As Chief Information Officer – PatientLink Enterprises, Renee Smith brings to bear her experience as a technology executive in the Pharmacy, Provider, and Clinical Trials spaces, deep expertise in data interoperability, and career-long obsession with patient involvement. For over 30 years, Ms. Smith has developed applications, delivered solutions, and led strategic technology transformations for Fortune 100 companies. Her acumen for seeing around corners, articulating a vision, defining strategies, assembling exceptional talent, and delivering the right technology solution sets her apart. Transforming and diversifying clinical trials and enabling clinical trials as a care option is Ms. Smith’s Goal. It is her professional mission and personal ministry to change lives through equitable access to better health.

Ashley Lakner joined Roche in May of 2023 and currently leads our Global Oncology Drug Discovery organization within pRED Oncology. Prior to stepping into this role she served as the Head of Strategy. Before joining Roche, Ashley was a member of the Oncology Development Leadership Team within Strategic Business Unit Oncology at Bayer, working cross functionally to develop, deliver, and execute Bayer Oncology’s new strategic roadmap. Prior to this role, Ashley served as the Head of Precision Molecular Oncology Research within Bayer R&D (Berlin, Germany & Cambridge, MA, USA). In addition to delivering a successful discovery pipeline, she served as Site Head of the new Bayer Research & Innovation Center in Cambridge, MA, USA.

Prior to joining the pharmaceutical industry she continued her academic research pursuits at the German Cancer Research Center in Heidelberg, Germany. Ashley holds a Ph.D. in Molecular Biology from University of North Carolina at Charlotte and completed Postdoctoral Research Fellowships in the Department of General Surgery & the Department of Internal Medicine at the Cannon Research Center within Carolinas Medical Center, in Charlotte, NC, USA.

As Chief Executive Officer, Jill Pellegrino brings over 15 years of leadership experience in patient recruitment, real-world evidence, and clinical research site operations. Jill is passionate about growing businesses that rely on innovative, data-driven methods to reach patients to provide them with opportunities to participate in research opportunities. Most recently Jill was at CVS Health where she was responsible for establishing and growing the Real World Evidence and Patient Recruitment businesses. At CVS Health, her businesses were successful in placing 35,000 patients into research opportunities in both clinical trials and research settings, drastically increasing diversity participation in research studies. Prior to CVS Health, Jill was General Manager of Accelerated Enrollment Solutions, which was comprised of 2,000 employees across 11 countries and encompassed a patient recruitment offering and clinical research site network of 160 sites. Jill received her bachelor’s degree from LaSalle University in Mathematics and Computer Science.

Elliott Labouré is a Senior Clinical Outcome Assessment (COA) Partnership Manager at RWS, where he specializes in Linguistic Validation and eCOA implementation. As part of the RWS Team, Mr Labouré plays a crucial role in supporting sponsors, eCOA providers, developers, academics and everyone in between to ensure that COAs are accurately translated, culturally adapted and linguistically validated for use in clinical trials worldwide. At this year’s conference, he will be discussing the race to faster eCOA implementation in clinical trials, sharing insights into how RWS is partnering with eCOA providers to streamline processes while maintaining high quality deliverables for patients.

Andrea Murison is Senior Director of Business Development at Kayentis, with 16 years of experience in the field of Clinical Outcomes Assessments (COA). She began her career focusing on licensing, copyright, and linguistic validation, later supporting teams specializing in qualitative research, developing and modifying COAs, psychometric analyses, and statistical analyses. This experience has helped her understand the importance of the application of metrology in Patient-Reported Outcomes (PROs). At Kayentis, Ms Murison leverages her experience in COAs to support the digital implementation of eCOAs in clinical trials. At Mobile Tech in Clinical Trials, she will be speaking about the race to faster eCOA implementation.

Tim leads the early clinical development (ECD) hematology and cell therapy group at BMS responsible for development of multiple modalities across diverse disease indications from pre-clinical stage to proof of concept. Tim is driven by complex clinical and scientific problems focusing on improving patients’ outcomes.

Mike Rayburn is a TEDx Presenter who teaches innovation, change and peak performance using world-class guitar and humor to create a transformational experience and generate exponential results. He has headlined Carnegie Hall, Las Vegas, and performed more than 5,000 presentations in 20 countries on five continents. Rayburn is a music/internet pioneering entrepreneur, feature artist on Sirius/XM and Artist In Residence at High Point University. His more than 1000 corporate clients include most of the Fortune 100, 500, and the top five, including multiple presentations for Walmart, Exxon, Wells Fargo, Lincoln Financial, UnitedHealth, IBM, Siemens, Verizon, Ford, Nationwide, MetLife, PepsiCo, Chevron, Sony, Allianz, and Liberty Mutual.

TBD

Afia Afzal is the Sr Director, Applied Innovation in the Global Development R&D Data Science organization at Johnson & Johnson Innovative Medicine (JJIM), where she leads a team dedicated to accelerating trial operations through Data Science. In this role, Afia is driving the development and deployment of cutting-edge AI/ML and Digital Health solutions across JJIM’s therapeutic areas. Additionally, her team focuses on developing and embedding productivity efforts and tools to enhance transparency and improve decision-making across the portfolio, ensuring that operations are not only innovative but also efficient.

In her 10 years at Johnson & Johnson, Afia has held multiple strategic roles. As the former Sr Director of External Innovation & Alliance Management, she led efforts to establish key partnerships with biotech companies, academic institutions, and governmental organizations, bringing advanced AI/ML technologies and multi-modal datasets into Johnson drug development pipeline. She played a critical role in driving innovations like early disease detection algorithms and regulatory-grade real-world evidence (RWE) for high-priority projects. In a prior role on the in the R&D Data Science Portfolio Management team, Afia spearheaded high impact use cases across Oncology, Cardiovascular, and Pulmonary Hypertension portfolios, contributing to transformative clinical operations and enhanced patient outcomes.

Afia has 15 years of leadership experience across healthcare, medical device, pharma, and consumer sectors, where she has developed and deployed innovative solutions and technologies. She is driven by a deep passion to improve patient outcomes and provide equitable access to life saving therapies. Afia holds a BS in Biomedical Sciences, a Post Baccalaureate in Public Health, and an MBA from Rutgers University.

TBD

Kevin G. Schmid combines over 23 years of experience in medical device senior management following a 21-year career high technology and high-volume global manufacturing operations. Previously, he had been involved in a number of companies in the medical device, telecommunications, and consumer products industries holding positions including Chief Executive Officer, Chief Operations Officer and board member. From 2018 through June, 2021, Schmid was the Chief Executive Officer for Common Sensing, Inc., a disposable injector pen dose monitoring and reporting technology company and board member since 2015. From 2016 to 2017, he was Vice President of Drug Delivery Systems for the Stevanato Group, a provider of innovative packaging and drug delivery solutions for the pharmaceutical industry. From March 2003 to April 2015, he was Vice President of Manufacturing, Operations, and Drug Delivery Systems for Insulet Corp., a company that designs and manufactures revolutionary, quality of life enhancing drug delivery systems. Schmid is also currently a director of Eitan Medical, an Israel based provider of connected infusion and wearable drug delivery solutions. He has a BSME undergraduate degree from Clarkson University and an MBA from Scared Heart University.

Dr Pauline Lau has worked in the medical industry for 25+ years and has expertise in both pharmaceutical and in-vitro medical device (IVD) product development. She founded Suntec Medical in 2005 to market biosimilars and key pharmaceutical products. Under her leadership, Suntec has successfully registered and exported pharmaceutical products globally. Suntec actively markets its products in pharmaceutical emerging countries. Suntec currently has over 1,500 formulated products from 400 suppliers with an emphasis on biosimilars and advanced formulations. Many of these products are either EU-registered or manufactured under EMEA or PIC/s GMP quality system. Suntec currently has 30+ pharmaceutical products registered for sale or under registration in various countries. We have a distribution channel of 800 customers in 40+ countries.

In 2016, Suntec started to enter the new drug development business. Currently, Suntec is focused on developing a portfolio for treating cancer, neurodegenerative diseases and more central nervous system diseases using “Multi-pathway, Immune-modulating, Nanocomplex, Combination-therapy” (MINC) technology platform.