Each specific service is managed by an SPI USA Senior Consultant and supported by SPI consultants and affiliated experts.




Mark Spinoglio
Mr. Mark Spinoglio is a Senior Consultant with SPI USA - Irvine. Mr. Spinoglio manages project teams located in the United States, Europe and Asia on international assignments that assist companies in creating growth through product development, leveraging R&D, market expansions and business-to-business partnerships.
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Douglas Thompson
Mr. Douglas Thompson is an Economic Consultant for SPI in Portugal. During his extensive career, Douglas has provided consulting to several clients within the private and public sectors. In this capacity, Douglashas provided extensive mathematical, econometric and statistical analysis, as well as financial modelling – he has also conducted several seminars and customized training courses for client staff.
Mr. Thompson has a vast experience in interacting with international agencies, such as the European Commission, the World Bank and the European Bank of Reconstruction and Development, among others. Besides, Douglas also has a comprehensive experience in relating with other foreign Governments/Institutions, such as the Government of Azerbaijan, Guyana,Thailand and Poland, for instance.
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Cindy Wu

Ms. Cindy Wu is a Consultant with SPI in Porto, Portugal. Ms. Wu has solid expertise in international marketing strategies, retail channel management and project financial modeling.

Prior to joining SPI, Ms. Wu worked for major firms within the Telecommunications and Consumer Electronics industries, in Berlin and Amsterdam, where she supported several projects regarding the European and Chinese markets.

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Milton Sousa

Mr. Milton Sousa is a Senior Consultant with SPI, in Porto. Milton has a comprehensive professional background, with extensive experience in marketing, strategy and engineering in the microelectronics industry. Mr. Sousa is focused on knowledge management, organizational development, entrepreneurship, strategic partnerships and business strategy. He has conducted several consulting projects in various industrial sectors within these areas. Milton also acquired in-depth knowledge of academia, while lecturing on Strategy and Organizational Development for the Masters in Innovation and Technology Entrepreneurship at the University of Porto/Portugal.

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Ashish Agarwal
Mr. Ashish Agarwal is the founder-CEO of ONCO Life Sciences Pvt. Ltd., established in 2005 and based in Pune, India. He is a first Generation Entrepreneur, a Gold medalist in pharmacy with a degree in Management. He commands more than a decade of diversified experience in Pharmaceutical. Diagnostic and Healthcare Industry with the first step into the industry set in 1990.
In his capacity he has experience across all departments of a healthcare corporation including New Product development, Production, Corporate Affairs, Sales, Marketing, Commercial, Logistics and International liaison and affairs.
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Tom Burkett, Ph.D
Dr. Burkett is an associate professor and director of the Biotechnology and Biomanufacturing program at The Community College of Baltimore County located in Catonsville, MD. In addition, Dr. Burkett is a regional director for the Northeast Biomanufacturing Center and Collaborative (NBC²); a National Science Foundation funded Advanced Technology Education Center.
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Colman Casey, Ph.D
Dr. Casey is currently employed by the University College Cork and responsible for setting up a training partnership between universities, technical institutes and the National Training Authority in Ireland (Fás) to service the needs of the pharmaceutical industry. He spent seven years as General Manager of an FDA/EMEA regulated multinational biopharmaceutical manufacturing company with over 900 employees. He managed almost $200 million of capital investment projects covering additional capacity and associated infrastructure and CGMP upgrades.
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Alison Demarest
Alison Demarest has more than 20 years of experience in biotechnology and FDA-regulated industries under GMP and GLP, in both consulting and operating companies.
She is a principal of Meridian BioGroup LLC, a compliance and validation service provider to the Maryland biotech community. Prior to Meridian BioGroup LLC, Ms. Demarest was director of quality and regulatory for BioReliance, an Invitrogen company and one of the largest contract biosafety/toxicology testing firms in the world.
She is a member of the PDA TRI Education Advisory Committee and a contributor to the ISPE Professional Certification Commission exam.

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Barry Friedman, Ph.D

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology and Aseptic Processing Arena. Dr. Friedman was most recently associated for seven years with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD, as the Director, Quality Control. Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill ‘n Finish manufacturer located in Baltimore, MD.

Dr. Friedman has over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include quality control, sterilty assurance and fermentation technology. In addition to the associations listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

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Collins Jones, Ph.D
Dr. Collins Jones is the coordinator for the Biotechnology Program at Montgomery College. In this capacity he works closely with a number of leading Biotechnology companies in Montgomery County including BioReliance, Human Genome Sciences and QIAGEN Sciences to develop and implement a curriculum that is current and industry relevant. The curriculum provides laboratory based instruction in proteomics, genomics, immunology, tissue culture, high throughput methods, and biomanufacturing including bioprocessing. In addition to his duties at Montgomery College, Dr. Jones serves as adjunct professor and advisor to the Biotechnology Masters Degree program offered by the Johns Hopkins University and is a consultant and facilitator for Team Business USA. He is also a co-founder of TechnoVisions, a company dedicated to creating multimedia resources for the Biotechnology community.
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Alex McClung
Mr. Alex McClung has more than nineteen years of experience in Manufacturing, Quality and Regulatory Affairs management. He has worked with companies of all sizes from start-ups to Fortune 500. Mr. McClung has led more than 20 US and international regulatory inspections, including FDA audits, that have opened multiple overseas markets and secured or defended domestic franchises worth over $4 billion/year. He has directed and collaborated in the production and commercialization of several drugs such as Neupogen®, Neulasta®, Epogen®, Procrit® and AraNesp®. Alex McClung has developed several regulatory documents for medical device and biotech product approvals, and executed corporate regulatory strategies to achieve unique de novo product classifications to protect patent positions and create substantial barriers for competing products. He has led multi-layered organizations of up to 300 people and managed inter-departmental budgets of over $35 million.
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Semih Oktay, Ph.D
Dr. Semih Oktay is the President and founder of CardioMed Device Consultants. Prior to founding CardioMed, he was Vice President of Regulatory Affairs and Engineering at MicroMed Laboratories, Inc (Petaluma, CA). In this capacity, Dr. Oktay provided engineering and regulatory consulting services to the medical device and related industries, and managed MicroMed's east-coast office.
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Paula Shadle, Ph.D
Dr. Paula Shadle is founder of Shadle Consulting, which offers consulting services for biotechnology and biopharmaceutical firms in quality, process development, and strategic planning to build quality systems. Prior to founding Shadle Consulting, Dr. Shadle worked in technical and quality control/assurance positions of increasing responsibility at Chiron Corporation, Scios Inc., GlaxoSmithKline PLC, and Bayer Corporation. At GSK she was director of downstream process development and biopharmaceutical quality operations, and oversaw QA, QC, analytical methods, and validation. Dr. Shadle was director of quality control of marketed products at Bayer Corporation.
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Ben Woodard
Mr. Woodard is the Director of the University of Maryland, Bioprocess Scale-up Facility. He is an experienced laboratory manager and department director with over twelve years of fermentation, cell culture and production purification experience. Before obtaining his present director position at the University of Maryland, he was the Manager of the Bioprocess Scale-up Facility. Mr. Woodard is an established instructor and has managed many of the University of Maryland's key outreach programs.
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