DIA: Driving Insights to Action

Oligonucleotides Driving Personalized Medicine Research

Oligonucleotides, short nucleic acid polymers used for research and genetic testing, have emerged as a critical element challenging scientists, clinicians and regulators working in personalized medicine. “Instead of targeting proteins like small molecules typically do, with oligonucleotides you're typically targeting nucleic acid, the DNA inside the cell, the genes in the nucleus, or the mRNA in the cytoplasm. So it greatly expands the capabilities of a drug to alter the biology of a cell,” explains Dr. Arthur Krieg, President and CEO of Checkmate Pharmaceuticals, an oligonucleotide expert and inventor on 48 US-issued patents. Dr. Krieg also serves on the program committee developing DIA’s Oligonucleotide-Based Therapeutics Conference. “It's a challenge for regulators as it's a challenge for scientists working in the field, too, to keep pace with all of this. That's one of the areas where the DIA/FDA Oligonucleotide meeting is so important,” he explains in this Global Forum podcast.

Celebrating 150 Years with Better Care for Canadians

In 2017, Canada celebrates its sesquicentennial – 150 years of Confederation! Changes in Canada’s health care product development and regulatory systems, such as the Protecting Canadians from Unsafe Drugs Act (“Vanessa’s Law”) and the rising tide of increased transparency within and between industry and regulators, aim to ensure another 150 years of health and prosperity for its citizens. “Health Canada has a number of transparency initiatives underway in terms of helping Canadians to better understand why or why not decisions are made in terms of pharmaceuticals and medical devices,” explains Marilena Bassi, Director of the Therapeutic Products Directorate at Health Canada in this exclusive Global Forum podcast. “All the changes being proposed by Health Canada are really to make decision-making by the consumer much more easy, for them to choose the right product for whatever condition they are seeking help with,” concurs Deirdre Cozier, Director of Labelling, Advertising and Operations at Pendopharm, a Division of Pharmascience in Canada. Marilena and Deirdre will co-chair DIA’s 2017 Canadian Annual Meeting.

Future Science & Drug Review: FDA Closing the Gap

What is regulatory science? Who does it impact and how? In this exclusive Global Forum podcast, Dr. David Strauss, Director of the Division of Applied Regulatory Science in the FDA Office of Clinical Pharmacology, discusses intersecting advancements in regulatory, basic, and clinical science, including the model-informed drug development provisions of PDUFA VI. “The Division of Applied Regulatory Science was created to move new science into the CDER review process and close the gap between scientific innovation and drug review,” explains Dr. Strauss. “We perform mission-critical applied research and review across the translational research spectrum that includes in vitro and in vivo laboratory research, in silico computational modeling and informatics, and integrated clinical research covering clinical pharmacology, experimental medicine, and postmarket analyses. We try to focus on things where FDA can really provide unique value.” Bonus Reading: Translating New Science Into the Drug Review Process: The US FDA's Division of Applied Regulatory Science.