- Janine Collins, MD, Brings Risk Management and Drug Safety Experience in Broad Range of Therapeutic Areas to European Market
BLUE BELL, Pennsylvania, Feb. 7, 2013 /PRNewswire/ -- United BioSource Corp. (UBC), a subsidiary of Express Scripts, is expanding its industry-leading pharmaceutical risk management services in Europe, where biopharmaceutical clients based in Europe or with a major operating presence on the continent can now better leverage the expertise of the market leader in the United States.
Janine Collins, MD, based in Geneva, Switzerland, will direct UBC's European Risk Management division, under the leadership of Annette Stemhagen, doctor of public health and fellow of the International Society for Pharmacoepidemiology, a leading adviser of drug safety regulations and programs in the United States. Dr. Collins, a graduate of St. George's Hospital Medical School in London, has expertise in:
- Developing European risk-management plans and risk-minimization strategies in response to regulatory requirements
- Designing and implementing mandated post-authorization safety studies
- Leading risk-management programs for two teratogenic products, Revlimid and Thalidomide
Sean Hart, UBC general manager & senior vice president, said, "It is vital for providers of risk-management and pharmacovigilance services to have experience working with the regulatory agencies in each European country and to understand the intricacies of a global launch that includes the European Union. Dr. Collins brings both of these to the table. A risk-management professional based in Europe, she is the right executive to support UBC's commitment to the region."
UBC is a market leader in North America in managing risk management and risk-minimization programs on behalf of pharmaceutical companies. UBC scientific experts have worked closely with the Food and Drug Administration (FDA) to develop Risk Evaluation and Mitigation Strategies (REMS) after the Food and Drug Administration Amendments Act of 2007 gave the FDA the authority to require a REMS from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. UBC currently is operating across Europe with key offerings in periapproval and post-approval research, pharmacovigilance, risk-management consulting and clinical-development services.
The addition of Dr. Collins secures UBC's place in Europe as a leader in providing risk-management services for the European drug market, Dr. Stemhagen said. "Dr. Collins developed her extensive experience in risk management as these concepts were evolving in Europe. She has a strong track record of relations with Rapporteurs, the European Medicines Agency (EMA), National Competent Authorities, healthcare providers and patient groups."
About United BioSource Corporation
United BioSource Corporation (UBC), a wholly owned subsidiary of Express Scripts Holding Company, is a global scientific and medical affairs organization that partners with life science companies to make medicine and medical products smarter for all stakeholders in the healthcare landscape. UBC helps deliver authoritative, real-world evidence to characterize product effectiveness, address safety risk and demonstrate value. UBC brings together recognized scientific and industry experts, research operations professionals and new technologies to provide innovative solutions across the product lifecycle. Services include clinical and periapproval studies, risk management and pharmacovigilance, product access and channel management, reimbursement and patient assistance, nursing and adherence, and data analytics. More information can be found at www.ubc.com.
About Express Scripts
Express Scripts (NASDAQ: ESRX) manages more than a billion prescriptions annually for tens of millions of people. On behalf of our clients — employers, health plans, unions and government health programs — we make the use of prescription drugs safer and more affordable. We innovate to enhance patient care, reduce pharmacy-related waste and increase therapy adherence. Through Health Decision Science(SM) — our new platform for discovery and innovation that's at the heart of creating value for patients and plan sponsors — we are making it easier for people to make better health decisions.
Headquartered in St. Louis, Express Scripts provides integrated pharmacy benefit management services, including network-pharmacy claims processing, home delivery from the Express Scripts Pharmacy(SM), specialty benefit management, benefit-design consultation, drug-utilization review, formulary management, and medical and drug data analysis services. The company also distributes a full range of biopharmaceutical products and provides extensive cost-management and patient-care services.
Thom Gross, Sr. Manager, Communications
Phone: +1 314-684-6321
SOURCE Express Scripts