Philadelphia, PA – August 9th & 10th, 2010 – You couldn’t tell it was conference host eXL Pharma’s first year foray into a new subject area: KOL Relationship Summit. The dialogue amongst the audience and speakers was top notch – all too often, a conference is a series of talking heads, but that was not the case. Thanks in no small part to Linda Harris (formerly VP, Pfizer – Wyeth Legacy) who organized the workshop, and Manley Finch (VP, SleepMed Inc) who did an excellent job moderating, the panel discussions were great and we all learned some new information and had a few “ah-ha” moments.
Key themes included:
- Regulation and compliance – Pharmaceutical and biotech companies are feeling the impact of regulation. More legal actions under the False Claims Act and Anti-Kickback statutes are being won resulting in large fines and corporate integrity agreements (CIAs.) CIAs are causing a great deal of pain as nearly everything has to be reviewed by legal counsel. The Sunshine Act and state statutes limit the total payments to physicians, which are causing companies to redesign their KOL management processes to track financial reimbursements.
- Fair Market Value – to meet regulations companies should establish a FMV policy that is flexible enough to handle the inherent changes in business. For example, if a KOL cancels their participation in a Scientific Advisory Board at the last minute, you need the flexibility to pay more to entice another KOL to change their plans and attend.
- As companies evaluate their KOL CRM systems¸ inevitably the debate turns to a centralized vs. a decentralized model. There was a healthy discussion on this topic, but from this participant’s perspective it was clear that a centralized model – for all its difficulties in a global company – mitigates some legal risks that would be more difficult to address in a decentralized approach.
- KOL Shortage – With regulations, research university compliance boards and public disclosures hassles abounding, many KOLs are just no longer willing to work with industry. With the need to separate commercial and medical affairs activities, Pharma has a greater need for KOLs to ensure they can gain market access. This means companies need to change their methods for finding KOLs and expand their definition. There will be a need for experts in Payor Policy Boards, Pharmacoeconomic, Standards of Care, Patient Advocacy groups, etc..
- ROI – return on investment – You cannot talk about KOL management without inevitably running into management wanting to measure ROI. When this topic was brought up the audience groaned in shared empathy. Yet there were no magic bullets. It’s a legal quagmire to have a KOL strategy that relates KOL efforts to an uplift in sales.
- Pharma is Shifting Overseas, both to conduct trials and develop new markets. This is creating new challenges across the spectrum of KOL Strategy, from finding KOLs to effectively engaging and communicating with KOLS.
- We heard from a KOL’s perspective, Dr. Michael E. Thase, which helped drive home the point KOLS do not want to be managed. Rather, they do want to have good mutually beneficial relationships with industry and relationships that ultimately helps the patient. Dr. Thase helped us understand how difficult it is becoming for KOLs to work with our industry. Dr. Thase had to appear before his compliance board and attest he was getting no remuneration and had no conflicts of interest just to be able to speak at the KOL Summit! Dr. Thase suggesed the industry should stop sponsoring any promotional speaking activities and reinvigorate its investing in continuing medical education (CME).
- For the Medical Science Liaisons (MSL) working with KOLs, it’s no longer about managing KOL; it’s about managing relationships - or better yet, managing experiences.
All in all the conference allowed industry and vendors come together to accelerate the adoption of new therapies that ultimately improve patient health.