Kattayoun (Kathy) Kordy, M.D.

Experienced consultant to leadership and teams to develop high-value therapeutics and new products across pharmaceutical, biotechnology, medtech, and digital platforms. Board member and advisor for biotechs and startup companies. Fractional Chief Medical Officer (Noa Therapeutics, Cellbricks Therapeutics). Clinical support for Business Development and Licensing assessments.

Developing and executing strategic initiatives to expand market share, revenue, profitability by creating new growth opportunities including program development, marketing, and sales for Under the Sisterhood, a women’s health oriented social impact platform offering bespoke corporate programs to support women for improved employee engagement, attracting/retaining talent, improved healthcare costs, and creating community.

Neurenati Therapeutics is a pioneering biotechnology company developing an innovative treatment for Hirschsprung disease, a rare congenital intestinal disorder with no approved therapies.

FimmCyte is pioneering first-in-class, disease-modifying immunotherapies for fibroinflammatory diseases, with a strong focus on women’s health. Supported the leadership team, which secured a successful research collaboration and exclusive option-to-license agreement with Gedeon Richter for the development and commercialization of a novel, first-in-class antibody targeting endometriosis.

As the Head of Rare Disease and Maternal-Fetal Clinical Development, Immunology, I am responsible for guiding the strategy and delivery of rare disease programs with direct accountability of maternal-fetal immunology indications, like hemolytic disease of the fetus and newborn (HDFN), fetal neonatal alloimmune thrombocytopenia (FNAIT), and warm autoimmune hemolytic anemia (wAIHA) within J&J’s Immunology development portfolio. I support the design, protocol development, implementation and reporting of all late-stage rare disease clinical trials and provide functional leadership, while helping to define late-stage rare disease development approaches for licensing and business development activities. I drive clinical strategy for health authority submissions and interactions, including filings for IND, IDE, Orphan Drug Application, and Breakthrough Designation. I help lead innovative strategies for market engagement activities and capability building in new maternal-fetal disease area for patients and PIs naïve to industry trials to successfully operationalize fit-for-rare trials. I amplify global visibility of rare disease trials via intensive conference and PI-engagement strategies, and novel multi-media outreach campaigns and strategic partnerships. I build high performing teams of world-class drug developers in rare disease and maternal-fetal clinical trials. I am also a member of the Leadership Teams for Immunology Development, Autoantibody, and Maternal-Fetal Immunology Disease Area Stronghold.

Recruited from academia after yearlong part-time sabbatical in Novartis’ Pediatric Center of Excellence providing expertise in the development of scientific and medical strategy from early to late development, including proof-of-concept efforts and transition to late clinical development, across a wide range of disease areas for pediatrics. Responsible for driving early and late stage strategic planning for pediatric studies across disease areas: • Early stage: Clinical expert on early strategic planning, indication selection, TPP development, first-in-pediatric designs, and innovative bioanalytical approaches for all disease areas including pediatric rare diseases, monogenic disorders, cell & gene therapy, hepatology, NASH, IBD, CVM diseases, infectious/tropical diseases, respiratory, dermatology, immunology. • Late stage: Clinical expert to late-stage development programs for pediatrics and rare diseases in immunology, dermatology, respiratory, GI, hepatology, infectious diseases/global health. Provided expertise on disease insights, innovative study designs and bioanalytical approaches for first-in-pediatrics, pediatric dominant, and rare disease indications. Led clinical contributions to multiple study designs/strategy, pediatric submissions (PIPs/PSPs), protocols, target patient profiles, integrated development plans, labeling, global health authority submissions and responses, and insights for technical R&D and indication selection. Consulted on multiple Business Development and Licensing (BD&L) activities across diseases including immunology, GI, hepatology, metabolic, and pediatric indications. Spearheaded pediatric data and digital projects, epidemiology efforts, real world evidence initiatives, and pediatric liver safety.

While in the Executive Director in Pediatrics role, I simultaneously undertook additional responsibilities as part of a personalized talent development program to enrich and quickly enhance an end-to-end development experience for top talent. As a clinical leader across several phase 2 and 3 programs in Immunology/Hepatology/Dermatology DU and Global Health DU, I led end-to end strategic planning and management, provided clinical leadership, drove oversight and execution of clinical development, maintained strong external collaborations, and supported overall program safety reporting with patient safety colleagues. I led clinical strategy of global regulatory submissions including an emergency use authorization for a rapidly accelerated COVID-19 asset, and a BLA submission for an ultra-rare disease utilizing investigator initiated study data and RWD. I spearheaded a novel artificial intelligence tool for digital histology, and led the development of a new data visualization platform.

Clinical faculty and research academician, led NIH-funded translational research lab.

Pediatric provider for Beverly Hills Pediatrics private practice After Hours Urgent Care in Beverly Hills, California.

Pediatrician in EmCare staffing weekends and holidays at Children’s Medical Center Urgent Care at University of Texas Southwestern, Dallas, TX and Cook Children's Medical Center Urgent Care Clinic, Fort Worth, TX.

Pediatrician in EmCare staffing Children’s Medical Center Urgent Care at University of Texas Southwestern.

Physician and clinical HIV fellow sponsored by the Division of Pediatric Infectious Disease at UT Southwestern. Provided HIV and general medical care for both pediatric and adult populations at the Waterberg Welfare Society (WWS), an NGO based in resource-limited rural Vaalwater, South Africa. Established a pediatric HIV disclosure program and support group at the WWS – one of the first of its kind in South Africa.

Postdoctoral trainee