Opportunity Mapping Expertise
Companies and institutions may want an early-stage analysis of feasibility and potential for their R&D programs or technology platforms to help raise or make an investment, or to attract BD partners. It may be to validate the selection of drug discovery targets, or for allocation of internal resources or R&D budget. Such early stage assessments can help a management team to explore scenarios for company growth, value creation, risk and financing needs.
We have rich experience mapping opportunities for individual programs, for multiple programs in a portfolio, for drug discovery platforms, or for enabling technology platforms. Opportunity mapping involves quantifying the realistic commercial potential, mapping out the go-to-market path, and describing the key risks and sensitivities. The process may also involve primary market research to garner additional expert opinion and to validate assumptions. Such assessments often involve making trade-offs between multiple potential lead indications, and across several geographic territories.
Target Product Profile Development
Of fundamental importance to the integrity of this kind of assessment is consistency between the assumptions driving commercial potential and those describing what it will take to get there. For drug products, the anchor point for this alignment is a realistic description of the launch product, captured in a Target Product Profile (TPP) which describes an achievable and competitive set of product performance parameters, against which all other assumptions should be grounded. Any significant mismatch between the assumed time, cost, risk and return for a program or platform can be extremely damaging for a business.
Commercial Opportunity Characterization
To characterize commercial opportunities, we typically start by listing all possible indications for a product or all applications for a technology and undertake a high-level prioritization. This may be followed by a deeper assessment of a lead indication. These assessments typically include a clear description and sizing of the target patient population, current market size and dynamics, identification of key medical and payer constituents, current medical practice and treatments, disease burden and unmet medical need, current and future drug and non-drug competition, pricing potential and value arguments, launch and patent expiry dates. In addition to the parameters above which feed into a peak year sales estimate, we often provide budget estimates to launch and sell the drug (i.e. marketing, medial affairs, commercial data infrastructure, supply chain, patient services and sales).
Path to Market
For path to market, we create a high-level map of the required discovery and development steps required for the lead indication. This often includes the key steps in the CMC process of delivering compliant clinical and commercial supply of drug product. For each major step we estimate the duration and cost. Key program risks or challenges are also described. Benchmarking analysis of drugs previously developed for an indication (or one similar to it) can yield information on the possible wording of the approved indication, the nature and number of trials required, the patient numbers needed to treat, the primary and secondary endpoints, and the duration of late stage trials. For nascent indications, we rely more heavily on our subject matter experts in all aspects of the discovery and development process, and on industry or KOL contacts, to derive assumptions