Indications

Experienced in a wide range of indications for drugs, novel antibodies, recombinant protein therapeutics, small molecules, vaccines, cell therapy, device and combination products throughout all phases of program development (Phase 0 – III) and commercialization.

• Oncology
• Cosmetic
• Cardiovascular
• Renal • Endocrinology
• Immunology & Infectious Diseases
• Orthopedics
• Pulmonary Disease

Program/Business Development

Experienced in performing market analysis, developing regulatory strategies, and communicating effectively to the business community for our clients

• Identification and management of Contract Manufacturing and Contracting Testing Organizations
• Program Development through identification of each client’s Critical Path
• Performed due diligence for clients as part of product or company acquisition
• Assisted clients with preparations for due diligence audits by potential business partners
• Performed detailed research and analysis on products and competition
• Assisted clients in developing strategies for product development and marketing
• Served as Project Manager, coordinating development activities in manufacturing, preclinical and clinical areas

Clinical

Proficient in writing clinical document and experienced in oversight and management of clinical trials for vaccines, therapeutics and drugs.

• Provided oversight of a oncology Phase I study
• Assisted with development of clinical study design
• Written numerous Phase I, Phase II, and Phase III protocols (oncology, vaccine and therapeutic protein)
• Written numerous informed consent forms (ICFs) and Investigator’s Brochures (IBs)
• Developed and implemented Case Report Forms (CRFs),
• Served as study monitors
• Conducted thorough GAP analysis of device/drug pivotal clinical trials
• Developed SAE Reporting SOP and documents for ten clinical trials
• Conducted site initiation and close-out visits for clinical trials
• Conducted retrospective clinical auditing of study data and documentation
• Conducted real-time auditing of large-scale, multi-center clinical studies to provide Quality Assurance oversight of protocol compliance, data acquisition, and trend analysis within and between sites
• Maintained SAE database and files for several Phase I/II trials.
• Provided medical writing services for Clinical Study Reports (Phase III trials) and regulatory submissions
• Served as virtual Clinical Department for several companies
• Conducted training in Good Clinical Practice (GCP) for study site personnel
• Conducted protocol-specific training for Investigators and Study Coordinators
• Lectured on topics such as vaccine clinical development and GCP at U.S. and international meetings and conferences
• Written Advisory Committee Meeting briefing package for clinical studies

Nonclinical

Experienced in developing and implementing effective preclinical programs for earliest entry into human clinical trials

• Developed preclinical study programs, balancing regulatory compliance with accelerated development
• Developed and/or reviewed and edited GLP toxicology protocols
• Monitored GLP toxicology studies
• Performed site visits and GLP audits at nonclinical Contract Research Organizations (CROs)
• Developed immunological study protocols and monitored studies.
• Interpreted raw data and study results from immunological and toxicological studies
• Designed proof of concept toxicity and efficacy studies

Facilities/Equipment and cGMP Manufacturing

Experienced in the high level design and development of modern manufacturing facilities that are commensurate with current industrial standards and regulatory expectations. Significant experience in facility and utility qualification and manufacturing operations.

• Developed Master Batch Production Records for a wide range of products, including biologics, drugs, and autologous cell therapies
• Conducted cGMP compliance audits, facility / quality gap analyses, and mock PAIs
• Participated in due diligence assessments specifically covering CMC and cGMP issues
• Developed and evaluated validation programs and protocols for analytical methods, manufacturing processes, cleaning methods, facilities, and equipment
• Provided scientific review of analytical methods and manufacturing processes resulting in successful product approvals
• Developed ICH-compliant stability programs
• Prepared and developed technical documents including Standard Operating Procedures (SOPs), Technical Reports, and Post-Audit Action plans to support quality assurance programs, facility commissioning, and cGMP compliance programs
• Assisted clients with implementation of Good Manufacturing Practices (GMP) commensurate with their product’s stage of development.
• Developed or reviewed/edited comparability protocols for a variety of products
• Served as company representative (“Man-in-Plant”) during product manufacture
• Advised on the design of GMP-compliant facilities for manufacture of biotechnology products.
• Developed protocols for commissioning of facilities and equipment (IQ/OQ/PQ).
• Performed gap analyses and third party audits of facilities and equipment for GMP compliance.
• Developed and conducted training on cell culture techniques
• Developed and conducted cGMP training for manufacturing personnel
• Lectured on topics relevant in today’s industry at numerous U.S. and international meetings and conferences
• Worked closely with clients to develop and optimize manufacturing processes.

Quality Assurance (QA) / Compliance

Experienced in creating and evaluating quality systems, providing analysis and input, and implementing new system and conducting audits and GAP analyses.

• Developed and implemented QA programs, to include Developed a Quality Manual, Validation Master Plan, and procedures for change control, out-of-specification investigations and reports, deviations, and Corrective Action/Preventive Action (CAPA), for a wide range of products, including biologics, drugs, and autologous cell therapies
• Provided QA signatory and representation to regulatory agencies for two biotechnology companies
• Conducted QA audits for numerous organizations
• Developed novel paradigms in Quality Assurance systems to ensure “cross-talk” among the various components
• Lectured on topics relevant in today’s industry at numerous U.S. and international meetings and conferences
• Provided technical writing services for the creation of Quality Assurance SOPs
• Assisted in development of Certificates of Analysis for product release
• Conducted numerous mock PAI audits with an experienced team of consultants (ex-FDA and industry)
• Audited and advised on two QSR systems for device manufacturers
• Reviewed CE-mark application for a device company
• Conducted basic and advanced GMP training, customized to client-specific needs.

Analytical Methods Development

Experienced in selection, design and review of analytical methods and auditing of QC laboratories for drug, biologic and device companies

• Provided training cell-mediated immunity assays
• Served as QC director for biotechnology and pharmaceutical companies, providing review of QC data and prioritization of laboratory activities.
• Assisted in the selection, development and/or technical review of a variety of analytical methods, including PCR, electrophoresis, HPLC, UV/VIS/Fluorescence spectroscopy; GC-MS, mass spectrometry, atomic absorption spectroscopy, ELISA, PRNT assays, monoclonal antibody production and characterization, Western Blot analysis, flow cytometry, intracellular cytokine production, cytotoxic lymphocyte proliferation assays, and in vivo potency assays
• Developed or reviewed/edited technology transfer protocols to promote successful methods transfer between internal departments and to external laboratories (CROs).
• Developed and written validation protocols for a variety of analytical methods.
• Developed and written stability programs and reviewed results for numerous companies.
• Reviewed and implemented compliant reporting systems for contract laboratories performing R&D or QC release
• Performed GMP compliance audits of QC laboratories

Regulatory

Experienced in developing strategies for companies to proceed through various regulatory pathways to market in the United States and Europe.

• Developed and implemented programs to prepare sponsors for Type A, B, and C meeting with FDA
• Developed CMC sections for regulatory submissions (e.g. IND, NDA, BLA) resulting in successful product approvals
• Planned and participated in numerous pre-IND meetings with FDA
• Planned and participated in EOP 2 and pre-BLA/NDA meetings
• Prepared and submitted over 100 INDs, IND amendments and Annual Reports to FDA
• Provided technical writing for five BLAs/NDAs (one in CTD format)
• Represented five companies as U.S. Agent or Authorized Representative
• Developed numerous strategic regulatory development plans
• Developed regulatory documentation management systems for 7 companies
• Prepared and submitted drug establishment registration documentation for foreign companies
• Planned and participated in numerous pre-CTA meetings with Health Canada, including preparation of meeting briefing packages, development of questions for the regulatory agency, organization of client rehearsals for the meeting, and moderation of the meeting.
• Prepared submissions requesting Orphan designation in the U.S. and Europe
• Prepared submissions requesting Fast Track designation
• Maintained submission databases and official regulatory archives for clients

Consistent, thorough and up-to-date analysis of your evolving needs is just the beginning of our commitment to your program. For a comprehensive assessment of your program requirements, please contact us by calling (720) 746-1190 or by email at info@cbrintl.com.