Archives: Speakers

Randy Messer is a Sr. Category Manager at Alnylam Pharmaceuticals has spent 15 years in the Pharmaceutical industry, with 12+ years of Strategic Sourcing experience across a wide range of categories. His prior role at Takeda Pharmaceuticals included time supporting categories such as Facilities, R&D, and Phase IV programs, as well as leading a team of Procurement Project Managers. In his role at Alnylam, he manages Clinical category spend (Phase I – III) and works closely with Clinical Operations stakeholders, along with CROs outside the organization. He received his MBA and BS from Boston College.

Melissa’s career spans manufacturing, research, quality, EH&S, strategy, and operations.  She started with Air Products and Chemicals as a production engineer, moved to R.R. Donnelley and Sons as a manufacturing supervisor and then transitioned to Pfizer in 2001.  Roles at Pfizer have given Melissa a breadth of experience across Pfizer’s divisions and functions.  Melissa completed her undergraduate studies in Chemical Engineering at Villanova University, has an MBA and is a Lean Six Sigma Black Belt.  Her leadership in operations and expertise in risk management led to her current role at Pfizer as the Head of Quality Risk Management for Clinical Development.  She is the lead author of the recently published TransCelerate manuscript on risk management. Melissa enjoys sailing, reading, and gardening in her free time.

Amanda Marie Gentile, MRes, is currently a Senior Clinical Scientist at Dicerna Pharmaceuticals where she is primarily focused on trial design, data analysis, and investigator outreach.  Together with the small but mighty Clinical Operations team at Dicerna, she is also heavily involved in clinical vendor selection and management of two clinical-stage programs in rare disease and infectious disease, respectively. Amanda has 10 years of experience in the field of Clinical Research, five of which have been spent directly managing clinical trials in small to mid-size biotechnology companies. Before her current role with Dicerna, Amanda held roles of increasing responsibility at Finch Therapeutics (Somerville, MA), Intarcia Therapeutics, (Boston, MA), and Acorda Therapeutics (formerly Civitas Therapeutics (Chelsea, MA)).

Amanda has a BA in Psychology from the College of Holy Cross, Worcester, MA and a Master’s of Research Methods in Psychology from the University of York, York, UK.

Dina Berdieva leads Project Management and Clinical Operations for the Bill & Melinda Gates Medical Research Institute. Dina has 18 years of industry experience which spans contract research organizations, small biotechnology and global pharmaceutical companies. Prior to joining Gates MRI she was the Executive Director of Clinical Operations for Boston Pharmaceuticals, an early phase translational medicine company. Dina also worked at Novartis Vaccines for almost nine years in various roles with increasing responsibility. During her time at Novartis, she oversaw global trials which led to regulatory approval for Flucelvax, Bexsero and an expanded indication for Menveo in children.

Dina grew up in Asia and Africa, earned her bachelor’s degree from Clark University and her Master’s in Public Health from Boston University.

Matt Weinberg is Director of Strategic Sourcing for Agios Pharmaceuticals, a biotech company focused on developing treatments for cancer and rare diseases through scientific leadership in the field of cellular metabolism.  The Agios Sourcing team is small but mighty.  Matt has responsibility for leading the group and also supports the Clinical Development and Commercial functions.

Christine has worked in leadership roles in biotech for the last twenty-five years, with experience in process improvement, outsourcing, partnership strategies and clinical technology leadership. Christine is currently Vice President of Clinical Business Operations and Innovation at Relay Therapeutics.

Susan Stewart has served as Kaleido’s Senior Vice President, Regulatory Affairs & Quality since April 2018. Ms. Stewart has worked for more than 27 years in biopharmaceutical regulatory affairs, with significant experience devising innovative strategies for novel therapeutics, overseeing regulatory submissions at various stages of product development and leading interactions with global health authorities. Previously, in addition to being an independent regulatory consultant for several years, she was senior vice president of regulatory affairs, quality, and compliance at Tokai Pharmaceuticals and vice president, regulatory affairs at Transmolecular. She also spent more than 13 years at Genzyme Corporation in regulatory and compliance roles, including serving as vice president, regulatory affairs. She received her J.D. from Concord Law School at Purdue University Global and her B.A. from the University of Massachusetts.  She holds both US and EU RACs.