Executive Director, Pharmaceutical Development
Shulin Ding, PhD
Dr. Shulin Ding joined AiViva BioPharma in 2017 as the head of pharmaceutical development. Dr. Ding has more than 35 years of applied research, drug development, and regulatory experience and has been a trailblazer in ophthalmic formulation development. In her current position, she is responsible for leading the development and production of novel delivery formulations that will be used for targeted local administration. Her expertise and extensive knowledge in formulation, Chemistry, Manufacturing and Controls (CMC), and drug product manufacturing technologies are critical to AiViva’s IND-enabling programs and IND submissions in dermatology, oncology, and ophthalmology.
Throughout her career, she has been a scientific leader in the pharmaceutical industry gaining extensive CMC experience in parenteral, ophthalmic, and dermatologic products, specializing in formulation, preformulation, process development, and scale-up of liquid and semi-solid dosage forms. Prior to joining AiViva BioPharma, Dr. Ding spent 13 years as a CMC lead with the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). In this role she was responsible for reviewing NDAs, INDs, and supplements submitted to CDER clinical divisions of Dermatology and Non-Prescription Products. Prior to joining the FDA, she worked as Principal Investigator for Trimeris Inc., based in Durham, NC. In this role, she was responsible for the formulation, preformulation, and process development activities of Fuzeon®, a lyophilized parenteral product approved in 2003 by the FDA for the treatment of HIV-1 infection. Before working for Trimeris, Dr. Ding worked in the Product Development Department as a Senior Formulation Scientist for more than a decade at Allergan Inc., based in Irvine, CA. During her time at Allergan, Dr. Ding spearheaded the formulation development for Restasis®, a novel, first of its kind, ophthalmic emulsion eye-drop of cyclosporin for dry eye treatment. Restasis® revolutionized the eyecare market and was the only therapeutic option for dry eye from 2003-2016 achieving over $1 billion in annual sales. Dr. Ding received a patent-of-the-year reward at Allergan in recognition of her work on Restasis®. She is a respected leader and essential AiViva team member, bringing proven knowledge and skills in CMC and regulatory.
Dr. Ding earned a PhD degree in Pharmaceutics from The Ohio State University, Columbus, OH, and a B.S. degree in Pharmacy from the National Taiwan University, Taipei, Taiwan.