For healthcare products that require clinical studies to support licensing or regulatory clearance the execution of the clinical plan is the most critical stage in the product development process of a company. For young companies the success of a clinical study is very crucial and determines if the company is able to continue its product development program and eventually get market approval by the regulatory organisations such as the FDA and EMA.
In this expert class the design of the clinical studies will being discussed from the perspective of three different healthcare products including an Immunotherapeutic compound, a heart rate home monitoring mobile app and a diagnostic biomarkers for respiratory tract infection. What are the requirements of the different clinical studies, the time lines, required partners and costs. Is it possible to speed up clinical studies by applying other strategies?
The expert class program is set up in an interactive way such that the participants have also the possibility to bring their own questions and discuss issues they encounter in their own (start-up) company and/or business case. The expert class will also give the possibility to broaden the participants network.
13.00 hrs. Welcome by Chrétien Herben (moderator)
13.30 hrs. Start Expert Class
Pitch participants (2 min. per participant):
- Company presentation and/or business case
- Share questions and/or issues on the topic
14.00 hrs. Leon Hooftman, CMO ISA Pharmaceuticals
ISA Pharmaceuticals develops targeted, rationally designed immune therapeutics harnessing the patient's own immune system. Leon Hooftman will explain how the clinical trials are designed from a company’s perspective and in view of the drug development strategy. Is it possible to align the business criteria of a company with the regulatory requirements?
15.15 hrs. Jonas de Jong, CMO Happitech
Happitech is the world’s first CE Certified heart rate software development kit (SDK) for Android and iOS. Once integrated to an application, our algorithms allow medical- grade vital signs monitoring directly through a smartphone. Jonas de Jong will show the participants how Happitech was able to implement the use of the first CE certified hart rate home monitoring App in the clinic. How were the healthcare professionals and hospitals being involved in the clinical studies. Which partners were essential for getting the approval and what are the do’s and don’ts for a young company.
16.00 hrs. Coen Breedveld, Co-founder Levels Diagnostics
Levels Diagnostics is developing a rapid diagnostic tool that allows medical healthcare professionals to assess the nature of an infectious disease, being bacterial or viral. Coen Breedveld will talk about the experiences of Level Diagnostics in designing and starting a clinical study for the identification of biomarkers involved in respiratory tract infections. The clinical study was set up in close collaboration with the LUMC and Spaarne Gasthuis Haarlem.
16.45 hrs. Discuss questions and issues from participants with the experts
17.15 hrs. Drinks, bites and networking!
18.30 hrs. End of Expert Class
LifeSciences@Work Expert Classes are a series of targeted (virtual) workshops organized in close collaboration with industry and academic experts
- The small-scale and personalized Expert Classes welcome Venture Challenge Alumni, Value Centre Alumni and NWO Take off Alumni.
- New early startups not (yet) part of our LS@W community but interested to join are also very welcome, provided there is a match with the LS@W community profile.
- Participation is free-of-charge for startup teams.
Registration is needed to attend!
Please send an e-mail to email@example.com to receive your confirmation and additional final information.