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 organizations (CDMOs) along with early clinical manufacturing (GMP); 6 clinical development candidates, 6 lead optimization programs, and 2 lifecycle programs;• 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, Quality, Regulatory, Clinical Pharm., and Clinical. o Alignment of technical approach, target product profile, program goals, timeline, and budget. Ensures chemistry and manufacturing controls (CMC) and GMP quality (QbD) are built into the development strategy. o Strategies incorporated approaches that include and support patient, caregiver, and healthcare professional perspectives.• 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 indication specific formulation approaches.• 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 required.• 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 administration other than oral solid dosage (OSD) forms.• 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 distribution to clinical sites; and preparation for commercial manufacture of the company’s products. CMC activities.• 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 in accordance to agreed criteria and timeline. Negotiated timelines, budgets, expectations on specifications, process controls, and quality, to accommodate regulatory and product requirements in both Frequency’s and Astellas’ agreed market territories, USA and Rest of World respectively. • 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 manufacturing (sterile lyophilization) requirements. Negotiated contracts and quality agreements acceptable to both Frequency and the partner.• 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 development of team members.

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• Due Diligence• Product Evaluation and Risk Assessment• Product Portfolio Assessment• Technology Evaluation• Development Team Coordination and Management• CDMO Evaluation and ManagementSelected Examples:• Client: Hired by CEO as acting CSO for a startup pharma company with proprietary flow chemistry technology to manufacture drug substances. Further develop technology and supporting facilities and capabilities, develop portfolio of products, engage potential investors, develop regulatory strategy, construct quality management system, and other duties as required.• Client: Hired by private equity firm to perform quality and regulatory due diligence on an acquisition target specializing in transdermal patch manufacturing.• Client: Pharma company located in Europe to perform due diligence on pharma development project acquisition and map out development strategy for a solid oral dosage form product for launch in Europe.• Client: Hired by the president of a growing CMO; Multiple projects leading to a multi-year assignment in the quality, regulatory, and manufacturing areas for primarily solid oral dosage form products.• Client: Start-up pharma company; identified gaps and opportunities in recently acquired IP, mapped out development plan to launch Rx & OTC products, developed cost and timelines, identified CROs & CMOs as potential partners, created investor presentations to fund the development.

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 accomplishing API synthesis and scale-up, formulation development, pre-clinical and clinical development, and regulatory strategy including face-to-face meetings with FDA.Led the technical team in the development and launch of several dietary supplements, the development of two entirely new brands pending launch, and the re-stage of the Fleet brand of products.The company acquired two brands in the space of a year. Integrated all of the R&D, medical / safety, quality, and regulatory functions of each brand within three months of the close of each transaction.Elevated the global pharmacovigilance function by hiring appropriate staff, incorporating improved procedures, and training across all organizations to resolve all observations from an MHRA inspection with no observations in subsequent inspections.Executed clinical studies in the US and Europe in support of Fleet products and development projects resulting in increased sales and improved safety.As a team member in the divestment of several Fleet companies, ensured Fleet’s strategic goals were met, ensured that deal terms were aligned with Fleet’s interest with respect to ongoing responsibilities, and ensured Fleet was in compliance with agreement post deal.

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 the experience and education level to support manufacturing and supply operations to become compliant with US (21 CFR 111, 210, & 211) and EU (ICH) requirements resulting in no unresolved regulatory inspection issues from US or international inspections.Developed and implemented improved SOPs, processes, training, and internal auditing such that the Swedish operations resolved all Swedish MPA compliance issues.Upgraded Fleet’s fledgling Project Management function by hiring experienced project managers and implementing an improved project management process such that the project throughput was tripled.

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 implement such technologies. Noven acquired a pharmaceutical company whose products and technologies filled the strategic objective.Led the development team for a mucoadhesive controlled release technology resulting in the development of products for vaginal delivery.Represented Noven at various conferences and symposia to support its business development efforts in selling Noven’s capabilities in product development through presentations one-on-one or to large audiences resulting in several development deals.

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 products.Produced clinical trial supplies for over 70 different clinical studies world wide in all phases of development as well as post approval.Aligned and integrated US Pharm. Dev. Dept. operational procedures with the UK Pharm. Dev. Dept. such that the procedures and systems were the same for both groups so that projects could be managed from either location.Key team member on due diligence teams in executing Shire’s growth strategy through acquisition of projects in various phases of development. Targets include Roberts Pharmaceuticals, Biochem Pharma, New River Pharmaceuticals (Vyvanse®), and Daytrana® transdermal amphetamine system for ADHD from Noven Pharmaceuticals.

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 (duration, location, dose) many of which included biodegradable polymer systems. • 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 millions of dollars in development contracts. • 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 Leuprolide acetate as a generic product for Lupron Depot®,o Long-acting microsphere olanzapine injectable,o Long-acting combination microsphere product containing testosterone, ethinyl estradiol, and progesterone.o Long-acting hGH microsphere injectableo Long-acting microsphere and implant formulations of goserelin, histrelin, and many proprietary drugs.

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