June 2016 Meeting Announcement, Joint Meeting of the Delaware Valley Mass Spectrometry Discussion Group and Chromatography Forum of the Delaware Valley

• Speakers:
  Lois Ann Beaver, US Food and Drug Administration, retired – Biosimilars Evolution and Demands on Analytical Scientists

• Date: Tuesday, June 14, 2015. 6:00 PM

• Time:
  Social Hour, Networking, Dinner and Poster Session: 6:00 PM. - Mendal Hall 2nd floor
  Talk: 7:30 PM. Mendel Hall Room 115, Villanova University
  Please RSVP to Kevin Owens kevin.owens@drexel.edu by 5 pm Thursday June 9.

• Place: Department of Chemistry, Villanova University (Room 115, Mendel Hall)

• Directions:

• Abstract: A perspective on the rapidly evolving field of Biopharmaceuticals and especially Biosimilars, (“copies” of biopharmaceutical products) will be presented. Scientific, legal and economic issues associated with production and marketing of biosimilars are undergoing development and change. In view of the increasing impact of these therapies on patients and providers, the significance of advances and the key roles of separation and characterization scientists will be demonstrated. Structural features of the biosimilar including the peptide chain, structural folding, purity profiles and glycosylation profile must be shown to be similar to the reference product. Current regulatory guidance and the sources to follow for future information and counsel will be cited.

• Bio: Upon graduation in 1963 with a BS in Chemistry and Mathematics, from Rosary Hill College, Lois Ann Healy (now Beaver) joined the U.S. Food and Drug Administration in Buffalo, NY as an analytical chemist where she developed a deep interest in separation science that continues to this day. At FDA headquarters she held several positions including overseeing the trace analytical work of FDA field labs, mass spectrometry projects and official method development. An idea conceived while working in the lab led to a dozen patents on a system and apparatus for real-time multi-dimensional chromatography, and the founding of an instrument company called Varex Corp. that functioned for 10 years in Rockville, MD. The last period of her multi-decade FDA career involved international activities in the Office of the Commissioner where she served as liaison with international organizations such as WHO (World Health Organization), OECD, (Office of Economic Cooperation and Development) and APEC, (Asia Pacific Economic Cooperation), served on numerous US delegations, and was a member of the FDA Pharmaceutical Quality Council that conceived and developed quality by design. Lois also led international projects on anti-counterfeiting of medical products and good manufacturing practices in emerging countries and established a pharmaceutical information center in Cairo. She is a member of the Washington Chromatography Discussion Group, the ACS Chemical Society of Washington, and the Chromatography Forum of the Delaware Valley and is on the organizing committees of HPLC 2016 and PREP 2016.

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