DIA: Driving Insights to Action

Dr. Kemal Malik Ponders “Is Innovation Always the Answer?”

In a world in which new therapies are being developed at a phenomenal rate, is innovation always the answer? Organized around the theme INnovation: Do You Win by Being IN?, our 28th Annual DIA EuroMeeting explored when, where, and how, innovation leads to advances in health care product development. In this podcast, DIA Global Forum Deputy Editor Dr. Alberto Grignolo interviews EuroMeeting Co-Chair Dr. Kemal Malik, who serves on the Board of Management for Bayer, Germany, about innovation and related topics.

EMA Senior Medical Officer Explains “Access versus Evidence Tradeoff”

As Senior Medical Officer of the European Medicines Agency, Dr. Hans-Georg Eichler has advised the EMA Executive Director on scientific and public health issues since 2007. Dr. Eichler concurrently serves on several medical advisory boards at the Austrian Ministry of Health, and will serve as Co-Chair for our DIA 2016 Annual Meeting in June 2016, in Philadelphia. In this conversation with DIA Global Forum Deputy Director Dr. Alberto Grignolo, Dr. Eichler shares his hopes for the utility of big data and real world data, and other critical issues in drug development and regulatory science.

DIA 2016 Co-Chair: "A Market for Ideas" in a Global Forum

Dr. Hans-Georg Eichler, Senior Medical Officer for the European Medicines Agency and meeting co-chair, discusses his "gold nugget" expectations for our DIA 2016 Annual Meeting in this compelling interview conducted by Dr. Alberto Grignolo, Deputy Editor for the DIA Global Forum.

Advances and Best Practices in Communications with Consumers and Health Care Professionals

Lesley Fierro, RPh, MS, PharmD (Fellowship Consultant, Rutgers Institute for Pharmaceutical Fellowships) from the DIA Medical Communications Community interviews three students presenting research posters at the DIA Medical Affairs & Scientific Communications 2016 Annual Forum: Leeann Lui, who discusses the importance of medical communications in joint ventures; Kristina Brundra, who explores the role of medical communications in a new product launch; and Monica Salah, who compares the different impact of pharmacists working with and without PharmD degrees in medical call centers. You can personally discuss this research with these authors at our Medical Affairs & Scientific Communications 2016 Annual Forum or Medical Affairs & Scientific Communications 2016 Virtual Conference.

Challenges in Deploying a Global Pharmacovigilance System

David Balderson, Vice-President of Global Safety Operations at Sciformix, discusses the challenges of deploying a global pharmacovigilance (PV) system and the different aspects of these challenges posed to small, medium, and large companies.

Challenges in Adverse Event Reporting and the Role of Specialty Pharmacies

Dr. Sameer Thapar (Assistant Professor and Advisor, Drug Safety & Pharmacovigilance, MS Clinical Trial Sciences Program, Biomedical & Health Sciences, Rutgers University) and graduate student Katelin Tonner-Ingram discuss the challenges faced by manufacturers regarding adverse event reporting, a recent shift in who is actually reporting adverse events, and the role of specialty pharmacies in risk management.  To learn more about adverse event reporting and risk management, plan to attend the DIA Pharmacovigilance and Risk Management Strategies 2016 conference.

Access & Attitude to Clinical Trial Technology: The Global Investigator Perspective

Adopting new technology is crucial if the pharmaceutical industry is to measurably improve drug development efficiency. Elisa Cascade (President, Data Solutions, DrugDev) expands upon an article in the October 2015 Global Forum she co-authored with Dr. Claire Sears (DrugDev Director of Investigator Engagement) and discusses in detail the findings from a 2015 survey of DrugDev network investigators to answer the question: With sponsors, regulatory authorities, CROs, and technology companies all working together, are sites, globally, prepared to implement new clinical trial technologies?

What Precision Medicine Means Today and Will Mean Tomorrow for Patient Care

Hosted by Global Forum Deputy Editor Dr. Alberto Grignolo, this podcast recaps and expands upon the Special Section: Precision Medicine in our June 2015 Global Forum with four of the authors who contributed articles to this section in a joint discussion of what Precision Medicine means today and the implications of this exciting new field for patient care. Joining Dr. Grignolo are Special Section Editor Dr. Gary Kelloff, Special Advisor at the (US) National Cancer Institute, NIH, and Global Forum Content Editor for Science, Discovery, and Translational Medicine; Dr. Ellen Sigal, Chairperson and Founder, Friends of Cancer Research; Dr. Eric Rubin, Vice President & Therapeutic Area Head, Oncology Early Development, Merck Research Laboratories; and Dr. Gideon Blumenthal, Clinical Team Leader for Thoracic and Head/Neck Cancer, CDER, FDA.

FDA Director of Division of Online Communications, CDER, Discusses FDA's First Mobile App

Paul Buckman, Director of the Division of Online Communications at FDA’s Center for Drug Evaluation and Research, discusses FDA’s first mobile app, the Drug Shortages app, and also the brand-new Orange Book Express mobile app. This podcast, hosted by Adam Istas, Global Forum Content Editor for Media, Communications and Social Media, also covers the ever-expanding role of mobile technology in our daily lives and the role of mobile applications in FDA’s efforts to improve proactive stakeholder communication. Read highlights from this DIA interview, or learn more about this app from the FDA website.

Pediatric Drug Development & Therapeutics in September TIRS

Our September issue of TIRS features a Special Section on Pediatric Therapeutics, a remarkable series of articles on pediatric drug development and therapeutics -- from new genomic targets for drug discovery, to new clinical trial paradigms, to formulation acceptability validation, to patient-centric global networks, to a comprehensive view of pediatric regulatory requirements. Stephen P. Spielberg, MD, PhD, FAAP, and Ronald Portman, MD, FAAP, discuss this amazing collection of articles, all in one convenient place, to help inform the future of pediatric drug development.