Archives: Speakers

Innovative and Collaborative Compliance Leader with expertise and proven success in developing business strategy and establishing quality management framework for start-up compliance departments in large established pharmaceutical companies. -Healthcare Compliance, Rx&D Code of Ethical Practices and HCP value transfer -GCP compliance, auditing, regulatory inspection support, CAPA -Training (facillitation, instructional design, LMS management, curricula development) -Procedural Document Management (SOP creation, Documentum, Process Mapping)

• Passionate about advancing biomedical innovation to improve human health.
• VP Executive and Senior Leader within the biopharmaceutical industry.
• Driving global regulatory and development strategies for drug development (clinical products), marketing applications, and lifecycle management (marketed products).
• Proven success in bringing breakthrough therapies from development to approval:
• Rubraca® (rucaparib), for ovarian cancer with germline or somatic BRCA mutations diagnosed by a companion diagnostic.
• Voxzogo® (vosoritide), the first and only therapy approved for achondroplasia (rare disease), the most common form of dwarfism.
• Scientific foundation: Key inventor of two FDA approved drugs:
• Zelboraf® (Vemurafenib, the first personalized/precision medicine targeting melanoma).
• Prezista® (Darunavir, targeting HIV infection).
• Committed to making a difference through teamwork and science.

Alumis empowers innovative biomarker strategies under my leadership, where I oversee the full lifecycle of biospecimen management across clinical trials. With over three years at Alumis, I’ve spearheaded the creation of SOPs, directed biomarker sub-teams, and implemented multi-omics collection strategies to support autoimmune and immunology pipelines. Collaborative efforts with biomarker scientists, medical monitors, and bioinformaticians have driven operational success in translational and precision medicine initiatives. Over a decade of expertise in translational medicine and biospecimen operations underpins my commitment to advancing precision medicine. Past roles at Arcus Biosciences and Gilead Sciences honed my skills in clinical trial biosample management, biomarker planning, and vendor collaboration. My leadership fosters a culture of innovation and operational excellence, ensuring impactful contributions to clinical development and personalized healthcare solutions.

My career has been built on the belief that we achieve more when we come together. My purpose is to connect people and organizations through a robust Strategic Sourcing and Supplier Relationship Management approach. Leading, solving problems, building relationships, coaching, and bringing bold ideas to the table is what I do best.

Clinical data expert with a track record of working effectively in the biotechnology industry. A seasoned data engineering leader with a focus on solving clinical data challenges. Skilled in building scalable clinical data pipelines. Proficient in R, SAS, Python, SQL, Machine Learning, and Data Analysis. Strong clinical data professional graduated from Stanford University.

Highly motivated and enthusiastic clinical operations leader with over 18 years of progressive leadership, focusing on operational efficiency, research excellence, and improvement of all clinical trial processes. – Effective communicator and innovative collaborator – Exceptional leadership skills – Unwavering commitment to excellence – Impressive ability to identify and reveal genuine disagreement through attentive listening and inquiry – Recognized for strategic and creative thinking skills – Innate ability to inspire and motivate others – Agile, with a proven track record of success – Highly esteemed for ability to support data analysis, customization, and reporting through strong technical and computer skills – Self-starter with a drive to go above and beyond expectations – Eager to learn new things – Enjoys professionally mentoring and managing people and cultivating a spirit of collaboration.

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.

Experienced analytical professional with a versatile background in the biotechnology industry and clinical research site. Skilled in project management, quality compliance, protocol development, site management, clinical pharmacology and clinical trials in autoimmune, allergy, cardiovascular, nephrology, neuromuscular, pain and pediatrics.

Shreya Badhrinarayanan, MD, FRSPH, is the Global Development Lead for Clinical Development, Oncology & Hematology at Pfizer. She leads clinical programs advancing antibody-drug conjugates (ADCs), bispecific antibodies, small molecules, and immuno-oncology (IO) biologics, driving innovative treatments in cancer care. Previously at Genentech, a Roche subsidiary, she provided strategic direction for the development of new Immuno-Oncology drugs by leading cross-functional teams and conducting medical monitoring of clinical trials. Earlier in her career, she served as a Physician with the National Health Service (NHS) in the UK, where she made significant contributions to clinical and research initiatives. Thriving in the field of medical leadership and management, Dr. Badhrinarayanan received the Edward Jenner Award from the NHS Leadership Academy. To further her passion for teaching, she served as an Honorary Lecturer in Medical Education and Simulation at the University of Adelaide Medical School, Australia. Her wide range of interests varies from AI in health care to D&I initiatives that have been embodied through her contributions to print and media as well as at conferences across the globe. In addition, she is the editor/reviewer of numerous high-impact journals, including the British Medical Journal. For her work and commitment towards public health, Dr. Badhrinarayanan was elected as a Fellow of the Royal Society of Public Health, UK. She received her medical degree from University of Sussex Medical School, UK, with numerous accolades.

Craig Ellison, Partner Sales Leader, Workday

Craig Ellison is a Partner Sales Leader at Workday, supporting customers and partners across the UK. In his role, he focuses on building strategic relationships, aligning Workday solutions to real business outcomes, and ensuring joint go-to-market initiatives deliver tangible value and long-term success for clients.