Managing Product Pipeline Communications

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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.

This management report will tell you how to balance these seemingly contradictory demands and how to handle all the forms “communication” takes today — from tweets to talking points, from press releases to the slides investors see on a conference call. You will learn:

  • The specific laws and regulations the FDA and SEC must enforce;

  • 6 dos and 6 don'ts for speaking publicly about a product in development;

  • 4 dos 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;

  • And much more.

With Managing Product Pipeline Communications you’ll be able to confidently account for the various perspectives — regulators on both sides, investors and the general public — and ensure that the right people get the information they should from you every time.

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Table of Contents

  • Introduction
  • Best Practices for Pipeline Communications
  • Managing Compliance Obligations
  • And More …

View the entire TOC

Who Will Benefit

  • Pharmaceutical and device company CEOs
  • Corporate spokesmen
  • PR officers
  • Compliance officers
  • Regulatory affairs officers
  • Marketing and sales officers
  • Advertising managers and staff
  • Marketing managers and vendors
  • Legal counsel
  • Anyone who might be talking to people outside the company (general public, the media, investors) about a product

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