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 […]
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 […]
