Le Lézard
Classified in: Health
Subject: PER

Former Senior Director of Clinical Laboratory Quality, Julie Ballard, Joins NDA Partners as Expert Consultant


ROCHELLE, Va., Oct. 29, 2020 /PRNewswire-PRWeb/ -- 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.

Contact
Earle Martin, Chief Executive Officer
Office: 540-738-2550
MartinEarle@ndapartners.com

 

SOURCE NDA Partners LLC


These press releases may also interest you

at 09:00
FluroTech Ltd. , ("FluroTech" or "the Company") is pleased to announce that FluroTest Systems Ltd. ("FluroTest") today released a white paper titled "The Evolving Role of Antigen Testing in the COVID-19 Pandemic Response." The report reviews the...

at 09:00
Taconic Biosciences, a global leader in providing drug discovery animal model solutions, announces the launch of the new ExpressMODEL®: Random Integration Transgenic (RITg) service, which reduces animal model generation costs and timeline. Many gene...

at 08:58
Telemis, the medical imaging, archiving and transmission specialist, has just posted its latest financial results. The company attained revenues of ?8.64M during the 2019-2020 period, which is a 5.5% increase on the previous year. For the 18th year...

at 08:56
As a growing chorus of health authorities point to aerosols as a key transmission route for SARS-CoV-2, the coronavirus that causes COVID-19, and as the U.S. rapidly sets new records for coronavirus cases, Aerapy, LLC, announced today that its...

at 08:55
Allied Corp. ("Allied" or the "Company") , an international medical cannabis company focused on creating and providing targeted cannabinoid health solutions to address today's medical issues is pleased to announce an endorsement contract with elite...

at 08:55
The mycoplasma testing market is expected to grow by $ 445.57 mn, progressing at a CAGR of over 11% during the forecast period. Click & Get Free Sample Report in Minutes The increasing focus on R&D of biopharmaceuticals is one of the major factors...



News published on 29 october 2020 at 03:00 and distributed by: