2019 Faculty

Gail Adinamis
CEO & Founder
GlobalCare Clinical Trials, LLC

Gail Adinamis is the CEO and Founder of GlobalCare Clinical Trials. She has over 35 years of comprehensive phase I-IV clinical trials experience including over 12 years of global clinical trials management at Abbott Laboratories and Astellas Pharma US. She founded the business model for centrally managed homecare services for clinical trials in 1992.

Kim Adler, BASc (Nursing), Cert. Oncology Nursing
Clinical Trial Nurse Consultant
MOR Trials, Calvary Mater Newcastle

I have been working as a nurse in the field of Oncology & Haematology for 30 years during which time I have been involved in some way or another in cancer research; from nursing patients on clinical trials, administering trial medication, coordinating oncology trials, to my current role as Clinical Trial Nurse Consultant/ Supervisor for the Medical Oncology Trial Unit (MOR Trials) at the Calvary Mater Newcastle. MOR Trials is comprised of trial coordinators, data managers, laboratory technicians, ethics specialists and finance staff who are all dedicated to the advancement of cancer research. Our team is committed to improving site processes to ensure our capacity to offer our patients quality clinical trial options. We are also interested in ways of improving the patient experience of participating in a clinical trial, as evidenced by ongoing quality projects within our unit.

Maryam Afshari, PharmD
Product Development Global Clinical Operations, Oncology

Maryam Afshari is currently a Global Studies Leader in Product Development Global Clinical Operations at Genentech in South San Francisco. She is responsible for managing the successful execution of global Phase III studies in the Tecentriq Lung Cancer program. She has a breadth of clinical development experience across several therapeutic areas including Oncology, Cardiology, and Respiratory. Maryam is a pharmacist by training and received her Doctor of Pharmacy degree from Touro University in California.

Rick Arlow, MS
Founder & CEO

Complion founder Rick Arlow was immersed in clinical research during a NIH funded MD/PhD medical scientist training program at Case Western Reserve University, which resulted in publications with several leading journals including Neuroscience. Although he loved the work, he was shocked at how cumbersome operations and regulatory compliance were for the research sites and how much time was wasted on manual tasks and paper binders. Inspired by his experience and drawing on his engineering background, Rick put together a world-class team experienced in clinical research and enterprise content management to build Complion, the first and only eRegulatory platform built specifically around the needs of clinical research sites. Rick is a frequent lecturer for several professional research organizations including ACRP, MAGI and SCRS. He was involved with a biotech business resulting in several patents and was recognized in Business Week’s “Top 25 Under 25 Entrepreneurs."

Lisa Bjornestad
Director of Site Alliance, Americas

Lisa Bjornestad has over 20 years of clinical research experience. She has extensive experience in site operations, having directed both early and late phase research centers for the better part of her career. She has also worked in Project Management and Business Development. Currently, she is the Director for the PAREXEL Site Alliance program in the Americas.

Jenine Caulkins
Vice President, Head Oncology Clinical Project Management

I have 27 years of pharmaceutical industry knowledge specializing in clinical development research trials ranging from phase I-IV studies. My primary focus in the last 18 years has been in the Oncology therapeutic area. My pharma knowledge includes 15 years of working at Pfizer in Clinical Development and Development Operations focusing on Central Nervous System, Cardiovascular and Oncology. For the past 12 years at Bayer, I have been working in Oncology, Cardiovascular, and NOHI (Neurology, Ophthalmology, Hematology and Immunology) in Clinical Development and Clinical Project Management.

Liz Christianson
Client Engagement Manager
PFS Clinical

Liz Christianson is a Client Engagement Manager at PFS Clinical. In her current role, Liz maintains a strong and detailed understanding of the clinical trial start-up process providing expertise to numerous types of healthcare institutions. Specifically, she works to offer strategic operational guidance for clinical research clients with complex requirements. Some areas of focus include study budget development/negotiation, coverage analysis development, training and review, trial financial management and CTMS utilization. She has been published in CenterWatch and ACRP's Clinical Researcher, spoken on HCCA platforms and has hosted numerous webinars to date.

Janet Christoff, BA, RN, CCRA
Manager, Regional Field CRAs
Seattle Genetics

Janet Christoff is a registered nurse who has been in the field of clinical research for over 20 years. She has worked for both CRO and sponsor companies in various therapeutic areas, beginning her career as a study coordinator, moving to the role of CRA and then into clinical trial management. She is currently a manager of regional CRAs with Seattle Genetics, a bio-tech company focused on the development of innovative treatments for patients with cancer. Throughout her career she has worked closely to improve communication with site staff, collecting feedback on protocol design and operational aspects of clinical trials. She recently took a leadership role in developing the Quality Control program for CRA staff, to ensure quality oversight at each clinical site.

Gary Conboy, BA, BSN
VP, Head, Clinical Development Operations, Oncology

Mr. Conboy is a 20+-year veteran of the drug development industry ranging from very small biotech to mid-sized pharma. The last 8 years have solely been oncology drug development. Prior to his experience in drug development, Mr. Conboy has done both basic science research in academic settings and Emergency Department nursing. Mr. Conboy currently works in the oncology Strategic Business Unit of Bayer where he is the Head of the Innovation Group. Mr. Conboy is based out of Bayer’s Cambridge, MA office.

Darren Cowan, RPN
Global Site & Study Operations, North America Area Head

Darren has been with Pfizer for over 18 years and in his current role of North America Area Head within the division of Global Site & Study Operations, he has overall responsibility for and accountability to deliver strategic and operational direction to the area management & staff to ensure deep understanding and execution of strategy, culture, and goals.

Jennifer Cutter, PhD
Senior Director, Clinical Trial Management

Dr. Cutter holds a PhD in Neuroscience and has clinical and academic research experience in pre-clinical conducting studies in oncology, imaging, and movement disorders. During her post-doctoral training she worked closely with biotech and pharmaceutical companies designing and executing translational experiments (bench to bedside) for cytostatic, cytotoxic, and gene-therapy compounds in brain tumors and other cancer models. Dr. Cutter has been at Medpace for over 9 years supporting the global oncology programs and working collaboratively with the medical and regulatory affairs teams to accelerate clinical development. She is experienced in the management of hematology and oncology trials focusing primarily in the solid tumor patient population, which includes experience with immunotherapy, targeted agents, novel biologic agents, and rare diseases.

Mellissa Dobraski, MA, CCRA
Associate Director, Global Project Lead Oncology Therapeutic Area

Mellissa has worked in the pharmaceautical arena since 1996, the last 17 at IQVIA, in a vartiety of roles, including Clinical Research Associate, Clinical Project Lead, Project Lead, and now Project and Program Oversight. Her therapeautic focus has been in oncology for the last 8 years. In addition to Project / Program Oversight, Mellissa is a subject matter expert in risk based monitoring (RBM) at IQVIA, leading and training project teams across indications within IQVIA to ensure the highest quality delivery of studies utilizing RBM.

Jennifer Doraski
Site Partnership Manager, Oncology

Jennifer Doraski has worked in the clinical research industry for 15 years within Site, CRO, and Sponsor settings. She has a broad range of experience, including Site Operations, Monitoring, Clinical and Quality Operations, Training, Mentoring and Regulatory. Prior to first entering the industry as a Research Dietitian and Study Coordinator, Jennifer worked as a Clinical Dietitian in Hospital, Community and Cancer Center settings. Currently, as a US Site Partnership Manager at Sanofi, she is using her previous experiences to build site relationships by promoting collaboration, transparent and proactive communication, and operational excellence. Joanne Dourado joined Eli Lilly and Company in 2001 as a Clinical Research Associate and has since held a variety of positions across the organization supporting the global development of medicines. Presently, Joanne leads the US organization responsible for the identification, qualification, support and collaboration with clinical trial sites participating in Lilly studies. Joanne and her team recognize the value of site and patient feedback in the design of efficient and effective studies, ultimately leading to improved clinical trial experiences.

Joanne Dourado, BSN, MBA
Director- Site Engagement

Joanne Dourado joined Eli Lilly and Company in 2001 as a Clinical Research Associate and has since held a variety of positions across the organization supporting the global development of medicines. Presently, Joanne leads the US organization responsible for the identification, qualification, support and collaboration with clinical trial sites participating in Lilly studies. Joanne and her team recognize the value of site and patient feedback in the design of efficient and effective studies, ultimately leading to improved clinical trial experiences.Joanne Dourado joined Eli Lilly and Company in 2001 as a Clinical Research Associate and has since held a variety of positions across the organization supporting the global development of medicines. Presently, Joanne leads the US organization responsible for the identification, qualification, support and collaboration with clinical trial sites participating in Lilly studies. Joanne and her team recognize the value of site and patient feedback in the design of efficient and effective studies, ultimately leading to improved clinical trial experiences.

Molly Downhour, MHA, BSN, NEA-BC, OCN, CCRC
Strategy Executive-Clinical Research

Molly has over 20 years of healthcare experience with specialization in oncology, research, and health care administration. Molly earned her bachelors of nursing and master of health administration as well as achieved and maintained her nurse executive advanced, oncology nurse, and clinical research coordination certifications. As a former director of a leading phase I clinical trial site, she has proven her ability to streamline processes resulting in improved clinical operation efficiencies, financial gain, and employee and patient satisfaction. Now Molly shares her passion, experience, and expertise with sites as the strategy executive for Medix Clinical Research.

Mark Fleury, PhD
Principal, Policy Development, Emerging Science
American Cancer Society Cancer Action Network (ACS CAN)

Mark Fleury is a policy principal for the American Cancer Society Cancer Action Network (ACS CAN). He specializes in research, drug development, and regulatory policies along with other science and technology-related projects. He led a coalition in 2016 that authored a landscape report on drug development challenges in pediatric cancer, and led another coalition in 2017 that created a report and recommendations focused on overcoming cancer clinical trial enrollment barriers. In addition to his ACS CAN experience, Mark’s policy work includes time as a Capitol Hill legislative advisor focusing on healthcare reform, and work at the American Association for Cancer Research (AACR). He holds a PhD in bioengineering from the Ecole Polytechnique Federale de Lausanne in Switzerland.

Emma Fountain, BSc (Hons)
Global Clinical Operations Lead & Head Clinical Project Management Oncology 4

I hold a BSC (Hons) degree in Pharmacology and Physiology and have over 17 years of experience in the pharmaceutical industry in clinical research and development study/project/program management. I have worked on phase I-III studies in various therapeutic areas, with 11 years of experience in Oncology across multiple indications including Mesothelioma, Ovarian Cancer, CRPC, HCC, NSCLC and mBC. I started my career at Servier R&D in 2001, initially joining as a CRA and then progressing in study and line management. I joined Bayer in 2008 as a global study manager and have held several positions within study and program management. I have been a Global Clinical Operations Lead since July 2017 and recently took on an additional role as a line manager of clinical project and study managers. I have worked on several complex programs leading and having oversight of the operational and strategic aspects of the studies within them.

Peter Fredette
Site & Patient Networks Director, Oncology

Peter Fredette has almost 20 years of experience in the drug development industry, including pre-clinical toxicology and all phases of clinical research. He is most experienced in oncology but has worked across many therapeutic areas. Peter’s current responsibilities include supporting CRO-Site alliances and thought leader engagement; site strategies for global and domestic oncology trials; and creating and implementing strategies to improve quality and accessibility of clinical trials for cancer patients around the world. Prior to this, Peter has held a variety of roles at IQVIA over the last 17 years, including trial monitoring, project management, and site & investigator relations.

Noelle Gadskill, MBA, ACRP-CP
VP, Research Operations
SignalPath, LLC

Noelle Gaskill is a research professional with nearly 20 years of experience spanning across the industry from sites to technology. Noelle more recently ran the operations of a large oncology network with over 150 locations and 75 FTEs. Today, she runs the research operations of SignalPath, a technology company delivering disruptive solutions for the purpose of generating ease and efficiency in clinical research operations. Noelle's extensive research experience began in the cardiovascular lab, then progressed into running an NIH center and managing the financials of a research cancer center. With clinical research as her personal passion, she is thrilled to be in the position today of providing innovation to the research operations space and with the goal of alleviating redundancies and operational burden on the sites.

Sharon Hanlon, MSN
Head of Clinical Engagement & Enrollment
Bristol-Meyers Squibb

Sharon Hanlon is Head of Engagement & Enrollment at Bristol-Myers Squibb (BMS). Throughout her 19 years at BMS, Sharon has held clinical development positions of increasing responsibility from Line Management to Project Management across multiple therapeutic areas including cardiovascular, metabolics, immunology and oncology. Sharon’s team builds relationships with site and patient groups to gather insights about their disease/clinical trial experience and explore potential tactics to recruit more patient and site friendly clinical trials. Sharon received her Master of Sciences in Nursing from Thomas Jefferson University in Philadelphia, PA and prior to her career in pharma, had a career as a critical care nurse, nurse educator and research nurse coordinator at hospitals in the Philadelphia area.

Betsy Henk
Associate Director, Research Quality
McKesson/US Oncology

I have been actively involved in Oncology Research for 31 years. I began my career as a data manager (Clinical Research Coordinator) for cooperative group studies. I started performing quality audits approximately 20 years ago.

Rhonda Henry, BSN
VP, Site Networks & Patient Centricity
PPD, Inc.

As vice president of site collaborations and patient centricity, Rhonda Henry leads PPD’s commitment to building strategic relationships with physicians and patients across the world with the objective to bring more treatment options to more patients. As a breast cancer survivor, Rhonda understands the importance of involving patients in the clinical trial process, while also making potentially life changing therapies more accessible to patients where they live. Rhonda joined PPD in 1991 as a clinical research associate. During her time with the company, she also held a variety of roles with increasing responsibilities on both the operational, as well as the commercial side of the business. Rhonda has a bachelor’s degree in nursing from the University of North Carolina Wilmington. She completed Lean Six Sigma training from Vanderbilt University and was a member of the first graduating class of PPD’s Global Leadership Program. Rhonda now serves as a mentor for PPD’s Global Leadership Program. Rhonda is a member of the Association of Strategic Alliance Professionals, the Oncology Nursing Society and an alumni of Women in Leadership. She also participates in the AVOCA’s Leadership Advisory Board for Patient Engagement.

Anne Marie L. Inglis, PhD
Head, US Clinical Operations

Anne Marie Inglis began her career over 20 years ago at GSK (formally SmithKline Beecham) as a Clinical Research Scientist, designing protocols and preparing Clinical Trial Reports for Phase I and Phase II Proof of Concept Studies. She moved into GSK Vaccines in 2006, where she became more involved in in-country clinical operations, managing teams of local study managers, local clinical trial supplies specialists, site selection specialists and clinical monitors. She was Head of US Clinical Operations for GSK Pharmaceuticals until 2018. She recently began a secondment within GSK supporting TransCelerate Biopharma initiatives. She received her PhD in Pharmacology at the University of Pennsylvania.

Elena Jouravleva, PhD
Director, Research Operations, CRO and Regulatory Affairs
US Oncology Research

Dr. Jouravleva has over 20 years of leadership experience in varying aspects of the life sciences industry and clinical research. She has supported clinical trials working with various pharmaceutical and biotech companies and contributed to approvals by various regulatory agencies, numerous pharmaceutical, diagnostic and device products. Dr. Jouravleva currently supports US Oncology Research, a clinical trial site management organization representing approximately 160 locations across the United States, as the Director of Research Operations overseeing Regulatory Affairs, IRB and the Complimentary CRO services groups. She holds Master of Science and Ph.D. degrees in Biology and focused her thesis on genetics of pathogenesis in Vibrio cholerae.

Marietta Kashmer,J.D.
Associate Director, Global Clinical Operations

Marietta Kashmer is currently an Associate Director of Global Clinical Operations in Oncology for Janssen R&D. She has previous experience as manager of Oncology site contracting at Janssen, as well as contracts counsel at the Eastern Cooperative Oncology Group. She received her Juris Doctor degree in 2009 from Villanova University, and currently resides in Saint Augustine, Florida.

Talal A. Kayyal, MD, MPH
CEO, Founder
Renovatio Clinical

Dr. Kayyal is a senior executive leader with extensive clinical research and biotechnology experience. Dr. Kayyal has been instrumental in clinical trial management and conduct in various medical disciplines. He has both a Master of Public Health in Epidemiology and Biostatistics, as well as a Doctorate of Medicine. He also serves as board member and primary reviewer on the institutional review board for Baylor College of Medicine and affiliated hospitals in the Texas Medical Center. Dr. Kayyal actively participates in review panels of medical journals. Dr. Kayyal founded Renovatio Clinical @ Renovatio Research Centers to provide the private healthcare sector with clinical research consulting services that help organizations stay abreast of cutting edge research in their respective specialties and conduct quality research efficiently while seamlessly preserving the functionality of their standard clinical operations. Renovatio possesses a highly credentialed team of clinical research experts that bring enormous value to physicians, sponsors, and CRO's that value integrated research solutions as they provide a guaranteed timely collection of high quality date.

Jessica W. King, CCRA
Senior Manager, Site Partnerships
Covance, Inc.

Jessica King is a Senior Manager in the Site Partnerships Division at Covance. Her 22 years of experience in the clinical research industry has provided her with a strong expertise in study execution, leadership, effective communication and a comprehensive understanding of what it takes to remain innovative and successful in the face of a constantly changing research environment. Prior to joining the Site Partnerships team at Covance, she has worked in several roles over the years, including study monitoring, global project management and trial site and sponsor relations. Although she has worked across multiple therapeutic areas, Jessica’s passion lies in the field of oncology which has been her focus for the last 13 years.

Krystyna Kowalczyk
Optimal Research

Ms. Kowalczyk is a senior executive in the Oncology clinical trial sector with over 25 years of experience in CRO and site leadership. She is currently driving innovations in Oncology trial start-up and enrollment solutions. As COO of Optimal Research her team has created a community of over 300 collaborating sites offering clinical trials as a real option for each patient taking Just-in-Time trial access a global reality for sites and physicians. Ms. Kowalczyk continues to collaborate with industry to identify unique approached to increase patient and physican access to oncology clinical trials.

Kim Kundert, RN, BSN
Vice President, Clinical Operations

Kim Kundert is an experienced research executive with a track record for success. She is the Vice President of Clinical Operations for VirTrial. Prior to VirTrial, Kim served as the Senior Vice President of Operations for Radiant Research/Synexus, the largest site network in the world. Kundert was responsible for overseeing operations and performance of 80+ research sites across the US. Additionally, she supervised the regulatory compliance and source document teams. Kim has served on pharmaceutical advisory boards and CRO planning committees providing input on protocol development and enrollment strategies from a site’s perspective. Kim is a winner of two Stevie Awards for women in Business- a Silver Stevie for Female Executive of the Year in 2012 and Best Executive in Service Businesses 2011.

Selin Kurnaz, PhD
Co-Founder & CEO
Massive Bio

Dr. Selin Kurnaz, CEO and cofounder of Massive Bio. After emigrating from Turkey and completing a PhD at the University of Michigan, receiving multiple engineering degrees, Selin spent more than a decade specializing in delivering revenue enhancement, margin optimization and capital efficiency improvements for Healthcare and Life Science companies. Her startup, Massive Bio, brings the latest knowledge in cancer care to patients treated at community practices in the US and worldwide. Selin has written and spoken extensively about life sciences in tech and how to deliver information in creative ways. Massive Bio is an alumni of eLab and PhilipsHealthworks Precision Cancer Care start-up acceleration programs.

Barry Lake
CEO & Co-Founder
Devana Solutions

Mr. Lake drives the strategic vision and execution of the leading cloud-based operations and data analytics platform for clinical research sites, site networks, ARCs and Health Systems. Through the capture of key start-up and performance metrics, Devana IGNITE fosters better accountability and process efficiency as site leadership leverages robust data analytics to drive operational improvements. IGNITE simultaneously allows sites to report historic and real-time performance data to industry Sponsors and CROs to validate trial performance reliability and predictability leading to more of the right trial awards. Even more transformative, Devana IQ for sponsors-cros combined with IGNITE allows clinical trial stakeholders at all levels to synchronize and share historic and active trial start-up and performance data. This data transparency innovation lays the foundation for true operational-alignment between sites, Sponsors and CROs drastically reducing clinical trial cycle time and costs and delivering therapeutic advances faster and more cost effectively to patients.

Dr. Jimmy Lin, MD, PhD, MHS
CSO, Oncology

C. Jimmy Lin, MD, PhD, MHS is the Chief Scientific Officer (CSO), Oncology at Natera and a TED Fellow. He comes from a long history as a pioneer in cancer genomics. Most recently, he led the clinical genomics program at the National Cancer Institute (NCI) at the National Institutes of Health (NIH). Previously, at Johns Hopkins and Washington University in St. Louis, Lin was part of one of the first clinical genomics labs in academia and led the computational analyses of the first ever exome sequencing studies in cancer, including breast, colorectal, pancreatic, glioblastoma, medulloblastoma and melanoma.
Lin has published in top academic journals, such as Science, Nature and Cell, and he has been an expert in national and international media outlets, such as New York Times, Forbes, Bloomberg Businessweek, The Washington Post, and the Financial Times.

Bob Millham, MS, MSc
Executive VP, Syneos Health Clinical Development
Syneos Health

Bob is an accomplished Oncology Drug Development Executive with Pharma, Biotech and CRO background. Experienced in roles including laboratory, clinical development and clinical operations. He successfully built and led high-functioning teams who executed clinical development programs across multiple indications and phases of development. Bob authored or co-author on eight peer-reviewed publications and over 20 peer-reviewed abstracts and presentations.

Susan Night, JD, LLM
Director Research Optimization
McKesson Specialty Health, US Oncology Research

Ms Night is Director of Research Optimization with US Oncology Research, a clinical trial site management organization representing 160 research sites across the United States. She has over 20 years of experience in healthcare and research ranging from policy, law, ethics, finance and strategy. Her most recent passion has been in the area of data integrity and development of optimal processes that support parties to clinical research to meet regulatory requirements and ensure participant safety.

Dawn Overcash
Director, Site Collaborations & Patient Centricity
PPD, Inc.

Dawn is part of the Site and Patient Access department at PPD with 20 years industry experience in clinical research. Dawn supports PPD’s Oncology Strategy and Data Integration efforts, which includes working with Oncology Networks, Academic Medical Centers (PPD Select), Data Vendors and PPD’s sister company Optimal Research with the Just In Time (JIT) model. She has experience working with pharma partners and global sites to set up oncology network practice guidelines for efficient start-up. Prior to working in Strategic Site Collaborations, she was Region Head for North America Site Start-up with a mission to improve start-up cycle times through efficiencies in processes.

Al O. Pacino II
President, Co-Founder
BlueCloud by HealthCarePoint

Mr. Pacino is a USA veteran and a senior executive and with over 35 years experience in clinical clinical research and healthcare. Co-Founder and current President of HealthCarePoint.com a leading global network of over 1,500,000 healthcare and clinical research professionals from more than 78,000
organizations focused on providing tools and “real-time” networking technologies that empower members to manage everyday operational, managerial and compliance processes by connecting healthcare and clinical research
stakeholders . Mr. Pacino is a past member of the Association of Clinical Research Professionals (ACRP) Editorial
Advisory Board and past chair of the Central Texas Chapter. He also serves as the VP for Collaborative Network
Development at the Alliance for Clinical Research Excellence and Safety (ACRES), and a member of Society for Clinical Research Sites (SCRS) Global Impact Partners among others and actively involved with NIH global standardization
programs. He is also a 12 year cancer survivor.

Amita Patnaik, MD, FRCP(C)
Medical Oncologist, Co-Founder

Dr. Amita Patnaik is an internationally recognized medical oncologist and co-founder of START (South Texas Accelerated Research Therapeutics) in San Antonio, Texas which operates one of the world’s largest phase I cancer research programs. She is the co-director of clinical research at START and the director of the START Fellowship Program. Her clinical interests include phase 1 drug development and malignancies of the breast and colorectum.

Jessica Piggee, MPH
Site Management Organization Business Manager
Sarah Cannon Research Institute

In Jessica’s role as the Sarah Cannon SMO Business Manager, she is responsible for building, maintaining, and managing sponsor relationships focused on the network sites of the Sarah Cannon organization. She serves as the main point of contact for sponsor needs related to SMO site structure and process guidance, clarification, and improvements. Jessica has been with Sarah Cannon in this role for over two and half years, but was previously with Sarah Cannon as the Senior Manager for Study Operations in the Tennessee Oncology Nashville Drug Development Unit for 9 years. Between these 2 roles, she managed the Hematology and BMT clinical trial program at Vanderbilt University Medical Center for 5 years. Jessica holds a Bachelor’s Degree from the University of North Carolina at Chapel Hill and a Master’s in Public Health from Boston University.

Gaelan Ritter, MS,MBA
Associate Director, Strategic Clinical Relationships, Global Clinical Operations
Bristol-Myers Squibb

Working in Global Clinical Operations for BMS, I manage strategic site relationships and innovations in trial planning and execution. My background spans many aspects of clinical research with experience in lab research, site operations, data management, and trial innovation. My current role focuses on clinical trial design, planning, and operations. Prior to joining BMS in 2014, I worked as a bioengineering researcher, a trial manager for a small biopharma company, and a trial coordinator at a research hospital.

Len Rosenberg, PhD, RPh
Head Clinical Operations
Beat AML, a division Leukemia & Lymphoma Society

Dr. Rosenberg is a 30 plus year executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, eclinical and contract research organization sectors. With his diverse background which includes executive management, clinical and regulatory operations, business development, eclinical technology solutions and new product/licensing evaluations, he brings tremendous hands on insights to optimizing the drug development cycle, from the early start-up stage to global product registration. Dr. Rosenberg is Head, Clinical Operations at Beat AML, LLC, a division of The Leukemia & Lymphoma Society and also Managing Partner of eP2Consulting, Inc. since 2001. Dr. Rosenberg received his Ph.D., from the Kellogg Pharmaceutical Clinical Scientist Program, University of Minnesota, College of Pharmacy and his Bachelor of Science, Pharmacy, from the Philadelphia College of Pharmacy and Science.

Archana Sah, BSc (Pharm), MSc (Pharm), PMP
Therapeutic Area Leader, Oncology
Genetech, a member of the Roche Group

Archana is a Clinical Research and Development executive with 22 years end-to-end leadership experience in developing medicines for patients having led and contributed to several FDA/EMEA drug approvals in Oncology, Immuno-Oncology, Precision Therapeutics, Rare Diseases, Metabolic Diseases and Women's Health. In her current role as the Therapeutic Area Leader, Oncology, she provides oncology expertise and strategic direction for molecules being studied in late phase and early development across the broad oncology portfolio for North America. She leads the oncology clinical operations organization in delivering the oncology portfolio including several breakthrough therapy designations and several FDA approvals. She is a strategic expert on therapeutic landscape/treatment trends and advocate for adoption of innovation, advanced analytics, real world data and data driven informed insights for advancing patient centric drug development.

She is the chair of the SCRS Oncology Board with a mission to cure cancer through efficiency in processes and strength in the partnership between clinical research sites, pharmaceutical companies, and patients. She is also the Chair of the inaugural Global Oncology Site Solutions Summit 2019 with a mission to create a collaboration forum for all oncology stakeholders for the benefit of site sustainability and to ultimately benefit patient access to oncology medicines.

Maxim Schillebeeckx, PhD
Sr. Manager
Guardant Health

I completed my PhD in molecular genetics and genomics focused on technology development while consulting for biotech. Since graduating, I have worked for various diagnostics companies focused on oncology and molecular testing with the goal of working closely with patients to provide access to the most innovative care.

Margaret Scott, MS, CCRC
Director of Research Operations
Cancer Care of Western New York/New York Urology

As the Director of Research Operations, Margaret is responsible for the development of the clinical trials departments of a large multi-specialty group. Prior to joining Cancer Care, Margaret has worked as a Data Manager, Clinical Research Associate, and a CRO Project Manager. Having experience from the perspective of multiple stakeholders has encouraged her to work with site, sponsor, and CRO teams to find opportunities for collaboration and efficiency.

T.J. Sharpe
Patient Advocate Cancer Survivor

T.J. Sharpe is a Stage IV melanoma patient who shares his journey through Stage IV cancer. He was diagnosed in August 2012 with melanoma tumors in multiple organs, four weeks after his son was born. He is a writer, speaker, and consultant to the biopharma/clinical research industries, bringing an educated patient voice as a true partner to healthcare and drug development.

Reneé Smith
Head, Early Development Oncology Capabilities and Alliances
Janssen Pharmaceuticals

Reneé Smith has over 25 years of experience in research and healthcare. Reneé currently holds the role of Head, Early Development Capabilities and Alliances in the Oncology Therapeutic Area at Janssen Pharmaceuticals. Reneé most recently served as Associate Vice President of Global Quality and Education at Sarah Cannon, where she greatly expanded their quality infrastructure and education resources with oversight of the research and blood cancer network quality programs. Her experience with clinical trials is in developing and implementing quality and educational programs for investigative sites and CRO operations. This unique perspective provides a good understanding of challenges each group faces. Reneé recently served as a Council Member on the American Society of Clinical Oncology (ASCO) Research Community Forum (RCF) as well as several working groups. Additionally, she has participated in research focused working groups with the Clinical Trials Transformation Initiative and the National Academies of Sciences, Engineering and Medicine.

Sandy Smith, RN, MSN, AOCN
US Oncology Research

Leads US Oncology Research, a clinical trials site management organization representing approximately 160 locations across the United States. US Oncology Research has enrolled over 75,000 subjects onto clinical trials since its inception and is managing over 350 clinical trials. With corporate offices located in The Woodlands, Texas, US Oncology sites are located in 26 states across the county.

Elizabeth Verderber, BS
Manager, Clinical Operations
PRA Health Services

Elizabeth Verderber has been in the CRO industry since 2004. She has worked as a Research Assistant, Clinical Research Associate, Clinical Team Manager and now is a part of leadership for clinical management. Throughout her entire clinical research career Elizabeth has been working in the oncology space including managing oncology and hematology studies from a clinical perspective. Elizabeth has been in her current role in clinical management at PRA for 3 years.

David Vulcano, LCSW, MBA, CIP, RAC
VP Clinical Research
HCA Healthcare

David is a well-known thought leader and change agent in the clinical research industry through numerous associations, boards, initiatives, publications, presentations and contributions. A native of New Orleans, he has a Masters degree in both Social Work and Business Administration and holds the additional status of Certified IRB Professional (CIP) and Regulatory Affairs Certification (RAC). He even is a Certified Blockchain Professional. Among other things he is the a Vice President and Responsible Executive for Clinical Research for HCA Healthcare, providing research-related compliance and strategy consultation to their portfolio of hospitals, physician practices and healthcare technology companies. He is also the President of the Nashville Angel Capital Group. David and his wife are empty-nesters living south of Nashville, Tennessee with where they involve themselves in work, family life as well as other charitable and entrepreneurial opportunities.

Barbara Weinrich
Clinical Research Manager, US SM&M, Oncology Therapy Area Lead

Barbara is a Clinical Research Manager in the US Site Management and Monitoring organization at AstraZeneca with 22 years of pharmaceutical industry experience. She is experienced in various therapeutic areas with a passion for oncology research. Currently, Barbara is the oncology therapeutic area lead in US Site Management & Monitoring. She is an active member of the RbQM Implementation team at AstraZeneca working to incorporate a risk-based monitoring approach internally and at research sites.

Stacey Yount
Vice President, Product
Medidata Solutions

Stacey Yount is the leader for Medidata’s Risk Based Monitoring and Clinical Trial Management platform. With 20 years’ experience in clinical research, Stacey is an expert in data management, pharmaceutical efficiency, clinical development, CRO operations, and innovation. This includes leadership roles in Data Management, Clinical Operations, and Statistics at Medidata, Covance, and Eli Lilly and Company.