In 2007, the Center for Drug Evaluation and Research (CDER, part of the U.S. Food and Drug Administration (FDA)) issued a draft guidance that defined the content and format of the Target Product Profile (TPP).
The TPP is a directional tool that has a significant impact on the drug development process with downstream implications for the commercial function and, in particular, its marketing organization. The Proposed Promotional Claim(s) (PPC) is another key component for optimizing product development and commercialization. The PPC captures what marketing will want to say about the product in promotion—and therefore what the labeling must state to permit these claims. Together, the PPC/TPP is also a statement of the overall intent of the drug discovery program and therefore is a critical tool in clinical trial design.
Start With the End in Mind
The PPC/TPP starts with the end in mind, that is, it projects what the product labeling must look like to meet customer needs, whether they are patients, physicians, nurses, pharmacists or payers.
For all these stakeholders, the drug must be differentiated and bring a clear value proposition to be relevant into the future—especially in the face of existing and new competition. Ultimately, the PPC/TPP helps to ensure that a new drug meets the needs of the marketplace in a sustained and viable way. Indeed, with a well-defined PPC/TPP, companies are more likely to deliver products that are medically and commercially successful. Moreover, companies that invest time to develop these strategic tools conserve time and free up resources in their development programs which can then be leveraged in different ways to further patient care.
To better understand the impact of the PPC/TPP to development programs, three executives representing Regulatory, Medical and Commercial departments were interviewed from the newly formed independent biopharmaceutical company, AbbVie. Their perspectives demonstrate why these three diverse functions must work together to guide the development of therapies in order to deliver strong clinical performance, patient benefit and health economic value.
Commitment to Collaboration and Cooperation
“Regulatory is committed to delivering on the PPC/TPP promise with its commercial partners in mind,” explains Tracy Rockney, JD, Divisional Vice President, Regulatory Affairs, Global Labeling, Advertising and Promotion; and DIA.HBA Steering Committee member. “That’s why Commercial must be highly engaged. Marketers ask the key questions and provide insights very early in the process, before R&D outlines the full clinical development program when it may be too late to meet commercial needs.”
Therese McCall, Ph.D., MBA, Head Global Medical Communications and Professional Strategies, Global Medical Affairs concurs: “Launching products with clinical and health economic profiles necessary for success requires early and ongoing engagement and input from many stakeholders within the organization. By involving Commercial from the start, ideally in the preclinical stage, a company can promote the right dialogue to optimize labeling for commercial success and promotability in an increasingly complex commercial environment.”
Renee P. Tannenbaum, PharmD, MBA, Head, Global Commercial Excellence, adds: “Commercial must weigh in and buy-in throughout the process because it is our function that provides insights into the proposed labeling’s impact in the marketplace. Companies must make every effort to address gaps identified through Commercial’s deep understanding of all key stakeholders.”
All three executives agree that the goal and indicator of success is when the final version of the PCC/TPP is similar to the annotated draft labeling.
How The Process Works
According to the FDA draft guidance and related company strategy, the Sponsor specifies the proposed claims and labeling concepts that become the drug development program goals. Then the Sponsor documents the specific studies intended to support the proposed labeling using the PPC/TPP to assist in a constructive dialogue with the FDA.
The proposed claims and supportive labeling provide a format for discussions between that Sponsor and the FDA throughout the drug development process. These discussions start in the pre-investigational new drug application (pre-IND) or investigational new drug application (IND) phases of drug development and continue through to discussions on post-marketing programs to pursue new indications or other substantial changes in labeling.
The TPP usually reflects key sections in the drug labeling and prioritizes the key features and attributes of the intended end-product. The focus is on strategic context; medical and commercial requirements and priorities; patient requirements; technical (research) and biological features; technical (development) requirements and feasibility; and desired versus minimally acceptable features. The drug company can draft and update pertinent sections of the TPP template that are intended to support the specific statements in labeling.
According to Rockney, “The PPC/TPP is a dynamic summary which changes as knowledge of the drug increases. While it gives the company a place to start, the PPC/TPP must evolve as information accumulates and the marketing and medical environment changes. Along the way, the document helps prioritize key decisions and minimize risk. That’s why everyone involved must be linked into the process, from scientists and research personnel to medical personnel, commercial interests and executive management.”
Explains Tannenbaum: “Commercial must participate in discussions that focus on the intended disease indication and proposed nature of the clinical benefit; routes of administration; speed of onset of action; duration of action; and even frequency of administration. Even questions about contraindications, storage and handling of the drug can impact acceptance and subsequent usage of a drug.”
Rockney says that “while FDA interactions are focused on the develop-ment program goals, the FDA’s agreement with any part of the PPC/TPP does not commit a company to language in the final label. Furthermore, the company is not obligated to pursue all stated goals, nor are constraints placed on the draft labeling ultimately submitted.”
Overall, the process encourages input, debate and changes along the way based on the realities of a market and a patient-focused approach.
Market and Patient Realities Rule
McCall underscores that successful products must address unmet patient needs and have value propositions that resonate with healthcare providers and payers. “It is no longer acceptable to develop drugs with registration as the sole objective. The evolving global environment is driving the need for new approaches to innovative drug development.”
“When it comes to innovating, companies must start with the patient at the core,” McCall continues. “This requires a deep understanding of the patient journey where there are true opportunities to create innovative solutions that focus on better patient outcomes. Commercial and Medical are critical and integrated partners in this discussion because of their unique understanding and perspective on the patient. These functions also balance the need to understand the commercial and reimbursement environment in which a drug will be launched.”
Meanwhile, Tannenbaum says: “We intimately understand the most critical competitive drugs and research how the drug will be reimbursed from country to country. We understand if and how specific populations vary because we study the diverse needs of key stakeholders, from physicians, pharmacists and nurses, to patient advocacy groups, partners and family members.”
Companies also need to drive greater efficiencies and shorter timelines. Significant resource investments to bring products to market must be optimized for innovation and efficiency, which is why internally aligned labeling claims are vital.
Tannenbaum concludes: “Commercial’s ability to identify the key factors driving success must come into play early. It’s rewarding that our Regulatory and Medical partners understand our value and welcome our input from beginning to end.”
Disclaimer: The views and opinions expressed by the interviewees in this article are those of the individuals and should not be attributed to their company.