DIA 2021
Featured Presentations:

 

Panel: Is There a Role for Federal Incentives to Stimulate Greater Diversity in Clinical Trials?

With combined experience running studies and drafting FDA rules, this panel will show why guidance on trial diversity has not produced results and help illuminate how incentives can translate guidance into thoughtful action.

June 29, 2021 4:00pm - 5:00pm EDT

 

Moderator:

  • Stephen Keith, MD, MSPH, Medical Director, Syneos Health

 

Panel: Using Real-World Data in Single-Arm Trials: When It’s Done, Why It’s Done, How It’s Done

As real-world data increasingly provide synthetic controls in single-arm drug registration studies, terminology and insights have evolved. The structured, multistep assessment process described addresses why, when, and where to use new approaches. Learn fundamentals of synthetic control arms & RWD integration into clinical trials; understand relevant key terminology; evaluate feasibility of using an external control arm in a clinical trial; weigh pros and cons of historical vs concurrent control arm data; identify potential external sources for control populations.

July 1, 2021 10:00am - 11:00am EDT

 

Moderator:

  • David Thompson, PhD, Senior Vice President, Real-World Evidence at Syneos Health

 

Course: Developing, Implementing, and Operating REMS Programs

The FDA may require your new or existing products to have a Risk Evaluation and Mitigation Strategy (REMS) program if serious safety concerns are identified in clinical trials or post-marketing. REMS gives manufacturers a pathway to market such products, but your organization may have a limited understanding of what it is, when it may be necessary, or how to implement. Learn how to expand your understanding of the challenges unique to products with an associated REMS and learn how REMS programs are developed, approved, launched, and operated.

June 23, 2021 9:30am - 12:30pm EDT

 

Moderators:

  • Jemma Contreras, Executive Managing Director, Advisory Group Lead, Syneos Health
  • Melissa Landers, Managing Director, Syneos Health

 

Forum: Development of Shared System and Shared REMS: Best Practices and Lessons Learned

This forum will focus on best practices and lessons learned for the development and implementation of Shared REMS. These topics will be discussed from the perspectives of the FDA, leaders in industry, and other stakeholders.

 

July 1, 2021 10:00am - 11:00am EDT

 

Moderators:

  • Jemma Contreras, Executive Managing Director, Advisory Group Lead, Syneos Health
  • Melissa Landers, Managing Director, Syneos Health
  • Kevin Holman, Director, REMS and Risk Management Center of Excellence, Janssen Pharmaceuticals
  • Kishore Gopu, Director, REMS Operations, Teva Pharmaceuticals

 

Poster: Proactive Feasibility Studies in Rare Disease

Rare disease drug development is one of the fastest growing areas for biopharmaceutical investment, but rare disease product development presents significant risks that sponsors must anticipate and navigate to be successful – especially in regards to recruiting a patient population indicative of the rare disease in question. This paper provides an overview of proactive global clinical trial feasibility assessments, to make the case that such an assessment can yield valuable information regarding patient recruitment and site selection for rare disease clinical trials as well as every other aspect of drug development and market access.

June 27 – July 1, 2021 EDT

 

Presenter:

  • Ray Huml, Vice President of Medical and Scientific Strategy, Head of the Rare Disease Consortium at Syneos Health Clinical Solutions

 

When 
Sun, Jun 27, 03:30 pm to Thu, Jul 01, 03:30 pm
Additional Details