Upfront

BMS Participates in V Foundation for Cancer Research Bike Ride

For the fifth year in a row, Bristol-Myers Squibb has launched the Coast 2 Coast 4 Cancer, a nearly month-long cross-country bike ride to raise money for cancer research. During the month of September, company employees ride nearly 3,000 miles from Cannon Beach, Ore., to Long Branch, N.J., with the goal of raising $1 million for the V Foundation for Cancer Research.

Medicines360 and Direct Relief Partner to Expand Access for U.S. Women

Medicines360, a mission-driven women’s health pharmaceutical nonprofit, and Direct Relief, a humanitarian aid organization, announced a partnership to provide Medicines360’s hormonal IUD, Liletta, free of charge to clinics that serve the most vulnerable women in the United States, such as uninsured women.

Medicines360 established an institutional patient assistance program (IPAP), known as the IUD Access Partnership, with Direct Relief to provide IUDs to clinics that serve women who cannot obtain the product through private insurance, Medicaid or other public funding.

“Unfortunately, access to the most effective forms of contraception, like IUDs, is an issue for many clinics where low-income women seek care," says Jessica Grossman, M.D., CEO of Medicines360. “This partnership delivers on our mission to expand access for the women who need it most, allowing them to avoid unplanned pregnancy if they choose."

Clinical Operations Leaders Taking Action to Unify Processes

Over the past year, there has been significant industrywide momentum toward streamlining clinical systems and processes, according to a survey of clinical operations professionals from Veeva Systems. Nearly all (99%) clinical leaders surveyed cite the need to unify their clinical environment. Most (87%) report their organizations are taking action with initiatives planned or underway to unify their clinical operations for improved trial performance.

“As organizations continue down the path toward a unified operating model, trial processes will be transformed for greater visibility and improved trial execution across the clinical lifecycle," says Jennifer Goldsmith, senior VP of Veeva Vault.

Rising Protocol Complexity Is Hindering Performance

Rising protocol complexity is hindering clinical trial performance and efficiency, and helping to drive up the cost of developing new drugs, according to a recently completed analysis by the Tufts Center for the Study of Drug Development.

“This trend will continue — and likely accelerate — as pharmaceutical and biotechnology companies target more difficult-to-treat and rare diseases, enroll more stratified patient populations, and collect higher volume and more diverse data," says Ken Getz, associate professor and director of sponsored research at Tufts CSDD.

Other findings include:
Phase I and II clinical trials are the most complex, based on numbers of distinct and total procedures, whereas Phase III trials have seen the highest increase in complexity during the past 10 years.

The total number of endpoints rose 86%, between 2001-2005 and 2011-2015, and procedures supporting these endpoints contributed a much higher proportion of data informing secondary supplementary, tertiary, and exploratory endpoints.

GSK Consumer Healthcare Partners to Address Cleft Lip and Palate

GSK Consumer Healthcare has announced a new five-year partnership with Smile Train, an international children’s charity with a sustainable approach to a single problem: cleft lip and palate. Smile Train empowers local medical professionals, by providing training and education, to provide 100%-free cleft surgery and comprehensive cleft care to children all over the world. Every year, one in 700 children is born with a cleft lip or palate globally. Clefts are the leading birth defect in many developing countries, and it is estimated more than 200,000 children are born with a cleft every year.

Drug Price Forecast Projects Lower Inflation in 2019

Vizient’s 2018 Drug Price Forecast estimates health systems can expect a 4.92% increase in the price of pharmaceuticals in 2019. This estimate represents an anticipated slower rate of growth as compared with previous Vizient forecasts, such as the 7.61% value projected for 2018.

Although the rate of price increases is projected to slow, the specialty pharmacy market is expected to continue its rapid pace of growth, which accounts for the majority of overall price inflation. According to a recent industry analysis, specialty pharmaceuticals now account for more than 46% of the total spend on drugs in the United States, in spite of being used for very small and targeted patient populations.

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Awards…

Chiesi USA Named a Best Place to Work
Chiesi USA was named among Triangle Business Journal’s 2018 Best Places to Work. The 50 Triangle companies were chosen based on an employee survey process conducted by Quantum Workplace.

Medidata Named Top Global Performer
Medidata has been selected for Fortune 100’s fastest-growing companies list. The company was named a top global performer for the second year in a row. The Fortune list recognizes top three-year performers in revenues, profits, and stock returns. The ranking provides a snapshot of the trends driving the global economy, including the continued dominance of the technology sector.

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PharmaVOICE 100 News

Jeff Berkowitz Takes Helm of Real Endpoints
Real Endpoints, which provides development and implementation of proprietary tools, has named Jeff Berkowitz as CEO and member of the board of directors. Most recently, Mr. Berkowitz served as an executive VP at UnitedHealth Group, CEO of its Optum International business, and as a strategic leader of OptumRx, its PBM. Mr. Berkowitz is a PharmaVOICE Red Jacket — 2014.

Donna Wray Joins inVibe Labs
inVibe Labs has appointed Donna Wray executive VP of sales and marketing. She has spent most of her career in various thought leader and entrepreneurial roles, and most recently was VP of multichannel marketing at TGaS Advisors. She is on the Health Literacy Initiative committee for Intellus. Ms. Wray is a PharmaVOICE 100 — 2017.