Bodo Lutz is working for Novartis since 2011 as an expert within Global Drug Development Quality
for clinical data integrity, risk management and company’s decentralized trial projects. In this position
he is an alliance manager for multiple partners ranging from clinical operation functions to external
parties advancing the acceptance and implementation of digital technologies enabling patient centric
trials.
He has more than 15 years of industry experience from CROs, Medical Device and Pharmaceutical
companies, in roles focusing on quality and compliance. He regularly provides university lectures on
quality topics for MSc Clinical Research programs.
Bodo Lutz, a German native, is an environmental engineer and marine biologist by education and
received his doctorate of natural sciences (PhD) from the Technical University of Munich, Germany.
Jessica Cordes studied Molecular Life Science in Luebeck and started her business career for 2 years at the Central Lab MDS Pharma Services as project manager.
She moved then to GlaxoSmithKline where she worked as country project leader for 4 years.
In 2013, she moved to MorphoSys, working in an international role as clinical trial leader overseeing clinical trials with antibodies.
2017 she moved to Medigene as clinical trial manager, planning and implementing a cell therapy clinical trial and in 2018 took over the leadership for Clinical Operations while building the group. In 2021, she joined Immatics being responsible for building a global cohesive Clinical Operations department and leading the operational strategy for the global conduct of all clinical trials.
Max Horneck has been the programmer and developer of one of the first EDC and IRT systems in the young internet-era in the 90s. For more than 25 years he worked in clinical IT and data management. He has a PhD in linguistics, philosophy and computer science. Currently he holds a position as head of clinical data management and eClinical systems at medac GmbH a midsize pharmaceutical manufacturer. With more than 20 years of CRO background, 10 years business consultancy and 5 years in pharmaceutical industry he combines the perspective of a CRO with that of a sponsor organization.
A seasoned supply chain professional specialized on clinical trial service outsourcing, supply and logistics. My current main focus is on defining Merck KGaA´s clinical innovation and digitalization strategy together with my counterparts in clinical Research & Development
Heather DiBenedetto is the Head of Therapeutic Operations at Moderna Therapeutics and is based in Cambridge, MA. Moderna Therapeutics is a platform company focused on messenger RNA therapies across a broad range of therapeutic areas including immune-oncology, infectious disease, rare disease and cardiovascular. Heather joined Moderna Therapeutics in 2016 from Novartis, Translational Clinical Oncology where she was the Global Head of Clinical Operations. She managed a global team of ~120 clinical operations, clinical scientists, compliance, planning, operational excellence and biomarker professionals overseeing >60 global oncology studies. Prior to Novartis, Heather led a Strategic Partnership and Start up group at Millennium Pharmaceuticals (now Takeda. Previously Heather held roles of increasing responsibilities on both the Biotech and CRO side. Heather holds a M.S. degree in Drug Regulatory Affairs & Health Policy from the Massachusetts College of Pharmacy & Health Sciences and a B.A. in Zoology from the University of Vermont. Heather is Regulatory Affairs (US) certified.
Susan Stewart has served as Kaleido’s Senior Vice President, Regulatory Affairs & Quality since April 2018. Ms. Stewart has worked for more than 27 years in biopharmaceutical regulatory affairs, with significant experience devising innovative strategies for novel therapeutics, overseeing regulatory submissions at various stages of product development and leading interactions with global health authorities. Previously, in addition to being an independent regulatory consultant for several years, she was senior vice president of regulatory affairs, quality, and compliance at Tokai Pharmaceuticals and vice president, regulatory affairs at Transmolecular. She also spent more than 13 years at Genzyme Corporation in regulatory and compliance roles, including serving as vice president, regulatory affairs. She received her J.D. from Concord Law School at Purdue University Global and her B.A. from the University of Massachusetts. She holds both US and EU RACs.
