Smart Drug Development & Design from Candidate to Phase I

Home  >>  Smart Drug Development & Design from Candidate to Phase I

BioRN_984x311_banner

This event will focus on key considerations for transitioning a molecule from discovery to phase 1 readiness including API and formulation development, pharmacokinetics, quality and CMC requirements, and incorporation of clinical supply services solutions to meet protocol, clinical site and patient needs.

Following the meeting, all Catalent speakers and executives will be available for private, no-obligation discussions on specific programmes and challenges. To request an appointment, please contact Annalisa Zuccotti (az@biorn.org).

    When: April 4 from 9.30 am to 2.15

     Where: Conference Center, Technology Park in Heidelberg

     Program (download)

9.30 am Welcome

9.45 am "A REFINED DEVELOPABILITY CLASSIFICATION SYSTEM TO ENABLE PRAGMATIC COMPARISON OF DRUG CANDIDATES AND FORMULATION APPROACHES" - tbc

10.30 am "MODELING THE PHARMACOKINETIC CHALLENGES OF ORAL SMALL MOLECULE DRUGS" by Dr. Jan Neelissen (Catalent Pharma Solutions)

11.15 am "IMPORTANCE OF API CHARACTERIZATION AND FORMULATION STRATEGIES TO OVERCOME ORAL BIOAVAILABILITY CHALLENGES OF SMALL MOLECULE DRUGS" by Dr. Rob Harris, Catalent Pharma Solutions

12 pm Lunch

1 pm "INTEGRATING QUALITY AND CMC INTO EARLY DEVELOPMENT" by Dr. David Elder, Principal Consultant

1.45 pm "STRATEGIC CLINICAL SUPPLY SOLUTIONS FOR EARLY PHASE CLINICAL TRIAL" by Dr. Carsten Schmidt, Grünenthal Innovation

2.15 pm Concluding remarks and meet the experts

The event is free of charge but registration is required.

Register now!

 

    About the speakers:

Dr. William Wei Lim Chin, Technical Specialist, Science & Technology, Catalent Pharma Solutions

William Wei Lim Chin is a Technical Specialist with Catalent Pharma Solutions. He has experience in in vitro and in vivo evaluation of pharmaceuticals formulations and drug delivery systems. He was trained in oral solid dosage formulation and process development for Phase 1 and 2 for pediatrics and first-in-human trials at AbbVie. Furthermore, he is familiar with regulatory/ethical requirements and risk-benefit assessment of early trials in the EU. William is a biomedical and pharmaceutical scientist by training and received his doctoral degree from the Department of Pharmacy at the National University of Singapore.

Dr. Jan Neelissen, Scientific Adviser, Science & Technology Catalent Pharma Solutions

Jan Neelissen is a Scientific Adviser at Catalent Pharma Solutions as a DMPK and PBPK modeling specialist. He has 18 years of industry experience in the field of DMPK, of which 17 years at AstraZeneca holding positions as Associate Principle Scientist delivering 7 clinical drug candidates, Associate Director in vitro DMPK and Associate Director Modeling and Simulation. Jan Neelissen is a biologist by training and received his doctoral degree from the University of Leiden, Netherlands.

Dr. Rob Harris, Chief Technical Officer, Catalent Pharma Solutions

Based at Catalent’s early-phase center of excellence in Nottingham, U.K., Dr. Harris provides technical guidance to Catalent’s formulation development and clinical trial manufacturing services. With more than 30 years of pharmaceutical industrial experience, he has worked in Good Manufacturing Practice environments for both commercial and investigational medicinal products at blue chip, contract research organizations and small and medium-sized enterprises, and has successfully managed the development of over 50 new chemical entities.

David Elder, Principle Consultant, David P Elder Consultancy

Dr. Elder has 41 years of service within the pharmaceutical industry, with Sterling, Syntex and 23 years with GSK. He is now an independent CMC consultant and has broad based experience in formulation and analytical method development. Dr. Elder obtained his PhD in crystallography from the University of Edinburgh. Dr. Elder is a visiting professor at King’s College, London. He is a Fellow of the RSC and chartered chemist and scientist. He is a member of the British Pharmacopoeia. He is the immediate past chairman of JPAG (Joint Pharmaceutical Analysis Group). He is a member of the Editorial Advisory Board for the Journal of Pharmaceutical Sciences. He has published 17 book chapters, 138 papers in international journals and has given 18 webinars and over 158 presentations at national/international symposia. He has 7 patents to his name. He has co-edited a book on the Analytical Characterisation and Separation of Oligonucleotides and their Impurities (with George Okafo and Mike Webb) and a second on the ICH Quality Guidelines (with Andy Teasdale and Ray Nims).

Dr. Carsten Schmidt, Head Clinical Trial Supply, Grünenthal Innovation

Carsten Schmidt is the Director of the Clinical Trial Supply department at Grünenthal’s Headquarter located in Aachen, Germany. He has 10 years of experience in the global management of clinical trial supplies covering all developmental stages and a broad variety of supplies like small molecules, biologics, or narcotic drugs as well as ancillaries. Carsten is a biochemist by training and received his doctoral degree from the Department of Biochemistry I – Receptor Biochemistry at the Ruhr University Bochum, Germany.