“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.
- 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.
