Onsite payment of The Road to the Biologic IND
UCSF - Byers Auidtorium, Genentech Hall , 600 16th St , San Francisco , CA 94158
February 20, 2014 from 14:00 PM to 17:00 PM (PDT)
$10 - $35
The Road to the Biologic IND
Best Practices When Filing Biologic Investigational New Drug Applications
Janssen Labs, the Johnson & Johnson California Innovation Center and the Janssen Biotechnology Center of Excellence invite you to 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 short presentations exploring the basic requirements and considerations necessary to achieve a successful biologic IND submission. The presentation will highlight the following:
- Key components of the Chemistry/Manufacturing/Controls section
- Expression, Purification, Analytics, Formulation, Fill/Finish
- Preclinical study design, species selection, material requirements, and timelines
- Regulatory requirements, strategies to minimize costs & timelines while balancing risk
|8:30 AM |||Registration, Breakfast, and Networking|
|9:00 AM |||Development of a Process Suitable for Manufacturing a Biologic Drug|
|- Cell culture
- Protein purification
- Product characterization
- Formulation & stability
|9:30 AM |||Toxicology of Biotechnological Products|
|- Goals of preclinical toxicology evaluations
- Why biopharmaceuticals are different from small molecule drugs - a toxicology perspective
- Unique considerations for biologics Typical First-in-Human Program
|• Preclinical toxicology program objectives, endpoints, findings of concern
• Factors to consider for biotechnology products: Species specificity, Immunogenicity, Antibody response
• Testing considerations
|10:00 AM |||Biologics Clinical Pharmacology|
|- Determination of the starting dose for the First-in-Human study using MABEL, PK/PD, allometric scaling and common drug approaches
- Immunogenicity Risk Assessment and Determination: preclinical and clinical impact
|10:30 AM |||Regulatory - Satisfy Statutory Legal Requirements for Testing in Humans|
- Data requirements: CMC, safety, clinical plan
- Pre-IND meetings
|11:00 AM |||Discussion and Q&A|
|11:30 AM |||Program Close|
- Barry Springer, PhD | VP of Technology, Strategy & Operations, Biotechnology Center of Excellence, Janssen R&D read bio»
- Steven Lang, PhD, MBA | Director, Biologics Research Analytical Discovery, Cell Line Development, Biotechnology Center of Excellence, Janssen R&D read bio»
- Pauline Martin, PhD | Senior Scientific Director, Biologics Toxicology, Biotechnology Center of Excellence, Janssen R&D read bio»
- Hugh Davis, PhD | VP and Head of Biologics Clinical Pharmacology, Biotechnology Center of Excellence, Janssen R&D read bio»
- Salvatore Morello | Director, Global Regulatory Affairs, Janssen R&D read bio»
$35 General Public
UCSF - Byers Auditorium, Genentech Hall
600 16th St
San Francisco CA 94158
Download the Mission Bay Map»
There are two parking structures on campus:
- the Third Street Garage (1650 3rd St | San Francisco, CA 94158) and
- the Community Center Garage (1675 Owens St | San Francisco, CA 94158-2265).
Parking fees should be paid at the payment window of the garage before exiting. Rates are $ 3.50/hour up to 8 hours or $28.00 for the whole day. Please visit UCSF Campus Life Services for more parking information.
There is also free all day street parking in the Potrero Hill area just a few blocks away.
Public Transportation | From BART:
Exit BART at 16th Street/Mission BART Station in San Francisco Wait for the Red UCSF shuttle at the NE corner of 16th St. and Mission (in front of Burger King). The Red UCSF shuttle will bring you to the Mission Bay Campus of UCSF.
Public Transportation | From MUNI:
Take T-line to UCSF Mission Bay Station, immediately after the Mission Rock Station. Mission Bay Station is the third stop after the ball park stop (as you head away from Downtown). From MUNI station, cross street to the Mission Bay Campus of UCSF.
Transit Trip Planner: 511 SF Bay
Barry Springer, PhD | VP of Technology, Strategy & Operations, Biotechnology Center of Excellence, Janssen R&D
Dr. Springer has more than 23 years of professional leadership experience split between large pharma and small bio-tech environments in the areas of drug discovery and technology development. Currently he is responsible for leading the Janssen Biotechnology CoE (formerly Centocor) technology, strategy and operations initiatives including leading its external scientific and business partnering activities. He leads the Biotech CoE efforts in establishing and maintaining internal and external collaborations, including managing the interface between large and small molecule research ac-tivities and technology platforms. Dr. Springer is also responsible for establishing the strategy for CoE partnerships with the newly formed J&J Innovation Centers. He leads the Janssen cross function integrated technology strategy that seeks to identify and fund new technologies of strategic value. Dr. Springer holds an undergraduate degree in Microbi-ology and a PhD in Biochemistry from the University of Illinois, Urbana, IL. He completed postdoctoral training in chemistry as a Helen Hay Whitney fellow at the University of California, Berkeley.
Steven Lang, PhD, MBA | Director, Biologics Research Analytical Discovery, Cell Line Development, Biotechnology Center of Excellence, Janssen R&D
Dr. Lang leads the Biologics Research Analytical Discovery and Cell Line Development groups at Janssen R&D. His groups are responsible for analytical characterization during lead optimization of biological candidates and developing high expressing cell lines for clinical and commercial protein production. Dr. Lang received his Ph.D. in Molecular Microbiology from State University of New York Stony Brook. He then undertook post-doctoral work at Stony Brook on DNA replication and J&J Pharmaceutical R&D in the Drug Device Pharmacology group. He re-ceived his MBA from Rider University.
Pauline Martin, PhD | Senior Scientific Director, Biologics Toxicology, Biotechnology Center of Excellence, Janssen R&D
Dr. Martin is a Senior Scientific Director in Biologics Toxicology within the Biotechnology Center of Excellence at Janssen R&D. Her responsibilities include the design, implementation and interpretation of data from nonclinical safety/toxicology programs to support human clinical dosing and registration of therapeutic biologic products (cell therapy, gene therapy) and biopharmaceutical products (antibodies, proteins, peptides, novel platforms and scaffolds). She and other members of the group interact with global regulatory agencies for biologics and biopharmaceuticals and address target and biologic-specific issues during the various stages of product development. Dr. Martin has a M.Sc. degree in neurophysiology and behavior, and a Ph.D. in pharmacology from the University of London. She has more than 20 years of pharmaceutical experience in the nonclinical safety assessment of small and large molecule therapeutics. She has presented at many scientific conferences and has published in a number of peer reviewed journals, most recently focusing on the potential of monoclonal antibodies to affect reproduction and development.
Hugh Davis, PhD | VP and Head of Biologics Clinical Pharmacology, Biotechnology Center of Excellence, Janssen R&D
Hugh M. Davis, Ph.D. is currently Vice President and Head of the Biologics Clinical Pharmacology department in the Biotechnology Center of Excellence, Janssen R&D, LLC, In this capacity he manages and leads all scientific and technical aspects of the Biologics Clinical Pharmacology department, including Pharmacokinetic (PK) Bioanalysis, Immune Response Assessment and Research, Pharmacodynamic (PD) Biomarker Analysis, PK and PD for all biologics programs, GLP Compliance, and Scientific Systems, Process and Project Management. Administratively, he is responsible for all aspects of the departmental operations, including people management (~ 130 employees), budget setting/review (~$27 MM annual operating budget), objective setting, human resourcing, project and resource management and portfolio prioritization. Functionally, Hugh is chair of the First-in-Human Readiness Committee for biologics, vice chair of the Clinical Pharmacology Center of Expertise, co-chair of the Bioanalytical Leadership Team and is a member of the Quantitative Sciences leadership team, Preclinical Development & Safety global leadership team, Biotechnology Advisory Council, China R&D Strategy team, Scientific Council for Oncology and the Centyrex Scientific Advisory Board. Dr. Davis obtained his Masters degree in 1983and his Doctorate degree in Biochemistry in 1985 from Villanova University. Dr. Davis has held scientific and management positions in Discovery Research at Rhone-Poulenc Rorer and Clinical Pharmacology at GlaxoSmithKline prior to joining Johnson & Johnson in 2001.
Salvatore Morello | Director, Global Regulatory Affairs, Janssen R&D
Sal Morello is a Director in the Global Regulatory Immunology Department at Janssen R&D. Sal has 20 years of experience in the pharmaceutical industry including 15 in regulatory affairs. He began his pharmaceutical career at SmithKline Beecham (now GlaxoSmithKline) as an analytical chemist, and held other positions in clinical research and regulatory affairs. He joined the regulatory team at Centocor (now Janssen R&D) in 2000. Sal has regulatory experience with biologics, drugs and devices. He has worked in all phases of drug development and across multiple disease areas such as Asthma, Diabetes (Type 2), Idiopathic Pulmonary Fibrosis, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease, and Ulcerative Colitis. Sal has successfully filed INDs and major marketing applications. In his current role, Sal is responsible for developing and implementing global regulatory strategies for Immunology compounds. Sal received his BS degree in Comprehensive Science from Villanova University and his MS degree in Quality Assurance/Regulatory Affairs from Temple University.