About DLR

Dr. Donald L. Reynolds

Dr. Donald L. Reynolds has held scientific, leadership and management positions in the Pharmaceutical, Contract Research and Consulting Services areas.  During his 30 years of service he has acquired a broad-based understanding of the drug development process and experience with both new products and generics.  He possesses extensive experience in bioanalytical and pharmaceutical chemistry, quantitative separation science, chromatographic theory, project management, process optimization and regulatory services, in both GLP and non-GLP environments.  He has served as a bioanalytical consultant for 27 US and International Clients.

Prior to establishing this consultancy in 2004, Dr. Reynolds most recently held the positions of Executive Director of Project Coordination and Executive Director of Bioanalytical Methods Development at Quintiles, Kansas City.  He previously acquired experience in pharmacokinetics, drug metabolism and bioanalysis through various staff and management positions at Hoechst Marion Roussel, Marion Merrell Dow, Marion Laboratories and Parke-Davis Pharmaceutical Research.

Dr. Reynolds has authored or coauthored 21 research papers and has given 47 presentations in the areas of method development strategies, assay methodologies, new technologies and pharmacokinetics.  He is currently serving as a peer reviewer for the Journal of Chromatography B.

Dr. Donald L. Reynolds received his BS degree in Pharmacy from Ferris State College and his MS and PhD degrees in Pharmaceutical Chemistry from the University of Kansas.



To facilitate the timely completion of drug development programs for US and International Pharma, Biopharma and CRO clients by evaluating and improving bioanalytical processes, ensuring that bioanalytical methods are appropriately designed and validated, and that quality bioanalytical study data are generated and accurately reported in accordance with current acceptable global Scientific and Regulatory practices


DLR Bioanalytical ConsultingBACKGROUND SUMMARY

  • Thirty years of bioanalytical, pharmacokinetic and drug metabolism experience in the pharmaceutical industry, in Pharma (16 years), CRO (4.5 years) and Consulting (9 years)
  • Experienced bioanalysis consultant – provided consulting services for new products and generics for 27 Pharma, Biopharma and CRO Clients
  • Thorough knowledge of the drug development process from lead generation through post marketing support
  • Proven successful track record in managing projects and technical teams, project milestone development and tracking, and timely project completion
  • Expertise in bioanalytical chemistry and chromatographic theory, including method development strategies and issues, method troubleshooting and validation, matrix effects, automation, long term storage stability programs, routine sample analysis (non-GLP and GLP), SOP preparation and review, data and report preparation and review, pre-qualification and GLP laboratory audits and ISR issues
  • Experienced in evaluating and implementing new technologies and designing innovative solutions to address bioanalytical issues at ultra-trace detection limits
  • Experience in quantitative separation science, including reversed-phase, normal-phase, chiral and ion interaction chromatography, column-switching, solid-phase extraction, direct injection, millibore and microbore HPLC, UPLC and LC-MS/MS and ICP-MS technologies
  • Provided support for IND/NDA/BLA submissions and prepared bioanalytical sections for submission



Bioanalytical Consulting Services 2004-Present

Donald L. Reynolds PhD & Associates, Inc., Lee’s Summit, Missouri 2005 – Present

President, Bioanalytical Consulting Services


Donald L. Reynolds, PhD, Lee’s Summit, Missouri 2004 – 2005

Owner, Bioanalytical Consulting Services

Provided expert consulting services to US and International Pharma, generic Pharma, Biopharma and CRO Clients to support the development of new and generic pharmaceuticals. Provided expertise in bioanalytical chemistry, drug development, scientific planning and troubleshooting and project / business / financial management

  • Developed bioanalytical strategies for method development and automation, provided troubleshooting for method validation and ISR issues, performed SOP and report review / revision, prepared proposal / study plan / report templates and training in methods development and new technologies for an International Client. Provided on-site consultation and laboratory support at their India site for ~ 4.5 months and provided off-site bioanalytical expertise via e-mail and teleconference
  • Prepared bioanalytical method development plans for 170 drugs to guide method development and validation activities for bioequivalence studies. Plans included a review of compound chemistry, stability, metabolism, active metabolites, available methodologies, recommendations for analyte(s) to quantify, extraction and chromatography strategies and proposed assay ranges
  • Actively involved in designing method development activities and troubleshooting assay issues for ~ 50 assays for Pharma, generic Pharma, Biopharma and CRO Clients
  • Provided data review and method troubleshooting expertise to resolve failed ISR issues for assays for 3 Clients
  • Performed 12 due diligence laboratory / process bioanalytical audits at US and International locations to support GLP and clinical (in the spirit of GLP) sample analyses
  • Reviewed assay methodology, validation data, sample analysis data and draft reports to ensure data were valid and met acceptance and submission criteria
  • Assisted in developing and finalizing SOPs and processes for a new GLP bioanalytical laboratory
  • Prepared Client reports for 26 method validation and bioanalysis studies
  • Served as a Project Manager and method development consultant for several Preclinical and Clinical bioanalytical projects outsourced by a Client to a CRO
  • Presented training seminars to Pharma and CRO Clients regarding sample extraction and method development strategies, column chemistry and silanol effects, column switching technology and LC-MS/MS matrix effects
  • Reviewed and provided guidance for CRO project proposal and pricing processes to improve profitability
  • Developed Client-specific templates for contract proposals, work plans and method validation and bioanalysis reports
  • Reviewed current CRO processes and proposed a project management tracking system to: define project resources and milestones based on approved contracts, schedule and track work progress toward the established milestones. Individual and departmental real-time metrics such as on time delivery (OTD), capacity, utilization, profitability and revenue recognition/invoicing dates upon milestone completion would be monitored and reported
  • Currently serving as peer reviewer for Journal of Chromatography B


QUINTILES, Inc., Kansas City, Missouri 1999-2003

Executive Director, Project Coordination

Developed and established the Project Coordination (PC) function to serve as the Client liaison for the Bioanalytical Sciences Department. Responsible for coordinating departmental project, tracking financial and schedule activities, managing Client contacts, expectations and communications, defining project scope and resource capacity, determining costs for proposed work, reviewing and revising work orders and Client proposals, establishing and tracking project milestones, preparing Bioanalytical Work Plans and maintaining central study files. Represented Client projects and timelines at internal matrix team and scheduling meetings, identified out of scope or additional work and delivered work product to the Client

  • Personally coordinated > 300 bioanalytical projects for 17 Clients and supervised the coordination of approximately 100 bioanalytical projects for 8 additional Clients
  • Directed the establishment and implementation of a new dose formulation analysis line of business
  • Responsible for developing and implementing a project milestone tracking system to track project resources and timing and to generate on-time delivery, capacity and profitability metrics


Executive Director, Bioanalytical Methods Development

Responsible for the rapid development and validation of sensitive, selective, high throughput, automated bioanalytical methods to quantitate drugs and metabolites in biological matrices, performing routine sample analyses for selected projects, defining drug/metabolite stability profiles in biological matrices and establishing sample collection, shipment and storage procedures to preserve sample and data integrity. Ensured that projects were conducted in accordance with GLP, FDA and OECD guidelines and that data were suitable for global submission

  • Coordinated the validation of 17 bioanalytical methods, the analysis of >14,000 study samples and the issuance of 39 reports to support >30 nonclinical and clinical studies
  • Organized and chaired a weekly Bioanalytical Method Development Discussion Group to provide a forum for scientific discussion, problem solving, timeline tracking and resource allocation to decrease assay development time and increase departmental productivity


Associate Director, Bioanalytics

Coordinated and tracked bioanalytical project activities from Discovery – NDA for selected drug candidates to meet project team and corporate timelines. Developed and validated sensitive and selective bioanalytical methods and performed sample analyses to support nonclinical and clinical studies. Responsible for LC-MS/MS, non-LC-MS/MS and large molecule projects

  • Coordinated the bioanalytical support activities for 8 drug candidates. Supervised the analysis of >16,000 samples for approximately 35 studies over 9 months, with >95% on time delivery
  • Served as a bioanalytical consultant to approximately 20 associates


Hoechst Marion Roussel, Inc., Kansas City, Missouri 1995 - 1998

Research Scientist/Group Leader, Scientist Provided bioanalytical support for drug discovery and compound selection activities. Developed and validated selective bioanalytical methods to quantitate drug molecules and metabolites in biological fluids and performed routine sample analysis activities to support clinical studies for selected drug candidates

  • Provided drug discovery support and expertise to aid in the timely selection and development of the best drug candidates
  • Supervised the development of >140 methods and contributed to the development of approximately 40 additional methods. Supported the completion of >60 nonclinical and >10 clinical pharmacokinetic/drug metabolism studies
  • Served as a bioanalytical consultant to approximately 30 associates
  • Designed and developed a fully tunable solid-state laser induced fluorescence system with nanosecond time-resolved fluorescence capabilities with photon counting sensitivity for HPLC detection


Marion Laboratories / Marion Merrell Dow, Inc., Kansas City, Missouri 1989 - 1995

Scientist, Senior Associate Scientist Developed and validated selective bioanalytical methods to quantitate drug molecules and metabolites in biological fluids and performed routine sample analyses to support clinical studies for selected drug candidates

  • Developed and validated 7 methods, supervised the development of 13 methods and contributed to the development of approximately 30 additional methods
  • Served as a bioanalytical consultant to approximately 35 associates
  • Chaired a multi-disciplinary project team and participated on five additional teams in several therapeutic areas to facilitate the development of selected drug candidates to the NDA


Parke-Davis Pharmaceutical Research, Ann Arbor, Michigan 1982 - 1989

Senior Scientist, Scientist Designed and completed bioanalytical, pharmacokinetic and drug metabolism studies to support nonclinical and clinical development of anti-allergy drug candidates from discovery – NDA. Developed and validated sensitive and selective bioanalytical methods, performed sample analysis, designed and implemented nonclinical pharmacokinetic and drug metabolism studies and designed clinical first-in-man protocol design synopses for selected drug candidates and relevant metabolites

  • Developed and validated 12 methods, supervised the development of 8 methods and contributed to the development of approximately 20 additional methods. Completed 35 preclinical and 6 clinical pharmacokinetic / drug metabolism studies to support development of assigned compounds
  • Served as scientific consultant to approximately 35 departmental employees
  • Participated on multi-disciplinary project teams in several therapeutic and non-therapeutic areas to facilitate the development of selected drug candidates from discovery to the NDA


DLR Bioanalytical ConsultingEDUCATION

  • Ph.D.-  Pharmaceutical Chemistry, 1983, The University of Kansas, Lawrence, Kansas, USA
  • M.S. -   Pharmaceutical Chemistry, 1980, The University of Kansas, Lawrence, Kansas, USA
  • B.S. -    Pharmacy, 1976, Ferris State College, Big Rapids, Michigan, USA


DLR Bioanalytical ConsultingAFFILIATIONS

  • American Association of Pharmaceutical Scientists (AAPS), 1986 – Present
  • Scientific Committee Member – North American Bioanalytical Forum, Kansas City, MO, 2000 – 2006
  • Registered Pharmacist, State of Michigan, 1976 – Present
  • Registered Pharmacist, State of Missouri, 2005 – Present
  • Registered Pharmacist, State of Pennsylvania, 2011 – Present
  • Registered Pharmacist, State of Florida, 2012 – Present