Powerful Community, Fresh Ideas

Astrid Scherer is the VP, Global Head of Clinical Data & Performance Excellence (CD&PE) at Bayer AG, leading the transformation of clinical development through innovative concepts, processes, and technologies. With extensive experience across strategy, pharmacovigilance, medical affairs, and commercial operations, she has spearheaded numerous cross-functional initiatives, including PV transformation and the implementation of the Medical Customer Powerhouse in collaboration with Veeva. Astrid is based in Basel, Switzerland, and holds degrees in Pharmacy and Translation/Interpretation from the Universities of Bonn and Cologne.

Javier has over 25 years of experience in the pharmaceutical industry, having held positions in quality, regulatory affairs (CMC/development), and regulatory operations. He is currently the head of regulatory operations at Teva, where he is responsible for implementing all regulatory systems and processes, focusing on bringing global digital solutions and innovations, specifically in the AI and Automation space, to improve working processes and regulatory outcomes. He is a subject matter expert for xEVMPD, IDMP, and eCTD and is involved in several ICH, EMA, and industry association working groups.

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

Paul is a technologist and business development professional whose experience spans 40 years – 8 years as a software engineer and 32 dedicated in life sciences. He currently leads Veeva’s regulatory strategy activities in Europe, helping customers maximize the value of Veeva RIM. He also has experience in business development, product management, product architecture, software development, and professional services at DxC, CSC and FCG.

Dominique joined Accumulus Synergy in 2022 as the senior vice president of regulatory innovation. Before joining Accumulus, Dominique worked in various leadership roles in regulatory operations for the past 25 years, most recently leading Amgen’s global regulatory operations function. In his role at Accumulus, Dominique engages with global health authorities and industry partners to drive regulatory innovation leveraging cloud technologies. Dominique has also been a Board member of the IRISS Forum since 2021. Dominique holds a Pharm D and a Master’s in International Regulatory Affairs from the University of Paris.

Regulatory operations publishing, data system, and processes expert with 25 years of experience encompassing medicinal, biologic, devices, food supplements, and cosmetics. Isabelle is a subject matter expert in eCTD publishing, managing a performing publishing team and RIM suite with the implementation of Veeva RIM within first GSK (Haleon) and now in Alvotech.

Hanna is a senior manager within Quality System & Compliance at Ascendis Pharma A/S in Copenhagen. She is responsible for driving improvements and developing quality processes. Hanna has more than 28 years of experience in the pharmaceutical industry, working with QMS processes, including quality risk management. She holds a chemical engineering degree from the Technical University of Denmark.

Balaji is a global delivery leader with 20+ years of experience in IT for Pharmaceutical R&D. He specializes in regulatory and quality functions and has led major transformations. Currently, he leads the regulatory and quality IT platform in AstraZeneca. He is passionate about building high-performance teams and setting up operating models, processes, and ways of working.

Jenny has 20+ years of experience working with regulatory information management systems in Arizona. When AstraZeneca implemented Veeva RIM, Jenny led the data governance workstream, defining data standards and principles. In 2022, she moved to a new role as the AZ Veeva RIM product manager to focus on setting up and leading the continuous improvement of AZ Veeva RIM. She works to establish priorities and develop the AZ Veeva RIM roadmap.

Head of Global Clinical Solutions Services, Marta oversees teams focused on eTMF, CTMS, SLD, eCOA and RTSM. She is a team oriented leader with almost 14 years of experience in clinical trials, leading cross-functional and multicultural teams, and working across global and local organizations.

Debbie is a senior director at AstraZeneca. She has worked in pharma for nearly 40 years across multiple domains and implemented content management solutions, most recently Veeva RIM.

Andrea Barz is an experienced leader with a distinguished background in quality assurance and management within the pharmaceutical industry. Currently serving as the lead digital quality at Bayer AG, she plays a pivotal role in advancing digital quality initiatives, focusing on the integration of innovative technologies to enhance quality assurance processes.

With over a decade of experience in various quality-related roles, Andrea has demonstrated exceptional leadership in managing cross-functional teams and driving transformative initiatives. Her responsibilities include overseeing digital transformation projects that streamline quality management systems and improve operational efficiency. Andrea’s commitment to excellence and strategic guidance has significantly contributed to the success of numerous high-impact projects. She holds a degree in Biopharmaceutical Technologies and is dedicated to fostering collaboration and continuous improvement within her teams, leveraging her analytical skills to navigate challenges and drive effective solutions in the dynamic landscape of the life sciences industry.

Dr. Aniela Heidebrecht is an accomplished IT professional with a strong track record in leading transformative initiatives within the healthcare and life sciences. Currently serving as the IT program lead for IQMS at Bayer AG, Aniela is at the forefront of a pivotal shift towards integrated quality management solutions. With a background as an IT product manager and a Ph.D. in Molecular Biosciences, she brings a unique blend of scientific expertise and strategic IT leadership. Aniela has been instrumental in driving digital cloud-native products, such as an Advanced Analytics Platform for the clinical environment, and has demonstrated exceptional leadership in fostering collaboration and driving strategic initiatives across the organization.

Olaf Ehses is a seasoned professional with over 25 years of experience in the life sciences, specializing in quality assurance for medical devices and pharmaceuticals. Currently serving as the business program lead in Corporate and Pharmaceutical Quality at Bayer AG, Olaf has demonstrated his expertise in various quality assurance roles throughout his career.

His leadership has spearheaded numerous projects, from new product development to technology transfer and IT system implementation. Olaf is a dedicated team player who strongly emphasizes collaboration, leveraging his analytical skills to drive effective team problem-solving and decision-making.

Carina is a motivational leader with 20+ years of in-depth clinical development experience through all stages and multiple therapeutic areas. Her business acumen, international leadership, and organizational development expertise complement her system lifecycle competencies. She focuses on establishing empowered, high-performing teams with a strong capability-based operating model. She has successfully delivered huge organizational and digital transformations while driving a holistic digital and data strategy for ClinDev execution.

Martin leads the clinical data collection capability area at Boehringer Ingelheim and has over 20 years of experience in biometrics and data science across academia and pharma. His team oversees the systems and processes for clinical data acquisition in clinical trials. Martin is passionate about organizational development and agile methodologies, Martin focuses on fostering user-centricity and end-to-end thinking in clinical development.

Vada is vice president, global head of regulatory intelligence & policy for Boehringer Ingelheim. He is a former FDA senior advisor for Regulatory Science with global regulatory policy & intelligence expertise in applying international standards to regulatory science and policy initiatives. His continued collaboration with national and international stakeholders promotes convergence in policy and strategy in the assessment of medicinal products worldwide. He received his degrees from Johns Hopkins University, the University of Southern California, and the University of Maryland.

Annalisa is the head of global regulatory affairs digital and publishing at Chiesi. With over 17 years of experience in the pharmaceutical industry, she has led numerous strategic projects, such as implementing Veeva RIMS and IDMP. She also plays a crucial role in advancing digital and data-driven initiatives across the R&D value chain. Her areas of interest include cutting-edge regulatory solutions and enhancing cross-functional collaboration to drive impactful changes and operational excellence.

Johanna is a pharmacist by training and has a PhD in clinical pharmacology. She has extensive experience in pharmacovigilance/drug safety, working in academia at the Uppsala Monitoring Centre, industry through a CRO company, and several global MAHs.

Matthew currently serves as the Senior Product Owner and is responsible for shaping and executing the technology roadmap in harmony with GSK’s global clinical operations objectives, with a specific focus on study start up. His concentration lies in consistently refining user experiences and business outcomes for solutions and systems catering to study start up.

Thomas has 20 years of experience in the pharmaceutical industry, specializing in Document Management Systems. Since 2013, he has been the Product Owner of GSK eTMF, delivering Veeva eTMF implementation project and eTMF migrations. Currently, he serves as the Tech Lead for the GSK Site Connect Implementation project.

Krisztián brings extensive experience in structural biochemistry, regulatory assessment, and strategic leadership. As a former assessor, he contributed to various EMA committees and working groups, playing a key role in shaping regulatory frameworks. He has been instrumental in modernizing regulatory operations and leveraging digital transformation to enhance efficiency and compliance. His expertise spans data management, operations, and content production, driving innovation across global subsidiaries. Through strategic foresight and innovation, Krisztián continues to shape the future of pharmaceutical regulation, ensuring excellence in a rapidly evolving landscape.

Andrzej has s robust career spanning various roles in IT and system engineering, He has demonstrated expertise in managing and enhancing business-critical applications such as Veeva Vault and Documentum. His work has been marked by a keen interest in improving processes, ensuring system integrity, driving continuous improvement and consistently contributing to the design and architecture of IT solutions. Joined Safety world at Haleon over a year ago.

Karol is an experienced system technology manager with a robust IT infrastructure, technology management, and product engineering background. Currently driving architectural consistency and maturity across quality and laboratory products and services at Haleon while managing organizational vulnerabilities and ensuring alignment with Haleon Digital & Tech quality standards. Proficient in Veeva platform, architecture, Azure, ITIL, service management, release processes, FinOps, CloudHealth, and databases. Outside of professional pursuits, Karol is a dedicated athletics enthusiast (marathoner), physiotherapy advocate, and automotive aficionado.

Anand is an enterprise data leader with over 20 years of experience designing and executing strategic and large-scale data initiatives. He has experience in life science, investment banking, insurance, and telecom. He is a certified chief digital officer, data professional, and black belt.

Ibrahim Kamstrup-Akkaoui is a senior leader in clinical data management at Novo Nordisk and has 20 years of experience working with data and clinical studies. Ibrahim has also led multiple projects that evolve the way data management is conducted at Novo Nordisk and the broader industry. He is currently leading the DataNow Program to renew the digital infrastructure for clinical studies, with end users and patients as the focus.

Carsten has over 20 years of experience in clinical data management, spanning programming, project management, and leadership. Passionate about process optimization, he is dedicated to simplifying workflows and driving efficiency in clinical research.

Srinivasan is a global leader in clinical data management and operations. He has built a multi-disciplinary data management function with a strategic focus on future success. As the head of data standards and integration at Novo Nordisk, he drives efforts to establish an efficient infrastructure for high-quality data.

Kamal is a regulatory operations team lead at OM Pharma with 17 years of experience in regulatory affairs and regulatory operations. He is in charge of electronic submissions, xevmpd/idmp, and regulatory systems management activities.

Andreas Särnberger has over 10 years of experience in the life sciences, in roles ranging from QA to validation. Andreas has a strong passion for IT compliance. At Recipharm, he has successfully merged the industry’s appetite for new technologies with the strict compliance requirements, enabling Recipharm’s journey into the cloud.

Laura Prada Alonso is a seasoned professional with a global perspective, specializing in strategic transformation projects within the digital quality domain. She has extensive experience managing multicultural teams and navigating complex organizational structures and has successfully led initiatives that drive operational excellence. Recently, Laura spearheaded the Veeva QualityDocs and Training implementation across Recipharm, enhancing and harmonizing processes across 17 sites. Laura is driven by her passion for creating meaningful change within organizations, ensuring every project has a solid business case, and its performance is continuously measured to guarantee alignment with strategic goals. Her ability to lead cross-functional teams in diverse, international environments is a key strength.

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.

Andrea Grau is a solution consultant specializing in R&D clinical operations across Europe. With over five and a half years of experience in life sciences R&D, Andrea brings a deep understanding of the industry’s complexities. Prior to joining Veeva, she worked at a leading CRO, where she managed global phase I-II clinical trials in oncology and rare diseases. Andrea holds a BSc in Biomedical Engineering from Pompeu Fabra University and an MSc in Industrial Management and Innovation from Uppsala University, equipping her with a strong foundation in both technical and strategic aspects of R&D operations.

Ardit is a Regulatory Engagement Manager within Veeva’s R&D Business Consulting team and leads global RIM implementations and complex business transformation programs.

He has 10+ years of management consulting experience, working with leading pharmaceutical & biotech companies. He has previously led global MDM implementations outside of Veeva.

Chris joined Veeva in March of 2024 and has been focused on Validation Management within the Veeva Quality Cloud. Before joining Veeva, 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.

Crystal is a Government Strategist at Veeva Systems, leading efforts to modernize data and submission standards. With leadership experience at the FDA and Booz Allen Hamilton, she specializes in regulatory submissions, data modernization, decision support, and interoperability. Passionate about leveraging technology for better healthcare outcomes, Crystal focuses on optimizing health IT solutions and improving decision-making through data.

Dorian is a product expert on the clinical operations team. His main goals are product communication and education for the clinical operations suite. With 10+ years of clinical experience, he joined Veeva as a clinical services consultant. He has extensive experience in European clinical operations and is ICH—GCP certified.

Eric is the product lead for Veeva SafetyDocs. Eric was previously a product manager on the Veeva Safety team, working on features across Veeva Safety Management. The main areas he worked on in core Safety are follow-up, SDK, narratives, medical review timeline, distributions, and correspondence.

Florent Lusardi is a product expert supporting the clinical product suite in Europe. With over 20 years of experience in the life sciences industry, he has worked with both CROs and clinical trials technology providers. His background spans engineering, technology services and consulting, and product management. His experience gives him a broad and deep understanding of the industry’s technology landscape and business processes, particularly in CTMS and clinical operations.

Francesca is a senior solution consultant for Veeva clinical operations in Europe. Over the last 10 years, Francesca has focused on increasing clinical development productivity through technology adoption and operating model improvements.
She has more than a decade of experience working in the life sciences industry from a technology vendor perspective and brings extensive experience in pre-sales and sales for cloud-based solutions. Before Veeva, Francesca held sales roles at Teckro, a technology company in the clinical space, where she was responsible for business development and product adoption.

With over 20 years of experience in clinical operations, specializing in study start-up and TMF management, he has worked closely with customers to optimize trial delivery. Passionate about supporting clinical trial sites, he focuses on developing innovative solutions to address their challenges and enhance efficiency in trial execution. His expertise lies in streamlining processes and leveraging technology to improve site engagement and trial success.

Graham is the general manager of Veeva LearnGxP, where he leads product strategy, customer engagement, and business development. With over 20 years of experience in the life sciences industry, he has held key roles in quality and manufacturing at leading organizations, including Pfizer, Merck, and Johnson & Johnson. His expertise spans regulatory compliance, operational excellence, and digital transformation within the sector.

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 Veeva Training. Prior to coming to Veeva, he worked for 18 years in the education industry as a developer, administrator, and product manager of learning management systems.

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

Joseph is an accomplished healthcare professional who has held leadership positions at major clinical research organizations, including IQVIA, Chiltern, PRA Health Sciences, and Biotrial, before joining Veeva as a solution consultant. Throughout his career, he has developed expertise in clinical operations, managing global teams, and driving strategic initiatives that improve clinical trial processes. His extensive background in the pharmaceutical industry has positioned him as a valuable resource for life sciences customers seeking to implement cloud-based solutions that enhance their clinical development workflows.

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 Veeva 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.

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

Mercedes is a biotechnologist with more than 10 years of experience in the pharmaceutical industry, specializing in regulatory affairs. She has been working at Veeva for the past two years, contributing to the digital transformation of the sector. Her career combines scientific and regulatory expertise to optimize processes in the healthcare industry.

Michelle Marlborough is the SVP of Product Management for Sites and Patients at Veeva. She has over 25 years of experience in life sciences and software development, with a passion for transforming clinical trials through innovative technology and analytics. At Veeva, Michelle is globally responsible for the product design, development and success of eCOA.

Mike is the strategy lead for Veeva 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 Veeva with over 15 years of extensive experience in the life sciences quality domain.

After having completed her Pharmacology BSc and PhD, Nicholl has spent the last 13 years focused on helping clients within R&D life sciences get drugs to patients faster by consulting in the CRO setting. Nicholl has collaborated with KOLs at Tufts University to develop methodologies to assess site, patient, and sponsor burden of clinical protocols. She has also supported clients with change management and end-user -training during their digital transformations.

Pinar Bérénice Bénet is a senior director of EU strategy for clinical operations at Veeva Systems. She has 15+ years of experience in the life sciences industry in clinical, medical, and commercial operations. Before joining Veeva, she consulted on strategy design for life sciences product launches across EMEA. She also worked at various CROs focusing on patient-site solutions. These experiences helped her better understand the operational challenges sponsors face in executing their clinical trials.

Rachael Wax is a solution consultant in the clinical operations space with a strong background in the industry, having previously held roles as a clinical research coordinator, CRA, and CTA before joining Veeva. She is passionate about helping ClinOps teams optimize their processes, enhancing efficiency in study management, and driving impactful solutions for clinical trials.

For the past 8 years, Ray has run Product for the EDC and CDB products at Veeva, helping Veeva to grow its Clinical Data business from scratch to where it is now. He has over 30 years of experience design and developing software for the enterprise and has been working in Clinical Data Management since 2012 when he was the COO and head of product at another EDC company. Prior to that, he worked in FinTech on low-latency and high-volume quantitative electronic equities trading.

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 Veeva, he leads the product management team responsible for Veeva RIM, driving the future of regulatory solutions.

Stephen has product management responsibilities for the Veeva QualityDocs, Station Manager and Training products within the Quality Cloud. He along with his dedicated team of product managers are focused on building excellent features across these products that solve our customer’s needs. Prior to joining Veeva, he spent almost 15 years at a healthcare technology company working on electronic medical record products.

Tom leads a team of product managers responsible for Veeva Clinical Operations. He has more than 10 years of experience leading development of eClinical solutions. He shares the belief that great products are built by listening to customers and putting them first.

Werner is a senior director in clinical strategy with 20+ years of experience in the pharmaceutical and life sciences industry, including roles in early-stage development, post-approval life-cycle management, and in the healthcare environment. His career began as an investigator at the University Hospital Vienna and later transitioned into the pharmaceutical industry. After a role as an assessor for vaccines at the Austrian Regulatory Authority, he entered the CRO industry and spent the last 12 years in operational, sales, and account management roles.