been working on revamping the company’s R&D for the past decade. While the lessons behind the lightspeed development for both Comirnaty and Paxlovid are now being incorporated into the overall R&D process at Pfizer, the truth is Dr. But once they got data they liked, they switched to the same lightspeed model that allowed them to produce Comirnaty so quickly at scale. They also used artificial intelligence and machine learning models to predict drug exposure and virus suppression before heading to trials. Dolsten says they acted like a “Navy SEAL action team.” Given the company’s experience in making small molecules for proteases in antivirals, they turned to an expert team to handle the challenge of developing this oral pill. The process behind the approach to Paxlovid was a little different. That means while they were evaluating various vaccine options, they were also working with regulators on continuous development and with CEO Albert Bourla and the product team to ensure they would be capable of manufacturing several billion vaccines for distribution if Phase 3 trials showed high efficacy. It allowed us to work in parallel across science, clinical studies, and manufacturing at scale.” “We set the project in reverse by saying, ‘We need to have a vaccine to turn this pandemic around by the middle of fall 2020.’ That reverse engineering allowed us to do things very differently. “Like planning for the launch of a new NASA rocket, you need a tremendous organization,” Dr. So, with all of these years of experience, why did he model the development of a vaccine for a worldwide pandemic on a trip to the moon? In his more than 30-year career, he has been involved in advancing more than 30 drugs and vaccines to approval, with Comirnaty and the oral antiviral COVID-19 treatment Paxlovid being the latest examples. Dolsten became President of Pfizer Worldwide Research and Development in May 2010, where he leads a team of more than 8,000 scientists and oversees all global research operations across six therapeutic areas. What-or more specifically who-you may not know is the man responsible for leading the development team behind this achievement: Dr. But it is likely you already know all of that. It was also the first COVID vaccine to ultimately be approved by the FDA under the brand name Comirnaty. That was the mindset that helped Pfizer, along with partner BioNTech, to develop the first vaccine for COVID-19-one that hit the market in record time, was the first vaccine to use mRNA technology, and arrived with an efficacy rate over 95%. But be patient as posts will appear after passing our moderation.Mikael Dolsten, MD, PhD Chief Scientific Officer and President, Worldwide Research, Development, and Medical Pfizer Inc.Īct like you are NASA and shoot for the moon. Depending on the number of messages we receive, you could wait up to 24 hours for your message to appear. Questions will be queued for posting immediately after moderationģ. Answers to questions will be posted immediately after moderationĢ. Read the community guidelines MathsGee Student Support Rulesġ. Enjoy our interactive learning resourcesĤ. Join expert live video sessions (Paid/Free)ĩ. On the MathsGee Student Support, you can:ĥ. We use a combination of generative AI and human experts to provide you the best solutions to your problems. Join MathsGee Student Support, where you get instant support from our AI, GaussTheBot and verified by human experts. ![]()
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