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[Leiden, NL] Road to the Clinic for Biologic Therapeutics

Johnson & Johnson Innovation, JLABS

Tuesday, 24 October 2017 from 08:30 to 13:30 (CEST)

[Leiden, NL] Road to the Clinic for Biologic...

Ticket Information

Ticket Type Sales End Price Fee Quantity
General Public 3d 1h 46m €25.00 €2.44
Student/Academic 3d 1h 46m €15.00 €1.94
Press 3d 20h 46m Free €0.00

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Event Details

JLABS SAN DIEGO EVENT Johnson & Johnson Innovation, JLABS and Janssen BioTherapeutics invite you to an in-depth look into the process of filing biologic Clinical Trial Authorisation (CTA) applications 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 CTAs 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 CTA acceptance.

Join us for a series of short presentations exploring the basic requirements and considerations necessary to achieve a successful biologic CTA submission. The presentation will highlight the following:

    - Janssen BioTherapeutics - 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 and requirements for a CTA submission package


8:30 | Registration and Networking
9:00 | Welcome
9:30 | Development of a Process Suitable for Manufacturing a Biologic Drug
  - Cell culture
- Protein purification
- Product characterization
- Formulation & stability
- Fill/Finish
10:15 | 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
11:00 | Coffee Break
11:15 | 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
12:00 | Regulatory - Satisfy Statutory Legal Requirements for Testing in Humans
  - Strategy
- Data requirements: CMC, safety, clinical plan
- CTA Submission Package
12:45 | Networking Reception
13:30 | Programme Close

Meredith S. Rocca, Ph.D., DABT | Senior Scientific Director and Head of Toxicology Sciences, Biologics, Toxicology, Janssen BioTherapeutics, Janssen R&D read bio»
Hugh Davis, Ph.D. | Vice President and Head of Biologics Clinical Pharmacology, Janssen BioTherapeutics, Janssen R&D read bio»
Birge Berns, M.D., MRCP, FFPM | Senior Director, Global Regulatory Affairs Immunology, Janssen R&D read bio»

€25 | General Public
€15 | Student/Academic
€30 | Onsite


Coming soon!


CORPUS Congress Center
Willem Einthovenstraat
1, 2342 BH
Oegstgeest, Neatherlands

Speakers' Biographies:
Meredith S. Rocca, PhD, DABT, Senior Scientific Director and Head of Toxicology Sciences, Biologics Toxicology, Janssen BioTherapeutics, Janssen R&D
Meredith S. Rocca, PhD, DABT, Senior Scientific Director and Head of Toxicology Sciences, Biologics Toxicology, Janssen BioTherapeutics, Janssen R&D. The Toxicology Sciences group designs, conducts, and interprets nonclinical safety studies and provides expert nonclinical safety scientific and regulatory input to Compound Development Teams for all biotherapeutics in the Janssen R&D portfolio.

Dr. Rocca received her BS degree in Animal Science from Cornell University and her MS and PhD degrees in Physiology from the University of Maryland Medical School. She has 20 years of experience in the nonclinical safety evaluation of biopharmaceuticals, including positions at Wyeth, Human Genome Sciences, Amgen, Elan, and Janssen.
Connect with Meredith: Connect on LinkedIn

Hugh Davis, Ph.D. | Vice President and Head of Biologics Clinical Pharmacology, Janssen BioTherapeutics, Janssen R&D
Hugh M. Davis, Ph.D. is currently Vice President and Head of the Biologics Clinical Pharmacology department for Janssen BioTherapeutics, 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.
Connect with Hugh: Connect on LinkedIn

Birge Berns, M.D., MRCP, FFPM | Senior Director, Global Regulatory Affairs Immunology, Janssen R&D
Dr Berns is a physician with > 20 years experience in early and late stage drug development including strategic, regulatory and operational aspects, therapeutic area focus on rheumatology, oncology and anti-infectives within Janssen/Centocor, Eisai and Aventis. Currently, she is leading multiple global regulatory biologic teams within the Janssen Immunology group, integrating inputs from regional and functional Regulatory Team members to create a coherent and unified global regulatory strategy across our Immunology portfolio. In her role, she is responsible for negotiations with Health Authorities around the world. She received her medical qualification from the University of Erlangen Nuernberg, Germany where she also received her MD in Forensic Immunology. She gained her clinical experience in the UK NHS. She obtained her MRCP(UK) and Fellowship of the Faculty of Pharmaceutical Medicine in the UK. 
Connect with Birge: Connect on LinkedIn

Do you have questions about [Leiden, NL] Road to the Clinic for Biologic Therapeutics? Contact Johnson & Johnson Innovation, JLABS

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When & Where

CORPUS Congress Center
Willem Einthovenstraat
1, 2342 BH Oegstgeest

Tuesday, 24 October 2017 from 08:30 to 13:30 (CEST)

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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 digital health sectors. The JLABS flagship opened in 2012 in San Diego at Janssen's West Coast Research Center, and since then has grown to eight locations including the Bay Area, Boston & Lowell, MA, Houston, Toronto and a ninth location, New York City, launching in 2018. For more information please visit

About Johnson & Johnson Innovation
Johnson & Johnson Innovation Limited focuses on accelerating all stages of innovation worldwide and forming collaborations between entrepreneurs and Johnson & Johnson's global healthcare businesses. Johnson & Johnson Innovation provides scientists, entrepreneurs and emerging companies with one-stop access to science and technology experts who can facilitate collaborations across the pharmaceutical, medical device and consumer companies of Johnson & Johnson. Under the Johnson & Johnson Innovation umbrella of businesses, we connect with innovators through our regional Innovation Centers, Johnson & Johnson Innovation | JLABS, Johnson & Johnson Innovation - JLINX, Johnson & Johnson Innovation - JJDC, and and our Business Development teams to create customized deals and novel collaborations that speed development of innovations to solve unmet needs in patients. For more information please visit or follow @JNJInnovation.

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[Leiden, NL] Road to the Clinic for Biologic Therapeutics
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