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プロジェクト・オプティマス:お客様のプログラムの促進に向けて、米国FDAと関与する方法

Special Live Session - in person at DIA!

Join us for this SPECIAL SESSION taking place during DIA Global 2022. This is a cocktail reception with presentation and Q&A hosted by Julie Bullock, PharmD & ex FDA and Demetrius Carter at the Hyatt Regency McCormick Place.

Given the launch of Project Optimus, how do you best navigate the evolving regulatory landscape and determine the optimal way to engage with the agency?  Join this special event at DIA 2022 to address key questions that will help you to create a plan that’s tailored to your needs, whether you are at pre-IND stage or already in the clinical phases.

  • What is the actual ask from the FDA on Project Optimus?
  • When should you engage with the agency?
  • What should you talk about with the agency and how should you prepare?
  • What are best practices for your regulatory engagement and submission?

Location: Prairie Room located on the 2nd floor of the Hyatt Conference Center

Space is limited
Register today for this in-person event at DIA 2022!

Thank you for registering for our special live session to be held on Tuesday, June 21st 5:30-7:30pm at Hyatt Regency McCormick Place (adjacent to the DIA Global conference at McCormick Place)

What to expect:

5:30 – 5:45 Refreshments

5:45 – 6:45 Presentation followed by Q&A

6:45 – 7:30 Refreshments

We will send email reminders ahead of the session.

We look forward to seeing you there!

講演者
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Demetrius Carter
SVP, Regulatory Services, Synchrogenix, a Certara Company
Demetrius Carter, RAC, is a clinical development executive with 20+ years of drug development experience in both the pharmaceutical and medical device industries. His experience includes roles at Glaxo SmithKline, Pfizer and JNJ before transitioning into the CRO industry. While at IQVIA, Demetrius held roles of increasing responsibilities in project management, clinical monitoring, and central laboratories. He also led global operations at Syneos Health for both the medical device and the oncology business units. Demetrius presently serves as the senior vice president, regulatory services at Synchrogenix where he oversees their regulatory writing, strategy, and operations functions. He has a Bachelor of Science in Biological Sciences from North Carolina State University and an MBA from Fairleigh Dickinson University. He also holds several certifications including Project Management Professional (PMP) from the Project Management Institute, Lean Six-Sigma Green Belt Certification from Villanova University, and the Regulatory Affairs Certification (RAC).
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Julie Bullock, PharmD
Senior Vice President, Global Head of Clinical Pharmacology & Translational Medicine

Julie has over 10 years of drug development experience within the FDA. Dr Bullock's past appointments include Clinical Pharmacology Team Leader and Senior Clinical Pharmacology Reviewer (FDA). Her regulatory experience was focused in the therapeutic areas of hematology/oncology and coagulation. She has unique insight in pediatric development, PK/PD approaches for biosimilar products, oncology dose finding strategy and streamlining development for breakthrough therapies and accelerated approval. Dr. Bullock has contributed to over 14 new molecular entity approvals during her 10-year FDA career.

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