Speakers

Before joining Alvotech in 2020, Ruth spent most of her career in global pharmaceutical companies. She has held many different roles in drug development, including leading clinical operations teams for the past eight years. TMF compliance is an area of key importance and a challenge for all working in the area of clinical trials. Ruth has been implementing eTMF systems for several years, which has improved management and inspection readiness. Currently, she is rolling out the Veeva Vault eTMF Essentials package at Alvotech.

Melissa De Swaef is the clinical operations processes and systems lead at argenx. She has 20 years of clinical operations experience, from CRA to project/line manager, trainer, and system expert in small CROs to big pharma. She is passionate about connecting people with process and technology and is currently looking to expand the use of Veeva Clinical Vault at argenx after successfully implementing eTMF.

Leonie has over 25 years of experience leading complex and high-impact transformational technology projects within clinical data management. Her projects frequently involve stakeholders from CRA/monitoring, clinical operations, safety case management, and IT/tech strategy. Currently, she is leading the implementation of Vault CDMS as an enterprise platform across GSK, looking at automation opportunities to improve efficiency, quality, and time to delivery.

Michel is a service-oriented leader of transformational change programs with experience across small and large pharmaceuticals, vaccines, biotechnology, and outsourcing companies. She has expertise in clinical study planning and operations, patient safety, biostatistics, and regulatory operations. In her current role, she is accountable for a suite of priority projects to create the interoperable ecosystem to progress late-stage pipeline assets, which reaches all functional development areas.

Sergei is responsible for clinical operations process updates and maintenance, analytics, and oversight at Idorsia. He has a master’s degree in pharmacy and over fifteen years of experience working in life sciences. He began his career as a CRA at Quintiles (now IQVIA) and spent several years as a global lead CRA at Actelion Pharmaceuticals. He joined Idorsia in 2018 and transitioned into his current role in 2019.

Douglas is the chief technology officer of KCR, responsible for the technology strategy for all KCR group entities. He comes to KCR with over 30 years of experience in the development and implementation of clinical trial technology solutions. Before joining KCR, he worked for eRT, Medidata, and eClinicalHealth, specializing in next-generation clinical trial/patient and site engagement technology.

Suah works as a product owner at Novo Nordisk, where she brings over 20 years of experience in the health industry. Before joining NovoNordisk, she worked as a CRA, study coordinator, and registered nurse in Australia and South Korea.

Trevor’s career in data management spans over 20 years. He has held various leadership positions at Syneos Health over his career, with the majority spent leading global FSP relationships. Most recently, Trevor led the adoption of Veeva CDMS within Syneos Health.

25+ years of experience in lifesciences with a focus on IT (Accenture, AstraZeneca, Teva, TFS). Specialize in complete IT transformation of people / culture / organizational structure, process / policies , and technology. Currently a member of TFS’s Executive Committee and country head for USA and Canada.

Hugo is responsible for Vault Clinical strategy in Europe and the successful adoption of Vault Clinical solutions by Veeva’s larger European headquartered customers.

Over the last 20 years Hugo has focused on increasing Clinical Development productivity through technology adoption and operating model improvements. Hugo’s career has spanned technology implementation at Phase Forward, management consulting at Accenture and Deloitte and corporate strategy at Quintiles, prior to joining Veeva in 2016.

Pinar Bérénice Bénet is the Senior Director of Strategy for Clinical Operations at Veeva in Europe. She has 15 years of experience in strategy consulting, solution design and business development in the life sciences industry spanning from Large Pharma Sponsors through biotechs to CROs across clinical, medical and commercial operations.

Her experience has been built on supporting life science Sponsors in implementing patient-centric and site solutions as well as designing pan-European product launch strategies across multiple therapeutic areas including oncology, Immuno-oncology, cardiovascular, gene therapies, diabetes and vaccines.

At Veeva, Pinar facilitates the digital transformation and decision making of the Sponsors and CROs across Europe.

Raymond Letulle leads the development of Veeva Vault CDMS, helping customers improve data quality and speed to cut the cost and complexity in clinical trials.

Raymond brings over 25 years of experience to Veeva delivering enterprise and cloud-based software. He comes to Veeva from Medrio, Inc., where he spent the past several years as chief operating officer and head of product, owning the product roadmap and delivery of their cloud-based eClinical EDC and eSource products. Through his many years of experience, Raymond has developing firsthand knowledge of the best practices and challenges faced by product, engineering, marketing, and sales in delivering technology products to market.

Raymond holds a bachelor of arts degree in economics from Rice University.

Richard is VP of strategy for Vault CDMS, and a 25-year veteran in life sciences. Richard is responsible for defining strategy and direction for Vault CDMS, especially concerning clinical data management. Richard brings Veeva customers both keen executive vision and proven operational experience in data management, eClinical solutions, and advanced clinical strategies.

Sid has been in industry for 29 years with experience as a leader within the Clinical Research and Healthcare technology industry. His experience has been defining and implementing technology strategies globally and growing operational teams to support clinical trial delivery in Data Management and Bistatistics. Sid offers extensive cross-functional and direct experience in all trial phases delivering high-quality customer and business goals in the large Pharmaceutical, Biotech and CROs business segments. Most recently Sid has been focused on growing Vault CDMS in the Enterprise CRO sector at Veeva.

Tim Davis has over 25 years of experience working in the Life Sciences industry from a pharmaceutical company, CRO, and technology vendor perspective.

Most notably he was the Founder & CEO of Exco InTouch Ltd, a patient engagement and eCOA mobile application provider, which he scaled through to a successful trade sale and exit in 2016.

Tim is currently Vice President of Strategy at Veeva Systems. His primary focus is on the strategic development of MyVeeva for Patients, a patient-facing application suite.

As VP of product management for clinical operations, Tom leads a team responsible for the Vault eTMF, SSU, CTMS, and Vault Payments products. He has over ten years of experience as an eClinical developer and product manager. Prior to working for Veeva, he worked on eClinical solutions for Medrio, TrialWorks, Parexel, and Quintiles. He shares the belief that great products are built by listening to the customer and putting them first.