reggie

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So far reggie has created 36 blog entries.

New Waiver in IRB Process Speeds FDA Single Patient Expanded Access Approval; Updated Information available on WCGF website.

On October 3, 2017, Dr. Scott Gottlieb, FDA Commissioner, testified before the US House of Representatives Subcommittee on Health, Committee on Energy and Commerce. He announced a significant change to the way that IRB may review single patient expanded access request involving investigational drugs or biologics. This change, which permits an IRB chair or designee [...]

November 8, 2017|General|0 Comments

How could a new treatment, given previously under expanded access, successfully treat a serious disease of the eye?

A treatment for neurotrophic keratitis, initially given under expanded access, has been approved for use in European countries. The treatment, a genetically engineered nerve growth factor, has been shown to heal the corneas of affected patients, including children. http://bit.ly/2yjsygw

November 7, 2017|General|0 Comments

WCG Foundation receives $50,000 from Johnson & Johnson

PRINCETON, N.J. Nov. 7, 2017—WCG Foundation has received $50,000 from Johnson & Johnson to help desperately ill patients get access to experimental medicines.

The gift supports WCGF’s efforts to help patients navigate the Food and Drug Administration’s expanded access program, which makes investigational drugs available to patients who have exhausted all other treatment and clinical trial options.

Learn More >

November 7, 2017|News|Comments Off on WCG Foundation receives $50,000 from Johnson & Johnson

What can a new atlas of DNA tell us about genetic probabilities?

Researchers funded by the National Institutes of Health (NIH) have completed an atlas of human DNA that influence gene expression. Gene expression is shown through observable traits like eye color or disease risk; this research has shown how some genes are turned off and on. Previously, such information was not available at this scale. However, [...]

November 3, 2017|General|0 Comments

Expanded access allows patients to receive innovative new drugs. How often does the FDA approve patients’ requests?

The FDA's expanded access program has allowed many desperately ill patients to receive experimental treatments in an effort to save lives. Just last fiscal year, over 1,700 requests were made by patients to access experimental treatments. The Food and Drug Administration's Center for Drug Evaluation and Research and their Center for Biologics Evaluation and Research combined [...]

October 31, 2017|General|Comments Off on Expanded access allows patients to receive innovative new drugs. How often does the FDA approve patients’ requests?

What is a .@US_FDA priority review voucher and how does it expand opportunity for #medicalresearch of #rarediseases?

The priority review voucher program incentivizes pharmaceutical companies to research drugs for very rare diseases. When a drug developer researches a rare disease, a voucher is received by that organization from the FDA to move another treatment, often for a more common disease, through the regulatory process more quickly. How does this program work? http://bit.ly/2f5RXjm

October 27, 2017|General|Comments Off on What is a .@US_FDA priority review voucher and how does it expand opportunity for #medicalresearch of #rarediseases?

What kind of information can be gained from a mock clinical trial? How can this procedure help us learn about diversifying clinical trials?

Two populations in the United States - one in Altoona, Pennsylvania, the other in Atlanta, Georgia - of similar incomes, but different racial backgrounds, were enrolled in a mock clinical trial to gauge participation given several variables. Some similarities, such as requests for background information, arose in both populations. But differences in requests for amenities such [...]

October 24, 2017|General|Comments Off on What kind of information can be gained from a mock clinical trial? How can this procedure help us learn about diversifying clinical trials?

What information can the donation of one patient’s tumor yield about metastasis?

Michelle Monje, MD, PhD, is a researcher studying a rare type of pediatric brain tumor, Diffuse Intrinsic Pontine Glioma (DIPG). This type of cancer often spreads quickly and the patient dies only months after diagnosis. The reasons for the quick metastasis have been unknown. However, parents who lost their child gave a generous donation of [...]

October 20, 2017|General|Comments Off on What information can the donation of one patient’s tumor yield about metastasis?

What is the iMPACT Program and how will it bring diversity to clinical trials?

iMPACT is a three-year pilot program focusing on the recruitment and retention of minorities in cancer clinical trials. Its aim is to remove barriers and improve access to cancer-related clinical trials and is a partnership between nonprofit organizations and the National Cancer Moonshot. The goal is to create a program that can be replicated throughout [...]

October 17, 2017|General|Comments Off on What is the iMPACT Program and how will it bring diversity to clinical trials?

How is it possible that a great many promising cancer drugs create a problem for research and trials? 

There are many new immunotherapeutic drugs for cancer in the research pipeline. Too few patients are available to fill the clinical trials,  as many are receiving treatment from physicians outside of the research institutions where trials are being held. In addition, many pharmaceutical companies are researching similar drugs, meaning there can be significant competition for [...]

October 13, 2017|General|Comments Off on How is it possible that a great many promising cancer drugs create a problem for research and trials?