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8th CROWN Congress -

8th CROWN Congress
January 22 - 24, 2019
Orlando, FL

An Elite Gathering of Clinical Decision-Makers Ready to Learn, Network and Engage on Topics Critical to the Effective Development, Execution and Management of Clinical Trials

Faculty – 8th CROWN Congress


Gail Adinamis
CEO, GLOBALCARE CLINICAL TRIALS, LTD

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Gail Adinamis provides vision, leadership, strategic planning and oversight for GlobalCare Clinical Trials. Ms. Adinamis is an accomplished executive with more than 35 years of comprehensive phase I-IV clinical trials experience, including more than 12 years of global clinical trials management at Abbott Laboratories and Astellas Pharma US. Ms. Adinamis founded the business model for centrally managed in-home and alternate site services for clinical trials in 1992.

Ms. Adinamis is an industry thought leader and has spoken at more than 30 industry conferences. She is an entrepreneur with strong business development and operational expertise along with a proven track record for success. She established and headed clinical trials divisions for three national home infusion companies. She was also the Founder and CEO for a niche clinical trials service organization providing a mobile network of clinicians to speed patient recruitment and increase compliance and retention for sponsored clinical trials.

Ms. Adinamis was recognized for two consecutive years by INC 500/5,000 as being among the leaders of the top 5,000 fastest-growing private companies in the United States and received merit-based awards for CEO of the Year and International Game Changer of the Year.


Bhanu Bahl
Senior Director, Head Research & Development Information Sciences, FORMA THERAPEUTICS

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Dr. Bhanu Bahl is a physician with a broad informatics background in R&D domain within biopharma and academia. She is a thought leader with 18+ years of expertise in information architecture, application development, and six sigma process engineering to implement platforms for data analysis and management in the large pharma, academia and biotech domain. Has progressive background in implementing emerging technologies to deliver data-driven insights, accelerating development of cutting-edge patient therapies.

As head of Research & Development Information Sciences (RDIS), responsible for managing, building and implementing solutions across biology, chemistry, translational and DMPK. Drive collaborations with IT, scientists, CROs and software vendors for achieving “data democratization” via implementing data-centric automated processes for acquisition, query, standardization, linkage, analysis and visualization. Manage RDIS 40+ informatics project portfolio across FORMA. Known for strategic planning; establishing data governance & optimized data pipelines; and implementing enterprise-wide models for information management. Prior to FORMA, Bhanu was held leadership positions at Merck, Novartis, Sanofi and Harvard.


Stephen Brannan, M.D.
Chief Medical Officer, KARUNA PHARMACEUTICALS

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Dr. Brannan is a neuroscience drug development expert who has held senior positions overseeing both clinical development and medical affairs with more than 15 years of industry experience. He is currently the Chief Medical Officer at Karuna Pharmaceuticals. Previously, Dr. Brannan was the Therapeutic Head of Neuroscience at Takeda and Vice President for Clinical Research and Medical Affairs at Forum Pharmaceuticals. Dr. Brannan has been active in the development of multiple important central nervous system treatments including Cymbalta, Exelon Patch, Trintellix, and VNS for Treatment Resistant Depression while holding various senior roles at Forum, Takeda, Novartis, Cyberonics, and Eli Lilly. His experience includes drug development, registration, medical affairs, launch and lifecycle management in the areas of anxiety, depression, epilepsy, neuropathic pain, schizophrenia, migraine, cognition, and Alzheimer’s and Parkinson’s diseases. Dr. Brannan is a member of several scientific societies and groups, including ISCTM, ISCDD, AARR, IOM Neuroforum, and CNS Summit (founding member). Prior to joining the Pharmaceutical industry, Dr. Brannan worked on the faculty at the University of Texas Health Science Center at San Antonio (UTHSCSA) where he specialized in seeing Mood and Anxiety disorder patients, ran a clinical research unit, and did neuroimaging research at the Research Imaging Center. Dr. Brannan trained in psychiatry at UTHSCSA and holds a M.D. degree from the University of Texas Health Science Center at Dallas (Southwestern Medical School). He has over 40 publications and routinely gives invited talks and presentations at industry conferences.


Liza Brienza
Director, GCP Inspection Management, MERCK

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Liza joined Merck in 2017 as Director, GCP Inspection Management responsible for managing all aspects of GCP inspections worldwide. This includes the preparation for, the management during, and any follow-up activities as needed for these inspections.

Prior to this role Liza worked at Pfizer where she held various positions in support of pharmacovigilance (PV) and good clinical practice (GCP) activities. Such activities included adverse event reporting, implementation of electronic reporting to European Health authorities, inspection readiness, and management of PV and GCP inspections globally as well as 3rd party License Partner PV audits.

Liza also has experience working in regulatory affairs in a medical device company and is a certified Six Sigma Method 1 instructor. Liza received her bachelor’s degree in biology from West Virginia University and a master’s of science in pharmaceutical medicine from Hibernia College in Dublin.


Paul Chew, M.D.
Chief Medical Officer, PHESI

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Paul Chew is a board-certified cardiologist and internist, serving most recently as Chief Medical Officer for Omada Health, a Silicon Valley-based digital therapeutics company aimed at preventing chronic disease. At Omada, Dr. Chew and his team launched the largest randomized clinical trial in digital therapeutics. Dr. Chew has also held several leadership positions at major pharmaceutical companies. At Sanofi, he served as Senior Vice-President, Global Chief Medical Officer in Paris, and U.S. R&D Head, and at Bristol-Myers Squibb he led the clinical launch of Glucophage® (metformin) in the U.S. and Europe. Dr. Chew is currently on the Board of Trustees for the U.S. Pharmacopeial Convention, which develops and publishes quality standards for drug substances, drug products, excipients, and dietary supplements in the USP–National Formulary (USP–NF), and is recognized by the FDA and 140 countries around the world. Dr. Chew spent 22 years at Johns Hopkins where he received his undergraduate and medical education, served his Osler medical residency, and was a member of the interventional cardiology faculty, holding joint faculty appointments in Radiology and Cardiology.


Steven E. Cohen, M.D
Executive Director, Search & Evaluation, Global Business Development, & Translational Medicine, DAIICHI SANKYO, INC.

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Following receiving a BA from Yeshiva University & an MD from New York Medical College, Dr. Cohen completed Internal Medicine Residency & Endocrinology Fellowship at Harvard Medical School, where he worked in the Laboratory of Dr. Ron Kahn at the Joslin Diabetes Center. Dr. Cohen has always continued practicing medicine & teaching the next generation of physicians while maintaining his academic appointment, initially at Harvard Medical School & the Brigham & Women’s Hospital, & presently as an Assistant Clinical Professor of Medicine, Department of Medicine, New York-Presbyterian University Hospital of Columbia.

Dr. Cohen began his career in the pharmaceutical industry in 2003 at Novartis Institutes for Biomedical Research in Cambridge, MA, where he held positions of increasing responsibility in Translational Medicine & Clinical Development (TMCP). He then moved to head Diabetes & Obesity in Experimental Medicine at Merck Research Laboratories in NJ. Dr. Cohen joined Daiichi Sankyo in 2008 to head Metabolism in External Scientific Affairs. Given his experience in the basic sciences & TMCP, he has been given increasing responsibilities in these areas & expanding his therapeutic reach outside of Internal Medicine to include Oncology, while maintaining his primary duties in the search for new compounds.


Karim Damji
Senior Vice President, Product Management and Marketing, SAAMA TECHNOLOGIES

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Karim plays a pivotal role in helping Saama realize its audacious goal of enabling pharmaceutical and biotechnology companies to accelerate the development of life-saving and life-altering therapies. He is responsible for driving product strategy for Saama’s AI-enabled data analytics solutions and identifying opportunities that lead to successful market share growth. Karim works closely with Saama leadership and the solution development and sales teams to expand Saama’s industry footprint. His intuitive understanding of data analytics’ potential to transform clinical development has informed and directed Saama’s strategic focus on the life sciences industry.

Karim has been integral to the successful launch and adoption of Saama’s innovative solutions, including the award-winning Life Science Analytics Cloud (LSAC) and Deep Learning Intelligent Assistant (DaLIA). During Karim’s tenure, LSAC was named one of the PM360’s Most Innovative Products of 2017, and was the impetus for Frost & Sullivan’s recognition of Saama with its 2018 Global Enabling Technology Leadership Award.

Karim also oversees the critical marketing initiatives and milestones that ensure potential client-partners embrace and leverage Saama’s offerings to inform and optimize their drug development efforts.

Karim joined Saama from Plantronics, where he led software strategy and product management. He also served in leadership positions spanning business development, product management, sales and network engineering at Cisco, Vocera Communications, MobileIron and DiVitas.
Karim’s experience and expertise have made him a go-to expert for commentary about emerging industry trends. He is a sought-after speaker and published author of industry commentary. Karim studied computational and applied mathematics at San Jose State University.


Dany DeGrave
Founder, Unconventional Innovation

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Dany DeGrave currently leads the implementation of various cognitive and other innovative technologies in departments like R&D and Regulatory Intelligence. He also explores and evangelizes blockchain applications in the healthcare space.

Dany is an engineer trained in biology and has over 20 years of industry experience at leading global vaccine companies GSK and Sanofi Pasteur. In various positions he contributed to the research, product and clinical development, manufacturing and regulatory submission of both companies’ line of vaccines. Next to vaccine and automation projects he developed and lead forward-looking change initiatives like “Project M: An Experiment in New Ways of Working, Inspiring Engagement, and Unleashing Talents” for which the team received multiple international awards.


Dominique Duchesne
Director, Clinical Operations Lead, BRISTOL-MYERS SQUIBB

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Dominique Duchesne is a Clinical Operations Lead with 20 years of experience in research across multiple therapeutic areas ranging from metabolics to immunology to infectious disease. She is a highly successful leader of global teams and development programs in a broad, matrix environment. As a manager of study-level operations team members, she is known for her strong communications skills and her interest in mentoring, and developing and promoting the careers of others. Dominique has extensive experience with vendor management in a variety of partnership models, and is a proven change leader and Kaizen leader, who drives innovation and is energized by new learnings, quality improvement challenges, and opportunities to streamline processes.


Betsy Fallen
Special Topics Consultant, SAFE BIOPHARMA ASSOCIATION

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Ms. Fallen is an authority on the business processes and associated use of information technology in drug development with a focus on regulatory and clinical. A passionate advocate for moving life sciences business on-line, Betsy is an expert on regulatory and clinical operations and applies her Six Sigma Green Belt skills to process and SOP development and efficiency.

Over the two decades of outstanding contributions at Merck, she was recognized for her leadership and excellent representation of the organization on internal transformational teams and in many industry initiatives. Now consulting, she continues to be recognized for her knowledge in technical innovation, process efficiency and ability to assess and assure compliance in documentation, execution and oversight.


Federico Feldstein
Vice President, Head of R&D Quality and Compliance, JOHNSON & JOHNSON

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Fred Feldstein joined Johnson & Johnson in 2015, and he currently leads the BioResearch Quality & Compliance (BRQC) Cross-sector and Janssen Leadership Teams and organizations. He is a member of the Johnson & Johnson Quality & Compliance Leadership Team, Janssen Quality Leadership Team, and Janssen R&D Operations Leadership Team.

Fred is leading the ongoing evolution of a Cross-Sector BRQC governance model that leverages and accentuates the team’s strengths across sectors to enhance the organization’s ability to serve its business partners and patients. Fred is responsible for driving the strategic direction of BRQC to deliver oversight of and drive adherence to Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Pharmacovigilance (GVP). Fred is also a board member of the Latino Resource Group and actively engaged with the development and implementation of strategies for increasing diversity in clinical trials.

Fred joined JNJ from Pfizer where he served as Vice President, Medical Regulatory Compliance. In that role, he was responsible for the process development and oversight of the Medical R&D Quality Management System, CAPA, issue management and escalation standards. During his 20+ year career at Pfizer, Fred served in a number of executive positions, including leading Medical R&D Innovative Pharma Quality, Preclinical & Consumer Quality. He has extensive experience in innovating and simplifying systems and procedures to assure quality oversight in clinical trials and data integrity in product submissions.

Fred holds a Bachelor of Science degree in Zoology and a Juris Doctor. Fred lives in Chatham, New Jersey with his wife and three children and enjoys soccer / fútbol, skiing, and running in his spare time.


Janet Freeman-Daily
Metastatic Lung Cancer Patient/Activist, GRAYCONNECTIONS.NET

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Janet Freeman-Daily, MS, Eng, is a retired aerospace systems engineer (trained at MIT and Caltech), freelance writer, and metastatic lung cancer patient/activist. She has had no evidence of disease since joining the ROS1 clinical trial for crizotinib in November 2012. Her focus is now on translating the experience and science of lung cancer for others. Her accomplishments include an award-winning blog at GrayConnections.net; cofounding #LCSM Chat on Twitter (lcsmchat.com), The ROS1ders (ros1cancer.com), and Hope with Answers (https://lcfamerica.org/lung-cancer-info/hope-with-answers/); speaking at ASCO, the NCI, IASLC, and other oncology meetings; coauthoring journal and media articles; serving as patient advocate for research organizations such as the University of Colorado Lung Cancer SPORE and Hutchinson Institute for Cancer Outcomes Research; consulting for industry; and serving as patient reviewer for The BMJ. She collaborates on projects with many lung cancer nonprofits.


Leesa Gentry
Senior Vice President, Infectious Disease, EVOTEC (US), INC.

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Ms. Gentry’s career spans 23 years within the CRO and pharmaceutical industries, including previous positions within Quintiles, Omnicare, and PPD. While at PPD, Ms. Gentry performed simultaneous roles of both Global Project Manager, and Sr. Research Specialist for Clinical Systems. While at Omnicare, Ms. Gentry was responsible for growth of a novel clinical research site network within long-term care. Her work in this area is featured in the Journal of Good Clinical Practice. Since joining Otsuka in 2005, Ms. Gentry has developed creative methods of trial implementation in clinical operations, data management and vendor management. Her work implementing registration trials within the developing world is featured in both the WHO Bulletin and Life Science Connect. Ms. Gentry received a Master of Arts in Psychology from the University of Mary Hardin-Baylor, and both a Bachelor of Arts in Psychology and Master of Science in Gerontology from the University of Central Missouri.


Janis Hall
Senior Consultant, THE AVOCA GROUP

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Janis Hall has over 25 years of experience in the healthcare industry with leadership roles in pharmaceutical, biotechnology, CRO, and medical diagnostic companies. While at Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), she was responsible for R&D sourcing, contracting, and supplier alliance management.

As Senior Consultant with The Avoca Group, Janis developed many of the quality oversight tools within the Avoca Quality Consortium® Knowledge Center. She is the mastermind behind the Oversight Capability and Maturity Model™ (OCMM) and Provider Qualification work streams, and a key contributor to Avoca’s Diligent® Vendor Qualification Platform.

Janis has been a chair, invited speaker, and panelist at numerous conferences. She holds an MBA from the University of Delaware and a BS in Chemistry from Towson University.


Ann Hegarty
Exec. Director GSMO — Head of CRO Oversight and Phase I, ALLERGAN

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Ann has worked in the field of Clinical Research for more than 25 years. Her time in the industry has been roughly divided in half between supporting clients as part of a CRO, and partnering with CROs as a manager in a Sponsor organization. Through these experiences, Ann has acquired a unique perspective for articulating expectations and evaluating outcomes. She’s worked across all phases of research beginning her career at what was, at the time, the largest Phase I center in the world. Since then, she’s had the opportunity to span various functions: Study Coordinator, CRA, Project Manager and Regional Operations Manager of CRA staff. She’s directly supported several FDA inspections and collectively worked to bring many important new products to market. Ann’s had the opportunity to watch the evolution of ICH GCP from its initial rollout through its most recent revision and had the good fortune to share her insights on these guidances with colleagues around the world. She is a member of ACRP and Austin Film Society.


Reginald Hooks
Associate Director, Clinical Operations, ACADIA PHARMACEUTICALS

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Mr. Hooks has been active in clinical research since 2004, beginning at the Departments of Medicine, and Biostatistics and Epidemiology at the University of Oklahoma Health Sciences Center. His career has included positions of increasing responsibility within the pharmaceutical and medical device industries on domestic and global studies, and has ranged from research in infectious diseases, neurological disorders, liver disease, maternal and child health, cardiovascular disease, gene therapy and in vitro diagnostics. His perspectives draw from working in clinical labs, managing research sites, serving as a field and in-house CRA experience as well as overseeing clinical operations for sponsor companies.


Alex (Wen-Yaw) Hsieh
Director - Clinical Development Quality, PFIZER

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Alex Hsieh is a Director of Clinical Development Quality Analytics in Quality Performance and Risk Management in Pfizer Clinical Development Quality. Alex joined Pfizer in March 1999. During the past 18 years, Alex held progressively responsible roles, moving from positions of Statistician to Master Black Belt, Project Manager, Risk Management facilitator, and most recently, to the director role in Quality Performance and Risk Management responsible for using quality analytics, including utilization of multivariate statistics and machine learning techniques, to drive quality excellence of clinical trials.

Alex has a breadth of experience in Pharmaceutical Sciences and Clinical Development and supported several new product developments as well as other developing compounds. Alex holds a B.S. in Physics from Fu Jen Catholic University, a Master’s Degree in Statistics from Columbia University, and another Master’s Degree in Pharmaceutical Engineering from the University of Michigan. He also is an American Statistical Association (ASA) – Accredited Professional Statistician (PStatÆ), American Society for Quality (ASQ) – Certified Master Black Belt (CMBB), Certified Six Sigma Black Belt (CSSBB), Certified Quality Engineer (CQE), and PMI’s Project Management Professional (PMP) and Risk Management Professional (RMP).


Gloria I-Hsuan Jen
Director of Clinical Operations, SRI INTERNATIONAL

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Gloria Jen oversees all clinical operations within the Phase 1 Unit, including supervision of Clinical Trials Unit staff, managing proposal preparation, providing input into clinical trial design, managing vendor and collaborator relationships, and ensuring operations comply with FDA, NIH, CLIA, GCP, and JCAHO regulations.

Prior to joining SRI in 2014, Ms. Jen was a business development manager at the Michigan Institute for Clinical and Health Research. Earlier, she was a project manager and clinical research coordinator at Lotus Clinical Research, where she facilitated the planning, execution, and regulatory documentation for Phase 1-3 clinical research studies in such areas as post-operative pain and opioid-induced constipation. During her graduate studies, Ms. Jen was a clinical research coordinator for peripheral arterial disease and Alzheimer’s disease studies at the University of Michigan.

Ms. Jen received a B.S. degree in biopsychology and cognitive science from the University of Michigan. Her M.S. degree in clinical research administration is from Eastern Michigan University. She is a certified Project Management Professional, a certified phlebotomy technician, and holds a Lean Healthcare certification.


Robert Igarashi, Ph.D.
Co-Founder, Chief Science Officer, CYTOSEN THERAPEUTICS

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Dr. Igarashi has a diverse background in life sciences and has played an instrumental role in executing the combination of Dr. Lee’s method of growing NK cells with Dr. Copik’s particle based natural killer (NK) cell stimulating technology. He has applied his biochemical and physico-chemical expertise to combine with immunology for developing and refining the nanoparticle based method for NK cell stimulation that could be used for ex vivo expansion as well as in vivo stimulation of therapeutic NK cells. Dr. Igarashi has been crucial in understanding the biochemical aspects of the plasma membrane particles interacting with NK cells and how they can be further innovated to add novel therapeutic dimensions for adoptive NK cell therapy.

Prior to joining CytoSen, Dr. Igarashi served on the faculty at the University of Central Florida as an assistant professor in the Department of Chemistry with a joint appointment in the Burnett School of Biomedical Sciences. Dr. Igarashi achieved his B.S. and M.S. in biochemistry at California State University Fullerton and Ph.D. in biochemistry at Utah State University and was a postdoctoral scholar at University of California, Berkeley.


Kelly Koziol
Client Services Lead, 4G CLINICAL

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Kelly Koziol, Client Services Lead at 4G Clinical, has over 13 years of experience in RTSM system implementations, integrations and support. Kelly has helped to lead RTSM standardization initiatives at a major pharmaceutical company and has seen the RTSM/IRT space from both the sponsor and vendor perspective. Kelly is a graduate of Seton Hall University with a BA in English.


Randy Krauss
Head Clinical Performance and Analytics, MERCK

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Randy Krauss is the Head and Director of Metrics, Analytics, and Performance within the Global Clinical Trial Operations at Merck. In this role, the group supports the optimization activities of planned studies, as well oversight/monitoring of performance across ongoing studies, processes, and external partners.

Prior to joining Merck in 2016, Randy worked at Shire and Alexion where he was responsible for prioritizing, planning and implementing high-value process improvement opportunities across Clinical Development. He also directed the development, implementation, maintenance and communication of performance metrics across all clinical departments and vendors.

Randy began his focus on this research discipline at Sanofi (formerly Genzyme), where he served as Director – Metrics, Analytics and Performance. There he led a cross-functional team (including Clinical Operations, Biomedical Operations and Regulatory Affairs) to identify and maintain KPIs and other metrics to ensure operational success and compliance related to product development and support across multiple therapeutic areas. His first position at Genzyme was as Associate Director, R&D Portfolio Management, where he conceived, developed and maintained an enterprise-wide tool containing project status, timelines and global development plans to drive the portfolio decision-making process. Randy also spent four years in academia at the Boston University School of Medicine, first as a Lab Coordinator in a biotech training program and as an Instructor of Biochemistry.

Randy received his B.S. from the State University of New York at Fredonia and his Ph.D. in microbiology from the University of Alabama at Birmingham. He completed his post-doctoral Fellowship at the University of Massachusetts Medical Center in Worcester.


Jim Kremidas
Executive Director, ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS

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Jim Kremidas is currently the Executive Director for ACRP, a nonprofit association the represents the clinical research enterprise. Prior to that he conducted consulting services for a variety of clients, including support for investigator sites, academic institutions, sponsors and suppliers. He was the SVP of Patient Recruitment at two large CROs for more than six years, where he and his team were responsible for developing and implementing patient enrollment strategies for global clinical trials. Prior to that, he spent 24 years with Eli Lilly and Company. From 1999 to 2008 he led their clinical trial patient recruitment and retention efforts. In this role, he focused on predicting and accelerating the enrollment rates for all corporate studies. While in Strategic Sourcing he was responsible for the outsourcing of clinical development projects to strategic suppliers, including CROs, scientific staffing firms and patient recruitment suppliers. Before his assignment in clinical development strategic sourcing, Mr. Kremidas led Lilly’s efforts to select and establish relationships with direct to consumer and professional advertising agencies, as well as to implement standardized processes for the development and implementation of marketing materials.

He is on the advisory board of CISCRP (a nonprofit organization focused on enhancing patient participation in clinical trials) and is also a volunteer for the Clinical Trial Transformation Initiative (CTTI) with Duke and the NIH. He is a frequent presenter at industry conferences and his articles/papers have been published in a wide variety of trade journals.


Aubri Lang
Clinical Trial Manager, TESARO, INC

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Aubri Lang, BS, CCRP is a Clinical Trial Manager at TESARO Inc., an oncology-focused biopharmaceutical company within the Greater Boston area.  She has been working in the oncology industry at clinical trial sponsors for 10 years, with roles focusing on management and oversight of late-phase registration clinical trials, vendor management, site monitoring, risk mitigation and management, process improvement, and inspection readiness.

Outside of Clinical Operations, Aubri took on a position as Project Manager for a company-wide initiative during 2018. Aubri has worked with industry accredited groups to present at national conferences on collaboration techniques to improve site-sponsor relationships, and is passionate about finding ways to improve efficiencies in clinical studies to ensure the patient is always put first.


Manny Lazaro
Vice President, Head of Clinical Operations, JOUNCE THERAPEUTICS

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Manny has held the position of Vice President, Head of Clinical Operations at Jounce Therapeutics since July 2016, where he is responsible for clinical strategy, planning and execution. Jounce Therapeutics is a clinical stage immuno-oncology company in Cambridge, MA dedicated to transforming the treatment of cancer. Manny started his industrial career 27+ years ago with positions of increasing responsibility beginning at Genetics Institute, Anika Therapeutics, Cubist Pharmaceuticals, Johnson and Johnson, Vertex Pharmaceuticals and Forum Pharmaceuticals.

Manny holds a Master’s of Science in Drug Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy and a Bachelor’s of Science in Biology from the University of Massachusetts at Boston. Before working in the device and biopharmaceutical industry, Manny served in the United States Air Force for 6 years as a Staff Sargeant.


Zabir Macci
Centralized Monitoring Manager — Process, Technology and Analytics, IQVIA

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Zabir is a Process Design & Analytics Manager for QuintilesIMS focused on their approach to risk-based monitoring (RBM), Data-driven Trial Execution. He brings expertise spanning risk-based monitoring, business analysis, continuous process improvement, and analytics for clinical trials. He is currently a process lead for Centralized Monitoring, including advanced analytics, for clinical trial design and execution. He holds a Bachelor’s degree in Computer Science from India and has an MBA in Management and Marketing from USA.


Atul Mahableshwarkar, M.D., DFAPA
Vice President, Clinical Development, BLACKTHORN THERAPEUTICS

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After studying Medicine at the Armed Forces Medical College in India, Dr. Mahableshwarkar completed a residency in Psychiatry and a fellowship in Neuropsychiatry at the University of Health Sciences/The Chicago Medical School. During 13 years of clinical practice he ran an inpatient ward, was Director of ECT services for 8 years and ran the Consultation/Liaison services. He was chief of Mental Health Services at the North Chicago VA Medical Center and Associate Professor and Vice Chair at the Department of Psychiatry and Behavioral Sciences at the University of Health Sciences/The Chicago Medical School. During 15 years in the Pharmaceutical Industry he has designed and conducted clinical trials globally in Alzheimer’s disease, anxiety disorders, bipolar disorder, major depression and schizophrenia and has lead the development program leading to the approval of a new antidepressant. His interests are in clinical trial methodology and he has been a founding member of the ISCTM and CNS Summit and a member of the Scientific/Program Committees for both societies. He has published in all, over 140 articles/posters/abstracts/invited commentaries and book chapter.


Amanda J. Moore, MSHS
Associate Director Clinical Operations and Development, SAGE THERAPEUTICS

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Amanda Moore in an established contributor within the clinical research industry. She has wide-ranging experience having advanced from coordinating at a research site, to working at a CRO, and now as a leader in biotech for over a decade. Amanda specializes in clinical development through full outsourced models and has developed innovative clinical trial designs and accelerated clinical development plans for rare diseases. She brings diverse perspectives to achieving operational excellence through her experience in CNS, infectious disease and immunology trials as well as her education focus in clinical research administration.


Harald Murck
Adjunct Professor, UNIVERSITY OF MARBURG

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Harald Murck did his training in psychiatry at the Max-Planck-Institute of Psychiatry in Munich, Germany with a focus on neurobiological understanding of major psychiatric disorders. His research focus covers translational approaches, including the optimization of late stage clinical development. He has broad clinical development experience from stage I to IV in psychiatric and neurologic indications from 18 years of experience in the pharmaceutical industry, including start-up (Amarin) to large pharma-organizations (Novartis, BMS). Recently, he successfully ran a development program in Parkinson’s disease (Acorda) and oversaw early clinical development candidates for Alzheimer’s disease at Axovant. He is the owner of Murck-Neuroscience and has in parallel an academic affiliation (Privatdozent) at the Clinic of Psychiatry and Psychotherapy the University of Marburg/ Germany. He is author or co-author of more than 80 peer reviewed publications and several book chapters. A patent in the area of personalized treatment of major depression is pending.


Sabrina Paganoni
Assistant Professor, Massachusetts General Hospital, SPAULDING REHAB HOSPITAL

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Sabrina Paganoni, M.D., Ph.D., is an Assistant Professor of Physical Medicine and Rehabilitation at Harvard Medical School and a physician scientist at the Neurological Clinical Research Institute of Massachusetts General Hospital.

She received her M.D. degree from the University of Milan, Italy and a Ph.D. in Neuroscience from Northwestern University (Chicago, IL). During her Ph.D., she worked on the molecular mechanisms of brain development. She then completed her medical training in Boston (residency at Spaulding Rehabilitation Hospital; fellowships in EMG/Neuromuscular Medicine and then ALS Clinical Research at Massachusetts General Hospital). She is Board-certified in Physical Medicine and Rehabilitation, Neuromuscular Medicine, and Electrodiagnostic Medicine.

Dr. Paganoni’s research focuses on therapy development for ALS and other Motor Neuron Diseases. She is committed to enhancing the efficiency of ALS clinical trials by leveraging novel trial designs and outcome measures. She designed and is currently leading three investigator-initiated ALS clinical trials where she is using a novel device to measure muscle strength and several cutting-edge neuroimaging techniques, bio-fluid biomarkers, and digital technology measures. She has also developed a niche in Primary Lateral Sclerosis (PLS), a rare form of Motor Neuron Disease. She is leading an international PLS registry, co-chairs the PLS Task Force at NEALS, and is a site investigator for the first PLS drug trial. She is an editorial board member for Muscle and Nerve and the American Journal of PM&R where she is also Associate Editor for the Section Evidence-Based Physiatry/Cochrane Corner. She has published 60 peer-reviewed papers and 6 book chapters. Her research has been funded by the NIH, several ALS Foundations and non-profits, and industry.

Dr. Paganoni is passionate about clinical care innovation and access to research for people with ALS. She co-chairs the Technology Committee and the Recruitment/Retention/Experience Committee at NEALS. She is working with other Harvard researchers on developing new shoulder and hand assistive technology devices that can improve function and quality of life for people with ALS. She has served as a judge for The ALS Association Assistive Technology Challenge, The ALS Association Clinical Management research grant program, the Shay Rishoni Patient Impact Award, and the Prize4Life ALS Assistive Technology Hackathon.

Dr. Paganoni has received several awards for her work including the NIH Rehabilitation Medicine Scientist Training Program Award (2012), the American Academy of Neurology Three-Year Career Development Award in ALS (2017), the Association of Academic Physiatrists Early Academician Award (2018), and the Spaulding Rehabilitation Hospital Walter R. Frontera Outstanding Researcher Award (2011) and Claire M. Donaldson Young Investigator Award (2018).


Costa Panagos
President, Clinical Operations, IQVIA

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Costa Panagos is president, clinical operations, responsible for the global delivery and customer experience of all IQVIA’s clinical development services, including our IQVIA CORE-enabled trials and virtual trials. He is also responsible for increasing the use of advances such as CRA technology and flexible staffing models to improve operational efficiencies.

Costa was recently chief executive officer of Q2 Solutions, the joint venture between IQVIA and Quest Laboratories. Under his leadership, Q2 Solutions became a leading global clinical trials laboratory services organization which includes Central Laboratory, Genomics, and BioAnalytical and ADME operations.  During his more than 19-year career at IQVIA, Costa has held several senior clinical and commercial leadership roles, including senior vice president and global head of IQVIA’s Global Laboratories as well as leading its Global Sales Operations organization. Prior to IQVIA, Costa held various roles in the pharmaceutical division of Bayer.

??Costa earned a bachelor’s degree in biology from Brown University and an MBA from the Booth School of Business, University of Chicago.


Kristen Perkins
Clinical Trial Manager, TESARO, INC.

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Kristen Perkins, MS, CCRP is a Clinical Trial Manager at TESARO, Inc., an oncology-focused biopharmaceutical company within the Greater Boston area. She has 10 years of global clinical operations experience in Phase II-IV trials within a variety of therapeutic areas across the industry (Sponsor, CRO, Site).

Kristen is passionate about trial management and inspired by patient focused drug development. In her current role, she leads a global Phase III trial and two North-American Phase II trials. Kristen has given past presentations on strengthening sponsor-site relationships and has developed standard tools and templates from these best practices.


Hariharan Rahul, Ph.D.
Visiting Researcher, THE MASSACHUSETTS INSTITUTE OF TECHNOLOGY

Josh Rose
VP, Global Head of Strategy, Research and Development Solutions, IQVIA

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As Vice President and Global Head of Strategy for the R&D Solutions business unit at IQVIA, he is responsible for building the strategy for the clinical development business, establishing strategic initiatives, and leading the identification of acquisition candidates. Rose earned an MBA from Duke University and a BS in Chemical Engineering from the University of Illinois in Campaign-Urbana.


Joshua Rubin, J.D., MBA, MPP, MPH
Program Officer for Learning Health System Initiatives, UNIVERSITY OF MICHIGAN MEDICAL SCHOOL DEPARTMENT OF LEARNING HEALTH SCIENCES

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Joshua C. Rubin, JD, MBA, MPH, MPP serves as Program Officer for Learning Health System Initiatives at the University of Michigan Medical School’s first-of-its-kind Department of Learning Health Sciences. He also serves as Executive Director and Vice President of the Board of Directors of the Joseph H. Kanter Family Foundation and as President and CEO of the Learning Health Community. Previously, Rubin served as a Senior Policy Fellow at eHealth Initiative (eHI) and as a Senior Consultant at IBM Global Business Services, working at the intersection of the health information technology, health policy, consumer engagement, and public health arenas in both roles. A life member of MENSA, Rubin holds a Juris Doctor (JD) law degree, a Master of Business Administration (MBA) and a Master of Public Policy (MPP) from Georgetown University, and a Master of Public Health (MPH) from the Johns Hopkins University Bloomberg School of Public Health.


Dennis Salotti, M.S., MBA, CCRA
Chief Operating Officer, THE AVOCA GROUP

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Dennis Salotti is COO of The Avoca Group and lead for the Diligent® Qualification Platform, the clinical research industry’s first centralized platform for clinical service provider qualification.

With more than 16 years in the pharmaceutical industry as a sponsor, provider, and consultant, Dennis has experience that spans preclinical research, clinical operations, data management, quality assurance, eClinical, business operations, and strategic management.

Prior to joining The Avoca Group, Dennis was Director of Operations for WriteResult, an eCOA provider, where he was responsible for client delivery across the portfolio of global clinical trials. He has previously held positions in research and clinical operations for Pfizer and Merck.

Dennis is an Adjunct faculty instructor for Drexel University College of Medicine’s graduate program in Clinical Research Organization Management, and a Member of the Board of Trustees for the Diabetes Foundation. His educational credentials include an MS in Clinical Research Organization Management from Drexel University, an MBA in Technology Management from the New Jersey Institute of Technology, and a BS in Biology from Sacred Heart University.


Michelle Shogren
Head of Innovation, Portfolio and Operations, BAYER

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Michelle is the Head of Innovation in Portfolio and Operations for Pharma Development at Bayer. She has over 20 years of experience in Clinical Research across many different roles. She began her journey as a research nurse and site director. From there she became a Clinical Research Associate at a CRO, and finally joined Bayer in 2008 where she has held multiple roles in Clinical Operations, Training and Quality, and now in Business Excellence and Innovation. Michelle’s greatest passion is customer focused innovation and responding to the voice of the patients and sites.


Supriya Shoroff
Associate Director, TMF, AMAG PHARMACEUTICALS

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Ms. Shoroff has more than ten years of experience in the pharmaceutical Industry and has held various roles in managing and overseeing Trial Master File (TMF) operations across Clinical portfolio. She is a Subject Matter expert with solid in-depth understanding of TMF Management processes and associated content listings. She has led multiple eTMF system Implementations, designed and developed business processes, lead Inspection Readiness initiatives and multiple agency Inspections. Besides being the Business owner of eTMF systems, she has also led and worked on complex data (records) migration projects and process improvement initiatives. Currently she is an Associate Director of TMF at AMAG Pharmaceuticals and is based in Boston, MA.


Stella Stergiopoulos
Assistant Director of Statistics and Analytics, Research Instructor, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT

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Ms. Stella Stergiopoulos manages multi-sponsored and grant funded research projects at Tufts CSDD.  She has experience conducting research on pharmaceutical industry practices and trends affecting pharmacovigilance, non-clinical drug development, pharmaceutical outsourcing practices, cycle time metrics, resource management, and protocol design.  She has also been a speaker at conferences and has published articles in peer-reviewed and trade journals.  Prior to joining Tufts CSDD, Ms. Stergiopoulos was a research associate at The Brattle Group and a researcher at Massachusetts General Hospital.  She holds a BA from Brandeis University, and an MS and MPH from Tufts University.


Jay Turpen
Senior Consultant, THE AVOCA GROUP

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Jay Turpen is a Senior Consultant with The Avoca Group. He has been in the pharmaceutical industry for 29 years and has held various leadership roles. Jay has a wealth of experience in GMP, GLP, and GCP environments with significant real-life experience in developing numerous new drug candidates.
His pharma experience started in GMP of small molecule and large molecule (biologic) active pharmaceutical ingredients (API). Jay has been involved in leading multiple clinical teams responsible for the clinical development and NDA preparation for multiple molecules in osteoporosis, diabetes, cardiovascular, neuroscience, and immunology. Jay also led a transformation effort for his company’s CLO organization that effected processes, systems, job definitions/descriptions, and organizational leadership to meet both GLP and GCP requirements.

Most recently, Jay was Senior Director for Clinical Project Management (CPM) where he was responsible for the clinical development for Alzheimer’s disease, autoimmune diseases, men’s health, pain, and other neuroscience indications. This CPM organization, under Jay’s leadership, successfully completed multiple NDA submissions, regulatory agency inspections, and received regulatory approvals for small molecule and biologic products demonstrating thorough GCP compliance. Jay retired from Eli Lilly & Co. at the end of 2017 where he was Sr. Director, Clinical Project Management – Biomedicines.


David Vulcano
Vice President, Research Compliance and Integrity, HCA HEALTHCARE

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David is a well-known leader and change agent in the clinical research industry. He was born and raised in New Orleans, Louisiana. He has a master’s degree in social work and business administration and holds the additional status of Certified IRB Professional (CIP) and Regulatory Affairs Certification (RAC). He is the Responsible Executive for Clinical Research for Hospital Corporation of America (HCA). He is and has been in many industry leadership roles both in the United States and globally, including Chair of the Board of Trustees for the Association of Clinical Research Professionals (ACRP). He is also the President of the Nashville Angel Capital Group. He is married with two children and lives south of Nashville, Tennessee where he involves himself in work, family life, and other charitable and entrepreneurial opportunities. David was recently honored with the “Outstanding Speaker” award, presented at the 2015 MAGI West conference.


Alana Wriggins
Head Site Management, North America, Acquisition Integration and Clinical Records Management, ALLERGAN

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Alana has more than 20 years of clinical research experience and has lead both regional and global cross-functional staff across project teams and facilitated numerous process improvement initiatives. She has been involved at the front-line of numerous FDA inspections. In her current role at Allergan, she leads the group responsible for the global oversight of TMF management and archiving, as well as, inspection readiness and acquisition activities. She is also responsible for site management activities in North America. Alana received her Bachelor of Science degree in Nursing from the University of South Carolina and her Master’s degree in health science, Clinical Research Administration from George Washington University. She is a member of ACRP and the Regulatory Affairs Professional Society.


Jean-David Zeitoun
Chief Medical Officer, INATO

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Jean-David Zeitoun is an MD, specialized in hepatology and gastroenterology. He also holds an Executive Master of Health Policy and Management from Sciences Po Paris, and a PhD in clinical epidemiology from Paris University. His research focuses on drug regulation, pharmaceutical R&D, health economics, therapeutic innovation and quality of care. He is the author of approximately 100 scientific articles, more than 40 of which were published in international journals. He is also a reviewer for several international scientific journals, including the JAMA Internal Medicine.

He is co-founder and Chief Medical Officer of Inato, a company helping pharmaceutical manufacturers to adequately select sites for clinical trials. Inato now have several big pharma companies as customers, acts at a global scale and irrespective of the disease area. Better site selection reduces the rate of non- or low-performing sites, and allows a greater with timelines and anticipated costs.


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