Pediatric Drug Development

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Pediatric Clinical Trials | Pediatric Research & Drug Development

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No longer an option: Pediatric considerations in drug development

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View all Vizient, Inc. Related forums: - Irving, Texas. Vice President - Pediatric Services. As of February, there were already 31 patients enrolled in the trial for 6 months, and it is set to launch in 5 other countries as of March Looking to the future, Gregory Reaman, FDA, presented ideas as to how to help accelerate pediatric drug development. After mentioning that there is currently no legislative fix in regards to developing pediatric cancer drugs, Reaman suggested: maximizing regulatory authority, FDA aiding the endeavors as much as possible, expanding opportunities for evaluating precision medicine approaches, taking advantage of paradigm shifts, follow up optimizing Orphan Drug Act opportunities, and pursuing rational science based strategies for when to evaluate new drugs in children and how successfully this can be integrated into existing therapies.

The second session consisted of a panel discussion on considerations for a pediatric master protocol. Within this context, panelists discussed trial design and molecular prioritization criteria; the role of a multi-stakeholder decision-making body and governance; logistical and operational considerations and challenges; and fulfilling regional pediatric regulations and addressing globalization challenges.

One of the main issues described by Rousseau was the fact that no company will be willing to sponsor a drug from another company.

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He went on to state that the onus is on academia and major institutions like NCI in the U. Without collaboration, we will never be in position to break through the disease — Kenan Onel, University of Chicago. Another issue brought up during the panel discussion was misalignment of incentives that may hinder robust pediatric drug development due to the high cost and potentially low return on investment. Though incentives exist in the U.

Pediatric Drug Development – Relevant FDA Laws and Changing Approach

In the final discussion of the panel, Martha Donoghue, FDA, stated that no one involved in the drug development and review process wants to be the barrier to that progress for patients. Vassal stated that the regulatory environment is essential to success in this area and that in the EU there needs to be improvement within the regulatory environment. He also discussed the positive aspects of globalization in drug development, and how there is not a need for two drugs on both sides of the Atlantic — that there should be one drug developed and then tested in both areas to see if it works.

Ahead of the forum, panelists created a white paper. The event was supported by the St. Click HERE to view the slides from session one.