Speakers

Dr Mire-Sluis is currently Head of Quality for Gilead Sciences. He was Head of Global Quality for AstraZeneca and Vice President, North America, Singapore, Contract and Product Quality at Amgen Inc. He was previously Principal Advisor, Regulatory Science and Review, Office of Biotechnology Products, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA, in Bethesda, Maryland.

He trained in Genetics and Biometry and has a PhD in Cell biology and Biochemistry. Dr Mire-Sluis was the Head of the Cytokine Group in the Division of Immunobiology at the National Institute for Biological Standards and Control, Potters Bar, UK. Dr Mire-Sluis specialized in the development of assays for the characterization and quantitation of biological products. He then became Director of BioAnalytical Sciences at Genentech and prior to joining FDA, was Executive Director of Analytical Sciences at CancerVax Corporation, San Diego.

Dr. Advant has served as Savara’s Executive Vice President, Global Technical Operations since March 2024. With approximately three decades of experience in the biopharmaceutical sector, he has considerable expertise in drug substance, drug product, and analytical development with early- and late-stage clinical and commercially approved biologics. Dr. Advant also has extensive expertise in technology transfer, scale-up and cGMP manufacturing (both internal and external) in a highly regulated environment. To date, Dr. Advant has helped launch multiple biologic assets across several therapeutic areas. Prior to joining Savara, he was VP, Manufacturing Operations at GSK, where he was responsible for multi-site drug substance and drug product operations. Previously he held roles of increasing responsibility at Celgene Corporation (acquired by Bristol Myers Squibb), Kemwell BioPharma, ImClone/Lilly, and Diosynth Biotechnology (now FujiFilm Diosynth Biotechnolgy), among others. Dr. Advant holds a Ph.D. in Pharmaceutics from the University of Connecticut.

Joanne is a seasoned biotech executive with over 30 years of experience across large pharma and early-stage biotech in the areas of operations, leadership, product development, process development, clinical & commercial manufacturing, and supply chain. Over the course of her career, she has contributed to the licensure and commercialization of numerous medicines across different modalities and therapeutic areas. She has fostered high-performing, empowered individuals and teams and mutually beneficial partnerships with both internal and external stakeholders.

Before Halozyme, Joanne most recently served as the Chief Technical Officer at Abata Therapeutics, a company developing Treg cell therapies for serious autoimmune and inflammatory diseases.  Prior to Abata, she served as the Chief Technical Officer at Aerium Therapeutics, Inc. and as the Chief Operating Officer and interim CEO at Boston Pharmaceuticals. Previously, Joanne served as the Executive Vice President of Global Pharmaceutical Development and Operations at Celgene Corporation where she oversaw the company’s Product Development, Global Manufacturing Operations, Supply Chain, Engineering and Quality functions. Joanne also served in leadership positions at other pharmaceutical and biotech companies, including Shire, Abbott Laboratories, Amgen, and Genentech. She has served as a member of the Board of Directors of public biopharmaceutical companies, including Orchard Therapeutics and Astria Therapeutics.

Joanne holds a Ph.D. in Biochemistry and Molecular Biology from Oregon Health and Science University and completed a postdoctoral fellowship in the department of Pharmaceutical Chemistry at the University of California, San Francisco.

Vinod Bulusu leads Products team in Global Technical Operations (GTO) and provides CMC leadership in Operations for Biologics modalities at AstraZeneca. Vinod, has about 20 years’ experience in commercializing biologics. Prior to AstraZeneca, Vinod worked at PwC as a management consultant and at Amgen led late stage process development and technology transfers. Vinod has a Masters in Chemical Engineering and an MBA.

Nick Warne is currently Vice President of Pharmaceutical Research and Development at Pfizer.  Nick has 36 years of industrial experience focusing on biologics formulation development, dosage form design and manufacturing process development.  He and his team have been fortunate to have contributed to the licensure of 25 biologics including clotting factors, growth proteins, mabs, vaccines and ADCs.  Nick holds numerous protein formulation patents and, with his group, has made over 100 presentations at national meetings and in journals.  Prior to his position at Pfizer, Nick had positions of increasing responsibility at Wyeth and Genetics Institute, and has been based in Andover, Massachusetts.  Nick received his PhD in Chemistry from Purdue University under the guidance of Professor Michael Laskowski Jr. He received his BS in Biochemistry, with Distinction in Research, from the University of Rochester.

Lisa Wyman is an accomplished biotechnology executive with more than 25 years of experience spanning technical operations, product development, global manufacturing, quality, and supply chain leadership. She has an extensive track record of advancing innovative therapies through development and commercialization, including ISEMBYLD (Scholar Rock), WINREVAIR and REBLOZYL (Acceleron Pharma), and VPRIV (Shire).

As Chief Technical & Quality Officer at Scholar Rock, Lisa leads Technical Operations, Quality, Manufacturing, Supply Chain, Information Technology, and Facilities. Throughout her career, she has built and transformed global organizations, established resilient commercial manufacturing networks, and guided companies through complex regulatory challenges and the transition from clinical development to commercial operations.

Prior to Scholar Rock, Lisa held senior executive leadership positions at Generate:Biomedicines and Acceleron Pharma, as well as leadership roles at Mersana Therapeutics, Shire, and Boston Scientific. She currently serves as an independent member of the Board of Directors of PepGen.

L.-C. Campeau obtained his Ph. D. degree in 2007 with the late Professor Keith Fagnou at the University of Ottawa in Canada. He first joined Merck Research Laboratories at Merck-Frosst in Montreal in 2007 where he was recognized for key contributions to the discovery of doravirine (DELSTRIGOTM & PIFELTROTM) a next generation non-nucleoside reverse transcriptase inhibitor for the treatment of HIV. In 2010, he moved from Quebec to New Jersey, where he has served in roles of increasing responsibility. L.-C. is currently Associate Vice President and the Head of Small Molecule Process Research and Development. Over his tenure at Merck, L.-C. and his team have made important contributions to >60 clinical candidates and 8 commercial products including the recently approved LIPFENDRATM, the first approved oral PSCK9 inhibitor, for which he co-led the early development team. Under his leadership, his organization was recognized with 5 EPA Green Chemistry Challenge Award and 2 Heroes of Chemistry Award. His passion for scientific excellence is exemplified by >95 publications and patents, and >100 invited lectures worldwide. L.-C. is a Fellow of the American Chemical Society (2026) and was elected Fellow of the Royal Society of Canada in 2022.

As Vice President of Pharmaceutical Sciences & Device Development at Merck, Allen is responsible for leading drug product formulation development, device development, as well as clinical supply manufacture.

Allen earned a Ph.D. in Chemistry from the University of North Carolina at Chapel Hill in 2000 under the direction of Royce W. Murray.  He has published over 60 research articles, served as co-inventor on 11 patents and authored over 120 presentations in the area of pharmaceutical product research.  He has organized a number of symposia and training courses on diverse topics within the field of pharmaceutical research.

Dr. Templeton is an active member in a number of professional organizations, including the American Association of Pharmaceutical Scientists (AAPS), International Pharmaceutical Federation (FIP) and the American Chemical Society (ACS). He served on various leadership positions with AAPS and ACS, including the board of directors for AAPS and was named as a Fellow of the Association in 2015 for his scientific accomplishments.  He was elected to both the 2010-2015 and 2015-2020 terms of the United States Pharmacopeia (USP) expert committee on physical analysis.