How do I move my compound to the next milestone? What types of studies will regulators require? The answers to these questions depend on your compound, its intended purpose, mode of delivery and many other variables. ABC Laboratories will help you answer them with carefully designed programs and studies, reliable data and well-formed applications.
Our Scientific and Drug Development Advisory Team is comprised of industry veterans and Ph.D.-level experts who have authored various sections of numerous Investigational New Drug (IND) Applications, and eight New Drug Applications (NDAs), including two that received first-round approvals from the FDA's Pulmonary Division.
With an average of 18+ years of experience in preclinical development, CMC development, cytotoxic and high-potency compounds, Quality Assurance, Quality Control and regulatory affairs, ABC's consulting team will help you devise strategies that minimize risk and strike that critical balance between regulatory compliance and practical economics.
JOHN ANDERS, Ph.D., Director of Biotech Development Services
To lead the development of a dedicated biotech team and laboratory, we recruited industry veteran, John C. Anders, Ph.D., who brings more than 24 years of experience in biopharmaceutical development from both the sponsor and CRO side of the business. Over his distinguished career, Dr. Anders has held several leadership positions building and leading advanced CGMP biotechnology analytical laboratories, and has expertise in time-tested and new technologies in protein chemistry, analytical methods and analysis of macromolecules by various methods. He played a major role in developing a pipeline of seven genomic expression tests for diagnosis and risk assessment of various types of cancer, including the successful completion of a pre-IND application to the FDA and development of a clinical protocol slated to begin soon.
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BRAD BENSON, Ph.D., Director of Biotech Development Services
As a 36-year veteran pharmaceutical industry, Brad Benson, Ph.D., is an accomplished pharmaceutical scientist and executive who brings both CRO and sponsor perspectives to the biopharmaceutical development process. Having served in positions from Staff Scientist through Executive Leadership, Dr. Benson understands what clients need from the lab to the boardroom. He is an expert in GLP and CGMP requirements, and has extensive experience with regulatory filings in the United States and Europe. In addition to program design services, Dr. Benson offers technical consultation in various areas of expertise, including characterization of biopharmaceutical products, manufacturing processes and licensing agreements.
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WAYLAND RUSHING, Ph.D., Director of Business Development
With experience on both sides of the bench, Wayland Rushing, Ph.D., is uniquely qualified to help clients map out the most efficient CMC development strategy based on a drug’s phase of development, timeline, type of compound, route of administration, available funding and more. He directed the activities of the Method Development/Validation group for many years. During that time he oversaw the development and validation of hundreds of methods for a wide array of products, including methods for extractables and leachables. In addition to his significant experience designing development programs, he also has experience drafting regulatory submissions, including NDA’s and IND’s.
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ABC has developed significant capacity and capabilities for CMC support. From challenging impurity identification and extractable leachable programs to robust stability programs, come see why ABC has been growing this service year over year. ABC has the capacity and expertise to meet all of your CMC needs, including inhalation product development.