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Symposium

Challenges in Peptide Drug Discovery & Development: Biology, Chemistry, PK, Delivery, Regulatory and Beyond


Speakers: Ved Srivastava (Intarcia), Richard Pittner (Escient), Jessica Hawes (FDA), Paul Feldman (Intarcia), Randy Mrsny (University of Bath), Mark Bush (Nuventra), Jenifer Vija (Charles River Laboratories), Cheryl Stults, (C&M Technical Consulting)
Organizers: Doris Zane, PhD (Intarcia)
Date: 12/4/2018
Time: 8:45-17:00
Registration fee (USD): Regular: $195; Academic: $125; Students & Unemployed: $35;
Location: Crowne Plaza, Foster City, CA
Major Sponsor:
Vendor show vendors registered to date: (3)Absorption Systems; Covance Inc; Intertek
Registration: http://www.PBSS.org
Registration deadline:12/3/2018  (it will close sooner if the seating cap is reached)

About the Topic

This symposium covers different aspects and challenges of peptide drug discovery and therapeutic candidate development including the following topics:

  • Peptide drug development from a chemistry perspective: (a) the status of peptide therapeutics progress and future directions, (b) advances in peptide engineering tools and techniques for converting a bioactive peptide to a drug like molecule from the chemistry perspective and (c) development of control strategies for peptide manufacturing form regulatory and industry perspectives
  • Approaches to discover, optimize, assess, and deliver combination peptide therapeutics for treatment of metabolic diseases
  • Oral delivery, cell-penetrating peptide, tight junction regulation
  • Nonclinical expectations to support clinical trials and NDA applications for different types of peptide products will be discussed.  Examples will be provided for peptide monotherapy and combination products.
  • Current regulatory expectations for packaging/delivery systems, risk-based approaches to material safety evaluation and examples to illustrate material challenges
  • Key factors affecting the absorption, distribution, and elimination of peptide drugs
  • Oxytocin and evidence for a role in weight loss/obesity: biology and clinical studies
  • And more…

Agenda

  1.  Why Peptide Therapeutics has Become an Innovative Strategy for Developing Biopharmaceutical Pipelines – Ved Srivastava (Intarcia Therapeutics)
  2. Addressing the Challenges of Peptide Drug Discovery and Delivery:  Combination Peptide Therapeutics to Treat Metabolic Diseases – Paul Feldman (Intarcia Therapeutics)
  3. Examination of a Paracellular Approach to Achieve Oral Peptide Delivery – Randy Mrsny (University of Bath)
  4. Nonclinical Studies Supporting Peptide Drug Applications – Jessica Hawes (FDA)
  5. Bioanalytical Challenges with Peptide Therapeutics – Title TBD – Jenifer Vija (Charles River)
  6. Pharmacokinetic Considerations in the Development of Peptide Drugs – Mark Bush (Nuventra Pharma Sciences)
  7. Material Considerations for Peptide Combination Products – Cheryl Stults (C & M Technical Consulting)
  8. Rethinking Oxytocin: Oxytocin and Peptoid Analogues: A novel Treatment for Obesity with Enhanced Safety/Efficacy – Richard Pittner (Escient Pharmaceuticals)


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2019-03-07, Promising therapeutic approaches and transnational medicine from SPARK: an academic-industry collaboration to advance novel therapeutics (A Joint Symposium by PBSS and Stanford SPARK Program)
2019-03-11, Clinical Trials Essentials: An Intensive One-Week Course (register for the full week or half day sessions)
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