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The Journey from Pre-Clinical to Patients:
How to Seamlessly Intertwine Healthy Normal and Patient Population Cohorts
Traditionally, clinical programs have adhered to an orderly model, where a therapy ran through a sequential model, going through Phase I, then Phase II, and Phase III, respectively. Today, this has changed. Simply look at the 21st Century Cures Act, and it’s clear that it’s becoming easier to put therapies in patients earlier.
But what do we need to see in healthy volunteers, and more importantly, what can be skipped, delayed, or safely evaluated in patient subjects to help advance the continuum of care?
The Uncommon Conversations in Drug Development Live series, hosted by Worldwide Clinical Trials’ scientific, operational and medical experts, is more than your average networking event. Designed with emerging to midsized biopharma and pharma in mind, it’s an uncommon environment for our peers to collaborate, meet like-minded execs, and gain introductions to those who have successfully faced the same challenges.
DATE & TIME : October 24, 2019 | 5:30 – 7:30 p.m.
LOCATION: Cafe Art Science | 650 E Kendall St, Cambridge, MA 02142
AGENDA: 1-hour moderated panel discussion followed by networking reception
WHAT TO EXPECT
Attendees will hear from leading experts about the future of drug development and how early phase programs are changing the way therapies move from pre-clinical to clinical for faster, more cost-effective research and development. Topics include:
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- Regulatory pathways
What should you ask agencies like the FDA and EMA? What about the divisions within them such as CBER, CDER, CDRH and CMPHU, COMP?
- Regulatory pathways
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- Cost and time efficiency
It’s a careful balance. For many programs, time is just as important as cost, and financial implications must be considered to minimize risks that ensure a safe and effective program.
- Cost and time efficiency
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- Commercialization vs. licensing
What are the pros and cons of each option?
- Commercialization vs. licensing
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- Streamlining drug development strategies
How can we pressure-test drug development methodologies using innovative design and operational solutions for first-in-human studies?
- Streamlining drug development strategies
MEET THE PANEL
Michael Murphy, M.D., Ph.D.
Chief Medical & Scientific Officer
Worldwide Clinical Trials
Randall Owen, M.D.
Chief Medical Officer
Navitor Pharmaceuticals
Patrick Noonan, Ph.D.
President
PK Noonan Pharmaceutical Consulting, LLC
Lona Sheeran
Senior Vice President, Clinical Operations Early Phase
Worldwide Clinical Trials
Jeffrey Stark, PhD
Director, Head of Pharmacokinetics
Worldwide Clinical Trials
Want to be a panelist?
CAN WE COUNT YOU IN?
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ABOUT WORLDWIDE CLINICAL TRIALS
Founded by physicians committed to advancing medical science, Worldwide is out to change how the world experiences CROs – in the best possible way. From early phase and bioanalytical sciences through late phase, post-approval and real-world evidence, we provide world-class, full-service drug development services.
With infrastructure and talent spanning 60+ countries, we execute predictable, successful studies with operational excellence across a range of therapeutic areas, including central nervous system, cardiovascular, metabolic, general medicine, oncology and rare diseases. We never compromise on science or safety. We’re never satisfied with the status quo. We’re the Cure for the Common CRO. For more information, visit www.worldwide.com.