Our team of experts brings diverse skills and extensive experience to deliver exceptional results and innovative solutions. Learn more about the professionals dedicated to your success.
Former Novartis VP, Data42 Head of Technology [CTO], Pascal is an experienced Technology Leader with expertise in health data and AI, adept at driving digital innovation, leading global high-performing teams, and leveraging diverse expertise in eHealth and digital medicine. Core competencies include:
The HTP42 Management Team leads the company’s vision, strategy, and growth, ensuring that our network of independent consultants delivers impactful results. Combining deep industry expertise with hands-on leadership, they drive excellence in project delivery, foster innovation, and cultivate strong client relationships across regions and sectors.
CEO, Managing Partner and Senior Advisor
Former Novartis VP, Data42 Head of Technology [CTO], Pascal is an experienced Technology Leader with expertise in health data and AI, adept at driving digital innovation, leading global high-performing teams, and leveraging diverse expertise in eHealth and digital medicine. Core competencies include data and AI strategy, business case development, architecting and building clinical data platforms, enterprise architecture, and program management.
Recruitment and Talent Development Specialist
Taline is a Recruitment and Talent Development Specialist with proven expertise in attracting, developing, and retaining high-performing teams. She designs and delivers performance management, leadership development, and career growth programs that drive results. Skilled in talent acquisition, onboarding, and learning & development, she has supported organizations in pharmaceutical and IT consulting sectors. Combining strategic HR insight with impactful employee engagement initiatives, Taline helps leaders build strong, agile, and motivated workforces.
HTP42 CTO, Graph Technology, Open-Source & Clinical Metadata Expert
Marius is a Program Tech Director with deep expertise in graph-based data science, data modelling, and open-source development. He has led strategic initiatives in pharmaceutical, healthcare, and technology sectors, including the design of the OpenStudyBuilder graph data model and API for Novo Nordisk. With a background spanning technical strategy, data architecture, and agile development, Marius has guided clients from concept to production, optimizing performance, scalability, and integration. A recognised thought leader and public speaker, he drives innovation by combining advanced data engineering with collaborative, open-source ecosystems that deliver impactful, standards-compliant solutions.
Exec Director, Head of Data Strategy, Management and Analytics
Linda is a data strategy and analytics leader with extensive experience driving transformation across pharmaceutical and healthcare sectors. She has led end-to-end re-engineering of clinical trial processes for global organizations, delivering impact through data-driven solutions, automation, and governance frameworks. As an executive advisor, Linda combines expertise in biostatistics, machine learning, and computational sciences with strategic leadership to accelerate research and optimize efficiency. Her track record spans enterprise data governance, digital health platforms, and advanced analytics that enhance scalability, compliance, and long-term value creation.
CEO, managing partner and Senior advisor
Former Novartis VP, Data42 Head of Technology [CTO], Pascal is an experienced Technology Leader with expertise in health data and AI, adept at driving digital innovation, leading global high-performing teams, and leveraging diverse expertise in eHealth and digital medicine. Core competencies include data and AI strategy, business case development, architecting and building clinical data platforms, enterprise architecture, and program management.
Singapore Partner and Enterprise technical Architect
Bala is a distinguished enterprise architect, TOGAF9 certified and AWS Cloud Solution Architect certified. He also holds a CISA (Certified Information Systems Auditor) certification. He spent the last ten years at Novartis, first as an enterprise architect for Regulatory, and then designing and building an award-winning (Gartner Life Sciences Award), 100% Cloud-based Data & Analytics platform from the ground up. This platform supports 130+ advanced analytics/AI use cases across 3 regions (US, EU, and China) in a demanding regulated environment (GxP validated & supporting Strictly Confidential Data Sets, China Cybersecurity Law).
Managing Director
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Executive Director
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The HTP42 Management Team leads the company’s vision, strategy, and growth, ensuring that our network of independent consultants delivers impactful results. Combining deep industry expertise with hands-on leadership, they drive excellence in project delivery, foster innovation, and cultivate strong client relationships across regions and sectors.
Executive Leader in Pharmaceutical Engineering & Operations (also relevant to Engineering)
Matthias is an executive leader in pharmaceutical engineering and operations with extensive global experience in site transformation, CapEx program delivery, and CDMO transition. He has led high-impact engineering and manufacturing initiatives across Europe, Asia, and the US, from greenfield builds to large-scale facility upgrades. At Novartis and Celonic, Matthias unified engineering teams, optimized manufacturing readiness, and managed global CapEx portfolios exceeding USD 2 billion. As a consultant and board member, he advises on GMP readiness, strategic sourcing, and operational excellence, helping organizations scale advanced therapy platforms and achieve sustainable performance improvements.
Mental Health Innovator & Operational Excellence Expert
Rachel is an operational excellence leader and mental health innovator with extensive experience driving large-scale transformation across healthcare, banking, telecom, and technology sectors. She has led billion-dollar enterprise portfolios, delivering measurable impact through agile governance, digital health initiatives, and strategic workforce transformation. As founder of ROCC GmbH, Rachel combines entrepreneurial ventures—including a digital mental health platform—with deep expertise in PMO leadership, cybersecurity programs, and business automation. Her track record spans executive advisory roles, cross-industry healthcare think tanks, and transformation leadership that enhances efficiency, scalability, and long-term value creation.
Marketing Advisor, Life Sciences & HealthTech
Karin is a global marketing and strategy executive with 20+ years of leadership across pharmaceutical, medical devices, and HealthTech sectors. She has held senior roles at Baxter, BD, Fresenius, and Medtronic, driving commercial growth, digital transformation, and post-merger integration across EMEA and APAC. With a PhD in Genetic Engineering and an MBA from London Business School, Karin combines scientific insight with strategic acumen. She advises HealthTech start-ups, builds ecosystems, and leads omnichannel marketing initiatives that deliver measurable impact across diverse markets.
Digital Strategy Transformation & Global Program Leader
Marco is a digital strategy and transformation leader with deep expertise in global program and portfolio management across pharmaceutical and healthcare sectors. He has built and scaled PMOs from the ground up, driving operational excellence, automation, and executive engagement to deliver measurable performance gains. At Novo Nordisk and Novartis, Marco led large-scale GxP digital transformation programs, optimized governance frameworks, and managed multi-million-dollar portfolios with global cross-functional teams. His skills span agile governance, change management, and digital platform delivery, enabling organizations to accelerate innovation, reduce costs, and achieve sustainable growth.
Strategic Consultant
Laura is a strategic consultant with expertise in project management, healthcare transformation, and governance. She has led IT transformation initiatives, optimized patient care pathways, and developed value-based healthcare funding models in collaboration with multi-stakeholder teams. Skilled in change management, analysis, and digital transformation, Laura delivers actionable recommendations that improve operational efficiency, care quality, and financial sustainability. Her work spans healthcare, IT, and management consulting, with a focus on aligning clinical, financial, and policy objectives to drive lasting organizational impact.
Scientific & Strategy Lead, Biotech Innovation & Global Health
Annette is a PhD-trained biotech executive with 15+ years of experience spanning translational research, pharmaceutical development, and global health strategy. She has led cross-functional R&D programs from discovery to clinical readiness, co-invented multiple patent families, and secured multimillion CHF non-dilutive funding. As Chief Scientific Officer at AC Bioscience, she drove innovation in immunomodulatory therapies for cancer and infectious diseases. Her strategic roles at WHO and COST reflect her impact on global health policy, drug development, and ecosystem building. Fluent in English and French, Annette combines scientific depth with strategic vision to advance biotech innovation and public health outcomes.
Product & Technology Leader
Michaël has held leadership roles as CTO, CPO, and CIO in startups, scale-ups, and renowned research institutions at the intersection of biomedical research, AI, and life sciences innovation He supports life sciences organisations in shaping product and technology strategy, building multidisciplinary teams, and driving transformation across R&D and clinical ecosystems. His experience spans AI-enabled biomedical solutions, and translational research platforms, always with a focus on execution, scalability, and impact. Michaël combines the agility of startup innovation with the governance and rigor of large organizations, enabling his clients to accelerate discovery, secure investment, and bring science-driven solutions to market.
Digital R&D Strategy & Partnerships Leader
François-Henri is an accomplished leader in digital R&D strategy with over 20 years of experience spanning life sciences, HealthTech, and financial services. He specializes in transforming pharmaceutical R&D through in-silico modeling and data-driven decision support, enabling organizations to accelerate clinical development and optimize outcomes. With a proven track record in building strategic partnerships, securing funding, and scaling innovative technology companies, François-Henri bridges the gap between science, technology, and business. Known for his ability to design agile operating models and lead cross-functional teams, he combines strategic vision with hands-on expertise in digital platforms, governance, and commercialization.
Senior Data & Analytics Executive, Data Mesh, Data Architecture, Data AI & Cloud Transformation Leader
Omar is a senior data & analytics executive with deep expertise in enterprise data strategy, analytics transformation, and AI-driven innovation. He has led strategic initiatives in pharmaceutical, chemicals, diagnostics, and consumer goods sectors, including the design and execution of global Data & AI strategies for companies like Novartis, Roche, Givaudan & Novo Nordisk. With a background spanning data architecture, governance, and cloud modernization, Omar has guided organizations from concept to implementation, optimizing scalability, compliance, and business impact. A recognized thought leader and advisor, he drives innovation by combining advanced analytics, modern data platforms, collaborative operating models and data mesh & data products implementations that enable digital transformation and data-driven cultures.
Healthcare AI Strategist & Digital Health Transformation Leader
Christian is a healthcare AI strategist and digital health transformation leader with over two decades of experience spanning pharmaceuticals, healthcare, and health tech. He has driven global digital innovation at Novartis and Amgen, built strategic partnerships, and scaled AI-driven solutions for chronic disease management, patient engagement, and commercial operations. As a venture partner and advisor, Christian guides health tech startups on clinical validation, scalability, and go-to-market strategies, while fostering corporate–startup collaboration to co-create AI-powered solutions. His expertise bridges strategic leadership, product innovation, and ecosystem building to accelerate impactful healthcare transformation.
Digital Health leader
Rado Adrian is a seasoned Digital Health leader and advisor with over 20 years of experience in driving transformative change in healthcare. He excels at integrating digital innovation into business strategies, focusing on value mastery and patient-centric solutions that advance Predictive, Preventive, Personalized, Participatory, and Population-based healthcare. With expertise in digital biomarkers, ML/AI, and convergence design, Rado builds collaborative ecosystems that deliver compliant, outcome-driven, and value-based digital health solutions.
Strategic Scientific Director – Genomics, Biotechnology & AI Innovation
Edward is a scientific leader at the intersection of genomics, biotechnology, and AI, with over two decades of experience in academia, pharma, and biotech. He has led computational genomics, bioinformatics, and AI-driven projects, from regulatory-compliant clinical pipelines to innovative gene therapy solutions. As founder of Oakley Genomics, he develops sustainable AI applications for genomic data analysis, integrating advanced machine learning, cloud-based storage, and proteomics automation. His career spans leadership roles at Novartis and research institutes, co-founding technology consortia, and mentoring scientists, consistently advancing the use of data-driven innovation to accelerate discovery and clinical translation.
Graph Data Scientist & Clinical Data Solutions Specialist
Juan Carlos is a Graph Data Scientist and Clinical Data Solutions Specialist with strong expertise in pharmaceutical, banking, and technology sectors. He specializes in building graph-based analytics, metadata management systems, and scalable pipelines to support regulatory compliance and advanced clinical research. Skilled in Python, R, SQL, SAS, Spark, and Neo4j, Juan has led projects involving CDISC-compliant MDR implementation, semantic annotation, and predictive modeling for study optimization. His experience spans API development, graph retrieval-augmented generation (RAG), and machine learning applications that enhance interoperability and accelerate data-driven decision-making. Passionate about innovation, he focuses on creating solutions that improve efficiency and deliver actionable insights across complex datasets.
Data & AI Strategy Leader
Steffen is an accomplished Data & AI Strategy leader with extensive experience in driving enterprise-level data transformation within global pharmaceutical organizations. He specializes in building scalable data ecosystems that enable advanced analytics and AI, ensuring governance, trust, and business impact. With a strong background in Real-World Evidence, health economics, and digital innovation, Steffen bridges the gap between technology and business, delivering solutions that accelerate R&D and improve decision-making. Known for his ability to lead cross-functional teams and implement agile operating models, he combines strategic vision with hands-on expertise in data platforms, automation, and compliance.
Global Digital Health & Pharmaceutical Innovation Leader
Digital Health leader and strategic advisor with extensive experience in Global Clinical data and digital Health innovation. Tracking record of delivering transformative healthcare solutions. Skilled in embedding emerging technologies—including AI—into business strategies to enhance clinical workflows. At Roche-Genentech, Stephane led the development of the Pharma Information and Data Landscape, establishing data-governance frameworks that ensured effective data flow, storage, and management across the value chain. As a consultant, he advises pharma and biotech organizations on optimizing clinical development processes, strengthening cross-functional collaboration, and implementing data-driven solutions—including AI/ML approaches—that accelerate innovation and improve patient outcomes.
Digital Transformation & Clinical Innovation Advisor, Life Sciences
Christian is a senior executive and global expert in digital health and clinical development with 20+ years of leadership in Life Sciences. He has driven transformation at Novo Nordisk, leading initiatives in digitalization, process optimization, and innovation across drug and device development. Christian pioneered the Digital Health journey at Novo Nordisk, managing full-stack software development and data science under GxP and SaMD compliance. With an MD and PhD in Endocrinology from the University of Aarhus and executive education from Harvard and Wharton, he combines deep scientific expertise with strategic vision. He advises on digital health strategies, decentralized clinical trials, and innovation ecosystems, while mentoring leaders and shaping the future of medicine and technology integration.
Data Strategy & Analytics Consultant | Data Mesh & Data Product Architecture Expert
Paul is a data strategy and analytics consultant with over 20 years of experience bridging business and IT to deliver scalable, value-driven data solutions across Fortune 500 companies. As a specialist in data mesh, data product architecture and computational governance, he has led large-scale data transformation initiatives across pharmaceutical, insurance, energy and finance sectors. With hands-on experience managing complex cloud platforms at organizations such as F. Hoffmann-La Roche and Bayer AG, and a proven track record of building federated, domain-driven data ecosystems, he combines deep technical expertise with strong leadership and stakeholder management to help organizations unlock the full value of their data.
Professor of Mathematics & Expert in Data Science, AI and Complex Systems
Laurent is a professor of mathematics and seasoned data science expert with over 25 years of experience bridging academic research and industry. As director of multiple ANR-funded projects and consultant for organizations such as IPSOS, and EPFL, he has led large-scale initiatives in knowledge graphs, NLP, LLMs, and machine learning across sectors including food, life sciences, legal tech, and energy. With 80+ publications, 1 CNRS/CEA patent, and 15 PhD theses supervised, he combines deep mathematical expertise with hands-on AI delivery to tackle complex, data-intensive challenges.
Executive Leader in Clinical Data Science, Biostatistics & Digital Health Innovation
Eric is an executive leader with extensive global experience in clinical data science, biostatistics, and digital health innovation. He has built and led large, cross-regional teams in pharma R&D, driving strategies in data analytics, AI, and adaptive trial design. At Sanofi, he established data governance frameworks, advanced AI applications in molecular imaging and digital biomarkers, and oversaw biometrics teams supporting development from early research to regulatory approval. As a consultant, Eric advises biotech companies on optimizing clinical development processes, fostering cross-functional collaboration, and implementing data-driven solutions that accelerate innovation and improve patient outcomes.
Senior Statistical Programmer & Clinical Data Automation Specialist
Phoebe is a Senior Statistical Programmer and Clinical Data Automation Specialist with extensive experience across pharmaceutical, healthcare, and biotechnology sectors. She excels in developing and validating clinical data to CDISC standards, preparing regulatory submission packages, and automating trial workflows. Skilled in SAS, R, and Python, Phoebe has led programming for global Phase II–IV studies, ensuring quality, compliance, and timely delivery. Her expertise spans SDTM, ADaM, TFLs, and eCRT, as well as building open-source tools to optimize study design and data integration. Passionate about process efficiency, she drives innovation that accelerates regulatory readiness and enhances trial outcomes.
Full-Stack Developer, Open-Source Contributor & Complex Systems Architect
Antoine is a seasoned full-stack developer with over 20 years of experience in tech, specializing in Python, Vue.js, and scalable system architecture. He has led and contributed to open-source initiatives across healthcare and pharmaceutical domains, including the development and maintenance of tools used in clinical data platforms. With a strong background in backend engineering, frontend development, and DevOps, Antoine brings deep technical expertise and a pragmatic approach to building robust, high-performance solutions. His work spans startups, enterprise environments, and freelance consulting, where he combines technical depth with agile collaboration to deliver impactful results in regulated industries.
Biostatistics Leader & Digital Health Strategist
Søren is a senior biostatistics and digital health strategist with over 20 years of experience in bridging the gap between clinical rigor and digital innovation. Having led global biostatistics units and successful regulatory submissions, Søren specialises in driving data-driven decisions that de-risk portfolios. As a digital ambassador, Søren has integrated agile methodologies in a corporate setting and has spearheaded innovative solutions such as clinical data platforms and the application of digital solutions (e.g. wearables) to accelerate timelines and enhance patient insights. His expertise spans drug development, project leadership, portfolio management, and cross-cultural team coordination, delivering impactful strategies that combine scientific rigor with data and digital transformation.
Medical Imaging AI Strategist | Oncology Innovation
Agata is a data scientist specializing in AI for oncology imaging and clinical trials. At Roche, she develops deep learning models for tumor segmentation and biomarker discovery. She built automated pipelines for CT, MRI, and PET analytics, integrating FAIR data principles. Her background spans medical devices, robotics, and radiotherapy imaging research. She led collaborations across clinical, AI, and bioinformatics teams to optimize radiomics workflows. Agata holds agile certifications and is trained at MIT Sloan in AI for Pharma & Biotech. Her work is published and presented internationally, driving innovation in precision medicine.
Biomedical AI Specialist | Data Science & Automation
Josephus is a data scientist with expertise in biomedical AI, NLP, and predictive modeling. He designs agent-based workflows and fine-tunes LLMs for clinical and research applications. At Novartis, he built CNNs for chemical analysis and interactive tools for lab data visualization. His academic work focused on RNA-seq, toxicity modeling, and large-scale genomic pipelines. He combines Python, R, and Bash with strategic thinking to drive innovation in life sciences. Josephus has co-authored multiple publications and mentors teams in reproducible research. His focus: scalable AI solutions for pharma, bioinformatics, and automation.
Data & AI Advisor, Life Sciences & Pharma
Roozbeh is a data and AI strategist with over a decade of experience across consulting, enterprise tech, and pharma. After completing a Master’s in Natural Language Processing at the University of Stuttgart, he held roles at Samsung Electronics, Bosch Research, and Accenture, where he built and led the DataOps capability for the EMEA region. He founded a boutique consulting firm focused on pharma and life sciences, delivering solutions in data platforms, MLOps, and vertical use cases such as patient cohort building and scientific Q&A bots. His clients include Roche, Bayer, MSD, and LVMH. Roozbeh combines deep technical expertise with strategic leadership, and actively contributes to business development, including partnerships and demo-ready solutions. He is available for full-time engagements and open to collaboration across the HTTP 42 network.
Consultant in Technical Product Development & Systems Architecture
Saurabh has led technical initiatives across ERP systems, banking platforms, and open-source applications, with a focus on backend architecture and product delivery. He supports organizations in designing scalable solutions, managing authentication frameworks, and driving digital transformation in complex environments. His experience spans international development, fintech, and enterprise software, combining hands-on execution with strategic insight. Based in Rwanda, Saurabh brings global perspective and regional expertise, enabling his clients to build resilient systems, streamline operations, and deliver impactful technology across sectors.
Expert in Clinical Drug Development & Strategic Program Leadership in Biotech and Pharma
Hervé is a seasoned drug development executive with over 25 years of global experience spanning early to late-stage development, acquired within Big Pharma. He has held strategic roles across research, clinical development, and project management, leading multiple programs from preclinical through clinical stages. Prior to founding Spes Bioventure, a consultancy dedicated to supporting start-ups and biotechs in drug development, he served as a Senior Global Program Head at Novartis, where he oversaw the global development of several neurological assets. His core expertise lies in crafting and executing differentiated Target Product Profiles, building robust program strategies, managing cross-functional plans from candidate selection through to drug registration and designing clinical studies. He also has substantial experience in asset evaluation and portfolio assessment.
Business Development & Regulatory Affairs Executive, Pharma & Medical Devices
Lars is a senior executive with extensive experience in business development, regulatory affairs, and quality management across pharmaceutical, biotech, and medical device sectors. He has led international market expansion and regulatory compliance initiatives, including CE certification (Class I & IIa), ISO 13485 implementation, and lean QMS design. He is also developing an AI‑based framework to automate the CE certification process. His career spans strategic partnerships, RA/QA leadership, and commercialization of innovative medical technologies, bridging technical and commercial teams to drive growth and ensure compliance. A trusted advisor and negotiator, Lars combines strong business acumen with regulatory expertise to deliver scalable solutions and sustainable market‑entry strategies.
Global Medical & Clinical Affairs Leader
Séverine is a medical and clinical affairs expert with over 20 years of experience leading international clinical trials and compliance strategies across pharmaceuticals, medical devices, and biotech. She has driven international studies, , managed global teams, MDR remediation and optimized CRO partnerships to ensure operational excellence. Former Vice-President at BioScience GmbH and Head of Medical Affairs EMEA at Alcon, she combines strategic leadership with hands-on expertise in clinical development, medical writing, and post-marketing surveillance and strong knowledge in health economics and regulatory environment, delivering impactful solutions for complex medical landscapes.
Senior Technology Executive – Life Sciences & IT Strategy
Paul is a senior technology executive with extensive experience in life sciences, specializing in clinical data platforms, IT strategy, and digital transformation. Over two decades at Johnson & Johnson, he led the architecture and global deployment of advanced clinical data solutions, including AWS- and Databricks-based platforms, and directed large-scale programs such as Statistical Computing Environment rollouts. A certified PMP, Paul combines deep technical expertise with cross-functional leadership, guiding organizations through complex platform implementations, vendor selection, and cloud transformation. His work consistently delivers scalable, compliant, and business-aligned technology solutions that enhance research outcomes.
Technology Leader
Homayoun brings over 30 years of experience in various roles as a technologist, encompassing research and development, design, architecture, strategy, and management. For the past 12 years, he has specialized as an IT architect and strategist, driving digital transformation and advancing data science and analytics across diverse industries. Notably, for the last 8 years, Homayoun has served as a Lead Architect in the Clinical Development Digital domain at Novartis, where he has played a pivotal role in shaping and implementing cutting-edge digital solutions.
Enterprise Data & Architecture Leader | AI & Clinical Technology Strategist
Tim has held senior leadership roles across global pharmaceutical and technology organizations, driving innovation in enterprise architecture, data platforms, and AI enablement. He supports life sciences and clinical development teams in shaping technology strategy, building scalable data solutions, and leading cross-functional engineering efforts. His experience spans cloud-native platforms, clinical data standards, and AI-driven analytics, with a strong focus on execution, compliance, and impact. Tim combines the agility of modern engineering practices with the governance of regulated environments, enabling organizations to accelerate transformation and deliver high-value digital solutions.
IT Senior IT Leader | Head of IT
Kannan is a seasoned IT Leader with over 15 years of international experience delivering end-to-end IT strategic solutions, IT advisory to the board, consulting, and managed services. As Program Director at Wipro Technologies, he oversaw Nestlé's global IT infrastructure across hundreds of countries, managing large-scale programs and leading teams of hundreds. He has since brought his expertise to the pharma sector, leading network and security transformation programs for biotech clients in compliance with GxP, GDPR, and HIPAA standards. With deep expertise spanning SD-WAN, multi-cloud transformation, network and cyber security, and large-scale outsourcing, Kannan has consistently driven major contract renewals, delivery transformations, and cost optimization initiatives across consumer goods, telecom, and life sciences sectors.
Senior Clinical Data Management Expert
Yannick has led clinical data initiatives across pharmaceutical, biotech, and CRO environments, with a focus on end-to-end data management, CDISC compliance and regulatory submissions. He supports sponsors and vendors in delivering high-quality datasets, managing outsourced teams, and ensuring readiness for audits and health authority reviews. His experience spans Phase I to III trials across multiple therapeutic areas, combining operational leadership with technical expertise on the full data management lifecycle (from CRF design to CDISC SDTM deliveries). Based in France, Yannick brings both global insight and hands-on execution, enabling organizations to streamline clinical workflows, meet regulatory expectations, and advance drug development with confidence.
Senior Expert in CDISC Standards & Clinical Data Operations
Nathalie is a senior expert in clinical data operations and CDISC standards with extensive experience leading the full data management lifecycle for global clinical trials. As founder of two CROs, she has overseen data for studies across multiple indications, delivered CDISC SDTM validation for FDA submissions, and trained hundreds of professionals worldwide. Her expertise spans database design, MedDRA and WHO Drug coding, SOP development, and regulatory compliance. A seasoned trainer and industry contributor, Nathalie has developed internal processes, authored study documentation, and driven knowledge transfer initiatives that elevate data quality and operational efficiency in clinical research.
Data Scientist & Clinical Programming Innovator
Skander is a data science leader and bioinformatics expert specializing in AI-driven solutions for clinical development. With a proven track record in deploying large language models, agentic workflows, and document-intelligence platforms, he accelerates trial operations and regulatory compliance across the pharmaceutical sector. His experience spans building scalable AI pipelines, implementing CDISC standards, and mentoring teams to adopt next-generation analytics. From developing Digital Twin models for cardiovascular decision support to creating RAG-powered platforms for clinical reporting, Skander combines deep technical expertise with strategic vision to deliver efficiency, quality, and innovation in drug development.
Data Standards Consultant & Program Director | Life Sciences & CDISC Expert
Nick is a data standards consultant and program director with over 15 years of experience bridging operational excellence and industry-wide innovation in life sciences. As former CDISC Open Rule Program Manager and authorized trainer for SDTM, CDASH, and related standards, he has led large-scale initiatives in data standards implementation, automated conformance, and regulatory submissions across pharmaceutical and clinical research organizations. With 25+ international conference presentations, active committee roles at PHUSE and E3C, and a track record of driving digital transformation at organizations such as Enovalife and CDISC, he combines deep domain expertise with proven leadership to deliver compliant, high-quality clinical data solutions.
Bala is a distinguished enterprise architect, TOGAF9 certified and AWS Cloud Solution Architect certified. He also holds a CISA (Certified Information Systems Auditor) certification. He spent the last ten years at Novartis, first as an enterprise architect for Regulatory, and then designing and building an award-winning (Gartner Life Sciences Award), 100% Cloud-based Data & Analytics platform from the ground up. This platform supports 130+ advanced analytics/AI use cases across 3 regions (US, EU, and China) in a demanding regulated environment (GxP validated & supporting Strictly Confidential Data Sets, China Cybersecurity Law).
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