New EU CTR: One Application, One Portal, One Decision

March 2, 2018

Harmonizing clinical trial assessment and supervision in the EU through the portal and database established by the new EU Clinical Trial Regulation, and maintained by the EMA, is not the only change rippling through clinical trials in Europe, explain Dr. Mireille Muller, Regulatory Policy Director for Novartis A-G in Switzerland; and Dr. Greet Musch, Director-General for Pre-Authorisation at the Federal Agency for Medicines and Healthcare Products of Belgium. Dr. Muller and Dr. Musch will help lead discussions on this topic at DIA Europe 2018.


US Generic Drug Policy: Less Cost, Same Impact

February 28, 2018

Maryll Toufanian, JD, Acting Director, US FDA Office of Generic Drug Policy, discusses the US FDA’s Drug Competition Action Plan, why US consumers can feel safe taking generic drugs, and how generic drugs can help reduce costs for healthcare patients and systems. Learn more at our Complex Drug-Device Generic Combination Products conference.


Multiple Pathways Complicate Opioid Pain Management

February 23, 2018

The World Health Organization recently estimated that, worldwide, more than 15 million people suffer from opioid dependence and roughly 69,000 people die from opioid overdoses each year. In this Global Forum podcast, Professor Edward Bilsky, an expert in opioid pharmacology and early-stage drug development who serves as the Provost and Chief Academic Officer at Pacific Northwest University of Health Sciences, discusses the importance of patient engagement in opioid pain management.


Breakthrough for Patients & Regulatory Science

February 22, 2018

Dr. Ellen V. Sigal, Chairperson and Founder of Friends of Cancer Research, discusses the advocacy organization’s role in the Breakthrough Therapy designation in this Global Forum podcast. Dr. Sigal is also Chair of the Board of Directors of the Reagan-Udall Foundation, serves on the Board of the Foundation for the National Institutes of Health, and serves on the Cancer Moonshot Blue Ribbon Panel established by Vice President Joe Biden.


DIA 2018 Co-Chair: Patient Activists Are “Our Best Friends”

February 16, 2018

In this Global Forum podcast, Dr. Julie Gerberding (Chief Patient Officer and Executive Vice President for Policy, Communications, and Population Health, Merck) discusses the evolution of patient engagement and her service as former Director for the US Centers for Disease Control and Prevention, as an executive sponsor of the Merck Women’s Network, and as honorary co-chair for DIA Global 2018 in Boston.


Need for Value Creates Opportunity for Patients

February 2, 2018

Today’s patients can get involved at either end of the “bench to bedside” cycle, explain Christopher McCabe, Executive Director and CEO, Institute of Health Economics (Canada), and Dimitrios Athanasiou, board member of United Parent Projects Muscular Dystrophy and patient representative to EURORDIS, who will also help guide patient engagement discussions at DIA Europe 2018.


Can Europe Optimize Healthcare Quality AND Pricing?

February 1, 2018

Processes to better determine a medicine’s value are discussed by Dr. Indranil Bagchi, Vice President, Value and Access, Novartis Oncology, and Dr. Thomas Szucs, Professor of Pharmaceutical Medicine and Director of the European Center of Pharmaceutical Medicine at the University of Basel, who will help lead discussions on value and access at DIA Europe 2018.


Rules for Successful Patient-Industry Engagement

January 23, 2018

Co-author Dr. Jeffrey Sherman, Chief Medical Officer / Executive Vice President at Horizon Pharmaceuticals, and DIA’s liaison to the Clinical Trials Transformation Initiative, reviews The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials with Ron Bartek, Co-Founder and President of the Friedreich’s Ataxia Research Alliance.


Multiple Channels Can Share “One Medical Voice”

January 18, 2018

Poonam A. Bordoloi, Associate Director, Strategic Medical Communications & Innovation, Celgene Corporation; and David Bowers, Medical Communications Director, PPD; overview the “One Medical Voice” theme running through DIA’s Medical and Scientific Communications Forum 2018.


Advertising & Promotion: What You Can (and Can’t) Say

January 4, 2018

Wayne Pines, President for Regulatory Services and Healthcare for APCO Worldwide, shares the history of healthcare products advertising and promotion, and previews DIA’s 2018 Advertising and Promotional Regulatory Affairs Conference.