Romit Jani
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 […]
Patrick Day
DATE/TIME September 25, 09:00 – 09:30 AM EST TITLE FDA Inspection Trends and Top Citations: A Focus on Facilities and Engineering SPEAKER Patrick Day, Principal Consultant, Lachman Consultants ABSTRACT FDA inspection activity continues to evolve, and the agency’s expectations for the physical plant are rising with it. This annual review examines the most recent inspection […]
Dhaval Desai
DATE/TIME September 25, 10:15 – 10:45 AM EST TITLE From Approval to Availability: Strengthening the Regulatory-Supply Chain Connection SPEAKER Dhaval Desai, Director of Regulatory Affairs & Supply Chain, Zydus Pharmaceuticals ABSTRACT This session will examine the connection between regulatory affairs, supply chain planning and external manufacturing partnerships as pharmaceutical products move from approval toward launch […]
Valdas Jurkauskas
DATE/TIME September 25, 10:15 – 10:45 AM EST TITLE The Three Cs of CDMO Selection: Capability, Capacity and Cost SPEAKER Valdas Jurkauskas, Ph.D., Senior Vice President, Oxia Therapeutics ABSTRACT Selecting the right CDMO remains one of the most important decisions a sponsor can make as a program moves from development toward commercialization. In this session, […]
David H. Windley
DATE/TIME September 25, 08:30 – 09:00 AM EST TITLE Demand Cometh Before the Fall SPEAKER David H. Windley, CFA, CPA, Managing Director, Jefferies LLC ABSTRACT After several years of flagging demand from weak biotech funding and pharma pipeline resets, demand is finally re-emerging…just in time for fall. We’ll cover the funding environment and development deal […]
Michael Spangler
DATE/TIME September 24, 02:30 – 03:00 PM EST TITLE Check Before You Choose: Making CDMO References Calls SPEAKER Michael Spangler, Principal Consultant, Spangler Consulting ABSTRACT Selecting a CDMO is more than a matter of their capabilities, cost, and timelines. A candidate must not only meet your needs for specialized technical expertise, but they must also […]
Gil Roth
DATE/TIME September 24, 11:20 – 12:00 AM EST TITLE 25 Years of Pharma Outsourcing: From CMOs to Strategic Partners SPEAKER Gil Roth, President, Pharma & Biopharma Outsourcing Association (PBOA) ABSTRACT As Contract Pharma marks the 25th anniversary of its Contracting & Outsourcing Conference, founding editor Gil Roth offers a “look back, look ahead” perspective on […]
Eric Langer
DATE/TIME September 24, 01:30 – 02:00 PM EST TOPIC The Biomanufacturing Capacity Crunch: Where CDMO Demand Is Still Outrunning Supply SPEAKER Eric Langer, President and Managing Partner, BioPlan Associates, Inc. ABSTRACT Biopharma companies continue to rely on CDMOs for development and manufacturing support, but many sponsors still struggle to find the right capacity at the […]
Piyush Modi
DATE/TIME September 25, 09:00 – 09:30 AM EST TITLE Before FDA Pushback: Using Regulatory Intelligence to De-Risk CMC Submissions SPEAKER Piyush Modi, Director, Regulatory Affairs, Amneal Pharmaceuticals ABSTRACT CMC issues remain one of the most common reasons regulatory submissions run into delays, particularly when gaps emerge around stability, process validation, analytical methods or manufacturing readiness. […]
Ben Locwin
DATE/TIME September 24, 9:20 – 10:00 AM EST TITLE The New Rules of Pharma Outsourcing SPEAKER Ben Locwin, Vice President, Reliant Life Sciences ABSTRACT The sponsor-CDMO relationship is changing as companies face tighter timelines, more complex products, supply chain pressure and rising quality expectations. In this session, healthcare executive Ben Locwin looks at what sponsors […]
