The growth of biopharmaceuticals is increasing rapidly, driven largely by their enormous potential to treat a wide array of human diseases. Today, biotechnology products represent an estimated 24 percent of the world’s pharmaceutical sales and approximately 50 percent of the top 100 products on the market. Biopharma’s current annual growth rate of more than 8 percent is double that of conventional pharma, and growth is expected to continue at that rate for the foreseeable future. The growth does not come without challenges, and there is increased demand on the bioanalytical community supporting the development of biopharmaceuticals. To keep pace with the expanding field, bioanalytical scientists must continually revisit and reassess new technologies and operational approaches to the bioanalytical characterization of an ever-diversifying class of products.
The purpose of this webinar is to provide an educational forum to discuss current issues and applications associated with the analysis of large molecules in biological matrices. The webinar is designed to include and encourage open exchange of scientific and methodological applications for large molecule bioanalysis. Goals and objectives of this webinar include:
- To provide a better understanding of the role and impact of critical reagents used in ligand binding assays.
- To provide insight into the interpretation of FDA’s Bioanalytical Method Validation guidance document in a practical laboratory setting, with a special focus on matrix stability of protein therapeutics and on dilutional linearity and parallelism of therapeutics dosed at high concentration in toxicological studies.
- To gain an understanding on the current state of the art of immunogenicity assessment.
- To gain insight into analysis of biopharmaceuticals through innovations in mass spectrometry.
Andy Vick, Vice President, Analytical Services, WIL Research
Dr. Andy Vick is currently a member of the senior leadership team at WIL Research, in Ashland, Ohio, serving as the Vice President of Analytical Services. In this role, he oversees the scientific, operational, and financial aspects of the analytical, formulations, bioanalytical, drug metabolism and pharmacokinetic services for sites in the United States. Prior to joining WIL Research, he was Executive Vice President and Senior Director of Pharmacokinetics, Dynamics and Metabolism (PDM) at Seventh Wave Laboratories where he supported strategic operations as well as scientific efforts across PDM especially in early stage drug development. In addition, Andy has been the Scientific Director of the BioPharma Services Division of Millipore, Principal Scientist within the Drug Disposition and Toxicology department of Eli Lilly and Company, and a preclinical scientist at Biogen. In these roles, Andy has contributed to the design, conduct, and interpretation of preclinical and clinical testing strategies for both small organic and biotherapeutic molecules across a variety of therapeutic indications and stages of development.
Andy is currently a Board Member and Chair of the Biotech special interest group of the International Pharmaceutical Federation. In addition, he has been an active member of American Association of Pharmaceutical Scientists (AAPS,) currently serving on the Executive Committee of the AAPS Foundation and AAPS’s Executive Council as Member-At-Large. He also sits on the Board of The Ohio State University’s College of Pharmacy. Andy received his BS (Zoology) and PhD (Pharmaceutical Chemistry) from The Ohio State University.
Binodh DeSilva, Executive Director, Immunochemistry and Biomarker Development, Bristol-Myer Squibb Company
Dr. Binodh DeSilva is the Executive Director of Immunochemistry and Biomarker Development at Bristol-Myer Squibb Company in Lawrenceville, NJ. She is responsible for leading the Immunochemistry and Biomarker Development group supporting bioanalytical support for all biologics from discovery to life cycle management. She received her Bachelor’s in Analytical Chemistry from the University of Colombo, Sri Lanka in 1987, and a PhD in Chemistry (Bioanalytical) in 1994 from the University of Kansas. She was a Post-Doctoral Research Associate in the Pharmaceutical Chemistry Department at the University of Kansas from 1994-1995. She was at Procter & Gamble Pharmaceuticals, Norwich, New York, from 1995-2001 and at Amgen, Thousand Oaks, CA leading the bioanalytical team from 2001-2010. She joined BMS in November of 2010.
Dr. DeSilva has been an active member of AAPS since 1997. Currently, she is a Member-at-Large on the AAPS Executive Committee. She was the past-chair of the Biotech section of the AAPS, member of the Steering Committee of the Global Bioanalytical Consortium representing North America. She co-chaired the Crystal City V workshop on the draft 2013 Bioanalytical Guidance in December 2013. She was a founding member of the Ligand Binding Assay Bioanalytical Focus Group (LBABFG) and a member of the Therapeutic Product Immunogenicity Focus Group (TPIFG). She has been a contributing member of the Applied Pharmaceutical Analysis and Workshop in Regulated Bioanalysis conferences, chairing and leading the discussions on large molecule bioanalysis related disciplines. She is also a member of the American Chemical Society. Dr. DeSilva has published several papers in renowned journals, and book chapters. She has presented her work at national meetings as both podium and poster presentations.
Valerie Leesch, Associate Scientific Director, WIL Research
Dr. Valerie Leesch is the Associate Scientific Director of the Immunoassay group at WIL Research, in Skokie, IL, where she has been employed for the last five years. At WIL Research, she has gained extensive experience with use of immunoassays for quantification of protein therapeutics in biological matrices and with immunogenicity testing. She directs method development, method validation, and sample analysis studies for PK/TK and immunogenicity studies in support of preclinical and clinical programs.
She earned her PhD at Northwestern University in biophysical chemistry, where she studied the binding kinetics of electron transfer proteins. After graduate school, Valerie worked for Baxter Healthcare for nine years in a bioanalytical services division, where she gained a wide variety of analytical expertise, ranging from drug discovery to post-marketing support.
Theresa J. Goletz, PhD, Founder, Theresa Goletz Consulting
Dr. Goletz received a BA in Biology from the College of Wooster in Wooster, Ohio, and a PhD from Baylor College of Medicine in Houston, Texas. After post-graduate studies at the National Cancer Institute/National Institutes of Health (Bethesda, Maryland) where she focused on vaccines and cellular therapies for cancer and infectious disease, Terry moved to the University of Pennsylvania School of Medicine, Abramson Family Cancer Research Institute and continued working on novel immunotherapies. Terry went on to hold positions of increasing responsibility at Centocor (a Johnson & Johnson company), initially in their vaccine group and later in immunogenicity risk assessment. The group she founded focused on in silico, in vitro and in vivo tools for assessing immune recognition and activation. After moving to Amgen, Terry continued efforts in mechanistic immunology, as well as bioanalytical assessment. In 2015, Terry founded a consulting group focused on immunogenicity risk assessment and immunomodulatory drug development.
Elizabeth Groeber, Director, Bioanalytical Chemistry, WIL Research
Elizabeth (Beth) Groeber is a graduate of The Ohio State University with a Ph.D. in Analytical Chemistry. Following her graduation, she joined a contract research organization in Austin, TX, CEDRA Corporation (now World Wide Clinical Trials) performing HPLC/MS/MS analysis of small molecules for GLP/21 CRF Part 58 compliant studies. From 2004 – 2012 she worked in Pfizer, Inc.’s bioanalytical group in the PDM (Pharmacokinetics, Dynamics, and Metabolism) department, in Groton, CT. Beth has been involved in bioanalysis for over 19 years and served in regulated and discovery support roles. She has experience and expertise in small and large molecule quantitation by LC/MS, including biomarkers and biotherapeutics. Beth currently is the Director of the Bioanalytical Chemistry group at WIL Research, Ashland, OH. She oversees the HTPK and regulated bioanalytical groups, and collectively focuses on small molecules, metabolites, biotherapeutics, and biomarkers for Pharmaceutical and agricultural products.
Who Should Attend?
This webinar is intended for current academic, industry, or government scientists who perform or have interest in the bioanalysis of large molecules, toxicologists, pharmacokineticists or clinical pharmacologists that utilize bioanalytical-derived data, and regulatory professionals in the biotech field.
Also, VPs, Directors, and Managers in the following areas:
- Bioanalytical chemists / scientists
- Clinical pharmacologists
- Chemistry related titles for: principal investigators, research scientists, scientific advisors, directors
WIL Research provides world-class research and development services for Pharmaceutical and chemical organizations. The company combines scientific expertise with an eagerness to truly listen and understand client needs. With more than 64,000 square meters of laboratory space and offices in North America, Europe and Asia, WIL Research offers extensive resources over a broad range of services. Areas of expertise include general toxicology, developmental and reproductive toxicology, juvenile toxicology, neurotoxicology, inhalation toxicology, infusion toxicology, genetic toxicology, pathology, safety pharmacology, ecotoxicology, environmental fate, immunochemistry, analytical/bioanalytical chemistry and ADME. The experts at WIL Research can also help with worldwide regulatory and compliance issues. The more than 1,300 team members, many with advanced degrees, have completed thousands of projects, often pioneering new techniques along the way. These skilled researchers use their scientific knowledge and their advanced listening skills to develop customized solutions that match the specific requirements of each project.