Who We Are
Fenton Fong, MSc.
Founder & Principal at xCellarate
•30 years of combined corporate and consulting experience in Pharma, Biotech and related industries.
•Execution of GMP consulting projects in China, Malaysia, USA, France, Nigeria, Cuba, Peru
•ISO9001:2015 certified Lead Auditor
•PDA Journal Editorial Board member
More of my bio...
Hi there, my name is Fenton, thanks for visiting xCellarate's site!
I've been working in the regulated healthcare products industry for over 25 years. My career is focused on Pharmaceuticals and Biotechnology and has evolved to include other related industries such as Medical Devices, Natural Health Products/Dietary Supplements, and more recently legal Cannabis.
My passion and skills lie in three broad areas of regulated healthcare products: Manufacturing, Quality and Regulatory Affairs. It seems that everything I do and the projects that I get involved in all these years somehow always fall within these three areas.
I still remember the first time I came across the term "Biotechnology" way back in my undergraduate years, while conducting a scientific literature search in "the library stacks", for a term project. -ie. long before the internet age and digital downloads! Something stirred deep inside when I came across this term, it was a pivotal moment of discovery of career direction for me.
I started out working in a fine chemical production plant, then in life science R&D laboratories, getting my work published, and eventually obtained my MSc. My career expanded into biopharmaceutical product development and commercial manufacturing, followed by Quality Assurance and Regulatory Affairs interaction with Health Canada & US FDA. My career naturally evolved into industry consulting, I've had an interesting and varied career journey that continues to take me down new avenues.
I enjoy sharing my knowledge and experience with clients and helping them with problem solving, execution of complex projects, and providing value-added solutions. We learn and grow together, the relationships that I've built and continue to build along the way are at the core of my purpose.
Feel free to contact me, we hope that xCellarate may be of service to you!
Fenton Fong, MSc
Corporate career highlights which I bring to xCellarate's clients:
Provision of consulting expertise to over 75 different company clients representing numerous product brands
Clients & GMP projects based in Canada and worldwide (Cuba, China, Singapore, Malaysia, Peru, Nigeria, USA)
Conduct of numerous GMP Quality & Compliance Audits
Ground-up development and implementation of a QMS management system for a state-of-the-art sterile biopharmaceutical product production facility (Health Canada GMPs, USFDA cGMP and EU regulations for aseptic processing)
Member of technical team responsible for coordinating the design of cleanroom facility, procurement of major equipment and contractors for facility construction and facility commissioning.
CMC Technical writer & team member for a successful NDA submission and US FDA approval of a block buster parenteral biopharmaceutical product
Compiled regulatory filings and strategy for variety of product types
Delivery of numerous GxP Training courses
John Simon, BSc., RAC, CQA, RQAP-GLP
•30 years of experience in Pharma, Biotech, Med Device and related industries in Alberta, 18 years as a consultant in Quality Management and Regulatory Affairs
•Certified Quality Auditor through the American Society for Quality. RAC Certification through the Regulatory Affairs Professional Society. RQAP-GLP Certification through the Society of Quality Assurance
•BSc (Biological Sciences), University of Alberta, 1991
•Product development and commercialization professional with 25 years of experience. Led and managed implementation in design and development, Quality Control and Regulatory Affairs for Medical Device, Natural Health Products, and therapeutics.
•Certified ISO13485 Lead Auditor, ISO 9001 Lead Auditor
Bruce Girton, MSc.
•32 years experience in small-molecule pharmaceutical development, with emphasis on analytical chemistry and quality control, including extensive experience with multi-functional CMC teams.
•Managed diverse programs from target selection/validation through clinical development and delivery.
•Subject matter expert in pharmaceutical analysis, including method development, method validation and method transfer, physical and chemical characterization of drug substances and reference standards, impurity profiles of drug substances and drug products, and stability studies.
•Versatile, innovative, productive and goal-oriented researcher, recognized for excellence across multiple disciplines, able to recognize and resolve technical, quality, regulatory, and organizational challenges encountered by pharmaceutical organizations.
Brian Tham, BSc., MBA
Brian Tham has over 20 years of experience in a variety of manufacturing, development and project management roles throughout the biotech industry.
Prior to Peregrine Bio, Brian served as Director of Project Management at Novavax, Inc., where he implemented a new, highly flexible CMC governance structure for a portfolio of vaccine development and cGMP manufacturing programs. Brian also led strategic initiatives for partnering opportunities related to a novel vaccine adjuvant.
Previously, Brian worked at GlaxoSmithKline as a Project Manager, leading cross-functional teams responsible for both in-sourcing and out-sourcing projects at all stages of development and commercialisation.
From 2004 to 2012, Brian was employed by Human Genome Sciences, where he had a leadership role in the design, construction, startup, validation and FDA inspection of HGS’ first commercial-scale, cGMP manufacturing facility. During this time, Brian also served as the Project Manager for several cross-functional BDS, CMC and manufacturing outsourcing programs.
Before moving to HGS, Brian worked at Lonza Biologics in a succession of manufacturing, process controls and project management roles culminating in a position as Process Lead for the design, construction, startup and validation of a 4 x 20000 L scale cGMP manufacturing facility.
Brian received his Masters of Business Administration from Georgetown University in 2010, and his Bachelors of Science in Microbiology & Immunology from The University of British Columbia in 1999.
Bob Valdes, MSc., MBA
Bob has over 25 years of experience in the GMP Manufacturing sector and currently serves as co-founder of Biotech Resources Group and UltraForce BioSolutions. Prior to BRG, Bob was Director, Large-Scale Manufacturing at Human Genome Sciences (now GSK) where he oversaw the manufacture of HGS’ first commercial product. Bob was the first manufacturing engineer hired by HGS in 2000 for their Large-Scale Manufacturing facility design effort where he was very hands-on from Business Concept to Commercialization.
Prior to Bob’s 12-year tenure at HGS, he was employed by Lonza Biologics (US/UK) from 1994-2000 in various positions in GMP manufacturing design, start-up, and operations. His first job as an undergrad, Bob worked near Boston at Charm Sciences as a pilot-plant microbiologist where he cultivated, lyophilized, and tested a variety of microbes.
Mr. Valdes holds Master’s Degrees from the University of Massachusetts and Johns Hopkins and a B.A. in Microbiology from the University of New Hampshire.
Ali Ardakani is a technical and entrepreneurial corporate development and operations biotech executive with over 20 years of experience in managing life science projects and companies. His experience includes managing R&D projects in the areas of oncology, respiratory, infectious disease, CNS therapeutics and medical devices, as well as fundraising, licensing and M&A.
Ali is the Founder & Managing Director of Novateur Ventures. To date, Ali has taken several projects from concept to FDA approval, including several 510(k)s, PMA for medical devices and several FDA INDs. He has also worked on commercialization and pharma partnerships, as well as several global mergers and acquisitions.