Ashot Petrossian, Ph.D.
Principal Manager, U.S. & President
Ashot Petrossian, Ph.D.Principal Manager, U.S. & President
Dr. Ashot Petrossian has close to 25 years experience in the biopharmaceutical and biotechnology industry in the various areas of product and process development for proteins, peptides and large molecules. Dr. Petrossian's core expertise is large scale GMP cell and microbial culture fermentation using production scale bioreactors, purification unit operations using tangential flow and large scale chromatography systems and final product presentation. Dr. Petrossian has expertise with the conceptual design and construction of GMP facilities for the production of biopharmaceuticals and all aspects of facility, equipment, process, cleaning and analytical methods validation. Dr. Petrossian held positions in operations and compliance at numerous biopharameutical and consulting companies.
Dr. Ashot Petrossian earned a B.S. degree in Biochemistry from Cornell and a Ph.D. degree in Biophysics from University of California at Berkeley.
Nigel Smart, Ph.D.
Nigel Smart, Ph.D.Principal Biopharma
Dr. Nigel Smart is founder and managing partner at Smart Consulting Group, a Pennsylvania based Life Sciences Consulting Company. Nigel has over 30 years of experience in the Pharmaceutical/Biotechnology industry dealing with Process Development, Manufacturing and Quality issues including time at Allelix Inc, SmithKiline Beecham and Sterling Winthrop, all connected with recombinant protein drugs and vaccines.
Nigel is a successful results oriented professional manager and consultant with significant technical expertise in process development, equipment and facility design, manufacturing, laboratory analysis/operation and regulatory/quality compliance. His personal interest is in the Lean manufacture of products produced through recombinant fermentation and Cell Culture, including vaccines, monoclonal antibodies and other therapeutic proteins. This includes the integrated aspects of downstream recovery/purification and QC laboratory operations associated with smooth supply chain operations. Nigel supplies additional expertise in strategic management, quality operations, validation and training. Nigel is a consultant and advisor to companies in the Life Sciences sector including: Nutritional supplement, pharmaceuticals, biopharmaceuticals, vaccines and combination drug/medical devices. Nigel is an expert in applying Lean principles to pharmaceutical processes to enhance efficiency, reduce waste and increase process profitability and a proponent of Lean approaches to biopharmaceutical manufacturing processes.
For the last twelve years, Nigel has been providing consulting services for operational problems and compliance related issues to the pharmaceutical and biopharmaceutical industry, including advice to the US government on manufacturing strategies to produce a variety of biological countermeasures for the biodefense program. Nigel has been a key advisor to the US government (BARDA) and has provided SME (Subject Matter Expert) input for a strategic report communicated to the White House associated with vaccine manufacturing strategy for production of key vaccine counter measures over the next 20 years.
Complementary to consulting for manufacturing, is an equally significant contribution to Quality Compliance consulting. Nigel has worked on 5 Consent Decrees and numerous Warning letter situations. In all cases companies have undergone significant remediation activities which have led to a successful outcome after re-inspection by the FDA and other regulatory agencies. More recently Nigel has been acting as a key advisor to the FDA on serious compliance issues associated with Consent Decrees and Application Integrity Policy.
Dr. Nigel Smart earned a PhD. in Fermentation Technology/Biochemical Engineering from Victoria University of Manchester, UK; Ph.D. Topic, Development of Clavulanic acid antibiotic fermentations from Streptomyces species. MS in Fermentation Technology/Biochemical Engineering, Victoria University of Manchester, UK and BS in Chemistry, University of Leicester, UK.
Abbass Kamalizad, Ph.D.
Principal Manager, Asia
Abbass Kamalizad, Ph.D.Principal Manager, Asia
Dr. Abbass Kamalizad is President and founder of ACPC Group, established in 2006, a consulting organization helping pharmaceutical and biotech industries in drug development, quality assurance, quality control, and regulatory affairs. Dr. Abbass experiences span over 18 years in drug development, directing QC and R&D laboratories in support of submission. Dr. Abbass has established and managed many GMP Laboratory Operations, e.g. AAI Pharma, IPS, Anchen Pharmaceuticals, Pharmaron. Dr Abbass Academic background is more than 15 years with research projects in chiral chemistry and chiral chromatography.
Dr. Abbass earned his B.S. in chemistry from Tehran University and Ph.D. in Analytical Chemistry from university of Massachusetts.
Ash Ramzan, Ph.D.
Principal Manager, EU
Ash Ramzan, Ph.D.Principal Manager, EU
Dr Ash Ramzan is President and founder of Woodley BioReg and has over 20 years of international experience within the pharmaceutical and biopharmaceutical industry. He has held a number of senior positions in product and clinical development, manufacturing to cGMP compliance, Analytical Development, Quality Control and Assurance, and Regulatory Affairs. Ash's special interest areas include Registration Drift, as well as running training courses for TOPRA, helping companies develop sound regulatory strategies, and providing project management. Ash continues to provide specialist consulting and ensures that the founding principles of quality, integrity and professionalism are robustly maintained.
Dr Ash Ramzan earned a Ph.D. from University of Liverpool in Protein Biochemistry.
Peggy C. Pence, Ph.D.
Principal Clinical Development & Regulatory Compliance
Peggy C. Pence, Ph.D.Principal Clinical Development & Regulatory Compliance
Dr. Peggy Pence, is President and founder of Symbion Research International, which offers over 35 years of experience in the research and development of traditional pharmaceutical and biotechnology-derived products, medical devices and in vitro diagnostics. Peggy began her career at Eli Lilly and Company and subsequently at Serono Laboratories, Triton Biosciences (Berlex Laboratories), and Amgen.In 1992, Peggy established Symbion Research International, a comprehensive scientific and regulatory consulting and contract research firm serving the pharmaceutical, biopharmaceutical, and medical device industries. Over the course of her career, Dr. Pence has worked with more than 50 companies and over 50 drugs, biologics, medical devices, and combination products. She has broad experience in all phases of clinical trials and regulatory affairs. She has enjoyed success in leading development programs for a number of novel therapeutics in multiple therapeutic areas, from designing first-in-man studies to directing pivotal licensing studies. Her medical device experience includes development of in vitro diagnostics and encompasses all three Classes of medical devices. She has prepared numerous regulatory submissions and consulted with the U.S. Food and Drug Administration concerning INDs, NDAs, PLAs/BLAs, 510(k)s, and PMAs.
Dr. Peggy Pence earned her B.S. in Microbiology from Louisiana Tech and her Ph.D. in Toxicology, with Pharmacology minor, from Indiana University.
Frank Mark, BS, MBA
Frank Mark, BS, MBAPrincipal Compliance
Frank Mark's experience includes over 30 years in the pharmaceutical and medical device industries. More than 20 years were spent in the pharmaceutical industry in Quality and Regulatory Affairs management with several established ethical pharmaceutical companies. Frank.s background includes extensive hands-on experience in Quality Operations, Research Quality Assurance and Regulatory Compliance. He has accomplished skills in the application of Current Good Manufacturing Practice regulations and validation concepts to all aspect of pharmaceutical, biologics and medical device manufacturing environments. Frank has successfully guided numerous companies in preparation for their first FDA Pre-Approval Inspections leading to successful PAIs. He has directed several multi-site remediation projects across the US, Canada and Puerto Rico and has provided quality oversight of commissioning and validation activities associated with a new cGMP construction, installation and start-ups. Frank assists clients with all aspect of quality system implementation, remediation activities, and regulatory compliance from R&D to commercial manufacturing operations. Frank also spent seven years with FDA.s Newark District Office performing comprehensive drug and medical device establishment inspections. With this experience, and experience as a quality systems and compliance consultant, and industrial experience in quality operations, Frank provides clients with the necessary compliance program management tools to build sustainable quality systems.
Frank Mark retains a BS degree in Chemistry and Graduate Studies in Business Administration.
Herb MathesonPrincipal Validation
Herb Matheson is the cofounder and President of Validation Technologies, Inc. He has over 30 years of experience in the pharmaceutical, biotechnology, and medical device industries and has managed the delivery of more than $100 million in contract commissioning and qualification services to clients, both nationally and internationally. Herb has effectively managed individual projects that have ranged up to $3 million dollars in size and has successfully applied the concepts within the ISPE Commissioning and Qualification Guide and ASTM E 2500-07, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.
Herb has a broad background in the validation of process utility systems, process equipment, controlled environments, and sterilization systems. He has broad expertise in the commissioning and qualification of facilities, utility systems, process equipment, and processes common to the industry. In addition to extensive experience in the development and validation of computerized data acquisition and control systems, Herb has extensive experience in the construction, commissioning, and validation of new facilities where he has functioned as the validation Project Manager for multiple projects. He has demonstrated the ability to apply Current Good Manufacturing Practice regulations and validation concepts, including Risk Based Approach, Quality by Design, Good Engineering Practices, and Integrated Commissioning and Qualification to efficiently execute validation projects of all sizes.
Herb Matheson earned a B.S. degree in microbiology from Michigan State University and a B.S. degree in Computer Sciences from West Coast University.
Alex Salottolo, MBA
Principal IT Systems
Alex Salottolo, MBAPrincipal IT Systems
Alex Salottolo, has spent the past 17 years in IT sales and management, nine of which have been spent in the IT consulting and staffing arenas. Alex has been involved in the ramp-up and successful sale of two firms, Execusoft, Inc. in 1997 and Inteliant, Inc., in 2000. Execusoft, Inc. grew dramatically under his direction and was sold to SOS Staffing services where he remained as a VP for 4 years. While with SOS, he played a key role in the creation and formation of Inteliant, the IT Staffing and Consulting group for SOS. In 2000, Inteliant's IT consulting group was sold and Alex played a major role in the ramp-up, sale and eventual integration into Herrick Douglass, Inc., the acquiring firm. Prior to his experience in the Staffing and Consulting arena, Alex held Senior Sales and marketing positions with IBM and Quadratron Systems Inc., a market leader in UNIX-based office automation applications.
Alex Salottolo holds a Bachelors in Economics from the University of Southern California.
Stan Wendzel, MBA
Principal Facility Finance
Stan Wendzel, MBAPrincipal Facility Finance
Stan Wendzel is Managing Director and founder of BioRealty, founded in 2005. Stan served as Senior Vice President of Lowe Enterprises where he was responsible for overseeing all Lowe Enterprises. build-to-suit and sale-leaseback activities throughout the United States. Prior to 2001 Mr. Wendzel served as Chief Financial Officer of Lowe Enterprises. western region. Stan has also served in senior management positions at The Koll Company, an international development firm, and Ernst & Young. Stan is a current board member of the National Association of Industrial and Office Properties (NAIOP), International Society of Pharmaceutical Engineering (ISPE) and a former board member of CoreNet Global and the Commercial Industrial Development Association (CIDA). Stan is also a member of the American Institute of Certified Public Accountants (AICPA) and a CPA, licensed real estate broker, and a LEED Accredited Professional with the U.S. Green Building Council.
Stan earned BA from University of California, Santa Barbara, and MBA from University of California, Berkeley and Columbia University.
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