An Introductory Lesson in Personalized Medicine

An Introductory Lesson in Personalized Medicine

Maria Shepherd • Data Decision Group

In the past, an axiomatic strategy for diagnostic companies was to avoid investment in the development of new diagnostic tests when no therapeutic treatment for the disease existed. Who pays for disease definition without follow-up therapy?

An about-face from this philosophy has been driven by industry expertise in genetics and the success of programs such as the Human Genome Project. Gene-directed drug discovery and development has emerged as one of the future’s powerful but indirect competitors to the medical device world.

The science of nucleic acid therapeutics has attained a new level, reaching a point where the combination of genomic data and therapy is at its strongest point ever. This combination of products has been labeled “pharmacodiagnostics.” Scientists and clinical researchers are working together to link one gene to one disease, and have created the hypothesis that nearly every therapeutic problem can be addressed by genomics and biomarker testing.

Why This is Important

The implications of personalized medicine are very clear in the field of oncology, but think of the impact throughout all medical industries/specialties that treat cancer through surgical tools. For example, in biliary endoscopy, plastic and metal stents are the gold standard to keep the bile ducts unobstructed when the patient has biliary cancer. As pharmacodiagnostics emerges, will those products still be relevant?

Impact on the Cardiovascular Device Sector

In a recent study, 52 U.S. doctors were asked, “In which therapeutic areas will the use of personalized medicine (i.e., use of genetic testing designed to tailor drug therapy to the individual) be most prevalent?”Oncology was the first-choice pick, with 30 responses (see Chart 1), but cardiology was the surprise second runner-up with 25 votes. In the device industry, cardiology shares the first place position with orthopedics as the two largest and most rapidly growing segments. Thus, the question becomes, how will personalized medicine specifically impact the cardiovascular device industry?

One reason for the interest in pharmacodiagnostic applications in cardiology is that clinical studies demonstrate a high level of inter-patient variability in response to commonly used cardiovascular drugs.2 The majority of studies addressing cardiovascular disease pharmacogenomics examine the potential genetic interactions of these drugs in large segments of the cardiovascular disease pharmaceutical markets, e.g., high blood pressure, congestive heart failure and high cholesterol levels. These conditions all are precursor states that lead to interventional and surgical cardiology procedures as well.
 

The Personalized Medicine Timeline

The doctors in this survey had widely differing opinions about the timing and impact of personalized medicine.

The Key Players in Personalized Medicine3

Although there are many players competing for leadership in personalized medicine, the largest company with the best research and development advantage is F. Hoffmann-La Roche Ltd. Roche’s sales in 2009 and 2010 were more than $45 billion. More than 50 percent of the company’s revenues were from sales of biopharmaceutical products in 2010. Eleven years ago, Roche underwent a restructuring to more specifically focus on biotech products; since 2007, its strategic focus has been on personalized medicine. Many of the company’s products currently in development focus on oncology—around 63 percent of its Phase III programs are indicated for cancer. In addition, IBM and Roche announced a partnership in 2010 to co-develop a nanopore-based technology that will directly read and sequence human DNA. The two companies believe that this technology could offer significant advantage in cost, throughput, scalability, and speed compared with other sequencing technologies that either currently are available or in development.4

Competition in the highly profitable medical device market will come from all directions. Understanding the macro trends will help all participants be more competitive in the space.

References:

1.The Future of Personalized Medicine, GLG & Bloomberg, 2011.

2. www.marketresearch.com, Pharmacodiagnostics, April 2009.

3. www.marketresearch.com, What’s Next in Biologics? May 2011.

4. www.genomeweb.com/dxpgx/roche-ibm-co-developing-nanopore-based-dna-sequencing-technology.

Maria Shepherd, founder of Data Decision Group, has 20 years of leadership experience in medical device and life-sciences marketing in small startups and top-tier companies. The firm quantitatively and qualitatively sizes opportunities, evaluates new technologies, and assesses prospective acquisitions. Shepherd can be reached at (617) 548-9892 or at [email protected] or www.ddecisiongroup.com.