Discuss, Deploy, or Defer: New Technologies in Real World Biopharmaceutical Manufacturing
Jeff Baker – Deputy Director, Office of Biotechnology Products, FDA
This is an exciting time in the development of new biopharmaceutical healthcare solutions driven by unprecedented understanding of biomolecular mechanisms, supporting analytics, applications of machine learning and artificial intelligence, new materials, container closure systems and delivery devices, and even advanced robotics. Nevertheless, the technologies actually used in commercial biopharmaceutical manufacturing in the United States have changed very little in the last 20 years with the majority of those changes resulting from incremental optimization. This talk will discuss possible root causes giving rise to this situation.
Developing an mRNA Vaccine for the Prevention of COVID-19
Tal Zaks – Chief Medical Officer, Moderna
Delivering an Entirely New Class of Medicines: From Rare Disease to COVID-19
John Maraganore – CEO, Alnylam Pharmaceuticals
Alnylam is working to get its third drug approved in three years. This talk will discuss the journey in bringing these therapies to market, building an effective pipeline, and developing a new class of medicines in 2020.
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R&D During a Pandemic – An Unprecedented Collaboration
Lotus Mallbris – Vice President & Global Head of Immunology Product Development, Eli Lilly
In the race to develop treatments for COVID-19, it will take unprecedented collaboration on a global scale that has never been done before. One such collaboration was the COVID R&D Alliance, made up of leading biopharma companies with the common goal of accelerating R&D by evaluating therapeutic candidates and developing innovative clinical trials. This panel will cover how real-world data is advancing COVID-19 treatments, the current clinical trials underway and how they were able to speed up the process, lessons learned from pooling collective knowledge and experiences, and how collaboration has shaped the response to COVID-19.
A Fireside Chat with Michelle McMurry-Heath – President & CEO, BIO
Dr. McMurry-Heath has joined BIO at a critical time in life sciences history. With a wealth of knowledge and experience ranging from large pharma, the FDA, and her work in academia, she has championed clinical trial evolution and the use of real-world evidence in product evaluation, promoted personalized medicine, and bolstered international preparation for pandemic disease threats. In a fireside chat with Dan Stanton, Xconomy’s managing editor, she’ll discuss how her experiences have helped her guide BIO in navigating COVID-19, promote a diverse and inclusive workforce, and keep the momentum of the industry moving forward with the most important thing in mind: delivering quality patient outcomes.