Bioanalysis Zone is delighted to offer its members unique access to two panel discussions. The panel discussions focus on two current issues facing the bioanalytical field: new technology integration in bioanalytical workflows and the sharing of scientific data.
Chaired by Amanda Wilson (AstraZeneca), the panel discussion on the sharing of scientific data focuses on the best practices with data sharing in the public domain, how to write a manuscript and key advice for a young scientist. The panel comprises leading CRO and pharmaceutical leaders: Melanie Anderson (Merck), Lawrence Goodwin (KCAS), Patrick Liu (Teva pharmaceuticals), Shane Needham (Alturas Analytics) and Jason Wrigley (Merck KgaA).
The panelists discuss:
- What are the best practices with data sharing in the public domain? [Time – 00:15]
- How do we share data in a patient-centric way? [Time – 00:15]
- How do you write a manuscript? [Time – 29:52]
- What advice would you give to a young scientist? [Time – 29:52]
We thank our contributing experts for their time and thoughtful contributions and hope that through having these open discussions, together we can progress the field of bioanalysis.
Head of Translational Biomarkers and Bioanalysis
Amanda started her career in the 1990s as a bioanalytical scientist and has spent over 20 years in the pharmaceutical industry working in a variety of Drug Metabolism and Pharmacokinetics (DMPK) disciplines supporting both small and large molecule projects. Amanda has managed DMPK multidiscipline teams delivering data for regulatory submission and as a former Director in Clinical Pharmacology and DMPK, Amanda ran a team delivering GLP/GCP bioanalytical data to early phase projects.
Amanda in her current role, as Director of the Translational Biomarkers and Bioanalysis in Drug Safety and Metabolism, Innovative Medicines Biotech Unit at AstraZeneca, has oversight for the delivery of bioanalysis data and toxicokinetic evaluation for non-GLP and regulatory facing toxicology examination of small molecules, nucleotide and protein therapeutics. In addition Amanda and her team are also responsible for the identification, measurement and translation of novel safety biomarker data in support and translation of pre-clinical investigational safety studies and complex in vitro systems.
Executive Director and Head of Bioanalytical Services
Mr Goodwin is the Executive Director of Bioanalytical R&D and LC–MS/MS Services at KCAS Bioanalytical & Biomarker Services in Shawnee, KS, USA. Business development, strategic planning, portfolio expansion, client-based solutions, and driving key scientific objectives for bioanalytical R&D and LC–MS/MS Services are among his primary responsibilities. Mr Goodwin brings with him the breadth of knowledge to provide scientific and technical leadership across the drug development spectrum including Discovery, Safety Assessment, and Biologics Testing Solutions areas; he has been with KCAS since January 2018. Lawrence Goodwin has significant drug development aptitude within pharmaceutical and CRO industries. He has lead teams responsible for bioanalytical programs from Discovery through New Drug Application filings. He has more than 25 years’ experience in the Life Sciences industry which includes most recently Eli Lilly and Company (MA, USA) and Charles River Laboratories (MA, USA). Leveraging tandem mass spectrometry, Lawrence has made significant contributions in the fields of Bioanalytical, Analytical, Safety Assessment, Biotherapeutics, and Integrated Drug Discovery. He has authored or co-authored more than 35 papers and presentations and provided over 150 internal documents.
Lawrence received his BS in Biological Chemistry from Fontbonne University, St. Louis (MO, USA) in 1986 and graduated Cum Laude. His continuing education includes the following areas: executive leadership, people and resource management, advanced instrumentation, and GLP training. He has been the recipient of numerous awards both as an individual contributor and as a leader, especially in the areas of tandem mass spectrometry, data management, and process/work-flow efficiency. He is the former chair of the Eli Lilly Mass Spectrometry group and is an active member of American Society for Mass Spectrometry, and a current member of executive leadership team at KCAS.
Melanie Anderson is a principal scientist at Merck Research Laboratories (PA, USA) and runs a small group in the Clinical Regulated Bioanalysis Space. Melanie has over 15 years’ experience in both Pharma and CRO settings conducting LC–MS/MS analysis for quantitation of small molecules and peptides. Melanie has participated in FDA inspections and contributed to regulatory filings. Additionally, Melanie has experience in non-compartmental pharmacokinetic analysis of atypical compounds. She received her BA in Chemistry from Hasting College (Hastings, England) in 2002, and a MS in Chemistry from Lehigh University (PA, USA) in 2002. Melanie’s scientific interests include analysis of unique matrices, unstable compounds, challenges in chromatographic separations, and at home micro sampling approaches for regulated clinical trials. Recently, Melanie has evaluated and helped implement micro sampling devices in animal and human regulated studies.
Co-Founder and Chief Scientific Officer
Alturas Analytics, Inc
Shane Needham received his BS degree in chemistry from Washington State University (WA, USA) and his PhD in chemistry from the University of Rhode Island (RI, USA). Dr Needham is Co-Founder and Laboratory Director of Alturas Analytics, Inc.; he manages all scientific aspects of the HPLC/MS/MS bioanalytical contract laboratory. Currently, his work is focused on the development and validation of assays for the determination of therapeutic agents and biomarkers from biological matrices. His laboratory has been a leader in the area of dried blood spot (DBS) analysis and micro flow HPLC-MS/MS to support DMPK research. Dr Needham has over 100 publications and external presentations in the area of LC–MS. He has over 25 years of LC–MS and analytical lab experience in the drug discovery through drug development stage in the pharmaceutical industry. He previously worked for Pfizer in Groton (CT, USA) where he developed and validated GLP and non-GLP LC–MS/MS methods for the trace analysis of drugs and metabolites in biological fluids. He also performed in vivo and in vitro structure elucidation studies of drugs and metabolites using HPLC/MS/MS and HPLC/MSn instrumentation.
Senior Product Manager
Based in the UK, Jason has held various technical and commercial roles during his 20-year career in analytical sciences. Jason joined Sigma-Aldrich in July 2013 as the Analytical Field Application Specialist for Northern EMEA. Following the acquisition by Merck KGaA (UK) Jason became Segment Strategy Manager for Pharma QC and in Feb 2018 Jason joined the Chromatography & Instrumental Analysis franchise team as Global Senior HPLC Product Manager.
Vice President of Biologics Research and Discovery