SOURCE: Xtalks

Xtalks Webinars

July 19, 2017 07:30 ET

Emerging Issues for Pharma R&D: A Practical Approach for Pediatric Drug Programs, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - July 19, 2017) - In this webinar scheduled for Wednesday, August 16, 2017 at 11am EDT (4pm BST/), industry experts Dr. Barry Mangum from Paidion Research and Dr. JF Marier from Certara will discuss how pediatric considerations fit into the overall drug development program. They will also make recommendations for addressing issues from both a practical and scientific perspective. Anonymized case studies will be presented with a review of historical issues with a focus on solutions for today (i.e. licensed comparators differences in US and EU, importation issues, and endpoint selection

Pediatric patients are not simply small adults. Children differ from adults in both disease pathophysiology and pharmacokinetics/pharmacodynamics (PK/PD). Maturation of metabolic capacity and renal function can impact drug clearance. In addition, changes in body composition can alter volumes of distribution, and changes in GI function can affect drug absorption. Yet historically, 80 percent of medicines used in children had little to no data guiding prescribers on proper use.

The pharmaceutical industry has numerous reasons not to develop pediatric drugs. Often, pediatric indications are not particularly profitable, and pediatrics in the US market represents only about seven percent of drug sales. From a practical perspective, pediatric development tends to be a low priority for product development teams who are focused on gaining regulatory approval for adults.

To address this market failure, regulatory legislation for drug development in pediatric patients was passed worldwide over the past decade. The number of drugs tested in and labeled for children has increased dramatically as a result. Despite this progress, pediatric drug developers still face numerous hurdles: heterogeneous patient populations, limited numbers of patients, and practical/ethical challenges with performing clinical studies in this vulnerable population.

Key discussion points:

  • What trends are emerging in the global pediatric drug development landscape with a focus on the US perspective
  • How to optimize the interactions with regulatory agencies, before or after the pediatric investigation plan (PIP) and managing the FDA-EMA Committee for Medicinal Products for Human Use (CHMP) parallel advice procedure
  • What to look for when engaging external expertise in pediatric drug development

For more information or to register for this complimentary session, visit: Emerging Issues for Pharma R&D: A Practical Approach for Pediatric Drug Programs

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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