How to hold your first in-human trial?
18-06-2019-14:00 tot 18:00
“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.
The workshop is part of an initiative to bring more programming, training and support for the Dutch life science innovators through Johnson & Johnson Innovation – JLABS. Johnson & Johnson Innovation – JLABS is a premier life science incubator program and a global network of open innovation ecosystems, enabling and empowering innovators to create and accelerate the delivery of life-enhancing health and wellness solutions to patients around the world. As a leader in innovation, JLABS helps entrepreneurs in pharmaceutical, medical device, consumer, and health tech bring healthcare solutions to patients and consumers.
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