Archives: Speakers

Matt Weinberg

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 Hurley

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.

Heather DiBenedetto

Heather DiBenedetto is the Head of Therapeutic Operations at Moderna Therapeutics and is based in Cambridge, MA.  Moderna Therapeutics is a platform company focused on messenger RNA therapies across a broad range of therapeutic areas including immune-oncology, infectious disease, rare disease and cardiovascular. Heather joined Moderna Therapeutics in 2016 from Novartis, Translational Clinical Oncology where she was the Global Head of Clinical Operations.  She managed a global team of ~120 clinical operations, clinical scientists, compliance, planning, operational excellence and biomarker professionals overseeing >60 global oncology studies.  Prior to Novartis, Heather led a Strategic Partnership and Start up group at Millennium Pharmaceuticals (now Takeda.  Previously Heather held roles of increasing responsibilities on both the Biotech and CRO side.  Heather holds a M.S. degree in Drug Regulatory Affairs & Health Policy from the Massachusetts College of Pharmacy & Health Sciences and a B.A. in Zoology from the University of Vermont.  Heather is Regulatory Affairs (US) certified.

Susan Stewart

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.

Kelsey Miller

Kelsey started her career in academics with The Boston Spine Group at the renowned New England Baptist Hospital. There she developed and managed their patient registries as well as their investigator and IDE clinical trials.  After 7 years at the Baptist she joined Impliant (a start-up medical device company), where she served as their Clinical Marketing Manager overseeing their US IDE, as well as post-market clinical trials in Brazil, Israel and Belgium. Since 2011 Kelsey has been with Intrinsic Therapeutics in their Clinical department successfully guiding the company’s flagship product through PMA approval.

Elena Gergert

–          Msc. in pharmaceutical science

–          Over 3 years experience in regulatory affairs within pharmaceutical and medical device industry

–          In depth knowledge about CCDS, labeling, IFU, SmPC and PIL preparation and coordination within global organizations

–          Experienced in pharmacovigilance, change management and project management