Best Practices - Preclinical Development Workshop
SESSION THEMESMaRS is proud to collaborate with the industry experts from Ricerca BioSciences, a leading pre-clinical development contract research group, to provide a comprehensive overview of pre-clinical drug discovery and development. The workshop will cover the entire drug development process, as it currently exists, from early drug discovery through chemistry, efficacy models and safety, all overseen by a regulatory process. This workshop will formulate a good understanding of the intricate elements required for effective drug development for the novice, as well as the biopharmaceutical professional. MORE INFORMATIONClick here to find out more about the MaRS Best Practices Event Series >> |  |
DATE | TIME | LOCATION
May 23, 20078:15AM - 3:00PM
Health Sciences Building
6th Floor, Room 610
155 College St, Toronto
Google map | UofT map
DOWNLOADS AND RESOURCES
James Ault, Quality and Regulatory Affairs:Richard Donaldson's presentation, VP Chemical Development:
Jack Jiang's presentation: Drug Discovery: The Origin of New Chemical Entity Pharmaceuticals
AGENDA
8:15 - 8:30am - Coffee and muffins
8:30 - 9:00am - Introduction and developmental overviewLeigh Berryman, COO, Ricerca BioSciences
An introduction to the many changes the pharmaceutical industry has seen over the past decades as a business and as a science, and their implication to drug discovery and development today. 9:00 - 10:00am – Drug Discovery – The origins of New Chemical Entity Pharmaceuticals
Jack Jiang, VP Medicinal and Analytical Chemistry, Ricerca BioSciences
Expectedly, the best solution comes at a price. NCEs are the most difficult type of products to develop, requiring the longest development time, the most stringent tests, the tightest FDA scrutiny, and the highest capital investment.
As a drug developer in such a competitive environment, what is your strategy to identify NCEs with the greatest potential for an approved drug product? We will go over the discovery process and address key issues along the path, while hopefully providing you with some insights for success.10:00 - 10:15am - Break
10:15 - 11:15am - Lead Candidate to IND, Chemical DevelopmentRich Donaldson, Director Process Chemistry Ricerca BioSciences
Once a clinical lead candidate has been identified, chemical development and biology testing are needed to gather the data required for IND filing. This work is best completed by coordination between chemistry and biology components. On the chemistry side, process research to develop a chemistry route that is sufficiently robust to synthesize test article for biology is the first requirement. Successful efficient scale-up to produce kilogram quantities of non-GMP and cGMP API is the ultimate goal. We will explore how these various programs fit together from the chemistry perspective. There will also be some discussion of what analytical chemistry is needed for chemistry and biology support.11:15 - 12:15pm - Pharmacology/Animal models for the Bio-Entrepreneur
Randy Jones, VP Biology Sciences, Ricerca BioSciences
Animal models of human disease are used to screen drug candidates for potential therapeutic efficacy focusing on pharmacology and mechanism of action. Established disease models require less time and development expense but may lack specificity. Custom model development and validation that lead to proof-of-concept studies are more expensive and time consuming.Application of in vitro cell-based and in vivo anti-tumor assays, anti-infectivity models, and anti-inflammatory models will be presented, as they are likely to remain important for development of drug candidates for an aging population.
Animal models are an important bridge between discovery and development as well as an initial opportunity to integrate biology and chemistry during the preclinical IND process.12:15 - 1:00pm - Lunch Break
1:00 - 2:00pm - Toxicology in Drug DevelopmentMike Watson. Exec Director Drug Development Services, Ricerca BioSciences
The basic science of toxicology will be explored – what type of testing is performed and why is it done and how that science is applied to the drug development process. What tests need to be performed before a drug is first administered to man? How do people look at the results of these tests and relate these results to proposed clinical testing programs? As the drug development program continues, larger and more complex clinical trials are performed. These need to be supported by further toxicology studies. We will review the progressive planning for the toxicology research program and look at the challenges that need to be overcome in planning a toxicology testing program to support drug development from lead optimization through IND to NDA.2:00 - 3:00pm - Regulatory IND process
Jim Ault, VP Regulatory Affairs, Ricerca BioSciences
Taken mostly from a US FDA perspective, the pieces and parts of an IND will be examined as well as the strategy that is necessary to formulate a successful regulatory plan. While the previous presentations have provided reference to the timing of events, the overall plan must accommodate circumstances that may become issues during the development process. Structured management of the strategy is the key element to meeting milestones and managing the risks. The most frequent reasons for clinical holds will be presented and discussed. Interaction with the regulatory authority and the required and optional meetings will be presented.3:00pm - Closing remarks and question period with panel
If you have any questions regarding this event, please contact Assunta KrehlEmail: akrehl@marsdd.com
Call: 416.673.8114
ABOUT RICERCA BIOSCIENCES
Ricerca Biosciences' integrated drug discovery service model is the only one in North America that can take hit compounds, then utilize medicinal chemistry coupled with ADMET to optimize those hits and take the compound deep into preclinical toxicology (in vivo), and on to an IND. Ricerca's chemistry group and pilot plant are also capable of making a drug candidate efficiently and scaleable for Phase I and early Phase II testing. Ricerca has been servicing the biopharmaceutical Industry with its unique "one-stop-shopping" service model for over 20 years.
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