Agenda

4th - 5th September 2017

  • 08:00 - 09:00

Registration and Coffee


  • 09:00 - 09:10

Chairperson’s Welcome Address


KEYNOTE

  • 09:10 - 09:50

Scope Versus Focus: Issues On Manufacturing Design, Capacity And Flexibility

  • Balancing the need for timely access to manufacturing capacity with effective pipeline management
  • Evaluating the flexibility of expanding manufacturing system in uncertain environments
  • Converting production lines from single product to multiproduct to create flexible manufacturing

Rohin Mhatre - Vice President, Biopharmaceutial Development, Biogen Idec

MANUFACTURING

  • 09:50 - 10:30

Advances & Challenges in Vaccines Development & Manufacturing

  • Review of the constraints and complexity of vaccine product development and manufacture
  • Evolution of bioprocess and analytics innovation and technologies to overcome these challenges
  • Strategy and leveraging innovation and technology for rapid product development (examples)
  • What does the future look like?

Tony D'Amore, Vice President, Product Research and Development, Sanofi Pasteur

  • 10:30 - 11:10

Networking Break


  • 11:10 - 11:50

Challenges & Advances in Pat & Predictive Analytics in Development & Manufacturing

  • Product, Process and PAT Variability - the impact on product quality and costs
  • Real Time Performance Monitoring of Bio-manufacturing processes
  • Calibration Maintenance and Transfer - are your calibration models fit-for-purpose
  • Is there a place for Software (Virtual) Sensors in bio-manufacturing

Julian Morris, Technical Director of the Centre for Process Analytics and Control Technology (CPACT)

  • 11:50 - 12:30

Streamlining Quality Management Process In Todays Distributed Manufacturing World

  • Integration of CMOs and license holders to manage complex issues of oversight and transparency using modern cloud-based quality systems
  • Opportunities to streamline the supplier assessment audit and onboarding processes
  • Efficiencies from integrating document and process quality systems to manage the broader product lifecycle

Jonathan Burd, Strategy Director, Vault Quality Europe, Veeva Systems

KEYNOTE

  • 12:30 - 13:10

Novel Single Chromatography Platform For Quasi-Continuous Purification of Complex Biological Molecules

  • Reflecting on the consensus set of metrics and potential approach to analysis
  • Identifying the potential gaps in capturing overall quality at the site or manufacturer level
  • Developing a management review that highlights opportunities and drives continuous improvement

Anthony Mire-Sluis, Head of Global Quality, AstraZeneca

  • 13:10 - 14:10

Networking Lunch


KEYNOTE

  • 14:10 - 14:50

Newswatch: Major Trends Impacting Supply Chains For The Next 5 Years

  • Accessing a full range of collaborative supply chain processes required to break down functional boundaries and enable the consumer-driven supply chain
  • Leveraging best practices in reducing costs through supply chain networking
  • Evaluating supply chain risks with single versus multiple sourcing
  • Managing complex supply chains in emerging Asian countries

Dr. Detlef Behrens - Head, CMO, Biocon

SUPPLY CHAIN

  • 14:50 - 15:30

Mitigating Damage: Controlling Supply Chain Disruption

  • Process Capability
  • CPV
  • Big data
  • Technology Components

Aaron R. Goerke, Ph.D., Head of Global Engagement & Deployment, F. Hoffmann-La Roche Ltd.

  • 15:30 - 16:10

Networking Break


  • 16:10 - 16:50

Technology Transfer: Building Bridge To Innovation

  • Pivotal role of technology transfer in drug discovery and development process for new medicinal product
  • Creating a systematic approach to successful completion of technology transfer
  • Negotiating leverage on restricting technology transfer agreements

Junyan Ji, Senior Scientist, Late Stage Pharmaceutical Development, Genentech

PANEL DISCUSSION

  • 16:50 - 17:30

Transforming a supply chain with end-to-end optimization, improved performance and new strategies for cost reduction

  • Establishing a governance structure that facilitates integration of the acquired asset
  • Monitoring performance and regulatory compliance
  • How to integrate the acquired asset into its existing operations
  • Optimizing the supply chain to realize synergy benefits
  • Successful integration leading to improved performance and cost savings.

Panelist: Dr. Detlef Behrens, Head, CMO, Biocon
Panelist: Aaron R. Goerke, Ph.D., Head of Global Engagement & Deployment, F. Hoffmann-La Roche Ltd.

  • 17:30 - 18:30

End of Day 1 & Drinks Reception


  • 08:00 - 09:00

Registration and Coffee


  • 09:00 - 09:10

Chairperson’s Opening Remarks


KEYNOTE

  • 09:10 - 09:50

Proteomic and Phosphoproteomic Characterisation of Recombinant Cho Cells To Identify Engineering

  • Use of quantitative label-free LC-MS/MS proteomic and phosphoproteomic approaches to identify differentially
    expressed proteins in bioprocess-relevant conditions such as temperature shift, high and low productivity, etc
  • Phosphoproteins have the potential to be cell engineering targets to improve bioprocess-relevant phenotypes.

Dr. Paula Meleady - Associate Director, National Institute for Cellular Biotechnology

QUALITY MANAGEMENT

  • 09:50 - 10:30

CMO vs In-House Manufacturing. What's the difference?

Dr. Lars Dreesmann - Head of Clinical Supply & Transfer, Boehringer Ingelheim
  • 10:30 - 11:10

Networking Morning Break


  • 11:10 - 11:50

Gene Therapy Process Design Towards Commercialization

  • Process and plant design for small volume products
  • Flexible processes vs. standard unit operations
  • Quality by design

Marian Bendik, Head of Gene Therapy Technologies, Process Development, Shire

  • 11:50 - 12:30

Novel Single Chromatography Platform For Quasi-Continuous Purification Of Complex Biological Molecules

  • The newly developed platform has better performance than the traditional single-column batch chromatography routinely used by industry, which only isolates the pure part of the product peak one is interested in at the expense of yield because the impure side fractions, containing valuable product, must be discarded. Our novel single-column process captures these side fractions by internal recycling until the entire product has been extracted while new feed is cyclically injected. This not only gives significantly higher yields of purer product, but also enables you to process more feed and thereby increase overall throughput.
  • The newly developed platform is based on a novel single-column device that mimics the operation of multicolumn chromatography through ingenious management and recycling of mixed fractions.
  • The single-column chromatograph can mimic the operation and performance of recent multicolumn capture and polish processes designed for the efficient separation and purification of monoclonal antibodies (mAbs), biosimilars, and viral vectors.
  • The single-column chromatograph can be easily integrated into the existing downstream processing platforms of complex biopharmaceuticals.

Prof José Paulo Mota – Chemical & Biochemical Engineering, Universidade NOVA de Lisboa, Portugal

CASE STUDY

  • 12:30 - 13:10

Training For Gestures, The Key To Success In Disposable In Biomanufacturing

  • Brief presentation of Ease , genesis and purposes
  • How hands-on training is a key factor for the use of disposable in biomanufacturing

Constance Perrot, EASE Project Director, University of Strasbourg

  • 13:10 - 14:10

Networking Lunch


REGULATORY COMPLIANCE

  • 14:10 - 14:50

Regulatory Impact On Trending Manufacturing Methodologies

  • Undertaking regulatory impact analysis for the proposed standards of current Good Manufacturing Practices
  • Demonstrating conceptual differences in regulatory pathways for biosimilarity and manufacturing process change
  • Regulatory approaches to industrial production of computer-aided 3D printing for restoration of tissue and organ function
  • Aligning evidentiary requirements and global regulatory perspectives on regenerative medicine

Prof. David James, Biosystems Engineering, Bioengineering, Cell Biology, The University of Sheffield

  • 14:50 - 15:30

Evolving Regulatory Inspection Environment

  • Data Integrity
  • New Inspection Protocol
  • Inspection Readiness

Henrietta Ukwu - Senior Vice President, Head, Global Quality and Regulatory Affairs, Otsuka Pharmaceutical Development & Commercialization

  • 15:30 - 16:10

Networking Break


  • 16:10 - 16:50

Drug-Device Combination Products: Regulatory Landscape & Market Growth

  • Forecasting technological convergence of new business model for growth and profitability of drug device combinations
  • Identifying critical challenges in designing drug-eluting medical devices
  • Developing specific regulatory competencies and subsequent approval of combination products

Dr. Jonathan Bones, Principal Investigator, NIBRT

PANEL DISCUSSION

  • 16:50 - 17:30

Shifting Focus: Stricter Control Over Outsourcing Partners

  • Manufacturing, regulatory and commercial challenges of biopharmaceuticals production
  • Effects of outsourcing on FDA resources
  • Approaching development of generics for DNA-derived biotech and therapeutics covered under BLAs

  • 17:30 - 17:40

Chairperson’s closing remarks and End of Day 2