Personalized Medicine –A Game with More Than One Nash Equilibrium

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There is a time and the time is now and is right for me… (1)

Welcome to the age of personalized medicine. With the mapping of the entire human genome, completed in 2003, many doors were unlocked and one of them was personalized medicine – prescription of tailored drugs and therapies based on our specific genetic code.

The key benefits of PM (Personalized Medicine) are better diagnoses and earlier interventions, more efficient drug development, and more effective therapies – in the words of the honorable Mr. Michael Leavitt, secretary of Health and Human Services (HHS) - “Personalized Medicine means knowing what works, knowing why it works, knowing whom it works for, and applying the knowledge for patients”.

PM is:

• Personalized, because it is based on an understanding of how genetic variation drives individual treatment
• Extrapolative, because it is able to identify what conditions a person might contract in the future and how will respond to a given treatment, thus enabling a tailored health strategy
• Defensive, because it shifts the focus from illness to wellness
• Involving, because it empowers patients to make informed choices and take responsibility for their own health.

Index:  Main Changes Affecting Health Care, the Stakeholders, the Importance of Training, the Payers View, Governments, FDA, EMEA  

Three Main Changes Affecting Health Care:

New Actors and New Relationships

Consumers can get health information from the Internet, social networking sites, fellow patients, and chat rooms (Miller, 2010).

Remote monitoring devices and mobile health applications allow people to monitor their own weight, blood pressure, pulse, and sugar levels, and send results electronically to health care providers. Patients can store and have access to their medical records online.

The Digital Revolution

Websites such as WebMD.com, MedlinePlus.gov, and many others, answer questions and provide links to discussion groups about particular illnesses. Social networks such as PatientsLikeMe represent another way to share information among chronic condition sufferers.

Genomics

Scientists have made extensive progress over the last two decades in understanding human genetics and the role of proteins and chemicals in gene behavior (Goodman, 2009) and researchers have made progress in determining who is most/less likely to benefit from possible treatments.

Stakeholders

PM is no longer about the pharma industry alone – the players/stakeholders go far beyond the pharmaceutical and biotechnology industries, presenting a new challenge in assembling diverse technologies and partners working together. Success in this space will require new approaches, new relationships, and new ways of thinking.

PM is a disruptive innovation that will require the development of new business models. Collaboration, Coordination and Communication will be a key to success and all these players/stakeholders will need to co-operate:

• Pharmaceutical/Biotechnology companies
• Diagnostics companies - DTC (direct-to-consumer) genetic testing products for in-home use are empowering consumers with real-time information, enabling them to predict their medical risks, detect disease earlier, and better manage their health status
• Consumer Products Companies - food and beverage companies have long fortified their products with vitamins and other nutrients, and through advancements in science and food manufacturing, they will increasingly tailor their products
• Information Technology (IT)
• Telecomand Mobile Health Systems - one good example is the Bask company, Tecnalia, which covers half of the Basque Country in Spain with remote monitoring. They use a system that is conscious of its surroundings, with networks of sensors and communications, and a mobile robot for therapeutic treatment and care support, enabling elderly/disabled/ill people to increase their independence and to stay a longer part of their lives in their own homes while being able to look after themselves.
• Infrastructure Supporting
• Integration of Data and Clinical Records
• Insurance Companies
• Primary Care Practitioners
• Hospitals
• PBMs (Pharmacy Benefit Managers) will sell personalized medicine services to employers, which are willing to pay them higher fees for improved health outcomes and lower prescription costs. They act as an intermediary between payers and all the other stakeholders in the health-care system. Their offer of new services, such as increasing patient compliance and participation in drug-related decisions with the use of diagnostics and comparative effectiveness can help save their clients’ money

Training of Primary Care Practitioners

Physicians and nurses will need training in genomics and proteomics and their clinical applications if they are to remain relevant in an era of personalized medicine. Without the right tools and the training required to use them effectively, the personalized medicine market will not advance in the provider space or elsewhere. Universities will have to update their programs to educate the next generation of physicians and nurses in the complex issues raised by genomic and proteomic science.

Payers View and Reimbursement Schemes

The payers’ approach to PM is critical, as their reimbursement schemes will influence diverse business models. The fact that in U.S., 25% of individuals change health plans each year (due to employment-based insurance), will make payers rethink coverage.  PM has the potential to reduce payers’ costs in the long term by providing the precise diagnostics required, avoiding unnecessary or ineffective treatments, preventing adverse events, developing prevention strategies, and delivering more effective, targeted therapeutics, and, if PM succeeds in preventing/successfully treating widespread chronic conditions, such as diabetes, the cost savings can be enormous.

Governments, FDA, EMEA 

Governments are the healthcare major funders; therefore, they will play a key role in the progress of PM.

One of the goals of the FDA’s Critical Path Initiative is to accelerate the development of approved biomarkers and related diagnostics. A joint work with EMEA could set global standards that would allow that once a new drug was approved in Europe it would be automatically approved in U.S and vice-versa, streamlining the approval process.

Current EU regulatory framework for pharmaceuticals is ready to deal with PM and some new products have already been authorized. The “Conference of European Perspectives in Personalized Medicine” (12 – 13 May 2011), concluded that there are still many challenges to be addressed at European, national, regional and local levels. The Conference was particularly timely within the context of the development of the Common Strategic Framework (CSF), which will govern EU research and Innovation funding from 2014.

Adriana Jenkins diagnosed with a rare form of breast cancer, credited personalized medicine treatment for living nearly ten years more.

There is a time and the time is now and is right for me…

Is Big Pharma ready for “Time and a Word”?

1. Yes –Time and a Word

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Contributor:   Cristina Falcão

- Lawyer – Portuguese Catholic University Lisbon (own practice – 1992 – 2003)

Published Law Articles (in Portuguese) http://www.box.net/shared/ru12sn0tgk

- Pharmaceutical Manager /Chief Science Officer/ Change Manager (2003 – current)

 At Farmácia F., Portugal.

• Vast Professional Experience and Knowledge both in Law and Pharmaceutical Issues; Working in Both Areas.
• Considered to Possess Strong Forecasting and Analytical Capabilities, Strategic Planning Experience, and Proven Leadership Ability with Diverse Multi-Cultural Peers and Employees
• Fluent in English, French, Italian, Spanish, Portuguese, and  a Moderate Knowledge of The German Language

Other areas of work and interest:

• Promotion of Public Health Programs, like “Living With Diabetes”
• Director of all Mandatory Recalls and Pharmaco Vigilance
• Qualified in Change Management Control
• Certification of Quality for Pharmacies
• Marketing for Pharmacies
• Conflict Management
• Familiar With Supply Chain Topics
• Trained in Cold Supply Chain Distribution of Drugs to Pharmacies
• Supporter of Technology Innovation Relating to Pharmacies and Supply Chains
• Assistance to Supplier of Pharmacy Logistics Database – Addressing Flaws and Suggesting Improvements
• Several Articles and Essays about Legal Subjects Related to Pharmaceutical Topics in Portuguese Pharmacy Publications

cristinafalcaofalcao@gmail.com

http://pt.linkedin.com/in/cristinalfalcao

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