Kristin Baird, M.D.

Dr. Kristin Baird is board-certified in Pediatric Hematology/Oncology and a subject matter expert in hematopoietic stem cell transplantation and cell and gene therapy (CAGT) regulatory affairs. Dr. Baird has over 18 years of clinical research experience in pediatric oncology at the National Cancer Institute (NCI) in Bethesda Maryland and 8 years of regulatory experience the in U.S. Food and Drug Administration (FDA) in the role of Medical Officer/Clinical Reviewer, within the former Office of Tissue and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER). After leaving the FDA and prior to joining Dark Horse Consulting Group, she worked as a Senior Director, Medical Strategy Lead, in the Cell & Gene Therapy Center of Excellence Therapeutic Science & Strategy Unit at IQVIA. 

During her time at the NCI, Dr. Baird served as the Principal Investigator on several clinical trials and was an Associate Investigator on over 30 clinical trials. Additionally, she served on the NCI Safety Monitoring Committee (SMC) and has over 50 peer-reviewed publications, several book chapters and multiple national and international presentations to her name.

While at the FDA, Dr. Baird served as a Medical Officer, expert reviewer, and one of the principal advisors to the Division Director and other Center senior staff for evaluating the safety and effectiveness of novel biologic cell and gene therapies, as well as Phase 1-3 clinical trial designs for oncology and hematology applications. As a consequence of the growing sophistication of product development during that time, the clinical evaluations and Sponsor guidance for which the medical officer assumed initial and substantial responsibility became increasingly complex and significant. Accordingly, Dr. Baird acquired extensive knowledge of applicable FDA laws, regulations, policies and guidelines and is adept at evaluating the vast body of clinical data submitted by the nation’s pharmaceutical industry and academic investigators to support Biologics License Applications (BLA), Investigational New Drugs applications (IND), Investigational Device Exemptions (IDE), and associated applications.

In addition to her role as a Medical Officer, Dr. Baird served as a member of several working groups and committees at the FDA including the CBER - IND Safety Report Process Working Group and the Oncology Subcommittee of Pediatric Review Committee (PeRC). Additionally, Dr. Baird served 2-year term as a Scientific Member of the FDA Institutional Review Board (IRB). Dr. Baird remains scientifically active in the oncology community, presenting at various professional meetings and continuing to publish in peer-reviewed oncology journals.

Dr. Baird has over 50 peer-reviewed publications, several book chapters and multiple national and international presentations, including the following regulatory-focused publications and presentations:

Regulatory Publications

1. Bouchkouj N, Kaushal M, Sharma P, Baird K. Regulatory aspects of gene therapy: The regulatory life cycle. Hematology/Oncology Clinics, Hematol Oncol Clin North Am. 2022 Aug;36(4):687-699. doi: 10.1016/j.hoc.2022.03.004. Epub 2022 Jun 27.

Regulatory Presentations

1. Invited Speaker. “Considerations for Design of Early-Phase Cell and Gene Therapy Clinical Trials”, Session: First-In-Human Trial Design, 28th Annual Meeting of International Society for Cell & Gene Therapy (ISCT), May 7, 2022, San Francisco, CA.
2. Invited Speaker. “Regulatory Challenges in Conducting Studies in cGVHD” delivered at the Joint Meeting of the 4th Chronic Graft-versus-Host Disease International Symposium and EBMT Transplant Complications Working Party (TCWP) Educational Course, in Zagreb, Croatia, from November 8-10, 2018.
3. Invited Speaker and panelist. FDA 101: Regulatory Considerations and Approval Pathways for Cell and Non-cell Based Therapies. ASH Immunotherapies Meeting. July 12 -13 2018, Washington DC.
4. Invited speaker and participant. FDA Visiting Scientist Program, UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI). Scientific and Regulatory Considerations for Gene Modified T Cell Therapy. November 15-16, 2017, San Francisco and Palo Alto, CA.
5. Invited Speaker. FDA 101: Regulatory Considerations and Approval Pathways for Cell and Non-cell Based Therapies. ASH Immunotherapies Task Force Meeting. April 26, 2017, Washington DC.
6. Invited Speaker. Workshop: Regulatory considerations for CAR-T Cell Therapy development. CAR T-Cell Summit, Boston, MA. September 5 - 8, 2017
7. Workshop Leader, FDA Mini-Symposium on CAR-T Cell Neurotoxicity. June 16, 2017, FDA White Oak Campus, Silver Spring, MD.
8. Invited Speaker. Clinical Considerations for CAR-T Cell Therapy - A Regulatory Perspective. Talk & Workshop, CAR T-Cell Summit, Boston, MA. September 15 - 16, 2016
9. Invited Speaker. Expanded Access to Investigational Drugs presented at the FDA 101 for the Pediatric Oncologist and Researcher Workshop. American Society of Pediatric Hematology and Oncology Annual Meeting, Minneapolis, MN. May 12, 2016
10. Invited Speaker and panel member: Vaccine and Engineered Cell Products. FDA: Childhood Cancer Advocacy Forum, Silver Spring, MD. April 22, 2016
11. Panel Member, Leukemia and Lymphoma Society AML Meeting; White Oak Campus, Silver Spring, MD. April 6, 2016

Kristin Baird Consulting
Clinical Cell and Gene Therapy / Hematology & Oncology Regulatory Consulting

IQVIA
Medical Strategy Lead, from the Cell & Gene Therapy Center of Excellence

FDA
Medical Officer

National Cancer Institute (NCI)
Staff Clinician
Pediatric Oncology/Hematology Fellow

Johns Hopkins Hospital
Pediatric Oncology/Hematology Fellow

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Dr. Baird received her undergraduate degree from the University of Pennsylvania and her M.D. from Temple University Medical School. She completed her General Pediatrics Residency at the Mattel Children’s Hospital at UCLA and completed her Clinical Fellowship training at the National Cancer Institute/Johns Hopkins University in the Pediatric Hematology/Oncology Fellowship Program, Johns Hopkins Hospital, Baltimore, MD and National Cancer Institute, Bethesda, MD. She is board certified in Pediatric Hematology/Oncology and General Pediatrics under the American Board of Pediatrics.