Speakers: Ved Srivastava (Intarcia), Paul Feldman (Intarcia), Randy Mrsny (University of Bath), Jessica Hawes (FDA), Jenifer Vija (Charles River), Mark Bush (Nuventra), Cheryl Stults (C&M Technical Consulting), Richard Pittner (Escient)
Organizers: Doris Zane, PhD (Intarcia)
Date: 2018-12-04
Time: 8:45-17:00 Pacific Time
Registration fee: (USD): Regular: $195; Academic: $125; Students & Unemployed: $35
Location: Crowne Plaza, Foster City, CA
Major Sponsor:
Vendor show vendors registered to date: (6)Absorption Systems; Celerion; Charles River; ChemPartner; Covance Inc; Intertek
Registration: http://www.PBSS.org
Registration deadline:2018-12-02  (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.
• Selection of bioanalytical assay format:  LCMS vs. ELISA; Case study where both types of assay format were used; Immunogenicity testing of peptide therapeutics – challenges in assay development and case study
• Key factors affecting the absorption, distribution, and elimination of peptide drugs
• Current regulatory expectations for packaging/delivery systems, risk-based approaches to material safety evaluation and examples to illustrate material challenges
• Oxytocin and evidence for a role in weight loss/obesity: biology and clinical studies

Detailed Agenda

8:45-9:00 AM: Introductions, Doris Zane, Ph.D., DABT (Intarcia Therapeutics) and Shichang Miao, Ph.D. (President, PBSS)

9:00-9:40 AM: Why Peptide Therapeutics has Become an Innovative Strategy for Developing Biopharmaceutical Pipelines – Ved Srivastava, Ph.D. (Intarcia Therapeutics)

9:40-10:20 AM: Addressing the Challenges of Peptide Drug Discovery and Delivery:  Combination Peptide Therapeutics to Treat Metabolic Diseases – Paul Feldman, Ph.D. (Intarcia Therapeutics)

10:20-10:40 AM: break

10:40-11:20 AM: Examination of a Paracellular Approach to Achieve Oral Peptide Delivery – Randy Mrsny, Ph.D. (University of Bath)

11:20 AM-12:00 PM: Nonclinical Studies Supporting Peptide Drug Applications – Jessica Hawes, Ph.D. (FDA)

12:00-1:00 PM: lunch

1:00-1:40 PM: Bioanalytical Challenges with Peptide Therapeutics – Jenifer Vija, Ph.D. (Charles River)

1:40-2:20 PM: Pharmacokinetic Considerations in the Development of Peptide Drugs – Mark Bush, Ph.D. (Nuventra Pharma Sciences)

2:20-2:40 PM: break

2:40-3:20 PM: Material Considerations for Peptide Combination Products – Cheryl Stults, Ph.D. (C & M Technical Consulting)

3:20-4:00 PM: Rethinking Oxytocin: Oxytocin and Peptoid Analogues: A novel Treatment for Obesity with Enhanced Safety/Efficacy– Richard Pittner, Ph.D. (Escient Pharmaceuticals)

4:00-4:30 PM: panel forum

4:30 PM: closing

Dr. Ved Srivastava is Vice President of Peptide Chemistry at Intarcia Therapeutics. Prior to that, he was the Head of Peptide Chemistry at GlaxoSmithKline, USA; and in the leadership role with Amylin Pharmaceuticals, USA. Ved is President-Elect of the American Peptide Society. Ved has significantly participated in the development and commercialization of SymlinTM, ByettaTM, and BydeureonTM, first-in-class medicines for the treatment of diabetes. He is the Editor of three books: Peptide-based Drug Discovery, Comprehensive Medicinal Chemistry III - Biologics Medicine (Vol 6) and ‘Peptide 2015’. He earned a PhD in organic chemistry from the University of Lucknow, India.

Dr. Paul L. Feldman joined Glaxo Pharmaceuticals, Research Triangle Park, North Carolina in 1987 after receiving his PhD from the University of California, Berkeley. From 1987-1995 Paul worked on a variety of drug discovery programs one of which led to the discovery of the marketed ultra short-acting analgesic opioid agonist remifentanil (Ultiva). In addition, he and academic collaborators worked on the biochemistry of nitric oxide production and first demonstrated that N-hydroxyarginine is an intermediate in the biosynthesis. From 1995-2000 Paul’s department worked on the discovery of antiviral agents for treatment of HIV and HSV. One of the highlights during this period was the discovery of the marketed HIV protease inhibitor, fosamprenavir (Lexiva/Telzir). In 2000 Paul became Vice President of Chemistry for the Metabolic and Viral Diseases for GlaxoSmithKline (GSK) Pharmaceuticals. His group discovered three assets, the HIV integrase inhibitor dolutegravir (Tivicay and component of Triumeq) approved in 2013 (Tivicay) and 2014 (Triumeq) for HIV treatment, cabotegravir, currently in Phase 3 trials for HIV treatment and prevention, and the ultra short-acting benzodiazepine, remimazolam (outlicensed, Paion), currently in Phase 3 trials. In 2010 Paul was named Senior Vice President and his responsibilities included leading the Enteroendocrine Discovery Performance Unit, part of GSK’s Metabolic Pathways Cardiovascular Unit, and leader of GSK’s R&D Medicinal Chemistry Center of Excellence. The Enteroendocrine Unit focused on the discovery and early stage development of optimized combination peptide hormones, luminally restricted small molecules, and GRAS potentiators to treat diabetes and obesity. Several of these agents advanced into phase 2 clinical studies. In 2015 Paul left GSK and helped co-found and was CEO of the biotechnology company, Phoundry Pharmaceuticals, Inc. which was focused on discovering peptide hormone therapeutics. In September, 2015 Phoundry was acquired by Intarcia Therapeutics, Inc. Paul currently is Head of Discovery and Translational Medicine and part of the executive management team for Intarcia. His Intarcia Discovery and Translational Medicine team is providing support for the registration and approval of the type 2 diabetes medication ITCA 650, a GLP-1 agonist, exenatide, delivered every 3 to 6 months via an osmotic mini-pump. Additionally, his team is progressing Intarcia’s pipeline assets in the following therapy areas: metabolic, neurology, immuno-inflammation (with biotech company Numab), and HIV (Pre-Exposure Prophylaxis in the developing world with the Bill and Melinda Gates Foundation).

Paul has served as an adjunct Professor of Chemistry, Duke and North Carolina State Universities, chair of Heterocyclic Compounds Gordon Research Conference (2000), member at large (2000-2003) and alternate councilor (2012-2014) to the Executive Committee in the Division of Organic Chemistry of the American Chemical Society, and chair of the Division of Organic Chemistry Fellowship Evaluation Committee (2003). In 2014 Paul received the North Carolina Section of the American Chemical Society’s Distinguished Lecturer award. Paul is currently on the editorial board for Organic Reactions. Paul has >100 scientific disclosures including scientific articles, invited lectures, book chapters, patents, and poster presentations.

Dr. Randy Mrsny currently holds a Professor’s chair of Epithelial Cell Biology at the University of Bath in the Department of Pharmacy and Pharmacology where he studies biological principles associated with normal epithelia cell function and how these are affected in disease states. His work in drug delivery is internationally recognized as evidenced by his election as president of the Controlled Release Society and to co-organize a Gordon Conference on Drug Delivery. He is also the CSO of Applied Molecular transport, a biotech company in the San Francisco bay area. Randy has been selected to the Medicine Maker 100 power lists for 2015 and 2016.

Dr. Jessica Hawes has eight years of experience in the Division of Metabolism & Endocrinology Products (DMEP), Office of New Drugs, CDER, FDA. She is the Pharm/Tox Acting Team Leader, DMEP and a member of 5 CDER subcommittees: Oligonucleotide Subcommittee, Pharmacokinetic and Toxicokinetic Subcommittee (Recording Secretary), Neurotoxicity Assessment Subcommittee, Biologics Subcommittee, and Women of CDER. Dr. Hawes is an invited member of 5 working groups in CDER: Oligonucleotide Research Program Working Group, ICH S3 Working Group, FDA Fatty Acid Amide Hydrolase Inhibitor Safety Assessment Working Group, CDISC/Phuse Working Groups, and the Fit for Use Phuse Collaboration Group for SEND. Dr. Hawes conducted her Postdoctoral Fellow at the National Cancer Institute (2005 - 2010) investigating cell signaling pathways, epigenetic regulation, genetic engineering, and brain cancer. Dr. Hawes received her PhD in Pharmacology from Yale University (2005) with specialization in areas of neuroscience, opiate addiction, cell signaling, and cancer biology and Bachelor of Science in Chemistry with a minor in Physics from Weber State University (1999).

Dr. Jenifer Vija, PhD (Analytical Chemistry, University of Washington). Jenifer is currently Scientific Director of Bioanalysis for Charles River Laboratories, supporting the Skokie immunoassay group and participating on a number of global CRL teams. Prior to this position, Jenifer was Director of Bioanalytical Sciences for WIL Research (acquired by Charles River in 2016), leading a team of scientists responsible for method development, validation, and sample analysis to support bioanalytical and immunogenicity testing for clinical and non-clinical studies using immunoassay based techniques. She held various positions of responsibility at WIL Research and Midwest BioResearch (MBR, acquired by WIL Research in 2009) since 2004, from establishing GLP-compliant procedures supporting small molecule bioanalysis to leading scientific operations for small and large molecule bioanalysis at the Skokie site. Jenifer started her career in 2001 at NeoPharm, a small pharmaceutical startup where she developed and validated bioanalytical methods supporting liposome-encapsulated drugs and novel nucleotide drug candidates using HPLC and LC-MS/MS. Jenifer is a member of the organizing committee for the Applied Pharmaceutical Analysis Regulated Bioanalysis Workshop. She has been responsible for over 1000 technical studies and reports during her >15 years in the pharmaceutical and contract research industries.

Dr. Mark Bush has over 18 years of experience in Clinical Pharmacology and Pharmacokinetics with a particular focus in clinical pharmacology study design and interpretation as well as PK and PK/PD modeling and simulation. His therapeutic concentrations include development of peptide, protein, and small-molecule drugs for endocrinology and metabolic-disease indications.

Dr. Cheryl Stults is Principal at C & M Technical Consulting, LLC, working with various local and global companies to advance the development of parenteral and inhalation products. Her primary area of focus is on device and packaging materials analysis and characterization for purposes of selection, qualification and control. She holds a PhD in Analytical Chemistry from Michigan State University and a Masters in Management from Aquinas College. Dr. Stults was co-editor of the Leachables and Extractables Handbook (Wiley 2012), is a science advisor for IPAC-RS and a USP Packaging and Distribution Expert Committee member contributing to development and revision of materials-related chapters.

Dr. Richard Pittner has over 25 years expertise in the discovery, validation, development and in-licensing of novel therapeutics and technologies. Richard is currently Vice-President and Head of Biology at Escient Pharmaceuticals. He was previously a consultant and active as a startup advisor and technology incubator in San Diego. Richard co-founded OXT-Therapeutics as Chief Development Officer, focused on the development of an oxytocin-based portfolio for metabolic disease. He co-founded an incubator group, BioShore Partners, which has recently progressed 2 product concepts into newly incorporated startups - Abvance and Aquros. Additionally, he is an advisor (acting SVP) to CPC/Xinbang in evaluating/in-licensing peptide therapeutic programs for the Chinese market. He spent several years at Eli Lilly and Pfizer where he led External R&D efforts, identifying, evaluating and in-licensing external drug assets. Previously, he spent 15 years at Amylin as Head of Discovery Biology developing novel peptide therapeutics for metabolic diseases (including Byetta and Symlin). He holds a number of patents, is the co-author of over 40 publications and received his PhD from University of Nottingham.