Dr. Cheryl Beal Anderson
VICE PRESIDENT & HEAD OF REGULATORY AFFAIRS
Center for Healthcare Innovation.
United States of America
Dr. Cheryl Beal Anderson, PharmD, MBA, is Senior Director, Global Regulatory Affairs at Lundbeck, a global CNS pharmaceutical company committed to making progress in mind and developing innovative treatment for Psychiatric and Neurologic diseases. The corporate headquarters are located in Valby, Denmark and US Offices in Deerfield, IL. Anderson leverages 20 + year career experience and knowledge in NDA/BLA, ANDA, FDA negotiations, FDA Advisory Committee experience to support the company’s vision to expand capabilities needed to obtain new drug approvals in the United States with an inclusive and collaborative leadership style with teams based in Valby, Denmark. Anderson leads the US regulatory strategy for registration, co-leadership for the Global Regulatory Response Team and Regulatory Filing Team. Externally, Anderson is the Lundbeck representative on multiple PhRMA LD-KITs (FDA Patient Focused Drug Development, Benefit: Risk Assessment, REMS and Adaptive Clinical Trial Design) and the DIA-HBA Leadership Project Steering Committee. Prior to Lundbeck, Anderson was Senior Director/Senior Fellow/Associate Director, U.S. Regulatory Affairs at Eli Lilly and Co. in Indianapolis, IN. Anderson led regulatory strategy staff for the Oncology, Cardiovascular, Autoimmune therapeutic areas and Pharmacogenomics and was the regulatory strategy lead on various product development teams. While at Lilly, she was the pharma Co-Chair with FDA that led to the publication of FDA Draft Guidance entitled, “Target Product Profile – A strategic development process tool” in 2007. Anderson also worked in Regulatory Affairs for Pfizer Global R&D, Parke-Davis and Alcon Laboratories. Prior to her pharmaceutical industry career, Anderson held full-time assistant professor positions at University of Texas College of Pharmacy (Austin, Texas) and University of Illinois at Chicago College of Pharmacy (Chicago, Illinois). Anderson was nominated for the Women and High Tech 2014 Leading Light ‘You Inspire Us! Award for demonstrating success in inspiring women in science, technology, and/or engineering to look beyond their own horizons. Anderson is also the recipient of the Center for Leadership Development, Business Award (Indianapolis, IN). Anderson holds professional membership in the Drug Information Association, Regulatory Affairs Professional Society, Healthcare Businesswomen’s Association (HBA) and International Society of Clinical Trial Management. Anderson is a member of the Executive Advisory Board, HBA Indiana Chapter and past president of the HBA Indiana chapter. She is a lifetime member of Jack and Jill of America and served on the National Executive Board as National Program Director, 2010-2012. Anderson is pursuing a Pharmaceutical and Healthcare Marketing MBA from the Haub School of Business, Saint Joseph’s University in Philadelphia, PA. Anderson completed undergraduate degrees in Biomedical Science from Texas A&M University (College Station, Texas) and Pharmacy at University of Texas (Austin, Texas). Anderson earned a post-graduate PharmD degree from the University of Texas at Austin and the University of Texas Health Science Center in San Antonio, followed by a one-year post-doctoral clinical pharmacy residency in psychiatric practice at San Antonio State Hospital (San Antonio, Texas).
Oncology, Cardiovascular, Autoimmune therapeutic