Tag Archives: Healthcare

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 Primary Research Helps Companies Succeed?

By Angela Justamante, M.S., Consultant at Insights in Life Sciences (ilS).

Market Research is an organized effort to gather information about target markets or customers. It is a very important component of business strategy. Market Research is one of the key factors used in maintaining competitiveness over competitors, providing important information to identify and analyse the market need, market size and competition. Market Research techniques encompass both primary and secondary market research. 1

Whereas secondary research, also known as desk research, involves the summary, collation and/or synthesis of existing research, primary research involves the collection of data directly from the source of knowledge (physicians, patients, payers, Company representatives,…).

Primary research is generally conducted by third parties, in order to maintain as much objectivity as possible. Those providers should ideally be familiar with the Efpia code of practice (which recommends how organization should interact with healthcare professionals and patient organizations) . 3 Data collected through primary research is interpreted using statistical or analytical methods and techniques to gain insights and support decision making.

Primary market research can be made through qualitative techniques such as in-depth one to one interviews or quantitative techniques such as questionnaires. 2

The following case studies, allows to gain a better understanding of how primary research can support companies’ decision-making.

Case study: NIVEA deodorant “Pearl and Beauty”

Beiersdorf is a big German personal-care company based in Hamburg, Germany, that includes brands such as: NIVEA, Eucerin and Atrixo. One of the main reasons of Beiersdorf’s success is the in-depth market research they conduct (in a global context). The aim of this market research is to gather end user views, which provides insights that ultimately result in the development of new products suitable for a global market.

A clear picture of how market research has helped New Product Development (NPD) at Beiersdorf, is the case of a NIVEA Deodorant called Pearl and Beauty aimed at young women.

The objective of this primary market research was to understand the motivations for using deodorant amongst female consumers. The research involved small discussion groups of females, which helped researchers understand the beliefs and motivations of this group and revealed an interesting finding: apparently NIVEA lacked a specific product that addressed ‘underarm beauty’ for the female consumer.

As a result, this primary market research revealed an unexplored market potential for NIVEA Deodorant. And, in order to fulfil this market need, NIVEA successfully launched to the market a Deodorant called Pearl and Beauty 4

Insights in Life Science (ilS) has successfully conducted primary research studies for a variety of life sciences companies, including: big pharma, biotech, start-ups, Tech Transfer Offices,  or even for other consulting organizations

We share three case studies below (slightly modified for confidentiality purposes), which try to illustrate how primary research adds value to our Clients:

Case Study 1:

A start-up biotech company focused in the field of neurology and ready to initiate a Phase II Proof-of-Concept for one of its products, was interested in understanding Key Opinion Leader (KOL) and payer perception of that product (“Product X”). For that purpose, ilS selected the best potential neurologists and payers (across the top 5 EU countries and the USA), prepared an exhaustive interview guide and held in-depth phone interviews with those experts (ilS InterviewsSM)

Insights collected through this primary research allowed our Client to understand expert perception of its Target Product Profile (TPP), and potential Market Access barriers. Those first-hand insights allow the Company to: 1. Revisit the Product Development Plan in an early stage, 2. Be better prepared to negotiate with licensors, 3. Attract investor attention during a potential fund raising phase

Case Study 2:

The Office of Technology Transfer of a Nordic University developing a new treatment in the field of Ophthalmology (“Product Y”), was interested in understanding end user clinical practice, existing unmet clinical needs, and market potential for “Product Y”. For that purpose, ilS conducted a primary research (ilS SurveysSM) with top ophthalmologists across the USA and the top 5 EU countries. With the support of the ilS NetworkSM, ilS identified the best KOLs, prepared an exhaustive online survey and collected expert insights. ilS analyzed the compiled information and shared a report with the Company allowing them to: 1. Decide whether or not to continue further developing “Product Y”, 2. Understand the potential market size for a rare ophthalmologic condition

Case Study 3:

A Global Pharma Company in preparation for the market launch of “Product Z”, needed to gain insights from several qualified oncologists in regards to their decision-making process, their product perception and values. For this purpose, ilS organised an onsite Advisory Board with several oncologists in order to capture their insights and gain consensus (ilS KnowledgeSM). More specifically, ilS created a well-designed moderator guide based on the client provided information, conducted the advisory board, collected the expert insights, analyzed the compiled information and shared a report. The Advisory Board provided sufficient insights to develop an optimal local strategy that could facilitate a smoother launch for “Product Z”

Those three case studies, illustrate how primary research supports life sciences companies to gather key data directly from the target customers, and adds value in regards to: target product profiling, clinical trial design, early market access plan, pricing strategy, licensing strategy, fund raising,…, which allow organizations to become more efficient and accelerate new product launch, which in the end will benefit patient health, which is what really matters.

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REFERENCES

  1. McQuarrie, Edward (2005), The market research toolbox: a concise guide for beginners (2nd ed.), SAGE, ISBN 978-1-4129-1319-5
  2. Wikipedia (https://en.wikipedia.org/wiki/Secondary_research)
  3. Efpia Relationships & Codes: https://www.efpia.eu/relationships-codes/
  4. NIVEA- Case Study, International Market Research (http://bit.ly/2Dk8POh)

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

 

 

Pricing and Reimbursement within the US Public Healthcare System – Part Two, Medicaid

photopin_oldmanautumn_smallby Emily Fielding

The legislative changes made under the Affordable Care Act are significant for Medicaid – the state program that provides health insurance for low-income individuals. In 2010, 16.5% of Americans had Medicaid coverage, but from 2014 it is being expanded to include every individual with incomes under 133% of the Federal Poverty Level who isn’t covered by Medicare. This removes the previous requirement for dependent children for eligibility. The Center for Medicare and Medicaid Services (CMS) is a federal body that monitors the Medicaid program, but states retain the right to choose to provide the program or not. Currently, all states have it. However, only 23 states and the district of Columbia will be participating in the Medicaid expansion, which a High Court Ruling deemed optional according to the constitution. Those states with Republican Governors are those that so far refuse to enact the legislation.

All states cover prescription drugs under Medicaid, though co-payments per prescription can vary between $0.50-$5.00, and there may be limits on the number of prescriptions a beneficiary can have filled each month/year. Furthermore, drug manufacturers must enter a rebate agreement with Medicaid in order to have their products covered. Details of how much is required for each drug can be found here. Under Obamacare, this rebate has risen from 15.1% to 23.1% of the average manufacturer price for innovator drugs, and is expanded to include Medicaid delivered by Managed Care Organizations.

This means not only is Medicaid expanding in terms of number of people covered, but the costs on pharma for each individual sale are rising too. Those listed as “preferred drugs” such as antiretrovirals, atypical antipsychotics, ARBs, statins, anti-platelets etc will be most affected. Pharma is prevented for offsetting this rebate rise with a price increase, as any price increases to offset will be offset themselves by an additional rebate. Currently, 600 drug manufacturers participate in this program, facilitating access to their medications for Americans on Medicaid. These companies will still benefit from the overall increase in sales expected from having more people covered under Medicare.

REFERENCES:

Sinclair, A et al (2010) Strategic Analysis – US Pharmaceutical Market Overview, Reference number: DMHC2621, Datamonitor

DeNavas-Walt, C, Proctor, BD and Smith, JC (2012) “Income, Poverty, and Health Insurance Coverage in the United States: 2011” U.S. Census Bureau, Current Population Reports, P60-243, U.S. Government Printing Office, Washington, DC

Schlosberg, C & Jerath, S (1999) Fact Sheet: Prescription Drug Coverage Under Medicare NHelp Available from: http://www.healthlaw.org/index.php?option=com_content&view=article&id=187%3Afact-sheet-prescription-drug-coverage-under-medicaid&catid=38&Itemid=192