From time to time, the holder of intellectual property will search for funding for development of a medical product. Very early in the process, a sophisticated investor will ask the following key questions:
Question #1: “Do You Own It?”
This relates to the strength of the patent portfolio, coverage and length of time of remaining exclusivity. GZP will examine the invention(s) and scientific underpinning of the intellectual property, provide a frank assessment of the desirability of the investment and assess for the patent holder a rating of the attractiveness of the portfolio.
Question #2: “Does it Work?”
The beauty of an idea and belief in a principle behind a medical product must be congruent with practical proof of acceptable safety and efficacy in a human population with a particular disease. Otherwise, a sound investment in further development is not likely. GZP will provide a comprehensive review of all nonclinical pharmacology, toxicology and mechanistic data, chemistry, manufacturing controls, previous human clinical information if available, and provide a document that objectively supports the development program.
Question #3: “Can You Get it Approved?”
Even proof of principle in a small clinical study cannot, by itself, convince the FDA that a product should be approved, or that large clinical trials are appropriate at any particular moment. An organized, logical, persuasive argument, based on sophisticated packaging of data, must be provided to the Agency to support a Sponsor’s arguments. GZP will provide an assessment of the strength of the regulatory, preclinical, manufacturing and clinical program, providing intellectual property holders and investors alike with a projected timeline, and milestones, covering the likely roadblocks and costs of moving a development program to a successful conclusion.
Question #4: “Can You Sell it?”
A medical product that passes through the safety and efficacy gauntlet associated with nonclinical and clinical trials can receive FDA’s blessing for marketing. However, the product must be capable of being practically marketed and acceptable to the patient cohort for which it is intended. Issues such as dose, means of administration, dosing interval, taste and acceptability to physicians must be taken into account long before approval. GZP will provide market intelligence, before the fact, for investors and Sponsors alike, to allow for the appropriate financial planning and decision-making prior to funding.