FEATURED CONTENT: BIO COVID-19 Therapeutic Development Tracker
BIO’s Industry Analysis Team has reviewed and annotated pipeline data from BioCentury and Biomedtracker to create an interactive view of the Covid-19 pipeline. This data will be updated weekly on Monday mornings.
BIOCOVID-19 Therapeutic Development Tracker. BIO’s Industry Analysis Team has reviewed and annotated pipeline data from BioCentury and Biomedtracker to create an interactive view of the Covid-19 pipeline. This data will be updated weekly on Monday mornings.
Institute for the Future: Living Paper Coronavirus. Developed and updated by scientists at the Institute for the Future at Katholieke Universiteit Leuven (KU Leuven) and partners, this resource provides a structured compilation of scientific data about the virus, the disease, and its control. Its objective is to help scientists identify the most relevant publications on COVID-19.
Operation Warp Speed (OWS)Vaccine Distribution Process. OWS has released a summary of distribution and administration of a COVID vaccine.
Meeting Summaries
Advisory Committee on Immunization Practices (ACIP)
Expert SystemClinical Research Navigator, CRN provides access to data through the real-time monitoring of biological content, including patent activities, grants, MEDLINE publications, clinical trials, National Institutes of Health (NIH)-funded research, adverse events, the most up-to-date scientific publications, industry news and even social media streams such as tweets.
Web Resources: Scientific Research Tools & Publications
SAS COVID-19 Scientific Literature Search and Text Analysis. A free visual text analysis environment that uses artificial intelligence (AI) and machine learning to quickly search tens of thousands of research articles on COVID-19 and deliver potentially lifesaving answers to these scientists.
Johns Hopkins Coronavirus Resource Center. Johns Hopkin’s had created a massive resource center in order to provide a complete picture of the effect of COVID-19 on the US and the World.
Department of Homeland SecurityMaster Question List for COVID-19. The U.S. Department of Homeland Security Science and Technology Directorate developed this “master question list” that summarizes what is known about COVID-19, what additional information is needed, and who may be working to address fundamental questions.
Clinical Development - Tools & Resources: COVID-19 Treatments and Vaccines
Web Resources: Data Sharing, Clinical Trials
FDA Coronavirus Treatment Acceleration Program (CTAP). FDA special emergency program to help move COVID-19 therapies as quickly as possible. Announced March 31, 2020. The FDA has aggregated all of their COVID activities here.
NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV). National Institutes of Health (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private partnership to develop a coordinated research strategy for prioritizing and speeding development of the most promising vaccines and treatments.
Reagan-Udall Foundation for the FDA and Friends of Cancer Research COVID-19 Evidence Accelerator. This initiative is bringing together the country’s leading experts in health data aggregation and analytics in a unified effort to share insights, compare results, and answer key questions about COVID-19 treatment and response as quickly as possible: Two interactive Workstreams:
Accelerator Parallel Analyses: Developing key research questions that multiple organizations and teams can address simultaneously.
Accelerator Lab Meetings: Share findings from interested data partners on critical questions.
BioCentury COVID-19 Research Gateway. Enables companies and researchers to submit details of investigational products directly to biopharma companies collaborating within the COVID R&D consortium. The consortium has 7 working groups: clinical phase repurposing, preventative vaccines, novel antibodies, novel small molecule antivirals, preclinical repurposing, data sharing or clinical trial acceleration. Companies in the consortium can be found here.
TransCelerate BioPharma Inc DataCelerate. A global technology platform that allows for multiple de-identified research and development data types to be voluntarily submitted, uploaded, converted, harmonized, and downloaded through an access-controlled, secured environment. DataCelerate is currently only available to TransCelerate and BioCelerate Member Companies.
NBCICOVID-19 Proposal. The NBCI hopes that their diverse network of communities across the US can assist Sponsors in recruiting volunteers for COVID-19 clinical trials. Members can reach out to the NBCI directly via email at dcbci2002@gmail.com if you are interested in learning more.
RHO Considerations for Starting Up Your COVID-19 Study Quickly. Rho’s whitepaper discusses the importance of key factors to consider when starting a COVID-19 Trial such as, site selection, site monitoring, data management, planning and documentation, and communication.
Harvard/ MRCT COVID-19 Clinical Research Flyers. The MRCT Center and Harvard Catalyst have collaborated on a series of COVID-19 clinical research handouts that can be included as general information, largely to prepare potential participants in advance of recruitment and consent. These introductory one-pagers are focused on different potential audiences: patients, friends/family members, health proxies, parents/guardians, children.
NASEMSocial Experts Action Network. The Societal Experts Action Network (SEAN) links decision-makers with social, behavioral, and economic science researchers who can provide evidence-based expert guidance that supports local, state, and federal policies and responses related to COVID-19.
FDA & Global Guidance
FDACOVID-19 Related Guidance. A complete guide of FDA activities during COVID-19 has been uploaded to the Agency’s website.
ACROCOVID-19 Resource Center. The Association of Clinical Research Organizations have collated FDA & Global Guidance on their site.
International Council of Biotechnology Associations (ICBA)United Against COVID-19. The ICBA have collated all global activities on their site.
Web Resources: Publications, Meeting Summaries
Science Magazine A strategic approach to COVID-19 vaccine R&D. Science Magazine published a piece on strategic approaches to COVID-19 vaccine R&D. The article's authors include Francis Collins and Tony Facui.
Manufacturing Tools & Resources: COVID-19 Treatments and Vaccines
Web Resources
BIO & BCG. Ensuring Sufficient Manufacturing Capacity for COVID-19 Therapeutics.
Initial findings from BIO and BCG work to help accelerate and increase the availability of COVID-19 therapeutics by identifying and addressing the industry’s most critical capacity bottlenecks and regulatory concerns. Includes key insights from interviews with ~20 companies developing COVID-19 therapeutics.
Rapid Aseptic Packaging of Injectable Drugs (RAPID). The RAPID Consortium was established as a public-private partnership between the U.S. Department of Health and Human Services and ApiJect Systems America, inventors of the BFS (Blow-Fill-Seal) prefilled syringe. RAPID’s mission is to strengthen America’s response to a national bio-emergency by building dozens of high-speed manufacturing lines, located on U.S. soil, able to deliver up to 330 million prefilled syringes a month.
United States Pharmacopeia (USP). USP is playing a critical role in the public health response to COVID-19 disease, caused by the virus SARS-CoV-2. USP is helping to accelerate the work of scientists and manufacturers developing vaccines and treatments, supporting front line workers impacted by shortages of critical drugs and personal protection equipment and helping to build a more resilient global medicines supply chain.
FierceBiotechManaging Clinical Trial Patient & Site Engagement During COVID-19: Guidance to Help Respond to Immediate Challenges. In order to help minimize the disruption of COVID-19 on clinical trial patient and site engagement, FierceBiotech has created a support guide for clinical trial sponsors. It includes strategies to help minimize risk to enrollment timelines while helping sponsors navigate FDA guidance on conducting clinical trials during a pandemic, all while prioritizing patient safety and care.
FDLI Webinar: Restarting Clinical Trials in Wake of COVID-19. FDLI will host a webinar on June 23. Covered issues will include remote source data verification, alternatives to onsite inspections of clinical trial sites, and best practices for ensuring integrity in the clinical trial despite COVID-19 modifications.