Webinar series: optimizing your bioanalytical strategy for complex and emerging therapies
With nearly half of all new therapy approvals classified as precision medicines, this approach has not only already had a tremendous impact on patients’ lives, but also holds great promise for the future of medicine. As therapies continue to evolve so, too, must our approaches, technology and methods. An effective bioanalytical strategy must be robust and adapt to changing needs as the data generated within your program is converted to in-depth understanding of your drug and its action in treating the disease. Join us for a series of roundtables to explore key considerations of biomarker, oligonucleotide and cell and gene therapy bioanalytical strategies.
Increasingly, biomarkers play a key role in therapeutic development programs and have been shown to improve drug approval success rates by nearly 3-fold. A biomarker strategy is particularly important where a precision medicine profile will be a key differentiator. With this tremendous growth in biomarker usage comes complexity from identifying proper context of use, navigating regulatory changes and considering the appropriate application of new and expanded technologies.
Join this roundtable to hear more about:
- Trends in biomarker usage in regulated environment vs exploratory environment
- Key considerations for developing a biomarker strategy for a specified context of use and evolving it as your program progresses
- Perspectives on using non-proprietary biomarker assays for your context of use
- Recent regulatory guidance and their applicability on the evolution of use for a biomarker assay
Who may this interest?
Associate Director, Director, Senior Scientist, Group Director, VP, Head, Research Scientist in:
- Bioanalytical Services
- Translational Research/Medicine
- Biomarker Development
- Personalized Medicine
Mark Arn
old (Moderator)
Director, Science and Innovation
Covance
Dr Mark Arnold collaboratively develops and delivers innovative scientific and regulatory strategy to meet current and future client needs – including ligand-binding, cell-based, qPCR and LC–MS/MS assays to quantify drugs and metabolites, antidrug antibodies and biomarkers to support PK/PD assessments. Previously, Arnold was Executive Director of the Bioanalytical Sciences Department of the Bristol-Myers Squibb Co (NY, USA) and responsible for both immunochemistry and LC–MS capabilities, including outsourcing to partner CROs.
For 35 years, Arnold has been involved in the field of bioanalysis, including the review and interpretation of regulations and guidance. He was co-chair of both the AAPS Crystal City V and VI Workshops (3–5 December 2013 and 28–29 September, MD, USA) and on the ‘FDA Draft Revised Guidance on Bioanalytical Method Validation’ and ‘Biomarkers’, respectively, served as the PharmSci360 (4–7 November 2018, DC, USA) Bioanalytics track Chair, is Vice Chair for PharmSci360 (26 October–5 November 2020, Virtual) and is an AAPS Fellow. Arnold received a BS in biology from Indiana University of Pennsylvania (PA, USA) and PhD in pharmacology from the University of Pittsburgh (PA, USA) and has over 100 peer-reviewed publications and podium presentations.
Katherine Landschulz
Cardiovascular/Metabolic Disease Therapeutic Area Lead, Covance Biomarker Solution Center
Covance
Dr Katherine Landschulz joined Covance in 2010 after 13 years of experience with three major pharmaceutical companies where she supported programs spanning discovery through Phase III. At Covance, she supports both biotech and large pharmaceutical companies with biomarker selection and strategy development, laboratory placement for method development and qualification/validation, feasibility study design and advises on the use of translational and exploratory biomarker data in drug development. Landschulz has a wide range of experience in drug discovery and development, genomic and proteomic biomarker assay development, translational biomarkers, clinical pharmacogenomics and biomarker strategies for diabetes/CV. She is the holder of two US patents and has co-authored dozens of publications across a wide range of therapeutic areas.
Erica Troksa
Associate Director, Translational Biomarker Solutions
Covance
Dr Erica Troksa drives overall scientific performance and quality delivery of on-time services for the Translational Biomarker Solutions team. She leverages her 16-plus years of experience in development, optimization and execution of bioanalytical immunoassays. Troksa has led development and validation of novel immunoassays for multiple platforms. Before joining Covance in March of 2013, she served as Field Scientist for EMD Millipore (MA, USA), training research scientists on proper techniques in multiplexing immunoassays, flow cytometry, protein quantitation and other technical applications. Troksa won the Klaus R. Unna Award as Outstanding Graduate Student at the University of Illinois at Chicago (IL, USA). She is the author or co-author of several peer-reviewed journal articles on various topics.
Charles (Eric) Thomas
Bioanalytical Scientific and Biomarker Lead
Covance
Dr Eric Thomas is an Associate Director, Bioanalytical Chemistry at Covance and serves as a site lead for both Indianapolis (IN, USA) and Somerset (NJ, USA) bioanalysis laboratories. In this role, Thomas manages the laboratory and support teams, consults with clients on regulatory and scientific questions related to analysis by LC–MS and works with global counterparts to maintain and improve consistency of processes across Covance’s eight bioanalytical laboratories. Thomas received his BS in chemistry from Rose-Hulman Institute of Technology (IN, USA) and his PhD in medicinal chemistry from the University of Michigan (MI, USA). With more than 20 years of experience in biological and analytical research, Thomas has authored or co-authored numerous peer-reviewed publications and presented at many industry events, including WRIB, AAPS, GCC and more.
Developing bioanalytical solutions to support oligonucleotide drug programs can be challenging due to the unique physicochemical properties of these molecules. To accelerate the development of your oligonucleotide and drive clinical success, you need a robust bioanalytical strategy and choice of platforms that can help you eliminate bottlenecks and accelerate timelines.
Join this roundtable to hear more about:
- Trends in approaches to the development of oligonucleotide therapies
- Key considerations for selecting the appropriate platform (LC–MS, LBA or qPCR) to meet the goals of your program
- Potential strategies that deliver more sensitivity
Who may this interest?
Associate Director, Director, Senior Scientist, Group Director, VP, Head, Research Scientist in:
- Bioanalytical Services
- Oligonucleotides
- Bioanalytical Chemistry
- Immunochemistry
Rob Nelson (Moderator)
Associate Director, Science & Innovation
Covance
Dr Robert Nelson is an Associate Director with Covance’s Science and Innovation team, focused on partnering with clients and internal staff to solve bioanalytical technology, scientific and regulatory issues, from discovery through post-market approval. Previously, Nelson served as Section Head, Bioanalytical Sciences, Exploratory Science & Translational Medicine at Novimmune SA (Geneva, Switzerland) where he was responsible for delivery of product-specific bioanalytical endpoints for nonclinical and clinical studies, including pharmacokinetic, pharmacodynamics, biomarker and immunogenicity endpoints. Building on his more than 15 years of biological and analytical research experience, Nelson is a Steering Committee member for the European Bioanalysis Forum (EBF), a Lecturer at the University of Geneva (Switzerland) and has authored or co-authored numerous peer-reviewed publications, abstracts and posters. Nelson received his BS in pharmacology and his PhD in molecular physiology from the University of Edinburgh (UK).
Troy Voelker
Associate Lab Director, Bioanalytical Chemistry
Covance
Dr Troy Voelker is an Associate Laboratory Director, Bioanalytical Chemistry. In this role, he oversees method development and method validation activities at Covance’s Salt Lake City (UT, USA) bioanalytical laboratory, consults with clients on regulatory and scientific questions related to analysis by LC–MS and works with global counterparts to maintain and improve consistency of processes across Covance’s eight bioanalytical laboratories. Voelker received his BS in chemistry from Utah State University (UT, USA) and his PhD in synthetic organic chemistry from the University of Montana (MT, USA). With more than 20 years of experience in biological and analytical research, with a focus on oligonucleotide bioanalysis, Voelker has authored or co-authored more than two dozen peer-reviewed journal articles, posters and presentations at industry conferences.
Jill Uhlenkamp
Staff Scientist III, Immunochemistry Services
Covance
Dr Jill Uhlenkamp has 12 years of experience in regulated bioanalysis supporting drug development for biotech and contract research organizations. Uhlenkamp joined the BioAnalytical Immunochemistry Services group at Covance in 2015 as a member of the method development team. In her current role as Method Development Lead she oversees method development activities in the Indianapolis (IN, USA) Immunochemistry group. Her experience includes small molecule bioanalysis by LC–MS but has largely focused on large molecule pharmacokinetic, immunogenicity and biomarker assays by ligand binding and related methods. Uhlenkamp received her BA in chemistry from the University of Minnesota, Morris (MN, USA) and her PhD in analytical chemistry from Iowa State University (IA, USA).
Paul Byrne
Principle Scientist, Cell and Gene Therapy
Covance
Dr Paul Byrne is a Principle Scientist at Covance, focusing on the evolving field of cell and gene therapies, providing scientific and regulatory leadership and direction on projects throughout the drug development continuum. In addition, he leads an integrated global Covance team delivering innovative analytical solutions for clients’ cell and gene therapy programs. In this role, Byrne also brings clients specialized expertise in the development and validation of analytical tools and strategies, development of regulatory-compliant and molecular biology. Byrne has over 20 years of industry experience and can frequently be found speaking at symposia on topics such as: analytical development challenges for ATMPs, biodistribution and safety assessment considerations for cell and gene therapies and more. Paul received his BSc (Hons) in biology from the University of Stirling (UK) and his MSc in research from the University of Glasgow (UK).
Developing a cell or gene therapy is a uniquely complex process requiring specialized bioanalytical scientific and regulatory insights and capabilities. Specialized expertise in cell and gene therapy, coordinated capabilities and impactful innovation across all phases of development can help you reduce the time and risk in bringing your therapy to market.
Join this roundtable for a discussion of key trends, challenges and best practices around:
- Complexity of gene therapy development and tailoring assay validation support to meet specific needs (e.g., PK, ADA, etc.)
- Current modalities (including CAR-T, cytokine analysis, etc.) and future trends
- Cell-based immunogenicity challenges and approaches
- Standardizing development for cell and gene therapies in the absence of conventional regulatory guidance
- Increased comparability in preclinical and clinical phases using genomic titre assays
Who may this interest?
Associate Director, Director, Senior Scientist, Group Director, VP, Head, Research Scientist in:
- Bioanalytical Services
- Immunology & Immunotoxicology
- Bioanalytical Chemistry
- Cell & Gene Therapy
- Immunochemistry
Paul Byrne (Moderator)
Principle Scientist, Cell and Gene Therapy
Covance
Dr Paul Byrne is a Principle Scientist at Covance, focusing on the evolving field of cell and gene therapies, providing scientific and regulatory leadership and direction on projects throughout the drug development continuum. In addition, he leads an integrated global Covance team delivering innovative analytical solutions for clients’ cell and gene therapy programs. In this role, Byrne also brings clients specialized expertise in the development and validation of analytical tools and strategies, development of regulatory-compliant and molecular biology. Byrne has over 20 years of industry experience and can frequently be found speaking at symposia on topics such as: analytical development challenges for ATMPs, biodistribution and safety assessment considerations for cell and gene therapies and more. Paul received his BSc (Hons) in biology from the University of Stirling (UK) and his MSc in research from the University of Glasgow (UK).
James Munday
Science Lead, Immunology and Immunotoxicology
Covance
James Munday gained his DPhil at the University of Oxford (UK) working in the field of cellular and molecular immunology. He then went on to do his postdoctoral studies at the Mount Sinai School of Medicine (NY, USA) 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 (Slough, UK), UCB (Brussels, Belgium) and Quotient Bioresearch (Manchester, UK). His current role is a Senior Scientific Director 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. Munday has had an active role in European Bioanalysis Forum (EBF) working with other members to seek alignment on a broad array of bioanalytical topics including science, procedures, business tools and technology, and regulatory issues.
George Hristopoulos
Senior Manager, Bioanalysis (Method Development and Validation)
Covance
George Hristopoulos joined Covance in 2019 after 12 years of experience in the large molecule drug development field, specializing in multi-tier immunogenicity, PK/PD method development, validation and implementation. At the Chantilly (VA, USA) Covance site, Hristopoulos oversees method development and validation. His diverse technical background has allowed him to apply various immunoassay platforms in a phase appropriate manner spanning early stage R&D to late stage clinical studies. Over the course of his industry career, Hristopolous has been instrumental in supporting various therapeutic modalities, including PEGylated-proteins, peptides, biosimilars, ADCs, monoclonal antibodies, bi-specifics, fusion proteins, oligonucleotides and gene therapy products. He has also been recognized for his contributions in improving GxP processes in both the pharmaceutical/biotech and CRO space.
Hazel Staton
QC Scientist, Cell and Gene Therapy
Covance
As a QC Scientist at Covance, Staton focuses on the field of cell and gene therapies, providing scientific and regulatory direction on projects ranging from development through to commercialization. In her role, Stanton focuses on working with clients to transfer, develop and validate a range of analytical methods with a focus on QPCR assay to support the IND enabling preclinical biodistribution studies, clinical shedding studies and the critical CMC titre assays.
Stanton has over 13 years of industry experience, working within a heavily regulated environment running molecular biology, virology, ELISA and potency studies.
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