- Advantages of smaller more agile organizations’ ability to react to patient, regulatory & market pressures
- Discussing internal innovations in production technologies and working with external partners to do the same
- How do we adapt our leadership, organizational structure and people management strategies?
- Lean implementations as a Smart Risk management tool
- Leveraging collaborations with big pharma to foster innovation and increase speed to market
Alison Moore is Senior Vice President, Process Development for Amgen serving both Operations and R&D organizations. She has held a number of senior roles within Amgen overseeing operations technology, process and product engineering , and corporate manufacturing where she oversaw supply chain, contract manufacturing, global distribution, manufacturing technologies, and operations risk management. She also headed up Amgen’s Fremont, California, manufacturing facility (AFR). Before heading up the AFR facility, Moore was a director in chemistry, manufacturing and controls regulatory affairs at Genentech. Prior to her time at Genentech, Moore had previously spent nine years at Amgen in various positions of increasing responsibility within the process development organization. Moore holds a Ph.D. in Cell Biology from Manchester University, England, and a bachelor’s in Pharmacology with Honors from Manchester University, England.
Tina M. Larson is Vice President of Technical Operations at Achaogen, a biopharmaceutical company committed to the discovery, development, and commercialization of novel antibacterials to treat multi-drug resistant gram-negative infections. Ms. Larson is accountable for Process Development, Manufacturing, Supply Chain, Quality Assurance and In Vitro Diagnostic Devices. Prior to Achaogen, she was at Genentech/Roche for 20 years where she was involved in every commercial biologic product launched by Genentech through roles of increasing responsibility in Automation Engineering, Manufacturing Science and Technology, Process Development, and Global Business Operations. Ms. Larson was a member of both Genentech’s and Roche’s Technical Development leadership teams, leading functions in the U.S. and Europe. She was recognized nationally in 2012 as a Healthcare Businesswomen’s Association (HBA) Rising Star. Ms. Larson received her B.S. in Chemical Engineering from Colorado State University.
Ashraf Amanullah, VP of Biologics Development and Manufacturing of aTyr Pharma, is a drug development and manufacturing executive with more than 20 years of demonstrated leadership experience in global pharma and biotechnology organizations, with expertise in process development, technical operations, cGMP clinical manufacturing, commercialization and life cycle management of antibody therapeutics, vaccines, gene therapy, cell-based therapeutics and recombinant proteins. Prior to joining aTyr Pharma, Ashraf was Senior Director at Gilead Sciences where he built a world class CMC organization, Director of CMC Development at Genentech. Prior to Genentech, Ashraf held various positions at Merck & Co. Inc. over nine year tenure, with responsibility for process development, cGMP manufacturing, and technology transfer and commercialization of vaccines. He is the author of 55 peer-reviewed publications, and his work has been presented at over 90 conferences. Ashraf received his Ph.D. in Chemical Engineering from The University of Birmingham (UK) and conducted post-doctoral studies with The University of Birmingham, Novo Nordisk, Merck & Co. Inc. and University College London.
Mayo Pujols is currently VP Global Head Car-T Operations and Technology at Celgene located in Summit, New Jersey. Prior to Celgene, he was the SVP of Technical Operations at Advaxis, Inc., a clinical-stage biotechnology company located in Princeton, New Jersey. He leads a team responsible for manufacturing, quality operations, process/analytical development, engineering, supply chain/logistics, and project management. Prior to this role, he was Advaxis’s VP of Technical Operations. Prior to that role he was Executive Director of Technical Operations at Merck supporting the vaccines and biologics franchises. Mayo has also worked in a number of other global and domestic roles throughout his career, including the areas of technology transfer, new product launches, validation, regulatory submissions/inspections, commercial/clinical manufacturing, and quality assurance/systems at Astra-Zeneca (MedImmune), Schering-Plough, and Merck.
Heidi Hoffmann, Senior Director, Supply Chain and CMC Team Lead of Sutro Biopharma, has 22 years of experience in biotechnology, specializing in process development, technology transfer, and manufacturing of vaccines and biological therapeutics. She began her career at Aviron working on vaccines for EBV, PIV, and influenza (FluMist®). She then joined Valentis, where she led the team responsible for process development, technology transfer, and clinical production of plasmid DNA for gene therapy. Dr. Hoffmann returned to vaccine work by joining VaxGen, working on process development and manufacturing of anthrax vaccine. Later, she transitioned into a technology transfer role, hiring and leading the VaxGen oversight team for the successful transfer of production of Bristol-Meyer Squibb’s Orencia® (abatacept) into the Celltrion manufacturing facility in South Korea. Dr. Hoffmann joined Sutro in February, 2011 and currently heads CMC and directs outsourced cGMP manufacturing for protein therapeutics and ADCs.