Deloitte in late January unveiled 10 things to watch for in the regulatory arena when it comes to life sciences, including changes involving the medical device sector.
The Pharmaceutical Research and Manufacturers of America (PhRMA) has a few thoughts about regulations, and shared them this week with President Trump, Vice President Pence and House Energy and Commerce Chairman Greg Walden, (R-Ore.). Speaking of what he called a "positive, productive meeting," PhRMA President and CEO Stephen J. Ubl said, “We discussed many areas of common ground including: Advancing stronger trade agreements to level the playing field with countries around the world; reforming our tax code to spur investment and job creation here in the United States; and removing outdated regulations that drive up costs and slow innovation. We believe if these policies are enacted, it will translate to up to 350,000 new jobs over the next 10 years as a result of growth in the biopharmaceutical industry."
On the same day, in addition to other board elections, the PhRMA board of directors elected Joaquin Duato, worldwide chairman, pharmaceuticals, Johnson & Johnson, as chairman, and announced UCB, Inc., of Smyrna, Georgia, as a new member. The company is a division of the global biopharmaceutical firm UCB, based in Brussels, Belgium. With a focus on severe diseases in immunology and neurology, the company employs more than 7,500 people in approximately 40 countries, and generated revenue of more than $4 billion in 2015. Among its most recent ventures is a strategic research alliance with Baylor College of Medicine in Houston focused on therapeutics for neurodegenerative diseases. The college's lead researcher in that area, Dr. Huda Zoghbi, was one of five scientists who received a Breakthrough Prize in December at a ceremony in Silicon Valley, where they each were given $3 million. The Breakthrough Prizes were founded by Sergey Brin and Anne Wojcicki, Mark Zuckerberg and Priscilla Chan, and Yuri and Julia Milner.
West-Ward Pharmaceuticals Corp., a generic prescription medication provider and subsidiary of Amman, Jordan–based Hikma PLC, announced that it is growing its existing Columbus, Ohio, facility by adding new machinery and equipment and making facility improvements that will help the firm add 65 jobs in 2017. West-Ward President Brian Hoffmann cited Columbus's strategic proximity to US customers as a key factor. The company also has a 276,000-sq.-ft. distribution facility in Obetz, Ohio, that broke ground in 2016 and will employ 30 once complete. West-Ward employs 1,255 in Columbus and has additional operations in Ohio, Tennessee and New Jersey. The company has 29 manufacturing facilities in 11 countries, including a robust presence in the Middle East and North Africa.
adjacent to the Dignity Health-St. Rose Dominican, San Martín campus. The new unit follows the establishment of PPD's Phase I unit in Austin, Texas. “This new state-of-the art operation will provide us with the capability to include healthy and patient volunteers in first-in-human through proof-of-concept trials, which are becoming progressively more complex in nature,” said Cindy Doerfler, vice president of PPD’s early development division. A 2015 Battelle report found Nevada was home to 570 clinical trials among 6,199 in 2013 across the US, estimated to have a collective economic impact of around $25 billion ($10 billion in direct spend by companies).
No doubt that new PPD site has high security measures in place, and rightly so. Intel Security this past fall released its McAfee Labs Health Warning report, which assesses the marketplace for stolen medical records; compares it with the marketplace for stolen financial services data; identifies healthcare-focused cybercrime-as-a-service trends; and profiles cybercrime targeting intellectual property in the pharmaceutical and biotechnology industries. "Corporate espionage has gone digital along with so many other things in our world," said Raj Samani, Intel Security's CTO for Europe, the Middle East, and Africa. "When you consider that research and development is a tremendous expense for these industries, it should be no surprise that cybercriminals are attracted to the ROI of this category of health care data theft."
A report released January 23 by the Tennessee Department of Economic and Community Development and the Center for Economic Research in Tennessee (CERT) highlights the relationship between economic development, health and education:
- Unemployment rates are correlated with private-sector job growth, poverty rates, median household income and labor force participation in Tennessee counties.
- Attainment of an associate's degree or higher has a strong correlation with lower unemployment rates, higher labor force participation rates, larger median household incomes and improved health outcomes in Tennessee counties.
- County health rankings are correlated with rates of poverty and labor force participation in Tennessee counties, as well as educational attainment of an associate degree or higher.
On a related note, the U.S. Chamber of Commerce Foundation, in conjunction with the Healthcare Georgia Foundation, the Greater Columbus Georgia Chamber of Commerce, and Columbus State University’s Center for Health Disparities and Community-Based Research, on February 2 will host the 12th regional forum of the “Health Means Business” campaign in Columbus. The effort "seeks to engage local and regional businesses to empower healthier individuals and communities through education, employment, and increased income. The Columbus forum will focus on how business and community leaders can promote better health through economic opportunity, particularly in rural areas."
A survey of corporate real estate executives at large corporations conducted by CoreNet Global and CBRE Group, Inc. has found that when a company focuses on employee health and wellness, workers report increases in engagement, retention rates increase, and absenteeism declines. The survey saw responses from 211 senior level executives in the corporate real estate profession. Eighty-nine percent of the firms represented in the survey reported that they are focused on health and wellness initiatives. When companies have focused on wellness efforts with specific goals, 19 percent reported a decrease in absenteeism, 25 percent reported increased retention and 47 percent reported increased employee engagement.
Vetter, a global contract development and manufacturing organization (CDMO) for development, aseptic filling and final packaging of injectables whose Chicago investment we documented last year, has announced the launch of operations in its expanded Visual Inspection and Logistics Center (pictured) located in Ravensburg, Germany. The $107-million expansion means 50,000 sq. m. (538,000 sq. ft.) of floor space offering a 35,000-pallet warehouse capacity for storing pharmaceuticals in refrigeration or room temperature conditions. By the end of 2017, the CDMO will leave its existing Holbeinstrasse site, and employees and departments will gradually be relocated to Ravensburg Vetter West, resulting in a working staff of approximately 800 employees.
“The requirements regarding final product inspection as well as transportation and storage of (bio)pharmaceutical materials are ever-increasing,” said Vetter Managing Director Thomas Otto. “Concentrating our supply chain processes in one site enables bundled resources for even more efficient and highly-secured logistic and quality control procedures.”