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BioNJ’s Clinical Development Virtual Briefing
May 17 @ 10:00 am - 12:00 pm
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Join us virtually on Tuesday, May 17, 2022 for BioNJ’s Clinical Development Briefing featuring speakers from the public and private sectors who will present on the vision for Protocol Design, Digital Data Flow and Applying COVID-19 Lessons.
Topics Include:
- Direction of Protocol Design toward rapid optimization of trial parameters early on in the clinical operations value chain
- Role of wearables and devices in decentralized trials and whether large-scale investment is justified based on COVID-19 lessons learned
- Future state vision for Digital Data Flow and how it will enable decentralized trials and better protocol design
| AGENDA | |
| 10:00 a.m. – 10:05 a.m. |
Welcome and Opening Remarks Debbie Hart, President & CEO, BioNJ Terese L. Bandy, Ph.D., Senior Director, Global Medical Capabilities, Development & Operations, Sanofi |
| 10:05 a.m. – 10:35 a.m. |
Protocol Design Industry and FDA have been working together for the last several years to accelerate the digital transformation of clinical trials to improve trial efficiency, data integrity and expand trial access to underrepresented populations. The COVID crisis has accelerated many of these nascent opportunities, including how sponsors and regulators can achieve protocol optimization from the outset of trial design, building pragmatic tools to overcome data fragmentation and implementing platform trials that harness real world evidence and adaptive designs to accelerate our ability to decipher safety and efficacy signals in discrete populations and treatment settings. As the COVID crisis ebbs, which of lessons are truly scalable and most likely to transform the clinical trial ecosystem in the next 3-5 years? Victoria L Chiou MD, Head, Clinical Excellence and Innovation, Oncology R&D, AstraZeneca |
| 10:35 a.m. – 11:05 a.m. |
Decentralized Trials & Covid-19 Lessons Learned An industry expert will discuss state of wearables as well as how to develop regulatory grade tools that answer critical questions about clinical and analytical validity, and how employing these tools change the operational/digital data systems — highlighting advanced in fields like oncology. Chris Benko, MBA, CEO, Koneksa Health |
| 11:05 a.m. – 11:35 a.m. |
Digital Data Flow This session will focus on the future-state vision for Digital Data Flow and how it will enable decentralized trials and better protocol design, including current challenges, lessons learnt from other industries and the necessary steps to take. Ashish Gupta, Senior Vice President, Head of Data & AI, Incedo |
| 11:35 a.m. – 12:00 p.m. |
Networking |
Registration is $45 for BioNJ Members and $65 for Future Members. If you would like to join BioNJ, learn about Sponsorship Opportunities or confirm that your Membership is up to date in order to ensure that you receive the Member rate, please contact Kim Minton at KMinton@BioNJ.org.
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