Ms. Ballard’s expertise in building new clinical laboratories and quality systems, in addition to her knowledge of CAP and CLIA accreditation and state regulations, makes her a valuable resource to our clients developing laboratory-developed tests and establishing CLIA-certified laboratories.
ROCHELLE, Va. (PRWEB) October 29, 2020
NDA Partners Chairman Carl Peck, MD, announced today that Julie Ballard, a Clinical Laboratory Scientist, has joined the firm as an Expert Consultant. Ms. Ballard’s expertise includes building new clinical laboratories and quality systems, regulatory compliance, laboratory operations and management, CAP and CLIA accreditation, and state regulations through the Laboratory Field Services (LFS) program in California and the Clinical Laboratory Evaluation Program (CLEP) in New York.
In addition, Ms. Ballard has experience launching novel high-complexity laboratory-developed tests including liquid biopsy-based next-generation sequencing and tissue-based gene expression profiling oncology tests, and phenotypic/genotypic HIV drug-resistance testing. Throughout her 25-year career, she has provided leadership and operational expertise to biotechnology start-up companies, including her recent position as Senior Director of Clinical Laboratory Quality at Seer, Inc. She also served in Clinical Laboratory and Quality Director positions at GRAIL, Guardant Health, TOMA Biosciences, and Genomic Health.
“Ms. Ballard’s expertise in building new clinical laboratories and quality systems, in addition to her knowledge of CAP and CLIA accreditation and state regulations, makes her a valuable resource to our clients developing laboratory-developed tests and establishing CLIA-certified laboratories,” said Dr. David Feigal, Manager of NDA Partners’ medical device practice.
Ms. Ballard earned her bachelor’s degree in clinical science from San Francisco State University. She is a California-licensed Clinical Laboratory Scientist and is certified by the American Society of Clinical Pathologists (ASCP) as a Medical Technologist.
About NDA Partners
NDA Partners is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.
Earle Martin, Chief Executive Officer