Complimentary Webinar for ISPE Members and Non-Members
A Two-Part Series Covering
Strategies, Approaches and Challenges In Selecting
a Contract Development Manufacturing Organization (CDMO)
Part 1: December 1, 2020 (Part 2 in January)
Format: GoToWebinar Instructions to join will be emailed one day prior
Shawn Cain is currently the Chief Operating Officer at LSNE, a pharmaceutical and medical device CDMO, acquired by Permira Funds in 2017. He has over 30 years of experience in combining process engineering and project management to direct the development and manufacture of sterile pharmaceuticals, cell-based biologics, and medical devices. Most recently he was at Organogenesis, Inc., specializing in bio-active wound healing. His past experience includes Director of Operations for Formatech, Inc., a pharmaceutical CDMO, Interim President and CEO of Arbios Systems, Becton Dickinson’s Discovery Labware, Biologics Business, VP of Operations for Circe Biomedical, where he led the development of the bioartificial liver technology. Cain holds six patents and received his MS degree in Biological Sciences from the University of Massachusetts and a BS in Biological Sciences from Northeastern University.
Steven Hager, PhD, is the Director of Science and Technology for Catalent Pharma Solutions. Dr. Hager joined Catalent in 2001 and is responsible for technology and innovation support for Catalent Biologics drug substance development and manufacturing. Dr. Hager received his BA from St. Olaf College and PhD from the University of Wisconsin-Madison in physiology and biochemistry and performed postdoctoral work at the University of Illinois Medical Center, Department of Biochemistry in Chicago, IL.
Alex Konstantinidis is the Director of Program Management at Pfizer. He has a strong record in program management and extensive anti-infectives experience, mobilizing cross functional teams to execute product development, from inception to FDA submission, and effective commercial manufacturing. He has seven years CMC program management experience. He has established PM teams to manage development and launch activities and ensured effective stakeholder engagement to accomplish team goals, address conflicts, and mitigate partnership and product risks. He has 14 years of technical expertise in roles of progressively higher responsibility in leading pharmaceutical companies performing product development, technology transfer, and establishing robust manufacturing processes.
Benir Ruano is the Vice President of Global Manufacturing and Technical Operations for Xeris Pharmaceuticals. He has 37 years of experience with biotech, pharmaceutical and medical device companies working in development, engineering, clinical and commercial manufacturing/supply chain. His previous experience includes technical leadership roles at CTI Biopharma, OSI Pharmaceuticals, Pharmatech, Aradigm, Sanofi Pasteur, Bio-Rad and Eli Lilly.