Emergency Use Authorizations - MMS Holdings Interview - MBP Season 2

The COVID-19 Vaccine has brought to the forefront an awareness of something called an Emergency Use Authorization (EUA). As a result, the questions swirl around what they are and what they mean to the safety of the vaccine and other therapies surrounding COVID-19. Listen in as we discuss this very important topic.   Our guests today are:  Dr Uma Sharma - Chief Scientific Officer - MMS  Dr Sharma provides oversight for all clinical activities especially submissions and complex regulatory projects. As needed by their sponsors, she leads advisory committee meetings and participates in advisory boards for drug development, as well as product defense strategies especially for critical safety issues and label strategy discussions. With more than 24 years of experience in the pharmaceutical industry, she has been an invited speaker at several national and international events.    Ben Kaspar, Senior Manager Regulatory Strategy Ben works with sponsors to plan their programs and navigate the regulatory submission process throughout the entire drug development life-cycle. Ben and team have a deep experience in regulatory science for drug/biologic development, designing innovative strategies to maximize the likelihood of regulatory approval of the target across a variety of therapeutic areas including rare diseases.   Here are some of the topics we cover today:   What is the last book you read?   What is an EUA and why are we hearing so much about them now?    Does a EUA allow a drug to be used around the world during a pandemic? Is this just a thing for the US or some subset of countries?    Are All COVID related approvals an automatic EUA?    If we are able to get an EUA for something like COVID, why can’t every unmet condition have an EUA? Certainly plenty of other conditions are even MORE serious to many people.    Are EUAs easier than regular approvals? Public perception is that these are a short cut and all studies are not completed. I think the thing I hear about the most is the “long term studies”...    Are EUAs here to stay after the pandemic? Will there be more EUAs than before? Have we broken through some imaginary barrier that will now allow us to do this more often?    What do you think the industry can learn from this effort for future growth and streamlining discovery/testing efforts?    Reach out to MMS Holdings... https://www.mmsholdings.com/  Dr. Sharma on LinkedIn - https://www.linkedin.com/in/umasharmaphd/ Ben Kaspar on LinkedIn - https://www.linkedin.com/in/benkaspar/  Reach out to me on LinkedIn https://www.linkedin.com/in/talktojesse/ or on my website at https://www.modernbiopharma.com/.