March 1, 2024
Walnut Creek, CA—Dark Horse Consulting Group (“DHC”), the leading global consultancy to the cell and gene therapy (“CGT”) industry, today welcomes Kristin Baird, M.D. to the consulting team as a Master Practice Expert with a focus in Clinical Regulatory. A subject matter expert in hematopoietic stem cell transplantation and CGT regulatory affairs, Dr. Baird has over 18 years of clinical research experience in pediatric oncology at the National Cancer Institute (NCI) in Bethesda, MD and 8 years of regulatory experience with the U.S. FDA in the role of Medical Officer/Clinical Reviewer.
Dr. Baird’s quarter-century of clinical and regulatory experience will be an asset to DHC clients seeking support for clinical regulatory strategy or regulatory writing support for early or late stage clinical regulatory submissions.
Kimberly Benton, Ph.D., DHC’s Master Principal and Head of Regulatory, stated, “I’ve known Kristin for more than a decade. She was a valued colleague at FDA, and I am excited about her joining DHC’s regulatory team and offering her keen insights into clinical trials and regulation to our clients.” Adds Katy Spink, Ph.D., Dark Horse Managing Parter and COO, “Kristin’s diverse clinical regulatory experience as a regulator, a clinical trial researcher, and a consultant enable her to bring a well-rounded strategic perspective in support of our clients. We are incredibly excited to welcome her to the team.”
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.
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 cell and gene therapies, as well as Phase 1-3 clinical trial designs for oncology and hematology applications. Due to the growing sophistication of product development during that time, the clinical evaluations and Sponsor guidance for which she assumed responsibility became increasingly complex and significant. During this time, Dr. Baird acquired extensive knowledge of applicable FDA laws, regulations, policies, and guidelines. Kristin is adept at evaluating the vast body of clinical data submitted by the 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, Kristin served a 2-year term as a Scientific Member of the FDA IRB. After leaving the FDA and prior to joining DHC, she worked as a Senior Director, Medical Strategy Lead, in the Cell & Gene Therapy Center of Excellence Therapeutic Science & Strategy Unit at IQVIA. 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 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. She is board certified in Pediatric Hematology/Oncology and General Pediatrics under the American Board of Pediatrics.
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About Dark Horse Consulting Group
Dark Horse Consulting Group, a global company with offices in the U.S., U.K., and Singapore, was founded in 2014 with the purpose of accelerating cell and gene therapies through unmatched consulting expertise. DHC’s collective knowledge spans product and process development, analytical development, device development, manufacturing operations, quality assurance, facility design & engineering, regulatory affairs, nonclinical development, project & program management, quantitative modeling, market expertise, and diligence & business strategy. DHC offers an unmatched understanding of the challenges faced by cell and gene therapy developers and applies best practices from this and other industries to address a diverse range of client needs.
