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A PEDIATRIC CANCER THINK TANK

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COMPASSIONATE USE (EXPANDED ACCESS) NEWS

(ASCO Educational Book) Before It’s Too Late: Multistakeholder Perspectives on Compassionate Access to Investigational Drugs for Pediatric Patients With Cancer

May 19, 2020

Patients and their families, physicians, drug companies, and regulatory agencies have common goals: to find effective therapies for life-threatening conditions. In oncology, the lines between clinical research and treatment are often blurred. more→

(Blog) FDA’s Project Facilitate is a Step in the Right Direction

May 17, 2019

Six is Lydia’s age in years. Six is also a number of months she lived after being diagnosed with DIPG. FDA’s Project Facilitate should help kids who, like Lydia, are denied compassionate use drugs. more→

(Blog) Make compassionate use program easy to navigate

November 12, 2018

The study we co-authored identified knowledge gaps and misperceptions about the compassionate use application process among pediatric oncologists and echoes new FDA’s Expanded Access Program Report. more→

(Pediatric Blood & Cancer) Physician perspectives on compassionate use in pediatric oncology

November 8, 2018

Full text Scott Moerdler, Lindy Zhang, Elena Gerasimov, Chong Zhu, Tamar Wolinsky, Michael Roth, Nancy Goodman, Daniel A. Weiser First published: 08 November 2018 Pediatr Blood Cancer. 2018 Nov more→

(Blog) Expanded Access Summit 2.0: It’s time for solutions

November 2, 2018

Expanded Access Summit 2.0 will address some of the unanswered questions on how to make expanded access feasible. more→

(Blog) Right to Try does not make compassionate use access easier

May 31, 2018

The new law doesn’t change a fundamental reality about compassionate use: the biggest hurdle is persuading a drug company to agree to provide access. more→

(KVC publication) Pediatric oncologists’ experiences with compassionate use. Abstract at 2018 ASCO annual meeting

May 17, 2018

The lack of knowledge and paucity of support in the application process are immediate actionable barriers to wider utilization of compassionate use in pediatric oncology. more→

(Nature Magazine) Fairer way to distribute last-ditch drugs gets real-world trial (Nature Magazine)

June 7, 2016

Drug companies’ compassionate policies hard to decipher, and experts are testing what they hope is a fairer system to distribute drugs. more→

(AACR abstract) Compassionate Use Navigator addresses challenges and facilitates access to investigational drugs for pediatric oncologists (Proceedings: AACR 107th Annual Meeting 2016)

April 20, 2016

Proceedings: AACR 107th Annual Meeting 2016; April 16-20, 2016; New Orleans, LA Elena Gerasimov, Lindy Zhang, Scott Moerdler, Michael Roth, Nancy Goodman more→

(KVC publication) Saved Josh: The gears of a successful patient advocacy campaign, Elena Gerasimov)

March 9, 2016

Read a detailed account of a case of a 7-year-old boy whose request to be treated with an experimental drug started the nationwide conversation about compassionate use. more→

Viral crossroads (BioCentury)

March 31, 2014

By Steve Usdin pdf

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