DATE/TIME
September 24, 2:00 – 2:30 PM EST
TITLE
From Formulation Development to Manufacturing Readiness: Working with CDMOs on Complex Products
SPEAKER
Romit Jani, Senior Director of Formulation Development, Solaris Pharma
ABSTRACT
Complex products require close coordination between formulation development, analytical methods, scale-up and manufacturing planning. In this session, Romit Jani will discuss how sponsor teams can work more effectively with CDMO partners on complex dosage forms, including semisolid, topical, sterile and other challenging products. The presentation will focus on what sponsors should look for in a development and manufacturing partner, how to support formulation equivalence and method development, and how to reduce risk as programs move toward exhibit batch manufacturing and later-stage readiness.
BIO
In addition to 5+ years managing a retail/specialty pharmacy, Romit Jani has over 12 years of experience in drug formulation, research, and development along with product lifecycle management, across topical, oral, nasal, otic, rectal, ophthalmic, and transdermal dosage forms. He is known for translating complex scientific and regulatory requirements into effective development strategies and for successfully engaging with health authorities. presented his work at numerous conferences alongside representatives from the FDA, industry leaders, and academic institutions.
Mr. Jani emphasizes clarity, accountability, and scientific rigor, evident from his work at Amneal Pharmaceuticals, where he led a dedicated team of scientists from early formulation development through scale-up and commercialization, with a strong emphasis on Quality by Design (QbD). Mr. Jani holds a M.S. in Pharmaceutical Manufacturing from Stevens Institute of Technology.
Outside of work, Romit serves as a peer reviewer for scientific journal and mentors students and early-career professionals in the industry, sharing insights on the current landscape, and contributing to initiatives that advance professional development and public health.
