Tag Archives: doctors

Guess who invented the Target Product Profiles…

By Itziar Escudero, Ph.D., M.B.A. Partner at Insights in Life Sciences (ilS).

A Target Product Profile (TPP) is a planning tool for therapeutic candidates based on FDA guidelines.

The TPP defines the minimal and ideal profile of the final marketed product and shows the ultimate goals of the proposed therapy development effort such as disease indication, patient population, delivery mode, treatment duration, treatment regimen, and standards for clinical efficacy.

Target-product-profile-template (1)

Fig1. Standard TPP (you can download a template here)

The TPP concept was used for the first time more than 20 years ago (in 1997), when FDA representatives and pharmaceutical sponsors were looking for ways to improve sponsor and FDA interactions during the drug development process.

The purpose of a TPP is to provide a format for discussions between a sponsor and the FDA that can be used throughout the drug development process, from pre-investigational new drug application (pre-IND) or investigational new drug application (IND) phases of drug development through postmarketing programs to pursue new indications.

The TPP embodies the notion of beginning with the goal in mind. That is, the sponsor specifies the labeling concepts that are the goals of the drug development program, documents the specific studies intended to support the labeling concepts, and then uses the TPP to assist in a constructive dialogue with the FDA.

The use of the TPP has evolved and nowadays does not only facilitate the dialogue between the sponsor and the FDA, but with other stakeholders (such as physicians and payers) as well.

In fact, at ilS we help Companies assess how those stakeholders (physicians and payers) “react” to the different TPP presented, including the minimally acceptable and the desired scenarios. For this purpose we count with a network of life sciences experts (ilS NetworkSM) from all over the world, including physicians and payers, with whom we conduct in-depth phone interviews and collect their perspective around the TPP.

Ideally, the TPP provides a statement of the overall intent of the drug development program, and gives information about the drug at a particular time in development. Usually, the TPP is organized according to the key sections in the drug labeling and links drug development activities to specific concepts intended for inclusion in the drug labeling.

The TPP is a dynamic summary that changes as knowledge of the drug increases. For optimal use, it is recommended to update regularly the TPP to reflect new information about the product.

Early TPPs can be brief depending on the status of the sponsor’s development process.

A well-organized TPP is also useful for updating quickly sponsor personnel who join the program for the first time.

The is part of the proprietary IND file. Nevertheless, a TPP does not represent an implicit or explicit obligation on the sponsor’s part to pursue all stated goals.

According to the FDA, sponsors have seen advantages of using a TPP at meetings early in the drug development process. Use of a TPP can facilitate the efficiency of sponsor-FDA interactions and communications. A TPP can help address issues early on in the drug development process thereby preventing late stage drug development failures and decreasing the total time involved with drug development.

In the same way, we at ilS, have seen advantages of using TPPs for Companies (sponsors) that seek stakeholder input. This tool allows physicians and payers to comment on the product profile in an organized manner and to evaluate different scenarios. We have observed that this tool is useful not only in later stages of drug development, but also in early stages where there is still so much room for change for the sponsors.

Interestingly enough, we have also found this tool useful for evaluating in vitro diagnostics (IVD) devices, adjusting the TPP template.

References:

https://www.ninds.nih.gov/Funding/Apply-Funding/Application-Support-Library/CREATE-Bio-Example-Target-Product-Profile-TPP

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080593.pdf.

The CBER Office of Cellular, Tissue and Gene Therapies (OCTGT) web page for industry education also has a Webinar on TPP

 

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How Can We Engage US Doctors in a New Healthcare System?

New-healthcare-system_ilSThe healthcare system in America has been in trouble for years, with many Americans struggling to receive the care they need and doctors and hospitals struggling to give it to them.

In the past, the healthcare system, at the hospital level, was organized around maintaining
the loyalty of individual physicians, who were seen by hospitals as their “real” customers since most of a hospital’s revenue came from doctors referring their own personal patients. This created a system where increasing volume was the main concern while working with doctors to improve quality of patient care and lower costs was of secondary importance. However, this old system is no longer effective, and the good intentions of individual doctors are not enough to ensure a high standard of care for patients. As a result, it has become clear that some big changes at the hospital level are needed in order to improve patient care and keep the healthcare system moving forward. However, these changes can be hard to make, especially when physicians are not on board. Most doctors and healthcare providers see such large changes as threatening and potentially harmful to their livelihoods. The need for better patient care makes it crucial for hospitals and healthcare organizations to find a way to get physicians to support and be active in helping with this transformation.

In the article “Engaging Doctors in the Health Care Revolution” Lee and Cosgrove (Chief Medical Officer at Press Ganey and CEO of the Cleveland Clinic respectively) recommend a way to modernize and revamp the healthcare system that many see as outdated, and even broken. They acknowledge the key role doctors have to play in this new system and suggest that while many healthcare organizations have recognized the need for change they have lacked a solid and united approach to make that change effective. In their article they propose a solution that reassures doctors while at the same time getting them to be proactive and involved in reforms. They present their plan to engage doctors in the following four steps:

First, organizations and leaders of healthcare centers, must offer their doctors a clear, shared purpose to engage in: better patient care. It’s important that this goal be the center of any changes, since in their hearts this is what true healthcare professionals strive for. It is also vital to engage doctors in this process by making them an active part of creating and implementing this goal. Creating statements of shared purpose can be a very effective way to center everyone’s focus on a common and concrete goal. Such statements also set the focus on patients, acknowledge that the current way of doing things is no longer efficient and assert that action, as a group, is what is needed to move forward.

Second, the leaders of healthcare organizations must appeal to physicians’ self-interest. Like everyone physicians are concerned with job security and financial incentives. This self-interest can be used as a way to further engage doctors in heightening patient care and working as team, by offering rewards for achieving objectives. If physicians feel that a new practice will improve patient care they don’t require large financial incentives. It is more important that incentives reward collaboration and are consistent with the goal of a shared purpose rather than offering a big reward for something physicians feel they cannot support.

Third, leaders must create a way for doctors to earn and maintain respect. Respect from their peers and the fear of losing that respect can create a very successful system of nonfinancial rewards and penalties that can get doctors on board with the new system. Organizations that have used a form of positive peer pressure, making physicians’ quality-performance data available to their peers and in some cases even the public, have seen an increased improvement in performance.

The fourth and final statement is related to the important of embracing tradition. Membership in an organization and adherence to the traditions that make that membership special can be a very powerful motivator. Maintaining and creating traditions allows organizations a way to implement standards and create consistency in how physicians are expected to interact with each other and work as a team. It is also effective because physicians know that they could be shunned or lose their job if they don’t comply with these standards.

Many organizations already use one or more of these motivations in some form or another, but the organizations that have seen the most success have implemented all four. Although these changes can be hard to make due to physicians, leaders must be positive and optimistic. They need to remind doctors that whatever they may have to give up will pale in comparison to what they will gain, personally and professionally, when patients’ needs come first. Leaders will also have to be ready to part ways with anyone who is not willing to make the necessary changes, and work as a team. Transforming healthcare at the hospital level is not an easy task, but in the long run organizations that want to be successful and lucrative while making a place for themselves in the evolving healthcare landscape, will be the ones that can productively engage their staff in making patient care better and more effective.


 Article written by Alexandria Kyle-Hammer, ilS Collaborator

Cosgrove, Toby, Lee, Thomas H. (2014, June). Engaging Doctors in the Health Care Revolution. Harvard Business Review,105-111