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Whippany, NJ, United States, 2010/03/23 - Image Solutions, Inc. (ISI), a leading provider of software and services to the life sciences industry, today announced that it has appointed Lisa Jenkins, Ph.D., to the position of Director of Regulatory Strategy.
Dr. Jenkins joins the company’s professional services unit – a global team that includes former biopharmaceutical industry professionals experienced in guiding companies through each phase of development. She will advise clients on all aspects of clinical development and global strategic regulatory affairs. The appointment adds muscle to ISI’s growing professional services business and enhances the company’s broad range of offerings in regulatory consulting.
With more than 10 years experience in industry, Dr. Jenkins’s background includes product development planning, global regulatory submission strategy, dossier preparation and submission, and post-approval life-cycle management. She specializes in product labeling activities and risk management planning, and has also served as U.S. Agent for several clients and performed routine regulatory maintenance activities. She has led global, cross-functional teams to bring new, innovative therapies to market. Prior to her position at ISI, Dr. Jenkins served as a Principal Statistician and Senior Manager of Regulatory Affairs at Wyeth, and most recently, as Associate Director and Regulatory Group Leader with Kendle International, Inc.
“Pharmaceutical and biotechnology companies are looking for seasoned counsel to help them navigate the highly complex and ever-changing regulatory environment. We are pleased to welcome Lisa and to be able to leverage her deep submissions- experience and unique quantitative background across our client base – from our emerging company clients seeking advice on their development strategies to large global organizations exploring options to penetrate new emerging markets,” said Kenneth VanLuvanee, Vice President of Global Professional Services at ISI.
ISI’s expansion of the team comes at a crucial inflection point for industry. Many biopharmaceutical companies are determining their regulatory strategies in an environment where they must more stringently manage risk and maximize their product portfolio value. Dr. Jenkins will be working with a team that helps companies more effectively manage interactions with regulatory agencies, produce world-class submissions, and define and deliver the most efficient paths to market approval.
“Our clients are nearly as varied as the people they aim to help. That is why ISI’s approach of providing adaptable roadmaps founded in strategic consulting and software was so appealing to me,” said Dr. Jenkins. “Regardless of the organization’s desired strategy, ISI’s vision is to form lasting strategic partnerships with our clients to help them most efficiently navigate through the product development, regulatory submission, and post-approval process.”
Dr. Jenkins maintains a number of professional affiliations, including the Drug Information Association (DIA) and the Regulatory Affairs Professionals Society (RAPS) and is an active member of DIA’s Drug Information Journal Editorial Board. Over the last decade, Dr. Jenkins has been published in a multitude of peer-reviewed industry journals, including Global Forum, Neurology, Journal of Neurology, Psychology and Aging. Her most recent publications have provided guidance on how Sponsors can make the most out of their regulatory agency meetings. She has presented at numerous industry conferences, including RAPS Annual Meetings and DIA Annual Meetings.
Dr. Jenkins joins ISI with a diverse background that includes time spent at the University of North Carolina-Wilmington as a research psychologist studying normal and diseased aging. It was during her term as the Senior Manager of Regulatory Affairs at Wyeth that she gained much of her invaluable experience, receiving the Wyeth Team of the Year Award twice and the Above and Beyond Award four times in a six year stretch. During her tenure at Kendle International, Inc., serving in the roles of Associate Director and Regulatory Group Leader, Dr. Jenkins led numerous New Drug Application (NDA) and Biologic License Application (BLA) teams which resulted in successful U.S. filings and one first cycle approval in 2009.
Founded in 1992, Image Solutions, Inc. (ISI) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI (imagesolutions.com) was among the first professional services firms to deliver electronic submissions to the industry and since has delivered thousands of electronic and eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organizations as well as the top companies in other regulated industries.
ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to over 20 recognised charitable organisations.