Clinical Operations Leader with extensive industry and clinical trial management experience with ability to manage high-performance teams and develop cost effective solutions.
Experience covers a multitude of aspects of clinical programs in Phase I, II, III, IIIB, and IV, globally.
Ethical and sequential problem solver with multi-therapeutic acumen in clinical study management;
and a proven track record of establishing, strengthening, and improving the processes and infrastructures through interfacing with various arms of organizations including Regulatory Affairs, CMC, Project Management Teams, and other KOLs and clinical team members.
Experienced Supply Chain professional and Certified Lean Greenbelt Champion with a demonstrated history of working in the pharmaceutical/biotechnology industry. Skilled in Supply Chain Strategy, Operations Management, Cross-Functional Leadership, and Continuous Improvement.
A result-oriented technical leader with extensive drug product (solid oral, oral liquid, parenteral) development experience ranging from Discovery Support through clinical development.
- Direct experience in managing multiple CDMOs to plan, coordinate, and execute external drug product development and manufacturing activities.
- Proven record of excellence at project management, workflow development, innovative technology implementation, and timeline/budget management.
- Technical expertise: pre-formulation, formulation and process development, biopharmaceutics, and PBPK modeling.
- Broad knowledge in drug development and direct experience in managing CMC team functions within multi-disciplinary (Discovery, CMC, Drug Safety, DMPK, Clinical Operations) development team.
- Highly collaborative, change-agile, and strong problem-solving ability in a fast-paced matrix environment.
23+ years of analytical, formulation and process development from early clinical to commercial products. More than 12+ years in cross-funtional team project, tech transfer, scale-up manufacture and CRO/CMO management.
Specialties:
Tech transfer, optimal lyophilization, GLP/GMP investigation, problem-solving skills.
Formulation concepts and development strategies for oral, parenteral, ophthalmic, topical and inhalation products, including nano-emulsion and nanotechnology.
Preformulation, shelf life prediction, specifications, protein stability and CMC.
Take initiatives. Strive for quality, teamwork, and honest communication.
Gerrit Nijveldt is currently Labeling consultant with EASi. Gerrit has more than 20 years of experience in Global labeling. He has a broad experience in developing and maintaining Company Core Data Sheets, US Prescribing Information and EU Summary of Product Characterisation, including the labeling for multiple development products (early phase to approval) and labeling for devices.
Gerrit is also an associate adjunct professor for Temple University School of Pharmacy teaching Global Labeling in the Quality Assurance and Regulatory Affairs Master’s Program.
Gerrit earned his MSc in Medical Biology from University of Utrecht in the Netherlands and started working in pharmaceutical industry in 1991, in the Netherlands, in Regulatory Affairs and Medical Information department
Vince Calderon is a Project Director at PSI CRO and is an experienced research professional working in the CRO setting for over 15 years. The majority of those years has been working in Oncology and Hematology studies in a variety of solid and non-solid malignancies. Vince Calderon has earned a Master of Business Administration from St. Edward’s University, a Master of Science in Health Research from Texas State University, and a Project Management Professional certification from the Project Management Institute.
Peter Shapiro, PhD, is the Senior Director of Drugs and Business Fundamentals for the Pharma Intelligence Center. He also serves as the Editor-in-Chief of GlobalData PharmSource. Peter previously was involved in the leading the integration of BioPharm Insight, Lead Sheet and PharmSource into GlobalData.
Prior to joining GlobalData, Peter was an Assistant Manager at Target Health, a Contract Research Organization (CRO) where he helped a diverse set of clients with the demands of bringing biologics, devices, and drugs to the market successfully. Peter also worked in small molecule drug development for Abbott Labs and on in vitro diagnostics at Ambergen, a diagnostic startup. Peter holds a PhD in Molecular and Cellular Biology from the Sackler Institute of New York University Langone Medical Center and is located in GlobalData’s office in New York City.
Ben is the CEO of LedgerDomain, founded in 2016 to bring blockchain solutions to enterprise ecosystems, unlocking a world of communal computing and real-time performance. After doing undergraduate and graduate work at MIT, Ben spent a quarter of a century incubating and investing in early-stage technology companies. In partnership with the Clinical Supply Blockchain Working Group (CSBWG), the world’s largest pharmaceutical blockchain consortium, LedgerDomain developed the world’s first iOS blockchain app for the clinical supply chain. In 2019, LedgerDomain also partnered with UCLA on a pilot for the US Food & Drug Administration (FDA) on a last-mile application that helps deliver lifesaving medications to babies.
