FDA NEWS: Rare Disease Grants, Idea Portal to Predict Future, FDA/EMA Clusters, Cyber Security Month – Drug and Device Digest

FDA BRIEF: Week of October 17, 2016 

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 21 FDA grants to stimulate product development for rare diseases

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AWARD of 21 new clinical trial research grants totaling > $23 million over 4 years

  • Boost development of products for rare diseases
  • To Principal Investigators from academia and industry (drugs and devices)
  • For 21 different rare diseases with little or no available treatment
  • Through the Orphan Products Clinical Trials Grants Program
  • For clinical studies evaluating product safety and effectiveness contributing to FDA approval

FUNDING

  • 24  % for cancer particularly devastating brain cancer
  • 43% for  pediatric patients as young as newborns
  • 1 medical device for neuroprosthesis
  • Funding rate: 31%

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Introducing FDA’s Emerging Sciences Idea Portal: Please Help Us Predict the Future

By: Donna L. Mendrick, Ph.D., Associate Director for Regulatory Activities, NCTR

Donna Mendrick

EMERGING SCIENCES WORKING GROUP formed in 2015

  • Representatives from FDA product and research centers & offices
  • Leverage scientific expertise and resources to conduct long-range horizon scanning
  • Emerging issues and cross-cutting scientific advances
  • FDA preparedness to proactively address  emerging issues and scientific advances

GOAL

  • Identify areas not yet addressed in current products e.g. brain-computer interfaces
  • Develop science-based planning, programs, policies, reporting, communication

EXPERTISE

  • Cast a wide net – Within and outside FDA
  • Experts in  private sector

PORTAL

  • For science and technology experts outside of government
  • Submit predictions on the next new things in their field of specialization – will barely show up on a web search
  • NOT looking for advances that are already under discussion.

 

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New FDA/EMA rare diseases and patient engagement clusters underway

by:

Jonathan C. Goldsmith, M.D., FACP, Associate Director, Rare Diseases Program, CDER

Sandra Kweder, M.D., Deputy Director, EU Office, EMA Liaison

Dr. Jonathan Goldsmith

Sandra Kweder

GLOBAL COLLABORATION

  • FDA collaborates with other countries and international regulatory agencies for global development programs
  • European Medicines Agency (EMA) is valuable collaborator : 4,500 scientists, supervises medicines for > 500 million people in 31 countries

FDA-EMA COLLABORATION

  • > 10 years
  • Work in groups called “clusters”
  • Summarized in EMA website.

RECENT CLUSTER:RARE DISEASE

  • To advance treatments for patients with rare diseases
  • Share information and review aspects of rare disease drug development programs
  • Identification and validation of trial end points
  • Potential trial designs
  • Flexibility in evaluation of drug development programs
  • Expediting review and approval

RECENT CLUSTER: PATIENT ENGAGEMENT

  • Incorporate the patient’s involvement and viewpoint in the drug development process
  • Develop common goals of expanding patient engagement activities
  • Finding patients as spokespersons
  • Train selected patients to effectively participate in agency activities
  • Report impact of patient involvement

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 FDA & NAtional Cyber Security Awareness Month

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National Cybersecurity Awareness Month. Proclaimed by President Obama each year

FDA POSITION:

  • Medical device cyber safety is large and shared responsibility
  • Requires diligence from all stakeholders: manufacturers, government agencies, health care organizations, health care professionals, cybersecurity researchers, and medical device user

FDA PARTNERSHIPS:

  • Public and private sector organizations
  • Department of Health and Human Services, National Health Information Sharing and Analysis Center (NH-ISAC), Medical Device Innovation, Safety, and Security Consortium (MDISS), Department of Homeland Security’s Industrial Control Systems Cyber Emergency Response Team (ICS-CERT)

FDA RECOMMENDATIONS: Employing cybersecurity best practices and good cyber hygiene

RESOURCES: Stop.Think.Connect.™ campaignCDRH website.

Are you safe online? Visit the online resource guide to find out. Brought to you by DHS Stop.Think.Connect.


 

 

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