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Q&A Session With Michael Hellerstein From GeoVax

Before taking the podium at our upcoming 2nd eRegulatory Submissions Summit, GeoVax’s Michael Hellerstein sat down with ExL to discuss his experience with implementing electronic submissions at a small company. Take a look below:


We’re excited to welcome you as a speaker at ExL’s 2nd eRegulatory Submissions Summit! What do you hope attendees will take away from your presentation on The Juggling Act of Implementing Electronic Submissions at a Small Company?

I am grateful for the opportunity to speak at the 2nd eRegulatory Submissions Summit, and I predict that it will be a very interesting and rewarding meeting! Since the conference attendees come from a variety of backgrounds, I will give a presentation that speaks to the interests and needs of employees at different types of companies. For employees of small biotech companies, my presentation will provide a very relevant case study as well as helpful advice on implementation of electronic filing systems. For employees of larger biotech and pharma firms, my presentation will provide insight into the unique challenges faced by the small biotechs that are their potential partners and acquisition targets. For providers of electronic submission products, my presentation will give an understanding of customers at small companies, their pain points, and ways that the service providers can help.


What are you most looking forward to gaining from your attendance at this year’s forum?

I am excited at the opportunity to network with fellow regulatory professionals and learn about their experiences with electronic regulatory submissions.


And lastly, what are some of the challenges you are facing in the industry?

My company is developing several vaccines that are badly needed from a public health perspective but will never be blockbuster drugs. For these programs, including Ebola and Lassa fever vaccines, we must rely on funding from governments and non-governmental agencies rather than investors. This situation creates a number of challenges. The grant and contract programs are extremely competitive, and it can sometimes be difficult to obtain funding even for a highly promising product. Grants and contracts are obviously a blessing to a company like mine, but they come with strings attached, and it can be complicated and frustrating to navigate the maze of rules and regulations pertaining to government-funded product development. From a regulatory perspective, such programs are often different from others in that the government holds the INDs. As a regulatory professional at a company whose products are being tested by the government, I must work not only with FDA but also with the government agency holding the IND and with other partner companies participating in the clinical trials. This situation creates unique and interesting challenges in communication and in managing by influence.


ExL is proud to partner and work closely with Geovax to build this year’s case study: The Juggling Act of Implementing Electronic Submissions at a Small Company. To find out more about Michael’s case study and other sessions, click here to review the agenda.


Click here to register.

Interested in sponsoring or exhibiting at ExL Events’ 2nd eRegulatory Submissions Summit. Reach out Andrew Sinetar, Senior Business Manager, at 212-400-6237 or to discuss presenting an educational session, distributing promotional items to attendees and other sponsorship opportunities.

posted in ExL Events News

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