Speakers: Dirk Mendel (E-Scape Bio), Stephen Gould (Genentech), Rana Samadfam (Charles River Laboratories), Peter Havel (UC Davis), Leon Hall (Mousera)
Organizers:
Date: Tuesday, May 31, 2016
Time: 12:30-17:00
Registration fee (US$): (USD$)Regular: $125; Academic: $75; For unemployed & students: $20; For vendor-show reps: $25; For major-sponsor rep (incl lunch): $0;
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: (1)Crown Bioscience Inc.
Vendor show vendors registered to date: (7)AIT Bioscience; Catalent; Charles River; ChemPartner; Cyagen Biosciences; eBioscience/Affymetrix; Nexcelom Bioscience
Registration: https://www.PBSS.org
Registration deadline:5/27/2016  (it will close sooner if the seating cap is reached)

About the Topic

Preclinical research and clinical research are two major components in the process of drug development. In preclinical research, one of the most important considerations is the use of animal models to study efficacy, mechanism of action and establish the pharmacokinetic/pharmacodynamic (PK/PD) relationship. Together with toxicology studies, these efficacy-related studies are essential for any new drug candidate to advance to clinical development and eventually reach the market. Questions are routinely asked and debated such as “how to select relevant animal models”, “how to optimize rodent models for reliability and predictability”, “what are the pros and cons of different models”, and “how to translate the animal results to clinical studies”. We have assembled an experienced team of speakers from academia, the biotech/pharma industry and contract research organizations to discuss these critical questions.

The workshop is designed for both pharmacologists and non-pharmacologists. Non-pharmacologists will benefit as they will gain a better technical understanding of the process and challenges, while experienced pharmacologists can see the best practices used by their colleagues at other companies.

The following topics will be covered at the workshop:

• Animal models in translational research: Fundamentals and Applications (Dirk Mendel, E-Scape Bio)
• Oncology: animal models and case studies (Stephen Gould, Genentech)
• Autoimmune Disorders/Inflammation: In vivo models and case studies (Rana Samadfam, Charles River Laboratories)
• Metabolic diseases: Fundamentals of Animal Models of Metabolic Disease (Peter Havel, UC Davis)
• Improving the predictability of rodent models (Leon Hall, Mousera)

Detailed Presentation Outlines:

Oncology (Dr. Dirk Mandel, E-Scape Bio and Dr. Stephen Gould, Genentech)
An overview of how to approach a new project from a translational perspective; how to start identifying the key questions for a given project

• A historical perspective to the use of preclinical mouse models in oncology research
• An understanding of the pros and cons of various preclinical oncology models and a working knowledge of how to select the most appropriate model or models
• Familiarity with best practices for the preclinical evaluation of oncology drugs in mouse models
• A full understanding of PK/PD/efficacy relationships and how to apply these to set robust clinical gates
• An understanding of exposure-response relationships and how these may impact decision making in the clinic
• An appreciation of how to approach multi-targeted vs specific compounds
• How to use reverse clinical translation to help set preclinical bars for advancing molecules
• What to expect in terms of animal modeling in the era of immune-based therapies
• An understanding of the potential of using client-owned animals (eg, dogs with cancer) for translational studies; when does it make sense?
• Examples of how these concepts have been reduced to practice to enhance the translatability of preclinical work and influence clinical development of compounds that have made it to market

Autoimmune diseases/inflammation (Dr. Rana Samadfam, Charles River Laboratories)

• Overview of in in vivo models used to characterize anti-inflammatory and immune modulatory drugs
• Overview and measurement of commonly studied mediators of immune and inflammatory responses.
• Therapeutic models of common interest for immune based diseases, including rheumatoid arthritis, psoriasis, asthma, inflammatory bowel disease/Crohn’s disease.
• Discussion of best practices for use of these models for evaluation of efficacy and mechanistic investiations
• Use of cell-based and molecular assays to characterize therapeutic responses.
• New and emerging technologies useful in characterization of immune and inflammatory responses.
• Strategic approaches for progression from early drug discovery screening to preclinical development, including use of biomarkers

Preclinical animal models (Dr. Leon Hall, Mousera)

• Limitations of current practices in preclinical research
• Developing more predictive models to address existing limitations
• Humanized mice in immuno-oncology applications
• Using humanized mice for other applications (safety/toxicity)

Metabolic Diseases (Diabetes/hyperlipidemia) (Dr. Peter Havel, UC-Davis)

• Review of established rodent models which have been used to study metabolic disease (obesity, insulin resistance and diabetes)
• Discuss limitations of monogenic rodent models which poorly represent the pathophysiology of these diseases
• Features of diet-induced obese rodent models of insulin resistance, which typically do not develop overt hyperglycemia sufficient to be classified as type-2 diabetes.
• Discussion of important differences between rodents in and primates with respect to metabolic physiology
• Characterization and advantages of the f UCD-T2DM rat model for studying type-2 diabetes, which combines polygenic obesity and insulin resistance with islet/ß-cell dysfunction leading to marked hyperglycemia and many of the typical features of type-2 diabetes in humans.
• Potential use of nonhuman primate models in drug development, such as the diet-induced rhesus monkey model of metabolic syndrome which exhibits insulin resistance, dyslipidemia and hepatic steatosis.