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Pioneering Biotech Advancements: A Conversation with Rachel King, CEO of BIO

Biotechnology Innovation Organization

Life sciences success by the numbers in Maryland’s Montgomery County

Class required to wear masks after COVID outbreak in Montgomery Co. school

BioHealth Innovation

Montgomery County, Maryland – Wikipedia

The 21st Century Cures Act: Big Pharma Handout or Drug Development Boon? – 2/1/2017

21st Century Cures Act Lowers Confidence In FDA-Approved Drugs And Devices – 2/14/2017

Outrage of the Month: 21st Century Cures — Gift to Big Pharma and Medical Device Companies, Bad Deal for Patients – 1/1/2017

Is the 21st Century Cures Act a Solution or a Problem? – 5/7/2019

21st Century Cures Act Benefits Big Pharma, Device Makers, Critics Say – 12/8/2016

“It also sets aside more research money for the National Institutes of Health — including $5 billion for the Cancer Moonshot initiative to accelerate cancer research, as well as brain and genomics research.

“Simply put: 21st Century Cures is an innovative game-changer and a truly once-in-a-generation opportunity to bring our healthcare system light years ahead of where it is today,” Republican U.S. Rep. Fred Upton of Michigan, the House’s chief sponsor, told the Los Angeles Times.

But the bill aims to further deregulate the pharmaceutical and medical device industry, critics say.

“When American voters say Congress is owned by big companies,” U.S. Sen. Elizabeth Warren (D-Mass.), said on the floor last week. “This bill is exactly what they are talking about.””

Weekly Address: Pass the 21st Century Cures Act – 12/3/2016

21ST CENTURY CURES ACT’S EFFECT ON PHARMACEUTICAL AND BIOTECHNOLOGY INDUSTRIES – 12/15/2016

“Vaccine-Related Provisions § 3091

Key Components

As soon as FDA licenses a vaccine (either initially or for a new indication), the Center for Disease Control’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) must consider the use of the vaccine at its next scheduled meeting, although it is not required to make a recommendation.

ACIP must make recommendations in a timely manner concerning the use of “certain vaccines,” including those that are (1) designated as a breakthrough therapy under Section 506 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or (2) could be used in a public health emergency.

No later than one year after enactment, the Secretary of Health and Human Services, along with the NIH, FDA, CDC, and Biomedical Advanced Research and Development Authority (BARDA) must submit a report to Congress on ways to promote innovation in the development of vaccines against infectious diseases and the identification of obstacles (and proposed remedies) to vaccine innovation. The Secretary may consult with representatives of relevant federal agencies and other stakeholders.”

Does the 21st Century Cures Act Give Big Pharma a Free Pass To Commit Fraud? – 2/11/2021

21st Century Cures Act – FDA

Huge thanks to Jules for all the 21st Century Cures links!!