CONTINUUS has assembled a world-class advisory team to ensure successful completion of our ICM (Integrated Continuous Manufacturing) Factory Project, enabled by our recent $69.3M contract with the United States Departments of Defense (DoD) Health and Human Services (HHS).
We are excited to welcome:
Moheb Nasr (Senior Regulatory Advisor), Franco Pieropan (Senior Quality and Compliance Advisor), Jim Powers (Senior Quality Systems Advisor), Steve Dreamer (Senior Pharmaceutical Engineering Advisor), Richard Priester (Senior Engineering and Construction Advisor).
Learn more about our newest advisory board members, and how their expertise will help us accelerate the delivery of high-quality and affordable critical care medicines to patients through our state-of-the-art ICM process.
Senior Regulatory Advisor
|Moheb Nasr is the Principal of his own consulting company, Nasr Pharma Regulatory Consulting (NPRC). NPRC was established in February 2018 and provides regulatory consulting with a focus on pharmaceutical manufacturing innovation and CMC regulatory strategy. Dr Nasr serves as a senior regulatory advisor for several chemical and biopharmaceutical companies in US, Europe, and Asia. In addition, Dr Nasr continues to play a leading role in global regulatory harmonization and introduction of modern pharmaceutical manufacturing platforms, including Continuous Manufacturing.
Dr. Nasr retired from GSK in August 2017. AT GSK, Dr Nasr was responsible for the development and the execution of GSK's global CMC regulatory strategy. In recognition of his scientific and regulatory contributions, Dr Nasr is an elected GSK Senior Research Fellow. Prior to joining GSK, Dr. Nasr spent over 22 years at US FDA, where headed the CDER CMC regulatory office. Dr. Nasr represented FDA and PhRMA at ICH, and was instrumental in the development of the Quality by Design (QbD) concept and several regulatory ICH guidelines.
Dr. Nasr obtained his Pharmacy and MS degrees at the University of Cairo, Egypt, and his Ph.D. degree in Chemistry at the University of Minnesota in Minneapolis, Minnesota, USA. Dr. Nasr is an elected Fellow of the American Association of Pharmaceutical Scientists (AAPS) and the recipient of AAPS Regulatory Science Achievement Award and numerous academic and US Government awards.
Senior Quality and Compliance Advisor
|Franco Pieropan recently retired from GSK, where he was the Senior Vice President of Quality at the Research Triangle Park office. He provided leadership, direction, and focus for Quality, ensuring that all products managed by Pharma R&D and Pharma Supply Chain met all Quality standards. Prior to this role, Franco was SVP Quality for the GSK Global Manufacturing & Supply organization.
With his 35 years of management experience (28 with GSK), Franco has an in-depth knowledge of pharmaceutical manufacturing plant products, processes, markets, and regulations. During his career, he successfully led laboratories and manufacturing sites, managed technically complex dose forms, developed and industrialized new products for international markets, and introduced innovative technology within a highly regulated environment.
Franco graduated in Chemistry at the University of Padua in Italy.
Senior Quality Systems Advisor
|Jim Powers is a quality, compliance, and lean leader with over 30 years of experience in working with biotech, pharmaceutical, cell and gene therapies, aseptic/sterile products, vaccines, generics, and APIs.
Professional experience includes over 30 years in leadership positions with Wyeth and Pfizer with a focus on quality, design and implementation of compliance/GMP-based solutions across global businesses, including quality systems, laboratory excellence, quality culture, deviation management, CAPA, change control, gemba walks, data Integrity and notification to management. Direct experience includes working with boards of health, including the FDA.
Jim chairs the ASTM E1578 Standard Laboratory Informatics Guide work group responsible for developing and updating open ASTM international standards on Laboratory Informatics.
Jim has a B.S. in Biochemistry from Penn State U. and a Masters of Science Administration. Jim is formally trained in Lean / Six-Sigma and Project Management.
Senior Pharmaceutical Engineering Advisor
|Mr. Dreamer is a recognized advisor to the pharmaceutical industry with eight years of consulting experience in, Senior Management coaching, Quality & Validation, Lean & Transformation & Six-Sigma, Organizational restructuring, and Factory assessments. His operational experience comes from roles as a Manufacturing Operations Senior Executive of 44 years, with roles at Abbott Laboratories, Schering-Plough, Johnson & Johnson, and Novartis. Areas of management and leadership include medical diagnostics, biologics, pharmaceuticals, nutritionals, sterile products, and chemical businesses, including Development and Commercial Operations. Steve has proven expertise in running global engineering organizations and building greenfield factories. He also has expertise in developing and auditing quality systems, and a very strong ability in applying “Lean Management” principles in assessing manufacturing operations and implementing transformational improvements along with organization corrections.
As Senior VP of Global Engineering at Novartis (10 years), Mr. Dreamer was responsible for launching and managing the company-wide Six Sigma / Lean Program. Mr. Dreamer’s organization included, QbD, PAT program, Continuous Manufacturing collaboration with MIT, building a continuous manufacturing pilot plant, Process Engineering, Project Management for new manufacturing & development sites and major plant expansions ($800,000,000/year), Engineering Standards, and Engineering Quality that included Commissioning & IQ/OQ. Steve also oversaw Maintenance Management and site engineering organizations for the manufacturing & development plants.
Steve has developed and led Operational Excellence programs since 2001. He formed an industry OpEx best practice sharing forum with the top five pharma companies. Steve has extensive international experience with cross-cultural change management and organizational redesign.
Steve has worked across the globe: 22 years in the US, 15 years in Europe, and six years in Central and South America, Canada and Asia.
Mr. Dreamer has been a leading speaker at Operational Excellence conferences and contributed to multiple magazine articles and books, including The Pathway to Operational Excellence in the Pharmaceutical Industry and Leading Pharmaceutical Operational Excellence. Steve has multiple professional interviews posted on YouTube.
Mr. Steve Dreamer holds a Bachelor's degree in Electrical Engineering. He is Master Black Belt in Lean, Six Sigma, and certified in Change Management. He also has extended leadership and business education from Harvard & Tuck/Dartmouth.
Senior Engineering and Construction Advisor
|Richard (Dick) Priester has spent his entire career engaged in the design and construction of process facilities. Since the early 1990’s, this has been exclusively in the biotechnology and pharmaceutical industries. As head of engineering for Biogen, he led the opening and development of the manufacturing site at Research Triangle Park, North Carolina. Since 2000, he has been an independent Owner Representative for pharmaceutical and biotech companies across New England, managing a large variety of FDA licensed manufacturing facilities.
Over the years, Dick has been active in ISPE (International Society for Pharmaceutical Engineering), first as a founding member of the Boston Area Chapter. He subsequently served on its international board of directors for seven years in various roles, including Chairman.
Mr. Priester has a Bachelor's degree In Mechanical Engineering from Cornell University, and an MBA from the University of Michigan.