Talking About Your Product Pipeline - Webinar CD/Transcript

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Talking About Your Product Pipeline: How FDA and SEC Regulate Life Sciences Communications

When your company has a product in development, whether drug, device or biotech, what you can — and can’t — say about it is tightly regulated by the FDA.

At the same time, the SEC requires that information of material value to investors be properly disclosed to them.

Of course, this SEC requirement involves exactly the same products you have in your pipeline, the ones that the FDA wants you to be very careful about discussing.

How do you balance these seemingly contradictory demands?

And further, how do you correctly use all the forms of “communication” available today, including tweets, talking points, press releases, presentations to investors and even "likes" on Facebook?

FDAnews presents two top attorneys — and experts on these topics — from nationally-recognized law firm Alston & Bird in a webinar CD and transcript titled Talking About Your Product Pipeline: How FDA and SEC Regulate Life Sciences Communications.

Firm partners Julie Tibbets and Matthew Mamak discuss and comment on the tricky issues surrounding the laws and regulations the FDA and SEC must enforce.

In just 90 minutes, you'll gain a fuller understanding of what exactly your responsibilities are and how to execute them without making mistakes that could damage your company's reputation and bottom line.

Ms. Tibbets and Mr. Mamak provide you with specifics that help you navigate your way through these treacherous regulatory waters:

  • 6 do’s and 6 don’ts for speaking publicly about a product in development
  • 4 do’s and 3 don’ts when talking with analysts and investors
  • Examples from case studies about communication that resulted in FDA enforcement actions, SEC penalties, and investor lawsuits

At the end of this session, you’ll be able to confidently account for the various perspectives — regulators on both sides, investors and the general public — and ensure the right people get the information they should from you every time.

  • Senior management
  • Legal
  • PR
  • Regulatory affairs
  • Anyone who might be talking to people outside the company (general public, the media, investors) about a product in development

Meet Your Presenters

Julie Tibbets is a partner in Alston & Bird’s Food, Drug & Device/FDA Group. She has built her practice around all aspects of FDA-regulated product branding, advertising, promotion and corporate communications, advising developers, manufacturers and marketers of FDA-regulated products on the regulatory risks and opportunities of their current product messaging.

Matthew Mamak is a partner in Alston & Bird’s Financial Services & Products Group. He regularly advises public and private companies and investment vehicles on capital structuring and raising, corporate governance, and securities regulation and compliance issues.