Swiss HLG - Covid-19 Resources

Adapting ongoing clinical trials

• FDA guidance on clinical trials: 
• CTTI webinair on best practices in following FDA guidance: 
• EMA guidance:
• Mitigating risks to trial integrity:
• Interim analysis with adaptive estimands:
• Blinded data review for adaptive estimands (Part I): 
• Blinded data review for adaptive estimands (Part II): 
• Adaptive hybrid design for rare diseases: 
• Virtual matched control methodology Part I:
• Virtual matched control methodology Part II: 
• Two stage adaptive design to address protocol violations: 
• Two stage adaptive design for patients with chronic conditions: 
• Two stage adaptive design for high risk patients: 
• Adaptive hybrid design for rare diseases: 
• Statistical Considerations for Clinical Trials During COVID-19: Natural History Controls for Survival Analysis
• Statistical Considerations for Clinical Trials During COVID-19: Blinded Data Review for Adaptive Estimands (Part III)
• Statistical Considerations for Clinical Trials During COVID-19: Independent DMC for Blinded Data Monitoring and Analysis
• Statistical Considerations for Clinical Trials During COVID-19: Phase 1 Cancer Trials
• The Impact of COVID-19 on the Drug Development Ecosystem
• Statistical Considerations for Clinical Trials During COVID-19: Confirmatory Adaptive Platform Trial (CAPT) Design for COVID-19 Treatment (Part I)
• Statistical Considerations for Clinical Trials During COVID-19: Confirmatory Adaptive Platform Trial (CAPT) Design for COVID-19 Treatment
• Qing Liu is available to help with clinical trial adaptation
• tranScript COVID-19 Panel Discussion: Navigating translational/early clinical development during COVID-19
• tranScript COVID-19: Developing Drugs and Biological Products for Treatment or Prevention - Background and New FDA Guidance
• Ardena - Webinar will provide sponsors and CROs with lean and compliant shelf-life extension approaches to minimise COVID-19 impact on clinical study progress
• Webinar: - DIA DIRECT: Estimands and Analysis Considerations for Clinical Trials Impacted By COVID-19
• Statistical Considerations for Clinical Trials During COVID-19: Natural History Controls for Survival Analysis (Part III)
• COVID-19 Panel Discussion: How to optimise clinical trial and regulatory outcomes after COVID-19 disruption
• COVID-19 Panel Discussion: How to optimise clinical trial and regulatory outcomes after COVID-19 disruption
• FPM Clinical Trials Resilience Survey – Report Published

Adapting business plans and operations

• Federal government support: 
• Innovaud business support tool: 
• Help for self-employed in Basel Stadt 1:
• Help for self-employed in Basel Stadt 2:
• Bio: Business Resource Center: 
• Imperial enterprise lab start-up survival guide part 1: 
• Imperial enterprise lab start-up survival guide part 2:
• Imperial enterprise lab start-up survival guide part 3:
• InnoSuisse start-up training: 
• Life Sci VC: 
• Swiss start-up funding:
• Webinair on leading teams through uncertainty: 
• Self care tips:
• Impact & Efficacy of Virtual Teamwork: How to overcome the challenges of COVID-19- Webinar
• Selling Technological products during COVID-19 - Webinar
• PitchBook-NVCA Venture Monitor
• Life Sciences Commercialization in the COVID-19 Era: Critical Pivot Points to Mitigate Risk
• Coronavirus (COVID-19) and Managing the Risks to Your Organization
• Impact & Efficacy of Virtual Teamwork: How to overcome the challenges of COVID-19 - Webinar
• The BIOPHARMA workplace and Coronavirus insight report
• Webinar: How to Adapt Your Regulatory Plan (Life Sciences)
• TranScrip COVID-19 Panel Discussion: Successful Medical Affairs in the “New Normal” after COVID-19

Industrial association and government resources

• Swiss Biotech Association: 
• DIA: 
• BIO: 
• Biocom: 
• Support for Swiss start-ups: 
• Initiative to support Swiss start-ups: 
• Swissnex China webinairs: 
• Xconomy report: 
• Webinar: Financing in times of COVID19 for Basel based Life Science and Hightech startups
• Financial aid granted by the Canton and the Confederation, for startups / scale-ups, impacted by COVID-19
• Security deposits for start-up
• Support measures for start-ups
• Launch of the guarantee programme for technology start-ups

Health authority guidelines

• FDA guidance on clinical trials: 
• CTTI webinair on best practices in following FDA guidance: 
• EMA guidance: 
• BioCentury guide to regulatory meetings: 
• FDA CTAP: 
• See also Biocom Regulatory Rundown: 
• FDA Updated on July 2nd their Guidance regarding conduct of clinical trials of medical products 
• Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment

Swiss task forces and initiatives

• EPFL:

Industry media resources

• BioCentury: 
• Xconomy report: 
• Visual capital poster: 
• BioCentury expands COVID-19 gateway to connect biotechs, researchers with COVID R&D consortium members
• Excellent resource and central hub of #SARSCoV2 and #COVID19 information. 

Partnering & collaboration resources

• BioTrinity: 
• Partnering against Covid-19: 
• Open innovation initiatives:
• Plug and Play Europe: 
• Life Science Austria Help Channel: 
• Join the Data-Powered Initiative to Stop COVID-19 through Collaboration, Research, & Innovation
• Covid-19 Open AI Consortium (COAI)
• NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options
• Industrial associations and government resources
• POWER UP PARTNERING ONE: ESSENTIALS (PLUS EXPERIENCED)

Sales & marketing resources

• Peer group support:

Scientific/academic publications

• Semantic scholar dataset:
• Elsevier information centre
• JAMA review of therapeutics:
• REACTing bibliography: 
• Bibliography:
• Therapies Bibliography 2:
• COVID-19 by the Numbers - Biology / Graphical Summary
• Bibliography updated _ Literature review of accepted relevant papers

Scientific materials and tools (reference samples etc)

• MIT compilation of public dataset and tools: 
• Semantic scholar dataset: 
• Twist Bioscience viral RNA controls: 
• Benchling pro-bono offer: 
• Scientific work on Covid-19
• Illumina Makes Software Toolkit Available Free of Charge to Support Worldwide Efforts to Combat COVID-19

Diagnostic, Therapeutic & Vaccine developments

• Milken Institute tracker: 
• Trial summary: 
• Certara webinair: 
• Considerations for vaccine development: 
• Considerations for vaccine development Swissinfo: 
• BioCentury: 
• Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19
• COVID-19 pipeline: Industry flexing its Abs in fight against coronavirus
• Bibiliography 12
• NIH Panel Issues Guidelines for COVID-19 Treatment
• A Real-Time  COVID-19 Clinical Trials Registry
• Summary of Covid-19 vaccines in development with timelines
• A real-time dashboard of clinical trials for COVID-19
• COVID-19 Clinical Trials Explorer
• The race for coronavirus vaccines: a graphical guide
• Time to step up: A call to action for the clinical and quantitative pharmacology community to accelerate therapeutics for COVID?19
• International regulators provide guiding principles for COVID-19 clinical trials
• COVID-19 Clinical Trial Dashboard
• Chinese Antibody Society, in collaboration with The Antibody Society, developed an interactive COVID-19 antibody therapeutics tracker 
• Trends in Pharmacological Sciences - Fruitful neutralizing antibody pipeline brings hope to defeat SARS-Cov-2
• COVID-19 TREATMENT AND VACCINE TRACKER
• BIO COVID-19 Therapeutic Development Tracker

Heathcare Conferences

• BioCentury guide:
• 2020/2021 Life Science and Pharma Events updated list

Hackathon

• The first patient-centric DayOne Health Hack
• EU vs. Coronavirus Challenge - Pan-European Hackathon

Interesting Reads / Literature

• Top working from home tips from around the world
• The mapping of the molecular epidemiology of SARS-CoV-2 in Iceland; New England Journal of Medicine (2020 Apr 14); presented by Dr. Kirstine Soegaard