Leslie Dow Consulting LLC
Specific companies supported are available upon request
- November 2007- Present
- Assisted a company with developing SDLC-related procedures to support developing and commercializing an NGS (Next Generation Sequencing)-based LDT-based liquid biopsy test. This test is being transitioned to FDA 820 compliance for submission as an IVD. Support for the company’s successful ISO 27001:2013 certification and Quality Assurance support for process and production software, procedure development, and training included.
- Assisted a company in commercializing a liquid biopsy-based NGS multi-cancer screening assay to develop a device SDLC along with production and process software validation procedures supporting the development and release of their test as an LDT. The software was later transitioned to IEC 62304 conformance and FDA compliance for approval as an IVD. Also assisted in the development requirements and validation of bespoke clinical study software.
- Assisted a best-in-class NGS human diagnostic startup in developing a sustainable, FDA-compliant, agile software development process. Managed a program to deliver a factory-based workflow application for an NGS DNA Super-Sequencer.
- Helped an exciting and innovative IVD startup develop a best-of-class molecular diagnostic system. The company was recently purchased with an expansion in assay offerings and markets.
- Assisted a major biotechnology tools provider to develop a Manufacturing Execution System (MES) using industry standards and off-the-shelf tools. When complete, this program will deliver a highly configurable system that leverages the ISA88 process standards. This Recipe-based MES allows a reduction in time to market from months to weeks, with no loss in quality, while improving traceability and reducing costs.
South Mountain Community College
- January 2017-December 2018
- Adjunct Faculty, Into to Biology for Majors
Applied Biosystems/Perkin-Elmer/Life Technologies
Tech Board Chair, Advanced Research & Technology, Business Development
- Nov 2005 – Nov 2007
- Responsible for the management of a group responsible for technology evaluations of potential technology acquisitions. In this role, Leslie developed and implemented a new technology review process and oversaw the automation of that process.
Sr Manager- SW, SDS/Arrays
- May 2003 – Nov 2005
- Responsible for the management of the SDS software for the 7000, 7300 and 7500 Real-time PCR systems including the validation of these systems for use in FDA regulated devices.
Sr Manager, DNA Sequencing and Fragment analysis software group
- Aug 2001 – Nov 2002
- Responsible for the management of the DNA sequencing and genotyping analysis software applications at AB, including Sequencing Analysis, GeneMapper®, SeqScape® Software, and the AB basecallers.
Senior Staff Engineer/Manager/Group Leader, Informatics
- May 1999 – Aug 2001
- Responsible for the design and development and on-time delivery of SeqScape® Software.
Senior Staff Scientist/HIV Group leader
- Jan 1996 – May 1999
- Responsible for the inception, design, and management of a program to develop a clinical assay based on automated DNA sequence analysis to determine the genotypic resistance of HIV to antiviral compounds.
Scientist/Senior Scientist, Human Genetic Analysis R&D
- June 1991- Dec 1996
- Responsible for much of the initial work demonstrating the clinical applications of DNA sequencing technology. This initial work includes defining the requirements of the automated heterozygote calling and allele analysis software. Management of key collaborations both domestic and international was integral in this development program.
Associate Scientist, DNA Sequencing R&D
- March 1989 – June 1991
- Investigation of the applicability of existing and proposed ABI technology to the problem of high throughput genomic DNA sequencing. Through sequencing, a cosmid derived from human chromosome 19 modifications to existing protocols were identified that would facilitate this analysis.
- PhD Chemistry 1988, University of Oklahoma
Issued Patents & Publications
- Google Scholar
- Method of Automated Calibration and Diagnosis of Laboratory
- Systems and Methods for Generating Automated Software Workflows for Biological Testing.
- Novel methods for HIV Sequencing and Genotyping
- Methods and Reagents for Typing HLA Class I genes