BiologicsMD Selected for $2.3
Million Department of Defense Contract
Company Developing Next Generation
Fayetteville, Arkansas - Feb. 9, 2011 - BiologicsMD, a drug
development company based in Fayetteville, Arkansas, has been
selected to receive a $2.3 million research contract from the
Department of Defense, announced Paul Mlakar, Chief Executive
Officer at BiologicsMD.
BiologicsMD is a start-up drug development company led by Mlakar;
Misty Stevens, Chief Operating Officer; Robyn Goforth, Chief
Scientific Officer; Jim Shook, Chief Development and Regulatory
Affairs Officer; Rob Gensure, Chief Medical Officer; and Michael
Thomas, Chief Marketing Officer. The team has expertise in
medicine, biochemistry, bioengineering, business, marketing,
product development and regulatory affairs.
The group is developing a new prescription osteoporosis medication
called PTH-CBD™, which promises three times the efficacy of
available bisphosphonate treatments with fewer side effects.
According to the National Osteoporosis Foundation, one in two women
and one in four men will be diagnosed with osteoporosis in their
Each year Congress mandates priorities for the Department of
Defense to direct their research programs through the awarding of
grants. Since the Department of Veteran Affairs is the largest
healthcare provider in the United States, osteoporosis and related
bone disease are a long-term health care and cost concern and as a
result are a congressionally directed research topic. The U.S.
Department of Defense Peer Reviewed Medical Research Program of the
Office of the Congressionally Directed Medical Research Programs
(CDMRP) received more than 600 applications and fewer than 10
percent were recommended for funding.
Funds from the contract will be used to develop the manufacturing
platform for PTH-CBD™. The next step for the company is to complete
the animal toxicology testing and then conduct a Phase I study in
patients with osteoporosis according to FDA requirements.
BiologicsMD's goal is to develop the product through a Phase I
human clinical trial and then sub-license it to a major
pharmaceutical company to conduct large safety and efficacy trials,
obtain FDA approval and begin marketing to osteoporosis
Reviews from the technical review committee highlight BiologicMD's
expertise in drug development, stating that "the investigators show
a clear and concise understanding of bone biology, drug discovery
and drug development… This proposal could have wide ranging
consequences. Each stage of the proposed research is carefully
crafted in a logical sequence." Mlakar believes that "this approval
process provides validation for the science behind a compound that
could help millions by improving quality of life and saving
The Department of Defense contract would be the first for the
company, which has operated on funding from private investors and
awards from successful business plan competitions.
BiologicsMD won the Grand Prize at the Rice University Business
Plan Competition in 2010, hosted by the Rice Alliance for
Technology and Entrepreneurship and the Jesse H. Jones Graduate
School of Business at Rice University. The company also won the
Best Life Science Award, the Heinlein Prize Trust for Space
Commercialization, the Courageous Woman Entrepreneur Award, and
Best Elevator Pitch Life Sciences. BiologicsMD also won the Global
Moot Corp Business Plan Competition in 2010 hosted by the
University of Texas.