Transitioning your drug from a vial to combination product

Lauren Orme has over 20 years of experience in pharmaceutical packaging, medical device and analytical services industries. Currently, Lauren leads the Regulatory Affairs Intelligence, Human Factors and Medical device labeling teams at West Pharmaceutical Services, Inc., Exton, PA. which ensures regulatory compliance by overseeing monitoring of, and compliance to, global regulatory requirements. Lauren earned a Bachelors of Science (B.S.) in Biology from West Chester University. She is certified as a Project Management Professional (PMP).

With more than 30 years of experience in the medical device and combination product industry, Meredith brings a blend of technical depth and commercial strategy to the field.  She spent her first 20 years of her career in engineering and program management, leading the development and launch of complex products from concept through commercialization.  Over the past decade, she has focused on strategic growth within contract manufacturing, helping organizations expand and scale their combination product capabilities.  Most recently, her work has centered on business development, partnering with pharmaceutical companies to bring innovative therapies to the market efficiently and reliably.

Matt Woods started with West in 2019 as the extractables supervisor after serving as both an analyst and a supervisor for a CRO for 13 years.  Currently, Mr. Woods’ role is manager of the extractables and leachables group where he leads West’s team of 20 dedicated extractables and leachables scientists.  Mr. Woods’ focus is partnering with internal and external customers to design and execute extractables and leachables studies to satisfy both the customer’s needs as well as regulatory expectations.  Mr. Woods has extensive experience designing studies for a wide range of drug products and packaging systems including combination products and medical devices.  Mr. Woods has a bachelor’s degree in biochemistry and molecular biology from Lebanon Valley College.