Lumis Team

Frauke Bach gained insight into the conduct and management of clinical trials from various angles over 8 years. Starting as a CRA monitoring clinical trials up to phase 3 for a large pharmaceutical company, she continued her career as a clinical project manager, first for an internationally operating mid-sized CRO (Contract Research Organisation), then for a clinical trial center of a renowned German university hospital. At the latter position, she contributed to academic clinical research in the field of stem cell transplantation. She focused on coordinating Investigator Initiated Trials (IITs) and was also instrumental in setting up a multicenter contract research study for the Federal Joint Committee (G-BA), in each case with responsibilities from the perspective of a sponsor representative.

Frauke has profound hands-on experience in clinical trial setup and conduct, as well as in sponsor oversight for a broad range of national and international clinical research projects. She manages projects here at Lumis in a strategic, solution-oriented, and creative manner.

Liam Spencer’s 8 years’ experience includes both pharmaceutical and medical device regulatory affairs. He has worked across different technologies, including; small chemical entities, ATMPs, biologics, vaccines, combination products, and class I-III devices. Working across all phases of development has allowed Liam to gather a broad understanding of regulatory affairs and, therefore, devise creative regulatory strategies.

This strategic and project management skillset was developed at his previous position as a global regulatory lead for a large CRO (Contract Research Organisation). Throughout his career he has also worked on complex international submissions and helped prepare a variety of regulatory documents such as IMPDs, protocols, investigator brochures, clinical evaluation reports, and device technical files. Liam has worked for companies of different sizes and backgrounds and, with his strong experience in a consultancy environment, he can tailor regulatory solutions to the client’s needs.

Liam ranked top of his cohort when he graduated with a first-class degree in Molecular Biology from The University of Sheffield and received several academic awards. He enjoys combining his strong scientific background with his regulatory knowledge to optimise product development.

Andrés Aguilar Caro has over 15 years of experience in managerial positions in operational and financial departments in the HealthCare industry. His experience is extensive as project coordinator and key leader on the implementation of integrations, as well as a contract manager. During the last years as head of proposals on clinical trial services, he has been involved as a budgeting builder and part of the negotiation Team in SaaS companies, medium and large CROs (Contract Research Organisations), building strong relationships with internal and external stakeholders along the duration of the studies. He is knowledgeable in the implications of the legal representation of companies that carry out the development of drugs in the European Union, UK and Switzerland.

Andrés carefully analyses our clients’ Request for Proposal (RFP) and provides tailored solutions to meet their needs and budgets. He is dedicated to building and maintaining strong customer relationships.

Stella D. Vu has over 8 years of professional experience in sales and operations, with 5 years dedicated to the life sciences sector. Her expertise spans regulatory services, medical devices, cosmetics, consumer products, and digital regulatory solutions.

At Lumis International, Stella supports business development activities by managing client relationships, coordinating with internal teams, and ensuring tailored solutions align with client needs. Her prior roles at Freyr and ProductLife Group have provided her with a strong foundation in regulatory compliance and strategic business development strategy.

Stella is committed to fostering effective communication between clients and experts, facilitating streamlined processes, and contributing to the successful delivery of projects.

Razia Fatima Imran is a Business Development professional with over 15 years in the Life Sciences industry. She supports Lumis’ Business development activities in India and USA. Her expertise ranges from promoting Sales in the Pharmaceutical and Clinical Research Organizations sector to mediating negotiations overseas and onshore.

She works as an independent consultant for Healthcare companies by outsourcing & partnering with Indian customers & counterparts.

Nasim Moradi has over 10 years of professional experience as an Executive Assistant in the medical and pharmaceutical industries, demonstrating a strong commitment to excellence throughout her career.

At Lumis, she actively coordinates projects with a customer-centric focus, ensuring smooth collaboration across internal teams. Her expertise spans a wide range of responsibilities, allowing her to effectively manage key tasks and drive successful outcomes. Additionally, her prior roles at Straumann Group and F. Hoffmann-La Roche further showcase her dedication to delivering high-quality support and expertise in the medical equipment and pharmaceutical sectors.

Nasim’s consistent drive and extensive experience highlight her commitment to supporting both teams and clients in achieving their goals.

Nancy Meyerson-Hess has over 30 years of experience in clinical research. She has led global teams of clinical research professionals within pharmaceutical and contract research organizations. She has been responsible for strategic planning and implementation within clinical operations and development for new chemical entities and treatment approaches. She has previously held Senior Management positions in clinical research and development, for pharmaceutical companies such as Roche and Pfizer, most recently as Head Clinical Operations & Compliance at Gruenenthal GmbH in Germany.

Nancy is currently an Associate Partner at admedicum Business for Patients, a company providing expertise in patient engagement activities for pharma and biotech. She has focused on providing best practices for success in clinical research, in areas such as Good Clinical Practice, Outsourcing and Inspection Readiness. She is a frequent speaker at international Conferences on clinical research, patient engagement and compliance. Nancy is a native New Yorker who has studied psychology, ethology and neurophysiology in the US and the UK.

Gabriele Faist has more than 28 years pharmaceutical industry experience with 25 years working in CROs. At the CRO she was responsible for overseeing clinical drug development programs which included line management of a group of more than 20 Project Leader, Senior Project Leader and Project Assistants as well as project related leadership of worldwide multi-functional teams to effectively implement projects; tracking the progress of programs to ensure that they are being completed on time and within budget; and ensuring the quality of all work within the programs.