Archives: Speakers

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.

Ph.D. Team/Project Leader with 20 years progressive experience in Global Bio/Pharmaceutical Development from Discovery to Clinical and Commercial Manufacturing. Lead increasing multifunctional groups of scientist, engineers and managers. Thrive in high-pressure environments of biotech start-ups, medium size companies, Big Pharma, CRO/CMO and virtual companies focusing on accomplishments and timely delivery of milestones. Adept in pharmaceutical project management, vendors and contract team management. Certified Project Manager and Supply Chain Manager.

Fabio is a Pharmaceutical Professional with almost 25 years of experience in the industry. He graduated from the University of Amsterdam with a Master’s degree in Medical Biology. He started his career in Clinical Operations working for Pharma, Biotech and various Clinical Research Organizations. Subsequently, he moved across to the Quality Assurance arena where he has spent the last 17 years of his career in various roles of increasing importance . Currently employed at Norgine as Director Global Quality, Fabio’s responsibilities include GCP, GLP, Commercial Quality / Codes of Practice, Competent Authority Inspection Management and he acts as Clinical Development, Medical Affairs and Regulatory Affairs Quality Business Partner. Following Brexit and after a 3-year tenure as deputy, Fabio assumed the role of  EU QPPV for Norgine in 2022 – a role he executes in parallel to his Quality role.

Dr Antonini received her M.D. from the University of Rome “La Sapienza” Magna Cum Laude, with Top Honors in all examinations. She has a PhD in Clinical Pharmacology. In more than 30 years of experience in Pharma Industry Dr Antonini has played a key role in many successful programs of drug development, capitalizing on her scientific leadership and on-the-job experience in the designing, implementation and interpretation of clinical trials. Among Dr Antonini’ accomplishments are a substantial contribution to the clinical development of a number of products in the cardiovascular (including but not limited to biomarkers and medical devices), internal medicine, metabolism, respiratory, oncology, immunology and neuroscience area. Dr Antonini has established valuable relationships and collaborations with many key scientific leaders in a number of therapeutic areas and this allowed her to build an innovative, strong partnership with Italian and International Academia in the field of Clinical Research.  As a peer interlocutor of Academy members Dr Antonini has been invited to be Lecturer in various Universities, has authored several peer-reviewed articles and has been invited as speaker in International events in the areas of Pharmaceutical Medicine, Methodology of clinical trials and Pharmacology.

Philibert is currently Head of the Vaccines patient Office for GSK Vaccines in Belgium. He is coordinating  patient insights gathering for clinical and medical projects, and internal awareness on the impact of diseases and vaccination.  He has been working in the Pharma industry for the past  15 years in the US, Canada, France and Belgium, in a variety of roles, such as Auditing, Key Account Management, Ethics and Compliance, and now Patient Office.

Michael is responsible for a team of 11 people and the overall delivery of the conducted studies. The group runs several studies in different indications with a clear focus on rare diseases. In 2016 AOP Orphan received approval for one new product (RAPIBLOC®). In 2019 AOP received the marketing authorization for their first biological (BESREMi®), after completing a series of clinical studies and successfully passing a series of EMA inspections under Michael’s responsibility.

Before joining AOP Orphan Michael has been operations manager for Haemophilia at Baxter.
Michael has many years of experience as a project manager and learned the job in clinical research from scratch starting as CRA at Amgen.
Michael received his Ph. D in biochemistry from the University of Vienna.

Experienced Innovation & Learning Specialist with a long history of working in the pharmaceuticals industry (20+ years) representing both pharma and CRO. Consistently rated as high performer, skilled in digital product development, learning & development and drug development.

Hasse is currently holding the position of Director of External Clinical Project Management at LEO
Pharma, a Danish mid-size pharma company focusing on dermatology. He has almost 20 years of
experience in the pharmaceutical industry and has for the past 12 years worked in different position
focusing on externalization and outsourcing in both research and development.
In his current position, Hasse is working to establish an alternative operating model for outsourcing
clinical trials at LEO Pharma and is furthermore responsible for the Clinical Trial Supply and
Partnership Management groups within Global Clinical Operations.