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Cytel Present at the ASA Biopharmaceutical Section Regulatory Workshop

The American Statistical Association Biopharmaceutical Section, in cooperation with the FDA Statistical Association, will host its annual Regulatory-Industry Statistics Workshop in Rockville, Maryland, this year, on “Statistics Post-Pandemic: Paving the Scientific Path to Treatments, Vaccines, and Diagnostics,” bringing together statisticians from industry, academia, and the FDA. Cytel experts will present the following:


Leading Drug Development into the Next Generation

Cytel moderator: Martin Frenzel, PhD
Co-moderated with Karen Price (Eli Lilly) and Dionne Price (FDA)

Statistical leadership is vital to the continued improvement of pharmaceutical drug development. It is well documented that the cost and time of drug development continue to grow at rates that are unsustainable. The statistical leader plays an important role in ensuring that drugs are developed more efficiently via innovative designs and analyses, that the right candidates move forward, and that decisions are made with a quantitative framework that properly balances all available data. The statistical leadership demonstrated throughout the COVID pandemic has led to many learnings, and now is the time to capitalize on those learnings to ensure they are carried forward. There is tremendous opportunity for statisticians to lead the pharmaceutical industry into the next generation of drug development.

In this session, statistical leaders from across industry and regulatory will discuss the current state of statistical leadership in drug development and opportunities to utilize statistical leadership to drive drug development forward. These leaders will also reflect upon the lessons learned historically that showcase the value of statistical leadership and discuss keys to the successful leadership. The intent of this session is to identify specific and actionable next steps to partner together to dramatically shift the role of statistician as leader in all phases of the drug development process. This session is in partnership with Biopharmaceutical Statistics Leadership Consortium (BSLC).


Integrating AI-Based Software as Medical Device (SaMD) in Drug Development

Round Table discussion lead by: Natalia Muhlemann, MD, MBA

Rising pressure to increase R&D productivity and the changing environment with increasing opportunities for personalized medicine, digitalization and patient involvement in their disease management, call for continuous innovations in clinical development approaches. Traditional clinical trials are based on broad eligibility criteria and measure average outcome for all enrolled patients. Personalized medicine has already shifted the direction of drug development from traditional ways to biomarker-based approaches. In drug development, biomarkers can be used to define drug target selection, patient selection, enrichment, dose selection, safety assessment, and efficacy assessment. In oncology, predictive biomarkers have been associated with about 60% of new oncology drugs, and Companion Diagnostics is the topic of increasing interest in drugs development. Number of innovative adaptive methodologies has been already proposed and discussed for population enrichment especially in oncology trials. Current Companion Diagnostics and biomarkers are mainly based on IVD/molecular/genetic biomarkers. Recent advancement of IA in imaging, miniaturization of wearable devices and increasing quality of RWD enable the expansion of biomarker concept to Software as Medical Device (SaMD), such as AI-based imaging and ML-based population enrichment algorithms, and biomarkers based on wearables devices. However, the methodologies for optimal and efficient integration of these novel approaches into drugs trials have not yet been extensively discussed. The successful integration of SaMD into clinical development program requires close collaboration between biotech and medtech experts. The objective of this round table is to discuss this topic with a participation of biotech, medtech companies and clinicians from academic hospitals involved in integration AI-based imaging and AI-based algorithms into drug development, and experts from both CDRH and CDER/CBER.


If you are attending the 2022 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, we hope to see you there!


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