Beyond Project Optimus: Challenges, Lessons Learned, and Protocol Design Considerations in Today’s Oncology Programs

A new dose selection paradigm is here in oncology. How can we optimise it?

  • Wednesday, April 16, 2025 | 10am EST (NA) / 3pm GMT (UK) / 4pm CET (EU-Central) | 60 mins
  • Free
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Why attend?

As the FDA continues to implement Project Optimus – a much-needed initiative to move away from unsafe and inefficient dose selection practices that could be threatening the success rates of pivotal oncology trials – the drug development community is experiencing significant effects on trial timelines and cost. Few can argue about the importance of this paradigm shift in oncology dose optimisation. However, as the initiative gains momentum, how can sponsors refine trial designs, invest in patient-centric strategies, and leverage innovative data analysis techniques to adapt to this new era of drug development?

Join us for an interactive panel discussion moderated by GlobalData, where esteemed medical oncologist, expert biostatistician and regulatory specialists from Fortrea share their experiences in designing and implementing protocols that address the needs of Project Optimus. They discuss the important motivations of the FDA’s dose optimisation initiative, the key changes and pain points that sponsors are facing in light of the guidance, and the latest best practice for designing a dose-finding study that meets the regulator’s needs.

Register now to secure your place for this engaging session!

Learning Objectives:

  • Why do we need Project Optimus, and how is it evolving? Hear the panel’s thoughts on the evolving regulations, from first-hand experiences to expectations for future adoption.
  • Transitioning from maximum tolerable dosages to biological optimal dosages is not easy – what is truly optimal under this new framework? Discover Fortrea’s biostatistics lessons learned in the areas of preclinical modelling, data integration, and first-in-human protocol design with the company’s experts in preclinical data modelling and biostatistics.
  • What does all of this mean in practice for your development plan and clinical trial? The panel discuss implications, challenges, and examples of finding biological optimal dosages in immunotherapy and bispecific antibodies study drugs.

 

Who is Fortrea?

Fortrea is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas. Our talented and diverse team of more than 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.

Speakers

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Shanthi Sundaramoorthy
Senior Director Strategy Delivery and Growth, Fortrea

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

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Luca Cantini
Medical Director, Fortrea

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.

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Richard McNally
Director Biostatistics, Fortrea

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.

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Mark Lovern
Executive Director Medical Scientist, Fortrea

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.

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Audrey Finesso
Senior Director Clinical Regulatory Strategist, Fortrea

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.

 

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