Pre-competitive collaboration among pharmaceutical companies is leading to advances in critical aspects of drug development. This podcast delivers expert discussion of TransCelerate's Clinical Quality Management Systems, based on their article TransCelerate's Clinical Quality Management System: From a Vision to a Conceptual Framework in the July 2016 issue of Therapeutic Innovation & Regulatory Science (TIRS).
Dr. Pamela Tenaerts serves as Executive Director of the Clinical Trials Transformation Initiative (CTTI), a public-private partnership of more than 60 organizations working together to identify and promote practices that will increase the quality and efficiency of clinical trials. In this exclusive podcast, Dr. Tenaerts reviews CTTI’s antibacterial drug development program, previews her session Opportunities for Improving Informed Consent of Clinical Research Volunteers at our DIA 2016 Annual Meeting in Philadelphia, and shares highlights of CTTI’s new strategic plan, with DIA Global Forum Deputy Editor Dr. Alberto Grignolo.
Who determines how much society and/or patients should pay for a medicine? And how are those determinations made? Dr. Alberto Grignolo, Deputy Editor for DIA’s Global Forum, discusses these and related questions with Professor Sarah Garner, Associate Director, Science Policy & Research, for the UK's National Institute for Health and Care Excellence (NICE), and a pharmacist with special expertise in the interface between Health Technology Assessment (HTA) and regulation. Professor Garner will participate in a panel discussion on Value-Based Health Care Decision Making: The Quest for Smarter Spending at our DIA 2016 Annual Meeting in Philadelphia.
Dr. Gigi Hirsch is the Executive Director of the MIT Center for Biomedical Innovation (CBI). As part of her mission to innovate the drug development process, Dr. Hirsch will serve as Co-Chair of the DIA 2016 Annual Meeting in Philadelphia, where she will also participate in a panel discussion on Europe and the US: Making Outcomes-Based Health Care Possible. “DIA provides an incredibly powerful platform for engaging globally around some of the most important innovations that are happening in real time and need to continue to evolve,” she explains in this exclusive interview with DIA Global Forum Deputy Editor Dr. Alberto Grignolo.
Effective engagement between patients and industry, regulatory agencies, and other stakeholders, requires organizational cultures that place high priority and focus on patients. As Associate Director, Diversity & Patient Engagement, for Bristol-Myers Squibb Company, Mary Stober Murray builds relationships with advocacy organizations, patient communities, and provider communities, to keep them informed, educated, and prepared to support clinical development of BMS compounds. Mary will contribute her voice to the panel discussion on Changing Cultures to Advance Patient Engagement during the DIA2016 Annual Meeting in Philadelphia, and shares her experiences in this exclusive interview with DIA Global Forum Deputy Editor Dr. Alberto Grignolo.
Dr. Yves Juillet, Secretary General of the Academy of Medicine Foundation in France, is one of the persons most responsible for DIA’s first formal steps into patient engagement. For more than two decades, Dr. Juillet has been deeply involved with DIA, serving on the Advisory Council of Europe, the Board of Directors, and as DIA President. In 2013, he was named Honorary President of the French Academy of Pharmacy and was also named a DIA Fellow, the organization’s highest honor. In this exclusive Global Forum interview, Dr. Juillet shares what inspired these first steps and reflects on DIA’s subsequent journey into patient engagement.
“Outbreaks are inevitable. Pandemics are preventable.” – DIA 2016 Keynote Speaker Dr. Larry Brilliant
As Chairman of the Skoll Global Threats Fund, whose mission is to confront pandemics, climate change and other global threats, and co-founder of The Seva Foundation, an international NGO whose programs and grantees have returned sight to more than 3.5 million people in more than 20 countries, Dr. Larry Brilliant is a catalyst for change around the globe. A United Nations medical officer in India, a key player in the successful World Health Organization (WHO) smallpox eradication program in South Asia, and soon-to-be author (Sometimes Brilliant, October 2016 release), Dr. Brilliant explores how emerging technologies are both facilitating and preventing the spread of pandemics, and previews topics for his DIA 2016 Keynote Address in this exclusive interview with DIA Global Forum Co-Editor for Media, Communications and Social Media Adam Istas (Quintiles).
Nanotechnology, mobile medical apps, 3-D printing, and other innovations in medical devices, companion diagnostics, and combination products, plus new Medical Device and In Vitro Diagnostic Device Regulations, are all part of the changing scientific, legislative, and regulatory landscape for Medical Devices in the EU. John Wilkinson, Director of Devices for the Medicines and Healthcare Products Regulatory Agency (MHRA), UK, and co-lead for DIA’s 28th EuroMeeting Medical Devices Theme, discusses these and related topics with DIA Global Forum Deputy Editor Dr. Alberto Grignolo.
The Health Technology Assessments (HTA) Theme of DIA’s 28th Annual EuroMeeting overviewed topics at the crossroads of regulatory, traditional HTA, and payer discussions. In this podcast, Edith Frénoy, Director for Market Access and HTA for the European Federation of Pharmaceutical Industries & Associations (EFPIA), Belgium, discusses current policies and upcoming issues with DIA Global Forum Deputy Editor Dr. Alberto Grignolo.
In February 2016, Dr. Holger Adelmann was appointed Senior Vice President and Managing Director for DIA Europe, Middle East and Africa (DIA EMEA). Dr. Adelmann previously served as the Global Head of Merck Serono’s Clinical Pharmacology and Clinical Biomarker operations, where he re-engineered the Clinical Biomarker and Companion Diagnostics business to better align with the company’s upcoming portfolio. In this podcast from DIA’s flagship offering in Europe, our 28th Annual EuroMeeting, Holger and DIA Global Forum Deputy Editor Dr. Alberto Grignolo discuss the progress and promise of DIA EMEA.