4 October 09:00 - 4 October 19:00
Johnson & Johnson Innovation, JLABS, Janssen Discovery Sciences and Karolinska Institutet Science Park invite you to an in-depth look into the process of filing a CTA. Whether your goal is to develop a pipeline through commercial launch or partner as early as possible, submitting a CTA 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 CTA approval, and we want you to be ready.
Join us for a series of short presentations exploring the basic requirements and considerations necessary to achieve a successful small molecule CTA submission. The presentations will highlight the following:
- Janssen Research & Development - a brief overview
- Preclinical Development strategies for pharmacokinetics, drug metabolism and toxicology
- Key CMC strategies to balance cost, time and quality risks
- Designing First-in-Human trials to highlight the qualities of your molecule
- Regulatory strategy, CTA requirements, and Pre-CTA meetings
Agenda:
9:00 Registration Opens, Networking andCoffee
9:30 Intro by Johnson & Johnson Innovation and KI Science Park
9:45 Introduction to Janssen Research & Development
10:00 Preclinical Development Strategies
- Designing drugable molecules with appropriate potency, selectivity, efficacy, solubility, kinetics and metabolism
- The importance of estimated low Dose to Man and high bioavailability
- Mitigate in vivo toxicology by in vitro toxicology screening
- Preclinical toxicology incl CV tox and mutagenicity evaluations before and during GLP toxicology
- Considerations for typical First-in-Human (FIH) Program
- Validation and translational aspects for positive human PoC (cellular - in vivo PKPD/Disease models)
- Predictive biomarker strategy and validation
- Budgetary aspects for this phase
11:00 Break
11:15 Chemistry, Manufacturing and Controls Strategies
- Optimizing manufacture of your Active Pharmaceutical Ingredient (API)
- The challenge of chiral APIs
- Drug product formulations for FIH
- Budgetary aspects for this phase
12:00 Lunch
13:00 Clinical Pharmacology
- Designing FIH trials
- Understanding PK/PD
- Biomarkers of safety and efficacy
- Budgetary aspects for this phase
14:00 Regulatory Overview
- Data requirements: CMC, safety, clinical plan
- eCTD
- Pre-CTA meetings and regulatory authority (EMA,FDA, MPA) support
- Regulatory Strategy
- Budgetary aspects for this phase
14:45 Break
15:00 Designing a Lean R&D Plan
15:30 Case Study
16:00 Discussion and Q&A
16:45 Networking and Drinks
18:30 Programme Close
Speakers
Kristof Van Emelen | Director, Emerging Sciences and Innovation, Janssen Discovery Sciences, Janssen R&D read bio»
Ann Lampo | Head Preclinical Project Development EU, Janssen R&D read bio»
Peter D'hoore | Senior Scientific Director, Janssen R&D read bio»
Erik Mannaert | Senior Scientific Director, Janssen R&D read bio»
Birge Berns | Senior Director, Global Regulatory Affairs Immunology, Janssen R&D read bio»
Sanjay Mistry | Head of External Value Creation, Janssen R&D read bio»
Fees:
FREE | Karolinska Institutet affiliate
30 € | General Public
15 € | Other Students/Academic
40 € | At the door
Location:
Karolinska Institutet Science Park
Tomtebodavägen 23A
171 65 Solna
Stockholm
Sweden
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