Ground Zero Pharmaceuticals, Inc. provides technology assessment of intellectual property owned by individuals or virtual and small firms, as well as on behalf of venture capitalists, pharmaceutical partners and others. This includes the scientific and technical review of the data and other information in a firm’s product portfolio, with recommendations on the most likely scenarios for regulatory and clinical success.
GZP will prepare your program for key investor 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?”
GZP will provide a comprehensive review of all nonclinical pharmacology, toxicology and mechanistic data; chemistry, manufacturing and controls; and 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.