Dr. Frauke Bach

Project Manager, Clinical Consulting Services

Frauke Bach gained insight into the conduction 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 set up and conduction 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

Senior Project Manager, Regulatory Consulting and Services

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.

Dr. Nancy Meyerson-Hess

Consultant Quality Management Services

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.