In 2001, LBR provided Wyeth Research with all regulatory study site start-up and maintenance, contract and budget negotiations, and project management for a global osteoporosis program that had 300 sites. As part of this study, Lois Rosenberger was the global project director managing a major CRO that was responsible for monitoring, data management, and statistics.
Since 2001 (preferred provider as of 2003), LBR has provided Wyeth Research with clinical site study start-up activities. LBR has been responsible for getting sites through the pre-initiation process, regulatory document collection, and IRB approval for over 3,000 clinical sites in women's health (osteoporosis, hot flushes, contraception), CNS (schizophrenia, depression, anxiety, Alzheimer's), endocrine (diabetes), oncology (breast cancer) and then maintaining regulatory documents throughout the course of the trials. For other Sponsors, LBR Regulatory has been responsible for these activities in prostate cancer (50 sites), ovarian cancer (58 sites), and women's health (400 sites).
Since 2004, a team of LBR employees has been dedicated to the conduct of the four pivotal Phase 3 studies that supported approval of the first drug for treatment of heavy menstrual bleeding (Lysteda™, November 2009) and one Phase 3 study in prostate cancer (NDA recently submitted).
In 2005, Lois Rosenberger's LBR Regulatory and Clinical Consulting Services won the Northern Kentucky Chamber of Commerce's top business award for professional service.
Thursday, June 16, 2005
Keeping employees happy wins small-business award
By Jeff McKinney, Enquirer staff writer
ERLANGER - Lois Rosenberger's major concerns when she started LBR Regulatory and Clinical Consulting Services in 2001 were generating enough business to continue to grow and retaining employees as her firm got bigger.
To help overcome those challenges Rosenberger used an unorthodox business plan: She began paying 100 percent of employees' medical benefits and giving them four weeks of paid vacation from their first day of work.
That strategy has helped her company grow from one employee to 22, expand three times to add more space and increase revenues by about 50 percent a year.
"The key secret to our success is keeping employees happy," Rosenberger said after accepting the Northern Kentucky Chamber of Commerce's top business award for professional service Wednesday.
"That's allowed us to be successful in delivering quality products to our customers," she said.
Overcoming business challenges was the theme at the Receptions Conference Center, where about 270 business leaders from the region attended the chamber's 2005 Small Business Success Awards. About 80 percent of the chamber's 1,900 members come from small businesses.
Criteria for the awards included financial growth over a three-year period, innovation and community service.
In 2009, LBR completed overall operational responsibilities of four (2 efficacy, one safety and one rollover) Phase III HMB studies for Xanodyne Pharmaceuticals. These studies were completed six months ahead of schedule and were the basis for FDA approval of the drug (Lysteda™) in November 2009, 180 days after submission of the NDA. At the start of the clinical development plan, LBR prepared the argument that resulted in the FDA agreeing that the drug met fast track requirements.
In 2012 LBR completed a Phase III study in prostate cancer which was a rescue project from a large CRO. LBR was able to turn the study around and complete enrollment on schedule.
LBR was responsible for managing the CMC activities and writing the CMC, Non-Clinical and Overall Clinical Efficacy and Safety sections of the BLA for the smallpox vaccine developed by Acambis that was approved by the FDA.
In addition to the BLA, LBR has written and maintained INDs for oncology projects and has been the regulatory department for multiple companies requiring US regulatory strategy and filing capabilities.