The Biopharmaceutical Development group provides consulting expertise relating to the scientific and regulatory aspects
of the development of biopharmaceutical products.
Our team has extensive experience from having worked in both regulatory agency and industry positions with a wide variety of products, to include innovative
therapeutic proteins, therapeutic vaccines, monoclonal antibodies, somatic cell therapies, tissue-engineered products, and biological generics.
In terms of “top ten” activities that we engage in:
- Identify Go/No Go decision points and evaluation criteria to move products seamlessly from one stage of development to the next
- Identify rate-limiting factors in product and/or manufacturing strategy
- Perform risk assessments, to include risk mitigation and prevention, in the areas of regulatory strategy, immunogenicity, and comparability
- Provide guidance on regulatory standards for analytical and bioanalytical method development and validation, including immunoassays
- Evaluate and develop preclinical study design to support early clinical development
- Assess clinical study design to enable efficient and effective approval
- Perform scientific and regulatory due diligence to support investment decisions
- Prepare regulatory agency technical (CMC) documents, responses to agency correspondence, and provide representation at agency meetings
- Develop regulatory strategy to insure the most effective regulatory pathway
- Prepare opinion papers and reports on scientific and regulatory issues
Our consulting expertise spans the biopharmaceutical development process from discovery through preclinical and clinical studies to post-marketing activities.
A unique aspect of our consulting service is its linkage to the resource specialists distributed across a Contract Research Organization that provides many of the
supporting product development services, including molecular pharmacology, safety pharmacology,
tissue cross-reactivity screening, immunoassay development, toxicology, clinical research,
central laboratory, and specialized biomarker facilities. Accordingly, biopharmaceutical
product development is provided by an extended group of specialists with a high level of
applied experience providing the client with a “case-by-case” scientific and regulatory-supported
approach rather than a “box-checking” approach.
