Christopher Mcdaniel Email & Phone Number

Orange County And Marin County, California, US

Cambridge, MA, US

• Led the functions of pre-formulation and formulation development within Sage. o Led pre-formulation and formulation development activities at contract laboratories and contract development and manufacturing.
• Developed formulation strategies in collaboration with Sage senior management and CMC teams and related functions including Early Research, Non-Clinical Development, Process Development, Analytical Development.
• Led the Sage side of the joint formulation teams with Sage alliance partners, Biogen and Shionogi (Japan-based). o Sage – Biogen – Shionogi: zuranolone lifecycle formulation approaches. o Sage – Biogen: SAGE – 324.
• Managed Sage’s external pool of labs and CDMOs for formulation, chemistry, and analytical method development and ensured Sage personnel select from vetted lab and CDMO partners; vetted new CDMO partners when occasion.
• Led the pre-formulation group to ensure the appropriate data are gathered to support decision making in lead optimization programs and early formulation development including data that would support routes of.
• Reviewed and approved formulation-related sections of FDA and EMA regulatory documents, development reports, and other CMC technical documents.

• Led the functions of drug substance and product development and manufacturing; analytical and bioanalytical methods development and product testing; clinical trial study drug manufacturing, labeling, packaging, and.
• Led the Frequency CMC team in Frequency’s co-development partnership of FX-322, a sterile lyophilized product, with Astellas Pharma working directly with the Astellas (Japan) CMC team lead to execute all CMC activities.
• Led the search for appropriate third-party partners (i.e., analytical laboratories, CDMOs, etc.), the vetting process, and selection to support Frequency’s drug substance and drug product development and commercial.
• Authored and reviewed pertinent CMC technical reports and FDA regulatory filings.
• Responsible for building the CMC capability within the company to support company business objectives ensuring the appropriate technical capabilities, continued CMC and GMP quality training, mentoring, and professional.

• Independent Consultant in Pharma and OTC ProductsAreas of Focus
• Pharma Product Development (domestic and international markets)
• Chemistry (drug substances)
• Drug product formulation development (OSD, sterile injectable, and long-acting injectables)
• Quality Systems
• Project Planning and Management

Tarrytown, NY, US

Led the global functions of R&D, Quality, Regulatory Affairs, Medical Affairs, Pharmacovigilance, and Project Management with responsibility for products in over 80 markets around the world.Led the development team as the executive sponsor actively setting tasks, time lines, and budgets for Fleet's development program for a chiral, small-molecule NCE.

Tarrytown, NY, US

Responsible for R&D, Quality, Project Management functions across all of Fleet's business units internationally. Led the technical team in the development of new OTC and dietary supplement products and a complete re-stage of Fleet products resulting in double-digit or high single-digit revenue growth year on year.Reorganized the quality unit and upgraded.

Miami, Florida, US

Filled a newly created position reporting to the CTO and responsible for searching out, evaluating, and, if required, testing new technologies that would broaden and diversify Noven’s portfolio of drug delivery and product development platforms.Proposed potential products using candidate technologies and estimated human and capital requirements to.

Tokyo, JP, JP

Created the Pharmaceutical Development Department with responsibility for outsourcing and managing all aspects of product development including API manufacture, formulation development, analytical methods, and clinical trial supplies manufacture, packaging, labeling, and distribution.Managed 23 development projects, five of which resulted in NDA approved.

Birmingham, Alabama, US

• Led a group of 13 scientists (Ph.D., MS, BS) and technicians in over 25 multi-year projects to develop advanced injectable or implantable drug formulations with specific biological system delivery requirements.
• Marketed SRI’s pharmaceutical product development services through scientific conference speaking and exhibitions as well as face-to-face client selling to pharma company development groups to bring in multiple.
• Wrote over 75 project proposals and presented the proposals to the prospective client. These proposals include a detailed plan of work, budget, and time line covering small and large molecules. Examples include o.

Birmingham, Alabama, US

Synthesis of new polymer systems for long-acting topical drug delivery systems and formulation incorporating such polymers.

Synthesis of new polymers for long-acting topical drug delivery systems and manufacturing troubleshooting.

Development of synthetic routes and manufacture kilogram quantities of candidate drug substances

Ph.D., Organic Chemistry

Mba

Ba, Chemistry