Development & Manufacturing Capacity

Coronavirus
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.

Status of Development - Tools and Resources: COVID-19 Treatments and Vaccines

 

Web Resources: Pipeline

  • 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.
  • BARDA COVID-19 Medical Countermeasure Portfolio. BARDA is tracking vaccine and treatment products as well as manufacturing capabilities.  
  • IQVIA Weekly Webcasts: Monitoring the Impact of COVID-19 on the Pharmaceutical Market. IQVIA is holding weekly webcasts that discuss the state of the market and the effect of COVID-19 on the biopharmaceutical market.
  • Expert System Clinical 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


 

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.  
  • Clinical Trial Transformative Initiative (CTTI)  COVID-19 Related Clinical Studies Spreadsheet.
  • Clinical Trial Transformative Initiative (CTTI)  Open Comment Opportunity on CTTI’s Master Protocol Draft Resources.  Protocols gleaned from this process will be made public by summer.
  • 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.
  • NBCI COVID-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.
  • NASEM Social 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

  • FDA COVID-19 Related Guidance. A complete guide of FDA activities during COVID-19 has been uploaded to the Agency’s website.  
  • ACRO COVID-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

Webinars


 

Manufacturing Tools & Resources: COVID-19 Treatments and Vaccines

Web Resources

  • BIO & BCGEnsuring 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.
  • The Coalition for Epidemic Preparedness Innovation (CEPI). CEPI provides news on collaborations relating to manufacturing.
  • 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.

Webinars


 

Clinical Development During COVID-19 Pandemic - Tools & Resources: NON-COVID Treatments

Web Resources:  Clinical Development During Pandemic Tools & Resources

Web Resources:  FDA & Global Guidance

Webinars