2018 ISPE Biopharmaceutical Manufacturing Conference

The scope, scale, and science of biologics manufacturing is quickly evolving as new modalities enter the space and cost pressures demand innovation that impacts the cost of goods and time to market.

Cell and gene therapy treatments are creating interesting containment and control challenges in all aspects of their manufacture and supply chain.

The solvent management requirements of Oligonucleotide manufacture present a new challenge for typical therapeutic protein facilities and staff.

Recently licensed small molecule continuous processes have paved a regulatory path for biologics, and the journey has already begun with process intensification becoming the norm in several unit operations.

From leveraging existing capacity with novel new processes, to implementing new and emerging technologies, this conference will bring together experts and leaders to ensure the Biomanufacturing industry successfully navigates these novel new processes and delivers on our promise of supply of life changing medicines to patients across the globe.


Who Should Attend

  • Bio Site Directors and above
  • Operations managers
  • Manufacturing, Quality Control and Quality Assurance heads
  • Procurement professionals
  • Engineering and Facility management heads
  • Contract Manufacturing interface heads
  • Key supply chain interfaces such as GE, Fisher et al
  • Process sciences, process development heads
  • Global Regulatory Authorities involved in (BLA, PAI, New Technologies)

Program Committee

Andre L. Walker, CPIP
Andre L. Walker, CPIP
Principal
Andre Walker Consulting
Darren Dasburg
Darren Dasburg
Vice President and Site Head, Boulder Manufacturing Center
AstraZeneca
Robert Dream, PE, CPIP
Robert Dream, PE, CPIP
Principal
HDR Company LLC
Jeffery Odum, CPIP
Jeffery Odum, CPIP
Managing Partner, Strategic Mfg
NNE
Vivianne Arencibia
Vivianne Arencibia
VP and Global Head, External Engagement for Novartis Group QA
Novartis
Antonio Moreira, PhD
Antonio Moreira, PhD
Vice Provost
University of Maryland, Baltimore County
Joe Famulare
Joe Famulare
Vice President, Global Quality Compliance and External Relations
Genentech, Inc.