Curriculum Vitae for Ellen Milano
Milano Regulatory Solutions, Inc. – 2001–Present
Boylston, Massachusetts, President
- Principal Consultant for Milano Regulatory Solutions, Inc., a firm providing regulatory and technical advisory services to organizations seeking to develop, approve, and market new pharmaceutical drugs and medical devices.
- 40+ years experience in the pharmaceutical industry with expertise in product development, regulatory affairs, analytical development, quality assurance and compliance, cGMP, cGLP, and integrity audits, and product specific pre-approval inspections.
- Regulatory and technical consulting services provided for chemistry, manufacturing, and controls (CMC) portions of Investigational and New Drug Applications (INDs and NDAs), Abbreviated New Drug Applications (ANDAs), Drug Master Files (DMFs), Supplements and Amendments. Preparation of technical responses for FDA Warning Letters and Deficiency Notifications.
- Preparation of Medical Device 510(k) Notifications and knowledge of Quality Systems Regulations.
- Technical liaison between client firms and FDA, and/or between client firms and contract analytical, product development, and manufacturing organizations.
- Experienced in conducting client specific training seminars pertaining to analytical development, method validation, cGMP, cGLP, and QSR compliance, and regulatory procedures for pharmaceutical organizations.
- Proficient in pharmaceutical project management and new product development planning.
- Responsibilities include reviewing and preparing SOPs and protocols for QC, Analytical Development, and contract pharmaceutical laboratories.
New England Biomedical Research, Inc. – 1998–2001
Northborough, Massachusetts, Vice President
- Provided regulatory affairs and product development consulting services to the firm’s clients. Provided guidance relating to the development and preparation of FDA submissions. Provided GMP and GLP compliance advice, training, and auditing services.
- Prepared CMC sections for IND, NDA, and ANDA submissions pertaining to new drug products, generic drug products and new orphan drug products.
- Provided technical advice and regulatory services pertaining to planning and preparation of DMF, IND, NDA, ANDA, and 510(k) submissions.
- Prepared responses to FDA Deficiency Notifications, Product Application Amendments, and Warning Letters.
- Prepared Annual Reports and Supplements for approved drug products.
- Responsible for preparation of Medical Device 510(k)s for domestic and international clients.
- Technical and regulatory liaison between foreign firms and US regulatory agencies.
Copley Pharmaceuticals, Inc. 1988–1998
Canton, Massachusetts, Director of Analytical Development
- Directed R&D Analytical Development Department for a mid-size pharmaceutical company producing primarily generic drugs and vitamins. Products included: tablets, capsules, syrups, inhalation solutions, creams, gels, aerosols, suspensions, powders, and sustained release dosage forms.
- Responsible for preparing analytical and CMC sections for more than 60 ANDA applications.
- Key individual participating with R&D team responsible for introducing over 50 new products, resulting in sales growth for the company of from $8 Million to $120 Million over an 8-year period.
- Supervised analytical development scientists with all aspects of test method development, validation, and laboratory compliance procedures.
- Prepared validation protocols and SOPs for analytical laboratory. Supervised technical and analytical transfer activities between R&D and the quality control.
- Department supervisor responsible for coordinating product specific FDA pre-approval inspections relating to analytical development.
Astra Pharmaceutical Products, Inc. 1973-1988
Westborough, Massachusetts, Senior R&D Scientist
- Developed and validated more than 100 HPLC stability-indicating procedures for new product submissions and prepared technical CMC portions of drug application dossiers.
- Directed pre-formulation and stability testing activities in the R&D laboratory. Supervised analytical chemistry group.
- 1988: “Stabilization of Epinephrine in a Local Anesthetic Injectable Using Reduced Levels of Metabisulfite and EDTA”
- 1983: “Formation of an Aluminum-Epinephrine Complex and Its Effect on the Addition of Bisulfite to Epinephrine”
- 1982: “Extraction of Soluble Aluminum from Chlorobutyl Rubber Closures”
- 1982: “Aluminum Catalysis of Epinephrine Degradation in Lidocaine HC1 with Epinephrine Injectable Solutions”
- 1979: “Crystal Structure of Epinephrine-Bisulfite”
- 1978: “Assay of Tocainide in Blood by HPLC”
- 1974: “Concentration of Heavy Metals by Complexation on Dithiocarbamate Resins”
The Massachusetts College of Pharmacy
- Boston, Massachusetts
- Masters Degree in Industrial Pharmacy and Chemistry, 1980
The University of Massachusetts
- Amherst, Massachusetts
- B.S. in Chemistry, 1973
- Regulatory Affairs Professionals Society (RAPS)