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Key Considerations & Best Practices for a Successful Clinical Trial

June 15, 2021

Session #3: Key Considerations and Best Practices for a Successful Clinical Trial
Plan for success. Recognize and minimize your risks. Choose partners wisely. Learn from others’ successes (and missteps). Join us June 15 to gather a wealth of insights from experts in clinical development, regulatory affairs, and private sector/government partnerships.

Agenda
12:00pm – 12:30pm: Opening Remarks

12:05pm – 12:10pm: Panelist Introductions

12:10pm – 1:10pm: Panel Discussion

1:10pm – 1:25pm: Q&A

1:25pm – 1:30pm: Closing Remarks

Topics
• Regulatory Strategy – Engaging with the FDA, Competent Authorities, etc.

• Trial speed and length

• The relationship between clinical trials and business plans

• Integrating clinical studies with your design control/development activities

• Engaging early on with potential partners

• Importance of developing a plan/strategy

• Sharing of best practices and advice

• Case studies/examples of well-run trials

• Conducting a trial during COVID-19

• Key opinion leaders

• CPT/Reimbursement strategy

Panelists
Stephen Tyrpak – Director, Clinical & Regulatory Affairs, of Garwood Medical
Kemi Olugemo – Executive Medical Director of Neurology Clinical Development, Ionis Pharmaceuticals, Inc.
Murray Sheldon – Associate Director of Technology and Innovation, FDA
Bert Hartog – Senior Director, Janssen Clinical Innovation at Johnson & Johnson
Hui-Hsing Wong – Senior Medical Advisor, Biomedical Advanced Research and Development Authority
Moderator: Rachel Rath – Director of BARDA Alliance, Johnson & Johnson Innovation

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