Speakers

Bio

Dr. Kalali is a physician-scientist, recognized globally as a leading innovator at the intersection of life sciences and technology, and a convener of collaborative high-impact forums. He is a board director of both private and publicly traded companies, and advises companies in the life sciences and technology sectors, universities, and investment groups. Dr. Kalali is the Co-Chair of the Decentralized Trials and Research Alliance (DTRA), Chairman and Chief Curator of the CNS Summit, a forum focused on the future of life sciences, and was the Founding Chairman, and sits on the Executive Committee of the International Society for CNS Drug Development (ISCDD), one of the first independent non-profits to bring together leaders in drug development to collaborate. He is a Professor of Psychiatry at the University of California San Diego, Editor of the journal Innovations in Clinical Neuroscience, and the Lead Editor of the book Essential CNS Drug Development., published by Cambridge University Press. He has authored over 250 peer-reviewed publications, and numerous book chapters. He has been involved in initiatives by the Institute of Medicine, as well as the NIH FAST and the NIH NCATS programs. Previously, for almost 20 years, he was the Global Head of the Neuroscience Center of Excellence at Quintiles, now known as IQVIA. In this role, he led the enterprise-wide strategy for neuroscience, encompassing drug development and health care services. He was responsible for numerous successful drug development programs that have led to dozens of approved new treatments for patients. Dr. Kalali regularly speaks at national and international scientific meetings on topics including leadership, drug development, clinical trials, innovation, technology, digital medicine, biohacking, and health.

Bio

Craig Lipset is the Co-Chair for the Decentralized Trials & Research Alliance (DTRA), the leading non-profit organization dedicated to the global adoption of decentralized research. Craig previously served as Head of Clinical Innovation at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures (Perceptive Informatics and Adnexus Therapeutics). In addition to DTRA, Craig serves on the Board of Directors for the Foundation for Sarcoidosis Research, on the Editorial Board for Therapeutic Innovation & Regulatory Science, and as an advisor for pharma, universities, investors and others seeking to identify and scale new solutions for medicine development. Craig is an Adjunct Assistant Professor in Health Informatics at Rutgers University, and an Adjunct Instructor at the University of Rochester Center for Health + Technology.

Bio

Jane has focused on improving clinical trials and patient experience for more than 25 years. Her passion is driving innovation into the trial design and execution to get medicines to patients faster. Currently she is the Program Director at the Decentralized Trials & Research Alliance. She worked at Roche / Genentech for 17 years in many roles, including operational program manager for hematology ultimately working on driving patient facing technology into global trials. In prior lives she held various roles in DCT optimization at LabCorp, and ran global trials at Lilly and Sanofi. She’s a Canuck who loves San Francisco and the ocean.

Bio

teffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine with special emphasis on adult respiratory medicine. Additionally Dr. Thirstrup has been appointed adjunct professor in pharmacotherapy at the Faculty of Health Sciences, University of Copenhagen.

From 2004-09 Steffen Thirstrup worked at the Danish Health and Medicines Authority (former Danish Medicines Agency) first as the Danish member of CHMP at the European Medicines Agency (EMA) for five years including 10 months as joint CHMP- and CATmember, followed by a short period as head of Danish Institute for Rational Pharmacotherapy dealing with HTA and best practice guidelines for primary care. In 2011 Prof. Thirstrup rejoined the licensing division at the Danish Health and Medicines Authority acting as Head of Division for Medicines Assessment and Clinical Trials. During this period Prof Thirstrup co-chaired the European Commission’s working group on market access for biosimilars medicinal products and acted as key scientific contact for the managing entity of the IMI beneficiaries for the PROTECT collaboration (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium). In March 2013 Prof Thirstrup joined the pharmaceutical consultancy company NDA Group as a full-time medical advisor on NDA’s regulatory advisory board. In April 2014 Prof Thirstrup was appointed as director for the Regulatory Advisory Board at NDA Regulatory Services Ltd.

Prof Thirstrup is author of more than 30 scientific papers, guidelines and text-book chapters as well as co-editor of 5th edition of Basal og Klinisk Farmakologi (Medical school pharmacology textbook in Danish).

Prof Thirstrup lives with his family in a small community (Værløse) just outside Copenhagen, Denmark

Bio

Meghana Chalasani is the Associate Director for Clinical Trial Innovation in the Office of New Drugs (OND) in U.S. FDA’s Center for Drug Evaluation and Research (CDER). She is the program manager for the CDER Center for Clinical Trial Innovation and also co-leads the New Drugs Regulatory Program’s Advisory Committee workstream, a modernization effort to enhance CDER’s advisory committees. Previously, Meghana led OND's Advisory Committee Team and Science Strategies program, and worked closely on CDER’s Patient-Focused Drug Development program. Meghana holds a master’s in Health Policy and Management from Columbia University and a bachelor’s in Medicine, Health and Society from Vanderbilt University.

Bio

Timil Patel is a medical oncologist in the Division of Oncology 3 at the U.S. Food and Drug Administration. His research focuses on modernizing cancer trials, particularly through decentralized and pragmatic approaches. Dr. Patel serves on the White House Cancer Moonshot's Data and Innovation Task Force and the FDA's Decentralized Trials Guidance working group. He completed hematology/oncology fellowship at Yale before joining the FDA.

Bio

Anindita (Annie) Saha is an Assistant Director for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). Ms. Saha is leading the development of partnerships, regulatory science, international collaborations, and operations for the DHCoE to empower digital health stakeholders in advancing healthcare and equity. She is working to advance the use of patient-generated health data, using digital health technologies (DHTs) in trials, and how to manage bias in DHTs and improve transparency. Additionally, Annie helped incubate and continues to support CDRH’s patient science and engagement efforts to advance the science and adoption of patient input as evidence, including patient preference information (PPI), clinical outcome assessments (COAs). Previously, Annie was the Director of Partnerships to Advance Innovation and Regulatory Science (PAIRS) where she oversaw a broad program portfolio, supporting a number of strategic partnership and regulatory science programs for CDRH. This included relationships with the Medical Device Innovation Consortium and other public-private partnerships, Network of Experts, Critical Path, and technology transfer. Ms. Saha began her FDA career as a researcher in the CDRH’s Office of Science and Engineering Laboratories in the Division of Imaging and Applied Mathematics in the area of imaging display technologies. Ms. Saha has a Bachelor of Science in Bioengineering and Minor in History from the University of Pittsburgh. She was a student researcher at the McGowan Institute for Regenerative Medicine working in tissue engineering and wound healing.

Bio

Eric S. Pittman is the Program Division Director for Bioresearch Monitoring West (BIMO-W) which is part of the Office of Regulatory Affairs’ (ORA) Office of Bioresearch Monitoring Operations (OBIMO) in the Food and Drug Administration (FDA). He is responsible for a group of professional investigators, supervisors, and support staff who work with each of FDAs product centers performing inspections of clinical and non-clinical trials, post-market adverse drug experiences, and risk evaluation and mitigation strategies. In addition to his division, Mr. Pittman is the U.S. Delegate to the Organisation for Economic Cooperation and Development (OECD) Working Party on Good Laboratory Practices.

Mr. Pittman previously led the Division of Human and Animal Food Domestic Operations in ORA Headquarters. Prior to that, he was a supervisory investigator in the Chicago District Office where he won the 2011 ORA Supervisory Investigator of the Year. He has also worked as a field investigator in the Chicago District and the Detroit District offices.

Mr. Pittman studied pharmacy and radiation physics in his undergraduate work at Purdue University. He also holds a Master of Business Administration from Youngstown State University.

Bio

Dr. Conenello is a virologist who received her PhD from Mount Sinai School of Medicine. She started her career at FDA as a Commissioner’s Fellow in CBER, later moving to CDRH as a medical device lead reviewer for microbiology diagnostics for 9 years. She is a subject matter expert in point of care and home use diagnostics with a focus on microbiology diagnostics. During the pandemic she was instrumental in the EUA authorizations for the first home collection kits and home use tests for SARS-COV-2. She joined BARDA/DRIVe in 2022 as a Project officer, to focus on de-risking cutting edge technologies, developing novel regulatory strategies, and facilitating decentralized care modalities for pandemic response. She currently leads the Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program aiming to catalyze clinical studies and healthcare delivery at real world locations where patients are seeking care today.

Bio

Brandon Maggio is a Director of Digital, Analytics & Performance, within Global Clinical Operations at GSK. Mr Maggio holds degrees in Biotechnology and Biochemical Pharmacology from the University at Buffalo and has dedicated 20 years to the pharmaceutical industry. He leads a diverse group of global innovators responsible for developing Digital Health strategies, implementing technology and innovative trial designs, optimizing processes to standardize new ways of working, and utilizing data to improve performance.

Bio

Amy Davis is the Associate Vice President leading Lilly’s Clinical Trial Foundations team, which encompasses all of Lilly’s clinical development processes, systems, and community-based research strategy. She is a Pharmacy graduate of Purdue University and practiced Pharmacy prior to joining Lilly. During her over 25 years at Eli Lilly, Amy has held numerous leadership positions that span therapeutic areas supporting clinical and integrated drug development, medical affairs, strategy and operations, and project/portfolio management. In addition to her leadership roles Amy is noted as a Diversity and Inclusion champion. Amy also serves as Lilly’s representative and Executive Committee Representative to Springboard Enterprises.

Bio

Carolina is a graduated pharmacist with 19 years of extensive experience in the pharmaceutical industry, specializing in clinical research. Starting as a Site Monitor, she has progressively advanced to the role of Project Manager, a position held for over a decade. With a robust background in diverse therapeutic areas including oncology, hematology, infectious and inflammatory diseases, as well as rare and blood disorders, she brings a wealth of knowledge and expertise to the table.

A recognized leader in managing Decentralized Clinical Trials, Carolina has successfully navigated the complexities of modern clinical research, ensuring the highest standards of quality and efficiency. Carolina's dedication to advancing medical science and improving patient outcomes has been a driving force throughout her career.

Passionate about innovation and collaboration, she continues to inspire and lead teams towards groundbreaking achievements in the pharmaceutical field.

Bio

Shelly Barnes is the UCB Global Innovations Lead . She is accelerating innovative strategies and solutions driving the improvement of the patient experience within the conduct of their clinical trials. Ms Barnes is delivering solutions using novel technologies, transforming from traditional clinical trials to patient preferred clinical trials while maintaining quality, compliance and stakeholder commitments. Ms Barnes actively represents UCB on several industry consortiums including DTRA, CTTI, TransCelerate and IMI.

Bio

Becky Kottschade is a clinical research administrator with more than 20 years experience in the field. Driven by her commitment to Mayo Clinic's primary value, the needs of the patient come first, Becky takes pride in leading the effort of defining best practice in how to successfully implement decentralized clinical trial capabilities from concept to large scale adoption. In her role as research administrator, she is focused on providing streamlined solutions and associated best practices for both people, process and technology improvements that allow researchers and study teams to provide the best care for patients on trial. In addition to her primary functions as an administrator, Becky has been recognized for her extraordinary commitment to relationship building, solutions-oriented excellence in customer service and leading teams through transformational changes at Mayo Clinic.

Bio

Zak Smith works on a variety of Tufts CSDD studies focusing on drug development performance, efficiency, economics, and innovation adoption. His research often focuses on protocol complexity, clinical trial participant and site burden, and diversity and representation in clinical trials. He also leads the analysis for the PACT consortium, which collects granular data on the use of DCT solutions and metrics of performance for the trials that deploy them. Many of these projects involve creating, compiling, and analyzing very large datasets. Zak completed his BS at Florida Southern College and received his MA from Brandeis University. He has worked as a research assistant at Harvard University and at the University of Massachusetts and began at Tufts CSDD as a research analyst.

Bio

Expert in clinical research, pediatrics, pediatric critical care/cardiology and clinical pharmacology with over 10 years of experience. As a Distinguished Professor with Tenure at Duke University and a key member of the Duke Clinical Research Institute, Dr. Hornik specializes in clinical trials, drug development, and clinical pharmacology. His extensive background includes designing and executing clinical trials, including decentralized designs, real-world data analyses, and community-engaged research projects. He is associate director of iCubed, DCRI's Center for Clinical Research Innovation, and co-principal investigator for the new partnership between iCubed and the Biomedical Advanced Research and Development Authority (BARDA) Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program to enhance decentralized clinical trial (DCT) capabilities to address public health emergencies (PHEs).

Bio

Dr. Derk Arts has more than 10 years of experience in medicine, research and data management. He also founded Castor and launched a platform that enables researchers to easily capture, standardize and integrate data from any source.

Her group is responsible for study design, data management, trial conduct and data analyses of global multi-center clinical trials. She has led digital transformation and de-centralized approaches in clinical trials at Eisai. One of her key focus is centralized and adaptive statistical risk-based monitoring approach to ensure quality clinical trial data. Her group is involved in building AI/Machine learning algorithms to predict disease diagnosis and disease progression trajectory, with use for screening and patient selection in clinical trials.

She is a governance member from Eisai on DIAN-TU platform trial with Wash U and with Alzheimer's Clinical Trials Consortium (ACTC) on clinical trial for prevention of Alzheimer’s disease.

Bio

Alison (Ali) Holland is Executive GM, Customer Value at Medable, and is chartered to work with our customers to align the design and execution of DCT platform technology and methodologies to achieve the optimized return on investment and outcomes of digitally enabled clinical research for subjects, sites and sponsors. Ali has over 20 years of experience in a variety of leadership roles, including Six Sigma Black Belt at Covance, and subsequently with LabCorp as Business Head and global General Manager of Customer and Therapeutic Business Units. Having been engaged in over 300 studies across Biotechs, Pharma and all geographies, Ali brings unparalleled clinical insight and technical excellence on the matter of operational needs for sites and patients.

Bio

With a background in information systems and clinical research experience spanning over 18 years, I enjoy working to build and implement solutions for this exciting and challenging industry. I invented RealTime-CTMS to solve many of the daily challenges that face clinical research sites, and my team is working on many innovative software solutions that will continue to create efficiencies for sites and the entities that interface with them. Additionally, my team at ImageBloom is advancing patient recruitment with innovative methods that deliver superior results. There is an exciting future ahead for the clinical research industry as technology will soon accelerate the evolution of methods that streamline data processing and communication between sites, CROs, Sponsors, IRBs and other important vendors. Collaboration and standardization will be the keys to our mutual success in this endeavor.

Bio

Caroline is a results-oriented and accomplished professional with more than 25 years of clinical research experience, and she’s responsible for driving global expansion, creating new service offerings and building corporate efficiencies for Advanced Clinical. Prior to joining Advanced Clinical, Ms. Redeker worked within multiple contract research organizations, a site management organization and one of the first professional independent research sites. She previously served in a corporate development role, primarily focused on the acquisitions and merger integrations of three companies. Caroline has also served in roles such as corporate officer, board secretary and multiple-level roles within patient recruitment, site budget/contract negotiations, business development and marketing. In the past decade, she has led and grown multiple business development and marketing teams and managed key strategic client relationships. Caroline is driven by the perspective of the client and is passionate about delivering exceptional service and a better overall experience for Advanced Clinical’s clients.

Ms. Redeker is a graduate from Central Michigan University and holds a bachelor’s degree in business administration with a double major in finance and management.

Bio

Jon Ernst is Vice President of In-Home Solutions at PCM Trials. Jon began his career in clinical research with Syneos Health with an early focus of post-merger integration and customer success through joint application design. Joining IQVIA in 2014, Jon led teams responsible for the design and execution of patient and site strategies and liaised with various global departments to optimize delivery and lower costs. Prior to joining PCM Trials in 2023, Jon was responsible for standing up the account management function within the life sciences vertical at Shearwater Health.

Bio

Dr. Richie is the National Executive Director of Research at Optum. She earned her Masters of Public Health from the University of North Florida and her Doctorate in Health Science from Nova Southeastern University. She started her research career at the Mayo Clinic in Florida where she served for nearly 20 years. She began as a Clinical Research Coordinator with a primary focus in Cerebrovascular Disease. Through a progression of leadership roles Dr. Richie served as the Research Operations Manager for all of research over a 5-year period including basic science, health services research and the clinical trial program. She joined Optum at the end of 2020 tasked with creating and expanding the research program. Overall her role in as National Executive Director at Optum is to build a cohesive network of community based sites through internal and external collaborative relationships.

Bio

Bernadette is currently the Head, Digital Trials, Client Solutions at Flatiron. She has previously held executive roles across multiple companies including, Vice President, Patient Experience at Science 37 where she led all patient access and engagement activities including feasibility, provider network, and patient outreach. Prior to her role at Science 37, Bernadette was the Executive Director of Clinical Trials at Quest Diagnostics, where she built patient and provider outreach and data and technology solutions to support the life sciences industry. Earlier in her career, Ms Tosti held a variety of clinical development technology, patient engagement and sales positions. She holds a bachelor’s degree in English from Boston College.

Bio

Faryar Ghaemi is a highly technical, user-focused product manager with over 10 years of experience. She has led successful product launches in the regulated pharmaceutical and clinical trial space. Faryar excels at bridging the gap between engineering and product, having previously worked as a software engineer. Her leadership in product strategy, regulatory compliance, and user experience has garnered industry recognition, including being named a Best Digital Health Solution Finalist at the Prix Galien. Faryar is passionate about improving the patient experience through innovative technology solutions.

Bio

Amanda Wagner Gee is an associate director at FasterCures, working on issues related to infrastructure and workforce to support clinical research closer to communities and co-leading the ENRICH-CT coalition. Her expertise is in areas related to clinical and preclinical research design and conduct. Prior to joining FasterCures, she worked at the National Academies on the Forum for Drug Discovery, Development, and Translation on projects related to the clinical trials enterprise, diversity and inclusion in clinical research, real-world data and real-world evidence, prevalent chronic diseases, reproducibility in biomedical research, and patient- and participant-engagement. She began her career as a research scientist working on drug discovery at the Harvard Stem Cell Institute and the National Center for Advancing Translational Sciences at the NIH. She received her master’s degree in cell biology from Duke University.

Bio

Deena Bernstein has deep expertise in healthcare leadership and the clinical research industry. Her career spans over twenty years in clinical research site development, operations and digital technology for the clinical research industry. Deena is a passionate leader with an entrepreneurial spirit that cares deeply about improving the clinical trial experience and process for study participants. She thrives on innovation and has held roles where she focused on delighting customers, participant engagement & retention, decentralized clinical trial models and clinical research as a care option. Deena has held leadership and executive roles at large Healthcare organizations, IQVIA (Fortune 500), IRO, and Datacubed Health, where she expanded her horizons by entering the mHealth space, to improve patient compliance and retention to increase data quality in clinical trials. Currently, Deena is the VP of Site Choice at TPS Global, where she works with Sponsors and sites to develop and implement embedded models that offer customized and innovative outsourcing solutions for clinical and site operations.

Speakers

DTRA 2024 Hosts

Amir Kalali, MD

Co Founder, Co Chair, DTRA

Bio

Craig Lipset

Co Founder, Co Chair, DTRA

Bio

Jane Myles

Program Director, DTRA

Bio

DTRA 2024 Speakers

Government Agency Speakers

Steffen Thirstrup, MD

Chief Medical Officer, European Medicines Agency (EMA)

Bio

M Khair ElZarrad, PhD, MPH

Director, Office of Medical Policy - Center for Drug Evaluation and Research, FDA

Bio

Meghana Chalasani

Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER, FDA

Bio

Timil Patel, MD

Medical Oncologist, Oncology Center of Excellence, FDA

Bio

Annie Saha

Assistant Director, Digital Health Center of Excellence, FDA

Bio

Eric Pittman

Director, Bioresearch Monitoring Division (West), FDA

Bio

Gina Conenello, P.h.D

Program Officer, BARDA, HHS

Bio

Kevin Bugin, Ph.D

Head of Global Regulatory Policy and Intelligence, Amgen

Bio

Shalini Mohan, MD

Executive Director, Head of Health Equity and Inclusive Research, US Medical Affairs, Genentech

Bio

Brandon Maggio

Global Head of Digital Operations & Process Optimization, GSK

Bio

Amy Davis

Associate Vice President, Clinical Trial Foundations, Eli Lilly & Company

Bio

Sharon Tamir

Digital Healthcare Innovation, Business & Research Strategy, Mitsubishi Tanabe Pharma America

Bio

Lauren Tobe

Director Regulatory Policy & Strategy, Eli Lilly and Company

Bio

Carolina Borges

Regional Study Manager - DCT Operational Lead, Sanofi

Bio

Shelly Barnes

Global Clinical Innovations, UCB

Bio

Rebecca Kottschade

Director, Research Operations, Mayo Clinic

Bio

Ramya Thota, MD

Associate Professor, Intermountain Healthcare

Bio

Zak Smith

Senior Data Scientist, Tufts Center for the Study of Drug Development

Bio

Christoph Hornik

Professor of Pediatrics, Duke Clinical Research Institute, Duke Clinical Research Institite - iCubed

Bio

Petros Okubagzi, MD

Vice President, Clinical and Translational Research, Medstar Health

Bio

Kento Asano

Associate Professor, Osaka University Hospital

Bio

Kouta Funakoshi

Associate Professor, Kyushu University Hospital

Bio

Kenichi Nakamura