The NIH has launched bold research projects throughout its history, but the proposed Advanced Research Projects Agency for Health would be able to move faster and take more risks, says NIH Director Francis Collins. The NIH reacted quickly in the face of the COVID-19 pandemic, but ARPA-H would not only provide a framework for addressing urgent problems and take risks "where there happens to be a particularly golden opportunity to push things forward and move across that Valley of Death," Collins says.
Based on input collected during two workshops held in November 2020 and April 2021 and stakeholder interviews, FasterCures has developed a journey map that delineates many of the questions that arise for patients and caregivers when confronted with an option of a cell or gene therapy. Join us for the unveiling of the Patient Journey Map and a conversation with experts about the nuances of the patient journey for someone considering cell and gene therapies. Register here.
An article in Cancer Discovery suggests that academic centers, industry sponsors and regulatory agencies continue following flexible strategies for clinical trials beyond the COVID-19 pandemic, including accepting electronic consent, remote infusions and monitoring, patient-reported outcomes, and community-based trial sites and labs. "The restrictions during the pandemic have highlighted that cancer clinical trials should be patient-centered, as opposed to centered on the study sites," said Antoni Ribas, a professor of medicine, surgery and molecular and medical pharmacology at the University of California, Los Angeles.
President Joe Biden's cabinet still lacks a nominated or confirmed leader for the $7 billion President's Emergency Plan for AIDS Relief, and a coalition of over 50 advocacy organizations are asking Biden to "immediately appoint a bold, creative and qualified" global AIDS coordinator. They say the lack of leadership is being felt in the US and abroad.
A $10 glass chip system called a high-throughput microfluidic enzyme kinetics chip enables the study of 1,568 genetic mutations at once and might help identify distant mutations that are druggable, according to a study in Science. A robotic system places mutated versions of enzymes in tiny wells on the chip, a microfluidic system delivers reagents to each well at once, and researchers determine how chemicals or acidity changes affect enzyme folding and function.
BioNTech is exploring development of a malaria vaccine using mRNA technology and will evaluate several vaccine candidates targeting the circumsporozoite protein, with the company planning to launch a clinical trial for the most promising candidate by the end of next year. BioNTech is also considering vaccine production in Africa in an effort to broaden its manufacturing capacity and boost global access.
The World Bank and the World Health Organization's COVAX initiative have partnered on a financing program aimed at speeding up vaccine distribution in developing countries, where the vast majority of people have not been inoculated against COVID-19. The program will allow COVAX to procure vaccines in advance, at competitive prices, with financial backing from the World Bank and other development finance institutions.
The US government is investing $200 million in Aspen Pharmacare's Gqeberha, South Africa, plant to expand the availability of Johnson & Johnson's COVID-19 vaccine across the African continent. The investment will increase the plant's capacity from 300 million doses to 400 million doses a year.
OM1, which works with organizations across the health care system to harness real-world data for medical research and clinical decisions, raised $85 million in a funding round led by D1 Capital Partners, Breyer Capital and Kaiser Permanente.
NIH Director Francis Collins and National Institute of Allergy and Infectious Diseases Director Anthony Fauci are calling for a five-year, multibillion-dollar initiative to develop vaccine prototypes for about 20 families of viruses with the highest pandemic potential. Barney Graham, deputy director of the NIAID's Vaccine Research Center, first proposed the idea at an NIH meeting in 2017 then outlined it in a 2018 Nature Immunology paper, and some vaccines are already under development.
The FDA's Center for Devices and Radiological Health needs more staff and funding to fulfill the center's public health mission, Director Jeffrey Shuren said. The CDRH's budget has remained relatively stagnant for years, pay has not kept up with private sector salaries and more resources are needed if some of the innovative approaches adopted during the COVID-19 pandemic are to continue, Shuren says.
FasterCures, a center of the Milken Institute, is driven by a singular goal: to save lives by speeding up and improving the medical research system. The Milken Institute is a nonprofit, non-partisan think tank determined to increase global prosperity by advancing collaborative solutions that widen access to capital, create jobs, and improve health.