Archives: Speakers

Michael’s background spans contract and proposal development; contract negotiations in multiple languages; set up and management of vendor oversight and governance programs; and related change management. He has worked for CROs as well as small and large biotechnology companies. Over the course of his career, he has worked on clinical development of 23 compounds currently marketed in 1 or more therapeutic indications.

Aditi Khurana, is an Associate Director of Project Management with Jazz Pharmaceuticals, Palo Alto, CA. She is a Project Management Professional (PMP) and is certified in Global Regulatory affairs (RAC). She holds a Bachelors in Neuroscience from University of California Los Angeles, and a Master of Business Administration from University of Illinois Urbana-Champaign.

She has 11 years of combined experience working initially in the biomarker identification, companion diagnostics & assay development space as an ASCP licensed Clinical Cytogenetics and Molecular Biologist, and later in project management roles leading planning for clinical development and regulatory submissions deliverables.

Key areas of focus include study concept development, IND and BLA submission planning, decision frameworks and developing strategic roadmaps for global product success.

Patrick is heading the Department Quality in Distribution, Artwork and Product Security @Merck since 2014. In this role he is deeply involved in all topics around distribution, warehousing, GDPs, validation and qualifications, risk assessment, etc. With his team he controls the worldwide shipments leaving all Merck manufacturing sites or CMOs.

Before joining Merck Patrick was working as GMP and GDP inspector for the Austrian national Health Authority. Being responsible for international inspections he gained a lot of insights into the pharmaceutical world and quality practices of various pharma companies. As a member of the GDP drafting group at the European Health Authority EMA he was deeply involved in the generation and implementation of the EU GDP guideline.

Patrick has also a broad knowledge in QC testing and product release as he worked in different QC labs for 11 years. He is a biotechnologist by training with a Master’s Degree of the University of Applied Science in Krems, Austria.

Georges France is leading the Quality integration process for GSK Consumer Healthcare further to the JV with Pfizer Consumer Healthcare in August 2019. Before that Georges was leading Quality globally for the Local Operating Companies (LOC) for the GSK Consumer Healthcare division. Prior to joining GSK, he was with at Novartis since March 2012. He previously worked at Pfizer as a Vice President of Global Quality Strategy and Global Affiliates Quality and prior to that, worked at Wyeth for 12 years.

Georges holds a Doctorate in Pharmacy and a Post-Graduate Degree in Pharmacology and completed the INSEAD Advanced Management Program.

He was EPFIA topic leader in the Expert working Group for the ICH Q10 guidelines regarding the Pharmaceutical Quality System as the ICH Q8, Q9 and Q10 Implementation Working Group. Today he is an EFPIA Expert for ICH Q12 Expert Working Group.

Marc Evrard is Global Logistics Validation Manager at Vifor Pharma in Switzerland. He is responsible for temperature, risk and generally speaking Good Distribution Practices compliance and emerging trends. Marc studied international business and tax law, he has a background working in the Telecommunication and Air freight before joining the Pharma industry. He has been working as clinical trial distribution project manager, in commercial transport operations and in transport validation before joining the Vifor Pharma Global Logistics team in February 2018.

Jennifer is a senior life sciences executive with over two decades of experience turning breakthroughs into life-saving treatments. Jennifer has successfully contributed to the global approvals of seven novel treatments, generating $20B value creation.

Jennifer has business expertise in R&D leadership, strategic planning, business revitalization, global operations, and regulatory compliance.

Jennifer received a B.S. in biochemistry and an M.S. in clinical research and regulatory administration.