Development & Manufacturing Capacity

Web Resources

• 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.
• 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) 
  • June 2020 Meeting Materials 
  • July 2020 Meeting Materials

Web Resources: Pipeline

• BARDACOVID-19 Medical Countermeasure Portfolio. BARDA is tracking vaccine and treatment products as well as manufacturing capabilities.  
• IQVIAWeekly 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

• 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.
• Duke-MargolisA National COVID-19 Surveillance System: Achieving Containment, April 7, 2020. Duke Margolis has launched a national surveillance system for tracking COVID-19 around the country.
• 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.

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

• FDACOVID-19 Related Guidance. A complete guide of FDA activities during COVID-19 has been uploaded to the Agency’s website.  
• FDA Vaccines and Related Biological Products Advisory Committee.  A public meeting discussing the general matter of the development, authorization, and/or licensure of vaccines indicated to prevent COVID-19.
• FDA Update from the Vaccines and Related Biologics Products Advisory Committee (VRBPAC) Meeting of October 22, 2020. The VRBPAC met on October 22, 2020, for a general discussion of the development, authorization and/or licensure of vaccines to prevent COVID-19. 
• 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. 
• International Coalition of Medicines Regulatory Authorities (ICMRA) COVID-19 Real-World Evidence and Observational studies. ICMRA hosted this meeting on April, 6, 2020.  

Webinars

• Duke-Margolis/Alexandria Summit Webinar: Developing a Therapeutic Response to COVID-19 Webinar (ACTIV), April 20, 2020.
• CITI Program Webinar:  Designing High-Quality COVID-19 Treatment Trials, April 23, 2020.  Additional COVID-19 related webinars hosted by CTTI can be found here.
• PCORI Webinar: Telehealth: Discharging COVID-19 Patients, April 28th. Additional COVID-19 related webinars hosted by PCORI can be found here.
• DIA Webinar: Study and Data Integrity Considerations for Clinical Trials Impacted by COVID-19, May 13th. The Webinar can be found upon the creation of a DIA account.
• NBCI Collaboration Webinar: Creating a New Path Toward Clinical Trials In the African American Community Utilizing a Faith-Based Scientific Approach. The webinar was hosted by BIO in collaboration with the National Black Church Initiative in December of 2019. Slides from the presentation can be found here.
• BIO/FNIHWebinar: Accelerating COVID -19 Therapeutic Interventions and Vaccines (ACTIV). BIO along with FNIH held a webinar to update members on the ACTIV program. The slides from the meeting can be found here.
• American Society for Microbiology Coronavirus Webinar Series: The Microbial Sciences Respond to COVID-19. The American Society for Microbiology has established a 3-part virtual Congressional briefing series covering diagnostics, vaccines, and therapeutics for COVID-19.
• Fierce BiotechWebinar: Necessity and Invention: Accelerating Innovations in Clinical Trials. The webinar was held on June 22nd.
• Duke Margolis and AlexandriaWebinar: Reopening in an Era of COVID-19. This webinar was held on June 23rd.
• FierceMarketsWebinar: Minimize the Impact of Trial Disruptions with RWD Driven Digital Recruitment and Operational Scenario Simulations. This webinar was held on June 24th.
• FierceMarketsWebinar: Virtualizing Clinical Trials: The Impact of Technology on the Patient Journey. This webinar was held on June 24th. 

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.
• 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

• Duke-Margolis/Alexandria SummitWebinar: Developing and Scaling COVID-19 Vaccines, May 14th.
• Duke Margolis Webinar Ensuring Sufficient Manufacturing Capacity for COVID-19 Therapeutics. This webinar explored strategies and policies to ensure sufficient manufacturing capacity for biologic COVID-19 therapeutics.
• FierceMarketsWebinar: Up to the challenge: Manufacturing’s central role in the cell- and gene-therapy revolution. This webinar was held on June 22nd.
• Duke Margolis Webinar: Ensuring Sufficient Manufacturing Capacity for COVID-19 Therapeutics. This webinar was held on June 22nd.
• FDA 

Web Resources:  Clinical Development During Pandemic Tools & Resources

• TransCelerate Tools:
  • Protocol Deviations Toolkit
  • Risk Based Monitoring Methodology & Tools
  • Quality Management System (cQMS)
  • Patient Considerations Guide 

• Clinical Trial Transformative Initiative (CTTI)  Tools:
  • Single IRB
    • Single IRB: Determination of Institutional Engagement Overview
    • Resource of Resources Document
    • Single IRB: Institutional Engagement Scenarios
    • Single IRB: Institutional Engagement Definitions
    • sIRB Flowchart: Determining Engagement of Institutions in Research
  • Recommendations for Use of RWE to Plan Elibility Criteria & Recruitment
  • Mobile Clinical Trials
  • Other Clinical Trial Tools (Mobile Clinical Trials, Patient Considerations etc.)
• Clinical Trial Transformative Initiative (CTTI)  Feedback Request: Share Your Experiences On Switching To Remote Visits For Clinical Trials During Covid-19.CTTI invites those with experience switching clinical trial in person visits to telehealth to share their experiences.
• FierceBiotech Managing 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.

Web Resources:  FDA & Global Guidance

• Ropes & GreyCOVID-19 Disruptions of International Clinical Trials. Comparing Guidances Issued by FDA, EMA, MHRA, and PMDA, April 2, 2020
• 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.  

Webinars

• Clinical Trial Transformative Initiative (CTTI) Webinar:  Best Practices on Conducting Clinical Trials During COVID-19, March 31. 
• FDA SBIAWebinar: Conducting Clinical Trials During the COVID-19 Public Health Emergency. 
• CITTI Webinar: Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Clinical Trials. On June 18th CITTI held a webinar on Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Clinical Trials and discussed barriers and solutions to enrolling a diverse patient population. 
• 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.