"To get where you want to go, you first need to define your destination," Bill Hanlon, PhD, chief development officer and head of global regulatory affairs for Covance said in an interview with partneringNEWS™, emphasizing a golden rule for drug development: think with the end in mind. "This approach is well-established with large pharma companies," he said. "However, many medium-sized and the majority of small biotech companies are shorter term players, focused on getting to proof of concept and then licensing their asset. They leave it to big pharma to take over at that point. Yet, there are good reasons why even a small, virtual biotech should think about the marketed drug during the earliest phases of drug development," he said.
"When you do not fully articulate the commercial value of your product and how it can be differentiated with payers, patients and prescribers, you are leaving money on the table when it comes time to license or sell your asset," he said.
“We all know the clock is ticking once patents are filed,” he said. "If you aren’t time efficient in the earliest phases, then you have reduced the patent-protected revenue life and potential return on investment for your late stage licensing partner, thereby devaluing your asset in the deal." Designing a structured development plan that supports a well-thought-out Target Product Profile (TPP) can minimize this risk and maximize the revenue potential for you and your development partners.
partneringNEWS (pN): We often hear it said that for early stage assets the only thing that matters is the science. Isn't this the primary focus early on?
Hanlon: That is the minimal expectation, yes. But you also need to differentiate your asset from other products currently on the market and ensure your stakeholders, such as providers, patients and payers, are considered. Focusing only on the science, without ensuring your drug will be used, prescribed or paid for, is not going to end in success. One way to ramp up your success quotient is with a Target Product Profile (TPP). A TPP describes what your product will be in its future state. It ensures you take into consideration the comparative effectiveness, or how your drug will interact with other drugs commonly taken by targeted patients. It requires a global mindset to determine country-specific needs where your asset would be registered and marketed. You can think of it as the label for the future drug—it includes the data to be generated during development and shows the risk-benefit balance. In creating a TPP, you define scenarios for minimum standards that must be met in order to advance your product. This helps you predetermine the criteria for making solid go/no-go business decisions at critical milestones of the development journey. The TPP considers what is already in the marketplace or in the development pipeline. It is an iterative and methodical approach to help determine and define how a product will benefit patients and be commercially successful—for you or your future licensing partner.
pN: Does the TPP message resonate with startups and emerging companies?
Hanlon: If a TPP is a new concept to clients, it may have a mixed reception. This is understandable if the company doesn’t think a TPP is applicable to them, or they feel they are too far along to change anything. However, I’ve seen quite a few programs fail—such as when focus is only placed on completing the studies, or the criteria or target is modified, without assessing the commercial viability of the drug. But many companies understand the value of a TPP, and although they might not enjoy stopping to create a formal document, they counsel with us to develop an approach based on past practice or other products on the market. A TPP is not a huge investment in time or money, and sponsors immediately see the value it brings—often using it to adjust their plan, reshape their development program, or include it in due diligence for later partnering or licensing negotiations.
pN: What concerns do emerging pharma raise in discussing the TPP process with Covance?
Hanlon: Emerging pharma companies are time and money conscious. They need to be sure they are investing wisely and generating the return their investors seek. They are caught between a rock and a hard place because they see the benefits related to a TPP, but are running against time and burn rate. They also seek exposure for their asset early in the development process. To help them find the right development partner, we created Covance MarketPlace, an online database where small pharma and biotech companies post their assets and large or midsize pharma organizations make connections when they are interested in licensing. In this way, Covance helps our clients connect to benefit both parties.
pN: When should a TPP plan be developed?
Hanlon: The TPP can be created at any time in early development, but we see it most often created about the time of an IND/CTA submission or during the First in Human SAD/MAD study. We recommend creating it early to benefit the sponsor and its stakeholders, as well as inform potential licensing or acquisition suitors.
Target product profile
Developing a drug is a very long journey, explained Hanlon, therefore it is critical to define the destination upfront. The TPP is like a postcard of your desired destination. It informs the data needed to differentiate the product in the market. A TPP articulates to a sponsor what is important to the key stakeholders:
• PATIENTS: Other medication that is currently available. Shortcomings, in terms of side effects, potency and interactions with another medication that the targeted patient group typically takes.
• PRESCRIBERS: The safety profile and benefit-risk for that specific patient, and how the benefits outweigh any patient concerns. When the agency reviews the clinical trial data they will be thinking about a population, but a prescriber is going to think about individual patients.
• PAYERS: The information needed for the formulary or for reimbursement. The new drug needs to not only provide benefit to patients, but also to the healthcare community to make it reimbursable.
While the TPP is the destination, the Clinical Development Plan (CDP) is the road map and outlines the right direction to take. For example, proving a product is equivalent to another drug going off patent will only deliver a generic price. But demonstrating how your asset is different and the value this brings to patients and the healthcare community will get a premium price versus off-patent or generic alternatives. The needs for a specific product and the decisions involved may require very different study designs. This is important to know as early as possible to ensure an efficient development plan that preserves patent life and speeds availability for patients. With a TPP, you’ll be able answer questions more effectively and more completely—and make decisions faster. A TPP contributes more value to a small company than going the journey without one, and the sooner you start, the better you position yourself for saving precious time and increasing your asset’s value.