Health

HEALTH • Spring 2016 23 A shot of healthy marketing! DON'T MISS OUT! You'll want to see and be seen in this quarterly publication! While the health care industry in our region is huge, there has never before been a single resource that delivers both industry news and analysis along with a consumer forum where industry experts can share their best advice and insights. Our regional HEALTH publication and E-newsletter will be aimed not only at health care professionals, but at health-care consumers, both retail and business. If you're a player in the health care field looking to promote your service, or if your business is trying to reach medical professionals and practices with products or services - we can help you deliver your message to this highly targeted audience. UPCOMING ISSUE DATES: • JUNE 13 Rehab & Sports Medicine / Pediatric Care Ad Deadline: June 2 • SEPTEMBER 19 Health Care Careers / Alternative Health Ad Deadline: September 8 For information on how to get your company's message in front of this highly targeted audience, contact Mark Murray, Associate Publisher at 508.755.8004 x227 or mmurray@wbjournal.com The Region's Quarterly Health Care Magazine HEALTH C E N T R A L M A S S A C H U S E T T S Conquering Lyme disease: A new approach? L yme disease is the most preva- lent vector-borne illness in the U.S., according to the Centers for Disease Control; and in 2014, 96 percent of confirmed cases were reported in 14 states, mostly in the Northeast and Midwest. Some of the heaviest concentrations were in Massachusetts and other New England States. The Centers for Disease Control and Prevention lists Massachusetts as the state with the second highest number of confirmed Lyme disease cases in the United States, and Lyme disease is a growing public health concern for residents and visitors to Massachusetts. The population of the 15 states in which Lyme disease is endemic – and therefore poses a risk of infection – tops 130 million, not including visitors to those states. MassBiologics, the biologics research and development arm of the University of Massachusetts Medical School, has taken on the challenge to discover and develop a medicine to prevent Lyme disease using a monoclonal antibody that provides pre-exposure prophylaxis (PrEP) by blocking trans- mission of the bacteria that causes Lyme disease from the tick to people. So how can we fulfill our mission to insure the availability and afford- ability of this medicine? To make the medicine available, it must be shown to be safe and effec- tive, which will require additional research. The cost of that research can be divided into eight buckets: 1) discovery of the medicine, 2) preclinical testing to demonstrate that the medicine is effective and safe in the test tube and in animals, 3) development of the processes to manufacture the medicine for human clinical investigation, 4) clinical testing in people to demonstrate safety and then efficacy, 6) consistent manufacture of the medicine to support regulatory filing, 5) regulatory approval of the medicine, 7) marketing, and 8) distribution. Each of these buckets holds widely varying amounts of cost, ranging from millions for discovery, small scale production and preclinical test- ing, to tens to hundreds of millions for human clinical testing, plus mil- lions for regulatory, manufacturing, marketing and dis- tribution. The clini- cal testing costs rep- resent the largest portion of the over- all development costs and include the three phases of clinical testing that are required for any new medicine to become licensed by the U.S. Food and Drug Administration. Our influence on the affordability of a medicine to prevent Lyme dis- ease is directly related to how quickly we can navigate the new medicine pathway. While the pharmaceutical industry has not addressed preven- tion of Lyme disease as a public health need largely because of con- cerns about the market and profit- ability, MassBiologics was founded on a mission to improve public health. Mark S. Klempner, MD, is the executive vice chancellor for MassBiologics and professor of medicine at the University of Massachusetts Medical School. HEALTHCARE INNOVATION By Mark S. Klempner

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