Umar Hayat, Ph.D. is VP of CMC and Supply Chain at Union Therapeutics and has more than two decades of experience in pharmaceutical development, manufacturing and supply chain. He held senior level positions with Relypsa (acquired by Galenica for 1.52B US$), Anacor (acquired by Pfizer for 5.2B US$) and Transcept Pharmaceuticals (revers merger with Paratek). He played a pivotal role in the development and commercialization of Veltassa® (USA and EU), a treatment for hyperkalemia, Intermezzo® for MOTN insomnia, Kerydin® for onychomycosis, and Eucrisa® for atopic dermatitis. Dr. Hayat is managing partner of Revive Pharm USA. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. Dr. Hayat received his Ph.D. in process engineering from INP-Toulouse, France and Post-Doctoral Fellowship from Ecole Polytechnique de Montreal, Canada. He received M.Sc. Chemistry degree from Punjab University, Institute of Chemistry

Saurabh is an experienced scientific leader with 20+ years of cross-disciplinary R&D experience across Bristol Myers Squibb, Arsenal Biosciences, and Sana Biotechnology, spanning drug discovery and translational research. He has deep expertise in precision medicine, biomarker strategy and assay development, multi-omics technologies, and functional genomics.

As a Senior Director at Arsenal Biosciences, Saurabh led teams developing AI foundation models for Immunology, IND-enabling genotoxicity assays, and molecular assays for translational PK/PD biomarkers. At Bristol Myers Squibb, he led the application of multi-omics, functional genomics, and Precision Discovery & Medicine approaches across Oncology, Immunology, Cardiovascular, and Neuroscience programs.

Previously, he led cross-functional teams at Sana Biotechnology and GenapSys, and was co-founder of Euveda Biosciences. Saurabh completed his Ph.D. and postdoctoral training at Johns Hopkins University.

Ann Mongan is a Subject Matter Expert in translational research and biomarker development, with her most recent role being Executive Director of Translational Research at Bristol Myers Squibb. With nearly two decades of experience, she has worked on more than 10 drugs (including ibrutinib and mezigdomide), from IND through all phases of development. Her experience spans multiple therapeutic areas, including oncology, neuroscience, and autoimmune diseases, and includes work at both large companies (BMS, AbbVie, Amgen) and small companies (Annexon). She received a PhD in Bioinformatics from UC San Diego and is also an expert in AI/ML and the integration of generative AI applications into science.

Hongda began his career as a research scientist in the biotechnology industry, specializing in small‑molecule drug discovery. He later transitioned into Regulatory Affairs, where he has focused on in vitro diagnostics (IVDs) and companion diagnostics (CDx). At Bristol Myers Squibb, he supports therapeutic asset development through the development of precision medicine and digital health regulatory strategies.

The  last 50 years I have worked to  address cancer disparities, advocacy -personally and nationally- for patient care, research, and to develop programs to save lives and improve outcomes for cancer patients and families. My work career in journalism and community relations was fulfilling, but after my diagnosis of breast cancer in 1974 and lymphoma in 2004, I have worked with thousands of patients as a volunteer, advocating for individuals and leading efforts to address compassionate care, access to services, prevention, treatment and research in the cancer space.

Dr. Mukhtar Ahmed is a strategic life sciences executive and early-stage company builder with a proven track record of bridging scientific rigor with capital-efficient business strategies. He currently serves as the Director of Project & Portfolio Strategy at Greenstone Biosciences, where he directs matrixed, cross-functional workflows to advance discovery pipelines to IND readiness and enables venture spin-outs. Additionally, Dr. Ahmed acts as a Strategic Advisor for Accanito Therapeutics, guiding capital strategy and foundational business operations to transition academic oncology assets into company-sponsored clinical trials.

Deeply embedded in the San Francisco Bay Area venture and academic ecosystem, he is also a Visiting Scholar at Stanford University, focusing on integrating advanced methodologies into practical drug development. A recognized thought leader in translational modeling, Dr. Ahmed has published extensively on regulatory modernization and New Approach Methods (NAMs)—including "Clinical Trial in a Dish" frameworks—in leading journals such as Circulation and Nature Reviews Drug Discovery. He holds a Ph.D. in Pharmaceutical Sciences from the University of Toronto.

Jim Routt is Chief Operating Officer of IQVIA Biotech, overseeing end‑to‑end project delivery for biotech and emerging biopharma sponsors. He brings 23+ years of industry experience, with deep expertise in oncology clinical development, having previously led the global oncology delivery organization across programs, customers and strategic partnerships. His leadership is grounded in a strong commitment to quality, compliance and patient safety, with a clear focus on delivering meaningful value to customers and improving outcomes for patients worldwide.

Lucrecia Marquez-Rosado, M.D., Ph.D., is a physician-scientist with over 20 years of experience in oncology, immunology, and drug discovery in both academia and biotech. She completed her clinical training at the Salvador Zubirán National Institute, earned her Ph.D. in Cell Biology from CINVESTAV, and finished a postdoctoral fellowship at the Fred Hutchinson Cancer Research Center. Before co-founding LuMiAL Bio, she held scientific roles at Boehringer Ingelheim, SIBTECH, and Nurix Therapeutics, where she led cross-functional teams involved in translational research programs.

Lucrecia expertise includes Novel Therapeutic Modalities, biomarkers and disease-positioning strategies, focuses on translating innovative science into clinically actionable oncology programs.

Energetic, hands-on leader, with broad experiences bridging IVD Product Development/commercialization and Clinical Trial design, operation and registrational activities. Successful commercial tests include CytoScan™ XON (Exon level CN detection), CytoScan™ Optima (Prenatal CN detection), Cytoscan® Dx (first-to-market FDA approved whole genome CN assay). Experienced in the entire product life-cycle with strong command of R&D, Manufacturing and Clinical Validation. Successful in balancing internal and external stake-holders and tying strategic goals with tactical execution. Passionate about people, teams and a culture of innovation. Experienced in : US and CE-IVD registrations, Observational Trials, Clinical Trial Management, LDT/IVD Product Development, Design Control/documentations, analytical and clinical validation, Commercialization, GLP, GCP, GMP compliance, Manufacturing Transfer, Reagent Development/Kitting , Laboratory Operations, Lead Internal/External collaborations, Technology Assessment/IP generation, Design of Experiments (DOE), Microarray analysis, Sequencing, Cell-free DNA analysis.

Experience
Accomplished, trilingual MD, PhD clinical oncologist with 18+ years of PHARMA / CRO in different countries.
Deep knowledge in Medical Affairs and Clinical Research and development, specifically clinical trials Phase I
included first in human through Phase IV
> Skilled professional in complex aspect of oncology and molecular genetics, gastrointestinal (gastric cancer, CRC
and HCC), genitourinary cancer, skin cancer and Immunotherapy including CAR-T cell, CAR NK-cell and others)
> Prior to joining PAREXEL, roles included serving as a Senior Oncology / Hematology medical manager in Ely Lilly,
GlaxoSmithKline, ROCHE and as a Latin America Medical Scientific Liaison ASCI (Antigen Specific Cancer
Immunotherapies) for GlaxoSmithKline
> Immediate roles prior to Parexel included 2 years as Oncology / Hematology Associate Medical Director at IQVIA

Expertise
> Expertise in a variety of solid tumors indications (gastrointestinal, genitourinary and skin cancer) and immuno-
oncology and Cell & Gene therapy
> Provide scientific and strategic guidance, training and advice
> Published author in several clinical literature citations in PubMed and other short contributions in oncology books
including update and reviews

Education
> Educate and training as a Clinical Oncologist in Universidad Central de Venezuela (UCV)
PhD in molecular oncology in Instituto Venezolano de Investigaciones Cientificas (IVIC)

Originally from North Carolina, my interest in clinical research started in college working as a research assistant for burn and transplant research and continued after graduation working at a Contract Research Organization. After moving to NYC, I wanted to move to the patient side of research and worked as a Radiation Oncology Clinical Research Coordinator at Montefiore Medical Center. After gaining experience and knowledge, I worked in Radiation Oncology at Memorial Sloan Kettering Cancer Center initially spearheading our newly created Quality Assurance program, and then moved into a supervisor role managing Clinical Research Coordinators. After relocating to the Bay Area, I shifted gears working in allergy research clinical operations with the Immune Tolerance Network. After realizing I missed the world of oncology and management, I found my current role as an Associate Director of Clinical Research Programs in the UCSF Cancer Center managing several programs.

Irene Acerbi Soto, PhD, PMP, holds a PhD in Biomedical Engineering from the Politecnico di Milano, with collaborative research experience spanning human lung cell biophysics at the Hospital Clínic de Barcelona and translational breast cancer research at the University of California, San Francisco.

Since 2016, she has led site research operations for the WISDOM Study, bringing deep expertise in clinical research operations, project management, and international collaboration. PMP-certified, Dr. Acerbi Soto is particularly passionate about working in multidisciplinary teams—bridging clinicians, engineers, and patient advocates to advance impactful oncology research.

I have worked in clinical research since 2011 holding different roles across various departments. Most recently working as clinical research manager at UCSF Cancer Center, Clinical Research Network Office (CRNO), since 2021.

Few people with a cause walk the talk as boldly and graciously as Christine Von Raesfeld, Lived Experience Expert/Citizen Scientist. Christine is a pillar of patient advocacy and allyship in the rare and chronic disease community. Through the lens of her own journey in healthcare, she has become a champion for patient voices, diversity and inclusion in clinical research, and equitable patient-sponsor partnerships.**

A sought-after speaker, Christine brings firsthand expertise to discussions on clinical trials, data rights, and digital health. She serves as an e-patient scholar with Stanford MedicineX and a Committee Member with the Partnership for Quality Measures (CMS), among other roles. Christine advises initiatives like Stanford's "Humanwide" Precision Medicine Program, the NIH All of Us Research Program, and the NIH HEAL Initiative. She co-authored the patient-led AI Rights Initiative with The Light Collective, focusing on ethical data use and personalized medicine.

Christine recently published a research paper analyzing her own complex medical journey[43dcd9a7-70db-4a1f-b0ae-981daa162054](https://journal.researchtothepeople.org/christine?citationMarker=43dcd9a7-70db-4a1f-b0ae-981daa162054 "1"), highlighting the value of patient-partnered genomics in understanding rare and chronic conditions. She has additional works on patient engagement and healthcare innovation forthcoming.

Recognized for her contributions, she has been named one of Silicon Valley Business Journal's Top 100 Women of Influence, a Silicon Valley Community Hero, a member of the 2021 HIMSS Future50, and one of Medika Life's 50 most influential voices in healthcare.

Silicon Valley entrepreneur, board member, and private investor. Extensive experience in founding and financing new companies and improving performance of existing companies.

Have previously served as CEO, Chairman, COO and/or CFO of four successful start-up companies that achieved an exit for investors, either through M&A or IPO. Functional areas of expertise include: general management, product development, fundraising, licensing, finance, marketing strategy, and governance.

Specialties: Managing the start-up and high growth process, research and product development strategy, team-building, and M&A / IPO preparation and implementation.

Keya brings 30 years of experience in drug development with both biopharma and clinical service providers. She joined Worldwide in February 2026 as our President, Oncology following the merger of Catalyst Clinical Research where she served as the Senior Vice President of Catalyst Oncology responsible for the execution of the Oncology CRO Operations.

Amy Raymond, PhD, PMP, is Executive Director and Therapeutic Strategy Lead with more than 25 years of experience in drug discovery and development. Her background includes progressive leadership roles in clinical operations and clinical strategy, with oncology clinical development experience spanning hematologic malignancies and solid tumors, rare to highly prevalent diseases, and all stages of the clinical development lifecycle.

In addition to her expertise in the unique dynamics of developing novel therapies for rare diseases, Dr. Raymond leads the Cell and Gene Therapy Hub at Worldwide Clinical Trials, leveraging a strong combination of scientific training and strategic leadership. Her development experience spans viral‑vectored gene therapies, TCR and CAR T-cell therapies for complex diseases, in vivo and ex vivo gene‑editing technologies, and a broad range of RNA‑based modalities. Her experiences confirm that understanding and aligning the needs of all stakeholders—patients and families, investigators and sites, regulators, and payers—is essential to delivering meaningful new therapies efficiently.

Dr. Raymond completed her doctoral training in molecular biology at University of California San Diego and post-doctoral training in molecular biology at Memorial Sloan-Kettering in New York City, New York, USA.

Dennis Velasquez is the Chief Commercial Officer at Biorce, where he helps pharmaceutical and biotech companies transform how clinical trials are designed and executed using AI. With a background in biochemistry, microbiology, and specialization in Pharmacology and a PhD in pharmacokinetics, Dennis brings over 17 years of experience bridging science, technology, and commercial strategy. At Biorce, he leads global partnerships and sales strategy for the first ever AI-powered assistant built to streamline protocol development, feasibility assessments, and operational planning. His work focuses on reducing protocol amendments, improving trial timelines, and helping sponsors make smarter decisions earlier in the R&D process. Known for his sharp scientific and strategic thinking, direct communication style, and deep passion for innovation, he is helping reimagine the future of clinical trials, supporting the pharmaceutical industry in delivering treatments to patients faster.

Osama Khan is a dynamic physician, consultant, and medical leader at the forefront of innovation in pathology and healthcare. A Stanford-trained Genitourinary Pathologist, Osama earned the prestigious Stanford Clinical Fellow Teaching Award for his groundbreaking contributions to medical education. His leadership and advocacy in pathology have earned him a spot on the American Society of Clinical Pathology’s (ASCP) "Top 40 Under 40" list, recognizing his transformative impact on pathology and laboratory medicine. Additionally, he has been honored with the College of American Pathologists (CAP) Leadership Award for his forward-thinking approach and commitment to the field. Currently, Osama serves as an Anatomical Pathologist at Natera, a trailblazer in cell-free DNA technology for detecting minimal residual disease in oncology patients. He is also spearheading the company’s digital pathology solutions, integrating cutting-edge technologies to shape the future of pathology practice. Osama also has expertise in digital workflows especially Artificial Intelligence within Healthcare and Pathology. Dr. Khan also provides expert consultation to top pharmaceutical, healthcare, and life sciences companies around the globe, helping to drive innovation and shape the future of medicine. A dual-board certified Anatomical Pathologist in both Canada and the US, Osama's expertise spans digital pathology, artificial intelligence, healthcare consulting, and medical leadership. With a passion for mentoring, education, and scientific advancement, he excels in medical writing, physician coaching, and the development of next-generation healthcare solutions. Osama’s unique blend of clinical excellence, technological innovation, and leadership makes him a driving force in shaping the future of medicine.

Chris Takimoto, MD, PhD, is the Global Chief Medical Officer of The START Center for Cancer Research. Chris has worked in oncology drug development for over three decades. He has extensive experience in early phase oncology trials both as a clinical investigator and as an industry sponsor.

Before joining START, Chris was the CMO for IGM Biosciences, a clinical stage, public biotechnology company, and he also was a Senior Vice President in Oncology at Gilead Sciences. Prior to that, he was the CMO at Forty Seven, Inc., a biotechnology company that was acquired by Gilead in 2020, and he was also a Vice President at Johnson & Johnson/Janssen R&D overseeing Oncology Experimental Medicine Early Development.

Chris was one of the original Phase 1 Investigators at START when it was founded in 2007, and he has held faculty positions at the Cancer Therapy and Research Center, the University of Texas Health Science Center San Antonio, the National Cancer Institute, and the Uniformed Services University in Bethesda, MD.  He completed fellowships in Medical Oncology and Clinical Pharmacology, and he is a graduate of the Yale University School of Medicine where he received his MD and a PhD in Pharmacology. Chris also holds an undergraduate degree in Chemistry from Stanford University.

Matt Confeld is Director of Clinical Research Methodology at Worldwide Clinical Trials, with over 12 years of experience in the pharmaceutical sciences. In his current role, Matt supports biotech companies by guiding their strategic regulatory, program design, and commercialization initiatives. Throughout his career, he has successfully navigated dozens of clinical-stage oncology programs from First-in-Human (FIH) trials through Phase 3. Matt's foundational scientific expertise is rooted in clinical pharmacogenomics and the pre-clinical drug development of nanoparticles across multiple solid tumors. Matt also actively bridges the gap between the laboratory and the clinic by serving as a translational research advisor to an NIH pancreatic cancer research center.