With over 25 years of experience in pharmaceutical R&D, Luman is a regulatory nonclinical expert specializing in small molecules, biologics, cell and gene therapies, and medical devices. A primary author of over 20 INDs and 5 NDAs/BLAs, Luman has led regulatory strategies, nonclinical GAP analyses, and program development across oncology, cardiovascular, infectious disease, and neuropharmacology. As an executive consultant at Management Consultants, Luman provides strategic nonclinical regulatory guidance to top pharmaceutical firms, leveraging extensive experience in regulatory submissions, compliance auditing, and global regulatory authority engagements to drive successful drug development and approvals.

In his current position as Senior Vice President, Technical for Regulatory Strategy at Parexel International, Dr. Winitsky is a member of the Cell and Gene Therapy Center of Excellence. He provides clinical regulatory support to clients for all phases of product development for cell and gene therapies. Prior to coming to Parexel, he served 11 years as a Medical Officer in OTAT/CBER (the FDA Office that regulates cell and gene therapies), where he transitioned from Primary Clinical Reviewer to Team Leader, and finally to Acting Clinical Branch Chief for General Medicine. During his FDA tenure, he reviewed or supervised review of INDs for a variety of classes of cell and gene therapies in over 50 clinical indications.

Christiane is a member of Parexel’s Cell and Gene Therapy Center of Excellence. As VP technical for CMC, her focus is on manufacturing consideration for advanced therapies of all types, including genetically modified cells and viral vectors. Christiane has spent over 12 years in regulatory agencies covering medicines, tissue, cell and gene therapy regulation. She was Unit Manager of the Biologicals Unit and a Senior Quality Assessor and UK delegate at the EMA committee for advanced therapies (CAT) where she was responsible for managing the portfolio of all UK ATMP products and also the Rapporteur for the EMA CAT Gene Therapy Guideline. She has experience with the EU, UK and US regulatory system.