The Road to the Biologic IND: Best Practices When Filing Biologic Investigational New Drug Applications

Mar 18 2015https://www.eventbrite.com/e/the-road-to-the-biologic-ind-best-practices-when-fi...

JLABS TEXAS EVENT The Road to the Biologic IND
Best Practices When Filing Biologic Investigational New Drug Applications


Program Overview:
JLABS, the Johnson & Johnson Innovation Centers 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:

    - Janssen Biotech, Inc. - your partner of choice
    - Key CMC strategies to balance cost, time and comparability risks
    - Non-Clinical safety assessment strategies for biologics
    - Determining and understanding PK/PD and immunogenicity
    - Regulatory strategy, IND requirements, and Pre-IND meetings


Agenda:

1:00 PM | Registration and Welcome
1:30 PM | Development of a Process Suitable for Manufacturing a Biologic Drug
  - Cell culture
- Protein purification
- Product characterization
- Formulation & stability
- Fill/Finish
2:00 PM | 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
2:30 PM | Q&A
3:00 PM | 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
3:30 PM | Regulatory - Satisfy Statutory Legal Requirements for Testing in Humans
  - Strategy
- Data requirements: CMC, safety, clinical plan
- eCTD
- Pre-IND meetings
4:00 PM | Q&A
4:30 PM | Networking Reception
6:00 PM | Program Close
 



Speakers: Janssen Pharmaceutical Companies of Johnson and Johnson

  • Barry Springer, Ph.D. | VP of Technology, Strategy & Operations, Biotechnology Center of Excellence, Janssen R&D read bio»
  • Steven Lang, Ph.D., MBA | Director, Biologics Research Analytical Discovery, Cell Line Development, Biotechnology Center of Excellence, Janssen R&D read bio»
  • Tim Coogan Ph.D., DABT | VP and Head of Biologics Toxicology, Biotechnology Center of Excellence, Janssen R&D read bio»
  • Hugh Davis, Ph.D. | VP and Head of Biologics Clinical Pharmacology, Biotechnology Center of Excellence, Janssen R&D read bio»
  • Bethany Paxson | Senior Director, Global Regulatory Affairs, Janssen R&D read bio»



Fees:
$35 General Public
$20 Student/Academic
$45 Onsite


Location:
Texas Medical Center
John P. McGovern Campus
2450 Holcombe Blvd, Suite X
Houston, TX 77021


Parking Information:
Please park in the self parking areas of the McGovern Campus. Grab a Token at the gate and bring it to the event space. We encourage carpooling and using the TMC shuttles.
TMC Map


Speakers' Biographies:

Barry Springer, Ph.D. | 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 Ph.D. 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.

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Steven Lang, Ph.D., 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.

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Tim Coogan Ph.D., DABT | VP and Head of Biologics Toxicology, Biotechnology Center of Excellence, Janssen R&D
Timothy P. Coogan Ph.D., DABT is Vice President and Head of Biologics Toxicology in the Biotechnology Center of Excellence within Janssen R&D. His group is responsible to design, implement and interpret the 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). The Biologics Toxicology group also interacts with global regulatory agencies for biologics and biopharmaceuticals as well as conducts investigative studies addressing target and biologic-specific issues during development. Tim has a Ph.D. in pharmacology and is Board Certified in Toxicology. He came to Johnson & Johnson from the National Cancer Institute in 1992 and has >20 years of pharmaceutical experience in the nonclinical safety assessment of both small and large molecule therapeutics. He has contributed to or guided the nonclinical development of a number of marketed drugs. Tim is also Head of the Preclinical Pediatric Team, a global team focused on providing guidance on nonclinical support for therapeutics to be used in pediatric populations and as an expert in this area, he has written a number of articles and book chapters on nonclinical support in pediatric drug development. Tim is a full member of the Society of Toxicology, a Past-President of the Mid-Atlantic Chapter of the Society of Toxicology, and an Adjunct Assistant Professor in the School of Pharmacy at Temple University.

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Hugh Davis, Ph.D. | 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.

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Bethany Paxson | Senior Director, Global Regulatory Affairs, Janssen R&D
Bethany obtained her BS in Chemistry in 1989. She started her career at Cephalon, Inc. (now Teva) and spent 4 years doing peptide synthesis focused on neurological diseases (ALS, AD). While still at Cephalon, Bethany transitioned to Regulatory Affairs. Since Cephalon, she has worked at 3 other PHARMA companies, including Centocor/Janssen (J&J) which she joined in 2001. She has over 20 years of global regulatory experience with both large and small molecules across multiple therapeutic areas such as Oncology, CNS, and Immunology. During her time in regulatory, Bethany has had regulatory responsibility for products targeting colon cancer, breast cancer, obesity, schizophrenia, ALS, Alzheimer's disease, narcolepsy, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Asthma, COPD, IPF, and Psoriasis. Since joining J&J, Bethany has held positions of increasing responsibility, first within the Centocor GRA organization and then in Janssen Global Regulatory Affairs as part of the Immunology Therapeutic Area. Bethany is a Senior Director performing the role of Global Regulatory Liaison (GRL). As GRL, she has overall responsibility and accountability for developing and implementing global regulatory strategies for Immunology compounds in development. Her current responsibilities include both large and small molecules and span all stages of development from pre-NME to marketed products. Bethany also supervises a group of 7 regulatory professionals within the Immunology TA.

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