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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

 

 

 

 

 

Contact Info:

Company:
JR Pharma, LLC

Francis J. Manella, CEO
645 Coatesville Road, PO Box 67
West Grove, PA 19390

Tel: (859) 640-3559

Fax: (610) 869-2912

Email: fjmanella@jrpharma.net

 

 

Good Company! Good Drink! Good Food! Good Program! Good Fun!

 

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