Speakers: Shaoling Li (Theravance), Karthik Rajagopal (Genentech), Cuiping \’Tracy\’ Chen (Depomed), Jason Gruenhagen (Genentech), John Chung (Amgen), Minli Xie (Medivation)
Organizers: Minli Xie (Medivation), Tracy Chen (Depomed), Shichang Miao (Chemocentryx)
Date: Friday, January 22, 2016
Time: 8:45-17:00
Registration fee (US$): (USD$)For unemployed & students: $30; For vendor-show rep: $35; Regular: $195; For major-sponsor rep (incl lunch): $0;
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor:
Vendor show vendors registered to date: (4)CoreRx; Etaluma, Inc.; Quotient Clinical Ltd; Simulations Plus, Inc.
Registration: https://www.PBSS.org
Registration deadline:1/20/2016  (it will close sooner if the seating cap is reached)

About the Topic

Controlled release formulation provides a variety of benefits compared  to the conventional immediate-release formulations.  They can reduce the frequency of dosing, maintaining a steady level, modifying pharmacokinetic profile to reduce side effects and improve patient compliance.  Many successful controlled release formulations have been developed for a wide range of drug delivery modalities.  This workshop provides an overview of fundamentals, technologties and challenges for development of controlled  release formulations, including considerations for injectables and oral solid-dosage formulations, considerations for biologics and small molecules.  The key topics discussed include determining the ideal release profile based on preclinical and clinical information along with modeling and simulation; formulation approaches and  techniques to achieve controlled release depending on molecular properties and route of administration, as well as establishing release profile and in vitro-in vivo correlation.  Case studies will be discussed to illustrate approaches to develop successful controlled release formulations.

This workshop will benefit scientists, analysts and BD associates, research associates, managers, directors, regulatory affairs, quality control, quality assurance, and device and process engineers currently working in the pharmaceutical and biotechnology industry who want to improve their understanding of the best practices in formulation development for small molecules and proteins. This workshop is also useful for non-pharma scientists who seek better technical understanding of processes, challenges and opportunities in the industry.

The following key topics will be discussed.

• Overview of controlled-release technologies and products in pharmaceutical application
• Controlled-release delivery of poorly water soluble drugs: strategies and case studies
• Fundamentals, technologies and cases studies for injectable controlled-release formulation for biologics
• Preclinical and clinical DMPK assessment of controlled-release formulation
• Analytical characterization and method development for controlled-release formulation development
• Utilizing Physiologically Based Pharmacokinetic (PBPK) Modelling and Simulation to Guide Controlled-Release Formulation Development

About the Speakers

Shaoling Li Ph.D (Theravance)

Shaoling Li is a seasoned pharmaceutical professional, strategic and technical leader specializing in pharmaceutical product development, drug delivery and CMC function.  She is currently the Director of Pharmaceutical Development at Theravance Biopharma, Inc. With over 18 years of extensive experience in the pharmaceutical product development and proven track records of developing products from early feasibility to clinical trials, and commercialization, Dr. Li has experience and expertise in various functional areas including preformulation, formulation and drug delivery technology development, process development, optimization and scale-up, product concept assessment and intellectual property development, as well as regulatory submission.  Dr. Li held various technical and management positions with increasing responsibilities during her tenure at ALZA Corporation, a company of Johnson & Johnson.  She played a key role in advancing numerous R&D projects from preclinical to various clinical stages.  She was crucial to the design and development of the drug products that reached $600M+ in sales after commercialization.  She has been involved in and/or led development of the innovative drug delivery technologies such as controlled-release drug delivery, nanoparticle technology, solid solution/dispersion, and lipid-based delivery systems for poorly water-soluble drugs.  Dr. Li has more than 20 scientific publications including papers, presentations and book chapter.  She is inventor / co-inventor of several patents.  Dr. Li received her BS degree in Pharmacy and MS degree in Pharmaceutics from China Pharmaceutical University, and Ph.D. in Pharmaceutics from the University of Iowa.

Karthik Rajagopal Ph.D (Genentech) 

Jason Gruenhagen Ph.D (Genentech)

Dr. Jason Gruenhagen has over 10 years of experience in the pharmaceutical / biotech industry serving in analytical development, regulatory, and quality functions.  Dr. Gruenhagenis currently a Senior Scientific Manager in the Small Molecule Pharmaceutical Sciences department at Genentech. His current responsibilities include analytical development for small molecule and antibody drug conjugate programs in the pre-clinical and early clinical phases as well as overall CMC team leadership. Prior to joining Genentech, Dr. Gruenhagen served as manager of Compliance/QA at A.P. Pharma (now Heron Therapeutics) and in analytical development and CMC regulatory roles at Alza Corporation. Dr. Gruenhagen received his BS degree in Chemistry at Truman State University and his PhD at Iowa State University under the direction of Edward S. Yeung. Dr. Gruenhagen has over 10 publications and numerous presentations across various topics in analytical chemistry.

Cuiping “Tracy” Chen Ph.D (Depomed)

Dr. Chen is a mother, wife, Cristian and currently a Director of Pharmacokinetics & Clinical Pharmacology. She joined Depomedin 2008 and was instrumental in the successful development of the gastroretentive formulation of carbidopa/levodopa for Parkinson’s disease and two NDA filings and numerous product launching. Her key responsibility lies in all aspects of clinical pharmacology and PK-PD/BA, including study design, execution, site monitoring, data analysis and interpretation, report writing, and regulatory filing. She is the go-to-person within the company on any questions related to the interplay between drug delivery technology, pharmacokinetics, and safety and efficacy. Prior to Depomed, Dr. Chen had served in an increasing responsibility in the area of pharmacokinetics, drug metabolism & bioanalysis in companies including Bristol-Myers Squibb, Pfizer, Johnson & Johnson and Celgene.  She serves on the journal of drug metabolism and disposition editorial board, has published more than 60 scientific papers/book chapters in peer reviewed journals and has been an invited speaker at national and international conferences in the area of pharmacokinetics-pharmacodynamics and drug delivery. She received her B.S. in Pharmacy from China Pharmaceutical University. After 6=years of teaching and research at the same University, she came to the States for her graduate study in the school of Pharmacy, UNC-Chapel Hill. Her PhD training was in the area of opioid blood-brain disposition and analgesic effects.

John Chung Ph.D (Amgen)

Dr. John Chung is a Senior Scientist within Oral Delivery Product & Process Development at Amgen.  He received his B.S. degree in bioengineering at UC Berkeley and attended graduate school at the University of Michigan where he obtained his Pharm.D./Ph.D. in Pharmaceutical Sciences.  He started his career at Simulations Plus where he was involved in the development of GastroPlus and DDDPlus.  He joined Amgen in 2011 and his current responsibilities include conducting biopharmaceutical evaluations for formulation selection and serving as the formulation development technical lead for various projects.

Minli Xie Ph.D (Medivation)

Dr Xie is Sr Director of Small Molecule Technical Operations at Medivation.  Dr. Xie started her education at Peking University in Chemistry.  She received a M.S. in Physical Organic Chemistry in 1994, and then Ph.D. in Pharmaceutical Chemistry in 1998 from the University of Kansas.  In 1997, she started her career at DuPont Pharmaceutical Company working on Discovery Pharmaceutics, Preformulation and Clinical Pharmaceutical Development.  After the merger, she joined Bristol-Myers Squibb and led the pharmaceutical support for discovery efforts in several therapeutic areas.  In 2004, Dr. Xie joined Genentech Inc, to build a small molecule pharmaceutics group with expertise from discovery support to NDA filing. She has been an integral part of the efforts to establish systems/processes suited for small molecule discovery and development at Genentech.  She joined Medivation in the summer of 2015 to help establish a comprehensive small molecule CMC organization supporting projects ranging from preclinical to commercial production.  Dr. Xie has over twenty publications, seventy presentations, and invited speaker to various  international conferences and universities.