Company: Novo Nordisk
Job title: Vice President, Clinical, Medical & Regulatory
Jyothis is an entrepreneurial physician-scientist with a track-record in global leadership. Leading clinical development of BI’s cardio-metabolic portfolio (which includes two blockbusters – Empagliflozin and Linagliptin)
His global outcome-trial leadership includes the pragmatic trial EXSCEL, the active-comparator trial CAROLINA, the CARMELINA trial with a renal-enriched population and the EMPEROR Heart Failure Program.
This decade-long experience in clinical development (>40,000 patients from >40 countries), helped design a lean global registration programme in CKD, with world-leading university partners (EMPA-KIDNEY).
He has dozens of publications in prestigious journals and multiple award-winning presentations complement >15 years of clinical practice -including senior roles in world-renowned tertiary hospitals. This foundation helped consolidate a team delivering high-impact publications in cardiology and diabetes, enabling the clinical implementation of Empagliflozin (EMPA-REG OUTCOME).
Regulatory interactions (FDA, EMA and PMDA) range from pre-IND to approvals, including FDA Advisory Committee and CHMP Oral Examination. Addressing evidence needs of payers, HTAs and guideline providers is also a key focus.
Panel Discussion: Demonstrating Opportunity in Renal to Support a Business Case: 9:30 am
day: Day One
Interplay Between Diabetes, Heart failure & CKD: What Can we Learn from Novel Drug Development? 8:30 am
day: Day One