Ajinomoto Althea, Inc., a leading contract development and manufacturing service organization, announced today it is appointing Dr. Lori McDonald as Vice President of Compliance at Althea. Althea’s contract manufacturing business continues to grow at a rapid rate driven by biotech companies outsourcing aseptic fill and finish parenteral manufacturing for clinical through commercial programs. Althea’s business has grown 25% annually since its acquisition by Ajinomoto in 2013. In 2016 alone, Althea increased its overall new business by 35%. To accommodate this steep growth trajectory, Althea has added a second fill and finish manufacturing shift and grown its headcount by 30%. In addition, the number of commercially approved drugs that Althea manufactures is growing at an unprecedented rate requiring Althea to further invest in its regulatory and quality teams.

To support and lead Althea’s regulatory excellence at this higher growth rate, Dr. McDonald will serve as Vice President of Compliance bringing with her a wealth of expertise and knowledge in the areas of CMC Regulatory Affairs, dossier filing (IND/NDA/ANDA/BLA) preparations, and FDA, EMEA, MHRA inspections. Prior to coming to Althea, Dr. McDonald served as Global Vice President of Quality, Product Supply Biotech, at Bayer Healthcare for 7 years. Prior to Bayer, she held a broad range of positions as Vice President of Global Quality & EHS at MDS Pharma Services, Vice President of Regulatory Affairs at Alder Biopharmaceuticals, and Executive Director and Site Head at Cardinal Health.

J. David Enloe, Jr., President and CEO of Althea states, “Althea continues to maintain an exemplary regulatory track record with agency approvals in numerous countries and now, with an increasing number of our clients’ new drug programs in Phase III and approaching commercial filing, we must further strengthen our expertise and maintain this best-in-class regulatory track record. We are eager to bring Dr. McDonald on-board as she has extensive experience and knowledge around CMC Regulatory and Quality systems. Dr. McDonald brings perspective from both the drug developer side as Vice President of Global Quality at Bayer Healthcare as well as from the viewpoint of a CDMO through her experience at Cardinal Health and MDS Pharma Services.”