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Product Commercialization
You start with the model and decide this agent has a chance for success in humans
How do you know if your product will succeed beyond animal models and Artificial Intelligence?
In conversation with the thought leaders, it certainly looks great and can have its place in the market post clinical trials.
Questions to start with: the product mechanism of action?
In terms of mechanism, does it act on the known receptor sites, such as sodium or potassium?
Will those actually limit the use of product such as, with potassium?
The delivery system of the product?
is it delivered orally, intrathecally? Or, as an attached device?
Broad use or rare disease? (This determines the potential size of the sales force)
Device or drug (including gene therapy)?
What are the efficacy rates in the marketplace? If there is only a ten percent seizure freedom difference between your gene therapy at $100K versus current products, is it worth the commercialization?
Anticipated pricing strategy? Rare disease over $100K? Broad use? $2K per month? In the US, what about Europe and their negotiated hardline pricing?
Food & Drug Administration?
Selection of the “right” Clinical Research Organization to conduct the studies in a cost effective, timely and efficient manner
Study site selection and key opinion leader involvement
Commercialize or license to another company? There are advantages and disadvantages for both
Leadership
Targeted Selection for the commercial team, what matters most for each of the positions? Is the resume enough? Hiring friends for roles? How do you know if people are the right fit for rare disease?
Incentive Compensation plans. For instance, rare disease IC plan must include LTI
Productivity means of success for the commercial team
First line leader impact assessment
Mid-level to executive level leadership, cost versus benefit
Sales Account Manager impact and assessment
Sales and Marketing Effectiveness
Marketing Plans aligned with medical and the sales team
Commercial team pain points
Situational Leadership
Performance Management
People development plan
Business Plans aligned with strategy and not just tactics
Sales people trained to influence and persuade
Clinical reprints available for the commercial team
Insurance and market access plans acceptance in balance without giving away revenue
Limited Distribution Network for rare disease to ensure of timely insurance approval and delivery to patients
Solutions offered to these and other questions in rare disease commercial sales
Advocacy partnership
Culture
Corporate culture – goal versus reality.
Ethical and uncompromised
Employee retention: Do employees really want to stay? Or, is there nothing better in the market?
Listening to feedback across the organization
Commercial team pain points
Employee retention: Do employees really want to stay? Or, is there nothing better in the market?
Silos, protect your job, versus connectivity in culture.
