Archives: Speakers

Andy Hinks is Director of Product Management at Signant Health, where he leads product development for clinical supplies management solutions. He brings nearly 20 years of experience in clinical technology and supply chain, including prior experience as a team lead in clinical supply chain before joining Signant. At Signant, Andy has progressed from Senior Business Analyst through consultant roles to his current position, developing deep expertise in clinical forecasting and supply planning.

Peter Hassett is a Product Director at Medidata, where he is focused on making life easier for clinical researchers. Peter has been utilizing technology to solve intractable human problems across the health IT industry for more than 25 years.

Previously, while running product strategy at a start-up for an enterprise tool used in clinical trials, he established a proven track record of designing, building, and delivering impactful products for patients, caregivers, and healthcare professionals. Throughout his career, he has specialized in navigating complex landscapes with a steadfast focus on privacy, international regulatory compliance, and education to transform how technology serves the medical community.

Shelley McLendon is Sr VP, Global Project Management, ICON Biotech. Her role involves developing and executing the strategic vision for Integrated Biotech, expanding service offerings, and enhancing biopharmaceutical solution delivery. She leads a global team of biotech experts, fostering innovation, excellence, and collaboration while building strong client and stakeholder relationships to support business growth. Shelley also oversees the integration of advanced technologies and methodologies to align biotech research with industry trends and regulatory requirements, collaborating closely with senior leadership and cross-functional teams to meet market demands and business goals.

Mads Kongsgaard Engelund, PhD, MSc, is Director and Head of Clinical Operations Leads at Novo Nordisk. With more than 20 years of experience in clinical research and global clinical operations, Mads has held leadership roles spanning clinical trial execution, project leadership, organizational development, and operational transformation. Prior to the current role, Mads led Clinical Operations in Novo Nordisk’s Cardiovascular, Kidney and Alzheimer’s Disease area, overseeing major global clinical development programs and contributing to several high-profile clinical trials. Earlier career experience includes leadership positions at IQVIA Nordics, where Mads headed the Scandinavian FSP clinical operations organization, as well as roles in trial management, clinical project leadership, and clinical research. Mads holds a PhD in Health Sciences and an MSc in Human Physiology from the University of Copenhagen.

I have more than 20 years of experience in the biopharmaceutical industry, with extensive expertise in clinical development and operations across vaccines, rare disease therapeutics, plasma-derived products, and cell and gene therapies.

For more than 18 years, I worked at MOGAM Institute for Biomedical Research and GC Pharma, where I developed extensive experience in clinical development, including registration trials for rare disease therapeutics, vaccines, and plasma-derived products. I was involved throughout the clinical development process from IND to NDA and regulatory approval, including Phase 3 programs targeting FDA approval and the development of pandemic vaccines such as influenza and avian influenza vaccines. I also gained extensive experience in GCP inspections and audits.

Since joining CHA Biotech in 2023, I have served as Director and Head of the Clinical Development & Operations Center, leading clinical development programs for cell and gene therapies targeting rare and intractable diseases.
My current focus is on developing effective clinical strategies and operational approaches to enable successful clinical development and ultimately bring innovative therapies to patients.

Career history

Current: Head of Clinical Development Unit

• Biotechs: clinical project director
• Samsung Bioepis: clinical program lead
• UCB: head of Clinical Project Management/ Site & patientsolution Asia lead
• Roche: vendor manager

IQVIA: CRA & regional start-up lead

Clinical Study Director and Clinical Lead at Kyowa Kirin, leading the execution of global clinical trials. Over 15 years of experience in clinical operations within the pharmaceutical industry, with expertise in immunology, respiratory diseases, and dermatology. Proven track record across the full clinical development lifecycle, from early- to late-stage development. Extensive collaboration with cross-functional global teams to ensure successful trial execution. Experienced people manager and certified Project Management Professional (PMP).