Archives: Speakers

Andrea Tassone is Global Head of Sustainable Manufacturing at Pernod Ricard, where he leads the transformation of industrial operations to embed sustainability at scale across the Group’s global manufacturing footprint. With extensive experience in ESG strategy, decarbonization, and operational excellence, Andrea drives initiatives to reduce carbon emissions, enhance resource efficiency, and accelerate circularity from raw materials to finished products.

He works closely with operations, engineering, and R&D teams to translate sustainability ambition into measurable impact, supporting Pernod Ricard’s “Good Times from a Good Place” 2030 roadmap. Passionate about pragmatic and scalable solutions, Andrea focuses on aligning environmental performance with business value, helping shape a more resilient and responsible future for the drinks industry.

Izzy brings together experience in climate and nature, food and drinks systems and agriculture, helping organisations accelerate their transition to a more sustainable future. She is currently the Sustainability Manager at Asahi UK, developing their sustainability roadmap and accelerating implementation across the brewing supply chain.

Prior to that, she worked at the World Economic Forum driving their work on Nature Positive Transitions, identifying priority actions for businesses to address nature impacts and build resilience across value chains, and spent 6 months independently researching regenerative farming in the UK. She started her career at Boston Consulting Group, advising clients on climate and sustainability.

Seasoned professional with a strong background in strategic product and business development. Having collaborated with healthcare professionals and patient communities globally for over three decades, her career spans a broad range of therapy areas in diverse sectors including: Virtual Twin Technology, Clinical Trial Software, Contract Research (CRO), Digital and IT Health, Nursing and Social Care, and Medical Device and Pharmaceutical manufacturing. Currently supporting Medical Device and Diagnostics companies in EMEA taking their innovations to markets worldwide and enabled with Dassault Systèmes Virtual Twin and Medidata Clinical Trial technology and expertise.

John Thomas is Vice President of Clinical Operations and Strategic Delivery at 1MED leading global clinical delivery and operational strategies across medical device and IVD programs. With over 20 years of experience leading early-development, pivotal, and post-market clinical investigations, he supports manufacturers in generating compliant, high-quality clinical evidence aligned with evolving Notified Body and regulatory expectations. John is recognized for his pragmatic, structured approach to clinical governance, execution excellence, and regulatory-focused clinical strategy.

Nebojsa Serafimovic is Head of Unit for Clinical Investigations and Performance Studies at the Austrian Federal Office for Safety in Health Care (AGES/BASG).
In this role, he is responsible for the regulatory oversight and assessment of clinical investigations with medical devices and performance studies with in vitro diagnostics and plays a key role in shaping both national and European regulatory processes related to the implementation of the MDR and IVDR. His work includes active involvement in EU-level coordination and harmonisation initiatives, notably as Lead of the EUDAMED Oversight CA Board (CIPS), Co-Lead of the work package on coordinated assessment under MDR Article 78, and Co-Lead in one of the COMBINE projects, focusing on the interface between clinical investigations of medical devices/IVDs and medicinal products.
Previously, he worked at Philips Austria in medical device engineering and at the Medical Response Center. He studied Biomedical Engineering at Graz University of Technology and at the TGM Vienna.
Nebojsa is an active member of the Clinical Investigation and Evaluation Working Group (CIEPSE) and contributes to several European task forces aimed at further developing and harmonising the regulatory framework for clinical investigations in Europe.

I have worked with both German consulting firm and a medical device manufacturer in Germany, where I led multiple China market registration and localization (domestication) programs. I have supported numerous Class III manufacturers using proper pathway strategy, gap assessment, technical documentation, testing/verification planning, and submission management—enabling successful NMPA registrations within approximately one year. For products transitioning from EU MDR compliance to full alignment with China’s regulatory requirements and applicable national standards, I can design and deliver a comprehensive, end-to-end solution covering standard mapping, evidence generation, documentation restructuring, and registration submission support.

Noelle Saldana is Head of Research Analytics (AI & ML) for the AI/ML Innovation Studio at Fortrea, enabling clinical trial transformations with AI. With over 15 years of experience at the intersection of data science, AI, and strategic leadership, Noelle has driven transformative initiatives across startups, nonprofits, and Fortune 500 companies. Her work spans embedding intelligent insights into cloud-native applications and driving pragmatic, collaborative approaches to AI adoption. She holds an A.B. in Applied Mathematics and Physical Anthropology from Washington University in St. Louis and an M.S. in Applied Mathematics from Cal Poly Pomona.

Klas Malmén is Senior Advisor at the Swedish Financial Supervisory Authority. He holds a government mandate to represent Sweden in the EU AI Board’s subgroup on financial services. Klas coordinates the authority’s work on AI supervision and leads preparations for the implementation of the upcoming AI Act. He also served as an appointed expert in the Swedish Government’s inquiry on national legislation related to the AI Act.

Dr. Henry D. Cremisi, M.D., F.A.C.P. is an accomplished nephrologist and clinical research leader with more than 20 years of experience spanning patient care, global drug development, and CRO leadership. At Caidya, he provides medical oversight and strategic guidance across renal, cardiovascular, and immunologic programs, with deep expertise in rare and complex kidney diseases, cardiorenal syndromes, and inflammatory conditions.

Before joining Caidya, Dr. Cremisi served as Senior Medical Director and Global Medical Lead at Vertex Pharmaceuticals, where he led global medical strategy for APOL1-mediated kidney disease and supported early-phase through pivotal programs in glomerular and genetic renal disorders. His work emphasized precision medicine, biomarker-driven development, and cross-functional collaboration across clinical, regulatory, and medical affairs teams.

Board-certified in Nephrology and Internal Medicine, Dr. Cremisi trained in both clinical nephrology and translational research, with expertise in renal pathophysiology, cardio-renal-metabolic disorders, and inflammatory mechanisms underlying diseases such as IgA nephropathy, lupus nephritis, vasculitis, and diabetic kidney disease. His experience extends to drug safety, medical monitoring, and global site engagement, with a deep understanding of ICH E6(R3) compliance, ALCOA-C principles, and best practices in investigator-sponsor collaboration.

At Caidya, he partners closely with sponsors to help de-risk development programs and advance innovative therapies for patients with rare kidney and cardiorenal diseases.