Jen Dumbleton leads the trial management team at Protas and is Product Owner of our clinical trials platform, Cantata. With 20 years’ experience in clinical research, she previously led one of the UK’s largest academic drug trials and held roles in monitoring and data management at a global clinical research organization.
Nijat Hasanli is the Head of Product at Lindus Health, an end-to-end clinical trial delivery company. Nijat has a PhD in Chemistry from the University of Oxford, where he worked on the discovery of novel materials. Before Lindus Health, he worked as a product manager at various early/mid-stage startups and invested in deep-tech startups.
Melanie Quintana is a Director and Senior Statistical Scientist at Berry Consultants, where she specializes in designing Bayesian adaptive clinical trials across a wide range of therapeutic areas. Her work includes platform trials and studies in rare and progressive diseases, with a particular focus on developing disease progression models to design more efficient and powerful clinical trials. Notable contributions include the HEALEY ALS Platform Trial, and modeling for conditions such as GNE Myopathy, Duchenne muscular dystrophy, Fibrodysplasia Ossificans Progressiva, Alzheimer’s disease, and frontotemporal dementia.
Prior to joining Berry Consultants, Dr. Quintana earned her Ph.D. in Statistics from Duke University and completed a Postdoctoral Fellowship in Biostatistics at the University of Southern California. During this time, she collaborated on multiple large-scale studies and consortium projects to develop and implement analytical strategies assessing genetic risk factors in complex diseases. These experiences sparked her enduring interest in Bayesian approaches for solving challenging clinical and research questions.
At Berry Consultants, Dr. Quintana leads a team of statistical scientist who are involved in the design of over 100 clinical trials each year. She provides mentorship, methodological guidance, and strategic leadership, fostering a collaborative and innovative team culture.
Lindsay Heyd is a Clinical Trial Project Director at the Neurological Clinical Research Institute at Massachusetts General Hospital, an academic organization that designs, develops, facilitates and conducts multi-center clinical trials in neurological diseases with a particular expertise in ALS. She has a focus on leading a functional group providing core comprehensive clinical trial infrastructure services for industry-sponsored and investigator-initiated clinical trials and collaborating with academic and government agency networks. Lindsay has over 20 years of experience in a wide variety of practice with study coordination, site management, TMF and study document control, vendor management, protocol development, regulatory and single IRB compliance oversight, and project management. Lindsay also works on the first platform trial, companion expanded access, and MyMatch programs for ALS at the Sean M. Healey & AMG Center for ALS, dedicated to developing effective treatments for ALS and to providing people with ALS access to experimental therapies.
Diane Heditsian's breast cancer advocacy work of twenty-two years is informed by her four breast cancer diagnoses and includes research, patient and policy advocacy. Diane brings to her advocacy work a background in communications and marketing as founder and CEO of deClarity, a 43-year global life science communications consultancy. She is a multiple Project LEAD Institute-trained research advocate. In 2009 Diane joined the University of California, San Francisco, Breast Oncology Program’s Breast Science Advocacy Core.
There she serves as a research advocate on the national I-SPY and WISDOM Studies. She supports researchers and clinicians at Stanford, other academic institutions throughout the country and scientists working in industry. Through Stanford’s Christina Curtis Lab she is a member of the NCI’s Metastasis Network. She serves on the planning committee of RISE UP for Breast Cancer as advocate lead. Diane guides Cancer Nation through its Cancer Policy and Advocacy Steering Committee and is an inaugural member of Susan G. Komen’s Advocates in Science. For 22 years she has served as a peer counselor, helping to support, educate and empower women at all stages of breast cancer to advocate for their own healthcare. She is a sought-after speaker and keynoted ASCO’s inaugural Cancer Survivorship Symposium, presenting An Advocate’s Prescription for Survivorship Care and a PCORI Annual Meeting. Diane was awarded a Fulbright Specialist designation in Cancer Advocacy to help countries around the world develop cancer advocacy initiatives.
Maria Pitsiouni is a PhD-trained oncology clinical development executive with over 16 years of experience leading Phase I–III programs across academic, cooperative group, and sponsor-driven environments. She currently serves as Senior Director of Clinical Program Management at Quantum Leap Healthcare Collaborative, where she provides strategic and operational leadership for the I-SPY family of adaptive oncology trials, including direct accountability for program execution, regulatory strategy, and FDA engagement.
Maria brings deep expertise in clinical development strategy, clinical operations, and portfolio leadership, with a demonstrated ability to translate scientific innovation into executable, high-quality clinical programs. She has led large, multi-site trial networks, built and scaled high-performing teams, overseen complex budgets and vendor ecosystems, and driven operational transformations that improved efficiency, data integrity, and regulatory compliance.
With extensive experience across the NCI Cooperative Groups ecosystem and direct responsibility for sponsor–FDA interactions, Maria is recognized for her ability to align cross-functional stakeholders—clinical, regulatory, data, statistics, and external partners—around shared development objectives. Her career foundation in basic science research informs a disciplined, patient-centric approach to advancing novel oncology therapies.
Maria holds a PhD in Vascular Biology from King’s College London and is motivated by the opportunity to lead programs that meaningfully accelerate patient access to innovative cancer treatments.
Luke Gelinas is a Chairperson at Advarra IRB where he provides analysis and guidance on complex ethical issues arising in the course of clinical research study design and human participant protection. He holds a Ph.D. in Philosophy with a concentration in Ethics from the University of Toronto and an M.A. in Religion from Yale Divinity School.
Victoria Manax is a Partner at Eckuity Capital, a growth equity investor providing strategic capital to companies across the healthcare sector. She is an accomplished medical oncologist with over two decades of expertise in the pharmaceutical/biotech industry, focusing on global drug/device development, nanomedicines, and product launch/commercialization. She has made indelible contributions to the field, particularly in shaping clinical trial landscapes with adaptive platform designs and biomarker integration.
Renowned for her innovative clinical trial designs, Dr. Manax played a pivotal role in the development, approval, and launch of billion-dollar products, including the standard of care for pancreatic cancer, breast cancer, and lung cancer. Holding multiple executive positions in companies such as Celgene (BMS), Abraxis Bioscience, and Duo Oncology, she has also served as the inaugural Chief Medical Officer for the Pancreatic Cancer Action Network, earning recognition as a respected panelist among FDA and regulatory agencies worldwide. Effectively overseeing numerous multimillion-dollar global clinical trial programs, Dr. Manax holds multiple clinical advisories, chair positions, and patents, exemplifying her commitment to advancing medical science and patient well-being.
An internationally recognized speaker, Dr. Manax has been featured in programs, including Harvard Business School, and is a proud recipient of the Belfast Ambassador award. She has received multiple distinguished honors, including Who’s Who in Healthcare, and is a government advisor for various US government organizations as well as to UK/Northern Ireland for Health and Life Sciences.
