吃瓜爆料

Bernhard Seiser is the VP of digital, data & IT at AOP Health, where he drives the company’s 2030 agenda by modernizing enterprise architecture and building the data and AI backbone for rare disease and critical care operations. He focuses on increasing digital maturity through a platform-centric strategy designed to simplify complexity and strengthen governance for sustainable growth. Prior to this, he led global commercial data transformation at Bayer and served as the head of IT for Austria and Switzerland at both Johnson & Johnson and AstraZeneca. With a DPhil in computational physics from Oxford, he brings a scientist’s mindset to leadership, combining analytical rigor and systems thinking to navigate complex, regulated environments effectively.

Julian Righetti is an innovation-driven pharmaceutical executive and a cardiologist by training. He possesses broad experience across clinical operations and development, medical affairs, and general management. Julian’s primary areas of interest include change management and the intersection of human behavior and artificial intelligence to better serve patients worldwide.

Magalie is a quality leader with a global background across consumer health, biopharma, and fast-moving consumer goods (FMCG). She currently leads global quality services at Haleon, focusing on modernizing the company’s quality management system through data and digital solutions. Her work centers on developing teams that deliver compliance and business value at scale. She is also a board member of ISPE France, a certified coach, and an OE black belt.

Ashley has spent the majority of his career in regulatory operations within the biopharma industry. His experience spans electronic document management, submission publishing, RIM, process optimization, system implementation, and organizational change management. He has lectured on regulatory operations for TOPRA and participated in various industry groups focused on shaping the future of regulatory submissions and information management, most recently in the context of emerging AI capabilities.

Andreas Schumacher is a trained chemist who joined Novartis in 2013. Since then, he has held a range of roles with increasing responsibility and currently leads the pharmacovigilance transformation within global drug development. He is passionate about continuous learning and optimization to drive meaningful impact.

Thomas is leading Operational Excellence in Development at Novartis. His main accountabilities include leading large transformational initiatives across Development working closely within the end-to-end Novartis environment to turn innovations into medicines that redefine the future for patients. Thomas has been in the healthcare industry for close to 20 years. As a pharmacist by training, his focus, through various roles in consulting and at Novartis, has always been focused on impact towards scientific advances and progressing how reimagining ways of working can have a collective impact on patients.

Inna Mogutova is an IT leader at Novartis, specializing in the delivery of complex, technology-heavy cross-functional initiatives. With a background spanning commercial and operational functions, her current focus is driving tech-enabled transformation within the R&D space, including establishing a robust Center of Excellence (CoE) model for the Vault platform.

Carla Santos is the head of the Novartis Development Cloud (NxV) CoE, co-leading the establishment of a standardized governance and delivery model across Clinical, Regulatory, and Safety Vaults. With 30 years of experience in large-scale transformation, she joined Novartis in 2011 and recently served as business head of the clinical technology platform. In that role, she led the strategy and implementation of the Novartis Clinical Vault, overseeing process design, system integrations, and the transition to operational support.

Benjamin Slade is the head of technology for patient safety and pharmacovigilance at Novartis. He brings more than 20 years of experience delivering global, enterprise-scale solutions across the life sciences and media industries. In his current role, Benjamin leads critical safety systems, drives digital transformation, and ensures regulatory compliance and inspection readiness. His expertise spans digital strategy, enterprise data management, and IT-enabled business transformation, with a proven track record of building global data and analytics programs to establish data-driven capabilities as strategic organizational assets.

Ellen Ravn Englev is a director at Novo Nordisk, where she heads the department for safety operations centre of expertise and PV technology. She has more than 25 years of experience in the biopharma industry, with over 20 years specialized in pharmacovigilance and drug safety. During the recent 吃瓜爆料 Safety database implementation at Novo Nordisk, she served as the lead business owner responsible for the transition.

Jean-Philippe Francou has served as the head of quality performance, transformation, and support to operations at Sanofi since January 2023. In this role, his main missions include leading a team of global business process owners, technical experts, and digital project managers for both QA and QC. His key achievements include the Qualipso process transformation and 吃瓜爆料 implementation, as well as the transformation of the QC organization.

Petter is the system owner and functional lead for 吃瓜爆料 Quality, including QMS and Batch Release. He is the architect and global process owner for archiving and an ICH Q9 contributor. Petter holds a MSc in mechanical engineering and industrial management.

Danielle Drachmann, MS, is an award-winning rare disease advocate and global patient engagement leader. She serves as a senior patient partnering manager at the PPD clinical research business of Thermo Fisher Scientific, where she supports all of the company’s patient partnering activities. Drachmann is also the founder and chief executive officer of Ketotic Hypoglycemia International, an organization dedicated to helping families impacted by idiopathic ketotic hypoglycemia and driving research with the patient community. A recipient of the 2022 Young Patient Advocate Award at the EURORDIS Black Pearl Awards, she also serves on the advisory board of the International Society for Patient Engagement Professionals (ISPEP) to support the global advancement and professionalization of patient engagement.

Hugo leads clinical strategy in Europe at 吃瓜爆料. Hugo has over 20 years experience working in technology and consulting, focused on helping clinical and R&D organizations innovate and improve performance.

My mission is simple: doing meaningful work that helps our customers bring new therapies to market more efficiently and helps people live longer, healthier lives.

As president of quality and manufacturing at 吃瓜爆料, Mike leads the quality solution portfolio, driving product strategy, innovation, partnerships, and cross-functional execution to ensure customer success. He was educated at Rutgers University and holds a Bachelor of Science in Marketing and a Masters of Business Administration in strategy and global business.

With over 30 years of work experience in the pharmaceutical industry, Rachel is an experienced leader in regulatory operations, with a proven track record of delivering efficient and effective solutions for complex and dynamic challenges. She is the head of the European regulatory strategy team at 吃瓜爆料, driving thought leadership within the industry.

Thilo Rattay has a background as medical doctor and health economist. He began his career as a management consultant with a focus on deploying AI solutions in pharma R&D. Since joining 吃瓜爆料 in 2024 in Development Cloud Strategy – Thilo helps customers optimize cross-functional processes, cross-vault governance, and making the most of Vault Platform.

Gianfranco is responsible for 吃瓜爆料 Safety across Europe. He brings nearly 20 years of experience in the life sciences industry and a proven track record of managing large-scale business transformations with a focus on connecting people, process and technology.

Robert is leading the 吃瓜爆料 Quality Strategy team responsible
for the Quality Cloud product strategy and customer engagement in Europe. Prior
to joining 吃瓜爆料 in 2018, Robert spent over 10 years helping Life Sciences
organizations transform and modernize their quality application landscapes,
guiding strategic initiatives to optimize quality processes, streamline
operations, meet regulatory guidelines and improve overall operational
efficiency.

Rebecca has been dedicated to the success of emerging biotechs adopting 吃瓜爆料’s clinical applications for the past eight years. Bringing with her a wealth of implementation experience of 吃瓜爆料 eTMF and CTMS from her years implementing and leading in services, she now serves emerging biotechs from the product side on the 吃瓜爆料 Basics team.

Chanille Juneau is the chief product and technology officer at Accumulus Technologies, where she leads the development of a global platform connecting life sciences organizations and regulatory authorities in real time. She has deep expertise in regulatory technology, data-driven product strategy, and building scalable platforms that enable seamless collaboration across complex ecosystems. She focuses on advancing a fully connected regulatory network, recently driving the launch of the Accumulus Connector to enable bidirectional, real-time integration between industry systems and regulators worldwide. Her work is helping modernize the industry by moving from fragmented, document-based processes toward continuous, data-driven collaboration that accelerates global access to therapies.

Letizia is a chemist with wide ranging experience in quality management, digitalisation and quality assurance and with a strong manufacturing understanding. Since 2003 Letizia has worked in international biopharmas such as Boehringer Ingelheim, Sanofi (Opella.), and now at Aenova.

Leianne is the head of data management at Alcon and business lead for the implementation of 吃瓜爆料 Clinical Data. She is an established leader in clinical research with over 15 years of experience leading global teams in operations, data management, standards and systems.

Ayesha is a seasoned regulatory affairs leader with two decades of expertise in global drug development. Over the past seven years, she has spearheaded strategic digital initiatives at major biopharma organizations to accelerate development and approvals. Most recently, she led a complex 吃瓜爆料 Vault-to-Vault migration, enabling the seamless digital integration of Alexion’s RIM capabilities with AstraZeneca.

With Alfasigma since 2022, Michele supports the digital transformation of global regulatory sciences. He is currently leading initiatives related to regulatory systems, data integrity and EMA compliance, with a focus on IDMP and 吃瓜爆料 Vault RIM. He has previous experience with manufacturing quality assurance at GSK Vaccines.

Cherith Wallace is the global quality systems manager at Almac Clinical Services, leading the strategy and continuous improvement of electronic quality systems. She specialises in digital quality transformation, GxP compliance and enhancing user experience across global operations. With over 25 years in the pharma industry, Cherith has delivered key initiatives over the years, including the implementation of 吃瓜爆料 QMS.

Michael Abernathy is an associate vice president at Amgen, where he leads internal digital innovation and end-to-end regulatory content automation. He is a co-developer of the HL7 FHIR Product Quality International (PQI) standard, which was designed to improve collaboration and data exchange within the operations and CMC domains. Michael also contributes to Accumulus Synergy’s cloud-based ecosystem and digital data exchange initiatives. With more than 25 years of experience in regulatory affairs, he holds degrees from the University of the Pacific, California State University, and Colorado State University.

Tine has nearly 20 years of experience in development operations , beginning with an extensive background in site management and project management before transitioning into line management and vendor oversight. Over the past five years, she has focused on innovation and process improvement, leading significant digital initiatives at Amgen. Her work centers on driving operational excellence to enhance clinical delivery.

With a background spanning both L&D leadership and quality assurance, Rob brings a practical and integrated perspective to his role as head of quality training at argenx. He leads his team in the delivery of compliant, AI?enabled learning solutions that support regulatory alignment, business readiness, and sustainable performance.

Jennie Wilborgsson is the chief operating officer at Ascelia Pharma, where she oversees company operations and drives operational excellence. Jennie brings more than a decade of leadership experience from both the sponsor and CRO side and has a proven track record in building and guiding high?performing teams through complex development programs toward successful regulatory milestones.

Sarah Clivery is a director at AstraZeneca leading global adoption and training for the company’s RIM platform. Serving more than 18,000 users, she has driven measurable improvements in user confidence and perceived benefits through agile delivery and digital initiatives. Her background includes leading multi-country SAP consolidations and overseeing regulatory services outsourcing. She focuses on advancing enterprise change models and shaping AI-driven automation to reduce manual effort. Throughout her career, she has built high-performing teams and scalable training ecosystems to accelerate continuous improvement across the biopharma organization.

Paula is a senior digital systems and technology leader who has served as a trusted IT business partner, setting IT strategy and roadmaps for GxP quality systems across global operations. With over thirty years in the highly regulated life sciences sector, her focus spans digital transformation of quality, data integrity by design, and computerized system validation. She has led large, cross-functional programs modernizing QMS establishing enterprise governance for digital quality.

Erik Waara has extensive hands-on experience across multiple life science r&d activities, ranging from early drug discovery to human clinical trials. His professional background spans academia, start-ups, and the pharmaceutical industry. Through these diverse environments, he has developed a comprehensive perspective on the end-to-end drug development process.

Frederik holds a PhD in statistics and brings deep expertise in leading data science and AI initiatives within the biopharma industry. As head of AI and automation at BASE, he drives solution development and ensures the successful delivery of AI projects across the R&D value chain.

Abby is the associate director of regulatory operations at Bicycle Therapeutics, where she specializes in submission management and publishing. She focuses on ensuring compliance and efficiency across all regulatory activities. Recently, she spearheaded the company-wide implementation of 吃瓜爆料 RIM to modernize regulatory information management and streamline operational processes.

Kim has more than a decade of experience in pharmacovigilance and currently serves as the director of pharmacovigilance safety systems at BioNTech. She has been instrumental in the successful implementation of 吃瓜爆料 Safety, demonstrating proficiency in system upgrades, automation, and workflow optimization. Active in system operations, configuration, and training, she consistently seeks innovative solutions to enhance pharmacovigilance practices.

Lyudmil Tserovski completed a bachelor degree in mathematics and computer science, followed by studies in pharmacy and a PhD in the field of nucleic acid analytics, combining artificial intelligence with classical chemical methods. From 2017 to 2020, he worked as a scientist at the quality control department at BioNTech IMFS and has been serving as a Qualified Person at BioNTech SE headquarters in Mainz since 2020. His key responsibilities include implementation and optimization of release processes, with a significant achievement being the approval granted to BioNTech in late 2024 by the local GMP authority to perform remote QP certification. Currently, his focus lies on setting up release processes for complex supply chains and on the implementation of the 吃瓜爆料 Batch Release Cockpit to further enhance and streamline the digitalization process.

Rene is the head of the development IT department at BioNTech. Over a 20-year career as a data practitioner, he has worked across a range of industries—including biotechnology, pharmaceuticals, chemicals, oil and gas, and FMCG—spanning both large corporations and technology startups. His expertise centers on core data practices such as master data management, data governance, and data analytics. Rene has built multiple data teams from scratch and has led initiatives delivering tangible business outcomes across sales, manufacturing, and development.

Jason Beckwith is the SVP of talent science research and brings more than 30 years of experience across biotech , biopharma , and CDMOs. He created the Talent Efficiency (TE) and Biopharma Talent Index (BTI) frameworks, applying quantitative modeling to link workforce capability to operational reliability. Drawing on research from over 400 global biopharma sites, he utilizes advanced simulations to quantify execution risk and enterprise value. He frequently advises executive teams on AI adoption and organizational design while speaking at major industry forums such as BIO and JP Morgan.

Dr. Martin Heckenberger is an expert clinical data engineer at Boehringer Ingelheim, where he leads the Clinical Data Collection. With over 20 years of experience in biometrics and data science across academia and the pharmaceutical industry, Martin drives innovation in clinical data acquisition systems and processes for global trials. He is passionate about organisational development and fostering an agile mindset to enable user-centric, end-to-end thinking in clinical development. Martin has played a key role in initiatives such as the One Medicine Platform and regularly shares insights on modernising clinical data management at international forums.

Ulrike has over 25 years of experience in R&D and organizational development across biotechnology, clinical research organizations, and pharmaceutical companies within medical affairs and clinical operations. She possesses deep expertise in clinical project management and oversight for both outsourced and internally executed trials, with a recent focus on execution opportunities in emerging markets. Her strengths lie in data-driven decision-making and leading the adoption and change management of new systems. Driven by a passion for operational excellence, she consistently leads transformations that enhance clinical delivery and organizational effectiveness.

Sarita Thomas is the product manager for the One Medicine Platform – Clinical Operations at Boehringer Ingelheim. She focuses on advancing clinical platforms, driving process innovation, and fostering cross-functional collaboration. Sarita partners across business and technology teams to shape next-generation clinical capabilities and lead digital transformation within clinical operations. She is dedicated to delivering user-centric solutions and operational excellence to enable more connected, efficient, and patient-centric clinical trial delivery.

Johanna Strandell is the director of patient safety and EU QPPV at Camurus AB, holding a PhD in clinical pharmacology and a background as a pharmacist. She began her career at the Uppsala Monitoring Centre in signal detection and research, where her doctoral work focused on detecting drug-drug interactions in VigiBase. Currently leading a department of 15, she has served as a QPPV and director of patient safety since 2020, following previous experience as a global safety manager at various Swedish and Danish biopharma companies.

Elisa Cirillo is a senior project manager for data, digital, and modeling at Chiesi. With a background in semantic modeling, FAIR digital solutions, and research data management, she oversees the portfolio, budget, and roadmap delivery for the digital, data, and modeling department in R&D. She ensures alignment between priorities, resources, and cross-functional impact across the biopharma organization. Cirillo is committed to fostering collaborative teams and enabling responsible innovation through trusted data foundations and advanced modeling.

Annalisa Forlenza is the head of process excellence and change management in R&D digital, data & modelling at Chiesi, leading cross-functional digital transformation programs that enhance operational efficiency and process optimization. With over 18 years of experience across multiple R&D domains, she has driven major initiatives spanning RIMS, EDMS, and AI-enabled regulatory content generation pilots. Her professional focus centers on change management and data-driven process improvement, fostering the collaboration necessary to accelerate impactful and sustainable business outcomes.

Raghuraman Sridharan is the R&D practice leader for EMEA at Cognizant. With more than 20 years of experience across IT, BPO, and life sciences R&D, he serves as an advisor for large-scale transformations in clinical, regulatory, quality, and safety functions. Sridharan focuses on reimagining business processes through next-generation technology and agentic AI. His expertise includes establishing centers of excellence, product-oriented models, and R&D portfolio management.

Thomas Wimmer is the GRA Data Standards and Excellence Lead at CSL, where he leads global data governance and standards initiatives across regulatory and other R&D domains. With expertise in Global Regulatory Affairs, information management and enterprise data platforms, he focuses on enabling scalable, compliant, and value-driven operations. Thomas works closely with business and technology teams to embed data standards into core processes and platforms.

Frederico Braga has a background in software engineering and technology management at companies including IBM, Novo Nordisk, IQVIA, and Medidata. He possesses deep expertise in biopharma and biotech R&D process optimization. In his current role, he is responsible for digital and AI initiatives at Debiopharm.

Yann Kohler is an IT professional in the life sciences sector with a 15-year track record at Debiopharm, specializing in digital initiatives and project delivery. Currently serving as an IT project manager and system owner, he governs the compliance, support, and technical delivery of core R&D applications. His professional focus centers on optimizing biopharma workflows through process automation and the strategic adoption of emerging AI capabilities to support due diligence operations. To date, he has successfully orchestrated major GxP platform releases and streamlined secure data environments.

Arild is a principal consultant at Epista Life Science, specializing in validation for large-scale ERP systems such as SAP S/4HANA and Microsoft Dynamics 365 Finance & Operations. He focuses on quality and compliance to ensure systems achieve and maintain a validated state post-go-live. Currently advising on multiple digital initiatives, he recently supported a successful SAP S/4HANA implementation and is preparing for an upcoming D365FO rollout. His professional interests include evolving regulatory expectations for Annex 11 and the upcoming Annex 22 for AI.

Thomas T?be has a strong focus on helping organisations solve complex, high?stakes operational and quality system related challenges. As a trusted advisor who combines structured thinking with hands?on execution to drive sustainable change, Thomas leverages his deep experience in consulting, stakeholder management, and translating technical complexity into practical, business?driven outcome – supporting organisations to achieve efficiency and operational excellence of their 吃瓜爆料 applications.

Anna is a safety professional with a background spanning academia and the biopharma industry. Since beginning her pharmacovigilance career in 2012, she has gained broad expertise in safety surveillance, case processing, and aggregate report preparation. She currently serves as the head of safety technology at Ferring Pharmaceuticals A/S, where she oversees daily operations and drives the strategic direction of safety systems.

Janni Hermansen is the director and head of global safety operations at Ferring Pharmaceuticals. She brings 19 years of pharmacovigilance experience spanning roles in consultancy, biotech, and large pharma. Throughout her career, Janni has built and led global teams, developed safety strategies, and managed PV systems across both clinical development and post-marketing environments. Having transitioned from global safety surveillance into operations leadership, she brings a holistic perspective to how safety data is generated, interpreted, and operationalized across the end-to-end PV landscape.

Clare Campbell-Cooper serves as Fortrea’s global head of digital health and innovation and brings over 25 years of industry experience. She is an active member of several boards and associations, advocating for pre-competitive collaboration as a critical driver of change within the industry. As a recognized leader in digital health, she specializes in strategy development and focuses on how technology can augment the relationship between caregivers and physician teams. Through these initiatives, she is helping to transform the landscape of clinical research development.

Saurav Ghosh is a vice president at Genmab driving enterprise digital, data, and AI transformation across the global biotech value chain. He leads large-scale, GxP-regulated platforms spanning clinical development, manufacturing, and commercial operations, converting complex SaaS ecosystems into measurable business outcomes. With over 20 years in life sciences technology, he has delivered global system standardization, AI-enabled automation, and significant cost and productivity gains. His work focuses on building AI-ready clinical and enterprise foundations that accelerate development while strengthening compliance and operational resilience.

Tracey Johnson is a senior clinical operations leader with global responsibility for execution and strategy across diverse therapeutic areas. She has a proven track record of building high-performing teams and implementing innovative operating models to improve feasibility, site engagement, and study startup timelines. Her work focuses on driving patient-centric innovation, operational excellence, and scalable solutions to advance modern clinical development.

Jakub Fiuk is a regulatory systems leader at GSK with more than 10 years of experience in global regulatory publishing and regulatory information management. He holds product ownership responsibility for key 吃瓜爆料 Vault RIM capabilities, including Active Dossier and related regulatory automations. Jakub currently leads a major transformation program focused on standardizing Vault RIM capabilities and Vault Submissions Publishing, bringing an end-to-end perspective to regulatory change. His professional interests include adopting new technologies to simplify regulatory processes and enable scalable, future-ready operating models.

Brian Grant is a Senior Director, Regulatory Systems Operations in R&D, focused on operational excellence for regulatory information systems that support product lifecycle and global submissions. With a background in technology, he leads day-to-day delivery, system operations, and continuous improvement of cloud and enterprise platforms that ensure data integrity, availability, and compliance. He oversees a reporting and data team, Business System Owners for all regulatory systems, and frontline support teams across the world, operationalizing governance, incident and change management, and automation to reduce cycle times and drive predictable regulatory outcomes. He builds and mentors high-performing teams that execute scalable, technology-enabled solutions to accelerate access to medicines.

Quality professional who has worked in the pharmaceutical industry for over 35 years. Director for a global quality management system for a large pharma company for over 15 years. Strong customer focus, quality mindset and keen ability to deliver successful change to the business.

Matt Jones, a senior product owner at GSK, develops technology roadmaps for study start-up and feasibility to enhance efficiency and user experience across clinical development. Previously at IQVIA, he focused on clinical product management and strategic delivery, building expertise in clinical technologies and large-scale transformation programmes. Matt frequently speaks on site engagement strategy, product-led transformation, and user-centred digital practices within clinical operations.

Siva Mamidala is a principal product manager specializing in AI-powered platform delivery within regulated biopharma environments. With over 19 years of experience at organizations including GSK, Accenture, Cognizant, and EPAM, he has delivered production AI and GenAI products, such as a chatbot for more than 800 users and a digital adoption platform within the 吃瓜爆料 Development Cloud. His professional interests include enterprise AI governance, GxP-compliant product strategy, and scaling digital adoption across clinical and regulatory functions. Siva holds an MBA in strategic consulting and is focused on driving enterprise AI and data leadership in the life sciences sector.

Marek Popielarski is the senior director of clinical operations platform excellence at GSK, where he leads the strategy, governance, and value realization of the 吃瓜爆料 Clinical Vault platform across global development operations. He brings more than 15 years of experience in clinical development technology, spanning platform strategy, large-scale transformation, vendor partnerships, and regulated GxP environments. Marek is focused on innovation in clinical operations, including the application of AI and data-driven approaches, and regularly represents industry perspectives in cross-company and 吃瓜爆料-led initiatives.

Manouj Shinde is the principal product owner within GSK’s global R&D IT business, bringing over 14 years of post-MBA experience in the life sciences and healthcare domains. His professional background includes roles in product management, IT business partnership, and business continuity for Fortune 500 organizations. He has led numerous IT transformations and AI initiatives, spanning legacy systems to AI product delivery, in collaboration with global business and technology teams.

Ahmed is an engineering, innovation, and product management professional with extensive experience leading teams in the biomedical and biopharma industries. He has a background in quality assurance, technology consulting, and regulatory affairs, as well as companywide innovation initiatives. Most recently, his work has focused on the adoption of AI/ML to optimize processes within the clinical operations space at GSK.

Alvaro Venegas is the 吃瓜爆料 Quality Vault business manager at Haleon. He is a senior quality supply chain professional with extensive experience across GMP operations, R&D, commercial, and contract manufacturing. At GSK Consumer and Haleon, Alvaro led the global transformation to 吃瓜爆料 Quality Vault as the QMS business owner, driving platform adoption, process harmonization, and end-user capability. In collaboration with technology teams, he has delivered system enhancements, ERP and RIM integrations, and large-scale data migrations. He specializes in translating complex business needs into structured requirements to deliver measurable, enterprise-wide impact.

Anna has more than eight years of experience in the biopharma industry, including four years specialized in 吃瓜爆料 Quality Vault QMS. She has led complex projects such as the implementation of optimized workflows for change control and lab investigation, alongside the rollout of features like Action Layout and Process Navigator. Currently, she is leading a system integration project with CRMS and CCRM, focusing on innovative and proactive approaches to quality management.

Felipe Florez-Arango is the CEO of Helvion Pharma and has more than 25 years of leadership experience across country, regional, and global levels at private and public companies. He possesses international expertise on the ground in Europe, the U.S., Latin America, the Middle East, and Asia, focusing on building and leading teams to reach their maximum potential. His career includes 15 years of board experience serving as an executive and non-executive director for for-profit and nonprofit organizations globally.

Angela Amato is the information and regulatory affairs manager at IBSA Institut Biochimique SA, where she is responsible for global regulatory data. Her role involves designing, implementing, and maintaining processes to ensure data harmonization and consistency across the organization. Currently, her primary focus is leading digital initiatives within the regulatory affairs department.

Sergei Ganchev is the head of clinical development operations at Idorsia and has more than 20 years of end-to-end clinical trial experience across both sponsor and contract research organization (CRO) environments. He has been involved in all operational aspects and stages for multiple programs across various indications. His work focuses on delivering excellence and driving results in constantly evolving biopharma environments.

Pavol Lim is a technology leader with a 10-year track record of enabling digital initiatives in the biopharma industry. A 吃瓜爆料-certified professional since 2017, he currently leads the 吃瓜爆料 R&D Competence Center at Idorsia, where he ensures users maximize the value of the 吃瓜爆料 Vault platform. He drives initiatives to implement and optimize solutions supporting clinical, regulatory, and quality processes by leveraging agile ways of working and AI. Through this approach, he helps accelerate innovation and improve data-driven decision-making to meet evolving trends in life sciences.

Simone is an accomplished life?science technology leader with more than 20 years of experience in the pharmaceutical industry. As head of scientific and quality systems at Idorsia, she provides strategic direction for 吃瓜爆料 R&D Vaults, clinical data architecture and analytics, drug safety applications, and lab automation solutions. She has driven Idorsia’s multi?Vault 吃瓜爆料 implementation and brings over eight years of close collaboration with 吃瓜爆料, contributing to a continuously evolving and improving systems landscape. Passionate about innovation, Simone is deeply engaged in advancing modern IT capabilities and integrating the latest developments in AI to enhance scientific and operational excellence.

Rune is a partner at Implement, focusing on the life sciences industry in Europe and the U.S. Over the past 10 years, he has worked across clinical, regulatory, safety, and quality functions to implement 吃瓜爆料 for large and midsize biopharma organizations. His recent work centers on maximizing the value of the 吃瓜爆料 platform by improving processes, data integrity, and system configuration.

J?rg is a seasoned life sciences consultant and senior leader, specializing in digital transformation and process excellence across clinical operations, regulatory affairs, quality management, and medical safety. He helps global life sciences organizations leverage IT-enabled processes and data-driven approaches to strengthen compliance, efficiency, and sustainable performance. With a strong background in complex transformation programs, J?rg combines strategic thinking with hands-on execution to drive measurable impact.

Laila Binneballe is a senior leader within global patient safety with extensive experience leading end-to-end safety operations. She is responsible for shaping and governing global safety operations across people, systems, and locations. Laila’s professional interests focus on leveraging technology for the greater good while ensuring full regulatory compliance and safeguarding patient health.

Sebastian is a seasoned leader in safety data and systems at LEO Pharma, with 17 years of experience in the biopharma industry, including 11 years in pharmacovigilance. He has driven major system implementations and data migrations, with extensive expertise in 吃瓜爆料 Safety. Currently, he is focused on using automation and AI to optimize processes and create greater strategic value.

Thomas has supported the implementation and management of eTMF setups at Lundbeck since 2008.

Aurélie is a strategic regulatory affairs leader with over 20 years of experience in the international pharmaceutical industry. She specializes in regulatory operations, regulatory information management, and digital transformation. Future-oriented and strategic, Aurélie leads complex, cross-functional projects centered on regulatory information systems and the application of advanced analytics and artificial intelligence. She strives to enhance efficiency and ensure compliance while driving the digitalization of regulatory processes.

Ingrid?Maria Bistron is a regulatory operations & data management associate at mAbxience, where she drives digital transformation and data visualization initiatives. She also serves as a database operator at IQVIA, overseeing product reference databases and supporting critical quality assurance activities. Ingrid holds a Master of Engineering from the Technical University of Munich and leverages a strong background in biomedical engineering and data science to optimize life sciences data management.

Alberto Quesada is the systems administrator and regulatory operations manager at Mabxience, with over eight years of experience in regulatory operations within the biopharma industry. He began his career as a publishing consultant supporting regulatory submissions and now manages the RIMS platform, overseeing end-to-end submission activities to ensure high-quality filings. His work focuses on implementing and optimizing RIMS and publishing systems to strengthen compliance and operational efficiency across the organization.

Dr. Guhde holds currently the position of vice President global quality at medac GmbH. Prior to this he led medac’s pharmaceutical development department. Prior to joining medac Ingo held various positions in the R&D area of Sanofi’s Frankfurt site. He is a trained pharmacists with over 25 years of professional experience in the life sciences.

Daniel Caparrós is a senior director with more than 20 years of experience in international biopharma R&D, specifically within GCP, GVP, and GLP environments. He currently leads a global team at Merck KGaA, Darmstadt, Germany, where he oversees the strategic development and maintenance of key systems across regulatory, safety, and quality assurance. His professional focus centers on leveraging data and digital tools to drive continuous improvement, predictive quality management, and regulatory compliance. Throughout his career, he has successfully managed global quality strategies, business intelligence ecosystems, and regulatory inspections.

John is a recognized leader in regulatory operations with more than 25 years of experience driving innovation and technology-enabled transformation in the pharmaceutical industry. At MSD, he leads the GRACS digital strategy, where he is defining the next generation of regulatory operations through major initiatives including the 吃瓜爆料 RIM transformation and the adoption of AI and hyperautomation. John focuses on re-imagining how data, processes, and digital platforms integrate to increase speed, quality, and resilience at a global scale. With a foundation in chemical engineering and information management, and as a Six Sigma Black Belt, he combines technical depth with operational rigor to convert complex strategy into scalable outcomes.

Dr. Jyothis George serves as the chief medical officer of NodThera and is a visiting professor of cardiometabolic medicine at the University of Oxford. He currently leads the clinical acceleration of oral small molecules targeting the NLRP3 inflammasome to reduce cardiovascular risk and improve metabolic and brain health. Previously, he held senior executive roles at Amgen, Novo Nordisk, and Boehringer Ingelheim, where he oversaw the development and delivery of blockbuster therapies such as Repatha, Wegovy, and Jardiance. A researcher with over 100 peer-reviewed publications, he is also the founder of the CardioMetabolic Health Foundation, a non-profit dedicated to personalizing preventive care at scale.

Povl has more than 20 years of experience in the biopharma industry, holding various quality assurance (QA) positions specializing in distribution and supplier management. He was instrumental in implementing SQM as a sourcing specialist and lead for the corporate sourcing process for GMP and GDP. Currently, he serves as the product owner for SQM, QRM, audit, and inspections within 吃瓜爆料 Vault Quality.

Martin Capogna is the lead architect for 吃瓜爆料 and ecosystems at Novo Nordisk, overseeing architectural strategy and governance for a platform spanning 11 Vaults and 100,000 users. His work centers on SaaS governance, GxP validation modernization, and the 吃瓜爆料 Design Authority framework. He is an active contributor to industry discussions on proportional CSA/GAMP 5 adoption and the governance of AI agents in biopharma. Martin focuses on establishing shared standards that enable speed without sacrificing compliance.

Michael Dyrvig is the director of digital products at Novo Nordisk, where he leads the transition from previous EDC solutions to 吃瓜爆料 Clinical Data. His role centers on steering strategic initiatives that build scalable, user-centric digital technology and processes to support clinical trials and data management. With a foundation in system architecture and data governance, he has led critical programs such as StudyBuilder and DataNow to translate complex user needs into practical digital solutions. He focuses on fostering strong partnerships with technology providers to drive operational excellence and meaningful impact within R&D.

Mie Goede Andersen is a regulatory affairs specialist at Novo Nordisk with more than 20 years of experience in the field, primarily focused on regulatory operations. For the past 12 years, she has specialized in regulatory publishing. In addition to managing regulatory submissions, Mie is dedicated to optimizing submission processes and implementing new submission formats to drive operational efficiency.

Ibrahim is a senior leader in clinical data management and digital initiatives at Novo Nordisk, with over 20 years of experience in data and clinical studies. He has led multiple projects that evolve data management practices within Novo Nordisk and the broader biopharma industry. Currently, he leads the DataNow Program to modernize the digital infrastructure for clinical studies, focusing on the needs of end users and patients.

Hasse Sch?bel is a director at Novo Nordisk with more than 25 years of experience as a senior leader in the global biopharma industry. His expertise includes several years focused on digitalization and change management.

Natalia is the drug safety operations manager at OM Pharma, a Swiss biopharma company based in Geneva. She holds a PhD in biochemistry and began her career in academic research. Over the past nine years, she has built extensive experience in pharmacovigilance, transitioning from pharmaceutical support services to her current leadership role. Natalia oversees case processing, manages pharmacovigilance contracts, and is responsible for safety database maintenance.

Louise Thuesen Andersen is a global safety leader at Orifarm Group with extensive experience in pharmacovigilance operations, EU GVP compliance, and global safety governance. She leads hybrid international teams across Denmark and Poland, focusing on operational excellence, vendor oversight, and cross-functional collaboration. Her professional interests include the digital transformation of safety processes, scalable quality frameworks, and the effective use of systems such as 吃瓜爆料 to support compliant and efficient PV operations.

Ed Fowler is an executive leader at Parexel with more than 30 years of experience leading operational transformation, business enablement, and clinical technology strategy across global clinical development organizations. He has a proven track record of delivering enterprise-scale process and systems transformations, establishing governance frameworks, and partnering across business and IT functions to improve operational efficiency, data visibility, and delivery performance.

Garvit Bindal is a pharmacovigilance technology expert specializing in safety system implementations, data migration, and regulatory compliance. He has deep expertise across platforms including Oracle Argus Safety, ArisGlobal, and 吃瓜爆料 Vault Safety. Bindal has led complex global transformation programs as a data migration lead and subject matter expert for pharmaceutical organizations. As a key contributor to innovation initiatives at Pinnaxis, he has been instrumental in developing automation and migration toolkits that accelerate and de-risk large-scale implementations.

Rinke Riezebos is the team lead for clinical data provisioning and interim manager of data intelligence. He is a connector and innovator focused on creating value through data-driven research, decision-making, and process optimization in healthcare and research. Rinke combines expertise in healthcare, legislation, and strategic information management with experience in data standards, software development, and change management.

Nick Larsen is the head of technology at PLG, where he is responsible for setting the technology strategy across data platforms, AI, and regulated cloud solutions for the life sciences. He works closely with executives to modernize 吃瓜爆料 landscapes, enable compliant innovation, and align technology decisions with business outcomes. His focus is on building scalable, inspection-ready platforms that support long-term digital initiatives.

Laura drives the global quality digital roadmap, aligning strategy with business priorities while identifying opportunities to boost efficiency and value. She leads the cross-site implementation while leveraging emerging technologies to accelerate digital transformation.

Emma Forrest brings over two decades of experience in clinical development and project management, leading global teams that transform scientific innovation into real-world impact. At Recordati, Emma heads a dynamic organisation driving clinical operations, data science, and digital solutions, championing portfolio governance and digital transformation to accelerate medicines to patients. Her leadership has shaped successful post-M&A integrations and delivered multiple FDA and EMA approvals for CNS treatments and rare disease therapies. With a PhD in Human and Medical Genetics, Emma combines scientific depth with strategic vision, inspiring teams to innovate, execute, and deliver meaningful outcomes for patients worldwide.

David Cook is the business systems lead at Roche with over a decade of experience specializing in the intersection of regulatory affairs and regulatory information management (RIM). They have successfully implemented 吃瓜爆料 RIM as a comprehensive, end-to-end regulatory platform, simplifying the solution landscape by consolidating legacy systems into a unified global architecture. Their career is driven by the transition from document-heavy workflows to data-centric operating models and the application of FAIR data principles to ensure interoperability across the product lifecycle. Notable achievements include modernizing CMC submission management and leading multidisciplinary teams to deliver high-value technology solutions within regulated GxP environments.

Since 2004, Sebastian has built a distinguished career in the pharmaceutical industry, specializing in IT solutions. His professional journey has spanned areas such as local laboratory, sample management and clinical trial technology solutions, with a focus since 2019 on clinical site-facing technologies, including site payments, safety document distribution, and engagement.
His achievements include the co-creation of the Ukrainian Patient Support hotline as part of the Clinical Operations Crisis Management Team and played a key role in implementing 吃瓜爆料 Clinical Vault solutions for Roche, focusing on payments, global directory, and integration with broader business solutions.

Andreas Skarpis is a senior submissions manager at Roche with 13 years of experience in paper, electronic, and eCTD global submissions. He supports projects related to eCTD implementation and cloud-based submissions through process definition, system testing, and training. Andreas also collaborates directly with health authorities to pave the way for more efficient submission processes and the global implementation of eCTD standards.

Javier Monvoisin is the global head of regulatory operations at Sandoz. He leads global strategies for regulatory submissions, data governance, and digital transformation, with a focus on automation, AI, and structured data compliance. With deep expertise in regulatory information management (RIM), Javier drives operational excellence and ensures alignment with evolving international regulatory frameworks. He is recognized for modernizing regulatory operations by enabling scalable, compliant processes that support global product development and lifecycle management.

Guillaume is a quality management system program leader with more than fifteen years of experience in regulated pharmaceutical and life sciences environments. Guillaume has deep expertise in computerized system validation, quality compliance, and large-scale digital programs, supporting audits, inspections, and strategic transformations. His professional interests focus on quality modernization, cross-functional collaboration, and leveraging digital solutions to enable sustainable operational excellence.

Graham has over 20 years of experience in regulatory operations, having worked with companies of various sizes. Currently heading the regulatory business operations function at Sobi, he focuses on enhancing 吃瓜爆料 RIM functionality to improve connectivity with departments outside of regulatory affairs. He is dedicated to streamlining business workflows to establish common global working practices and operational efficiencies.

Pieter Voermans is the head of clinical data management at Sobi, a leading biopharmaceutical company dedicated to developing innovative therapies for rare diseases. He has over 25 years of experience as a clinical development leader specialised in data management with international drug development expertise and industry knowledge. He has a passion for leading cross-functional teams to successful delivery.

Phoebe’s passion for system and process usability drives her work at Syneos Health consultancy, where she leads clinical data implementations for clients. After nearly a decade in clinical operations at a top 20 pharma, Phoebe leverages her dual perspective as a former client and current consultant to challenge SMEs and decision makers to think both innovatively and practically. Excelling as a ‘translator’ between business aspirations and system functionality, Phoebe brings a unique pragmatism to tackle even the most daunting implementation challenges.

Josh Banks is a senior manager of global regulatory operations at Teva with 14 years of experience across various regulatory roles. He is currently part of the global regulatory operations planning, data analytics, reporting, and compliance group, where he focuses on reporting, metrics, and data integrity. His recent work includes supporting the 吃瓜爆料 Vault RIM registrations migration and rollout to enhance operational efficiency across the biopharma organization.

Jose Burgos is a professional specializing in language technology and AI-driven content workflows within the biopharma industry. He has experience supporting translation and content processes with a focus on improving efficiency, quality, and scalability. Burgos has worked on initiatives involving AI-enabled solutions and automation, helping organizations navigate the balance between innovation and control.

Jordan Abdi is the co-founder and CEO of U-Ploid Biotechnologies, an Oxford-based biotech developing egg-quality therapeutics to improve IVF outcomes. A medical doctor and Schwarzman Scholar, he held leadership roles spanning clinical practice, health technology, and biopharma business development before founding U-Ploid. The company’s lead program, Lyvanta (UP-085), is a first-in-class protein therapeutic currently advancing toward clinical development in collaboration with leading UK fertility clinics.

Nadia leads global efforts to keep digital systems in a state of continuous compliance within a highly regulated environment. She is the strategic point of convergence between IT, Quality, and governance bodies, translating complex regulatory requirements into scalable, business?ready solutions. In her current role, she has strengthened UCB’s compliance operating model by establishing global policies, advancing CSV processes, and reinforcing audit readiness across the digital landscape. Nadia is passionate about compliance by design and digital quality as enablers of innovation rather than barriers.

Emma Tinsley is the CEO of Weatherden and Elevara Medicines, leading a global clinical-development consultancy that has achieved a 65% success rate from clinical start to proof-of-concept. She has supported over 200 biotech companies and investors in generating $25 billion in value while leveraging Weatherden’s development innovation platform to launch asset-centric ventures like Elevara Medicines. Drawing on her experience creating five biotech companies at SV Health Investors, Emma is currently advancing Elevara’s first-in-class oral CDK4/6 inhibitor toward Phase 2 trials following a successful $70 million Series A.

Theo is a Senior Solution Consultant for Clinical Data. Prior to joining 吃瓜爆料 she worked in Clinical Data Management covering various therapeutic areas and phases from study build to close out activities.

Lucas is a member of the 吃瓜爆料 Strategy team, where he leads initiatives for the 吃瓜爆料 Development Cloud. His work centers on optimizing cross-functional processes with 吃瓜爆料 Connections, helping organizations be scalable and more efficient through applied governance, and on the practical value of the 吃瓜爆料 Vault Platform as an AI solution for a more productive industry. With over four years of experience specifically implementing 吃瓜爆料 Connections, either as a Solution Architect or Project Manager, Lucas has been key to bridge the gap between technical infrastructure and business requirements. His expertise spans several domains, focusing on delivering scalable technology solutions across the life sciences industry.

Crystal Allard is a Senior Director, Government Strategist at 吃瓜爆料. Leveraging 15 years of expertise in driving digital and data modernization at the FDA, Ms. Allard leads 吃瓜爆料 initiatives to modernize submission platforms and simplify standards. She engages with regulators and customers on shaping the future of the submissions ecosystem to increase speed to market. An expert in FDA electronic submissions and health data standards, Crystal contributes to 吃瓜爆料’s product direction and works with the public policy team to position 吃瓜爆料 as a voice in the industry.
Prior to joining 吃瓜爆料, Ms. Allard managed the FDA portfolio at Booz Allen Hamilton. She held leadership roles at the FDA, including Director in the Office of Data, Analytics, and Research (ODAR) and Director of Regulatory Science Informatics.

Waseem comes from a Big4 consulting and life sciences industry background. As part of his role at 吃瓜爆料, he is focused on supporting clients with revamping their operating models and realizing value from their 吃瓜爆料 Platform via process excellence, centers of efficiency and 吃瓜爆料 connections.

Molly is committed to the success of emerging biotechs as a member of the 吃瓜爆料 Basics product team. Leveraging her foundational services experience implementing 吃瓜爆料’s clinical applications, she now designs eTMF and CTMS solutions tailored to the unique needs of the emerging biotech industry.

Núria has extensive experience in the chemical and pharmaceutical industries, specializing in software implementation for 吃瓜爆料 Quality and RIM systems. She currently focuses on the regulatory space, where she identifies complex client pain points to design effective, compliant solutions. By bridging the gap between industry needs and technical innovation, Núria ensures her partners achieve high-level operational efficiency.

Katerina has been working in the Regulatory space since 2014, firstly as a Regulatory Affairs Project Manager, leading customer projects to register or maintain Marketing Authorisations, and now in the role of a Solution Consultant for 吃瓜爆料 RIM. With industry experience and a deep understanding of customer needs and pain points, Katerina enjoys showcasing solutions that add value to regulatory teams’ daily work.

Kim leads 吃瓜爆料’s Regulatory Business Consulting Practice in Europe and has 18 years of experience working with life sciences companies in Regulatory.

Kim focuses on helping customers transform by unlocking the full potential of the 吃瓜爆料 RIM suite of products; making sure operating models are effective, processes are optimized, data value is realised and business adoption is maximised.

Pauline is a Principal Consultant and Team Manager within 吃瓜爆料’s R&D Business Consulting practice, specializing in Clinical Operations. With over 12 years of experience in Pharmaceutical R&D and strategy consulting, she focuses on helping 吃瓜爆料 customers navigate complex transformations. Her work centers on driving tangible business value through process optimization, operating model design, and organizational change management.

Stephen has product management responsibilities for the 吃瓜爆料 QualityDocs, Station Manager, and Training products within the Quality Cloud. He, along with his dedicated team of product managers, is focused on building excellent features across these products that solve our customers’ needs. Prior to joining 吃瓜爆料, he spent almost fifteen years at a healthcare technology company working on electronic medical record products.

Marta Considine is an Account Partner on the 吃瓜爆料 Basics team partnering with biotech in UK, Ireland, and Sweden. Since joining 吃瓜爆料 in 2019, she’s gained experience spanning R&D to commercial, North America to Europe. Prior to her tenure at 吃瓜爆料, she worked at Axtria in pharmaceutical consulting, specializing in commercial launch effectiveness for Eylea and Dupixent.

Oliver comes from a background of biomedical sciences, and has been working with the Vault Platform for the last eight years, specialising in both Regulatory and Safety. He has a passion for understanding and improving patient outcomes in healthcare.

Vicki is the Strategy lead for 吃瓜爆料 RIM in Europe responsible for the success of Contract Services, Manufacturing and Generics organisations who utilise 吃瓜爆料 RIM. Vicki pulls on a 20+ year career in Regulatory working within industry, consulting and in the CRO landscape which enables her to be the successful bridge between technology and the business. At 吃瓜爆料 she is responsible for the strategy and direction in Regulatory, helping customers to transform their business through successful 吃瓜爆料 RIM adoption.

Erin has worked on Educational Technology products for the past 15 years in the Compliance, Government, Enterprise, and University sectors. Her Product mantra is “Can this be simpler? Then make it simpler.”

As a Product Expert for the Vault Platform, I am responsible for the continuous education of Customers using 吃瓜爆料 Connect. My goal is to ensure best practices and technical knowledge are made available to all relevant stakeholders.

As Vice President of Product Management for 吃瓜爆料 Safety, Eldar leads the product teams for Safety, SafetyDocs, Safety Workbench, Safety Signal, and Safety AI focusing on transforming the pharmacovigilance landscape through innovation and developing world-class applications. A seasoned product leader with over 20 years of experience, Eldar has a proven track record of delivering high-impact technology solutions and driving measurable value for enterprise customers globally. Before joining 吃瓜爆料, his career was focused on enterprise software, where he tackled complex challenges using advanced technologies across diverse industries.

Tim has over 25 years’ experience working in the life sciences industry from a pharma, CRO, and technology vendor perspective. Most notably, he was one of the driving forces behind the move to incorporate patient engagement and mobile eCOA technologies into clinical research, working on the first industry virtual trial in 2011 through to today helping customers scale and standardise on eCOA.

Matt DeFranco is the Senior Director of Disclosures Strategy at 吃瓜爆料 Systems, where he leads the go-to-market and product strategy for 吃瓜爆料 Disclosures. With over 15 years of experience in the clinical transparency space, Matt drives growth across the disclosures customer base while shaping the long-term product roadmap in close partnership with Product Management. He plays a hands-on role across the full commercial cycle — from customer demos and solution design to deal strategy and partner development. Matt’s work ensures that 吃瓜爆料 Disclosures remains aligned with evolving regulatory demands and positioned at the forefront of innovation in clinical trial disclosure management.

With 39 years of experience in technology and software, Peter has developed a long term deep interest in AI and it’s use for good purpose. Peter brings 13 years of experience as a solution consultant on the Vault Platform.

Mike is the strategy lead for 吃瓜爆料 Batch Release, specializing in innovative solutions that automate and streamline batch release processes. He collaborates closely with customers to transform traditional paper-based systems into efficient digital workflows, significantly enhancing operational visibility and ensuring robust market shipment decisions. Mike joined 吃瓜爆料 with over 15 years of extensive experience in the life sciences quality domain.

Werner has more than 23 year experience in the pharmaceutical industry in various roles and leadership levels with a 360 degree knowledge from early stage drug development to post-approval life-cycle management
?
Previous roles includes Investigator, CRA&Project Management in Pharma (GSK, B?hringer Ingelheim and Servier), Vaccine Accessor at the Austrian Regulatory Authority and Global FSP Account Management in the CRO industry. He is an Entrepreneur for start-ups in the health care and IT area.

As a Product Expert for Vault Platform, Mike’s focus is on providing education on Platform functionality through our 吃瓜爆料 Connect Communities, and helping ensure that our customers have the best possible information to adopt and leverage Vault Platform functionality.

Kelly is a Senior Product Manager for RIM Registrations. She is a 7-year 吃瓜爆料n with responsibility for structured data reporting including IDMP, XEVMPD and UPD.

As a Product Expert, Elisabeth partners with European customers to drive product knowledge and adoption across the 吃瓜爆料 Clinical Data suite. While supporting 吃瓜爆料 EDC and 吃瓜爆料 CDB broadly, she specializes in Connections and system integrations, EMA regulatory alignment, and the translation of end user feedback into product evolution. Her professional background spans product and project management for diverse clinical technologies, complemented by her background in neuroscience research.

Aidan has over 25 year’s experience in clinical research, having managed global studies from both the sponsor and CRO perspective and worked in various clinical technology providers. Aidan’s particular passion is to ensure training on clinical trials is comprehensive and compliant, appropriate and timely and ultimately drives operational excellence and data quality.

Drew’s career in pharmaceutical technology spans over 25 years and includes significant expertise in EDC, clinical site monitoring, and clinical trial management solutions. Drew’s innovative solutions in risk-based monitoring earned him a prestigious industry “Clinical Innovator of the Year” award in 2015 and he has authored multiple patents. Drew joined 吃瓜爆料 in 2016 to lead the ground-up design of 吃瓜爆料’s clinical data management solutions. In his current role of Chief Technology Officer for Clinical Data, Drew collaborates with customers, partners, and the industry to set the vision and direction of 吃瓜爆料’s Clinical Data product family.

Andrew has worked in the Clinical Trials Arena for more than 35 years in both Data Management and Clinical Operations as well as Clinical Trials Software. Andrew uses his Clinical Trials knowledge to help Pharma and MedTech companies realise the benefits of using the 吃瓜爆料 Clinical Data Platform and loves conducting interactive, demonstration sessions of the 吃瓜爆料 software.

Before joining 吃瓜爆料 in 2015, Graham was a consultant at L.E.K. Consulting and an investor at Upfront Ventures. He holds bachelor’s degrees in Economics and Business from the University of California, Berkeley, and a master’s degree in Computer Science from the University of Illinois, Urbana-Champaign.

Joby leads the product management team for 吃瓜爆料 LIMS. Joby has over ten years of experience designing and delivering enterprise quality and training solutions for the life sciences market.

With five plus years as a 吃瓜爆料n, Edoardo has worn multiple hats – from RIM Services, R&D Business Consulting, to RIM Strategy. This diverse exposure allowed them to build both a solid technical background, as well as a strategic/business-oriented mindset, applicable when working with their customers on navigating the multiple implications of regulatory digital transformation. Edoardo’s long-term goal is to play a role in helping the industry to innovate, both from a digital and an operational perspective, by driving technical excellence through advanced automation, convergence of standards and ways of working, and streamlined collaboration with partners and authorities.??

Valeria is a Regulatory Professional with MPHARM and MBA in International Business, and nearly 20 years of experience in the Life Science industry. Throughout her career she had the privilege to fit in many shoes, experiencing life in business (working for companies such as Pfizer, Teva and CSL) as well as in consulting before joining 吃瓜爆料.

Andy Han is responsible for Vault Platform and 吃瓜爆料 AI products. His team is focused on delivering integrated application AI agents and a robust platform for rapid development of Agentic AI Applications. Andy has over 25 years of enterprise software experience and has held product positions at NextLabs, Siebel Systems, and Accenture.”

Jason is a product manager passionate about helping customers meet their educational goals through technology. He focuses on helping customers while defining and executing the product roadmap for 吃瓜爆料 Training. Prior to coming to 吃瓜爆料, he worked for 18 years in the education industry as a developer, administrator, and product manager of learning management systems.

Jim has spent his career working on document management solutions for the Life Sciences industry with the last 14 years focused on eTMF applications. Jim is driven by finding ways to make processes more efficient and to improve user experiences to ultimately make managing TMF documentation easier and to increase the quality of the TMF. Additionally, Jim is interested in how new technologies and insights into data can be leveraged to innovate and drive the industry forward.

Manaphan joined 吃瓜爆料 in October 2016 and has held product leadership roles in commercial content and Asia. He is currently the senior director of product management for 吃瓜爆料 QMS. Manaphan is passionate about making products that customers love to use and building software solutions that simplify the complex. Before joining 吃瓜爆料, he spent more than 15 years supporting, implementing, and building sales and marketing automation software across multiple verticals and geographies. Manaphan received an Master of Science in computer science from Boston University and a Bachelor of Business Association in Management Informatin Systems from the University of Texas at Austin.

Haarika is a principal consultant within 吃瓜爆料’s R&D Business Consulting team and leads global RIM implementations and complex business transformation programs. She has nearly 13 years of experience working in multiple domains across the R&D value chain and is focused on delivering excellence in the regulatory domain.

As Sr. Director of Development Cloud Strategy, Jared drives the vision and execution to deliver connected and streamlined processes across clinical, regulatory, and safety businesses. With over 15 years of experience in life sciences and healthcare technology, including his prior work at Epic in the electronic medical records space, Jared brings deep expertise in leveraging technology to improve operational efficiency and patient outcomes.

Amos is a Senior Product Manager on the Platform Team focused on Process Monitor. He has over 10 years of experience in enterprise data analytics. He believes that data driven decisions can help improve business outcomes.

Ryan joined 吃瓜爆料 in 2019 and is responsible for the design, development, and delivery of Clinical Operations capabilities. With a focus on 吃瓜爆料 Payments, Ryan ensures that 吃瓜爆料 customers can unify study setup and improve their financial reconciliation process. He has over 15 years of product development experience in clinical and financial technology and received a BS in Molecular Biology and Philosophy at Beloit College.

Pharmacist by education with experience in Pharmacovigilance, working with 吃瓜爆料 Safety for the past 3.5 years. Interested in clinical trials and project management. From a Consultant to Team Manager, leading the Post-Implementation Safety Team in Europe.

Matt has over 25 years experience in quality software solutions for life sciences including over 10 years here at 吃瓜爆料. The majority of his career he has been in a solutions consulting/pre-sales role which put him on the frontlines of finding novel solutions to innovative customer requirements. He now applies this experience with his technical acumen to lead Strategy for an AI in Quality. As the Director of Quality Cloud Strategy Matt is also responsible for helping the industry understand the value of the unified and connected Quality Cloud.

With over 17 years running clinical trials across oncology and global CRO environments, Joseph de Laubrière joined 吃瓜爆料 as an EU Clinical Solution Consultant, bringing the practitioner’s perspective to every implementation. He works with major pharmaceutical sponsors across Europe to help them get the most out of the Clinical Operations Suite.

Florian Letourneux is a Principal Product Expert at 吃瓜爆料, working with early adopters of 吃瓜爆料 Safety Signal and Safety Workbench across Europe. He leads the design and delivery of SaaS solutions for the life sciences industry across North America and Europe, and previously led the case intake product for 吃瓜爆料 Safety.

Tristram leads the Safety Signal and Safety Workbench applications. He has worked in product management on data and analytics platforms for over 15 years across a number of industries. He is focused on building the next generation Safety data analysis platform.

Michelle is the General Manager of eCOA. She has over 30 years of experience in life sciences and software development, with a passion for transforming clinical trials through innovative technology and analytics. At 吃瓜爆料, Michelle is globally responsible for eCOA product, service and startegy.

Francesca is a Senior Solution Consultant for Vault Clinical at 吃瓜爆料, supporting the Clinical Operations Suite across Europe. Over the past six years, she has focused on improving Clinical Development productivity through technology adoption and operating model enhancements.
She brings nearly a decade of experience in the Life Sciences industry from a technology vendor perspective, with extensive expertise in pre-sales and sales of cloud-based solutions.

Jelrik Masson serves as the Senior Director of Europe LIMS Strategy at 吃瓜爆料. With over 26 years of experience in Life Sciences, he brings deep expertise from his leadership roles at industry leaders like PerkinElmer and Waters, as well as his tenure managing the French branch of LabWare. Before joining 吃瓜爆料 to advance their cloud-based LIMS solution, Jelrik held sales leadership positions at L7 Informatics and Tetrascience. He is an expert in laboratory technologies ranging from LIMS and ELN to SDMS and data platforms.

Rich is a strategic thought leader in life sciences technology, specializing in regulatory information management. His extensive experience has been instrumental in developing innovative software solutions that empower organizations to accelerate time-to-market while ensuring compliance. At 吃瓜爆料, he leads the product management team responsible for 吃瓜爆料 RIM, driving the future of regulatory solutions.

Kaitlyn Moore leads the product development of 吃瓜爆料 Disclosures, drawing on her extensive experience in healthcare and clinical trials software to create innovative user experiences. She has spent nearly 15 years leading software development teams.

Marius is the product architect for 吃瓜爆料 Safety, focused on helping the life sciences industry innovate and solve complex problems. Since 2017, Marius has been on mission to modernize pharmacovigilance on one unified system, drawing upon his 20 years of experience in building world-class products and platforms towards this goal. Prior to joining 吃瓜爆料 in 2015, Marius worked at a leading FinTech, where he built their enterprise lending compliance platform and designed their next-generation products.

Innovation Theatre – 吃瓜爆料 employee

Ardit is a Business Consulting Leaders in 吃瓜爆料’s R&D team and leads global RIM implementations and complex business transformation programs.

He has 10+ years of management consulting experience, working across the R&D value chain with leading pharmaceutical & biotech companies. He has previously led global MDM implementations outside of 吃瓜爆料.

Graham O’Keeffe is a leader in GxP compliance and digital learning for the life sciences industry. Graham has been a vocal advocate for moving beyond “check-the-box” compliance. As the General Manager of 吃瓜爆料 LearnGxP, Graham leads the strategic direction for one of the industry’s most comprehensive libraries of accredited GxP training content.

Amanda is a seasoned leader who joined 吃瓜爆料 in 2015 with a strong background in people management and clinical software. Over the past decade, she has led many global EDC implementations to success and built the Clinical Data Services team from the ground up. Currently leading Clinical Solution Consulting in Europe, she works closely with sales and strategy to uncover customer needs and demonstrate the value of the connected clinical platform.

Pratyusha leads AI strategy for the Regulatory market. In this role, she is responsible for long term product direction, market growth, execution and customer success of AI in the regulatory space. She has more than 20 years of experience in software product strategy, enterprise customer sales engagements, product management and engineering in life sciences and healthcare industries.

Bipin is a seasoned Solution Consultant with 25+ years’ experience delivering impactful solutions across life sciences. He excels at turning complex challenges into practical, patient-centric cloud solutions that drive site engagement.

Paheli Patel is the Product Manager for 吃瓜爆料 Submissions, leveraging over five years of expertise across product management and implementation consulting. Recently, she spearheaded the Content Plan Viewer Enhancements to create a more intuitive user experience and developed the ability to Create Global Content Plan from Active Dossier to streamline global regulatory filings. Paheli is passionate about uncovering customer challenges and addressing them through high-productivity features that prioritize efficiency and usability. Her overarching goal is to significantly accelerate the path to Health Authority approvals, helping teams get life-saving products to market faster than ever before.

Chris joined 吃瓜爆料 in March 2024 and has been focused on Validation Management within the 吃瓜爆料 Quality Cloud. Before joining 吃瓜爆料, Chris spent the last 20 years focused on validation, environmental, health, and quality enterprise SAAS applications as both a product manager and solution architect. Chris is passionate about solving industry problems through solutions that customers love to use and helping move the life science industry forward.

Alexis plays a pivotal role in enhancing client engagement and optimizing data solutions. She is responsible for identifying customer challenges, demonstrating tailored solutions that meet customer objectives, and delivering business value to the organization. With extensive experience in patient-focused technologies, Alexis has previously held various roles across the clinical technology industry, focusing on product management, roadmap development, and client engagement. Her expertise in the clinical trial industry has been instrumental in helping companies launch their patient technology initiatives, driving innovation and improving patient outcomes.

Bernat is a Senior Manager of 吃瓜爆料 Validation Management Strategy at 吃瓜爆料 Systems. With five years at 吃瓜爆料 spanning all Quality and Manufacturing solutions, Bernat brings a wealth of experience. Previously, he contributed to Roche Diagnostics by developing software for diagnostic devices and supervised clinical trials for cardiovascular diseases at Novartis. His extensive pharmaceutical industry knowledge and technological expertise uniquely position him to bridge the gap between technology and business transformation.

Erita started her career conducting research at a pharmaceutical company. She first joined 吃瓜爆料 as a professional services consultant and implemented the Clinical Application Suite for global enterprise customers. Today, Erita is a Senior Product Manager on the 吃瓜爆料 Clinical Operations team and is responsible for designing and delivering capabilities for Site Connect.

Armaan comes with over 12 years of experience in the life-sciences industry with an expertise in large-scale transformations across R&D. He brings experience from both consulting and pharma having worked at Bayer in the past. His areas of interest include platform operating model. metrics and performance management and process efficiency.

Euler Santi is the Product Owner for 吃瓜爆料 Quality Basics. He has been with 吃瓜爆料 for over 5 years and helped develop our Training product since his early days. Today his main responsibility is our QualityDocs and Training offering for Basics.

Mercedes is a dedicated Solution Consultant specialicing in the 吃瓜爆料 RIM suite, bridging the gap between complex regulatory requirements and high-performance solutions. She has over 10 years of experience in the pharmaceutical industry, including the landscape of Regulatory Affairs and Operations.

Anna holds a degree in Biotechnology and began her career in professional services, focusing on implementation across Clinical and Quality domains. Anna then transitioned into solution consulting, where she has spent over three years delivering tailored product demonstrations to both SMB and enterprise clients. Throughout this time, she has developed strong expertise in quality systems and customer engagement. She currently serves as the Vault Training application lead, driving product expertise, enablement, and strategic client discussions.

Marcel combines deep scientific and industry expertise with years of strategy consulting to drive Development Excellence within the biopharma industry. As an Engagement Manager and Team Manager within R&D Business Consulting (Development Excellence), he helps industry leaders to design best-fit operating models, streamline R&D workflows for efficiency and solve complex cross-domain challenges.

Madison has spent the past eight years ensuring the successful adoption of 吃瓜爆料’s Quality applications. She has extensive experience implementing QualityDocs, Training, and QMS for customers of all sizes. Now she focuses on empowering emerging biotechs as a product owner building out the Quality Basics offering.

Brian heads up product management for 吃瓜爆料 Batch Release. In this role, he is responsible for building a solution that will help pharmaceutical companies qualify their products with improved time to market and increased confidence. Prior to 吃瓜爆料, Brian founded Propel Software, a PLM and QMS solutions provider and held Product Management roles at Apeel Sciences, Equilar, and Oracle.

Steven has been dedicated to the success of emerging biotechs adopting 吃瓜爆料’s regulatory applications for the past eight years. He brings with him a wealth of implementation experience from his time in services, where he implemented and led teams for Vault Submissions, Archive, and Publishing applications. Now, he serves emerging biotechs from the product side on the 吃瓜爆料 Basics team.

Kyle started his career regularly using 吃瓜爆料 systems at a medical device company. He fell in love with the product and joined 吃瓜爆料 as an associate consultant. Now, after 10 years with 吃瓜爆料, Kyle is a director of product who leads a team responsible for the development of some of our core and emerging Clinical Operations applications; eTMF, Study Startup, and Site Connect. Kyle is also heavily involved in the design and development of new capabilities such as CRA Central, an application for CRAs to do all activities related to a Clinical Trial.

Jeff Steward is the lead Solution Consultant in North America supporting 吃瓜爆料 Connections and 吃瓜爆料 Process Excellence. After 10 years working in Industry and for Life Sciences technology vendors, Jeff came to 吃瓜爆料 in 2013 where he now uses his R&D cross-domain experience within Solution Consulting to demonstrate the value of 吃瓜爆料 Development Cloud applications.

Gareth Sully is a Senior Director at 吃瓜爆料 Systems, focused on transforming Clinical Operations through technology, strategy, and measurable value delivery. With over two decades of experience in global clinical trials, he works with top pharmaceutical companies to modernise operating models and unlock efficiencies across the study lifecycle. His work centres on site engagement, digital collaboration, and data-driven decision-making. Gareth is a recognised leader in driving site-centric innovation to accelerate clinical development outcomes.

John is a Senior Product Manager at 吃瓜爆料 based in the UK working in the RIM Product Management Team, specializing in connecting RIM to other 吃瓜爆料 applications including Clinical, Quality, Safety, Medical and PromoMats. His current focus areas are: Enhanced Change Management between QMS and Regulatory, Ad Promo Submissions between RIM and PromoMats, the new RIM to Medical Connection and connecting product data across the 吃瓜爆料 ecosystem. John has a strong background in implementation, systems integration and development following over 25 years’ experience in IT working across a number of market sectors.

Martino Tomizioli is a Solution Consultant at 吃瓜爆料 Systems with a strong focus on Quality and regulated processes. He brings a Ph.D. background and extensive experience in pre-sales and solution consulting for 吃瓜爆料’s Quality and compliance platforms, helping pharmaceutical and biotech companies streamline quality, validation, and regulated operations.

Manny Vazquez has spent 20 years in the research industry dedicated to Clinical Data Management across Biopharma, CRO and technology. He currently sits on the Society for Clinical Data Management Board of Trustees and hosts Unblinded: A Clinical Podcast.

Jordan has deep expertise across all areas of RIM. Working across Vault Connections, to Submissions Publishing. Now focused on bringing 吃瓜爆料 AI into RIM.

Eric is the product lead for 吃瓜爆料 AI for Safety. Eric was previously a product manager for 吃瓜爆料 SafetyDocs and 吃瓜爆料 Safety, working on features across both applications.

Originally a Molecular Biologist, Reto turned towards Life Sciences Management and Strategy Consulting many years ago. Within 吃瓜爆料, he enjoys working across R&D domains focusing on our DevCloud.