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
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
Scientific/academic publications
Scientific materials and tools (reference samples etc)
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
Hackathon
Interesting Reads / Literature