About DLR

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

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

• 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

• 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

• 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