“How to Hold Your First-In-Human trial?” is a clinical trial workshop bringing together experts in the field from Johnson & Johnson, CROs and research centres to discuss advantages, challenges and experiences in running trials around the globe. The content will include insights in study design, cost/incentives, speed, quality, the participant pool, communication and language, partners, your market, the standard of medical care, data integrity, and also regulatory aspects to consider around ATMPs, vaccines, and other applications.
Meet one-on-one with the panel and improve your pitching skills!
Topics will include:
- The questions you should be asking – what, why, where, when and how?
- The importance of proactive planning and the right partner
- Partner/vendor/country selection
- Regulatory environment
- Study populations and design
- Safety considerations
- Study location considerations
- What are the real differences/advantages for a young company that has limited resources going to other locations for clinical trials?
- Standard of medical care and data integrity in THAT country
- Timelines & costs
There will be plenty of time for discussions and networking with the speakers.
14:00 Registration and networking
14:30 Welcome from Johnson & Johnson Innovation – JLABS
Elena Fernandez-Kleinlein, Interim Head of Johnson & Johnson Innovation – JLABS
14:45 Adding salt to the soup without tasting. Has SAD gone MAD?
Adam Cohen, Director, Centre for Human Drug Research
15:10 Early development and clinical pharmacology
Maroesja Van Nimwegen – GCDO Early Development Trial Leader Associate Director, Janssen Biologics
15:35 Coffee break
15:50 Nuts and bolts of early clinical research
Aernout van Haarst, Director Scientific Affairs, Celerion
16:15 Trials & errors and learning from mistakes (in a safe learning environment)
Marcel Kenter, Director, Paul Janssen Futurelab
16:40 Panel discussion with the audience:
Aernout van Haarst
Maroesja Van Nimwegen
Moderator: Elena Fernandez-Kleinlein
17:25 Networking reception
18:00 Program close