The Road to the Biologic IND

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11/09/2014 10:00 11/09/2014 13:00 America/New_York The Road to the Biologic IND LabCentral , 700 Main St , Cambridge , MA 02139 Johnson & Johnson Innovation, JLABS false DD/MM/YYYY

The Road to the Biologic IND

LabCentral , 700 Main St , Cambridge , MA 02139

September 11, 2014 from 10:00 AM to 13:00 PM (EST)

$10 - $35

Best Practices When Filing Biologic Investigational New Drug Applications

Program Overview:
Do you have a solid plan to achieve IND acceptance? Filing a biologic Investigational New Drug (IND) application might be the next step in advancing your company's early-stage drug development program. Janssen Labs, the Johnson & Johnson Innovation Centers and the Janssen Biotechnology Center of Excellence invite you to an in-depth look into the process of filing an IND. 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 clear blueprint for IND approval, and we want you to be ready

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


8:00 AM | Registration, Breakfast, and Networking
8:30 AM | Development of a Process Suitable for Manufacturing a Biologic Drug
  - Cell culture
- Protein purification
- Product characterization
- Formulation & stability
- Fill/Finish
9:00 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
9:30 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
10:00 AM | Regulatory - Satisfy Statutory Legal Requirements for Testing in Humans
  - Strategy
- Data requirements: CMC, safety, clinical plan
- eCTD
- Pre-IND meetings
10:30 AM | Discussion and Q&A
11:00 AM | Program Close

Speakers: Janssen Pharmaceutical Companies of Johnson and Johnson

  • Steven Lang, PhD, MBA | Director, Biologics Research Analytical Discovery, Cell Line Development, Biotechnology Center of Excellence, Janssen R&D read bio»
  • Tim Coogan PhD, DABT | VP and Head of 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
$20 Student/Academic
$45 Onsite

700 Main St
Cambridge, MA 02139

Speakers Biographies:

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.

Tim Coogan PhD, DABT | VP and Head of Biologics Toxicology, Biotechnology Center of Excellence, Janssen R&D
Timothy P. Coogan PhD, 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 PhD 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.

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.

Johnson & Johnson Innovation, JLABS

About Johnson & Johnson Innovation, JLABS 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), New York City, and with Shanghai opening in 2019. For more information please visit or follow @JLABS.

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