Personalized Medicine Bulletin The source for business, legal, and regulatory developments shaping an evolving industry

Category Archives: Economics of Innovation

Business Models for Personalized Medicine

Posted in Economics of Innovation; FDA; FDA Guidelines; Genetic Testing; Personalized Medicine; Reimbursement

Personalized medicine is moving from concept to reality, fueled in part by advances in sequencing technology and data analysis. However, significant business challenges remain that hinder growth and adoption of personalized health care. One such challenge how to is pay for the research and development of new diagnostics and therapies when the target patient population does not fit the traditional pharma “block buster” model. Thus, the health care industry is searching for viable business models to fund personalized therapies and companion diagnostics. How does one attract investment? How does one navigate the regulatory pathway? Will payors reimburse the diagnostic? How does one price the product and service?

The Personalized Medicine Business Summit will tackle these issues on May 14th, in San Francisco. Industry heavyweights such as Steve Burrill, Dr. Elizabeth Mansfield of FDA and Ronnie Andrews of Life Technologies will share their experience and insights on evolving business models for personalized medicine.  Further information is provided at www.personalizedmedicinesummit.com.

Patent Pool Simplifies Development of Personalized Medicine

Posted in Economics of Innovation; Gene Patents; Genetic Testing; Personalized Medicine

One argument often cited against patenting is that multiple patents can cover one product, its preparation and use, creating a so-called “patent thicket” that must be unwound like a bowl of spaghetti before a new technology is free of potential liability. Cooperation and collaboration among patent holders in the form of a patent pool is one means to provide a one-stop-shop for coordination and management of patented technology. A patent pool is an agreement among patent holders to provide access to patented technologies based on an agreed-upon fee structure. Patent pools have been used in high technology and other fields but typically not in technologies supporting health care.

The National Institutes for Health announced the formation of a patent pool to provide a one-stop shop for worldwide access to diagnostic discoveries for personalized medicine. The pool is managed by MPEG LA and available under the name “the Librassay.” MPEG LA promotes the Librassay as a landmark collaboration among the National Institutes of Health (NIH) and other leading health care innovators, such as Johns Hopkins University, the Ludwig Institute for Cancer Research, Memorial Sloan-Kettering Cancer Center, Partners HealthCare, The Board of Trustees of the Leland Stanford Junior University, The Trustees of the University of Pennsylvania and the University of California, San Francisco.

This and similar collaborations are supportive of the advancement of personalized medicine and underlying technologies. For example, simplified and coordinated access to numerous patented technologies would support whole genome sequencing, which sequences and identifies numerous genetic markers simultaneously.

The Economics of Innovation: Part II

Posted in Economics of Innovation; Personalized Medicine

In my June 10th, 2012 post, I  noted a report on the current debate whether or not patents promote or impair innovation in the diagnostic field.  Last week at the 2012 Biotechnology International Organization (BIO) International Convention, Joseph Damond, vice-president for international affairs at BIO reportedContinue reading this entry