Agenda
- 12:00 PM - Registration, Lunch, and Networking
- 12:30 PM - Development of a Process Suitable for Manufacturing a Biologic Drug
- Cell Culture
- Protein Purification
- Product Characterization
- Formulation & Stability
- Fill/Finish
- 12:50 PM -Toxicology of Biotechnological Products
- Preclinical toxicology program objectives, endpoints, findings of concern
- Factors to consider for biotechnology products: Species specificity, Immunogenicity, Antibody response
- Testing considerations
- 1:10 PM - Regulatory � Satisfy Statutory Legal Requirements for Testing in Humans
- Strategy
- Data requirements: CMC, Safety, Clinical plan
- eCTD
- Pre-IND Meetings
- 1:30 PM - Panel Discussion and Q&A;
- 2:00 PM - Product Show & Raffle
OVERVIEW
Whether your goal is to develop your pipeline through commercial launch, or partner as early as possible, submitting an IND is a critical early milestone. Even with big pharma and VC firms competing for the most promising compounds, the bar is still quite high and startups are expected to demonstrate a solid plan for achieving IND acceptance to be taken seriously. Join us for a series of presentations followed by an interactive panel discussion exploring the basic requirements and considerations you must be aware of when planning for a successful IND submission. Presentations will highlight the following:
- Key components of the Chemistry/Manufacturing/Controls
- Expression, Purification, Analytics, Formulation, Fill/Finish
- Preclinical study design, species selection, material requirements, timelines and cost considerations
- Regulatory requirements, strategies to minimize costs and timelines while balancing risk
- Tips for presenting an attractive package for acquisition
SPEAKER
- Michiel Ultee, PhD, Chief Scientific Officer, Laureate BioPharma
- Robert Burford, PhD, VP Regulatory Affairs, Laureate BioPharma
- Brian Rogers, PhD, DABT, MBA, Founding Partner, VP of Toxicology, Pacific Biodevelopment
- Vu Truong, PhD, Founder, Chief Scientific Officer, Aridis Pharmaceuticals
- Steven Chamow, PhD, President and Principal Consultant, S. & J. Chamow, Inc.
Cost & Registration
-Regular Price: $30
-Partners' Network: $20
-BioCenter Members: Free
-On-site Registration: add $10 to the above
Space is limited for this event, so early pre-registration is recommended to avoid disappointment on the day!
VENUE
The San Jose BioCenter
5941 Optical Court
San Jose, CA 95138
Click here for venue directions»
SPEAKER BIOS
Michiel Ultee, PhD, Chief Scientific Officer, Laureate BioPharma
Michiel E. Ultee, Ph.D. , has more than 25 years of experience in the biopharmaceutical industry and has worked with antibodies since 1975. He serves as Laureate Pharma's scientific head and has been part of their biopharmaceutical operations team since 1987. His prior positions include Vice President of Process Sciences and Director of Manufacturing & Technical Operations.
Dr. Ultee began his career in Research and Development, where he was part of the team that developed two licensed biopharmaceuticals. He holds four U.S. patents and has published numerous scientific articles. Prior experience includes postdoctoral research in immunology at NYU Medical School. He is a frequent speaker at biopharmaceutical conferences, and a member of the editorial advisory boards of Bioprocess International and Biopharm International. Dr. Ultee earned his graduate and undergraduate biochemistry degrees from Northwestern University and Dartmouth College.
Robert Burford, PhD, VP Regulatory Affairs, Laureate BioPharma
Dr. Burford joined Laureate Pharma in November 2010 with an impressive career in the pharmaceutical industry that has spanned the past 41 years.
Dr. Burford holds a Ph.D. in pharmacology/toxicology from the University of Western Ontario, Canada, and has held various positions with innovator and emerging drug companies, as well as contract research firms. These positions included preclinical pharmacology and toxicology at Bio-Research Laboratories in Montreal, and 17 years at Searle Pharmaceuticals, where he held various positions including Director of Clinical Research, Medical Director of Life Sciences Division, and Director of Scientific Affairs. Thereafter, he was the Director of Clinical Research at Biovail Laboratories, V.P. of Product Development at Axonyx Inc, and V.P. of Preclinical and Regulatory Affairs at Sequoia Pharmaceuticals.
For the past 16 years he has been President of the American Clinical Research Consultants Inc. where, as an industry consultant, he has offered expert advice and counsel in preclinical toxicology and early phase clinical development of new drug products and medical devices. He has represented both domestic and foreign clients before the FDA and HPB, being thoroughly familiar with the regulatory requirements of medical product approval in the U.S. and Canada. He is a past president of the Society of Toxicology, Canada, Secretary General of the International Union of Toxicology and a member of the American Society for Clinical Pharmacology and Therapeutics, among others.
Brian Rogers, PhD, DABT, MBA, Founding Partner, VP of Toxicology, Pacific Biodevelopment
Dr. Rogers has over 20 years of industrial toxicology experience primarily in biotechnology and pharmaceuticals, including five years at Genentech. During this time he has extensively interacted with the FDA and authored over 60 IND and several NDA and BLA nonclinical sections on behalf of clients. He holds a Ph.D. in Toxicology from the University of North Carolina, Chapel Hill, NC and a B.S. in Environmental Toxicology, University of California, Davis, CA (UCD). He is a Diplomate of the American Board of Toxicology (since 1993) and also holds an MBA from and was an adjunct professor at the UCD School of Management.
Vu Truong, PhD, Founder, Chief Scientific Officer, Aridis Pharmaceuticals
Dr. Truong is a founder of Aridis and has over 12 years experience in biopharmaceutical drug development. He formerly served as head of the Formulation Technology Department at MedImmune and Sr. Scientist at Aviron. His product development experience includes FluMist�, CAIV-T� vaccine, Synagis� mAb, Vitaxin� mAb, anti-IL-9 mAb, RSV/PIV vaccine. He is an expert on formulation and delivery of macromolecules and vaccines. Dr. Truong received his Ph.D. in Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine.
Steven Chamow, PhD, President and Principal Consultant, S. & J. Chamow, Inc.
Dr. Chamow has more than 20 years of experience in biopharmaceutical product development. He is currently a principal consultant helping to design and implement CMC strategy for companies developing biotechnology products. During his career, he has contributed to the development of three marketed products (Avastin, Natrecor, Vectibix). Previously, he served as Senior Vice President, CMC, at Intradigm Corporation, a
private biopharmaceutical company focused on developing RNAi therapeutics (acquired by Silence Therapeutics). Prior to Intradigm, Dr. Chamow was Vice President, Process Sciences, at Genitope Corporation and at Abgenix, Inc., (acquired by Amgen) where he built the company�s process sciences department and helped to lead the design and construction of Abgenix� award-winning production facility in Fremont, CA. Before Abgenix, he served as Director of Biopharmaceutical Development at Scios, Inc. (acquired by J&J;), and as a scientist and senior scientist in process development at Genentech, Inc. (acquired by Roche). Dr. Chamow was educated at the University of California (UC Santa Cruz, B.A. in biology; UC Davis, Ph.D. in biochemistry), and completed postdoctoral training at the National Institutes of Health. Dr. Chamow is author or co-author of more than 45 scientific publications and patents and co-editor of a 1999 book entitled Antibody Fusion Proteins.
