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

Oct 25 2017https://www.eventbrite.co.uk/e/munich-de-road-to-the-clinic-for-biologic-therape...

JLABS SAN DIEGO EVENT

EVENT IS SOLD OUT - NO ONSITE REGISTRATION

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



Agenda:

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



Speakers:
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»


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


Partners:




Location:

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


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

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