Your Endpoints Will Drive Your Endgame
The endpoints define the label, the label defines the message, the message drives access and uptake, and uptake defines the endgame.
Unlike the world of the 90’s and early 2000’s, companies can no longer count on large sales and marketing spend to compensate for the lack of a compelling value proposition. Especially where time with physicians is increasingly difficult to get.
Determining what endpoints are meaningful to each of the stakeholders can be a challenge as they often have divergent interests, but it needs to be understood before finalizing your clinical trial design.
For example, pivotal trials conducted vs placebo may insure that a product gets a clinical response, but reimbursement and utilization may lag once the product is marketed. Similarly, a 510K or 505(b)(2) path to approval may be faster and less expensive, but a compelling value proposition may be harder to achieve, especially if the new product is more expensive than the current standard of care.
Harris Kaplan is Managing Partner of Red Team Associates, a boutique life sciences consultancy, and CEO of Healogix, a life sciences marketing research company. His resume includes work on the introduction of more than 100 new products including drug, biotech, device, and diagnostics. He is a commercial strategist who frequently presents and authors pieces on how the shift from a provider to a payer and patient centric world impacts new product innovation. Harris’ understanding of these seismic shifts in the life sciences landscape has made him a leader in the space and much sought after by clients ranging from startups to large multinationals. Harris excels at helping companies develop their commercial and go-to-market plans in support of new products. He has also been an advisor to multiple venture capital and private equity groups relative to assist their portfolio companies.
Harris’ articles have appeared in In Vivo, Medical Marketing and Media, and Product Management. He has presented at Intellus Worldwide Institute, Windhover’s Therapeutic Area Partnerships, IN3 Device Conference, World Orphan Disease Conference, Life Science Alley, the Biotech Conference at UC Berkley, Pharmaceutical Strategy Conference, and the Drug Information Association. He was also nominated as one of Pharma Voice’s most inspiring people in 2011.
Harris Kaplan, Managing Partner
Red Team Associates