On April 23, Michael Reilly participated in the Food and Drug Law Institute (FDLI) 2013 Annual Conference, speaking on a panel on the priorities and challenges facing the FDA and the Center for Biologics Evaluation and Research (CBER). Following presentations … Continue reading
On December 13th, ASBM members were invited to take a tour of a biologics manufacturing facility in Rhode Island to learn about the intricacies and complex processes involved with making biologic medicines.
On December 6th, Chairman Richard Dolinar, M.D., and Executive Director Michael Reilly toured a biologic manufacturing facility in Longmont, CO. Several ASBM members also participated on the tour which was arranged to help attendees better understand the complexities of manufacturing … Continue reading
The Alliance for Safe Biologic Medicines (ASBM), the International Cancer Advocacy Network (ICAN) and AZBio hosted “Biosimilars Policy Forum: Ensuring Patient Safety” on September 27, 2012 in Phoenix, AZ, to discuss the complex challenges the Food and Drug Administration (FDA) … Continue reading
On September 13, Dr. Dolinar presented on two panels at the DIA/FDA Biosimilars Conference: Guidances, Science, and BsUFA in Washington, D.C. His first panel was on Pharmacovigilance, Naming, and Labeling and the second panel was on Interchangeability. DIA Presentation on … Continue reading
On June 4, Alliance Chairman Dr. Richard Dolinar and Executive Director Michael Reilly presented at the Canadian Patient Experts in Health Technology forum in Toronto, Canada. The forum was organized by Durhane Wong-Rieger, president of the Canadian Organization for Rare … Continue reading
On February 27, 2012, the Alliance for Safe Biologic Medicines and Bloomberg Government hosted a lunch time Biosimilars Forum on Capitol Hill to discuss the FDA’s draft guidance documents on biosimilar product development.
By Kathy Feegal Dr. Richard Dolinar, the Alliance’s chairman, was a keynote speaker at a biosimilars roundtable discussion in Boston, MA on October 5, 2011. The event was hosted by Northeastern University and was attended by numerous stakeholders from across … Continue reading
The Alliance for Safe Biologic Medicines joined with the Virginia Biotechnology Association at an event to expore with patients, advocates, physicians and other healthcare providers the importance of maintaining patient safety as the U.S. FDA’s top priority while it works … Continue reading
The Alliance for Safe Biologic Medicines and Pennsylvania Bio hosted an event entitled, “Biosimilars Policy Forum: Ensuring Patient Safety” in Philadelphia, PA, on August 17, 2011 The purpose of the forum discussion was to explore with community members, including policymakers, … Continue reading