explore -WSS

explore

author：focus 2025-10-03 00:38:44 - browse：167

Peter Marks, Director of the Center for Biologics Evaluation and Research at the US Food and Drug Administration (FDA), testifies during a Senate Health, Education, Labor and Pensions Committee hearing to discuss the on-going federal response to Covid-19 on May 11, 2021 at the US Capitol in Washington, DC. — FDA's Peter Marks JIM LO SCALZO/POOL/AFP via Getty Images

WASHINGTON — The Food and Drug Administration needs dozens more reviewers if it wants its so-called Operation Warp Speed for rare disease therapies to take off, the agency’s biologics chief said Monday.

The administration launched the rare disease pilot program, dubbed START and modeled after the record race for a Covid-19 vaccine, this September. Peter Marks, head of the Center for Biologics Evaluation and Research, has spearheaded both initiatives.

“If we were really to expand this significantly, [it] would require us to get dozens of additional staff members,” Marks told listeners during a gene therapy discussion hosted by the Alliance for a Stronger FDA. “One could say ‘Oh my goodness, he’s asking for more headcount again.’ Well, if this really does reduce the time to development by 25 to 50% … it probably won’t take industry too long to do a net present value calculation to say ‘Oh, it’s worth making sure that they have their extra 20 or 30 or 40 reviewers.’”

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： State Dept. review finds Biden bears some blame for Afghanistan failures
Next article： Devoted Health’s losses in Medicare Advantage persist

leisure time

hotspot

WSS

Unique patient identifier: Experts argue the benefits, pitfalls

Eye stem cell transplant could help restore vision in injured people

Johnson & Johnson sued for allegedly overpaying for workers' drugs

AstraZeneca stays mum on Medicare drug pricing negotiations

ActiGraph execs on goal of drug approvals with digital endpoints

Why Novartis is going to walk from its acquisition of MorphoSys

hotspot

explore

explore

Trump demands the U.S. pay no more for drugs than other countries … again

New details revealed about Purdue's marketing of OxyContin

State Dept. review finds Biden bears some blame for Afghanistan failures

An interview with Robert F. Kennedy Jr. on vaccines

Medical leaders decry Supreme Court decision on affirmative action

Patient advocates sound warning on FDA proposal on salt intake

Guidelines to prevent youth baseball injuries need more muscle

Gene therapy for Afghan refugees’ infant will be fully covered

The high cost of giving birth even with insurance

Global cancer cases to surge 77% by 2050, WHO report says

hotspot

Ukraine taking heavy casualties 10 weeks into its counteroffensive

Global cancer cases to surge 77% by 2050, WHO report says

Bernie brings in new pharma CEOs to talk drug prices

Lung cancer is America's deadliest cancer. Yet so few get screened

Lung cancer is America's deadliest cancer. Yet so few get screened

A neonatal nurse in a British hospital has been found guilty of killing 7 babies

focus

leisure time

hotspot

Wikipedia