Office of Minority Health Newsletter vol.8

Newsletter vol.8  |  FDA Office of Minority Health

What's New in the Office of Minority Health?

We hope your fall season is off to a wonderful start! As we wind down during this last quarter, we would like to provide you with exciting news on some of our upcoming events for the remainder of the year and highlights of recent OMH activities. In this issue you’ll find information about health disparities lectures and panels, OMH exhibits, and new health resources available from our partners. We hope you enjoy the newsletter and always welcome your feedback and ideas at OMH@fda.hhs.gov.

Upcoming Events:

FDA‒University Maryland CERSI Workshop on Pediatric Master Protocols 

FDA and University of Maryland CERSI are co-hosting a workshop on September 23, 2016 from8:30am – 4:30pm at the FDA White Oak Campus that will focus on will focus on pediatric master protocols. Master protocols that run continuously and evaluate numerous investigational products simultaneously are being used to expedite clinical trial investigations for many medical products. The workshop will provide a forum for discussion of the regulatory and scientific concerns of pediatric master protocols and clinical trial design considerations for these protocols. Additionally, applications of pediatric master protocols to specific therapeutic areas will be discussed. Registration is required. You find more information here.

NIH Scientific Workshop on Zika Virus 

The National Institutes of Health (NIH) will host “Bridging Knowledge Gaps to Understand How Zika Virus Exposure and Infection Affect Child Development” in North Bethesda, MD, on September 22-23, 2016. The workshop is sponsored by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and Office of Research on Women’s Health (ORWH). The event is free, but registration is required. For more information about the workshop—location, agenda and registration—please visit the workshop website.

Organ Transplant PFDD Meeting On September 27, 2016, FDA is conducting a public meeting on Patient-Focused Drug Development for Patients Who Have Received an Organ Transplant. The public meeting is intended to allow FDA to obtain patient perspectives on the impact of organ transplantation on daily life, patient views on receiving an organ transplant, and decision factors taken into account when selecting a regimen for organ transplantation management. Register now!

Exhibits and Presentations: American Public Health Association and Health Literacy Annual Research Conference

We invite you to visit our exhibit at the American Public Health Association’s 2016 Annual Meetingin Denver, Colorado October 29-November 2, 2016.  In addition to our exhibit table, the OMH staff will also participate in a poster presentation, "Reducing Health Disparities through Tailored Communications: FDA Office of Minority Health's Outreach and Communications Program,"  an oralpresentation, "Increasing Clinical Trial Participation Among Minorities - The Food and Drug Administration's Office of Minority Health's Multi Media Campaign," and a roundtable, "Closing the Health Disparities Gap- the Food and Drug Administration's Office of Minority's Health's Strategies to Improve African-Americans Health." Please check your conference agenda for the exact dates and locations of our exhibit and presentations! 

We are also presenting at the Health Literacy Annual Research Conference (HARC) in Bethesda Maryland, which is being held October 13-14, 2016. The Office of Minority Health will discuss strategies for communicating with limited English proficiency (LEP) populations and the importance of creating culturally competent health materials. You can register and learn more about the conference here.

Clinical Investigator Training

FDA and University of Maryland CERSI will offer a three-day course for clinical investigators to receive training from FDA medical officers and senior scientists--along with other experts--in all aspects of clinical studies: preclinical and clinical science, statistical structure of trials, ethical requirements, and regulatory considerations. In addition, the course will help foster communication between clinical investigators and FDA and will enhance investigators' understanding of FDA’s role in experimental medicine. The course is being held November 7-9, 2016 and registration can be found in the training and continuing education section of our website.

In Case You Missed It:

Clinical Trials Champion Campaign September is Sickle Cell Awareness Month and we thought this would be the perfect time to revisit our Clinical Trials Champion campaign! On World Sickle Cell Day, we released a collection of 6 PSAs featuring Shirley Miller, a FDA patient representative, who graciously shares her story about living with sickle cell disease, while also letting others know why diversity in clinical trials is important. You can view the PSAs here and you can find more information about clinical trials on ourwebpage.

American Society of Nephrology and FDA Podcast: Recognizing Ways to Increase Diversity in Clinical Trials

The American Society of Nephrology's latest ASN Kidney News podcast is now available to download for free. The podcast explores the topic of disparities in clinical trials with a focus on why it is an important issue, as well as various programs and potential solutions to improve diversity. Assistant Commissioner for Minority Health, Dr. Jonca Bull, and FDA Center for Drug Evaluation and Research (CDER) Medical Officer, Dr. Patrick Archdeacon, are special guests for the episode. You can download the podcast at: http://ow.ly/9Y6X3048Iym

Clinical Trials Symposium

The Office of Minority Health partnered with the University of Miami to host a two-day seminar in Coral Gables, FL September 14-15, 2016. The symposium, “Improving Clinical Research in the Age of Precision Medicine,” focused on scientific, regulatory, and ethical aspects of clinical trials as well as quality assurance practices. It also provided important updates on FDA Regulatory requirements for clinical trials and perspectives from the front lines of clinical research. FDA Commissioner Dr. Robert Califf was the keynote speaker and our Assistant Commissioner for Minority Health, Dr. Jonca Bull, also gave a presentation. More than 500 participants attended the event.

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Job Announcements:

FDA is Recruiting for a Chief Scientist

The U.S. Food and Drug Administration is seeking a new Chief Scientist! Become a part of the Department that touches the lives of every American. At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans. This position is located in the Food and Drug Administration (FDA), Office of the Commissioner (OC), in Silver Spring, MD. Applications will be accepted until September 29, 2016. No previous federal experience is required…read more.

Partner Resources:

FDA Women’s College Health Resources Help students ace their health. The FDA Office of Women’s Health has free resources for your Back to School planning, campus events, and health promotion activities throughout the school year. Join health professionals, parents and over 150 colleges and universities who are participating in FDA’s National College Women’s Campaign. You can order free bulk copies of fact sheets and posters, download the new College Women’s Toolkit, or re-pin the Healthy College Women's Poston Pinterest.

HHS Viral Hepatitis Website 

As part of efforts to increase awareness of the current viral hepatitis crisis, the U.S. Department of Health and Human Services (HHS) launched a new, dedicated HHS viral hepatitis page atHHS.gov/hepatitis. This new website will enable the department to expand its commitment to fostering partnerships and action in the fight against viral hepatitis. The department encourages you to visit the new website and check out recent blogs, learn more about viral hepatitis, and learn how to get involved. Be sure to check back often, as information is being continually updated.