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Promoting Effective Drug Development Programs: Opportunities and Priorities...

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FDA Building 31

White Oak Campus

10903 New Hampshire Avenue, BLDG 31, the Great Room (Rm 1503)

Silver Spring, MD 20903

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ABOUT THIS EVENT

The purpose of the meeting is to solicit specific, actionable policy suggestions for the review staff of the FDA’s Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND) regarding opportunities to promote effective drug development while maintaining the FDA’s regulatory standards for the assessment of safety and effectiveness of new drug products. Of interest are efforts that could be implemented in the near-term and that cut across multiple therapeutic areas.

TOPICS FOR DISCUSSION

FDA is engaged in multiple, high-priority policy initiatives to facilitate effective drug development. Effective drug development programs leverage the best available scientific knowledge to characterize the benefits and risks of a potential product and generate the data necessary to support product approval. Current FDA endeavors in this area include evaluating the potential use of real-world evidence in regulatory decision-making and the incorporation of the patient perspective into drug development and review. FDA has previously released comprehensive plans or frameworks for the advancement of these efforts; therefore, these topics are not the focus of this meeting.

This meeting is an opportunity for OND division leadership to receive input directly from the public. We are particularly interested in the following topics:

  1. We are interested in input from stakeholders about where OND can provide additional guidance or prioritize additional scientific discussion in the near-term to improve clarity and encourage effective drug development. Given that OND’s portfolio includes a diverse spectrum of drugs and diseases, such input should focus on specific policy needs for various clinical areas linked by a shared therapeutic context (e.g., drugs intended to treat serious, life-threatening rare diseases; non-serious, self-limited conditions; etc.), rather than focusing on any specific disease or condition.

  2. Over the past decade, advances in scientific knowledge have led to unprecedented targeting of drugs to the underlying genetic or molecular pathophysiology of a disease. For many diseases, however, the current state of knowledge does not provide opportunities for such precise targeting, but patients living with these diseases require therapeutic innovation as well. Recognizing that each disease has unique considerations, we are interested in specific suggestions for guidance or policy development that OND could undertake to facilitate drug development for diseases not currently amenable to targeted therapies.

  3. Some therapeutic areas, particularly those that include serious and life-threatening diseases, have begun to implement novel trial designs, such as the use of master protocols to study multiple therapies and/or multiple diseases under a common infrastructure. We are interested in stakeholders’ views regarding the advantages and disadvantages of extending these approaches to additional therapeutic areas, and what guidance development would be most useful.

  4. FDA has published many guidances intended to explain the Agency’s current thinking regarding drug development topics that are not specific to a particular disease or indication. If stakeholders believe that OND review divisions are implementing these guidances in different ways, which are not explained by case-specific features, this may reflect a need for guidance revision or additional policy development. We are interested in hearing specific recommendations for topics where further clarity of the Agency’s current thinking may be warranted.

  5. Innovative approaches can bring additional uncertainty to drug development, since the advantages and disadvantages of the approaches may not yet be fully understood by either the Agency or sponsors because of their novelty. Sometimes, a well-understood development pathway may be chosen solely because of existing precedents in the therapeutic area. We would like to hear how OND can promote effective drug development programs when this tension exists.

REGISTRATION

Persons interested in attending this public meeting, either in person or by webcast, must register above by midnight (Eastern Time) on October 10, 2019. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization.

MEETING AGENDA

The full meeting agenda will be available a few days before the workshop.

REQUESTS FOR ORAL PRESENTATIONS

During online registration you may indicate if you wish to present. To facilitate agenda development, registrants requesting to present will be contacted to provide information regarding which topics they intend to address and the title of their presentation. We will do our best to accommodate requests to present. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate. All requests to make oral presentations must be received by the close of registration on October 10, 2019.

ONLINE ATTENDANCE (WEBCAST)

This meeting will be available for online viewing, on the day of the meeting via the following link: https://collaboration.fda.gov/ond110719/. If you have used Connect Pro before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overviewExternal Link Disclaimer.

SPECIAL ACCOMMODATIONS

If you need special accommodations due to a disability, please contact Eithu Lwin at (301) 796-0728 or EiThu.Lwin@fda.hhs.gov by October 30, 2019.

VISITING FDA

Entrance for the public meeting participants (non-FDA employees) is through Building 1. Please allow time for routine security checks, as procedures will be performed. For parking and security information, please refer to Public Meetings at the FDA White Oak Campus.

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Date and Time

Location

FDA Building 31

White Oak Campus

10903 New Hampshire Avenue, BLDG 31, the Great Room (Rm 1503)

Silver Spring, MD 20903

View Map

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