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.
NOEL PREMKUMAR, Ph.D., Chief Scientific Officer, Pharmaceutical Division
Dr. Premkumar has more than twenty years of industry experience conducting in-vivo and in-vitro xenobiotic metabolism studies, and has extensive knowledge of FDA, ICH, EPA, OECD, and JMAFF guidelines. Noel has been with ABC Laboratories since 1990, and was a key player in establishing and developing the in-vivo and in-vitro metabolism and bioanalytical programs at ABC Laboratories. As Chief Scientific Officer, he interacts with clients, peers, and various federal agencies to evaluate and implement new developments, and works with ABC representatives to educate, implement and execute these findings. Dr. Premkumar obtained his Ph.D. in Biochemistry from the School of Basic Life Sciences, University of Missouri-Kansas City, under the mentorship of Dr. Ronald A. MacQuarrie and Dr. Grace Sun.
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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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WAYLAND RUSHING,Ph.D., Senior Program Manager
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.
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