Abby Kennedy earned her BS in Chemistry from Allegheny College and her PhD in Organic Chemistry from the University of Arizona. She began her career in drug discovery as a medicinal chemist at Exelixis. After completing a Clinical Trials Design and Management Certificate at San Francisco State University, Abby transitioned into clinical operations and became a Clinical Trial Manager, taking on roles of increasing leadership at XOMA, Genentech, Principia Biopharma, and CymaBay Therapeutics. She is now at Jasper Therapeutics, overseeing clinical operations, data management, and biostatistics. Over the past 25 years, Abby has volunteered and mentored through ACS, AWIS, HBA, and ACRP.

Kelly Smith is a CEO, legal strategist, and contracts leader with 20+ years of experience across the biotech, pharmaceutical, and technology sectors. He has a proven track record of founding and scaling service organizations, driving operational efficiency, and negotiating high-value contracts on both the buy- and sell-side. His expertise includes consulting, clinical trial operations, contract lifecycle management (CLM), vendor outsourcing, and compliance. Kelly is known for implementing best practices that streamline operations, reduce costs, and accelerate timelines. He is also the author of two industry books, Contracts in Biotech and The Biotech Roadmap.

Georgina Fulgar is a seasoned clinical development professional with more than 30 years of industry experience supporting organizations of all sizes. Her background includes clinical site and sponsor GCP inspections. Georgina understands the pain points across the development lifecycle and partners with sponsors, vendors, and sites to support—and course-correct—program execution. She has consulted for more than 15 years and most recently partnered with V2, leading clinical operations.

Ben Rogers, LMK’s Senior Manager of TMF Education and Employee Development, is responsible for LMK’s TMF University, including the delivery of accredited TMF University courses and the thorough evaluation of student competency assessments. He also oversees LMK’s Corporate Training & Education Program where he leads the development of training content and resources for LMK staff and clients. He has extensive experience in the clinical research industry and has worked in nearly every facet of TMF, from Document Technician to Senior Manager of Site Management Services and TMF.

Alexander Markiel is Senior Director, Head of Clinical Systems and Trial Master File (TMF) at Apogee Therapeutics, where he leads inspection-ready clinical systems and TMF processes for in-house and outsourced studies. He oversees procedural documentation, training, and risk-based quality controls to support Good Clinical Practice (GCP) compliance. With 20+ years of experience, Alexander specializes in process improvement, SOP development, and cross-functional leadership to enhance operational efficiency and quality.

Bruno is an opinion leader in Clinical Operations, partnering with biotechnology companies to design and execute global development programs, with deep expertise in rare diseases and ophthalmology. He leads Operations at Spruce Bio, developing drugs for rare and orphan diseases. Most recently, he served as SVP, Global Clinical Operations at Opthea and SVP, Development Operations at BridgeBio, where he built high-performing teams and advanced late-stage clinical portfolios. Over a 30+ year career spanning big pharma, biotech, CRO, and diagnostics, he has led functions across the full development spectrum. Bruno holds a B.S. in Pharmacy from Université Laval and an M.S. in Pharmaceutical Sciences from Université de Montréal.

Lyssa Villarreal has more than 20 years of experience in preclinical and clinical R&D, including 14 years of sponsor-side experience. She has worked across all phases of clinical research, leading trials from Phase I through Phase III. Her therapeutic experience includes neurology, inflammation, virology (COVID-19 and HIV), and oncology.

Laurel-Ann Schrader is a resident TMF subject matter expert. She is a Certified TMF Manager with 21+ years’ experience. Her expertise includes TMF inspection readiness, preparation, and support; best practices for clinical document processes, procedures, and cross-functional culture; eTMF implementation and management; and the real-world application of the TMF Reference Model. She previously worked in clinical operations at Ardea Biosciences, ICON, BioPharm Systems, and Amylin Pharmaceuticals. Laurel is an active participant and contributor to the TMF Reference Model working groups and is a thought leader in the TMF industry.

Leesa Gentry serves as Chief Clinical Officer at RenovoRx and previously held the role of SVP of Clinical Operations. Her background includes four years as SVP of Clinical Development and Operations at Evotec and a 13-year tenure at Otsuka Pharmaceutical, where she advanced from Program Manager to senior leadership positions, including Director of Clinical Management. Earlier in her career, Leesa spent a decade in management roles across several contract research organizations, including IQVIA and PPD. She holds an MA in Psychology, an MS in Social Gerontology, and a BA in Psychology, and brings more than 30 years of experience in clinical development.

Anthony Maida is Chief Clinical Officer, Translational Medicine, for Oncotelic Therapeutics, Inc. and its joint venture, SapuBioscience, LLC. A clinician by background, Dr. Maida focuses on the clinical development of immuno-oncology therapeutics for solid and hematologic malignancies.

Shienal Patel is Vice President and Head of Clinical Affairs at Myra Vision Inc. and a clinical development leader with more than 20 years of experience across medical devices and pharmaceuticals, with particular expertise in ophthalmology, oncology, and respiratory medicine. She currently leads the development of the Calibreye TGT System for glaucoma. Previously at Genentech, Shienal played a key role in advancing the Port Delivery System (Susvimo), spanning trial design and execution through regulatory strategy. A recipient of multiple Roche awards, she is recognized for strategic leadership, operational excellence, and a strong commitment to mentoring future leaders.

Yulia Khalina is a clinical operations executive with a decade of experience building and running global clinical trials. She holds a degree in neuroscience from Vanderbilt University, and her experience spans academic research, medical devices, and biotech startups. Yulia brings together bold strategy, cross-functional collaboration, and disciplined execution to bridge the gap between scientific breakthrough and the patients waiting on the other side

Angela DeLuca is a pharmaceutical executive focused on advancing global clinical development excellence through innovative operational strategies and early adoption of digital health initiatives to optimize the R&D landscape and accelerate products to market. She is a senior leader known for translating strategy into clear narratives that elevate people and performance, and for connecting teams across cultures to achieve strong results. Angela is passionate about digital health, product and talent development, and improving access to medicines. Her experience spans oncology, immunology, neuroscience, eye care, and aesthetics.

With nearly 30 years in life sciences, Christine is a strategic leader dedicated to solving challenges, optimizing processes, and driving innovation. Her experience spans CROs, sponsors, academia, non-profits, and technology vendors, giving her a unique perspective on industry needs. At TransPerfect, she develops and implements innovative solutions that deliver real impact. Chris is committed to turning ideas into results, consistently exceeding expectations through her expertise in quality, business strategy, and technology. Her dedication to continuous improvement ensures clients stay ahead in an evolving industry.

Daniel Swiecz is the Country Therapeutic Area Lead at Genentech, driving clinical strategy, delivery, and cross-functional alignment across global development programs. He turns site and operational intelligence into actionable plans that strengthen feasibility, optimize country and site partnerships, and accelerate high-quality execution. Daniel has led enterprise innovation through site feedback mechanisms and operational risk frameworks that inform portfolio planning, and he’s known for simplifying complexity in matrixed environments.

Deena Shaar is a clinical operations consultant with experience across medtech, diagnostics, and humanitarian health programs. She brings perspective from sponsor, site, and vendor environments, including roles within a Fortune 100 healthcare organization and high-growth startups. With ACRP and EMT certifications, and a background in biology and mathematics, Deena has built and scaled clinical departments and designed operational strategies that reflect real-world patient access. A trained Angel Advocate with the Tigerlily Foundation, she is passionate about amplifying underrepresented voices, strengthening patient trust, and advancing inclusive healthcare.

Laura O’Donnell is a high-engagement leader with more than 20 years of experience in clinical operations and a passion for improving the patient and site experience. As Head of Global Site Engagement at GSK, she harnesses the Site Voice of the Customer to remove friction and make clinical research faster, better, and more human.
Beginning her career in bench science with a focus on immunology, Laura advanced through biotech and pharma leadership roles, specializing in trial optimization and strategic site partnerships. She has built a US Study Start-Up unit, led site-centered innovation initiatives, launched a global site feedback program, and developed a flexible partnership model.

Antonio Drea is a Director at TransPerfect Life Sciences, where he specializes in patient recruitment and retention services, as well as commercial strategy for global clinical research initiatives. With extensive experience helping clients accelerate therapy development, Antonio partners with leading healthcare organizations to improve access to life-changing treatments and empower patients through innovative, accessible information solutions.

Jane is a strategic leader focused on accelerating AI transformation within the pharmaceutical industry, with a strong emphasis on enterprise risk management (ERM), governance, and responsible innovation. She specializes in translating emerging technologies into practical business value, aligning AI strategy, governance, and risk frameworks to drive sustainable outcomes. With experience leading cross-functional initiatives, Jane works at the intersection of innovation, operations, compliance, and healthcare. She is passionate about building scalable AI capabilities, strengthening organizational resilience, fostering collaboration across stakeholders, and enabling the organization to responsibly harness data and technology to improve decision-making, efficiency, risk management, and patient outcomes.

Katy Van Pelt is a life sciences attorney and Vice President, Head of Ethics and Compliance, and Data Protection Officer (DPO) at Arcus Biosciences, a clinical-stage biopharma company. In this role, she is responsible for developing and managing the global compliance and data protection programs. Prior to Arcus, Katy held various legal and compliance roles across the life sciences industry, including positions at large law firms, large pharmaceutical companies, and one of the first AI tech-bio companies.

Spencer Chen is VP and Associate General Counsel at Karius, a diagnostics company. A USPTO-registered patent attorney with 25+ years as in-house counsel in life sciences, he has negotiated 400+ clinical and operational agreements for global Phase 3 trials, advised on cross-border clinical data compliance under HIPAA and GDPR, and integrated IP strategy with clinical research. A nine-year AI-native legal practitioner, Spencer is past President of the ACC SF Bay Area Chapter.

Angie Nolet is based in Seattle and serves as Vice President of Consulting & Information Governance at TransPerfect Legal. Before going in-house, she was a trial lawyer at Lane Powell, where she focused on commercial litigation involving design-build disputes. Earlier in her career, Angie served as a Deputy Prosecuting Attorney at the King County Prosecuting Attorney’s Office, specializing in gang-related crimes.

Angie earned her JD from the University of Washington and her bachelor’s degree from the same institution. She also holds a CEDS certification from the Association of Certified eDiscovery Specialists. In 2023, Angie was a finalist for the Financial Times Innovative Lawyer (North America) award for outside counsel management, and in 2020, she was named one of Best Lawyers “Ones to Watch”. She has served as a Trial Advocacy Fellow at the University of Washington School of Law and held leadership roles with the UW School of Law Moot Court Honor Board Advisory Committee and the King County Washington Women Lawyers Board. Outside of work, Angie restores vintage cars, runs, and co-hosts eDiscovery Chicks: The Podcast About All Things eDiscovery & Legal Tech.

Dr. Mahrukh Banday is a biotechnology executive at X-Therma, combining full P&L accountability with deep scientific expertise (DVM, PhD). Renowned for translating innovation into enterprise value, she architects growth across the entire corporate lifecycle.

In her past as a key executive at Curiox Biosystems, she built the global commercial strategy that propelled the company to a successful $100M IPO. Previously, at Becton Dickinson, she managed portfolios up to $245M and engineered high-growth turnarounds. At X-Therma, she delivers relentless execution, building the high-performing teams and infrastructure necessary to secure global market leadership.

Ljubomir Buturovic is VP of Machine Learning at Inflammatix, Inc., where he leads the development of ML-powered, blood-based clinical diagnostic tests for emergency care. With more than 20 years of experience in clinical AI/ML, he has contributed to multiple FDA-cleared diagnostic products and holds patents as lead inventor. His work spans the full lifecycle from AI research and model development to clinical validation and regulatory compliance. He is an active voice on the responsible adoption of AI in medicine.

Amanda Marvel is a senior marketing, advertising, and operations executive with a proven track record of leading award-winning teams, delivering high-impact global campaigns, and driving operational excellence across in-house agencies. Since 2023, Amanda has served as Senior Director of Global Marketing Operations at Gilead Sciences, where she leads content production globally.
Prior to joining Gilead, Amanda spent nearly 15 years at Intel, most recently as Marketing Director, where she led global product campaigns and launch creative that elevated brand visibility and business performance. Her experience spans B2B, B2C, B2I, and HCP audiences across the tech and healthcare sectors, consistently delivering strategies that connect, inspire, and perform.

Bruno Larida is a biomedical executive focused on accelerating medical innovation to improve patient lives. He leads fundraising and strategic partnerships to advance next-generation cancer immunotherapies. With deep expertise in clinical diagnostics, Bruno bridges diagnostics and therapeutics to enable more precise, immune-driven treatments. His background spans global market development and navigating complex healthcare challenges, including pandemic response. He also teaches biomedical startup creation in Europe, supporting the next generation of innovators, and is passionate about turning breakthrough science into real-world impact for patients worldwide.

Garima Mehta is a global digital marketing leader driving growth across biotech, healthcare, and medtech. Her expertise spans omnichannel strategy across paid media (PPC, display), organic search (including SEO/AEO/GEO), content marketing, social media, and email. Garima has led global B2B and B2C campaigns that deliver measurable performance, and she is passionate about building brand authority and connecting innovative life sciences solutions with the audiences who need them.

Jase George is a healthcare leader with more than 30 years of experience across biopharma, MedTech, consumer health, and digital agencies. With scientific training as a microbiologist, he brings senior commercial leadership experience across five multinational companies on three continents. Jase has a proven track record delivering AI-enabled commercial strategies, operating model design, marketing transformation, customer experience initiatives, and operational efficiencies that drive measurable business results.

Jaidyn Nguyen brings 17 years of biopharma experience with a 360° perspective, spanning early clinical development strategy through site-level execution. Her work across Phase I–IV trials has given her a deep understanding of operational complexity, vendor ecosystems, and the realities of delivering studies on the ground. She is currently a consultant, VC investor, and stealth founder, focused on building and backing solutions that address critical inefficiencies in clinical research. Her mission is to give patients a better life by transforming how clinical trials are designed and delivered.

Angela DeLuca is a pharmaceutical executive focused on advancing global clinical development excellence through innovative operational strategies and early adoption of digital health initiatives to optimize the R&D landscape and accelerate products to market. She is a senior leader known for translating strategy into clear narratives that elevate people and performance, and for connecting teams across cultures to achieve strong results. Angela is passionate about digital health, product and talent development, and improving access to medicines. Her experience spans oncology, immunology, neuroscience, eye care, and aesthetics.

Garrett’s 20 years of industry experience started at the Site, CRO and Patient Recruitment levels of clinical R&D.  For the past decade at TransPerfect, he’s helped Sponsors, CROs and Site Networks with their evolving strategies for: eClinical technology implementation and adoption, TMF Management & Inspection Readiness, Medical Writing, and Translations Management.  Schedule time to brainstorm, problem solve, discuss Best Practices and catch up on industry trends.