- How are biology and patient needs influencing risk-based investment and networking structure in the manufacturing space?
- Discussing route and location of administration, including MDCP considerations, components and suppliers, design standards including image selection, and packaging network design
- Exploring flexible facilities, integrated clinical launches, and capital risk avoidance in the quest to get fast to clinical and fast to respond
- Understanding the need for early investment in platform changes. How is the emergence of ADCs, modality blurring, and market considerations changing the way we traditionally work?
- Talking about access issues including regionalization and localization, IP considerations, and how higher order BSL and/or OEB availability impacts what we can do, and where we can do it
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SVP, Global Biologics Operations
Merck
Dave Maraldo leads Global Biologics Operations within the Merck Manufacturing Division (MMD). In this role, he oversees manufacturing and supply of Merck’s Biologic portfolio of products. Dave has been part of Merck for over 20 years. Over his career, Dave has supported all of Merck’s current vaccines and biologics franchises at various stages of their life-cycle, including multiple roles in process development, commercialization, operations, and manufacturing science & technology. He served as committee Co-Chair overseeing cross-functional pharmaceutical development and manufacturing strategy across all modalities. Dave has recently joined the Board of Advisors of the School of Engineering at Widener University. Dave’s most advanced degrees include a Ph.D. in Chemical Engineering from Drexel University and MBA degree from Lehigh University.
SVP Global Supply Chain Management
Merck
She leads a global team with presence in 40+ markets, responsible for all aspects of Supply Chain Operations and Value Chain Management (Product and Manufacturing strategies) at Merck across Small Molecules, Biologics, and Vaccines. She has held roles of increasing responsibilities across the value chain in Manufacturing, Technical Operations, Engineering, LEAN/Six Sigma, and Supply Chain Management. Bala has a Bachelor’s degree from the University of Madras, India, a Master’s Degree in Electrical Engineering from Southern Illinois University in Carbondale, and Executive education from Harvard Business School. Bala lives in Doylestown, Pennsylvania, with her husband and three kids (2 humans and a pug).
SVP Development Sciences and Clinical Supply
Merck
Mike received his B.S. in Chemistry from Pennsylvania State University and his Ph D. from Harvard University. Upon graduation he accepted the position of Sr. Research Chemist within the Merck Process Research group where he focused on the development of efficient synthetic processes to drug development targets.
In 2006 Mike accepted the position of Senior Director Process Research at Cephalon, Inc. While at Cephalon, Mike continued to focus on the development of efficient manufacturing routes to pharmaceutical agents.
Mike returned to Merck to lead Pharmaceutical Development in 2007; contributing to numerous product launches, including: Janumet XR, Belsomra, Zepatier. Later he returned to lead Process Research and was subsequently promoted into his current role leading Development Sciences and Clinical Supply.
Executive Director, Oncology Marketing
Merck
Courtney leads a team that drives long-term strategy for Merck’s Oncology business – ensuring that we can achieve and sustain a leading Oncology business – delivering on our ambition to save and improve lives of cancer patients around the globe.
Courtney has worked at Merck for 6 years – across access, policy, business development & strategy. Prior to joining Merck she was a consultant at Bain & Co and worked in neuropharmacology basic lab research. Courtney has a Bachelor of Science (hons) & has worked across European, American & Asia Pacific markets.
