Mike Ramstack
`Pharmaceutical Development, CMC, and Manufacturing Consultant
`
`Summary
`Accomplished scientist/engineer with over 35 years’ experience in the design and development of
` medical devices, pharmaceutical products and manufacturing processes. Successful track record of
` progressing products from bench-top to commercialization.
`
`Specialties include: drug product development, process development and scale up, project
` management, managing vendors, CRO’s, and CMO’s, tech transfer, troubleshooting, authoring CMC
` regulatory filings, intellectual property assessment, microencapsulation, micro- and nano-particle
` drug delivery technology, experimental design(DOE), emulsions/suspensions, lyophilization, polymer
` science, solid state characterization, aseptic process design, and GMPs.
`
`Experience
`Principal and Owner
`April 2015  -  Present
`Consulting services include:
`• Drug product development and characterization
`• Process development and scale up
`• Project management
`• Identifying and managing vendors, CROs, CMOs,
`• Tech transfer & trouble-shooting
`• Authoring CMC regulatory submissions
`• Microencapsulation
`• Nano-, micro- particle drug delivery
`• Intellectual property assessment
`
`Recent client experience:
`• Provided technical support to law firm for patent defense case against generic product entry.
`• Drafted Formulation Development Report and supporting reports for NDA submission of
` microencapsulation product for small start-up.
`• Provided process development guidance on chemotherapeutic nanoparticle product for startup.
`• Served as VP of Technical Operations for nanoparticle start-up.
`• Preformed 3rd party technology assessment, identified additional consultants, vendors and CMOs
` for veterinary sol-gel medical device.
`• Provided CMC assessment on nasal drug delivery product for small start-up.
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`• Assisted in troubleshooting and provided formulation guidance on microencapsulation products for
` several large and small pharma companies.
`
`Scientific Fellow II
`July 2013  -  August 2015 (2 years 2 months)
`Lead company efforts in the process development and manufacture of platinum based drugs and
` targeting nanoparticles. Managed suppliers and CMOs for production of clinical materials.
`Developed pilot scale capability for producing drug-loaded polymer and liposome nanoparticles.
`Guided process development and clinical manufacture of company’s first product, BTP-114, a
` cisplatin pro-drug. Authored IND CMC section.
`
`Principal Fellow, Pharmaceutical Sciences and Manufacturing at Cerulean Pharma, Inc
`2008  -  July 2013 (5 years 7 months)
`Lead company efforts in the development of processes for making drug-loaded nanoparticles.
` Coordinate activities with suppliers and CMOs for the manufacture of tox and clinical supplies.
` Troubleshoot manufacturing issues. Guided CMC effort for CRLX301, a docetaxel loaded
` nanoparticle into Phase I clinical trials.
`
`Research Fellow at Alkermes (previously Medisorb Technologies LP)
`1991  -  2008 (18 years)
`Directed technical project teams and maintained client relationships in the development of
` controlled release microsphere products and processes.
`Accomplishments include:
`• Technical/ Scientific lead in the development of Risperdal® Consta®, the company’s first
` commercially successful product.
`• Principal in the development of two succeeding microsphere products: Vivitrol® and Bydureon®
`• Guided batch size scale-up efforts from gms to 10’s of kgs.
`• Developed novel and proprietary microencapsulation method using non-toxic solvents.
`• Developed propriety extraction procedure to reduce residual solvents in product.
`• Authored pharmaceutical development sections of NDA.
`• Led teams to investigate causes and identify corrective measures for product/process defects.
`• Consulted as Technical Expert for company patent defense and opposition cases
`
`Product Engineering Supervisor at DuPont
`1981  -  1990 (10 years)
`Developed extracorporeal therapy devices including plasmapheresis system (instrument and
` disposables) and immuno-depletion columns. Managed R&D team. Coordinated internal research
` and external contract projects for instrument design, consumable manufacture, and sterilization.
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`Senior Research Scientist at Johnson & Johnson
`1978  -  1981 (4 years)
`Developed cardiovascular surgical products including membrane oxygenator and blood filters.
` Managed device development laboratory. Developed product specifications and manufacturing
` processes. Conducted in-house laboratory and external animal product performance tests.
`
`Education
`Northwestern University
`Ph.D., Chemical Engineering, 1974 - 1976
`Northwestern University
`MS, Biomedical Engineering, 1972 - 1974
`University of Notre Dame
`BSME, Mechanical Engineering, 1968 - 1972
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`AMN1054
`IPR of Patent No. 7,919,499
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`Mike Ramstack
`Pharmaceutical Development, CMC, and Manufacturing Consultant
`
`Contact Mike on LinkedIn
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`AMN1054
`IPR of Patent No. 7,919,499
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