The Road to the Biologic IND

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15/11/2012 12:00 16/11/2012 14:30 America/Los_Angeles The Road to the Biologic IND Janssen Research & Development LLC , 3210 Merryfield Row , San Diego , CA 92121 JLABS San Diego together with Janssen R&D false DD/MM/YYYY

The Road to the Biologic IND

Janssen Research & Development LLC , 3210 Merryfield Row , San Diego , CA 92121

November 15, 2012 from 12:00 PM to 14:30 PM (PST)

$10 - $35

EVENTIn Partnership With:
Laureate Biopharmaceutical Services

Program Overview:
Prescience International invites you for an in-depth look into the process of filing a biologic Investigational New Drug (IND) application and the procedures necessary for advancing your company’s early-stage drug development program. Whether your goal is to develop a pipeline through commercial launch, or partner as early as possible, submitting an IND is a critical early milestone for every biotech company. With big Pharma and VC firms competing for the most promising compounds, startups are expected to demonstrate a solid plan for achieving IND acceptance.

Join us for a series of presentations, hosted by Laureate Biopharmaceutical Services, exploring the basic requirements and considerations that you need to be aware of when planning for a successful biologic 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 and timelines
• Regulatory requirements, strategies to minimize costs and timelines while balancing risk

Michiel Ultee | Chief Scientific Officer, Laureate BioPharmaceutical Services
Robert Burford | VP Regulatory Affairs, Laureate BioPharmaceutical Services
Brian Rogers | Founding Partner & VP of Toxicology, Pacific BioDevelopment

11:00 AM | Registration, Lunch, and Networking
11:30 AM | Development of a Process Suitable for Manufacturing a Biologic Drug
- Cell Culture
- Protein Purification
- Product Characterization
- Formulation & Stability
- Fill/Finish
12:00 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
12:30 PM | Regulatory – Satisfy Statutory Legal Requirements for Testing in Humans
- Strategy
- Data requirements: CMC, Safety, Clinical plan
- eCTD
- Pre-IND Meetings
1:00 PM | Discussion and Q&A
1:30 PM | Program Close
1:30 PM | Optional Tours of Janssen Labs

Speaker Biographies:
Michiel Ultee | Chief Scientific Officer, Laureate BioPharmaceutical Services
Michiel 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 Biopharma's scientific head and is the leader behind Laureate's Scientific Series, which spotlights the organization's strategies and methods in working together with clients' scientists to overcome challenges in biopharmaceutical development and manufacturing biopharmaceutical products. Ultee has been part of Laureate's biopharmaceutical operations team since 1987 with positions including Vice President of Process Sciences and Director of Manufacturing & Technical Operations.

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. Ultee earned his graduate and undergraduate biochemistry degrees from Northwestern University and Dartmouth College.

Robert Burford | VP Regulatory Affairs, Laureate BioPharmaceutical Services
Robert Burford joined Laureate Biopharma in November 2010 with an impressive career in the pharmaceutical industry that has spanned the past 41 years. 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 | Founding Partner & VP of Toxicology, Pacific BioDevelopment
Brian Rogers is a co-founder of Pacific BioDevelopment and serves as VP of Toxicology. He 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. His experience enables him to design strategic pharmacology and toxicology programs for clients. Rogers holds a Ph.D. in Toxicology from the University of North Carolina, Chapel Hill and a B.S. in Environmental Toxicology from the University of California, Davis. 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 UC Davis School of Management

JLABS San Diego together with Janssen R&D

Johnson & Johnson Innovation, JLABS (JLABS) is a global network of open innovation ecosystems, enabling and empowering innovators to create and accelerate the delivery of life-saving, life-enhancing health and wellness solutions to patients around the world. JLABS achieves this by providing the optimal environment for emerging companies to catalyze growth and optimize their research and development by opening them to vital industry connections, delivering entrepreneurial programs and providing a capital-efficient, flexible platform where they can transform the scientific discoveries of today into the breakthrough healthcare solutions of tomorrow. At JLABS we value great ideas and are passionate about removing obstacles to success to help innovators unleash the potential of their early scientific discoveries. JLABS is a no-strings-attached model, which means entrepreneurs are free to develop their science while holding on to their intellectual property. JLABS is open to entrepreneurs across a broad healthcare spectrum including pharmaceutical, medical device, consumer and healthtech sectors. The JLABS flagship opened in 2012 in San Diego at Janssen's West Coast Research Center, and since then has grown to ten global locations including the Bay Area, Boston & Lowell, MA, Houston, Toronto, Beerse (Belgium), with New York City, opening in June 2018, and Shanghai in 2019. For more information please visit or follow @JLABS.

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