Team & Experience | Leiam Life Sciences

Meet the Team

Our team consists of a network of highly experienced professionals with strong credentials in R&D, Regulatory affairs, Quality Assurance and non-GMP/GMP facility development. The team has worked together in their previous roles with several notable accomplishments-

Commissioning of a state-of-the-art cGMP facility (Design, Build, Deliver)
3 successful IND submissions with Health Sciences Authority (HSA), Singapore
Build and certification of Analytical and Process Development Laboratory
Successful completion of Regulatory audit of a global CDMO's manufacturing facilities
Developed and executed IND-enabling GLP Preclinical studies for three clinical programs
Established qualified release testing assays for Phase-3 clinical batches

Founder Consultant

Yadunanda (Nandu) Budigi, PhD

Dr. Budigi is a biologics drug development specialist with deep experience in regulatory science, analytics, manufacturing, antibody and biomarker discovery. He has over a decade of corporate drug development experience in USA and Singapore where he led multiple drug development programs from discovery to Phase-3 trials with successful regulatory submissions completed in record times. In his most recent role, Dr. Budigi served as Head of R&D and Acting Chief Operating Officer of Tychan Pte Ltd, a Singapore-based Biotechnology company that pioneered rapid response platforms for drug translation. He led the design, build and commission of manufacturing facilities ranging from non-GMP process development and analytical laboratories to qualified GMP facilities.

Consultant

Ravi Kadire

Ravi is a Quality Professional with > 20 years of international experience in Biologics, Cell & Gene therapy, Pharmaceuticals & Medical Device QA/QC Operations. Ravi holds a Master's Degree in Microbiology & Degree in Chemistry and is a certified ISO 13485 lead auditor, IASSC certified (lean six sigma) Black belt, IC Agile- Certified Agile professional, and a member of the Parenteral Drug Association (PDA). Ravi has vast experience in regulatory audits such as USFDA, EMEA, HSA, TGA etc. Ravi has served as Head of Quality for Biotechnology companies and in senior quality roles in large Bio-Pharma such as MSD, Roche, Genentech, Lonza and Allergan. In his most recent role Ravi was Head of Quality for Tychan Pte Ltd, where he deployed novel and innovative approaches towards developing nimble quality management systems.

Consultant

Debbie Lee, PhD

Debbie is an experienced R&D specialist with strong scientific knowledge in several areas including infectious diseases, antibody discovery, assay development and pre-clinical studies. In her most recent role Debbie was Associate Director of R&D and head of Preclinical studies for Tychan Pte Ltd, where she led antibody discovery and IND-enabling preclinical activities for multiple programs including efficacy, toxicity, and pharmacokinetic studies. She has deep experience in working with wide range of research institutions and international Contract Research Organizations (CROs), to design and implement GLP studies for pre-clinical and clinical projects that enabled several successful IND submissions.