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Francis (Frank) J. Manella
Pharma, Biotech & Device Consulting
Mr. Manella has nearly four decades of technical, regulatory and executive experience in the US, EU and Asia Pacific pharmaceutical, biotechnology and medical device/IVD industries. Prior to starting his own consultancy (JR Pharma. LLC), he was the founder of Coldstream Pharmaceuticals, LLC, an aseptic products CMO located in Lexington, Kentucky.
Specializing in business turnarounds (marketing, managerial, financial and/or regulatory), business start ups and organic growth, Mr. Manella has a proven track record on three continents. His experience includes sales, marketing, operations, regulatory affairs, quality/compliance and research at big pharma (Pfizer, Bristol Myers-Squibb), biotech (Life Technologies) and medical devices (Bespak). This eclectic background led to General Manager roles at AL Pharma, President at Blaine Pharmaceuticals and CEO of Coldstream Pharmaceuticals where he raised $21 Million in start up capital. Mr. Manella has had international experience with regulatory responsibilities in Scotland, New Zealand and Japan. He also lived in Cambridgeshire, England for nearly two years heading up a new business unit on a unique medical device for meter dose inhalation use. Academic experience includes heading the Center for Pharmaceutical Science & Technology at the University of Kentucky’s nationally ranked College of Pharmacy. His long and distinguished career in the health care industry has developed an extensive network of contacts.
Capabilities
Strategic Business Development
Business and Marketing Plan creation
SWOT analysis for acquisition/divestiture
Licensing & Acquisition (brands up to full divisions)
Rx, OTC, biotech, devices/IVD’s, nutraceuticals – US/EU/Asia Pacific
Creative deal structures
Brand claim development
Primary/secondary marketing research
Raised over $21 Million in capital 2002-2008
Regulatory/Quality/Compliance
Pre-submission meetings with FDA & EMEA
Site inspections by FDA including PAI’s
Filing of IND/NDA/ANDA’s and IDE/PMA/510K’s
“Planned Error Program” to eliminate audits
Recognized Process Validation expert
Certified ISO Auditor; lead international certification efforts
Eclectic business experience allows for proper Risk Management
Operations/Technical
Designed, built commissioned and validated 21,000 ft² aseptic processing CMO
Beta-site for GSK’s “closed vial filling system”, revolutionary aseptic filling line/portable isolators
Design of biotech (protein production) and GMP lipid manufacturing facility
Pilot Plant start up/small scale specialty penicillin synthesis
Managed sterile and non-sterile packaging operations with up to 18 lines and 350 employees
Therapeutic Experience
SVP/LVP’s
Sets & devices
Antibiotics
MDI’s
Dermatology
Gastrointestinal
Anti-virals
Medical devices/invitro diagnostics
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