DIA: Driving Insights to Action

TransCelerate BioPharma Clinical Quality Management System Conceptual Framework

A podcast featuring the activities of a TransCelerate BioPharma working group addressing Quality Management Systems (QMS) and their initial outline of a proposed conceptual framework for a clinical QMS. TIRS Editor-in-Chief Dr. Stephen Spielberg leads the conversation with Deb Driscoll from Merck, who leads the TransCelerate Quality Management Systems Initiative and Ann Meeker-O’Connell from Johnson &Johnson, who is the lead author on a paper “Enhancing Quality and Efficiency in Clinical Development Through a Clinical QMS Conceptual Framework: Concept Paper Vision and Outline” in the September, 2015 issue of TIRS.

Patient Engagement and Rare Diseases at DIA

Durhane Wong-Rieger, President & CEO of the Canadian Organization for Rare Disorders speaks with Alberto Grignolo about patient involvement and engagement, and the future of drug development for rare diseases. Dr. Wong-Rieger is the first DIA Board Member to represent the voice of the patient. 

Ethical Considerations in Policies on Drug, Device, and Companion Diagnostics Development

Dr. Wendy Lipworth, Dr. Ric Day and Dr. Luann Van Campen discuss the ethical dimensions of policies on medicine development in this podcast, hosted by TIRS Editor-in-Chief Dr. Stephen Spielberg. To view all articles from the TIRS Special Section on Ethics, click here. 

Medical Communications Transformation and Impact on Health Care Community

Medical communications departments are constantly evolving to keep up with the changing landscape of health care. DIA is proud to provide a forum for Medical Communications professionals at our annual Medical and Scientific Communications Annual Meeting, which held its 25th anniversary event in 2014. To recognize the changes that have occurred within the medical communications field over the last 25 years, we were pleased to include a special section devoted to the Medical Communications Transformation in the November issue of TIRS. This podcast highlights several of the authors from that section discussing globalization and new media trends that influence medical information dissemination and the effect this is having on the emerging healthcare landscape. 

To read the articles discussed in this podcast see below: 
Article 1: Introduction to the Special Section on Medical Communications: Medical Communications Transformation Within the Emerging Health Care Landscape. 
Article 2: Review of the Evolution of Medical Information in Light of Changes in the External Landscape. 
Article 3: Medical Information Services: How Are We Trending?. 
Article 4: Serialization: Benefits Beyond Regulatory Compliance.

Challenging the Value of Source Data Verification

Non-profit group TransCelerate BioPharma Inc. has brought together several working groups to identify more efficient and effective approaches to the process of new drug development. In this podcast, Dr. Stephen P Spielberg discusses efforts to improve quality control in clinical trials with key contributors to the TransCelerate efforts. Participants are Nicole Sheetz, Advisor, Clinical Innovation and Implementation, Eli Lilly and Company, Brett Wilson, Associate Director, Central Clinical Services, R&D Operations, Bristol-Myers Squibb; and Mark Travers, Vice President, Head of Clinical Study Units, Clinical Sciences & Operations, Sanofi. Click here to read the full article. 

The Impact of Collaborative and Risk Sharing Innovation Approaches on Clinical and Regulatory Cycle Times

A discussion of the consequences of mergers and acquisitions on medical product development times with Joseph DiMasi and Kenneth Getz of the Tufts Center for the Study of Drug Development. Click here to read their article from the July 2014 issue of TIRS.

How to Get Published with DIA

Learn more about opportunities to publish with DIA, where to find author guidelines and how to submit your manuscript, from Judy Connors, DIA’s Associate Director, Editorial Services. 
 

Perspectives on Statistics

TIRS Statistics Editor Richard Zink and fellow Editorial Board member Rick Turner discuss the January 2014 Special Issue on Statistics, and the future of statistics in drug development. Read this special issue.

An Expanded Role for Patients in Clinical Trial Design

A discussion with Dr. Anne Rowzee of the Center for Drug Evaluation and Research, US FDA about patient input into the design of studies of medicines for multiple sclerosis. Click here for the full article. 

Women and Children First—Time for a Coalition to Address a Substantial Patient Need

A conversation with Dr. Lode Dewulf and Editor-in-Chief, Dr. Stephen P. Spielberg about Dr. Dewulf's article in Therapeutic Innovation & Regulatory Science, the official journal of the Drug Information Association, addressing therapeutics during pregnancy. Click here to access the full article.