Archives: Speakers

Noelle Saldana is Head of Research Analytics (AI & ML) for the AI/ML Innovation Studio at Fortrea, enabling clinical trial transformations with AI. With over 15 years of experience at the intersection of data science, AI, and strategic leadership, Noelle has driven transformative initiatives across startups, nonprofits, and Fortune 500 companies. Her work spans embedding intelligent insights into cloud-native applications and driving pragmatic, collaborative approaches to AI adoption. She holds an A.B. in Applied Mathematics and Physical Anthropology from Washington University in St. Louis and an M.S. in Applied Mathematics from Cal Poly Pomona.

Klas Malmén is Senior Advisor at the Swedish Financial Supervisory Authority. He holds a government mandate to represent Sweden in the EU AI Board’s subgroup on financial services. Klas coordinates the authority’s work on AI supervision and leads preparations for the implementation of the upcoming AI Act. He also served as an appointed expert in the Swedish Government’s inquiry on national legislation related to the AI Act.

Dr. Henry D. Cremisi, M.D., F.A.C.P. is an accomplished nephrologist and clinical research leader with more than 20 years of experience spanning patient care, global drug development, and CRO leadership. At Caidya, he provides medical oversight and strategic guidance across renal, cardiovascular, and immunologic programs, with deep expertise in rare and complex kidney diseases, cardiorenal syndromes, and inflammatory conditions.

Before joining Caidya, Dr. Cremisi served as Senior Medical Director and Global Medical Lead at Vertex Pharmaceuticals, where he led global medical strategy for APOL1-mediated kidney disease and supported early-phase through pivotal programs in glomerular and genetic renal disorders. His work emphasized precision medicine, biomarker-driven development, and cross-functional collaboration across clinical, regulatory, and medical affairs teams.

Board-certified in Nephrology and Internal Medicine, Dr. Cremisi trained in both clinical nephrology and translational research, with expertise in renal pathophysiology, cardio-renal-metabolic disorders, and inflammatory mechanisms underlying diseases such as IgA nephropathy, lupus nephritis, vasculitis, and diabetic kidney disease. His experience extends to drug safety, medical monitoring, and global site engagement, with a deep understanding of ICH E6(R3) compliance, ALCOA-C principles, and best practices in investigator-sponsor collaboration.

At Caidya, he partners closely with sponsors to help de-risk development programs and advance innovative therapies for patients with rare kidney and cardiorenal diseases.

Dr. Shane Johnson is a Senior Scientist at Clinical ink with a background in neuroscience and 9 years of experience in machine learning, biomarkers, and digital health technology. Dr. Johnson is interested in leveraging emerging connected device data streams and AI to improve clinical trials and patient outcomes.

A passionate and experienced Computational Biologist (Ph.D. Bioinformatics, M.S. Statistics – University of Michigan), I specialize in pioneering algorithm development for DNA consumer products and applying advanced statistical modeling to clinical biomarker data for immuno-oncology programs. My technical skills span population & statistical genetics, cancer genomics, statistical inference, and machine/deep learning. In industry, I’ve successfully led multidisciplinary teams with 10+ reports to architect and implement cutting-edge biomarker platforms—from automated data ingestion to live longitudinal visualizations and advanced machine learning models for safety and efficacy endpoint—and have directed critical biomarker analyses (e.g., for BiTEs) to inform pharmacodynamics, mechanism of actions, patient stratification, mitigate risks, and advance drug development.

I have a background in sports physiotherapy, and in total over 20 years of professional experience, including 13 years in clinical research. I worked for five years as a Clinical Safety Manager at genae, a Medical Device CRO (now acquired by IQVIA) and for over three years as Clinical Evaluation Lead at Agfa, a manufacturer of medical imaging equipment. Currently, I am the Head of the Clinical Safety Department at QbD Clinical and in parallel, I operate at the interface of clinical and regulatory functions, contributing to strategic decision-making on clinical evidence and clinical development.

Bhargav Joshi is a senior Clinical Affairs professional specializing in ophthalmic devices, dermal fillers, and orthopedic products. He leads EU MDR–compliant clinical investigations and PMCF programs across Europe and supports market-specific clinical and regulatory strategies for the United States, China, Japan, and Australia, effectively bridging regional differences in clinical evidence requirements.

Louise Oliver is CRO Strategic Operations Manager at Almac, where she leads a global team responsible for building strategic partnerships with CRO clients and driving best practices in study operationalisation. Based at Almac’s global headquarters in Northern Ireland, Louise brings more than 25 years of experience across clinical trials, having progressed from Clinical Research Associate to Project Manager and ultimately Head of Clinical Operations for an early‑phase CRO.

She holds a PhD in Biomedical Engineering from Ulster University, with advanced studies in vaccine development at the University of Oxford and in pharmaceutical medicine at King’s College London.

A champion of balanced GCP–GMP delivery, Louise has implemented a global engagement framework and optimised clinical supply chains to accelerate start‑up and improve delivery performance.

Joanne Biggadike is a regular speaker at data led events, providing insights and sharing expertise. Joanne joined Schroders in July 2024 to lead their Data Governance function. With over 20 years of experience in the Finance Industry, Joanne has been focusing on Data Governance since 2016; specialising in creating and leading organisation-wide Data Governance strategies and Frameworks. Joanne works collaboratively with both business and technical teams as a non-technical specialist. Joanne is an advocate for non-invasive Data Governance which promotes data as a valued asset. Joanne’s mission is to help organisations and their clients achieve their full potential through effective and efficient data governance practices.