Our last newsletter reviewed the role, process, and utility of the Target Product Profile (TPP).
In the biopharma industry, the target product profile (TPP) is a critical tool for guiding the development and commercialization of new drugs.
- Blueprint for Success: TPP outlines desired indication, patient population, mechanism of action, dosage, administration, adverse reactions, and efficacy benchmarks.
- Evolution and Complexity: Reflects advances in biotechnology, molecular therapies, and regulatory expectations.
- Collaborative Effort: Involves input from medical, regulatory, and commercial teams to ensure a comprehensive strategy.
- Commercial Considerations: Aligns development with market needs, optimizes resources, and enhances communication.
By incorporating the target product profile from the start, companies can effectively steer their products toward successful market entry and meet unmet patient needs.
This month, as promised, we continue with three real-world examples of how our clients have used the TPP in practice.
Case Study #1 — Vision and Competitive Intelligence
The target product profile serves different purposes at different stages of a product’s life. The following example describes the important role the TPP played along the development journey in an emerging biopharmaceutical firm:
- The company was moving its lead asset from IND to clinical phase. We worked with the leadership team to create a TPP that defined the unmet medical need the company was seeking to address, identified the patient population that could most benefit, and established aspirational goals for treatment outcomes to support their investor communications.
- As the product completed Phase 1 testing, we worked with the newly established development team to evolve the target product profile using the emergent data to clarify the vision for the product and set the path for Phase 2. Given very long lead times and considerable investment impacts, considerations at this stage included defining the desired site of drug administration (i.e., caregiver or patient self-administration in this case) and associated formulation and dosage format requirements to facilitate patient acceptance.
- Once Phase 2 data were in hand, the TPP was further refined to finalize Phase 3 trial design and to ensure the claim structure would optimize payer response and provide the differentiated profile needed to compete in the marketplace.
- At this stage, a rigorous competitive intelligence exercise was an input to ensure changes in the landscape were considered in the registration plan.
Case Study #2 — TPP: A Team Sport
Creating a robust target product profile requires the involvement of a committed team: preclinical scientists, medical experts, regulatory gurus, commercial analysts, financial advisors, manufacturing specialists, and company leaders.
We conducted a workshop for a client’s development team to physically bring together remote-based functional leads as they were locking in their Phase 3 trial design. We first aligned on the process illustrated in the figure below, ensuring pre-work was done by the participants to inform the discussion.
The firm’s preclinical scientists offered insights into pharmacokinetics and pharmacodynamics, while its medical experts shed light on clinical trial design and mechanism of disease.
The regulatory lead outlined FDA and EMA expectations and endpoints, while the commercial teams described market dynamics and advocated for the patient perspective. Meanwhile, the CFO outlined funding milestones and budget considerations the team needed to adhere to.
Case Study #3 — Beware of the Outdated Target Product Profile
A lesson learned from a big pharma client serves as a cautionary example of what happens when the team doesn’t maintain the TPP as a living, fluid blueprint.
- The client engaged us six months into the launch of their intravenous cancer chemotherapy drug. Their TPP had been set several years earlier at the end of Phase 2, and the clinical team forged ahead with development and registration.
- Although a potentially serious competitor had been identified, no contingency planning was done to allow adjustments to positioning or claim structure to anticipate changes in the market landscape.
- Now, the competitive threat was a reality, and the clinical standard of care shifted almost overnight. Our client was caught flatfooted with a product that seemed to have lost its reason to exist.
- Had the client adjusted their target product profile along the way, they could have built-in contingencies to allow adjustments to their profile and modify their claim structure to preserve a defensible role regardless of the competitive threat. We helped the client identify a niche where the rationale for their product was unchallenged to salvage the brand.
Time to Get Started
To ensure you are ready to unlock your asset’s full potential, involve your cross-functional team, engage external experts where needed, and collaborate to shepherd your team through the development of an inspiring target product profile and embark on your journey toward commercial success.