DIA: Driving Insights to Action

DIA Forum Acts on Statistical Impact of 21st Century Cures

The 21st Century Cures Act provides significant funding for scientific and medical research to promote innovation that speeds development of treatments for cancer and similar devastating diseases. Many such innovations, like using real-world evidence and patient-centered drug development, themselves require innovation in how data is collected and analyzed as scientific and regulatory evidence. In this exclusive podcast, Deputy Director for the Duke Margolis Center for Health Policy Dr. Gregory Daniel shares his expert perspective on the role that statisticians will play in advancing these initiatives. A Senior Advisor to the Reagan-Udall Foundation for the FDA, Dr. Daniel will also be a featured speaker at DIA’s Annual Statistics Forum. “What FDA really needs is to engage with statisticians within FDA but also outside of FDA, to better understand these statistical techniques, establish best practices for them, and how to ensure that their results are valid and reliable,” he explains. Register to attend DIA’s Annual Statistics Forum!

Q12 Aims to Align CMC with Accelerated Development & Approval

Dr. Moheb M. Nasr, who serves as Vice President, CMC Regulatory Strategy for GlaxoSmithKline, is a member and rapporteur of the Expert Working Group for the ICH Q12 Guideline, Technical and Regulatory Considerations for the Pharmaceutical Product Lifecycle. “We realized that the ICH 8 through ICH 11 Guidelines were mostly on the development stage of the life cycle, and there is a gap that needs to address the commercial phase of the life cycle,” he explains in this exclusive Global Forum podcast. “Hence, there was an agreement to develop an ICH Q12 to address this gap and in particular to develop a roadmap to facilitate the management, from the technical, commercial, and regulatory perspectives, of the life cycle.” Dr. Nasr also serves on the program committee for DIA’s 2017 CMC Workshop, where he will co-chair the session that further explains the Benefits and Challenges of ICH Q12 Life Cycle Management. Register to attend the DIA 2017 CMC Workshop!

EuroMeeting Preview: Real-World Data + AI = Clinical Evidence?

Using social media and artificial intelligence (AI) in health care product development presents opportunities and challenges to regulatory systems and professionals in the EU. “The use of artificial intelligence, in terms of deep learning tools but also automation and things like that, is an area in the making, and there are a number of companies which are involved in these kind of tools and trying to adapt them to use in the pharmaceutical and clinical environment,” explains Dr. Joseph Scheeren, Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer Consumer Care, Switzerland. “We will see a high flight of these tools in order to help us to further generate real-world evidence for the use of medical evidence questions.” In this exclusive podcast, Dr. Scheeren further explores this topic and previews the Major European Regulatory Science Challenges DIAmond session which he will co-chair at the DIA EuroMeeting 2017 in Glasgow, Scotland. Register for our DIA EuroMeeting 2017 today!