How We Did Things Differently During COVID and Learnings for the Future

Session Description

Drug development provides multiple challenges ranging from scientific to logistical to geopolitical; translation from preclinical to clinical, balancing adequate safety and efficacy in the patient population of interest, high cost of conducting clinical trials, long time for development, competition for patient availability, regulatory requirements for meaningful differentiation etc. The 2019-2020 global pandemic of COVID-19 is one of the greatest medical challenges of modern times and needless to say many of the challenges of mainstream drug development got amplified.

There was an unprecedented need for fast development of meaningful preventative therapies for COVID-19. Organizations reacted with a desperate bid to search for treatments and launched multiple human experiments to get to answers fast. This led to further chaos but over time organizations rose up to the challenge. Scientists got organized, developed strategic plans for streamlined study conduct/data generation and decision making. Further the power of new tools e.g. artificial intelligence, machine learning and digital technologies was harnessed to guide their plans, study design and conduct.

Regulatory agencies also reacted in sync by evaluating the unmet vs. risk with modified lens, use of clinical pharmacology and translational science principles to bridge gaps in information and publishing new guidances. In summary unprecedented challenge created by COVID-19 led to innovative unprecedented adaptations in drug development.

This however begs the question, can we interpolate this innovative thinking, approaches and learnings back to mainstream drug development? This proposed panel discussion aims to raise and discuss the questions; what specific issue were we trying to address, what was needed for it to be successful and what modifications/adaptations are needed to apply these learnings to mainstream.

Learning Objectives

1. Upon completion, participants will be able to understand examples of disruptive/innovative ideas to implement them in post-pandemic era and mainstream drug development.

2. Upon completion participants will be able to formulate strategies to address barriers in implementing new learnings into drug development.

Session Schedule

1:15 PM - 1:19 PM ET
Opening Remarks
Indranil Bhattacharya, PhD and Ravi Singh, PhD

1:19 PM - 1:26 PM ET
Balancing Unmet Need versus Risk During Public Health Emergencies
Kellie Reynolds, PharmD

1:26 PM - 1:36 PM ET
Agility, Collaboration and Digital Tools: Taking Learnings Back into Everyday Drug Development Business
Anne Heatherington, PhD

1:36 PM - 1:47 PM ET
Use of Artificial Intelligence in Site Selection: Learnings From COVID-19
Najat Khan, PhD

1:47 PM - 2:15 PM ET
Live Q&A and Closing Remarks
All Speakers