RDPF! webinar : 23rd April : Dr John Whyte

Announcement

Webinar 23rd April 8am PST
organised by Rare Diseases Patients First !
For details contact Dr. Speid at lspeid@sndtm.com with RDPF! In the subject line

Free online seminar about the Drug Development Process for Patients
with Rare Diseases. Please share widely with friends and family
“The Rare Diseases Patient at the Center of it All”

You are cordially invited to a free WEBEX (seminar). This seminar is being organized by Rare Diseases Patients First! a non-profit that provides unbiased information to patients with rare diseases, and parents with children that have rare diseases. Our goal is to provide information that will empower you to make a difference in the drug development and clinical trial processes for rare diseases.

Patients with rare diseases are very busy. This is one hour that will be an effective use of your time.
Date: 23rd April 2015
Time: 8 am PST (US West Coast); 11 am EST (New York Time); 4 pm Local Time in the United Kingdom; 5 pm Local Time in Europe
Duration: 1 hour
Special Guest Speaker: Dr. John Whyte, Director, Professional Affairs & Stakeholder Engagement, U.S. Food and Drug Administration
“Patients are experts in their disease, and we need to include their input.”
- Dr. John Whyte

Format: A presentation will be followed by an interactive question and answer session. This is your opportunity to have your Questions about patient engagement answered. Not everyone can travel to Washington DC for the special patient engagement meetings that FDA holds. This is your opportunity to tell us about your concerns.

How can I register for this Webinar? Please email Dr. Speid at lspeid@sndtm.com with RDPF! In the subject line. She will send you the WEBEX login information.

What will it cost to take part? This Webinar is absolutely FREE. However, because space is limited, please make best efforts to take part if you register. We will not be making recordings available at this time.

RDPF! Website: The website will be activated after the trademark (in process) is approved.
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RDPF! BLOG
Free online seminar about the Drug Development Process for Patients
with Rare Diseases. Please share widely with friends and family

Bio for Dr. John Whyte, Special Guest Speaker
JOHN J. WHYTE, MD, MPH
Director, Professional Affairs & Stakeholder Engagement
U.S. Food and Drug Administration

John J. Whyte, MD, MPH is currently the Director of Professional Affairs and Stakeholder Engagement at the Center for Drugs Evaluation and Research at the US Food and Drug Administration. In this role, Dr. Whyte works with health care professionals, patients, patient advocates, and others involved in the use of medicines. His office provides them with a focal point for advocacy, enhanced two-way communication, and collaboration, and assists them in navigating the FDA on issues concerning drug development, review, and drug safety. He also oversees the Safe Use program and supports the ongoing partnerships and activities under the Safe Use Initiative.
Previously, Dr. Whyte served as the Chief Medical Expert and Vice President, Health and Medical Education at Discovery Channel, the leading non-fiction television network. In this role, Dr. Whyte developed, designed and delivered educational programming that appeals to both a medical and lay audience. This included television shows as well as online content.

Dr. Whyte is a board-certified internist. He completed an internal medicine residency at Duke University Medical Center as well as earned a Masters of Public Health (MPH) in Health Policy and Management at Harvard University School of Public Health. Prior to arriving in Washington, Dr. Whyte was a health services research fellow at Stanford and attending physician in the Department of Medicine. He has written extensively in the medical and lay press on health policy issues. His book Is This Normal? The Essential Guide to Middle Age and Beyond has won numerous awards. His most recent book, AARP New American Diet: Lose Weight, Live Longer is a national best-seller.

Background
Patients with rare diseases need unbiased and accurate information about their rare diseases, how to manage it on a day to day basis, and the best treatments that are available to them. Many also want to be consulted about how their disease affects them on a day to day basis, so that this input may translate into better new treatments.

Patient engagement in the drug development process is a rapidly developing field. It is particularly important in the area of rare diseases because the number of patients with a rare disease is limited. This requires drug developers to gather the most appropriate data during the clinical trials. In order to do this, they must have a clear understanding of what is important to the patients with the rare disease that they are developing the new treatment for. No one knows a rare disease better than the patient that is living with it. RDPF! Website: The website will be activated after the trademark (in process) is approved.

We will be exploring patient engagement in relation to the regulatory framework.
• What does patient engagement look like?
• What regulatory framework is the FDA putting in place for patient engagement?
• How will FDA protect the patient as pharmaceutical firms seek to engage with them?
• How can conflicts of interest be adequately addressed?
• Will there be a need to reassess the risk versus benefit paradigm as patients with rare diseases provide their input?
• Are patients going to be able to access experimental treatments even before they are approved?
• What do parents of children with rare diseases need to know about the availability of experimental and unapproved treatments for compassionate use?
• What are surrogate endpoints and how can patients help to clearly define them for drug developers?
Sponsors for Webinar 003

“The Rare Diseases Patient at the Center of it All”
We are thankful to the Sponsors of Webinar 003 for helping us to spread the word to patients and parents of children with rare diseases.
Rare Diseases Patients First! is an organization that seeks to provide free and unbiased educational content about the drug development process to patients with rare diseases, and parents of sick children with rare diseases. RDPF! Website: The website will be activated after the trademark (in process) is approved.

To Register: Please email Dr. Speid at lspeid@sndtm.com with RDPF! In the subject line. She will send you the WEBEX login information.
Cost: FREE – This is free, but space is limited. If you take a space, please make best efforts to take part. We will not be making recordings available at this time. RDPF! Website: The website will be activated after the trademark (in process) is approved.