Carmen Bellebna is a seasoned professional in the medical device and healthcare technology sector, with a diverse background spanning biotechnology, quality management, and regulatory affairs. She holds multiple advanced degrees, including a Master’s in Health and Medical Management, and diplomas in Biotechnology and Industrial Engineering.
Currently, Carmen serves as the Director of Quality & Regulatory Affairs at Deepeye Medical GmbH, where she spearheads the CE marking process for AI-powered medical device software. Her focus is on Software as a Medical Device (SaMD) in the ophthalmology sector, specifically working on treatment planning systems for neovascular Age-related Macular Degeneration (nAMD). Her expertise in implementing quality management systems compliant with MDR 2017/745 and EN ISO 13485 ensures cutting-edge medical software meets rigorous regulatory standards.
With over two decades of experience, Carmen has held key positions at notable organizations such as TÜV SÜD PS GmbH, where she worked as a Lead Auditor for medical devices. Her proficiency extends to auditing quality management systems, assessing technical documentation, and evaluating sterilization processes across various medical device categories.
Wafaa Hassan, MSc, is a Senior Pharma Analyst in the Digital team at GlobalData’s London office. Her responsibilities involve writing reports and providing insights on digital strategy across disease areas and channels. Prior to working in the digital team, Wafaa worked in the thematic research team at GlobalData, where she contributed to quantitative and qualitative analysis reports on disruptive themes and technologies, with a focus on Pharma, Healthcare and Medical Devices sectors. Prior to joining GlobalData, Wafaa studied for an MSc in Healthcare Management at City, University of London.
Chloe has spent the last 10 years working within healthcare communications, gaining experience across advertising, medical strategy and education and clinical trials. Her experience spans the full product lifecycle, from protocol review and early phase clinical trials through product launch and then lifecycle management. Through this she has worked with a broad stakeholder group including marketing, medical affairs, clinical development and operations, market access and field force teams, as well as with small, medium and big pharma.
Chloe is a strategic thinker and loves partnering closely with her clients to really understand their challenge. She is skilled at bringing in the right expertise at the right time to enable her clients to think further about the work they are doing, innovate when needed and ultimately deliver for the best outcomes for patients. In her current role, Chloe provides strategic leadership to her clients across a range of site engagement activities, from standalone IMs through to broader strategic communication planning for sites. She is passionate about creating programmes that allow true collaboration between site and sponsor, enabling studies to perform well and build relationships that last beyond the end of a single study.
Chloe has worked across a number of therapy areas with extensive experience in rare disease, oncology, ophthalmology and gastroenterology. Prior to working within healthcare communications, Chloe gained a degree in Human Biology from the University of Birmingham and further training in Human Nutrition.
Lina Gaggi, Product Manager, has over 10 years’ experience in computer engineering developing and delivering the products that customers want. With a keen eye for user needs, she knows how to find the right solution that reduces complexity and makes software enjoyable. Focusing on the life science industry at this stage in her career, she’s a dedicated product manager that can distill the big picture in order to find robust solutions for small tasks, that in the end deliver value to customers.
Jeffery Wong is the Senior Director, Strategic Partnerships & Client Services at Nucleus Network, one of the world’s largest Phase I Clinical Trial Service provider with operations spreading across both Australia, the USA and the UK.
A strong business development professional, Jeffery graduated from RMIT University, holds a Masters in Business and Biotechnology with a major in Pharmaceutical Sciences. During his 20 years with Nucleus Network, Jeffery has seen the growth of Nucleus Network from a 24 bed not for profit organisation to its current capacity of over 400 phase I beds spread across the globe.
Jeffery has a passion in supporting industry members to achieve their clinical development goals and leverages on his extensive knowledge in business development, project operation, clinical study design and regulatory affairs.
Paul Larochelle currently serves as Senior Director (Planning Team Lead) for Global Clinical Supply Chain at Takeda, where he serves as a member of the GCSC Leadership Team and is responsible for managing a team of professionals overseeing the forecasting and planning of clinical study supplies. His role encompasses the strategic and operational aspects of clinical supply chain management in therapeutic areas such as oncology, neuroscience, gastrointestinal diseases, vaccines, and rare diseases. Paul’s leadership extends to cross-functional projects aimed at implementing new capabilities, conducting due diligence of potential acquisitions by the company, and improving existing processes.
Previously, Paul held various roles at Biogen Corporation and Genzyme, a Sanofi Company, where he honed his expertise in clinical asset planning and clinical supplies management. His contributions to these organizations included serving as a lead contact for multiple clinical programs, developing supply chain strategies, leading continuous improvement projects, and serving as Fellowship Coordinator and Student Preceptor for dozens of students.
Paul has a BS in Biology from Providence College, PharmD from MCPHS Boston, and an MBA from Worcester Polytechnic Institute. He also completed a Post-PharmD Industry Fellowship in Clinical Research/Investigational Product Management with MCPHS-Worcester and Genzyme Corporation. He is Chair of the Dean’s Advisory Board at MCPHS School of Pharmacy – Boston, a member of the Pharmacy Advisory Board at Western New England University, and a member of the Advisory Board for the Clinical Trial Supply global conference series.
Chris has over 35 years’ varied supply chain experience, having worked for several blue chip companies in a number of industries including 3rd party logistics services, automotive, medical device, nuclear fuels and biotech/pharmaceuticals.
Originally from the UK but now based in Switzerland, he has been involved in life science – biotech/pharmaceuticals & medical device – for over 20 years of his career and has latterly been SVP Global Supply Chain at Clover Biopharmaceutical before last year moving to Argenx as Head of Distribution.
He has developed, implemented and managed global healthcare supply chain strategies and operations on 6 continents. This has included different set-ups in multiple countries, including many in the Emerging Markets as well as the developed world.
Chris has a degree in economics from Manchester University, an MBA from Aston University and a postgraduate diploma from London University. In his spare time, he plays golf badly and loves to sample great Italian food and red wines!
Monika Martyka has over 14 years of experience in clinical research and currently serves as Director of Clinical Operations at TFS HealthScience. She leads complex clinical projects, overseeing cross-functional teams, optimizing clinical processes, and ensuring alignment with regulatory standards. Monika excels in managing the intricacies of clinical trials, including protocol development, patient recruitment, and compliance, while driving operational efficiency to meet critical milestones.
Her expertise in both clinical and operational management has made her a key player in advancing healthcare through rigorous research methodologies. Dedicated to fostering collaboration and innovation, Monika is committed to the successful delivery of high-impact clinical trials that contribute to the development of cutting-edge therapies and improve patient outcomes globally.
