PHARMACY

Diplomat Pharmacy boosts data security with new chief information security officer appointment

BY Michael Johnsen

FLINT, Mich. – Diplomat Pharmacy on Thursday announced the addition of Shannon Beltrand to their senior leadership team as chief information security officer. In this role, Beltrand will be responsible for securing and properly monitoring Diplomat's data, systems and facilities to ensure that Diplomat is secure both internally and externally. Additionally, she will play key roles in systems auditing and business continuity planning.
 
"We are very excited to have someone of Shannon's caliber and experience joining the Diplomat team," stated Jeffrey Rowe, director and EVP operations at Diplomat. "Her expertise in cyber security will allow Diplomat's patients and partners to have confidence that our systems and data are governed for state-of-the-art protection."
 
Beltrand brings over 20 years of experience in information technology with several years experience in security of information systems and overall security management. Most recently, Beltrand worked as the director of information security and service management at Data Recognition Corporation, leading the company's enterprise information security program and IT service management processes. Prior to that role, Beltrand served as the company's director of software development, director of information services, manager of information services and project manager of information services.
 
In addition to her extensive experience in technology and data, Beltrand holds a Bachelor of Arts in American Studies from Pine Manor College in Chestnut Hill, Mass., and a master's degree in organizational leadership and technology from St. Catherine University in St. Paul, Minn.
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GPhA establishes new division in Biosimilars Council

BY Michael Johnsen

WASHINGTON — The Generic Pharmaceutical Association announced Thursday the launch of the Biosimilars Council, a division of GPhA.
 
“Following unanimous Board of Directors’ approval, the Biosimilars Council is the culmination of the Association’s longstanding and unwavering commitment to patient access to safe, affordable and lifesaving biosimilar medicines," stated Craig Wheeler, GPhA board chairman and president and CEO of Momenta Pharmaceuticals. "The GPhA Biosimilars Council is designed to meet the unique needs of healthcare companies as they navigate this emerging space,” he said.
 
“In addition to being a voice with policymakers, this new division will be an invaluable partner for patients, providers, manufacturers, consumer groups and stakeholders from all corners of the supply chain seeking to stay apprised of critical developments regarding biosimilars,” Wheeler said. “The GPhA Biosimilars Council also will be a key resource for organizations seeking relationship building opportunities, and a forum for indepth scientific, regulatory, legislative and policy discussions.”
 
The Biosimilars Council will comprise manufacturers and stakeholders working to ensure a positive regulatory, reimbursement, political and policy environment that supports patient access to these more affordable new medicines. The Biosimilars Council also is the industry’s first educational resource for the general public and patient groups seeking information about the safety and effectiveness of biosimilars.
 
Among the first offerings of the Biosimilars Council is a new educational handbook, "The Next Frontier for Improved Access to Medicines: Biosimilars and Interchangeable Biologic Products." This publication explains the benefits and science behind biosimilar medicines — safe, effective alternatives to costly biologic therapies. It explains who will benefit from access to these medicines, outlines the legal and regulatory framework, and illuminates the quality manufacturing and development process in approachable language. 
 
The GPhA Biosimilars Council will begin operations immediately. As per recently adopted changes to the GPhA bylaws, a Biosimilar board, elected by members of the Biosimilars Council, will develop the Association’s biosimilar activities and programming consistent with the longstanding mission of GPhA and the association’s board of directors. With a roster of committed members and full startup funding, the new division will supplement GPhA’s regulatory, government affairs, policy and communications/education team to support anticipated activities. The GPhA Biosimilars Council will welcome all biosimilar companies dedicated to bringing more affordable biosimilar medicines to US patients as it works to continue its leadership in supporting this emerging industry.
 
“GPhA and its members historically have been the industry pioneers on biosimilars, beginning with their role as the fundamental organizing force behind the law which created the biosimilar pathway. The Biosimilars Council is the next evolution in this leadership, and will ensure these new medicines will deliver tremendous benefits for both our health and our healthcare system,” said GPhA president and CEO Ralph Neas. “We look forward to continuing to work with our strategic partners and all stakeholders who share our vision of the transformative potential of biosimilars and interchangeable biologics.”
 
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Sandoz introduces generic Copaxone to treat MS

BY Michael Johnsen

HOLZKIRCHEN, Germany – Sandoz, a Novartis company, on Thursday announced the U.S. approval of Glatopa, the first generic version of Teva's Copaxone (glatiramer acetate injection) 20 mg/ml one-time-daily multiple sclerosis therapy.
 
"Sandoz, together with Momenta, is proud to be the first company to receive FDA approval for a substitutable generic version of this important therapy," stated Peter Goldschmidt, president of Sandoz US. "The approval of Glatopa reinforces Sandoz leadership in complex, differentiated generic products and further demonstrates our commitment to offer patients and payors a full range of therapeutic options."
 
MS is a debilitating disease affecting about half a million individuals in the U.S. alone; only half of those diagnosed are currently treated.
 
Glatopa, developed in collaboration with Momenta and produced entirely in the U.S., is indicated for the treatment of patients with relapsing forms of MS, including those who have experienced a first clinical episode and have magnetic resonance imaging features consistent with MS.
 
 
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