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[Munich, DE] Road to the Clinic for Biologic Therapeutics

Johnson & Johnson Innovation, JLABS

Wednesday, 25 October 2017 from 12:30 to 18:00 (CEST)

[Munich, DE] Road to the Clinic for Biologic...

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Ticket Type Sales End Price Fee Quantity
General Public 24 Oct 2017 €25.00 €2.44
Student/Academic 24 Oct 2017 €15.00 €1.94
Press 24 Oct 2017 Free €0.00

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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


12:30 | Registration and Networking
13:00 | Welcome
13:30 | Development of a Process Suitable for Manufacturing a Biologic Drug
  - Cell culture
- Protein purification
- Product characterization
- Formulation & stability
- Fill/Finish
14:15 | 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
15:00 | Coffee Break
15:15 | 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
16:00 | Regulatory - Satisfy Statutory Legal Requirements for Testing in Humans
  - Strategy
- Data requirements: CMC, safety, clinical plan
- CTA Submission Package
16:45 | Networking Reception
18:00 | Programme Close

Barry Springer, Ph.D. | Vice President and Head of Strategy, Technology and External Innovation, Janssen BioTherapeutics, Janssen R&D read bio»
Tim Coogan Ph.D., DABT | Vice President and Head of 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



BioM Biotech Cluster Development GmbH
Am Klopferspitz 19a (IZB West II)
82152 Martinsried
IZB West II BioM Conference Room, 3. floor

Speakers' Biographies:
Barry Springer, Ph.D. | Vice President and Head of Strategy, Technology and External Innovation, Janssen BioTherapeutics, 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 BioTherapeutics (JBIO) technology, strategy and operations initiatives including leading its external scientific and business partnering activities. He leads JBIO 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 JBIO 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.
Connect with Barry: Connect on LinkedIn

Tim Coogan Ph.D., DABT | Vice President and Head of Biologics Toxicology, Janssen BioTherapeutics, Janssen R&D
Timothy P. Coogan Ph.D., DABT is Vice President and Head of Biologics Toxicology for Janssen BioTherapeutics 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.
Connect with Tim: 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 [Munich, DE] Road to the Clinic for Biologic Therapeutics? Contact Johnson & Johnson Innovation, JLABS

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When & Where

BioM Biotech Cluster Development GmbH
Am Klopferspitz 19a
82152 Martinsried

Wednesday, 25 October 2017 from 12:30 to 18:00 (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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[Munich, DE] Road to the Clinic for Biologic Therapeutics
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