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Your search for Ellen V. Sigal, PhD,Ellen V. Sigal, PhD matches 24 pages

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Watch Now: Discussion on Eligibility Criteria and the Impact on Access to Clinical Trials

On Friday, April 9, 2021, ASCO and Friends of Cancer Research (Friends) co-hosted a live virtual event, which brought together experts from across the health-care sector to discuss the recent release of the new ASCO-Friends recommendations for modernizing eligibility criteria to improve patient...

covid-19

FDA Collaborating on Use of Real-World Data to Inform COVID-19 Response Effort

On June 18, 2020, the U.S. Food and Drug Administration (FDA) took an additional step in harnessing real-world data to help inform the agency’s overall response to the COVID-19 public health emergency. The FDA announced its participation in the COVID-19 Diagnostics Evidence Accelerator, a...

covid-19

COVID-19 Evidence Accelerator Leverages Real-World Data

The Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) in collaboration with Friends of Cancer Research recently announced the COVID-19 Evidence Accelerator, an expansive public-private partnership combining the efforts of academic, government, and private sector organizations...

Friends of Cancer Research Hosts Annual Leadership Awards

On September 24, 2019, Friends of Cancer Research (Friends) hosted its 23rd Annual Cancer Leadership Awards Reception. The event honored individuals who have been champions of cancer research and steadfast advocates for patients: Anna Barker, MA, PhD, Professor and Director, Transformative...

issues in oncology

Project Facilitate: FDA’s Plan to Ease Expanded Access to Novel Therapies

The U.S. Food and Drug Administration (FDA) plans to provide oncologists with greater help in acquiring expanded access to investigational therapies. Deemed Project Facilitate, the pilot program was announced at a press briefing during the 2019 ASCO Annual Meeting. Project Facilitate is essentially ...

issues in oncology

Accelerated Approval Program: For the Benefit of Patients

A DIAGNOSIS of any life-threatening cancer or other serious illness has always been a world-shaking event for those touched by significant disease, and most of us have known—or will know—the frustration, helplessness, and desperate sense of urgency provoked by the words, “The disease is worsening,...

Amy Abernethy, MD, PhD, Named Principal Deputy Commissioner of Food and Drugs

ON DECEMBER 17, 2018, the U.S. Food and Drug Administration (FDA) announced that Amy Abernethy, MD, PhD, will replace Rachel Sherman, MD, MPH, as Principal Deputy Commissioner of Food and Drugs. Dr. Abernethy most recently served as Chief Medical Officer, Chief Scientific Officer, and Senior Vice...

issues in oncology
legislation

Why Right-to-Try Laws Are Dangerous

Why wouldn’t you support a patient with a terminal illness the “right to try” any therapy that may save his or her life? The answer to this question—one engulfed in a political debate in Congress—seems simple. It is not. [Editor’s Note: [Editor’s Note: On May 30, 2018, the President signed into...

legislation
health-care policy

Why Right-to-Try Laws Are Dangerous

Why wouldn’t you support a patient with a terminal illness the “right to try” any therapy that may save his or her life? The answer to this question—one engulfed in a political debate in Congress—seems simple. It is not. [Editor’s Note: On May 30, 2018, the President signed into law the Trickett...

issues in oncology

Friends of Cancer Research Rethinks Traditional Clinical Trials

Ellen V. Sigal, PhD, Chair and Founder of Friends of Cancer Research (Friends) began the annual meeting with a conversation with Douglas R. Lowy, MD, National Cancer Institute (NCI) Acting Director, and Robert M. Califf, MD, U.S. Food and Drug Administration (FDA) Commissioner. “Cancer research is ...

Reagan-Udall Foundation Announces Appointments of Ellen V. Sigal, PhD, and Richard L. Schilsky, MD

The Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA), an independent nonprofit organization that works to advance regulatory science to help support the scientific mission of the FDA, has elected Ellen V. Sigal, PhD, as its new Chairman, and Richard L. Schilsky, MD, as Vice ...

issues in oncology

Putting Patients First: My Journey in Advocacy

When I lost my only sister to breast cancer in 1986, patients like her had devastatingly few choices. Over the intervening decades, sustained commitment to biomedical research at the National Institutes of Health (NIH) and major technologic advances have led to transformative changes in cancer...

Friends of Cancer Research Honors Oncology Leaders at 20th Anniversary and Announces Partnership

Friends of Cancer Research (Friends) celebrated its 20th anniversary September 21 at a special event in Washington, DC. The event honored Janet Woodcock, MD; Eric Lander, PhD; and Sean Parker. Dr. Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug...

In Memoriam

The ASCO Post remembers the following specialists in oncology who passed away in 2015–2016. Please write to editor@ASCOPost.com to recognize and pay tribute to others in a future issue. Mark R. Green, MD January 3, 1945–February 23, 2015 “Few people have impacted cancer clinical research in the...

issues in oncology

Friends of Cancer Research Encourages FDA to Modernize and Consolidate

“In order to take advantage of today’s advancements in science, drug development, and patient treatment, the U.S. Food and Drug Administration’s (FDA’s) structure needs reorganization to focus its resources and ensure the best outcomes for patients. Friends of Cancer Research (Friends) proposes...

lung cancer

Activation of Innovative Lung Cancer Master Protocol Officially Announced, Enrollment to Begin in March

At a recent meeting in Washington, DC, Friends of Cancer Research and the Engelberg Center for Health Care Reform at the Brookings Institution officially announced activation of the Lung Cancer Master Protocol, a new research strategy that has the potential to hurdle or bypass known clinical trial...

lung cancer

Lung-MAP Launches: First Precision Medicine Trial From National Clinical Trials Network

A public-private collaboration among the National Cancer Institute (NCI), SWOG Cancer Research, Friends of Cancer Research, the Foundation for the National Institutes of Health (FNIH), five pharmaceutical companies (Amgen, Genentech, Pfizer, AstraZeneca, and AstraZeneca’s global biologics R&D...

lung cancer

Lung-MAP Trial Debuts—Other Personalized Studies Will Follow

Oncologists now have a means of bringing personalized medicine to advanced squamous cell carcinoma, and it involves a biomarker-driven clinical trial that maximizes the chance of successful treatment and new drug approvals. Lung-MAP (Lung Cancer Master Protocol) is a unique concept in which the...

Margaret Foti, PhD, MD (hc), Receives Ellen V. Sigal Advocacy Leadership Award

Margaret Foti, PhD, MD (hc), Chief Executive Officer of the American Association for Cancer Research (AACR), received the Ellen V. Sigal Advocacy Leadership Award from the national advocacy organization Friends of Cancer Research (Friends) at its 18th Annual Cancer Leadership Awards Reception held...

issues in oncology

Expert Panels Offer Five Proposals to Address Challenges in Regulating, Implementing Next-Generation Sequencing

At the third annual Blueprint for Drug/Diagnostic Co-Development forum, cohosted by Friends of Cancer Research in Washington, DC, and the Alexandria Center for Life Science in New York, two panels tackled considerations in simultaneous development of drugs and companion diagnostics. Friends of...

Nationally Regarded Oncology Nurse Practitioner, Mary Pazdur, RN, MSN, Remembered by Friends and Colleagues

Oncology nurse practitioner Mary Pazdur, RN, MSN, spent her professional life bettering the clinical care and outcomes of cancer patients, culminating in her career at the National Cancer Institute (NCI), in the Laboratory of Tumor Immunology and Biology, working with patients on cancer vaccine...

issues in oncology

A Blueprint for Drug/Diagnostic Development: Expansion and Use of Curated Genetic Databases

In a continuation of a 2014 conference that explored regulatory considerations and strategies for next-generation sequencing, the Friends of Cancer Research, with support from Alexandria Real Estate Equities, Inc, Pasadena, California, met to discuss the issues and problems of coordinating drug and ...

health-care policy
issues in oncology

Clinical Trial System Badly in Need of Overhaul, Say Panelists at Friends-Brookings Conference

Cancer clinical trials in three distinct phases, as they have been conducted for decades, are probably no longer the best way to bring a drug or biologic agent to market. This was the consensus of three panels at the 8th Annual Conference on Clinical Cancer Research convened by Friends of Cancer...

lung cancer

Lung-MAP Launches: First Precision Medicine Trial From National Clinical Trials Network

A unique public-private collaboration among the National Cancer Institute (NCI), SWOG Cancer Research, Friends of Cancer Research, the Foundation for the National Institutes of Health (FNIH), five pharmaceutical companies (Amgen, Genentech, Pfizer, AstraZeneca, and AstraZeneca’s global...

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