2018 Speaker Biographies

Teresa Ancukiewicz, Senior Manager, Clinical Trials, Boston Scientific

Teresa Ancukiewicz is Senior Manager in Clinical Operations at Boston Scientific for the last 13 years, CCDM. She is responsible for providing leadership on outsourcing initiatives and Risk Based Monitoring. She has over 20 years of experience in data management, process development and improvement, and vendor management. She is active in the DIA Annual Meeting Program Committee, former member of the SCDM Board of Trustees.

Peter Antinozzi, PhD, Assistant Professor, Department of Biochemistry, Department of Internal Medicine (Section of Molecular Medicine), Department of Genomics and Personalized Medicine Research, Center of Diabetes Research, Center on Diabetes, Obesity, and Metabolism, Wake Forest University School of Medicine

Dr. Peter Antinozzi received his Ph.D in Biochemistry from University of Texas-Southwestern, Dallas. He is an Assistant Professor of Internal Medicine, Genomics and Personalized Medicine. He is a Recipient of JDRF Award to study the sorting and trafficking of autoantigens produced by the pancreatic beta-cell. He is also Recipient of American Diabetes Association Junior Faculty Award to identify and study genes involved in Type-2 diabetes.

Mary Arnould, Director, Clinical Science Operations and RBM Lead, Astellas

Mary is Director, Clinical Science Operations and RBM Lead at Astellas. Her pharmaceutical career spanning over 25 years has included site monitoring, site monitoring management, development of technology and process solutions for site monitoring execution and leading RBM implementation efforts. She has been involved in RBM implementation at two pharma companies focusing on process refinement, technology deployment, and change management.

Ashish Atreja, MD, MPH, FACP Chief Technology Innovation and Engagement Officer, Medicine Icahn School of Medicine at Mount Sinai

As Chief Technology Innovation and Engagement Officer, Medicine, Dr. Atreja leads the Sinai AppLab (www.sinaiapplab.org), a one-of-a-kind collaborative hub to build and test disruptive mhealth technologies. Dr. Atreja leads scientific registries for the American Gastroenterology Association and serves on the Innovation Advisory Board for American College of Cardiology. As an intrapreneur, Dr. Atreja has won innovation awards at Cleveland Clinic and Mount Sinai, successfully licensed technologies from academic centers and advises startups, accelerators and Fortune 500 companies in digital medicine. More recently, Dr. Atreja launched the first enterprisewide app curation and prescribing platform (www.rxuniverse.com) and established Network of Digital Medicine (www.nodehealth.org) to connect innovation centers worldwide and share best practices for digital medicine innovation and implementation.

Sarah Bednarski, Associate Director, Strategic Monitoring, Sunovion

Sarah is currently leading the implementation of risk-based monitoring within Sunovion Pharmaceuticals. Sarah received her B.A. in Neuroscience from Johns Hopkins University and her M.S. in Statistics from The University of Georgia. She has held various roles in clinical operations, working in early stages of RBM at both large and small companies. Her educational foundation in science and mathematics drives her passion to collaborate between operations and data science to strategize on optimal ways to conduct a trial.

Saloni Behl, Associate Director, Commercial Planning, Otsuka Pharmaceutical

Bio coming soon

Michael J. Benecky, PhD, Senior Director, Global Regulatory Affairs, Precision and Digital Medicine, R&D Chief Regulatory Office, GlaxoSmithKline

Mike received his B.A. in Biochemistry from the University of Wisconsin-Milwaukee and his Ph.D in Biophysical Chemistry from Princeton University. Mike continued his academic research career as a Post-Doctoral Fellow at Northwestern University and as an Assistant Professor at the University of Wisconsin Medical School-Milwaukee Clinical Campus. Mike then entered the in vitro diagnostic industry where he held product development positions of increasing professional responsibility. Mike gained expertise in the preparation of FDA IDE and PMA medical device submissions for lasers used for vision correction surgery at Bio-Reg Associates. At QIAGEN (formerly Digene), Mike led the Regulatory /Clinical Affairs Group that prepared numerous FDA PMA submissions for the first FDA approved HPV DNA test for cervical cancer screening. Mike Benecky joined GSK in October 2011 as Senior Director, Global Regulatory Affairs in Precision and Digital Medicine located in Research Triangle Park, North Carolina. In the area of Digital Medicine, Mike currently assists GSK Teams in regulatory strategy during use of digital health technology in both clinical trial and commercial settings. Recent projects include the commercial launch of the MyAsthma mobile medical app in the EU and inclusion of digital sensors and mobile apps within GSK clinical development programs.

John Cai, MD, PhD, Executive Director, Real World Data Analytics & Innovation, Merck

Dr. Zhaohui (John) Cai is Executive Director, Real-world Data Analytics and Innovation, in the Merck Center for Observational and Real-World Evidence (CORE). He is leading a team of data scientists and outcomes researchers to generate scientific evidence and insights through innovative and advanced RWD analytics and predictive modelling. John has 20 years of experience in biomedical and clinical research, including 16 years of applying biomedical informatics across academic, biotech, and pharmaceutical settings. John received his medical training from China Medical University and his Medical Informatics training from the Children’s Hospital Informatics Program in Harvard Medical School. Pursuing a passion for both medicine and computing, John has co-authored peer-reviewed publications in the areas of medical informatics, machine learning/data mining, clinical trials, and cancer genomics. He also serves in the American Medical Informatics Association (AMIA) Industry Advisory Council.

Owen Charles, RN, MBA / HCM, Formerly Outsourcing Manager, Central Clinical Planning & Solutions, Bristol-Myers Squibb

Owen Charles, RN, BA, MBA has over 20 years of biopharmaceutical R&D outsourcing experience including most recently 17 years at Bristol-Myers Squibb. His areas of expertise include management of large global CRO Alliance Partners, as well as local CROs in China, Israel, Russia, and Japan; strategic sourcing and outsourcing processes, due diligence, governance; and NIR, Early Phase, and Regulatory Affairs outsourcing. Leadership with cross functional teams and business partners has included development and implementation of governance and operational strategy, optimizing processes and building professional teams to exceed business objectives. Prior to joining BMS, he was Director of Clinical Operations for SCIREX (now Premier Research), and spent six years as a Research Scientist/ Program Administrator for the Nathan Kline Institute for Psychiatric Research, overseeing a high volume research site at Bellevue Hospital in New York City.

Julia Clennell, PMP, Manager, Operations and Quality ,Clinical Trial Strategy, Berry Consultants

Julia Clennell is Manager of Operations and Quality for the Berry Consultants’ Clinical Trial Strategy Team, whose mission is to accelerate the clinical development process by designing and implementing innovative, adaptive, and platform trials across all therapeutics areas. Julia’s experience and skills include adaptive and platform trial operational expertise; clinical trial design experience (with an emphasis on phase I and II clinical trials); clinical trial management with a focus on innovating the clinical operations process, protocol development, CRO selection and management, pharmacovigilance and regulatory; forming and maintaining strategic collaborations; identifying programmatic challenges and opportunities and developing result-driven operational strategies. Strong knowledge and experience in oncology and immunology. Julia earned an undergraduate degree from UC Berkeley and obtained a project management certification. Prior to joining Berry Consulting, Julia was the Director of Operations for the I-SPY program, which is comprised of a series of standing trials established to use scientific innovation to guide the use of new agents for women with locally advanced breast cancer. She played a key role in developing and implementing strategic processes for the operational management of the I-SPY 2 TRIAL (phase 2 breast cancer adaptive platform trial) leading to significant decrease in study start-up times, execution cycle times, and operating costs of managing the trial and the development and oversight of a multi-institutional phase 1 network. Julia also worked for 4 years as a research associate investigating the effects of B and T cells on autoimmunity.

Lori Ann Correia, Director, Clinical Operations & Patient Advocacy, Inozyme Pharma

Bio coming soon

Nurcan Coskun, PhD, Global Risk Based Monitoring Program and Technology Solutions Manager, Medtronic

I have 20 years of clinical research experience, contributing in roles such as Clinical Research Manager and Clinical Research Associates Supervisor, Global Clinical Operations Oncology Group Leader, Project Leader, Clinical Monitoring Manager and recently as Global Risk Based Monitoring and Technology Solutions Manager. After obtaining my M.Sc. and Ph.D. degrees on Cancer Epidemiology, completed my Master degree on Medical Informatics at Erasmus University, Rotterdam in the Netherlands. During my studies, I worked as Researcher in the field of Cancer Epidemiology especially in Registries and conducted clinical trials as data manager and statistician. I contributed in the activities of SOP writing, trainings, publications, leading task forces on different topics and presenting at congresses and meetings. My current focus is on Risk Based Approach to Clinical Trials. With collaboration with other authors one whitepaper published on RBM in Medical Device companies and attend the conferences as speaker on the subject.

Christine Crandall, Head, Strategic Clinical Planning, GlaxoSmithKline

Christine Meyer Crandall is the Head of Strategic Clinical Planning at GSK with over 19 years of experience in project management and clinical operations. She is responsible for a team focused on the delivery of robust, quality data to optimize trial scenario planning and improve clinical development plans. Christine has extensive knowledge and expertise in designing and deploying innovative and transformative strategies concentrating on protocol feasibility, site selection, recruitment planning, budget estimates and timelines. She has the ability to work with matrix team members towards the successful completion of project goals. Christine has had previous positions at AstraZeneca and Covance. She holds a B.A. in Neuroscience from the University of Pennsylvania with a M.S. in Pharmaceutical Sciences from Temple University.

Kristin Demafeliz, Senior Associate Director, Research Partnerships, Michael J. Fox Foundation for Parkinson's Research

Kristin Demafeliz leads the recruitment and retention team at The Michael J. Fox Foundation (MJFF), focused on supporting on-time recruitment and retention of clinical research participants. Collaborating with research teams in academia and industry, the recruitment and retention team provides field-tested recommendations and resources for the broader research community and specific study teams. Understanding the need for faster participant enrollment, MJFF is committed to helping researchers develop robust, multi-modal recruitment and retention strategies that align with the patient journey and also fit the needs of a specific study. Before joining MJFF, Kristin worked in the technology sector, marketing and scaling business-to-business and business-to-consumer products. Kristin also has experience in non-profit consulting, partnering with organizations to develop strategic plans and relationship management strategies.

Joe Dustin, Principal, Mobile Health, Medidata Patient Cloud

Bio coming soon

Carolina Errobidart, Central Monitor, Global Data Strategies & Solutions (GDSS), Bristol Myers-Squibb

Bio coming soon

Nnamdi Ezeanochie, MD, DrPH, Manager, Behavior Science, Johnson & Johnson

Dr. Nnamdi Ezeanochie is a Manager on the Behavior Science and Advanced Analytics team at Johnson & Johnson. He has extensive professional experience in technology-based health care and behavioral science implementation and research, with a unique focus on developing-country settings. His research expertise focuses on mobile technology adoption and implementation, health care program management, community and health behavior services, support services, evidence-based recommendations, IT healthcare solutions, and disease outbreak management. On the Health and Wellness Solutions team at Johnson & Johnson, Nnamdi focuses on providing scientific evidence to support digital health solutions that are integrated with behavior change techniques. He holds a DrPH in Community and Behavioral Health from the University of Colorado, an MPH in International Development from the University of Sheffield, UK, and an MD from the University of Nigeria.

Rosalie Filling, Vice President, Clinical Operations, Endo Pharmaceuticals

Rosie earned her B.S. in Biology, Minor in Chemistry from the University of Pittsburgh. She has 19 years of clinical trial experience. Rosie began her career at PPD as a Research Assistant and moved into her first management position at PPD. She was responsible for the rapid site start-up and ongoing management of enrollment and site regulatory requirements across all therapeutic areas. After 5 years, she left PPD and began her pharmaceutical Sponsor career at Guilford Pharmaceuticals in Baltimore, MD. At Guilford, Rosie was responsible for the overall strategy for execution of clinical trials including the outsourcing needs and overall budget management for all of Research & Development. Guilford was acquired by MGI Pharma. Post the acquisition, Rosie was chosen to lead the new Clinical Operations team to establish a new set of processes and strategy for the new organization. MGI’s focus was on acute care and oncology. The new organization was very successful and was later acquired by Eisai. During Rosie’s tenure at Eisai, she moved into post-marketing and was responsible for executing Oncology and CNS post-marketing trials. Rosie then joined Teva in 2009, where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Rosie joined Lupin in August 2014 to stand up the Clinical Operations Division. She recently joined Endo Pharmaceuticals in February 2018 as Vice President, Clinical Operations accountable for Clinical Operations, Biometrics, and Medical Writing. She has surrounded herself with highly skilled and energized colleagues and has laid the foundation for a successful clinical operations department. Rosie has been an active contributor to 6 NDAs, 8 SNDAs, and 6 ANDAs. Rosie resides with her husband of 18.5 years, Josh. They have 2 daughters Marlee (17) and Chloe (13) and two adorable boxer puppies, Brutus and Bodi. In her spare time you can find her at the gym, hiking or on the sidelines watching her daughters play soccer!

Charlotte French, Independent Consultant; Former Executive Director, Portfolio Relationship & Sourcing Management, Medical and Development, Astellas

Charlotte's most recent role was the Executive Director, Portfolio Relationship & Sourcing Management at Astellas Pharma Global Development, leading the global sourcing activities for Medical & Development. In this role she led the Service Provider Relationship Management team together with the Outsourcing/Contracts. Charlotte also led the implementation of a tripartite Sourcing Strategy for the Development organization. Prior to joining Astellas in May 2017, Charlotte was Senior Director, Contracting and Outsourcing within Global Clinical Operations at EMD Serono. In this role she led the team of Contract/Outsourcing Managers responsible for supporting the commercial aspects across both the Regional and Global Clinical Operations portfolio. Prior to her transition to Pharma, Charlotte had more than 15 years in the healthcare industry during which time she has led a number of different business functions within CRO sector at ‘top three’ CRO’s, including Finance & Administration, Global Bids and Contracts and Global Management Services. One of her key strengths is the ability to assess opportunities for improvement and then work across multiple functions to develop and measure process improvement initiatives. This was demonstrated during her tenure in the non-governmental environment for a period of three years during which she provided support and leadership on contract/grant management to ensure audit readiness for a number of country assignments in African and Asian countries, including a move to Ghana to lead a regional program for Neglected Tropical Diseases.

Rose Gerber, Director, Patient Advocacy and Education, Community Oncology Alliance (COA)

Rose Gerber is the director of patient advocacy and education for the Community Oncology Alliance, a national organization that advocates for the preservation of high quality, affordable and accessible cancer care for patients. Her experience includes, appearing on national television (MSNBC) to speak about cancer care, meeting with legislators in Washington, DC on cancer policy issues, and developing cancer programs. Rose has been speaker, educator, and moderator for a broad range of audiences, including state oncology societies, hospitals, cancer clinics, pharmaceutical partners, and various cancer organizations and conferences. She also serves as an invited member on national patient advocate panels, steering committees, and cancer coalitions. Rose was recently awarded National Breast Cancer Leader of the Year by Breast Cancer Wellness magazine. Rose is a cancer survivor and clinical trial participant.

Nikhil Gopinath, Senior Product Manager, Saama

Bio coming soon

Jacqueline Gough, Advisor, Clinical Risk Management, Eli Lilly and Company

Jackie Gough is currently an Advisor in Clinical Risk Management at Eli Lilly and Company including responsibility for Risk Assessment as well as Risk-based Monitoring groups. Jackie spent the past three years with the RBM team, initially as a Central Monitor and then as the leader of the group. Jackie spent almost 20 years as a Statistician, followed by five years as a Data Scientist in the pharmaceutical industry. Her last 13 years have been with Eli Lilly and Company. Jackie leads the Central Monitoring subteam in the RBM workstream for TransCelerate and is the author of two papers on Central Monitoring with that group.

Farhan ‘CJ’ Hameed, MD, MS, Director, Clinical Informatics Lead, Digital Medicine and Pfizer Innovation Research (PfIRe) Lab, Early Clinical Development, World Wide Research & Development, Pfizer, Inc.

Dr. Farhan ‘CJ’ Hameed is a biomedical informatician with extensive experience in healthcare, academia and clinical research informatics. Dr. Hameed is currently leading the medical informatics initiative at Digital Medicine group in Early Clinical Development (ECD) at Pfizer and focusing on development and implementation of semantically driven interoperable ontologies along with clinical and sensor data standards for multiple therapeutic areas. He also specializes in developing integrated clinical solutions through electronic data capturing (EDC) and eSource applications, EHR interoperability including Clinical Decision Support Systems (CDSS) development and implementation, use of wearable devices in clinical studies, and AI/Machine learning in clinical trials. CJ is also involved in several collaborative efforts with internal and external scientific groups for developing and promoting patient technology through clinical research informatics standards especially within digital biomarkers space and collaborating across clinical study teams and external organizations for data sharing and implementation of exploratory data initiatives. Before joining Digital Medicine group, CJ served within Quantitative Medicine and Neuroscience Research Units at Pfizer. He also holds adjunct faculty position at Northeastern University, Boston and has served as an adjunct assistant professor of pharmacy practice at Chicago State and Midwestern Universities. As an active member of Healthcare Information and Management Systems Society (HIMSS), Health Level-7 (HL7), American Medical Informatics Association (AMIA), Clinical Data Interchange Standards Consortium (CDISC) and Pistoia Alliance, he contributes to several research informatics initiatives and also leading TransCelerate Patient Technology Insight Workstream. Dr. Hameed holds a master’s degree in health informatics from Northeastern University, a medical degree from Dow University of Health Sciences. He completed psychiatry-training program at the Institute of Behavioral Sciences and also a fellow of the Healthcare Information and Management Systems Society.

Beth Harper, MBA, President, Clinical Performance Partners

Beth is the President of Clinical Performance Partners, Inc., a clinical research consulting firm specializing in enrollment and site performance management and facilitating productive sponsor-site relationships. Beth leverages her 30 years of site, SMO, CRO, Pharma, Consulting, Training and Service Provider experiences, both domestically and internationally, to identify solutions for optimizing the clinical trials process.

Dawn Harper, Executive Director, Clinical Operations, Strongbridge Biopharma

Bio coming soon

Heather Hernandez, Director, Business Development, Seeker Health

Heather Hernandez is passionate about developing health solutions. She has worked managing Clinical Trials, in all phases, for both medical device and biotech companies for nearly a decade. Now as a Director of BD for Seeker Health, she’s helping Clinical Ops Leaders accelerate enrollment into their clinical trials. Heather is thrilled to share out learnings from the Seeker Health experience. In her free time, Heather enjoys serving as an alumni advisor to the BEAM, Stanford Career Education team, serving on the PHE Next Council, playing volleyball and running marathons. Heather graduated with a B.A. in Human Biology from Stanford University.

Angelique Hopkins, MPH, Associate Director, Clinical Trial Analytics, Business Insights & Analytics, Bristol-Myers Squibb

Angelique Hopkins is an Associate Director of Clinical Trial Analytics in Business Insights & Analytics at Bristol-Myers Squibb supporting clinical trial planning. She has a B.S. in Biology from The College of New Jersey, a M.P.H from Drexel University and is completing her doctoral work in epidemiology.With 10 years of experience in clinical trial planning, forecasting, and analytics, Angelique is passionate about the use of data to driven faster and more informed decision-making.

Chris Hoyle, MBA, Executive Director, Elite Research Network

Mr. Hoyle entered clinical research in 2001 after obtaining his MBA. While working at a dedicated research site, he was involved in all aspects of investigator site management, including patient recruitment, budgets and contracts, and business development. He founded the Elite Research Network in 2004. Since then, Mr. Hoyle has been responsible for leading the company from a network of four sites to its current size of twenty-seven sites. He earned his BS in Zoology from NC State University and his MBA from UNC – Wilmington.

Kevin Hua, Senior Manager, AI/Machine Learning Development, Bayer

Dr. Kefeng (Kevin) Hua has 20 years of experience working in design and development of advanced analytics models in healthcare, insurance, banking, retail and manufacturing industries, as well as in building AI-based applications for accounting firms. He is a senior manager at Bayer LifeScience iHUB, responsible for developing machine learning/data mining application to improve Bayer’s core businesses. Prior to Bayer, he was a machine learning specialist at Deloitte Consulting and a research manager of AI at Center for Advanced Research of PwC. He hold a Ph.D in artificial intelligence from Swiss Federal Institute of Technology in Lausanne, Switzerland. His work in analytics has won the Analytics Leadership Award from IU Kelley School of Business in 2014 and INFORMS Data Mining contest in 2008.

Esther Huffman, Associate Director, Monitoring Excellence, Bristol-Myers Squibb

Esther is an Associate Director in the Global Monitoring Excellence Group at Bristol-Myers Squibb, where she has spent the past seven years developing and operationalizing the Risk-Based Monitoring methodology. In her current role, Esther drives the changes in technology, process, and monitoring support to embed RBM as “business as usual” at BMS. Esther has 20 years’ experience in clinical trials, with a focus in site monitoring and the evolving Site Monitor role. At BMS, Esther has been focused on Monitoring Technologies and SOPs, Strategic SDV, TransCelerate and Risk-Based Monitoring activities. She is especially interested in global monitoring processes and ensuring that site-facing roles have the support they need to excel. Esther is a proud graduate of Washington and Lee University and did her post-graduate work at Vanderbilt University.

Melissa A. Hurst, MSM, MBA, Clinical Outsourcing Manager, CSL Behring

Bio coming soon

Elena S. Izmailova, PhD, Senior Director, Novel Data Streams and Devices, Takeda Pharmaceuticals International, Inc.

Bio coming soon

Aniket Joshi, Associate Director, R&D Innovation, Otsuka Pharmaceutical

Aniket Joshi has a PhD in Biomedical Engineering from Univ. Of Michigan. He has over 10 years of experience in translational biomarkers in R&D organizations at Merck and Novartis. In his current position as Associate Director of R&D Innovation at Otsuka Pharmaceuticals, Aniket is tasked with identifying and implementing innovative approaches to solve challenges facing the clinical trials.

Kim Kaiser, Principal, Kim Kaiser and Associates, LLC representing LUPUS RESEARCH ALLIANCE

Bio coming soon

Nechama Katan, Central Monitoring Manager, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer

Nechama Katan, Central Monitoring Manager at Pfizer, is a “Data Wizard with Personality.” She helps organizations access and use their data to drive business decisions. Nechama blends an ability to write code and provide prototypes with an interest in driving the “business conversation." In addition to working with various organizations, she is an experienced instructor in Statistics, Operations, Data presentation and Metrics development. Her education includes an MSc from NYU in Mathematics and an MA from Columbia University in Statistics.

Francis Kendall, Technology Evaluation and Implementation Leader, Product Development, Roche

Francis has over 25 years experience in the industry working at several major Big Pharma companies (Hoecsht, Sandoz, Nycomed, Roche, Novartis & now Roche) mainly leading and working within Biometrics groups, His first degree is in Applied Statistics, then he went on to be a Chartered Statistician and Chartered manager and also completed his MBA. He has a keen interest in new technology and the democratisation of data. His current role is within the Strategic Innovation group which helps the organisation look at future digital strategies and opportunities such as Machine Learning and Big Data.

John S Klein, MS, MBA, Director, Global Regulatory Affairs, IQVIA

John as more than 25 years of life science experience focusing on process optimization and R&D project management, with an emphasis on technology solutions that streamline data acquisition and decision-making in pharmaceutical development. John has worked with diverse functional areas to identify opportunities for process change and workflow redesign for both domestic and global projects, with both internal and external customers. In addition, led workshops and training sessions conducted in many countries, incorporating regional variations into global processes and workflow. He also helps companies navigate global regulatory requirements and processes related to asset divestment and acquisition. John has a BS in Biology from Westminster College (PA), an MS in Medical Microbiology/Immunology from the University of Dayton, and an MBA in Health Care Administration from Cleveland State University.

Joe Kunakorn, MS, Associate Director, Headquarters Clinical Quality Management, Oncology, Quality & Continuous Improvement, Merck

Joe is an Associate Director in Headquarters Clinical Quality Management at Merck and is dedicated to implementing clinical quality risk management initiatives to ensure quality and inspection readiness in clinical trials. Joe is a Quality Management professional with over 17 years of experience in the pharma, biopharma, and medical device industries. He has been a leader in the development of robust Quality Management Systems via the conduct and hosting of audits, management of CAPAs / complaints, controlled documents, training programs, change control and validation efforts, and ensuring compliance with medical device and drug development regulations. Joe holds a M.S. in Biomedical Sciences, a B.S. in Biological Sciences, and Regulatory Compliance Certification.

Sheri Kuss, Clinical Quality Lead, Clinical Development Quality, Global Product Development, Pfizer, Inc.

Ms. Sheri Kuss has over 20 years of clinical research experience in the industry working at pharmaceutical, medical device, CRO and biotechnology companies. Sheri's vast range of expertise has developed from her roles within clinical trial monitoring, clinical trial management, operations, clinical quality assurance, compliance, training and continuous improvement. Sheri has a proven track record of establishing and delivering inspection readiness and regulatory compliance training tools and programs as a direct result of her experiences hosting and preparing for more than 15 pre-approval regulatory agency inspections. In the area of operational excellence, she demonstrated success in leading business process teams and improving upon existing quality management systems through continuous improvement initiatives. Sheri's Sponsor and CRO experiences give her a unique quality insight and a practical approach to the risks and operational compliance issues related to the conduct of clinical trials and quality management systems.

Jzaneen Lalani, COO, Curemark

Jzaneen Lalani is the Chief Operating Officer of Curemark, LLC, a privately-held biopharmaceutical company with a Phase III FDA fast track designated drug candidate for Autism. With over 15 years in biotech and healthcare, Jzaneen’s experience extends from capital markets to mergers and acquisitions, from investor relations/corporate communications to organizational development - at both private and publicly traded companies. As a former public company General Counsel and Corporate Secretary, Jzaneen also brings years of hands-on corporate governance and SEC compliance experience. With her current experience leading the team of a scrappy start-up to her years of experience in large law firms and mid-cap publicly traded companies, Jzaneen has a deep understanding of growth challenges, the need for continued innovation and the balance between preservation and innovation. Currently, Jzaneen oversees the day-to-day operations at Curemark, which includes oversight over the company’s 30-site Phase III clinical trial. Her background in operations and law gives her a unique ability to harmonize interests, identify and close gaps and foster collaboration. Tasked with positioning the company for growth, Jzaneen’s role spans all aspects of the company’s business, including finance and fundraising. Prior to joining Curemark, Jzaneen served as Chief Corporate Counsel and Corporate Secretary for HMS Holdings, Corp. (NASDAQ: HMSY), where she was responsible for corporate/securities, human resources and corporate governance matters. As a key advisor to the CEO and a member of the executive team, Jzaneen was on the frontline of strategy development and execution. She also played a key role in the company’s acquisition strategy and integration process. Jzaneen also served as the General Counsel and Head of Investor Relations for Memory Pharmaceuticals, Corp. (NASDAQ: MEMY), a biopharmaceutical company focused on CNS disorders. In addition to working on a series of post-IPO secondary debt and equity financings, Jzaneen was a member of the core team that led the sale of Memory to Roche. Jzaneen holds a Bachelor of Science from Queen’s University, a law degree from the University of Victoria, Canada and a Master of Law and a Master of International Affairs from Columbia University.

Janis Little, Vice President, Global R&D Quality, Allergan

Janis Little is Vice President, Global R&D Quality at Allergan. In this role she is responsible for the oversight of the R&D quality function, setting strategic direction for the organization and ensuring development and implementation of a risk-based audit program for pharmaceuticals, biologics, medical devices, cosmetics and generics for preclinical, clinical, and pharmacovigilance activities, and related computerized systems, inspection management, quality metrics and product development quality assurance. Prior to joining Allergan, Janis was Global Head, Product Development Quality Auditing at Roche/Genentech where she was responsible for a comprehensive quality program, including audit oversight for clinical, preclinical, and pharmacovigilance activities, and computerized systems, inspection management, quality harmonization, pandemic planning, investigations, ethics and training, CAPA management, and quality metrics. Prior to joining Roche/Genentech, Janis held leadership positions in clinical and pre-clinical compliance, clinical operations, and medical affairs at Johnson & Johnson (Ethicon, Johnson & Johnson Pharmaceutical Research & Development, Centicor), Altana Pharma and Hoechst-Roussel Pharmaceuticals.

Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis Communications, LLC

Robert Loll is the SVP of Business Development & Strategic Planning at Praxis, and has been designing and deploying patient recruitment campaigns since 2004. Robert has a clinical background of 17 years and is an advisory board member for The Center for Information and Study on Clinical Research Participation (CISCRP).

Maria Makarovskaya, Director, Vendor Management, Global Clinical Development, Tesaro

Bio coming soon.

Angie Maurer, RN, BSN, MBA, Clinical Quality & Risk Management Consultant, GRAIL, Inc.

Angie has spent over 19 years in healthcare and 15 years in the drug development and medical device industries spanning biopharmaceutical, medical device and CRO organizations. Her experiences include drug safety, study monitoring, study and program management, process development, therapeutic area and clinical operations training, and risk management. Over the past several years Angie has concentrated her efforts on clinical operations process development and implementation of risk management tools and trainings to support risk management programs.

Margaret McDonald, PhD, Senior Director, Real World Data and Analytics, Patient & Health Impact, Pfizer, Inc.

Margaret McDonald, PhD, MS, MT(ASCP) is a Senior Director in the Real World Data and Analytics (RWDnA) group, part of the Patient and Health Impact function at Pfizer. Currently, Margaret supports the Internal Medicine, Rare Disease, and Consumer portfolio in the development and delivery of insights using real world data and analytics. Her work includes using rapid cycle query tools for analyses leading to potential studies, consultation on study design, uses of data, and serves as RWD liaison to Pfizer EU and LATAM country colleagues. Research focus includes population studies, burden of illness, gaps in healthcare services, and healthcare disparities. Prior to this position, Margaret led the Population Health efforts within Outcomes Research, creating reports used externally by Pfizer colleagues and external organizations.

Mark Milberg, MBA, MSW, Director, Clinical Procurement and Outsourcing, Ultragenyx

Mark Milberg has over 24 years of management and operational experience in the biopharmaceutical, medical device, and healthcare industries. He currently works as Director, Clinical Procurement and Outsourcing at Ultragenyx Pharmaceutical, supporting all of the clinical programs in this clinical-stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases. He worked at Medtronic previously for 7.5 years in increasingly responsible positions. His last position was Sr. Strategic Outsourcing Manager.

Georgia Mitsi, Senior Director, Search & Evaluation, Digital Healthcare, Sunovion Pharmaceuticals

Georgia Mitsi, PhD, is Senior Director, Search Evaluation & Digital Health Care Initiatives at Sunovion, where she oversees initiatives that focus on integrating digital health technologies into Sunovion’s solutions to contribute towards the goals to significantly to empower patients to better manage their symptoms and improve quality of life for those who are living with chronic medical conditions. She also contributes to Sunovion’s support of public-private partnerships designed to accelerate digital health care solutions. Dr. Mitsi is a hands-on digital innovator with expertise in health outcomes and health economics research and experience in pharmaceutical and health care industry consulting. She is an active blogger on a variety of digital health care topics, and has authored numerous scientific publications and two novels. Dr. Mitsi has been a long-time supporter and mentor to digital health start-up companies. She holds an MBA in international business from the University of Miami School of Business Administration, and a PhD in Pharmacoepidemiology and MSc in Applied Medical Sciences from the University of Patras.

Rick Morrison, President, Comprehend Systems, Inc.

Bio coming soon.

David Nickerson, Head, Clinical Quality Management, EMD Serono

Dave has 30 years of industry experience spanning the disciplines of Drug Metabolism & Pharmacokinetics, Project/Program Management, and Clinical Quality Management. He joined EMD Serono (a business of Merck KGaA, Darmstadt, Germany) in November 2016 as Head of Clinical Quality Management. His previous 23 years had been with Pfizer. Dave was a member of the Expert Working Group that was responsible to develop the addendum to ICH E6 (ICH E6 R2).

Brian Nugent, Senior Director, Clinical Compliance, GRAIL, Inc.

Brian has spent over 30 years in health care and 15 years in the drug development industry spanning both biopharmaceutical and CRO organizations with director-level responsibility for quality, clinical operations, process development, TMF and safety. Over the past several years, Brian has concentrated his efforts on clinical operations process development and the establishment of quality systems to include QRM/QbD, as well as the standardization of risk management plans.

Margaretta Nyilas, MD, Senior Vice President Clinical and Business Operations, Otsuka Pharmaceutical Development and Commercialization (OPDC)

Margaretta Nyilas, M.D., Biopharmaceutical Executive with over seventeen years of diverse, global industry experience (CNS, Oncology, Analgesia, Anti-infective, pediatric trials and Digital Health) with proven ability to deliver high value assets such as Abilify™, Abilify Maintena™, Rexulti™. Strong business acumen driving transformational change in clinical and business operations to maximize efficiency leading to quality and timely execution of large scale, global clinical development portfolios from early development through life cycle management (approximately 91studies at 3000+ sites in 50+countries with 30,000+ subjects resulting in 14 major global regulatory submissions and approvals over the past 5 years). Recognized as a clinical trial innovator in executing industry first end-to-end e-Trials with digital health technology. Strategic lead in establishing Alliance Management function in support of an expansive due diligence work resulting in asset and corporate acquisitions (co-development and co-promotional agreement for 5 compounds with Lundbeck, acquisition of Astex, Avanir). Currently serving as Senior Vice President of Clinical Management and Business Operations of Otsuka Pharmaceutical Development & Commercialization, Inc overseeing multiple functions (Clinical Operations, Project Management, Outsourcing and Corporate Projects). Member of number of internal and external alliance executive governance committees. Previously acted as an Executive Medical Director heading Clinical Research at Purdue Pharma L.P. overseeing the development portfolio from PhI to PhIII clinical trials, primarily focusing on analgesic research. Formerly held diverse levels of medical and managerial positions at Otsuka and BMS leading global development programs in adults and pediatric patient populations in mainly focusing on CNS and oncology therapeutic area. Obtained Medical Doctorate (MD) degree at Semmelweiss Medical University in Budapest, Hungary and a specialty in Clinical Pharmacology from the Post Doctorate Faculty at the same University. Having lived both in Europe and United States possessing a versatile, cross-cultural understanding and flexibility working within diverse organizations with hands on global work experience in Europe, Japan and emerging markets such as India, Southeast Asia and South America. Currently working and residing in New York, NY USA. Areas of expertise: Global Pharmaceutical Development, Clinical Operations, Alliance Management, Outsourcing, Program Management, Pediatric and Digital Health Trials.

Erin O’Boyle, Senior Director, Clinical Contracts and Outsourcing, FibroGen, Inc.

More than 15 years of operational and management experience in conducting all phases of clinical trials. I am currently responsible for providing leadership and management of all outsourced clinical vendors that are working with FibroGen on a variety of studies. These studies range from large Phase 3 global studies to small Phase 2 rare disease studies. While at FibroGen, I have successfully collaborated with the clinical teams and vendors to implement processes (i.e. translation, on-site monitoring expectations, drug destruction) that have saved significant costs, reduced timelines and improved consistency. Prior to joining FibroGen, I worked at Heron Therapeutics as the Associate Director of Clinical Development and ran the clinical program for Sustol®, from the first Phase 1 study up through the NDA. Over the years, I have fostered and maintained relationships with vendors and sites. I learned that in order to continue to have a support team that is happy and wants to work on your study(s), communication, a contract that clearly outlines the roles & responsibilities of each party and working hard with your vendors will be your strongest and best assets for achieving study goals

Scott Ohanesian, Senior Vice President, Commercial Operations, QuickSTAT

Bio coming soon

Ramya Palacholla, MD, MPH, Scientist, Partners Healthcare Connected Health Innovation, Harvard Medical School, Massachusetts General Hospital

Dr. Palacholla has extensive training in Medicine, Public Health and Connected Health and has successfully contributed to design, implementation and rigorous evaluation of several connected health solutions. Dr. Palacholla’s goal of improving access to high quality equitable healthcare, promoting wellness, preventing diseases and limiting the complications of chronic diseases motivated her to exploit the ubiquity of modern technologies to find innovative means of engaging patients. Her research interests have been focused on health outcomes research, systematic literature reviews/ meta-analysis, study designing, and data analysis with a focus on building patient self-management; improving patient-physician communication and the efficiency of clinical workflow. She has designed several pilot studies including randomized controlled trials focused on personal health solutions, mobile phone applications, tele-monitoring programs in addition to analyzing datasets for these projects. Currently, she is a Post-Doctoral Research Fellow in the Data Science & Analytics team which is responsible for designing rigorous research methodologies to evaluate digital health interventions at Partners Connected Health.

Krupa Patel, Director, Business Enablement Organization, Merck

Bio coming soon

John Reites, Chief Product Officer & Partner, THREAD

From entry level to executive leader, John’s career includes 14 years as an intrapreneur at Quintiles, the global leader for healthcare research and commercialization. He has led two internal startups from formation thru product development to global growth and execution scale. John is currently leading a third startup focused on Digital Health Acceleration. Named one of the Top 100 Influencers in Digital Health, he provides expertise and execution experience in digital health strategy, virtual clinical research, Phase I - IV clinical research, patient reported outcomes, Apple ResearchKit/CareKit, mobile health, omni-channel experience and virtual reality. His experience spans more than 150 clinical research programs in 52 countries supporting the majority of top biopharmaceutical companies and providers. John is also a keynote speaker and published author featured in various conferences, journals, articles and media outlets.

Beth (Elizabeth) Robinson, RN, MSHS, Executive Director, Clinical Compliance and Operations, Horizon Pharma

Bio coming soon

Beatriz Rocha, MD, PhD, Vice President, Head of Strategic Product Development Consulting, Covance

Dr Beatriz Rocha has more than 30 years of professional experience that spans from academia and government to industry. It includes clinical practice in anesthesia and pain management, clinical research, basic research, and regulatory affairs during the last 14 years. As a board certified anaesthesiologist and behavioural pharmacologist, Dr. Rocha spent 20 years in clinical and laboratory practice and in 2001 she joined Merck Research Laboratories in Rahway, NJ. As a clinician, in the Pain Clinic of the Federal University of Rio de Janeiro (Brazil), Dr. Rocha developed and implemented the oral morphine program for cancer pain control, was the medical monitor in studies evaluating pharmacological and/or behavioral training approaches for the management of non-malignant chronic pain, and the medical monitor in studies evaluating regional blockade for the management of post-surgical pain. Dr. Rocha has extensive experience interacting with Board(s) of Health (BoH), including FDA (US), European Medicines Agency (EMA), Health Canada (HC), and Ministry of Health, Labor and Welfare (MHLW/PMDA) in Japan, in several therapeutic areas of oncology, immunology, urology, dermatology, respiratory and CNS. Dr. Rocha is a worldwide recognized expert in the area of addiction and abuse liability. She serves in the College on Problems of Drug Dependence (CPDD) Board of Directors, and is the Chief Operating Officer of the Cross Company Abuse Liability Council (CCALC). At Covance, Dr. Rocha currently heads the Strategic Product Development Consulting group that offers overall regulatory and medical consultancy across the entire continuum of drug and medical devices development.

Christopher Rull, Vice President, Solutions Consulting Leader, PAREXEL Access

Christopher leads the Solutions Consulting group across PAREXEL Access. In this role, Chris is responsible for ensuring that our Access based portfolio of services is considered and enabled in developing responses and solutions for our customers. This includes leveraging our Expert Consultants, Medical Communications, Pharmacovigilance & Safety, Real World Data Solutions (RWDS), and Operational/ Real World Evidence (RWE) areas to create optimal support for your product or portfolio. Christopher has over 18 years of healthcare experience including most recently holding leadership roles at UBC and EMD Serono. Chris Rull recently rejoined PAREXEL having gained valuable experiences in leadership, consulting and general management across both Biopharamceutical Manufacturers and large health care conglomerates in the Commercial and formulary space. Over the past 15 plus years, Chris has seen and participated in the evolution of all aspects of Supplier Management for R&D and Medical Affairs/ Commercial Access, inclusive of Strategic Partnership & Alliance Management in the industry. In those roles he has had the opportunity to collaborate on a global basis with CROs, small and emerging biopharma, large biotech companies all the way through the largest pharmaceutical companies in the world to support initiatives focused around change management, oversight, business & commercial management, portfolio delivery, and innovation.

Dennis Salotti, Vice President, Operations, The Avoca Group

Dennis Salotti is the executive lead for Operations of The Avoca Group and is head of Avoca’s Industry Research and Diligent™ Centralized RFI Platform divisions. Dennis leads the strategy and execution of bespoke research projects and Avoca’s broader industry-leading research on quality, risk innovation and clinical trial execution. He is also responsible for the strategy and operations of Diligent, the clinical research industry’s first centralized platform for clinical service provider prequalification. 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 clinical research organization, 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.

Stuart Shaw, Risk Based Quality Management Implementation Project Lead, Boehringer-Ingelheim

Bio coming soon

Michelle Shogren, Head of Innovation in Portfolio and Operations, Pharma Development, Bayer

Michelle has 20+ years experience in Clinical Trials starting as a Research Nurse, SIte Director, and continuing on to multiple positions in clinical operations, process excellence, and business excellence and innovation. She is passionate about customer focused innovation with a special focus on reducing the burden to patients and sites while enhancing the data.

Gurparkash Singh, Manager, Electronic Health Records (EHRs), Janssen R&D

Gurparkash Singh is a Manager, Electronic Health Records (EHRs) at Janssen R&D. He has been involved with different successful cross company collaborations overseeing understanding and reuse of clinical and real world data. His current interests include repurposing of health and clinical data, and understanding of EHRs to streamline and optimize the clinical trial process. He has over 20 years of broad experience in Pharma including entrepreneurship, lab research, medical writing, regulatory submissions and now data sciences. He obtained his Phd from University of Windsor, Ontario, Canada, and a postdoctoral training from Emory School of Medicine in Atlanta, Georgia.

Cassandra Smith, Associate Director, Investigator and Patient Engagement Projects, Global Clinical Development Operations, Janssen R&D

Cassandra brings 15+ years of pharmaceutical industry experience – 10 of which have been within the Johnson & Johnson family of companies. During her career, Cassandra has held various roles supporting clinical trial operations of Phase I-Phase IV studies and she is currently Associate Director, Investigator and Patient Engagement Projects at Janssen Research & Development.

Nina Spiller, Vice President Clinical Management, Otsuka Pharmaceutical Development and Commercialization (OPDC)

Nina Spiller is Vice President, Clinical Management at Otsuka Pharmaceutical Development and Commercialization, Inc. (OPDC). In this role, Nina is responsible for the oversight of Clinical Management and Clinical Outsourcing, and also leads selected corporate projects. In this role, Nina oversees efforts to innovate the clinical trial process and to implement new technologies into trial execution. Nina has over 25 years of experience in the pharmaceutical industry, largely within clinical development, and has worked previously at Bristol-Myers Squibb and SCIREX Corporation. She has a Doctor of Pharmacy degree from the University of Maryland.

Eric Stary, Manager, Clinical Outsourcing, Pharmacyclics

Eric Stary, MS, MBA, has spent the last 5 years as an Outsourcing Manager and leader for a large and a mid-size biotech, working on everything from global CRO selection for large Phase 3 Oncology Trials to setting up key suppliers for ancillary services such as IRT and Biomarker Labs. Prior to that Eric spent 12 years at two CROs working in various roles of increasing responsibility across the clinical trial management spectrum.

Michele Stonier, CRO Infrastructure Lead, Vendor & Outsourcing Management, BMS

Bio coming soon

Linda Sullivan, Co-Founder & President, Metrics Champion Consortium LLC

Linda B. Sullivan is Co-Founder & President of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has been a featured speaker at Performance Metrics, Risk-Based Monitoring, Quality Management & Clinical Trial Oversight industry meetings. Ms Sullivan received a B.S. in Biology from Trinity College and a M.B.A. from Dartmouth College where she was named a Tuck Scholar.

Yiwen Sun, Senior Clinical Research Associate, Samumed, LLC

Yiwen started her professional journey in clinical research just as the industry was adapting to a risk-based approach to trial management. She has the unique experience of growing alongside RBM and is an advocate for its adoption at Samumed. Over the past 2 years, Yiwen actively participated in this transition and gained first-hand experience evolving from a traditional CRA into a central monitor. She is an integral part of the RBM team that continues to lead the company towards its risk-based trial management goals. Yiwen graduated from UCSD as a Bioengineer in 2011 and has been with Samumed since 2013.

Jens B. Thuesen, CTMS Business Development, BSI Business Systems Integration AG

Jens B. Thuesen, CTMS Business Development, BSI Business Systems Integration AG Jens B. Thuesen is a CTMS and CRM pioneer, having 25 years of experience with such software systems. Jens founded BSI Business Systems Integration AG in 1996 after recognizing the need to provide open architecture products with both high functionality and an intuitive UI. He now plays an active role in business development: He focuses on best practice processes for clinical operations and introduces technologies such as Blockchain or Machine Learning to the pharma industry.

Jennifer Turgiss, Vice President, Behavior Science & Analytics, Johnson & Johnson

As an applied scientist and practitioner in population health management, Jennifer Turgiss spent a decade creating, measuring and optimizing wearable technologies and digital solutions to improve health and wellbeing in the employer market. She holds two patents in this domain. As a business executive, Turgiss worked in several health-related start-ups across the U.S., the U.K., South Africa and Italy. She designed and implemented health and wellbeing programs, including fitness, sports performance, and weight-, stress-, hypertension- and arthritis-management. At Johnson and Johnson, Turgiss and her team of behavior scientists build digital health behavior change interventions targeted toward the individual user and the health care provider. Turgiss uses traditional statistical and advanced data science methods to evaluate and optimize the interventions to amplify health and wellbeing.

Laszlo Vasko, Senior Director, Information Technology, Clinical Operations & Innovation, Janssen

Laszlo Vasko has over 2 decades of experience leading information technology enabled change initiatives in pharmaceutical drug development. He recently joined Janssen Pharmaceutical, as Senior Director Business Technology Leader for Clinical Development and Innovation. Prior, Laszlo worked at AstraZeneca R&D Information for the past 18 years, implementing and supporting capabilities for Clinical Operations, Bio-Statistics, Safety, Regulatory and Project Management. Laszlo has Masters degrees in both Clinical Research Management (Drexel) and Information Science (Penn State). Laszlo is passionate about advancing the science of drug development with information technology. He worked across functional, regional, and organizational boundaries, driving novel solutions such as improving clinical development program design, leveraging healthcare data in design and recruitment, unstructured knowledge mining, analytics, and more. He is the co-lead of cross industry initiative partnering with Phuse and CDISC to establish an information model supporting Clinical Development Design. The model aims to structure information underpinning clinical design decision making. Laszlo has an international background, having had the opportunity live, work, and study in Sweden, France, and Hungary

René Wheat, Senior Director, Global Project Management, Infectious & Rare Diseases, Clinical Research Service, ICON

Bio coming soon

Charles Wolfus, Vice President, Digital Health, Technology and Business Operations, MyoKardia

Mr. Wolfus is a biopharma digital health leader committed to improving the lives of patients with cardiovascular disease by advancing and applying digital health tools

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