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Workshop

Preclinical Development & IND (Investigational New Drug) Filing


Speakers: Cuiping “Tracy” Chen (Jazz Pharmaceuticals), Ph.D.; Xingrong Liu (Biogen), Ph.D.; A. Jacob Jabbour (Neurocrine), Ph.D., DABT; Gerry Burker (Crinetics Pharmaceuticals), Ph.D.
Organizers: Cuiping “Tracy” Chen (Jazz); Jennifer Yang (Ultragenyx); Rosa Luo (Crinetics)
Date: 2019-10-11
Time: 8:45-17:30 Pacific Time
Registration fee (USD): Regular (incl lunch): $195; For unemployed or Academic (incl lunch): $30; For vendor-show rep (incl lunch): $35; For major-sponsor rep (incl lunch): $0
Location: Country Inn and Suites, 5975 Lusk Blvd, San Diego, CA 92121
Major Sponsor: (2)Catalent Pharma Solutions; Wuxi
Vendor show vendors registered to date: (15)AIT Bioscience; Alturas Analytics; BioIVT; Celerion; Certara; ChemPartner; JOINN Biologics; KCAS; MicroConstants; Q Squared Solutions; Quotient Sciences; SEKISUI XenoTech; Sinclair Research; SOLVO Biotechnology; Thermo Fisher
Registration: http://www.PBSS.org
Registration deadline:2019-10-10  (it will close sooner if the seating cap is reached)

About the Topic

Workshop Agenda

Time                              Topic                                                                        Presenter

8:45-9:15am                   PBSS Welcome and Introduction                            Cuiping Chen

9:15-10:30am                 Chemistry, Manufacturing, and Controls                Gerry Burke

10:30-10:40am               Major Sponsor’s Presentation                                 

10:40-10:55am               Break

10:55-12:25pm              Non-Clinical Pharmacology & PK                          Xingrong Liu

12:25-1:25pm                Lunch will be provided

1:25-3:25pm                  Toxicology in Drug Development                           Jacob Jabbour

3:25-3:45pm                  Break

3:45-3:55pm                  Major Sponsor’s Presentation                                 

3:55-5:00pm                  Clinical Development Plan/Interaction with FDA   Cuiping Chen

5:00-5:30pm                  Panel Discussion                                                      All Speakers


About the Speakers

Dr. Cuiping “Tracy” Chen, Ph.D. has more than 20 years of experience in applying knowledge in PK, PD, clinical pharmacology and drug delivery to the discovery and development of safe and effective remedies. Currently, Tracy is a senior director, clinical pharmacology and early development at Jazz Pharmaceuticals. Her roles at Jazz include leading a cross-function early development team for clinical pharmacology study strategy and execution, supporting clinical development, regulatory submission/interpretation, medical education, publication, lifecycle management, and IP strategy, reviewing in-license programs, identifying and managing CROs and consultants in the areas of DMPK/Clinical Pharmacology. Prior to Jazz, Tracy had worked in both drug discovery and development in companies including BMS, Pfizer, JNJ, Celgene and Depomed. She is on editorial Advisory Board for Drug Metabolism & Disposition and frequent reviewer for Clinical Pharmacology & Therapeutics. She has near 40 peer-reviewed papers, book chapters and patents in the area of DMPK, drug delivery and clinical pharmacology. She received her Ph.D. in Drug Delivery and Disposition from the University of North Carolina at Chapel Hill in 1997.


Dr. Xingrong Liu received his Ph.D. in pharmacokinetics from the University of North Carolina at Chapel Hill in 1998. He has been representing DMPK discipline in many drug discovery and development teams at Pfizer, Roche, Genentech and Biogen in the last 20 years. His drug discovery and development research work covers from target identification to clinical development. He worked on a variety of drug discovery and development programs in neuroscience, inflammation, oncology, ophthalmology, and antibiotics areas. His research interests include drug design, development of novel in vitro and in vivo brain penetration assessment methods, and modeling and simulation approaches to guide and expedite neuroscience drug discovery and development. Currently, he is the head of the DMPK department at Biogen. He coauthored 61 research papers, book chapters, and patent.


Dr. A. Jacob Jabbour, Ph.D., D.A.B.T.,has extensive experience in scientific research in toxicology including 19 years of experience in nonclinical safety assessment both in contract research organization (CRO) and pharmaceutical industry focused on approval of pharmaceutics. His expertise in drug discovery and development includes design, oversight, and data interpretation of toxicology and safety pharmacology studies to assess safety of biologics (monoclonal antibodies, peptides, vaccines) and small molecules across several clinical indications such as CNS, endocrinology, cardiovascular, antimicrobials, inflammation, and oncology. This culminated in successful submission of several INDs and 3 NDAs. While at Optimer and Neurocrine, he played a key role in Dificid® NDA approvals (both FDA and EMA) and Ingrezza® NDA approval (FDA). Currently, he is a Director in the preclinical department at Neurocrine overseeing several NCE toxicology programs.


Dr. Gerry Burke is the Senior Director, CMC responsible for API, analytical methods, formulation/process development, and clinical supplies at Crinetics Pharmaceuticals, a company focused on development of novel therapeutics targeting peptide hormone receptors for the treatment of rare endocrine disorders and endocrine-related cancers. Prior to Crinetics, he was responsible for formulation and process development for immediate and controlled release dosage forms, clinical manufacturing, scale-up, and technical transfer to commercial manufacturing sites at Ardea Bioscience. Ardea Biosciences received product approval for Zurampic® and Duzallo® where Dr. Burke contributed to global filings with worldwide regulatory approvals and launch readiness. His experience also includes equipment design, installations and qualifications, and product technical transfers worldwide. He has over twenty five years’ experience in the pharmaceutical industry employed in small to large pharma companies, including a CMO, leading to over twenty product launches including NCE, OTC, Generic, and Nutraceutical products. He has authored patents and publications and has been an invited speaker on topics including fluid bed processing, solvent processing, FATs, sourcing CDMOs, and statistical process capability analysis. Dr. Burke earned his Ph.D. degree in Pharmaceutics from the University of Iowa and his B.S. and M.S. degrees from Massachusetts College of Pharmacy and Allied Health Sciences.

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