1. Product Management & the FDA

2. Agenda/Scope What is different about managing products in a regulated industry? – Devices; Biologics; Pharma; Consumer goods; Software What is the typical role for Product Manager? What is missing? What is possible?

3. What we actually talked about… Intros & backgrounds PM role in regulatory strategy Early engagement Points of overlapping interest (regulatory, marketing, quality) How to get early publishing and thought leadership without scaring regulatory What are your claims? The simple mater of coding & coverage Will DTC get rolled back? What labeling challenges does patient-specific therapy present? Biologics How does increased post-market surveillance effect PM?

4. What can go wrong? Regulatory group posture & biases Marketing ( v. ) Pre-launch education Identifying MAB Staking out a position

5. Shared Interests: Venn Diagram: FDA & PM Usability, human factors, Labeling for clinicians; labeling for patients Safety & efficacy Efficacy out-of box experience, compliance, technique, digital dexterity

6. Continuum of PM Expertise HF Lead Investigator recruitment Behavioral sciences Experiment design Bio-statistics