Audrey Finesso, PharmD, MsC, Clinical Regulatory Strategist has 25 years of professional experience in regulatory affairs from industry (pharmaceutical companies and biotech companies) to consultancy. She worked in different global regulatory affairs departments and gained a strong experience in clinical and regulatory strategy, unmet medical needs, life-threatening diseases (onco/hematology) and orphan diseases. She joined the consultancy world in 2017 and is currently supporting Pharmaceutical and Biotech Industry stakeholders with the aim to expedite their development programs and interact with key global Regulatory Agencies (EMA, FDA, National Agencies) through different regulatory/expedite pathways.
Mark Lovern, PhD, is Executive Director of Medical Science Services at Fortrea, and has 25+ years of experience in the application of model-informed drug development (MIDD). Throughout his career, Mark has led and contributed to numerous projects involving quantitative pharmacology. Prior to his present position, Mark spent over 10 years at Certara in a variety of capacities. His work history has been split between biopharmaceutical companies (GSK and UCB) and companies that support the biopharmaceutical industry (Quintiles and Certara.) In addition to modeling pharmacokinetic and pharmacodynamic data across a wide variety of compounds and therapeutic areas, Mark has also taught over 50 technical training workshops on modeling tools and methodology. His most recent therapeutic area experience has been with therapies for infectious disease, metabolic, and autoimmune disorders.
Mark was awarded a Ph. D. in Biomathematics from North Carolina State University in 1997. His favorite leisure activities include hosting dinner parties, traveling, reading, and enjoying films.
Richard McNally has over 30 years of experience in the pharmaceutical industry and 20 years of experience in oncology. He has worked at small and large CROs and in biotech. At Fortrea, he is a subject matter expert for the design of clinical trials, including early and late phase oncology, the design and analysis of cell and gene therapy studies, and for adaptive design clinical trials. He advises both internal project teams and external clients on the design and statistical analysis of clinical studies, and he assists project team in developing clinical trial protocols and statistical analysis plans. He also sets up and manages Data Monitoring Committees across a wide range of therapeutic areas. He has been at Fortrea for thirteen years.
Luca Cantini, MD, PhD, is Medical Director at Fortrea, based in Leiden, the Netherlands. Dr. Cantini has 10 years of experience in oncology clinical drug development from academia to CROs, dealing with all aspects of early and late phase clinical trials. As a Medical Oncologist, he has been actively involved in translational research in Immuno-Oncology with a special focus on thoracic cancers. He earned his medical degree from the University of Pisa, Italy and completed his medical oncology fellowship training at the Polytechnic University of Marche, Ancona, Italy. In 2020, he was awarded with the ESMO Translational Research Fellowship, to carry on a project titled “ENSURE study – dENdritic cell therapy combined with SURgEry in mesothelioma” at the Erasmus MC, Rotterdam, the Netherlands. During the Fellowship, he decided to pursue a PhD trajectory at the same Institution, which has been finalized in 2022. Besides the ESMO Fellowship, he has been awarded with the IASLC Early Career Education Award, the ESO Grant for participating to the “18th ESO/ESMO Masterclass in Clinical Oncology,” the ESMO Grant for participating to the “Translational Research Unit Visit,” the ESMO Travel Grant for participating to the “2022 European Lung Cancer Conference,” and the NRS Travel Grant. He has authored 60 manuscripts in peer-reviewed journals. He joined Fortrea in December 2022.
Shanthi is a Senior Director in Strategic Growth & Delivery team in Oncology. She contributes to the development of best operational strategy for new and existing clients by linking with all Fortrea business units and all applicable services and new initiatives the company has developed.Shanthi has more than 25 years of experience in clinical research in Oncology for most part and in both Investigational Drug and MDD trials. Before joining Fortrea, she was a Senior Director in Strategy at ICON and prior to that at IQVIA. Shanthi joined Fortrea in 2019. Shanthi has more than 20 years of experience in running Phase I oncology clinical trials
Suzanne McNally is an Executive Director in Portfolio Management with over 20 years of leadership experience in clinical trial management. She holds a BA (Hons) in Nursing and brings strong financial acumen, innovation, and a proven track record in overseeing multi-therapeutic, global Phase I-IV drug trials. Suzanne has clinical research experience in oncology, neurology, ophthalmology, GI, general medicine, and infectious diseases, managing complex global projects with high quality.
As a proactive leader, Suzanne excels in navigating challenging operational complexities and site dynamics, providing innovative solutions to meet tight timelines and budgets. She is a certified PMP, Lean Six Sigma, and a member of the global Women in Leadership alumni.
Stephanie joined BMS in March 2022 and is currently a Senior Global Trial Manager managing early phase immuno-oncology and hematology studies within the HOCT pillar. She also supports Diversity in Clinical Trials efforts throughout the organization.
Stephanie holds a Master of Public Health in Health Management and Policy, a Bachelor of Science in Biology and a Bachelor of Arts in Chemistry.
Stephanie is a PMP and CCRP Certified Clinical Research Professional with extensive experience in Phase 1-4 trials. She has been in the Clinical Research Industry for over 16 years, beginning as a research assistant at an academic site then transitioning to coordinating trials at the VA for a total of six years. Since moving to sponsor level operations, Stephanie has managed early and late phase trials at both large pharmaceutical companies and small device start-ups. Her experience in this industry as well as within clinical sites has provided her with extensive knowledge in the clinical operations field.
Dan has spent his career building and taking to market enterprise software solutions to evolve capital markets technology and improve workflow across the industry. Dan’s passion for data visualization led to his co-founding of ChartIQ (which sold to S&P Global in 2022), and his drive to solve industry app overload led to his co-founding of the interoperability platform, Finsemble, in 2017. Dan is currently President and Co-founder of interop.io, formed from the merger of Glue42 and Finsemble.
Jonathan Leland is a mechanical engineer by education and has extensive experience in reliability and lubrication engineering. Prior to joining ExxonMobil, Jonathan spent six years as a reliability engineer and condition monitoring program owner at Flint Hill’s Resources Pine Bend refinery, a leading crude oil refinery in Minneapolis, Minnesota. For the past six years, he has served as a lubrication engineer with ExxonMobil, specializing in providing technical expertise to the mining, paper, construction, and refining industries.
Marcel Remp studied from 1999 – 2003 Electrical Engineering in Munich. From 2007 – 2009 he graduated as a Master of Business Administration (MBA) with focus on Marketing Management at Reutlingen University. After studying at the University of the Federal Armed Forces in Munich, Marcel Remp served as an officer and company commander in the German Bundeswehr (1995 – 2008). From 2002 to 2007 he worked as a development engineer in body development and exterior development at the BMW Group in Munich. From 2008 he moved to the SGL Group and held various leadership positions in the field of lightweight construction with Fiber reinforced plastics parts. Since 2015 he is working for the Automotive and Mobility Market Development for Mitsubishi Chemical Group.
