Charity Tillemann-Dick, Author of "The Encore, A Memoir in Three Acts"
Charity Tillemann-Dick is an American-born soprano and top-selling classical recording artist. She is also a recipient of two double lung transplants. Her memoir, The Encore, was published by Atria Books / Simon & Schuster in October 2017. Tillemann-Dick has performed across the United States, Europe, and Asia in venues as diverse as the Rose Theater at Lincoln Center in New York City; the Kennedy Center in Washington, DC; the National Palace of the Arts in Budapest, Hungary; the American Embassy in Beijing, China; and the National Statuary Hall in the United States Capitol. She has collaborated and performed with noted conductors and musicians including Éva Marton, Bruno Rigacci, Joela Jones, Marvin Hamlisch, Bono, Zoltán Kocsis, Joan Dornemann, and former Secretary of State Dr. Condoleeza Rice. Some of her operatic roles have included Titania in A Mid Summer’s Night Dream, Gilda in Rigoletto, Violetta in La traviata, and Ophelia in Ophelia Forever. She has also performed for numerous presidents, prime ministers, members of Congress, and world dignitaries.
In 2014, Tillemann-Dick released her debut album, American Grace, which reached #1 on the Traditional Classical charts on Billboard. She was accompanied by Joela Jones and Richard Weiss, principal pianist and cellist for the Cleveland Orchestra.
After receiving a diagnosis of idiopathic pulmonary arterial hypertension in 2004, she served as the national spokesperson for the Pulmonary Hypertension Association (PHA), working to raise awareness, increase federal research funding, expand stem cell research, and promote preventative and alternative medicine. In September 2009, she received a double lung transplant at the Cleveland Clinic in Ohio. After complications from rejection, she received a second double lung transplant in January 2012.
Since receiving her transplant, Tillemann-Dick has shared her amazing story and vocal talents at numerous conferences and events around the country, including: TEDxMidAtlantic in Washington, DC; TEDMED 2010 in San Diego, CA; the 6th National Learning Congress on Organ Donation in Dallas, TX; and the EG Conference in Monterrey, CA. Tillemann-Dick was named a Glamour Hero in October 2005, and she has been featured on NPR Weekend Edition with Scott Simon, CBS This Morning, CNN with Dr. Sanjay Gupta, TED.com, The Huffington Post, The Washington Post, and BBC Radio.
Tillemann-Dick was raised in Denver, Colorado, with her 10 brothers and sisters. She later studied music at the Peabody Institute at Johns Hopkins University and the Franz Liszt Academy of Music in Budapest, Hungary, where she was a Fulbright Scholar. She currently resides with her husband in Baltimore, Maryland.
Senior Vice President and General Manager, Health Sciences Global Business Unit, Oracle
Steve Rosenberg, senior vice president and general manager of Oracle Health Sciences, has more than 30 years of experience leading development, services, support, and consulting, in addition to significant industry experience in life sciences and healthcare. Some of Rosenberg's key contributions to the industry include cloud-based solutions including an integrated approach to clinical trial management, new methodologies for patient-reported outcomes, and the introduction of advanced analytics for at-risk healthcare payers and providers.
Meet the industry thought leaders who will discuss the digital transformation of clinical trials, cloud utilization, AI, mHealth, and more.
Associate Vice President and Global Head, R&D Business Process Consulting, HCL
Sunil Agarwal is associate vice president and global head of R&D business process consulting at HCL America Inc. He is a business process and technology executive with more than 22 years of global experience in life sciences R&D. Agarwal started his career in clinical operations with a CRO (a spinoff from GSK) in Germany. Since then he has held multiple roles of increasing responsibility for various pharma and SI companies including Takeda Pharmaceuticals and Cognizant. He is a thought leader and speaker at various international industry forums and an active contributor to analyst and advisory forums (IDC, Gartner, Everest). He holds M.Tech and B.Tech degrees in computer science from the University of Dortmund, Germany and a Management Certificate from Boston University.
Vice President, Product Management, Oracle
Andy Alasso is the Global Vice President of Product Management within the Oracle Health Sciences Business Unit. Andy and his team are responsible for defining, specifying, and facilitating the delivery of 20+ products within Oracle’s Clinical Research, Pharmacovigilance, and Healthcare portfolios. Prior to his current role, Andy led product management for several product portfolios within Healthcare services company Optum. Prior to Optum, Andy was Director of Clinical and Regulatory IT at Astra USA (now part of Astra Zeneca). Overall Andy has over 25 years of experience in providing software solutions to the Life Sciences and Healthcare industries.
Linda Amato-Smith is a director within the global product development group at Pfizer. She currently leads the global business team responsible for clinical data management systems, including Oracle Clinical and Oracle Health Sciences InForm solutions, to ensure delivery of the technical roadmap and business enablement initiatives within the platform, driving portfolio delivery. She has 25 years of experience in the pharmaceutical industry supporting dictionary management and data management.
Director, Research Project Management, GE Healthcare
Sher-ree Beekman has more than 15 years’ research experience, with nearly 10 years in the medical device industry. She has an MBA and a Bachelor of Science degree in physiological sciences. She began her career as a study coordinator, supporting Phase 2 through 4 hematology and oncology trials. Throughout her career, Beekman has held positions ranging from regulatory affairs leader to project manager. In her current role, she leads the Research Project Management Office of the Global Research organization at GE Healthcare, one of the world’s largest medical device companies. Her team provides the entire Global Research organization with operational support, which includes contracting, payments processing, supporting GE Healthcare’s investigator-sponsored research portfolio, and implementing the clinical trial management system.
R&D IT Program Manager, GSK
Nate Blevins has worked in tech and pharmaceutical R&D for 25 years. In his early career, he worked for a startup company that developed some of the first clinical study electronic data capture systems in the industry. One of the early systems that Blevins developed led to multimillion dollar revenues for Covance. Since then, he has implemented systems across most of drug development including phase I data capture, study management, data management, quantitative sciences, safety, and regulatory information management. Blevins worked on these things at AstraZeneca for 17 years, and now at GSK for the past 5 years. At GSK he is currently working as R&D tech program manager on the Accenture Life Sciences Cloud, implementing the metadata repository and Oracle Health Sciences Data Management Workbench. Looking to the future, Blevins is very energized by new technologies and opportunities to accelerate delivery of life-changing treatments to patients.
President, Lash Group
Thomas J. Bramley PhD, is president of Lash Group, an organization that provides comprehensive services focused on improving patient access, care coordination, and outcomes. Prior to his current role, Bramley served as president of Xcenda, another AmerisourceBergen business unit, a strategic consulting company focused in health economics, outcomes research, reimbursement, market access, and staffing solutions throughout the healthcare industry. Bramley received his Bachelor of Science in pharmacy from Drake University in 1997 and his Doctor of Philosophy in pharmaceutical and health outcome sciences from the University of South Carolina in 2001.
Director of Safety Analytics, Oracle
Michael Braun-Boghos has been working in medicinal product safety for 24 years. He spent 13 years in the European PV headquarters of Fujisawa and Astellas, ultimately leading the Safety Data and Quality Management group. Thereafter he joined Relsys, the developer of Argus software, and finally came to Oracle Health Sciences with the Relsys acquisition in 2009. As a member of the safety strategy team, Michael helps drive the product roadmap of Oracle Health Sciences Safety Cloud.
Project Director, Covance
Nadine Brown is a certified project management professional at Covance. She has more than 20 years of clinical research experience and has successfully managed full-service global trials. Soon after receiving her Master of Public Health degree in epidemiology, Brown, worked for several clinical research organizations where she led full-service clinical trials in a plethora of therapeutic areas including renal transplantation, HIV, diabetes, women’s health, cardiovascular disease, and rheumatoid arthritis. Brown moved within the business process and solutions division in Covance where she could help improve business processes to ensure clinical programs are run more effectively and efficiently. Brown currently serves as the product lead for Oracle Health Sciences Site Activate Cloud Service and Oracle Health Sciences Site Analyze Cloud Service (formerly goBalto). In this capacity, she is responsible for all training activities in addition to the testing and deployment of new releases. She also works with the IT department to ensure that the solution integrations are properly maintained and continually enhanced to accommodate the needs of the operational team.
Clinical System Analyst II, Rho
April Cobb, clinical system analyst at Rho, has four and a half years of experience in clinical research. Her experience includes three and a half years focusing on transplantation as a project manager. She assisted in the implementation of Oracle CTMS at Rho. She is responsible for user support, system configurations, and oversight of other CTMS technology projects.
Director of Strategic Accounts, Perficient
Rudolf Coetzee, director of strategic accounts, Perficient, works with clients to implement innovative solutions that support their clinical data management, pharmacovigilance, clinical trial management, data warehousing, and analytics activities. Prior to joining Perficient, Coetzee founded a staffing and digital marketing firm and worked as a clinical scientist audiologist.
Business and Configuration Lead, PPD
Leila Cukic has 11 years management experience and is dedicated to the launch and implementation of Oracle Health Sciences Site Select (formerly goBalto) solutions. She now works as business and configuration lead for the Oracle Health Sciences Site Select internally, and is the leader of the goBalto business support team.
Global Head of Consulting, Navitas Health Sciences
John D’Antonio is Navitas Life Sciences global head of consulting. His focus is on driving groundbreaking programs to elevate practices among global pharma, diagnostic, medical device, and biotech industry leaders. He produces results that are clearly measurable on the basis of improved ROI and IRR.
Director, Pharmacovigilance Informatics, Sunovion Pharmaceuticals Inc.
Elena Davison has led a global multinational team at Sunovion Pharmaceuticals Inc. since 2015 and is responsible for pharmacovigilance technology and the delivery of the regional and global clinical and postmarketing safety data reports, datasets, and analyses required to develop the safety profile of all regionally and globally marketed products.
Davison has more than 15 years of experience in technology and informatics in the life sciences industry and has a unique expertise that spans clinical and postmarketing data standards, systems, and data aggregation. Prior to Sunovion Pharmaceuticals, Davison led data and informatics teams and data and systems initiatives at Ariad Pharmaceuticals (now Takeda), Infinity, Syndax, and Altus Pharmaceuticals. Davison holds a master’s degree in business with concentration in computer information systems from Suffolk University and undergraduate study from Moscow State University. She has previously presented on the topics of clinical data standards, handling of blinded data in pharmacovigilance aggregate reporting, E2B challenges, and managing a global information management group.
Consulting Technical Manager, Oracle
Dr. Anil Dhiri is an entrepreneurial business analyst with more than 35 years of experience in drug development. He believes in rapid economic justification for forging alliances between IT and business and is a change agent influencing people to optimize processes thorough enablement of appropriate technologies. Within Oracle Health Sciences safety practice his primary focus is interfacing clinical electronic data capture systems to Oracle Argus Safety.
Managing Director, Life Sciences, Accenture
Jennifer Duff is a sales and account lead in Accenture’s North America life sciences practice where she is currently leading the growth of global R&D operations for life sciences clients. She has more than 20 years of experience in the life sciences industry and more than 15 years of experience in global R&D services outsourcing.
Director, Clinical and Technical Data Management, Pfizer
Wade Fairbanks is director of clinical and technical data management at Pfizer. He has more than 30 years of experience across multiple industries including public safety, semiconductors and computer manufacturing, hospitality, oil and gas, retail, and pharmaceuticals. Fairbanks recently led a crossfunctional team to implement the Nurocor MDR at Pfizer and currently serves as system owner. He is currently engaged in supporting the Data and Automation initiative at Pfizer, which includes multiple objectives to further integrate MDR content and capabilities into the clinical trial end-to-end process.
Vice President of Information Technology, R&D, Allergan
As a leader of R&D IT, Joe Fleming has over 20 years of experience in clinical, regulatory and pharmacovigilance, ranging from strategy creation to team development to program execution. He is focused on partnering with stakeholders to align business challenges with technology solutions while maintaining the company interests of financial stewardship and building strategic, innovative value. Fleming is working closely with the business teams to define secure new clinical, regulatory and content management platforms to sustain go forward direction of the company. He is also engaged on defining the digital road map for the R&D business and creating new digital capabilities to deliver the drug development process of the future.
Director of Process, Program Management Office, ICON
Dr. Diane Francisco joined ICON in 2014 as a director of business process improvement and later took a position of director of study startup technology, leading the implementation of the Activate and Analyze platforms. In her current role as director within ICON’s Program Management Office, she is responsible for partnering with ICON SSU and clinical operations leadership to lead global cross-functional transformational change initiatives and process optimization. Francisco has more than two decades of experience in the CRO and medical device industry. She has extensive experience working with service line subject matter experts and clients in analyzing and redesigning complex processes to improve efficiency and effectiveness. Previous to ICON, Francisco worked at Covance for 11 year as a global Lean Six Sigma Master Black belt; she also held leadership roles at a medical device company, running the manufacturing facility, and at PPD managing the bioanalytical R&D and discovery groups. She received her PhD in analytical chemistry from Purdue University.
Director, Global Study Startup and Essential Documents, Allergan
Lorena Gomez has more than 20 years of experience in clinical development, having started her career as a phase I coordinator in 1996. She has gone on to hold leadership roles in both clinical operations and project/program management, and is currently the global director of strategic startup and essential documents at Allergan. Prior to starting with Allergan in 2016, Gomez oversaw startup strategy and clinical outcomes assessment management across all therapeutic areas at AbbVie.
Gomez holds a BS in microbiology, a BA in molecular biology, and was an NIH fellow in the University of Texas at Austin Pharmaceutics PhD program. In 2011, she was awarded the Pharma Times Clinical Researcher of the Year silver medal in the Project Management category and was a core team member for both the TransCelerate Shared Investigator Platform and Investigator Registry Initiatives.
Andy Greenberg has more than 20 years of experience developing and leading high-performance teams and launching technology-based products in the life sciences, healthcare, and wellness spaces. Leveraging a deep understanding of how to utilize data and analytics to translate user behavior into an actionable roadmap, he successfully drives product and organizational improvement with leading pharmaceutical companies.
Director, Clinical Trial Management Systems, Covance
Annie B. Harris is the director and business owner of CTMS in the Data and Technology department at Covance, Inc. She has more than 26 years of experience in the development and support of the clinical trial management system in support of clinical operations, project management, reporting, and analysis of clinical trial activities. She leads the teams that perform user access provisioning, study setup, EDC/IVR/ lab data mapping, reporting, and global process workflows for the CTMS system. In addition, she is responsible for leading requirement gathering for system upgrades, integration efforts with outside systems, and migration efforts to and from Oracle’s Siebel Clinical Trial Management System and the CDA reporting platform. Harris is the chair of the Women’s Empowerment Network (WEN), Employee Resource Group at Covance. The vision of WEN is to empower women to value and conquer their personal and career development goals inside and outside the workplace. She is a founding member and board secretary of Women of Color in Pharma (WOCIP), a nonprofit 501c6 informal network of women committed to providing an environment that nurtures and empowers women of color employed in the pharmaceutical industry. Harris earned her BA in business administration from Kaplan University.
Director, Global Clinical Data Standards, Merck
Brooke Hinkson has more than 20 years of experience in various research settings including an academic health research center, CRO, technology vendor, hospital, biotechnology firms, and large pharmaceutical companies. Over the past 15 years she has focused on data standards development, implementation, governance, and process optimization, including technology enablement. Hinkson joined Merck in August 2016 as the director of global clinical data standards, responsible for the clinical information governance vision and strategy. She leads global clinical data standards development and maintenance activities and is the business sponsor of Merck’s metadata repository program. Prior to joining Merck, Hinkson was the global head of clinical information governance at Sanofi and was the associate director of program management within the Standards & Architecture group at Genzyme for eight years prior to the Sanofi acquisition of Genzyme in 2011.
Senior Director, Site Intelligence and Activation, PPD
Malcolm Horsley joined PPD in November 2017. One of his key responsibilities is PPD’s Oracle Health Sciences Site Select Cloud Service (formerly goBalto) “business as usual” support team. Prior to joining the PPD team, he spent 18 years as a management consultant, mostly in the life sciences sector. Horsley has worked with many of the top 10 global pharmaceutical companies in his previous role, implementing transformational change and performing interim management roles.
Senior Director, Clinical Operations, HCL
Veselka Ilieva is senior director of clinical operations at C3i Solutions, a HCL Technology company. Ilieva is a business executive with more than 17 years of experience in corporate environment, 10 of which were in managing partnership and projects with companies from the life sciences industry. Ilieva’s experience in clinical operations dates back to 2008 when she joined C3i Solutions’ team, and ever since then she has been involved in multiple projects on a global level for companies including Medidata, Novo Nordisk, Pfizer, Medtronic, Leo Pharma, UCB, and WCT. She has participated in multiple pharma events in Europe and USA such as Pharmacovigilance Europe, Partnership in Clinical Trials, CPHI Worldwide, and Outsourcing in Clinical Trials. Ilieva holds an eMBA degree from the American University in Bulgaria.
Senior Director, Pfizer
Timothy Joy is senior director and the head of data acquisition and patient technologies at Pfizer. He is responsible for leading a team tasked with managing the acquisition of external clinical trial data and associated technologies, including eSource and patient reported outcomes.
Joy has been at Pfizer since 2003, when he joined development informatics and was responsible for implementation and support of Pfizer electronic data capture systems. Since joining global product development in 2006 he has held multiple positions with increasing responsibility. He represented Pfizer on an industry council to redesign and implement enhanced versions of electronic data capture. Additional key programs of work include the development and implementation of a global clinical trial data warehouse.
Joy has been involved in numerous projects and initiatives to redesign investigator site support, implementation and usage of novel patient technologies, and creation of Pfizer’s eSource strategy. Before joining global product development, he was head of Pfizer’s global clinical data services technical operations group.
Practice Director, R&D Solutions, HCL
Neeraj Kaushlendra is the practice director of life sciences R&D solutions at HCL. His responsibilities include driving business transformation through the adoption of digital technology in the R&D space and working with partners such as Oracle. Over the past nine years, he has managed relationships, advised CXOs and senior leadership, worked with partners and delivered value-oriented technology solutions for several of HCL’s key clients such as Otsuka, Biogen, CSL Behring, Merck, and Pfizer. Prior to his work in the life sciences industry, Kaushlendra advised G500 clients in several industries including media, retail, finance, banking, insurance, and mining on their technology roadmap and strategic initiatives for more than seven years. He holds an MBA from Indian Institute of Management, Indore and a B.Tech from Indian Institute of Technology, Kharagpur.
Associate Director in Clinical Business Operations, Imbrium Therapeutics
Liz Khachadoorian is an associate director in clinical business operations at Imbrium Therapeutics, and she has more than 25 years’ experience in the healthcare and pharmaceutical industry. Working in a vendor alliance management role she has fostered external clinical partnerships and oversees performance management. This includes financial and contract management, budget negotiations, clinical trial forecasting, and due diligence activities related to licensing opportunities.
Senior Director, Strategic Feasibility, PPD
Chris Komelasky joined PPD in 2016 and is a senior director in strategic feasibility. In this role, he leads the global investigator services team and a portfolio of strategic data, technology, and process improvement initiatives helping to enable the vision of the site and patient access team and its move toward data-driven decision-making. In his previous roles, he helped lead the design and build out of the rare disease and pediatric Center of Excellence and its supporting strategy, capabilities, and service offerings, as well as the commercial integration of Evidera, PPD’s real-world evidence service provider. Komelasky has extensive experience as a management consultant and healthcare executive in the areas of strategy, operations, data analytics, commercialization, and business transformation. Prior to joining PPD, he was at GlaxoSmithKline for 5 years, and spent around 10 years in management and strategy consulting at Accenture and ZS Associates. Komelasky holds a BS in systems engineering from the University of Virginia and an MBA from Duke University’s the Fuqua School of Business.
PharmD, Clinical Business Consultant for Goldblatt Systems, MolecularDx
Dr. John Kriak graduated from Duquesne University with a PharmD. He has worked with Goldblatt Systems since 2007 and with MolecularDx since its inception. In his current role Kriak is working with the executive team at both MolecularDx and Goldblatt Systems to develop and implement business development and clinical product strategies. Kriak is also a medical subject matter expert for both MolecularDx and Goldblatt Systems.
Director of Data Standards, GSK
Linda Lander is a director of data standards at GlaxoSmithKline with a focus on standards technologies and metadata-driven solutions. She has 35 years of experience in the pharmaceutical industry and holds a BS in nursing from Temple University. Lander has led numerous clinical data standards initiatives including acting as business lead for the implementation of a metadata repository solution to drive end-to-end, industry-aligned standards and efficiencies.
Chief Executive Officer, Novotech
Dr. John Moller joined Novotech in January 2014 to lead the expansion of Novotech’s Asia operations, and became CEO in 2017. Prior to Novotech Moller was managing director of IVF Australia and Queensland Fertility Group and sat on the board of the parent company Virtus Health. He was previously a management consultant with the Boston Consulting Group, specializing in developing growth and operational improvement initiatives with a focus on healthcare. Moller has a medical degree from the University of Auckland, a degree in advanced logic from the University of Canterbury, and an MBA from the University of Oxford.
Senior Manager, Accenture
Bruce Novick is a senior manager in Accenture’s accelerated life sciences solutions organization. Novick has been with Accenture since 2012 and has more than 20 years of industry experience in clinical R&D operations and IT. His experience includes clinical trials management systems, clinical data management, biostatistics, data warehousing, cloud solutions, and applications of automation and AI. His experience also includes R&D operations at organizations including global pharmaceutical, biotech, and CROs.
Senior Director, Product Strategy, Digital Trials, Oracle
Jonathan Palmer leads product strategy for digital trials within Oracle Health Sciences. He is responsible for defining and delivering new innovative digital/mHealth solutions, and he is passionate about changing the way we do clinical research through the use of technology. He has spent more than 20 years within Oracle’s clinical business teams, delivering solutions through a number of roles in sales, consulting, and product strategy. Prior to Oracle, Palmer worked within data management and clinical IT at Quintiles, Parexel, and IBM.
Vice President of Product Strategy, Oracle
Bruce Palsulich has more than 25 years of experience in the healthcare and life sciences industries. He currently oversees safety product strategy at Oracle Health Sciences, including the Argus and Empirica software suites, and with a specific emphasis on leveraging observational and other big data sources for product and patient safety. Prior to joining Oracle, he was one of the founders and served as vice president of Relsys International, leading the development of Argus, before serving as president of Timeln Inc. He later returned to Relsys as the chief innovation and strategy officer and then joined Oracle through the acquisition of Relsys. Palsulich earned a Bachelor of Science in information and computer science from the University of California, Irvine.
Maria Perkinson has more than 20 years of experience delivering business and IT transformation solutions. She has extensive experience in clinical trial operations and management and is an expert in applying program management, process improvement, innovation, and change management methodologies. Perkinson has led many large-scale, global initiatives within the pharmaceutical industry, including process optimization and technology improvements, and driving operational efficiencies. Her technical experience, background in analytics and process improvement, and ability to bridge disparate organizations and disciplines brings critical value as technology and innovation play an increasingly important role. She holds a Bachelor of Science degree in business management from Gannon University and is an ASQ Certified Six Sigma Green Belt.
Managing Director, Accenture
Derek Pollock has built an impressive background of building and leading cutting-edge pharmaceutical services companies. He now brings his expertise and experience to developing solutions and services aimed at better understanding the patient, engaging with them and enhancing the R&D and commercial lifecycles to improve lives.
Global Director, Contract Management and Global Monitoring Operations, Allergan
Dave Posselt has more than 25 years of experience in site contract management, R&D finance, financial planning and analysis, and clinical financial planning operations. He started his career as a financial analyst with Pharmacia/GE Healthcare. He has gone on to hold leadership roles in contract management and R&D finance and is currently the global director of site contract management and global site monitoring operations. Prior to starting at Allergan in 2015, Posselt was the head of trial budget and resource planning, head of oncology R&D finance, and director of US clinical R&D finance at Novartis Pharmaceuticals. Posselt holds a BS degree in accounting and an MBA, both from Rider University. He is also a certified public accountant licensed (inactive) in the State of New Jersey. He is a member of the American Institute of Certified Public Accountants and is a former emergency medical technician.
Clinical Team Lead, Rho
Dr. Nick Poulson, clinical team lead, has a PhD in cell biology and more than seven years of experience in managing, leading, monitoring, and coordinating phase 2 through 4 clinical trials across various therapeutic areas. He has overall accountability for the execution of clinical operations activities from project initiation through closeout and is responsible for coordinating the functional team members and their activities and liaising with project management and the sponsor. Poulson also serves as Rho’s clinical operations lead/liaison on the CTMS management team.
Director, Life Sciences Data Warehousing and Analytics, Perficient
Prabha Ranganathan is a delivery director at Perficient and is responsible for delivering data warehousing and analytics solutions for various life sciences and healthcare companies. Prabha works closely with customers, providing strategic advice on clinical data flows, data reviewing, and cleaning using the latest technological tools and solutions. Ranganathan has experience in building and releasing products from concept to release at Oracle, having held roles including product manager, architect, and lead developer. During most of her career, she worked on enterprise products dealing with large volumes of data from various sources. With a clear understanding of business and strong technical knowledge, she brings a unique skillset to solve complex problems. She received her MBA from Babson College and MS in computer science from the Illinois Institute of Technology.
Director, Product Owner, Pfizer
Mark Rewers is a director within the Global Product Development group within Pfizer Inc. and the business owner of the Oracle’s Siebel Clinical Trial Management System. He led the CTMS team at Pfizer that implemented Siebel Clinical Trial Management System in October 2017. He has more than 25 years in the pharmaceutical industry, supporting many areas and systems including CTMS, EDC, and safety. During those 25 years he has held positions in IT and on the business side, which has allowed him to gain valuable insights on the technical side along with understanding the business processes needed to support CTMS.
Principle Solutions Consultant, Oracle
Lee Russell has been working in clinical IT for more than 20 years, with the majority of that time spent supporting medicinal product safety for drug, device, and vaccine manufacturers. He has worked at tier 1 pharma companies and regulatory authorities where he implemented custom, Oracle Adverse Event Reporting System, and Oracle Argus multivigilance systems. As a member of the sales consulting team, he provides presales support for the Oracle Health Sciences Safety Cloud.
Senior Director, Database Management, Pfizer
Ralph J. Russo is the global head clinical database management at Pfizer. In this role he is responsible for all clinical trial database builds across the various systems used at Pfizer. He has more than 30 years of experience in the pharmaceutical industry. Prior to joining Pfizer, Russo worked at Merck where he was responsible for groups including external data acquisition and clinical database management. He also spent 14 years at Wyeth where he was responsible for designing clinical trial databases using the Oracle Clinical suite of applications. Prior to this, Russo worked on various drug development teams in support of discovery research as a research chemist at Wyeth. Russo has an MBA with a concentration in management information systems from Temple University’s Fox School of Business, a Master of Science degree in chemistry from Seton Hall University, and a Bachelor of Arts degree in chemistry from Rutgers University.
Consulting Practice Director, Oracle
Sagar Shah has worked in the software industry for more than 18 years, focusing on pharmaceutical applications. He joined Phase Forward in 2007 as part of the InForm EDC platform professional services team. He joined Oracle Health Sciences through the Phase Forward acquisition in 2010. As part of the global consulting team at Oracle, Shah leads a team of technical consultants to provide enablement and integration services for central designer and Oracle InForm EDC platform.
Vice President of Product Management, Oracle
Andrea Sim has more than 25 years of experience in the healthcare and life sciences industries. She currently heads up product for the Activate, Select and Analyze solutions at Oracle Health Sciences. Prior to joining Oracle, Sim was also the Vice President of Product at goBalto and McKesson RelayHealth. She has worked in healthcare technology for over 20 years, delivering products and business value to enterprise customers. She has also worked in consulting at First Consulting Group, WebMD and Carescience. Sim earned a Bachelor of Arts in Molecular Cell Biology for the University of California at Berkeley.
Director, Clinical Operations Solutions, Perficient
Param Singh has been working in the life sciences industry his entire career. As the director of clinical trial management solutions at Perficient, he developed the clinical trial management team to become one of the best in the industry. Singh leads a highly skilled team of implementation specialists and continues to build lasting relationships with clients. He has a knack for resource and project management, which allows clients to achieve success. He has been with Perficient, via the acquisition of BioPharm Systems, since 2008. Prior to joining the company, he guided the clinical trial management group at Accenture.
Global Vice President, Life Sciences Product Strategy, Oracle
As the global head of life sciences product strategy for Oracle, Jim Streeter collaborates closely with Oracle customers, regulatory agencies, analysts, and industry thought leaders to develop and help execute the overall business and product strategy for Oracle Health Sciences. He previously held leadership roles at PPD in both operations, as the head of global clinical technical operations and EDC, and in IT, as global head of systems development, business operations teams, and elinical strategy and innovation. Streeter has 29 years of data acquisition and analysis experience utilizing computerized systems and has focused on eclinical systems and processes for trials for the last 19 years. His experience includes implementing end-to-end eclinical solutions and processes across all therapeutic areas and all phases of studies. His early experience in eclinical was gained at Pfizer, where he was senior director of global clinical data services, heading the global data acquisition department for the company’s global research and development organization. Prior to joining Pfizer, he was a senior hardware, software, and systems engineer for the US Navy Underwater Sound Laboratory with a focus in data acquisition and analysis.
Associate Director, Clinical Development, Oyster Point Pharma, Inc
Kristen Striffler has more than 15 years of experience within the clinical operations field. She began her career at a startup pharmaceutical company as a clinical trial assistant and has held various positions of increasing responsibility since then, including clinical research associate, senior CRA, and study manager. Prior to joining Oyster Point, Striffler was a global clinical trial manager at Amgen. In addition to ophthalmology, her experience includes oncology and cardiovascular. She holds a Bachelor of Science degree from the University of Delaware.
IT Risk Management and Compliance Senior Manager, Pfizer
Linda Thibeault is a senior manager in the Digital and Technology Risk Management and Compliance organization at Pfizer. She has more than 30 years of experience in information technology including project management, software engineering and development, software quality engineering, and risk management and compliance. Thibeault has supported IT in a diverse range of industries including aerospace, manufacturing, and pharmaceutical. Her areas of expertise include project management, system development lifecycle, software quality engineering, GxP regulatory compliance, and IT risk management.
Vice President, Life Sciences Solutions, HCL
Anil Verma is a vice president at HCL responsible for life sciences industry solutions and service offerings. In his current role, he works with industry CxOs to drive business transformation through the adoption of digital technology in life sciences industry. This includes HCL’s partnership with Oracle to develop mHealth solutions for drug development, remote patient monitoring, and collection of real-world evidence. Verma has been with HCL for 12 years. Prior to this role, he was responsible for managing HCL’s relationship with some of its key clients including Merck, Biogen, Gilead, Otsuka, CSL Behring, and Incyte. He holds a Bachelor of Engineering and a master’s degree in international business from prestigious Delhi School of Economics. He is a self-proclaimed foodie and loves to blog about his cultural experiences one plate at a time.
PhD, Chief Scientist and Director of Laboratory Operations, MolecularDx
Dr. Laura Voeghtly currently serves as the chief scientist and director of laboratory operations at MolecularDx in Windber, Pennsylvania. Her role includes incorporating best-of-breed and innovative genomics-testing technology to support programs in forensic toxicology, cancer genomics, and pharmacogenetics. Voeghtly received training at Penn State University, and earned a PhD in cellular and molecular pathology from the University of Pittsburgh School of Medicine. She has extensive experience in medical center laboratories, serving as the manager of the clinical pathology laboratory at Bloomington hospital and conducting research at the Windber research institute. Voeghtly is an expert in applying innovative genomics technology to support patient reporting and assay development.
Senior Manager, Study Planning, Abbott
Jason Waclawek is a senior manager of global clinical study planning for Abbott’s medical devices division. He and his team are responsible for developing cost models across a broad portfolio of device therapies, including neuromodulation, cardiovascular, structural heart, cardiac arrhythmias, and heart failure. Waclawek’s educational background is in finance from Purdue University. He has more than 15 years of forecasting and analysis experience in the health sciences, healthcare, and technology industries.
Associate Director, Clinical Operations Lead, CSL Behring
Jennifer Weaver has more than 15 years of experience at global CROs, pharma, and biopharmaceutical companies. For the last 7 years, she has been with CSL Behring and is currently the associate director, clinical operations lead. In her role, Weaver oversees process standardization and harmonization. She is currently the business lead on multiple clinical systems including CTMS, Oracle Health Sciences Site Select Cloud Service (formerly goBalto), and implementation of the risk-based monitoring system. Her experience working across multiple companies, studies, and systems has provided her an in-depth knowledge of clinical study management, system processes, governance, and change management.
Vice President, Clinical One Product Management, Oracle
Liam Wood is vice president of eClinical product management for Oracle Health Sciences. With more than 20 years in the life sciences and healthcare industries he has a wealth of experience in the development, implementation, cloud deployment, and support of software in this highly regulated and complex industry. Prior to Oracle he worked for Optum in software development and Covance in data management.
Chief Technology Officer and Senior Vice President of Product Development, ActiGraph
Jeremy Wyatt is the Chief Technology Officer at ActiGraph, an industry leading global provider of physical activity and sleep monitoring solutions for the pharmaceutical and academic industries. Wyatt’s 20 years of experience in working with low-power micro-electro-mechanical systems and related cloud technology have given him a unique perspective on the challenges and opportunities of deploying wearable technology to produce meaningful patient data. He has an undergraduate degree in electrical engineering from the University of Florida and an MBA from the University of West Florida.
ActiGraph’s ecosystem of medical-grade physical activity monitors and cloud software ensure clients are collecting pure, raw signal data from patients for small and large studies. ActiGraph’s long-standing history in academic research gives the company a unique foundation for helping clients derive novel, meaningful insights from wearable sensor data.
Senior Vice President, Global Head of Feasibility, Site ID and Study Startup, ICON
Helen Yeardley is a project management and clinical trial executive with more than 25 years of clinical research experience spanning CRA, PM, and department head responsibilities within both CRO and pharmaceutical companies. Her broad therapeutic expertise includes management of phase I-IV studies from IND to NDA, regionally and globally, and oversight of investigator-initiated studies. She is a member of several executive steering/governance/operational committees.
At the executive level, Yeardley is responsible for building and managing a project management group globally, right-sizing and upskilling a global clinical trial management group (n=500+), implementing a risk-based monitoring module to accommodate new regulatory guidelines, centralizing a support and review group, enhancing and streamlining productivity, career and talent development and succession planning, proposal and budget development (on a project and department level) and approval thereof, and line management of up to 15 direct and 1,100 indirect reports. She has also been responsible for bid defense presentations, MSA and contract negotiations, strategic alliance management, discussion of commercial terms for large-scale deals, and a key driver in change management of a new operational model.
Manager, Digital Clinical Trials, GSK
John Yonchuk has 20 years of experience working in the pharmaceutical industry, and the last five years focused in digital clinical discovery and development. He is a member of the GSK Digital Clinical Trials team which aims to transform how GSK conducts its drug development through the use of digital, data, and analytics tools. His work in this space includes the evaluation of wearables and sensors, leading development of mobile applications, and development of custom platform solutions for trial data collection and analysis. As a member of the Digital Clinical Trials team at GSK, Yonchuk is focused on how GSK’s development organization captures, ingests, processes, analyzes, interprets, and reports its data across the organization. He holds a B.S. in Biology from The Pennsylvania State University and an M.S. in Clinical Pharmacology from Thomas Jefferson University.
Senior Clinical Systems Analyst, Rho
Kate York, senior clinical systems analyst, serves as the CTMS process program manager at Rho, Inc. in Chapel Hill, NC. Prior to turning her attention to CTMS, York spent 12 years as a project manager on federal autoimmune clinical trials. Her work as a project manager lead her to join the CTMS team at Rho, with a goal of leveraging the wealth of clinical knowledge at Rho into a system that could reduce training burden, standardize common processes, and increase translation of new innovations across study teams. In her role as the CTMS process program manager, she is responsible for user support, system training and documentation, and facilitation of CTMS-related business process projects.
Vice President, Oracle
Elliot Zimmerman has over 22 years of experience with enterprise application implementations, user adoption, support and account management. For the last 5 years, Zimmerman has led the implementation and support teams at goBalto where he led a global team to manage all customer engagements.