What Preclinical Studies should be Conducted to Enable an IND?



October 26, 2010
11:30 a.m. to 1 pm EST

Instructor:  Stanley A. Roberts, Ph.D., D.A.B.T., Principal, SAR Safety Assessment LLC (an independent consulting company)

Symposium Course Description: This course will provide a comprehensive discussion of the types of preclinical studies that should be conducted to file a successful IND.  This talk will focus on the types of pharmacology, pharmacokinetic (PK), drug metabolism (ADME), toxicology and pathology studies that can and/or should be conducted for both small molecular weight (NCE) and biotherapeutic (NBE) candidate compounds.  The various strategies and experiments including study design objectives and details will be presented for many of these studies.

Learning Objective Bullet Points: 

  • Develop an appreciation of what preclinical studies should be done to demonstrate safety and efficacy for a successful IND application.
  • Present the objectives, study details and strategies for the planning, conduct and reporting of the various preclinical studies.
  • Compare/contrast the studies and strategies conducted for NCE and NBE candidate compounds.
  • Develop an appreciation of the value of scientifically integrating all of the data and observations that are generated by the preclinical development of a candidate compound.
  • Understand the regulatory expectations for the studies to be submitted in an IND.


Who Should Attend:  Scientists and managers in Discovery, Drug Safety, Drug Metabolism and Project Management

Stan Roberts Instructor Biography:  Stan Roberts is an independent consultant in toxicology, drug metabolism, pharmacokinetics and drug development.  He has over 29 years in scientific and management positions in large (Sandoz, Abbott & Pfizer) and small (CovX) companies.  He has planned, conducted, interpreted and reported all types of toxicology studies plus created development plans and strategies. Accomplishments include authoring over 400 internal final reports, major contributions to numerous regulatory submissions (IND & NDA) and conducting research that has determined the human relevance of animal toxicities. Stan has also held leadership roles in Drug Metabolism and PK during which ADME/PK research was significantly reoriented directly resulting in a marked improvement in the quality of new drug candidates selected for further development.  Stan’s experience in targets includes neuroscience, inflammation, immune modulators, lipid modulators, infectious and metabolic disease using both synthetic new chemical entities and large (peptides, proteins & monoclonal antibodies) molecules. Stan is experienced with in-/out-licensing activities, representation on multidisciplinary teams and has presented to the FDA.  He participates in numerous committees and special projects for PhRMA and BIO.  Stan has a BS (Animal Science), MS/PhD (Pharmacology & Toxicology) from Purdue and post-doctoral fellowship in Molecular Toxicology.  He is also a Diplomate of the American Board of Toxicology.

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