Authors: Naamah Maundrell, Future Science Group
In late 2016 Bioanalysis and Bioanalysis Zone organized a second panel discussion comprising experts from leading CROs, consultancies and pharmaceutical companies to converse about the changing world of bioanalysis. Key opinion leaders engaged in open and sincere dialogue to work together through some of the key challenges the industry will face in the coming future.
Our panelists, Melanie Anderson, Lieve Dillen, Luca Ferrari, Martijn Hillhorst, Zamas Lam, Marco Michi, James Munday, John Smeraglia, Neil Spooner (Chair), Scott Summerfield and Dieter Zimmer discussed key issues facing the bioanalytical community including:
Please click the links below to view the full length videos of the panel discussion:
- How do we access the required skill sets?
- What will the future bioanalytical laboratory look like and what skills will this require ?
- How do we embed science in the Pharma-CRO partnership?
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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.
Dieter Zimmer, PhD, is an analytical and pharmaceutical chemist by training. He held positions with increasing responsibility mainly in the pharmaceutical industries but also in the Crop Science industry and in CROs. He became founder and owner of “Zimmer BioAnalytics & More”, ZBAM, a consulting company, in 2013. His key expertise are quantitation of drugs, pesticides and their metabolites in complex (biological) matrices by LC-MS/MS, regulatory and discovery bioanalysis, bioanalytical outsourcing and pharmaco-/toxicokinetics. He was representative in the European Bioanalysis Forum (EBF) and Global CRO Council (GCC) for his former companies. He is a member of the Global Bioanalytical Consortium (GBC), and of the German and Swiss Mass Spectrometric Societies, DGMS and SGMS. He authored or co-authored 32 papers in peer reviewed journals, about 20 posters and more than 40 oral presentations at national and international workshops and conferences and was the organizer of 10 LC-MS conferences under the patronage of the DGMS.
Senior Lead Scientist
Bioanalysis (Europe), Covance
James Munday gained his D.Phil at the University of Oxford working in the field of cellular and molecular immunology. He then went onto to do his postdoctoral studies at the Mount Sinai School of Medicine in New York where he published his work on transcription factor regulation of hematopoiesis and vasculogenesis. Following on from his academic career he moved into industry posts at Celltech, UCB and Quotient Bioresearch. His current role is a Senior Lead Scientist at Covance where he has extensive experience of supporting large molecule drug development programs with a variety of analytical assays for assessing PK, ADA, PD and biomarkers. James has had an active role in European Bioanalysis Forum working with other members to seek alignment on a broad array of bioanalytical topics including science, procedures, business tools and technology, and regulatory issues.
Lieve studied chemistry/biochemistry at the university of Antwerp (Belgium) and after a postdoc fellowship on mass spectrometric characterization of peptides and proteins present in adrenal medulla, she joined Janssen Pharmaceutica where she was initially responsible for chromatographic evaluation of endogenous molecules in support of discovery projects. Thereafter, she has worked in the genomic technology department on proteomic strategies for target identification and validation. 13 years ago she joined the bioanalytical department and was mainly involved in the quantitative analytical support of ADME and PK/PD in the discovery and preclinical projects. She is also continuously involved in scouting new technologies and applications (HRMS, micro-LC, capillary microsampling, quantification of new drug scaffolds (peptides, oligo’s) with LCMS) to improve both science and efficiency in the bioanalytical community. In April 2014 she transferred to the development bioanalytical team as lead of the method development group. Since February 2016 also operational duties were added to her responsibilities.
Dr. Luca Ferrari is Laboratory Head, Small Molecule Bioanalytical R&D at Roche Innovation Center Basel since 2013. He received his Master of Science Degree in Chemistry from the University of Padova (Italy) in 1992. He spent 17 years at GlaxoSmithkline covering different roles with increasing responsibility. As a Technology Leader, he was first responsible for implementation of innovative LC-MS/MS methods in regulatory bioanalysis. He was then appointed Head of Bioanalysis in 2001. In 2010 he joined Aptuit Verona S.r.l. as Head of Regulatory Bioanalysis. He possesses excellent understanding of chromatography, mass spectrometry, GxPs and current global bioanalytical guidance. He has been member of the board of Directors of the Analytical Chemistry Division of SCI (Italian Society of Chemists) for three years. He is author or co-author of several peer reviewed scientific papers in the field and speaker at several scientific conferences.
John is Senior Director of Bioanalytical Sciences at UCB with laboratories in the UK and Belgium. He has responsibilities for bioanalytical sciences to enhance and revolutionize the way that the quantitative bioanalysis is performed from pre-clinical development to post marketing for NBE’s and NCE’s . He is also responsible for providing bioanalytical leadership for the quantification of mechanistic biochemical biomarkers to advance drug development. John has held bioanalytical leadership positions in the US and EU with innovator drug development companies and CROs. Achieving his first degree in Medical Technology (B.Sc.) and his second degree in Biomedical Sciences (M.Sc.). His has developed his experience in bioanalytical sciences for the last 26 years.
Scientific Officer – Technology Leader, Technology Leader – Bioanalytical Expert
Dr Marco Michi (master’s degree in Analytical and Physical Chemistry) is a technology leader and scientific officer at Aptuit Verona, Italy. He has fifteen years of Bioanalysis experience working for Pharma and CRO companies. During these years he mainly worked in quantitative determinations of small molecule in a regulatory environment. In his actual position Dr Marco Michi has the responsibility of the implementation of new technologies, problem solving, regulatory compliance and scientific overview. He defines the best bioanalytical processes, the new instrumentation to be purchased and new strategic investments. He is also experienced in computer system validation and has designed and implemented a LIMS bespoke application liaising QA and IT departments.
Associate Director of Bioanalytical Science
PRA Health Sciences
Martijn Hilhorst is the Associate Director of Bioanalytical Sciences for PRA Health Sciences. Martijn studied analytical chemistry at the university of Amsterdam followed by a PhD period at the university of Groningen where he developed strategies for the determination of impurities in drugs using electrokinetic separation techniques. After a postdoc position in the field of therapeutic drug monitoring with LC-MS/MS, he worked as a research scientist in the field of lab automation, drug discovery and proteomics for over 6 years before joining PRA 11 years ago. At PRA he is leading a team of scientists responsible for the development of LC-MSMS methods for the analysis of small molecule drug candidates and their metabolies for regulated bioanalysis. He is also contributing to general process improvement in the laboratory, implementation of lab-automation, client contacts, troubleshooting, replacement of the scientific director and judging request for future work based on analytical feasibility. He is (co)-author of several publications and speaker on international.
Merck Research Laboratories
Melanie Anderson is a principal scientist at Merck Research Laboratories 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 pharmcokinetic analysis of atypical compounds.
She received her B.A. in Chemistry from Hasting College in 2002, and a M.S. in Chemistry from Lehigh University in 2007. 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.
Senior Director, Head of Bioanalysis
Scott is currently a senior director and head of small and large molecule Bioanalysis at GSK. Having completed a PhD and post-doctoral fellowship in proteomics, Scott started in the Pharma industry in 1997 as a bioanalytical scientist at SmithKline Beecham. At the formation of GSK in 2001, Scott moved to Neuroscience Drug Discovery and led a variety of teams supporting bioanalysis, metabolite id, in vitro DMPK screening and blood-brain barrier research projects. Scott returned to Drug Development in 2008 to lead the UK bioanalytical group and work in matrix roles aligned to therapy area units (Neuroscience and Biopharm). Scott became head of Bioanalysis at the start of 2016 within the division accountable for Bioanalysis, Immunogenicity and Biomarkers.
Zamas joined QPS in 2000 and held various scientific and business assignments with increasing responsibility until his current post. Prior to QPS, Zamas had both technical and business posts in The DuPont Company in Central Research & Development, Haskell Laboratory for Toxicology and Industrial Medicine, and Agricultural Products. At Haskell his focus was mostly on mechanistic studies, metabolism, and setting up LC MS/MS techniques to support discovery and development. He also represented DuPont on an ECETOX task force on bioaccumulation. Zamas earned his Ph.D. in mass spectrometry and polysaccharides from the University of British Columbia, and his post-doctoral training in glycoproteins from Harvard University School of Public Health.