San Diego, CA 92121, US
PrimaPharma, Inc. is a contract manufacturer of drugs, medical devices, and diagnostic products. PrimaPharma has been in operation since 1992 and is an ISO 13485 certified (BSI) and FDA (Drug & Device) inspected facility.
PrimaPharma, Inc. (“PrimaPharma” or “the Company”) is a privately-held Contract Development and Manufacturing Organization (“CDMO”) focused on the manufacture of specialty pharmaceuticals, medical devices and diagnostics. The Company manufactures products for sale commercially, as well as clinical trial materials. PrimaPharma is registered as a “drug establishment” with the Food and Drug Administration (“FDA”) and is ISO 13485:2003 Quality System certified by the British Standards Institute. The Company has a successful track record of FDA inspections over the last five years.
The Company’s 30 employees operate a 23,000 square foot, leased facility in the Sorrento Valley area of San Diego with one ISO Class 5 Aseptic Filling Suite (“Class 100 Clean Room”). The Company provides sterile fill and manufactures ophthalmic drugs and medical devices for the commercial market, which understandably places it among the most regulated manufacturers in the world.
PrimaPharma is seeking a capital investment of $2.0 -2.5 million for capital improvements in combination with an additional $2.0 million in equipment financing to support the Company’s Strategic Growth Plan. Generally, PrimaPharma’s growth strategy involves adding automated production capacity, and manufacturing drug products in partnership with marketing organizations rather than just manufacturing those products on a contract basis for other parties.
PrimaPharma is supported strategically and financially by its majority shareholder Hampar Karageozian (“Mr. Karageozian”), founder and CEO of Allegro Ophthalmics, LLC (“Allegro”–http://www.allegroeye.com). Mr. Karageozian’s 40 years of experience in ophthalmic drug development brings the potential for numerous new business opportunities to PrimaPharma. Mr. Karageozian has provided PrimaPharma $1.3 million in funding in the past year to support PrimaPharma’s operations and fund its new capital projects.
Chief Executive Officer
Mark T. Livingston
Mr. Livingston is a Senior Executive experienced in operations, finance, strategic planning, start-up companies & company turnarounds. Founding Partner at accounting firm Campbell Boyd & Livingston, President & Chief Operating Officer at Motels of America, Inc., President at Road Runner Sports, Inc., CEO at Price Quest, Inc., President at Soluciones Technologias, President & CFO at Belstar Systems Corp., an executive at Danco Labs and a founding shareholder of PrimaPharma’s predecessor entity, Sorrento Biochemical, Inc.
B.S. Business Administration – San Diego State University, California Certified Public Accountant (non-practicing), California Real Estate Broker. Prior member of the Young Presidents Organization, advisory board member for Blanchard Training and Development, board member of The Planning Forum, chairman of The Management Consulting Services committee for the San Diego chapter of the California Society of Certified Public Accountants.
Vice President Development
Anthony D. Dziabo
Mr. Dziabo is a Senior Executive experienced in R&D, engineering, product development, regulatory affairs, operations and general management related to medical device, pharmaceutical, and chemical specialties industries with over 30 years of experience in the industry at major companies such as Allergan and Medtronic Cardiopulmonary. He has been employed as a Quality Control and Research Chemist, Manufacturing Manager, Plant Manager, and as a Director and Vice President of Product Development and Engineering. Mr. Dziabo has been awarded over 20 patents, helped to generate over $1 billion in product sales and has been instrumental in launching successful products worldwide.
Bachelor’s of Arts degree in Chemistry from Mansfield State University, PA , MBA with Honors at Pepperdine University, Malibu, CA.
Vice President Operations
Mr. Braga has provided services to PrimaPharma since 2009 under an agreement with his consulting firm Biowerks, Inc. He has acted as the Company’s Vice President, Manufacturing and Facilities since that time. In this role, he is responsible for Manufacturing, Contract Products and CGMP Facilities Operations.
Before joining PrimaPharma, Mr. Braga was Vice President, Manufacturing Operations, at Artes Medical, a publically-traded dermal aesthetic company (currently known as Suneva Medical, Inc.). Mr. Braga was responsible for worldwide manufacturing operations, in San Diego, California and Frankfurt, Germany.
Prior to Artes Medical, Mr. Braga held various manufacturing and clinical management positions at Anosys, Inc, Cohesion Corporation, Collagen Corporation and Genentech, Inc. Mr. Braga has also provided consulting services to several Fortune 500 Biotech companies such as Johnson & Johnson, Sartorius Corporation, and Nektar Therapeutics.
Mr. Braga received his B.S. in Biological S
Nayaz Ahmed, Ph.D, RAC, CQA
25 years of academic, pharmaceuticals, biologicals and medical devices experience with PhD in chemistry.
Specialties: Quality, Regulatory Affairs and Technical Leadership to include: Design, R&D, Analytical and Bio-analytical Chemistry-Method Development, Validation and Transfer. Quality, CMC, Compliance and Regulatory support for US and EU regions. Drug Discovery and Generic Drug Development. GMP audits, proposal development, negotiation and contract laboratory management. Establishment and Implementation of quality functions for the manufacture of quality products under US and EU regulatory environment
Senior scientist experienced in commercial and R&D pharmaceutical microbiology and quality system validations. He has over 25 years of experience as a microbiologist, and is one of the original members of PrimaPharma’s management team. Mr. Chaudry has extensive experience with regulatory agencies and has represented PrimaPharma in its FDA and ISO inspections for two decades.
Mr. Chaudry earned a Bachelor of Science degree in Microbiology from the University of California in San Diego.