Highlights of the Quebec “Drug Discovery to Development” Symposium

Highlights of the Quebec “Drug Discovery to Development” Symposium

In today’s drug development climate, we’re encouraged to “think global, act local.” I have had the privilege of supporting the development of important new therapies for clients around the globe. But sometimes, it is helpful to take a step back and look at the exciting science going on in your own backyard. With that spirit in mind, I recently attended “Discovery to Development VII: Screening and Testing in the Current Era”, a symposium held at the Institut Armande Frappier in Laval, Quebec, Canada. The event was co-sponsored by CiToxLAB and Centre National de Biologie Experimentale (National Center for Experimental Biology).

This year’s meeting was the 7th annual one-day symposium organized by Jean-Pierre Moreau, a scientist/consultant with over 25 years of experience in preclinical and clinical drug development in the Montreal-area pharma/biotech/CRO space.

The highlights of the meeting included:

  1. New players in the Quebec biotech community: PairImmune and Biodextris are newly-formed CRO’s and each gave presentations on their capabilities. These companies were formed as a result of the closure of the GSK vaccine facility in 2015. Not surprisingly, both companies offer services tailored to immunology, vaccine production, bioproduction, and related analytical services
  2. Insights into transporter-mediated DDIs: Solvo Biotech provides in vitro models in order to characterize drug transporter mechanisms at work in NME’s. Transporter data is now mandated by FDA and other regulators as part of NDA submissions as this can have direct implications on potential drug-drug interactions in a clinical setting. Solvo has built a database of marketed drugs and their known DDI characteristics.
  3. Certara Strategic Consulting supports development of First Needle-Free Rescue Treatment for Severe Hypoglycemia: Claude Piché from Locemia Solutions (formerly AMG Medical) presented their journey in developing an intranasal delivery system for glucagon. The “icing on the cake” was the deal they signed last year with Lilly. Certara Strategic Consulting (CSC) did two pharmacokinetic studies for AMG Medical on glucagon in 2011 and 2012. In his talk, Claude recognized all their consulting partners, including CSC.  A rare but well-deserved Quebec biotech success story!
  4. Business partners from the States: Several preclinical CRO’s from the New England region have joined to form the Northeast Preclinical Network. They offer a range of in vivo/in vitro drug development services, including PK services.
  5. Lessons from Bial: The symposium closed with an open forum discussion on the Bial clinical trial tragedy from earlier this year. The discussion focused on the available preclinical data for the drug in question. The consensus was that the Bial drug may block another unidentified protein or biochemical pathway. Given the low target specificity and minimal efficacy of the compound, the audience questioned why it was brought into clinical development in the first place. My colleague, Neil Benson, recently gave a webinar on this topic and how quantitative systems pharmacology informs drug development.

The Canadian biotech community is clearly making important contributions to drug development both locally and globally. I look forward to hearing even more exciting research developments at next year’s symposium.

All information presented derive from public source materials.

Certara Strategic Consulting accelerates pediatric drug development

My colleague in Montreal, Dr. JF Marier, recently wrote an article for Applied Clinical Trials on how modeling and simulation can help sponsors ensure that informative pediatric trials are performed and will gain approvals based on a smaller number of pediatric patients. I hope that you’ll read this article and let me know what you think in the comments section!

Mark Reimer

About the Author

Dr. Reimer leads a highly skilled team of clinical pharmacologists, pharmacometricians, biostatisticians, and medical writers who are committed to providing high-quality, regulatory-compliant PK/PD analysis and reporting services for the pharma/biotech industry. He is an experienced leader in the development of new drug therapies with over twenty-five years of progressive scientific, managerial and executive responsibilities in the field of drug research, including ADME/T and bioanalysis. His experience includes the design, execution and interpretation of a wide variety of preclinical services used in the pharmaceutical and biotechnology industries to bring new molecular entities through the drug development process. He led preclinical research efforts at Theratechnologies, a major Canadian biopharmaceutical company, and was responsible for the inception, build-out, and consistent profitability of the drug metabolism unit at MDS Pharma Services, at the time one of the world’s top-five contract research organizations. Dr. Reimer earned a PhD in chemistry at the University of Manitoba and completed a post-doctoral fellowship at the College of Pharmacy of the University of Arizona.