In this exceptional open dialogue held earlier this year at the 10th WRIB meeting in Orlando (FL, USA), our panel of experts discuss some of the fundamental questions raised with respect to outsourcing in regulated bioanalysis.
In part 1 of this panel discussion, a panel of leading CRO and Pharma Directors assess the current situation of outsourcing in bioanalysis, and discuss the direction of outsourcing of regulated bioanalysis in the future.
- Outsourcing strategies
- Drivers and business models in outsourcing
- Scientific exchange and interactions between CROs and Pharmas
- Sharing and discussing data between CROs and Pharma
- Cost–effectiveness of outsourcing
To view more videos and find out more about this panel discussion click here.
Spooner Bioanalytical Solutions Ltd
Neil Spooner (Ph.D., C.Chem., M.R.S.C.) is the Founder and Director of Spooner Bioanalytical Solutions, a consultancy based in Hertford, UK. Neil is also a Senior Visiting Research Fellow at the School of Life and Medical Sciences, University of Hertfordshire (Hertfordshire, UK) and the Deputy-Chair and Secretary of the Reid Bioanalytical Forum. He has published extensively, with over 50 peer reviewed manuscripts and more than 30 podium presentations at international Conferences and Symposia.
Neil has extensive experience in the quantitative bioanalysis of drugs, metabolites and biomarkers in the pharmaceutical industry and contract research organisations in the UK and USA. In over 20 years of industrial practice at GlaxoSmithKline, he has led groups operating in the discovery and regulated arenas of clinical and pre-clinical quantitative bioanalysis and metabolite identification. Neil has extensive experience of successfully leading inter departmental and cross functional initiatives, including implementation of new technologies and workflows (such as microsampling), outsourcing quantitative bioanalysis, development and implementation of automation approaches and design of new scientific facilities. Back to Top
Director and GLP Test Facility Manager
Amanda is the Director and GLP Test Facility Manager for the pre-clinical bioanalysis and toxicokinetics (BA/TK) department in the Drug Safety and Metabolism function at AstraZeneca.
Amanda started her career as a bioanalytical scientist at Fisons Pharmaceuticals and has spent over 20 years in the pharmaceutical industry working in multiple DMPK disciplines supporting both small and large molecule projects.
Amanda, in her current role, has the responsibility for the delivery of bioanalysis and toxicokinetic data for non-GLP investigational toxicology and early pivotal toxicology evaluation of small molecules and nucleotide therapeutics. The BA/TK team also provide scientific and regulatory compliance guidance to the AZ externalization and Early Clinical Development functions. Back to Top
Director Clinical Regulated Bioanalysis Group
Merck Research Laboratories
Dr. Woolf currently directs the Clinical Regulated Bioanalysis Group of Merck Research Laboratories, West Point, PA. He received his B.A. in Chemistry from LaSalle College in 1982, and a Ph.D. in Analytical Chemistry from Seton Hall University in 1986. From 1986 to 1990 he was a member of the Drug Metabolism/Pharmacokinetics Dept. of Berlex Laboratories.
He joined Merck Research Laboratories in 1990 as a research fellow. Dr. Woolf and his group have supported numerous clinical development projects that have led to the successful registration of Merck compounds. Since 1986, he has authored or co-authored over 50 research papers pertaining to bioanalysis and pharmacokinetics. His major research interests include the utilization of novel HPLC approaches in bioanalysis and the bioanalysis of unstable compounds. Back to Top
Executive Director Head of Translational Medicine
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Senior Vice President and General Manager, Laboratory Sciences
Roger Hayes, PhD, is Senior Vice President and General Manager, Laboratory Sciences, at MPI Research. Before joining the company in 2011, Dr. Hayes has held numerous leadership positions in the global life sciences industry and academia, leading teams in the development of state-of-the-art bioanalytical and analytical techniques, including mass spectrometry, chromatography, and automation in bringing medical and chemical products to market.
For nearly two decades, he has led strategic and research initiatives for large pharmaceutical companies that included both GLP and non-GLP preclinical studies and clinical trials. At Merck Research Laboratories, Dr. Hayes directed the regulated bioanalysis group in support of preclinical and clinical safety trials and also advanced efficiencies for method development and validation. At Parke-Davis Pharmaceuticals, he managed the instrumentation support department, headed the bioanalytical groups for both safety and discovery research, and performed cutting-edge work as the leader of the drug metabolism mass spectrometry group.
Before 1993, Dr. Hayes spent several years at Procter and Gamble, where he developed new analytical technology and processes. His career is rooted in academia, beginning at the University of Adelaide in Australia, where he received his PhD in 1985 and performed innovative research in gas phase ion chemistry. From there, he went to the University of Nebraska-Lincoln, where he served as an assistant director/assistant research professor and continued his groundbreaking research, with an emphasis on advancements in the use of mass spectrometry. Most recently, he served as President of Bioanalytical Operations, at Cetero Research where he focused on establishing overall corporate direction for bioanalytical and analytical services.
Dr. Hayes has published extensively and has taught numerous aspects of LC/MS method development. He is an active member of the American Society for Mass Spectrometry and the American Association of Pharmaceutical Scientists. Back to Top
Associate Director of Bioanalytical Scientific Operations
Stephanie Cape, PhD, is the Associate Director of Bioanalytical Scientific Operations at Covance, Madison, WI.
She received her B.S. in Chemistry from University of IL- Urbana/Champaign in 2003 and her PhD in Analytical Chemistry from the University of Wisconsin- Madison in 2007. Dr. Cape’s graduate research was focused on developing high resolution mass spectrometric methods to enable discovery, characterization, imaging, and quantitation of neuropeptides.
Dr. Cape joined the field of regulated Bioanalysis as a method development / validation chemist initially at PPD and subsequently at Covance. Within the Covance Bioanalytical team, she has held a variety of leadership roles including oversight of bioanalytical study direction, validation, and method development. Additionally, Dr. Cape serves as the primary operational lead for on-site regulatory inspections and participates in aligning global SOPs and best practices to industry standards. Back to Top
Associate Director/Senior Scientist in BioAnalytical Sciences
Dr. Surinder Kaur is an Associate Director/Senior Scientist in BioAnalytical Sciences at Genentech/Roche in South San Francisco, California. She has twenty plus years of biotechnology experience across diverse large molecule and small molecule bioanalytical areas, with multiple successful regulatory filings, publications and patents. She received her B. Sc. in Chemistry from Durham University, England and a Ph. D. from the Chemistry Department at Bristol University, England. Dr. Kaur conducted post-doctoral research at the University of California, San Francisco in the laboratory of Al. Burlingame.
Dr. Kaur established the mass spectrometry core laboratory at Chiron Corporation to develop analytical methods for biotherapeutic process development and small molecule drug research. In 2001 she joined Lumicyte Inc. as a Proteomics Director, developing mass spectrometry biochip methods for biomarker discovery. She joined Genentech, Inc. in 2004 to establish a multi-disciplinary immunoassay and mass spectrometry group of approximately fifteen scientists and research associates responsible for the bioanalysis of antibody-drug conjugates (ADCs) through nonclinical and clinical development. Dr. Kaur’s group is responsible for bioanalytical strategies and assay development/validataion for ADCs, including pharmacokinetic assays, immunogenicty assessment, in vitro biological characterization and metabolism/catabolism strategies. She is also responsible for a mass spectrometry core facility establishing innovative approaches for biotherapeutics development and is a Pharmacology team leader for an oncology program. Back to Top
Senior Director – Scientific, Bioanalysis and ADME
Prior to joining Q2 Solutions in 2011, Dr. Lowes was an executive management scientific leader of Advion BioServices. Dr. Lowes started his industrial career at VG Biotech in the UK that became the LC/MS instrument entity of Waters Corporation. In 1995 Dr. Lowes joined the CRO group that became Advion and focused his career on regulated bioanalysis with particular emphasis on LC/MS. He has remained very connected on regulatory developments in bioanalysis and is a founding member of the Global Bioanalysis Consortium (GBC) and a past-chair of the AAPS Bioanalytical Focus Group. At Q2 Solutions, Dr. Lowes leads the scientific disciplines around LC/MS bioanalysis for both small molecule and biomolecule applications including biomarker assays. Dr. Lowes has over 40 peer reviewed publications on bioanalysis and is a frequent speaker at national and international conferences.
Dr. Lowes earned his Ph.D. in analytical chemistry from the Open University, United Kingdom. Back to Top
WW Head of Bioanalysis
Having studied for a PhD and post doctoral fellowship in proteomics Scott moved into the field of regulated Bioanalysis in 1997 when joining SmithKline Beecham. In 2001 Scott moved to Neuroscience Drug Discovery to lead a bioanalytical team supporting PK, in vitro DMPK and metabolite id work. In 2009 he returned to the regulated bioanalytical group, initially as a Section Leader and subsequently as Site Head and currently as WW Head of Bioanalysis at GSK. Scott has experience of small and molecule bioanalysis as well as leading both bioanalytical and discovery and development project teams across GSK. Back to Top