To Insource or Outsource Drug Product Development and Manufacturing? That is the Question

By Patricia Van Arnum - DCAT Editorial Director

February 17, 2016

What is the optimal approach for pharmaceutical development and manufacturing? An upcoming DCAT Week '16 education program provides first-hand insight from leading pharmaceutical companies on how they are approaching partnerships with raw material suppliers, CDMOs, and CMOs.

Among the speakers, this program will provide insight from Bristol-Myers Squibb and Pfizer on the key metrics and best practices used to reduce the time and cost associated with drug product development and manufacturing.

Optimizing drug development and manufacturing is crucial for successful commercialization. Overcoming drug formulation and delivery challenges while ensuring high-quality, reliable supply for clinical and commercial products becomes even more daunting with difficult actives and biologics. How are companies approaching partnerships with raw material suppliers, contract development and manufacturing organizations (CDMOs), and contract manufacturing organizations (CMOs)?

The education program, Evolving Business Models and Partnership Strategies for Drug Development Challenges, which will be held Tuesday March 15 from 1:00 to 3:30 PM, will provide insight from leading pharmaceutical companies on insourcing and outsourcing decisions and how suppliers successfully differentiate themselves in an evolving business climate. Nancy Barbour, Ph.D., Vice President, Drug Product Science & Technology, Bristol-Myers Squibb, will examine the company's fit-for-purpose model and the key metrics and decision criteria for insourcing and outsourcing pharmaceutical development of solid dosage products. Deborah DuFresne, Executive Director, Strategic Portfolio Selection & Management, InnoPharma, Inc., a subsidiary of Pfizer, Inc., will examine best practices in managing sterile drug product manufacturing and supply in light of tightening industry capacity, supplier consolidation, and evolving product and service requirements.

A fundamental question for CDMOs and CMOs is what is the optimal business model for their pharmaceutical customers. In traditional models, companies typically focus on providing either active pharmaceutical ingredient (API) or drug product development and manufacturing. But is this the optimal approach? In a panel discussion from both the buy and sell side, panelists will examine the advantages and disadvantages in using and providing the so-called one-stop for CDMOs/CMOs of a vertically integrated offering of API and drug product development and manufacturing. In addition to the aforementioned speakers, joining the panel will be CDMOs/CMOs of different size and maturity in apply this model.

Panelists include: Nancy Barbour Ph.D., Vice President, Drug Product Science & Technology, Bristol-Myers Squibb; Deborah DuFresne, Executive Director, Strategic Portfolio Selection & Management, InnoPharma, Inc., a subsidiary of Pfizer, Inc.; Syed T. Husain, Chief Commercial Officer, AAI Pharma Services/Cambridge Major Laboratories; Vivek Sharma, CEO, Piramal Pharma Solutions; and Laura Parks, Ph.D., Senior Vice President, Corporate Operations & Strategic Initiatives, Patheon.

Information on the program, including how to register, may be found here.