Now that the full scope of the pandemic and the lockdowns are in full view, Endpoints is assembling 3 live action webinars on Zoom to discuss several critical aspects of what’s happening now.
Sign up for one or all, right here. And check out the links below for more details on these events. — John Carroll
How are manufacturing operations handling the immense challenges involved in ramping up production ahead of data and approvals?
How are biopharma execs dealing with the impact of Covid-19 on trial sites and R&D plans? What innovative new ideas are being used as a workaround? How do you prioritize in this environment, when your staff is sheltering at home?
The financial demands of drug development don’t stop with an outbreak. What kind of deals are biotechs making now? What determines terms and valuations? And where are we headed in terms of deal flow through 2020?
The pandemic has roiled R&D plans, created new priorities overnight and generally forced a major shift in many global manufacturing operations. We’ll be talking to a group of the top manufacturing execs around the world about the new reality in their field.
How have they adapted in the face of the pandemic? And what’s ahead?
register to watchAs Chief Technical Operations and Quality Officer, Juan Andres is responsible for the supply of product required for Moderna’s preclinical and clinical development programs, as well as scaling the CMC (chemistry, manufacturing and controls) processes across Moderna’s portfolio. Mr. Andres also will lead all CMC late-stage development and future commercialization activities.
Mr. Andres was previously the Global Head of Technical Operations (Manufacturing and Supply Chain) for over 25,000 Novartis employees across all of its divisions. In this role, he had responsibility for all of Novartis’ manufacturing sites, and related support functions and technologies worldwide, overseeing small molecules drug substance and drug product, as well as biologics drug substance, drug product and technical development. Mr. Andres’ previous roles at Novartis included Group Novartis Quality Head, Global Head of Technical Research and Development, and Global Pharmaceutical Operations Head. Prior to Novartis, Mr. Andres worked at Eli Lilly & Co. for 18 years in a variety of manufacturing, production and quality roles in the United States, Puerto Rico, UK and Spain, most recently serving as Vice President, Pharmaceutical Manufacturing.
Mr. Andres holds a Master degree in Pharmacy from Alcala de Henares University in Madrid and completed an advanced development program at the London Business School.
Kay Schmidt was named Senior Vice President, Technical Operations of Catalent Pharma Solutions in February 2019. Ms. Schmidt joined Catalent in 2009, holding several leadership roles in product development across multiple drug delivery dosage forms. Most recently, she provided leadership to Catalent’s global virtual Project Management Organization for new product introductions, in addition to her role as Vice President, Product Development in the company’s Biologics and Specialty Drug Delivery business unit. Prior to joining Catalent, she held various leadership roles at GE Healthcare developing and delivering diagnostic imaging technologies. She is a certified Six Sigma Green Belt, and has a bachelor’s degree from Carroll University, Wisconsin and a master’s degree from the University of Wisconsin-Whitewater.
John D. Carroll is a biotech analyst and writer with decades of prize-winning experience in journalism. A co-founder of Endpoints News, he has covered biopharma for the past 17 years. Aside from his daily industry coverage for FierceBiotech, where he was named editor in 2003, leaving in 2016, Carroll has been a regular speaker at biotech events around the globe. He’s been quoted by The New York Times, The New Yorker, Financial Times, The Times of London and more. He’s also keynoted at biotech gatherings around the world and addressed student audiences at MIT and Harvard.
Carroll has contributed stories from Central America and Ireland to the Dallas Morning News and Time and wrote for the Houston Press. He spent 6 years as editor and publisher of the Dallas Business Journal, was publisher of Texas Business and early in his career was part of a Pulitzer Prize-winning team of reporters and editors at the Kansas City Star & Times.
Dr. John Shiver serves as Sanofi Pasteur's Senior Vice President of Global Vaccine Research and Development. With more than 29 years of vaccine and pharmaceutical research and development experience, Dr. Shiver has led teams of scientists to develop novel vaccine and monoclonal antibody candidates against a broad range of diseases including HIV, universal influenza, HPV and many more. He has authored more than 150 articles and co-authored 68 awarded patents. Dr. Shiver holds a B.S. degree in Chemistry/Mathematics from Wofford College; a Ph.D. in Physical Chemistry from the University of Florida, and completed a postdoctoral fellowship in Biophysics at Purdue University.
Dr. Stefan Wildt is Head of Pharmaceutical Sciences and Cell Therapies Translational Engine at Takeda Pharmaceutical Company Limited. He is responsible for the development and execution of an end-to-end vision and strategy for pharmaceutical sciences, ensuring the necessary capabilities for an innovative and modality-diverse pipeline. He is also responsible for the seamless transfer of technology to Global Manufacturing & Supply and Global Quality and the establishment of Takeda’s cell therapy capabilities.
Everyone in biopharma has had to deal with a new reality after the pandemic hit. Trial plans have been derailed, communications with staff have been disrupted, old schedules no longer apply. But through it all, biotech execs are getting things done. We’ll talk to a panel involving some of the most experienced vets in the business as they discuss managing a drug development operation in a radically different world.
Michael is CEO of Arrakis. In addition, Mike currently serves on the Boards of Directors of Novartis Venture Fund, Obsidian Therapeutics, and Scholar Rock and on the Scientific Advisory Board of FutuRx.
Previously, Mike was Chief Executive Officer of Obsidian Therapeutics, a venture-funded company focused on applying synthetic biology to gene and cell therapies. Prior to Obsidian, Mike was Founder and Chief Executive Officer of Padlock Therapeutics, a venture-funded company focused on autoimmune disease, acquired by Bristol-Myers Squibb in 2016.
From 2012-2013, Mike served as Senior Vice President, Early-Stage Pipeline, at Biogen Idec, with responsibility for managing the company’s development programs through clinical proof-of-concept.
He joined Biogen Idec in March 2012 following its acquisition of Stromedix, a venture-funded company focused on fibrosis and organ failure, where he was Founder and Chief Executive Officer. Prior to founding Stromedix in 2006, Mike served as Executive Vice President, Research at Biogen Idec, with responsibility for the company’s discovery research activities in Cambridge and San Diego.
From 1994 to 1999, Mike was at ARIAD Pharmaceuticals, where he was Executive Vice President and Chief Scientific Officer. From 1986 to 1994, Mike was on the scientific staff of Cold Spring Harbor Laboratory in New York, where his research focused on mechanisms of signal transduction and gene regulation. Mike was a postdoctoral fellow with Dr. Robert Weinberg at the Whitehead Institute.
He holds a PhD in Biochemistry from University of California, Berkeley, and a SB in Life Sciences from Massachusetts Institute of Technology.
Dr. Pushkal Garg has over 15 years of experience in clinical drug development and oversees all clinical development activities at Alnylam.
Dr. Garg previously served as Vice President, Global Clinical Research, Immunoscience at Bristol-Myers Squibb (BMS). While at BMS, he was instrumental to the late-stage development and approval of Nulojix® (belatacept) for kidney transplant recipients, and for supplementary biologics license applications (BLAs) for Orencia® (abatacept). Preceding this, Dr. Garg held various roles at Millennium Pharmaceuticals.
Dr. Garg received a Bachelor of Arts in Biochemistry from the University of California, Berkeley, and his M.D. from the University of California, San Francisco. He completed residency training in Internal Medicine at UCSF, was a fellow in the Robert Wood Johnson Clinical Scholars Program at Johns Hopkins University and served on the faculty of Harvard Medical School and the Brigham & Women’s Hospital in Boston.
David Chang, M.D., Ph.D., is the President, Chief Executive Officer and Co-Founder of Allogene. He previously served as Executive Vice President, Research & Development, and Chief Medical Officer of Kite, a Gilead Company. He has an industry-leading track record of innovation in the field of oncology drug development, including the development of YescartaTM (axicabtagene ciloleucel), the first CAR T therapy approved for non-Hodgkin lymphoma. From 2002 to 2014, he held senior leadership roles at Amgen, including Vice President of Global Development and Head of Hematology-Oncology. During this time, David spearheaded personalized therapy strategies underlying the success of Vectibix® (panitumumab). He also provided therapeutic area leadership to pivotal programs for Blincyto® (blinatumomab), a bispecific T cell engager antibody in acute lymphocytic leukemia and for IMLYGICTM (talimogene laherparepvec), a first-of-its-kind oncolytic immunotherapy in melanoma. Prior to joining Amgen, David held dual appointments as Associate Professor of Medicine and of Microbiology, Immunology and Molecular Genetics at the David Geffen School of Medicine at the University of California, Los Angeles. He obtained a B.S. in biology from the Massachusetts Institute of Technology and M.D. and Ph.D. degrees from Stanford University. David completed an internship and residency in internal medicine at Brigham and Women’s Hospital and a fellowship in medical oncology at Dana-Farber Cancer Institute at Harvard Medical School, where he was a Howard Hughes Medical Institute postdoctoral fellow.
Dr. Seely is an endocrinologist with over 20 years of drug development and biopharmaceutical company leadership experience. At Medivation, she served as Chief Medical Officer from 2005-2015 and led the development of XTANDI® (enzalutamide) for the treatment of metastatic castration-resistant prostate cancer from IND-enabling studies through to NDA approval and post-approval clinical studies. Dr. Seely currently serves on the Board of Directors of Blueprint Medicines. She completed her residency in internal medicine at Yale-New Haven Hospital and a basic science and clinical fellowship in endocrinology and metabolism at the University of California, San Diego.
John D. Carroll is a biotech analyst and writer with decades of prize-winning experience in journalism. A co-founder of Endpoints News, he has covered biopharma for the past 17 years. Aside from his daily industry coverage for FierceBiotech, where he was named editor in 2003, leaving in 2016, Carroll has been a regular speaker at biotech events around the globe. He’s been quoted by The New York Times, The New Yorker, Financial Times, The Times of London and more. He’s also keynoted at biotech gatherings around the world and addressed student audiences at MIT and Harvard.
Carroll has contributed stories from Central America and Ireland to the Dallas Morning News and Time and wrote for the Houston Press. He spent 6 years as editor and publisher of the Dallas Business Journal, was publisher of Texas Business and early in his career was part of a Pulitzer Prize-winning team of reporters and editors at the Kansas City Star & Times.
Alok is the Vice President of Life Sciences at Egnyte where he is responsible for building and executing the company's strategy for the life sciences market segment. Alok works across the organization to verticalize our marketing, sales, product, compliance, and account management practices for this domain. Before joining Egnyte, Alok was a YCombinator-backed entrepreneur and started two vertical software-as-a-service companies. He was honored with a 20 under 40 award by Endpoints News in 2018. Prior to his career in software, Alok spent over 15 years as a scientist: he took part in postdoctoral work at Harvard University with George Whitesides, and has published papers in Nature and Nature Chemistry. Alok holds a PhD from Northwestern University and BS from Cornell University.
Contrary to what many people may have thought, the outbreak that has stymied so many organizations has pushed biopharma into overdrive on dealmaking. On top of the new alliances being formed for Covid-19, companies are also coming together on a long list of new projects related to core research areas.
What stage — discovery, early-, late- — is getting the most attention and how do you work terms on this new blizzard of deals being formed overnight?
Chris leads strategy, operations, data analytics, and content development. Prior to founding DealForma, Chris held research, management consulting, and industry analytics roles within biopharma at UCSF, Recap, Deloitte, Thomson Reuters, and BioCentury. He enjoys the opportunity to contribute to industry thought-leadership and is frequently invited to speak to industry groups about biopharma business development and licensing. Chris holds degrees from the University of California Berkeley.
As Vice President of Business Development, Abbas Kazimi is responsible for corporate development, partnerships and collaborations. Abbas joined Nimbus in 2014 as Director of Business Development. In that role he drove several of the company’s key transactions, including the licensing agreement with Genentech in 2015, the sale of Nimbus’ clinical NASH program to Gilead in 2016, and the strategic immunology alliance with Celgene announced in 2017. Prior to joining Nimbus, Abbas spent a decade in planning and executing strategic transactions for life sciences clients with industry partners and financial investors across the globe, most recently at Extera Partners, LLC. He earned his M.A. from Harvard University and his B.A. from the University of Texas at Austin.
Peter Meath serves as the Managing Director and Life Sciences Industry Head for Middle Market Banking & Specialized Industries. Prior to joining J.P. Morgan, he was a co-founder of Square 1 Bank, the second-largest de novo bank startup in US history, and only the second bank in the US to solely focus on emerging growth technology, healthcare and life sciences companies. Peter led the bank’s technology and life sciences practice in the Southeast and Mid-Atlantic, serving venture capital- and private equity-backed clients and investors from Florida to Pennsylvania. Previously, Peter served a one-year venture capital fellowship with Intersouth Partners, an $800 million venture capital firm in Durham, NC. Peter also spent time at Silicon Valley Bank, first in the bank’s first southeast regional office in Atlanta and then as one of the founding team members of its Research Triangle Park office in North Carolina in 2001. Peter graduated from the McIntire School of Commerce at the University of Virginia and holds a Master of Business Administration from the Fuqua School of Business at Duke University. Peter is based in Raleigh, N.C.
Melita brings over 20 years of life sciences corporate development, commercial, and investment expertise. She has led deals with combined value over $5 billion, and upfront consideration exceeding $500 million. Recent partnerships include Sangamo’s Biogen CNS collaboration, Kite/Gilead gene editing oncology partnership, and Pfizer ALS collaboration; and the acquisition of TxCell, a leader in the emerging field of regulatory T cell therapies.
Previously, Melita led teams at Adamas, focused on neurological disorders; and Ascendancy Healthcare, with a mission to bring innovative treatments to China. Before that, Melita held roles in business development and commercialization, leading marketing for Ipsen’s specialty endocrinology brand, and directing market research activities for multiple brands including the launch of the company's flagship neurology product.
Melita started her career in venture capital and fund management, at Bay City Capital and Lombard Odier Darier Hentsch.
Melita received her BA in Biology from the University of California at Berkeley.
Dr. Marianne De Backer has been a strategist, scientist, business leader, deal maker and corporate investor in the healthcare industry for more than two decades. At Bayer, she leads the global strategy and innovation agenda for Pharma. Prior to joining Bayer, Dr. De Backer had an impressive career path at Johnson & Johnson (JNJ), her last role as global head of M&A operations and Divestitures for the Pharmaceuticals Group.
She is a member of the Board of Directors of Gladstone Foundation, Ecohealth Alliance and Arrowhead Pharmaceuticals (ARWR). Born in Belgium, she holds an MBA from Erasmus University Rotterdam, a PhD in Biotechnology and Master in Engineering from the University of Ghent, and a MSc in Molecular Biology from the University of Brussels.
John D. Carroll is a biotech analyst and writer with decades of prize-winning experience in journalism. A co-founder of Endpoints News, he has covered biopharma for the past 17 years. Aside from his daily industry coverage for FierceBiotech, where he was named editor in 2003, leaving in 2016, Carroll has been a regular speaker at biotech events around the globe. He’s been quoted by The New York Times, The New Yorker, Financial Times, The Times of London and more. He’s also keynoted at biotech gatherings around the world and addressed student audiences at MIT and Harvard.
Carroll has contributed stories from Central America and Ireland to the Dallas Morning News and Time and wrote for the Houston Press. He spent 6 years as editor and publisher of the Dallas Business Journal, was publisher of Texas Business and early in his career was part of a Pulitzer Prize-winning team of reporters and editors at the Kansas City Star & Times.