Technology Transfer

Robert has supported the development and commercialization of multiple cell therapy products and processes including decentralization of CD19+ CAR T therapies, development of hospital cellular therapy labs, including expansion of the NIH Center for Cellular Engineering, as well as the expansion of the first commercialized CAR-T therapy process capabilities. Other Cell therapy programs included remediation support for cellular and media manufacturing programs, and guidance for multiple CAR-T manufacturing automation advancements. Robert supported the COVID-19 response by establishing global safety systems for three major vaccines. He has led hundreds of international product transfers utilizing both internal transfers and CMO’s at multiple top 10 Pharmaceutical companies. He is a graduate of the Rochester Institute of Technology (RIT) with a BS in Engineering and has completed advanced degree studies as well as completing his PMP certification. He is an international speaker and author.

Mr. Lardée began his career as an Analytical Chemist in the vitamins and pharmaceuticals division at Solvay-Duphar (Netherlands), eventually advancing to the role of Analytical Expert. After several years in this position, he transitioned into Pharmaceutical Technology, where he was responsible for developing a wide range of dosage forms from toxicology and clinical phases through to market approval.

Leveraging his broad hands-on experience and strong ability to translate technical knowledge into strategic project execution, Mr. Lardée was appointed Global CMC Project Lead at Solvay Pharmaceuticals (later Abbott Healthcare Products). In this role, he supported multiple clinical programs and managed the lifecycle of marketed products.

Prior to joining ProPharma, he served as R&D Director at Centrient Pharmaceuticals, where he was technically accountable for establishing the Finished Dosage Forms franchise. Mr. Lardée brings over 35 years of experience in the pharmaceutical industry.

Simona Mills is the Director of Product Lifecycle Management in the Quality and Compliance service line at ProPharma. She has more than 22 years of industry experience in pharmaceuticals, biologics, and combination products. Simona previously worked for a CMO with its own generics line of parenteral products before joining ProPharma. Her expertise is in Quality (Validation, Quality, Quality Engineering, and Regulatory Affairs) and Project Management, with additional experience in facility construction/start-up, remediation, and people and project management. Since joining ProPharma, Simona has earned her PMP certification and has worked on a variety of projects including Tech Transfer, Compliance/QMS, Inspection Readiness, Remediation, 505(b)(2) commercialization, Auditing, etc. She established and leads the Inspection Readiness/PAI Readiness services at ProPharma. Simona Mills studied Chemical Engineering at The Ohio State University.

Dr. Eric Good is an energetic, award-winning leader with extensive domestic U.S. and international organizations. For the past 10 years Dr. Good has been a Director, Compliance & Quality at ProPharma Group. Prior to joining Propharma, Dr. Good spent 25 years in Aseptic Manufacturing, Project Management and Quality Assurance in many Fortune 500 companies. His strengths include quality systems integration and implementation, process improvement, and cross-functional working relationships. In addition to serving as Adjunct Faculty for University of Maine Systems, he has also been an Adjunct Faculty at the University of Phoenix, St. Louis campus.

Rob Turner brings 20+ years of experience and is over the Program & Project Management service line at ProPharma. He has worked across nearly every life sciences vertical, via small, large molecule, devices, and combination products companies with a mix of small, mid-sized, and top 10 life sciences companies. He has worked his professional consulting career at a mix of large, mid-sized and boutique consultancies. As an experienced life sciences strategy and operational excellence consultant, Rob has successfully delivered strategy, post-merger integration, technical, process optimization, and organizational change projects, some resulting in awards recognitions by his clients. Finally, he has also authored several thought capital pieces (across his companies) while also participating in webinars, capturing and sharing these key learnings with industry colleagues.

Gina Quati is the Director of Business Development for Europe at ProPharma, where she focuses on building strategic partnerships with companies across the DACH region and throughout Europe. With nearly a decade of experience in the pharmaceutical industry, Gina brings a strong background in operational Regulatory Affairs, Quality and Pharmacovigilance on an international scale. Her deep understanding of the pharmaceutical landscape allows her to effectively address the complex needs involved in technology transfers. She plays a pivotal role in aligning the right stakeholders, bridging cross-functional teams, and facilitating collaboration across departments and disciplines. Known for shaping optimal project scopes, Gina ensures seamless execution and outstanding service implementation throughout every stage of the technology transfer process.

Tom has been with ProPharma going on 8 years and brings over 25 years of Medical Device, Pharma & Biotech sales and management experience. Tom began his career in recruiting for some of the world’s largest pharmaceutical and medical device companies in the world. Tom moved on from recruiting into sales and has successfully led teams across the U.S. and has received many accolades and awards for his above and beyond support of his clientele. He now leads the Quality and Compliance business development team here at ProPharma.

Ewelina Czerniec-Michalik is an Associate Director at ProPharma in the Netherlands, specializing in pharmaceutical technology transfers and product life-cycle management. With a strong background in CMC, GMP and cross-functional project leadership, she oversees complex programs involving multiple CDMOs and mentors a team of project managers. Ewelina has a scientific foundation in analytical chemistry and over 16 years of experience in development and validation of manufacturing technologies, analytics and packaging. She is passionate about optimizing processes, facilitating communication and alignment across various disciplines.