As the Clinical Digital Health and Innovation Lead within Global Clinical Development at Chiesi, Dr Eva Topole spearheads diverse cross-functional collaborations with the aim to integrate digital health solutions into patient-centric clinical trial designs, aiming to alleviate patient and site burden. Her primary focus extends to defining novel endpoints that align with patients' needs, achieved through collaboration with clinical teams across various respiratory therapeutic areas. Leveraging her clinical expertise and profound knowledge of respiratory therapeutic area, coupled with a passion for innovation, Dr Topole collaborates with relevant functions in R&D to build capabilities that enhance clinical trials, ensuring they better cater to patients' needs and provide insightful data across different respiratory therapeutic areas.

Before joining the pharmaceutical industry, Dr Topole served as a Senior Consultant in Respiratory Medicine and led the Functional Respiratory Diagnostic Department at the University Clinic of Respiratory Disease and Allergy in Golnik. Subsequently, she assumed the same role at the University Medical Center Ljubljana.

Rucha Shah has been living with a rare disorder. Her commitment lays in advocating for accessible healthcare and improving health outcomes for the broader patient community, especially the next generation of patients. Currently, Ms Shah leads a patient advocacy group for patients and caregivers at the Children’s Hospital of Philadelphia and the Hospital of University of Pennsylvania. She also collaborates with various national organizations and pharmaceutical companies on bringing forth initiatives which make meaningful connections within the disease community, improve the quality of life for patients and to increase awareness within the larger community.

Ms Shah attained her Master of Science degree in Clinical Research Organization and Management from the Drexel University School of Medicine in Philadelphia, PA. She further completed certificate coursework in Advancing Health Equity from ECOG-ACRIN Cancer Research Group and Research Advocacy Network as well as certificate coursework in Artificial Intelligence in Pharma and Biotech from the Massachusetts Institute of Technology. Professionally, Ms Shah works as a clinical research project manager within the oncology space. She strives to apply the "lessons learned" from her patient advocacy experiences to her professional work by building the trials to be more patient centric and accessible.

Recent Works: Woolford T, Andemariam B, Blaylark R, Colasanti R, Shah N, Jonassaint C, Trimnell C, Sheth S, Davis J, Gallagher E, Zaidi AU, John H, Shah R. Setting Industry Standards for Patient Engagement, Partnership and Care: The Patient Vision Project. Poster and Oral presentation at NORD. October 16, 2023. Washington DC, USA.

Roslyn (Roz) Schneider, MD, MSc, FACP, FCCP, is a physician and patient, dedicated to human-centered design in healthcare and research. That is, intentional listening, partnering and co-creating with people living with various conditions to accelerate positive outcomes.

The consistent thread through Dr Schneider’s career is aligning practices with what people articulate they need and want in their lives. She’s practiced Internal Medicine, Pulmonary, and Critical Care Medicine, hospital administration, academia, consulting, and in industry where she's co-created guidance, tools, and calls to action toward making person-inclusiveness standard practice across the industry. Separate from her BioMarin role, in the community, Dr Schneider is Chair of the Board of the American Lung Association’s New Jersey Chapter.

Dr Schneider received her Medical Doctorate from Mount Sinai School of Medicine in the US, and Masters in Pharmaceutical Medicine from Hibernia College in Ireland. She practiced and led postgraduate medical training for 20 years and was a Clinical Professor of Medicine at the Albert Einstein College of Medicine. She was awarded Global Fellowship in Medicines Development by GMDP Academy in 2023, is a fellow of the American College of Physicians, American College of Chest Physicians, recognized in 2021 by CUNY School of Medicine with their Strong Women in Medicine Award, and in 2023 with their Dean’s Distinguished Alumna Service Award.

Alicia Staley is the VP Patient Engagement at Medidata.  She has over 20 years of experience in software design and information systems management and works to infuse the patient perspective throughout the product development lifecycle and help engage patients in novel ways.

Alicia is also a three-time cancer survivor, first diagnosed with Hodgkin’s disease as a sophomore during college. Over the past 10 years, she has applied her engineering background to improve the patient experience for those dealing with cancer.  With an extensive network of patient advocates and non-profit organizations, she collaborates with a wide range of stakeholders to improve processes and policies that affect patient care and clinical trials.  She has co-led several research studies on how patients share information in online forums and seek out clinical trial opportunities.

An early adopter of social media, she co-founded #BCSM, which attracts over 1,000 global participants each week to its scheduled online discussions. Since its launch, #BCSM has been showcased at SXSW in 2013, 2014, 2015, and 2017 and is recognized as the gold standard for disease-specific social media networks.  She’s co-led numerous research studies on how patients share information in online forums

She is the 2019 eyeforpharma Patient Champion award winner for her extensive patient advocacy and engagement work. She truly understands the critical issues facing patients seeking to engage in clinical research.  With a keen focus on improving access to clinical trials, Alicia is passionate about making a difference for patients seeking clinical trials.

TBA

Kalli Dircks joined Morgan Stanley in 2006. She is a Managing Director and Co-Head of the Healthcare Equity Capital Markets group. She has been with the firm for 18 years and has held positions across the Equity Syndicate desk and Healthcare Capital Markets.

After earning his Bachelor’s Degree from Menlo College, John received an MS from Stanford University and both a MS and PhD from MD Anderson Cancer Center where he discovered that IL-10 directly activates anti-tumor CD8+ T cells. John conducted post-doctoral work for a year at DNAX Research Institute and became a Scientist at Schering Plough where he developed PEGylated IL-10 (AM0010) as an immunoncology asset. He then founded Targenics, later merged with ARMO Biosciences (briefly a publicly traded company), to clinically develop AM0010 and other immune oncology assets. ARMO Biosciences was acquired by Eli Lilly in 2018 for a $1.6B up front deal. As a founder and Senior Director of Technical Operations at ARMO, John led the manufacturing and pre-clinical research teams.

John served as the Director of Immunoncology R&D at Medimmune LLC and is the author of 28 manuscripts and 52 granted or pending patents. After reviewing the immunoncology space for two years at MedImmune and developing such diverse projects as innate and T cell agonists, CART and other cell therapy projects as well as novel immunostimulatory antibody drug conjugates, John has most recently founded Deka Biosciences. Deka is the next generation cytokine development company created to solve the challenges associated with harnessing the massive potential of cytokine therapy. With the challenges in developing T cell agonists and cell therapy programs, it is likely that cytokine combinations coupled with targeting modalities administered in conjunction with precision patient selection will be clear value drivers for the pharmaceutical industry for years to come.

Dr Selena Daniels, PharmD, PhD, serves as the Deputy Division Director in the Division of Clinical Outcome Assessment at the FDA. She provides direction, oversight and leadership to a team of expert analysts who provide consultation and advice on clinical outcome assessment (COA) endpoint development and validation, including considerations for clinical trial design, conduct, analysis, interpretation and reporting for regulatory determinations of medical product benefit.

Prior to joining the FDA in 2015, Dr Daniels worked in the Health Economic and Outcomes Research (HEOR) group at Allergan, Inc (now Abbvie) for almost five years, where she developed and executed HEOR strategies, as well as developed and implemented innovative COA strategies and endpoints for clinical trials.

Dr Daniels received her Doctor of Philosophy degree in Education at Nova Southeastern University and Doctor of Pharmacy degree at Loma Linda University.

Jennifer Stewart, PhD, has devoted her career to oncology research with an immunology focus. She has worked in both academia and the CRO (contract research organization) space for more than 25 years. Throughout her career she has been involved in both preclinical and clinical research in support of various drug development programs. In her current role at TD2, she is focused on leveraging flow cytometry and predictive biomarkers to drive client programs forward.

Dr. Stewart has a PhD in Biochemistry and Molecular Biology and serves on the Board of the Northwest Flow Cytometry Society providing educational outreach to the local scientific community. She is also co-chair of the AAPS Flow Cytometry Action Programming Committee and is very engaged in biomarker discovery for drug development.

Joana Claverol , is the Clinical Research Director at Barcelona Children’s Hospital Sant Joan de Déu, Spain, where she leads the clinical trials office since 2012 and the Patients engagement in research area since 2015. The Clinical Research Unit is a reference unit for pediatric patients nationally and internationally, specializing in innovative treatments for highly complex patients with rare pediatric diseases. She has more than 13 years of experience in medical and clinical research in the pharmaceutical and biotechnology industry, with special knowledge and experience in drug development and clinical trial design, and all regulatory and methodological aspects related to clinical research. She holds a postgraduate in Senior Management Program of Health Institutions by IESE Business School, a Master in Pharmaceutical Marketing by Universitat Pompeu Fabra, a Master of clinical trials at Universitat de Barcelona and a BS Degree in Biological Sciences by Universitat Autonoma de Barcelona.