A pragmatic approach to the buy vs build manufacturing dilemmaPublished: January 6, 2020
Thursday, 16th January 8:00 PST; 11:00 EST; 16:00 GMT; 17:00 CET
The decision to outsource manufacturing or produce a therapeutic product in house plagues many biopharmaceutical executives. Each decision requires a careful assessment of multiple variables such as timelines,IP protection, forecast, capital allocation, technical capabilities, and market strategy. Every situation is unique and typically requires compromises and often results in valuable lessons learned.We will present a case study of one economic assessment of a buy versus build decision model. The panel will discuss other scenarios to generate a useful discussion of the possible options and the potential outcomes.
Attendees will learn:
- Financial modeling of buy vs build scenarios
- Considerations when manufacturing at a CMO
- Benefits of outsourcing or insourcing
- In-house manufacturing options for retrofitting existing structure, stick-built or modular builds
- Technical challenges when manufacturing gene therapies
Joseph Phillips, Ph.D, Senior Vice President & Head of Pharmaceutical Development, ArmaGen, Inc.
Joseph Phillips has over 27 years leadership experience in the biopharmaceutical industry in research & development, clinical and commercial manufacturing of biologic therapeutics and small molecule drug entities, global CMC regulatory submissions, and new drug product launches. His leadership roles include manufacturability assessment for drug candidate selection, drug substance and drug product process development and manufacturing, and labeling/packaging unit operations.
He developed “product attribute sciences” as a capability to gain greater insights and deeper understanding of how cell line selection, cell culture media constituents and processing conditions can be designed to deliver targeted molecular attributes, high production yields and robust biologics manufacturing processes. This is executed using advanced genomics, proteomics and metabolomics tools at candidate molecule selection, process development and clinical trials’ material production.
Currently, he leads CMC, manufacturing and clinical suppy operations at ArmaGen for biologic therapeutics developed for neurological disorders and neurodegenerative diseases.
Most recently, he served as independant consultant providing expertise in bioprocess and product development, manufacturability, QbD, cGMP production, technical operations, quality and global CMC submissions.
Formerly, he was at Amgen serving in several leadership roles in process and product development, culminating in successful implementation of re-configurable, single-use/disposable, biologics manufacturing technology delivering targeted product quality at predictable cost of goods.
Prior to joining Amgen, Joseph worked at Upjohn (Pfizer/Pharmacia) and GSK in successive leadership roles in drug substance and drug product development. Joseph received his Ph.D. in pharmaceutics and analytical chemistry from Brighton University (UK), his M.Sc. in organometallic chemistry from University of Sussex (UK) and his B.Sc. in applied chemistry from Brighton University (UK).
Nacim Haderbache, Commercial Strategy Leader, GE Life Sciences
Nacim has a MSc in Mechanical Engineering from Arts et Metiers ParisTech (Paris) & an Advanced Master’s Degree in Strategy & Management from ESSEC Business School (Singapore). He has 5 years’ experience in different marketing roles in Asia (Singapore based) as well as 3 years in his current role of Global Commercial Strategy Manager in Europe (Paris based); all within GE Healthcare. Nacim’s role is to support GE Healthcare’s commercial teams globally by designing business frameworks and models that increase their ability to win customer deals and take educated internal investment decisions.
Carol Houts, Director of Regulatory Affairs, Germfree, Inc.
Carol Houts is the Vice President of Quality and Business Strategy for Germfree, an offsite clean room construction company that provides facility solutions for biopharmaceutical applications. Carol is an executive with over 25 years’ experience in pharmaceutical, and biologics product development, quality, regulatory affairs and clinical research. Carol has worked intensively to have constructive and cooperative interactions with the FDA and other global regulatory agencies through formal meetings, regulatory submissions, inspections and compliance remediation projects. Prior to joining Germfree, Carol has worked extensively to build companies organizational and service capabilities to increase revenue and sustain long-term growth. Carol has led business development activities to achieve funding, and developed business plans for demonstrating investment opportunities.