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Mar 12
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7:00am - 8:00am

Registration and Morning Coffee

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Showing of Streams
9:15am - 9:55am

Networking Refreshment Break and Grand Opening of the Exhibit & Poster Hall

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Showing of Streams
Showing of Streams
3:15pm - 3:45pm

Networking Refreshment Break in Exhibit & Poster Hall

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Showing of Streams
5:15pm - 6:30pm

Cocktail Reception in Exhibit & Poster Hall

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7:00am - 8:00am 60 mins
Registration and Morning Coffee
8:00am - 8:05am 5 mins
Plenary Session
Conference Opening & Welcome
8:05am - 9:15am 70 mins
Plenary Session
Knowledge and Technology Management to Launch and Lifecycle Management
  • Jerry Murray, PhD - Vice President, Amgen
9:15am - 9:55am 40 mins
Networking Refreshment Break and Grand Opening of the Exhibit & Poster Hall
9:55am - 10:00am 5 mins
Flexible & Smart Facilities
Chairperson’s Opening Remarks
9:55am - 10:00am 5 mins
Early Stage Process Development
Chairperson’s Opening Remarks
9:55am - 10:00am 5 mins
Late Stage Process Development
Chairperson’s Opening Remarks
9:55am - 10:00am 5 mins
Commercial Manufacturing & Beyond
Chairperson’s Opening Remarks
9:55am - 10:00am 5 mins
Viral Safety
Chairperson’s Opening Remarks
9:55am - 10:00am 5 mins
Sponsorship Opportunity
Chairperson’s Opening Remarks
9:55am - 10:00am 5 mins
Hands on Training Course
Chairperson’s Opening Remarks
10:00am - 10:30am 30 mins
Flexible & Smart Facilities
Next Generation Biomanufacturing and Facility Implementation: Technical Advances in Manufacturing Technologies to Improve Process Productivity
  • Parrish Galliher - CTO Upstream and Founder, Xcellerex Inc., GE Healthcare Life Sciences
10:00am - 10:30am 30 mins
Early Stage Process Development
Keynote Address - Technology and Innovation for Commercial Manufacturing: Living at the Interface of Development and Manufacturing
  • Paul Wu - Head of Upstream Development, Bayer U.S. LLC
10:00am - 10:30am 30 mins
Late Stage Process Development
Keynote Address - Technology and Innovation for Commercial Manufacturing: Living at the Interface of Development and Manufacturing
  • Paul Wu - Head of Upstream Development, Bayer U.S. LLC
10:00am - 10:30am 30 mins
Commercial Manufacturing & Beyond
Next Generation Biomanufacturing and Facility Implementation: Technical Advances in Manufacturing Technologies to Improve Process Productivity
  • Parrish Galliher - CTO Upstream and Founder, Xcellerex Inc., GE Healthcare Life Sciences
10:00am - 10:30am 30 mins
Viral Safety
A novel dual orthogonal virus inactivation in a single unit operation in antibody production
  • June Zou - Process Scientist, Bayer Healthcare LLC
10:30am - 11:00am 30 mins
Info
Flexible & Smart Facilities
Thought Leaders Discussion: Multiproduct Facilities Review – Evaluating Costs of Goods and Practicalities of Implementation
  • Adam Goldstein - Principal Scientist, Roche
  •  Multiproduct facilities 5 years + on – What are the realities of implementing? 

  • Evaluating the cost of goods for multiproduct facilities and cost saving initiatives 

  • Strategies to implement high flexibility and fast product turnovers  

  • Strategies for cleaning and cleaning validation that minimise downtime for product changeovers 

  • Applicability of multiproduct plants for low volume products

10:30am - 11:00am 30 mins
Early Stage Process Development
Early Stage Process Development And Interfacing With Late Stage
  • Aaron Chen - Principal Scientist, Seattle Genetics
10:30am - 11:00am 30 mins
Late Stage Process Development
Early Stage Process Development And Interfacing With Late Stage
  • Aaron Chen - Principal Scientist, Seattle Genetics
10:30am - 11:00am 30 mins
Commercial Manufacturing & Beyond
Thought Leaders Discussion: Multiproduct Facilities Review – Evaluating Costs of Goods and Practicalities of Implementation
  • Adam Goldstein - Principal Scientist, Roche
10:30am - 11:00am 30 mins
Viral Safety
Effective inactivation of a wide range of viruses by pasteurisation
  • Michael Burdick - Associate Director, CSL Behring
11:00am - 11:30am 30 mins
Flexible & Smart Facilities
Transformation of CAR-T Manufacturing Through Use of Closed-Processing, Process Automation and Strategic Raw Material Configuration
  • Randy Schweickart, MS - Director of Engineering, Juno Therapeutics, Inc
11:00am - 11:30am 30 mins
Early Stage Process Development
Developing Phase 1 Process with Line of Sight to Commercial
  • Sigma Mostafa, PhD - Vice President, Upstream & Downstream Process Development, KBI Biopharma
11:00am - 11:30am 30 mins
Late Stage Process Development
Developing Phase 1 Process with Line of Sight to Commercial
  • Sigma Mostafa, PhD - Vice President, Upstream & Downstream Process Development, KBI Biopharma
11:00am - 11:30am 30 mins
Commercial Manufacturing & Beyond
Transformation of CAR-T Manufacturing Through Use of Closed-Processing, Process Automation and Strategic Raw Material Configuratio
  • Randy Schweickart, MS - Director of Engineering, Juno Therapeutics, Inc
11:00am - 11:30am 30 mins
Viral Safety
Virus barrier filtration – Eli Lilly Case Study
  • Sean O'Donnell - Principal Research Scientist, Eli Lilly & Co
11:30am - 12:00pm 30 mins
Flexible & Smart Facilities
Panel Discussion: Transforming Production Processes and Strategies for Smaller Volume, Novel, More Complex Products
11:30am - 12:00pm 30 mins
Early Stage Process Development
Panel Discussion: Can We Achieve Single-Phase Process Development?  What will it Take?
  • Nikki Nogal, PhD - Senior Consultant, Biologics Product Development Specialist, Latham BioPharm Group
11:30am - 12:00pm 30 mins
Late Stage Process Development
Panel Discussion: Can We Achieve Single-Phase Process Development?  What will it Take?
  • Nikki Nogal, PhD - Senior Consultant, Biologics Product Development Specialist, Latham BioPharm Group
11:30am - 12:00pm 30 mins
Commercial Manufacturing & Beyond
Panel Discussion: Transforming Production Processes and Strategies for Smaller Volume, Novel, More Complex Products
11:30am - 12:00pm 30 mins
Viral Safety
The Use of Detergents in Viral Inactivation – Case Study on a Patented ECO Alternative
  • Alexis Henry, MSc. - Senior Associate Scientist, Biogen
12:05pm - 12:35pm 30 mins
Flexible & Smart Facilities
Technology Workshop
12:05pm - 12:35pm 30 mins
Early Stage Process Development
Technology Workshop
12:05pm - 12:35pm 30 mins
Late Stage Process Development
Technology Workshop
12:05pm - 12:35pm 30 mins
Commercial Manufacturing & Beyond
Technology Workshop
12:05pm - 12:35pm 30 mins
Viral Safety
Technology Workshop
1:40pm - 1:45pm 5 mins
Flexible & Smart Facilities
Chairperson’s Opening Remarks
1:40pm - 1:45pm 5 mins
Early Stage Process Development
Chairperson’s Opening Remarks
1:40pm - 1:45pm 5 mins
Late Stage Process Development
Chairperson’s Opening Remarks
1:40pm - 1:45pm 5 mins
Commercial Manufacturing & Beyond
Chairperson’s Opening Remarks
1:40pm - 1:45pm 5 mins
Viral Safety
Chairperson’s Opening Remarks
1:40pm - 1:45pm 5 mins
Sponsorship Opportunity
Chairperson’s Opening Remarks
1:45pm - 2:15pm 30 mins
Info
Flexible & Smart Facilities
Modular Platform Delivery Considerations for Today’s New Drug Production Facilities: Case Studies from Recent Design Competitions
  • Peter Cramer - Vice President Life Science Facility Design, Exyte U.S., Inc

Modular Facility Design and standardization initiatives continues to be at the forefront of new construction techniques aimed at reducing cost and schedule while keeping quality high.  This presentation will cover four (4) recent case studies of facility prototypes that leverage new ways of integrating modular systems to their fullest.  Prototype designs include: 

  • Single Use Biotech / Drug Substance 

  • Cell & Gene Therapy 

  • Fill Finish / Drug Product 

  • Antibody Drug Conjugate 

Biopharma wants to make new drug products more accessible and at the same time be able to quickly respond to changes in the way new drugs are produced and the variations in product demand.  The industry is challenged to deliver truly flexible biopharmaceutical manufacturing facilities with significant reductions in schedule, cost, and client operating resources. 

To achieve these goals, design firms in the Life Sciences market are now capturing many of their best practices for flexible manufacturing into a prototype facility design where modular and other pre-engineered systems can be evaluated for use on a project.  The platform-modular approach along with a set of analysis tools allows life science companies to rapidly ascertain the economic advantage of using a prototype design and the degree to which modular and pre-engineered systems can be leverage to reduce cost and schedule while retaining the overall quality they need.  

This presentation will show recent modular prototype designed and the platform design approach that was used to create them.  These prototypes demonstrate how companies can leverage the best systems the modular market now has to offer.  

1:45pm - 2:15pm 30 mins
Info
Early Stage Process Development
Speed to IND: are stable pools or transient gene expression viable manufacturing options?
  • Yves Durocher, PhD - Section Head, Mammalian Cell Expression - NRC Human Health Therapeutics Research Center, National Research Council Canada

Chinese Hamster Ovary (CHO) cells are a workhorse expression host for production of protein-based biotherapeutics. Expression from stably transfected CHO clones is just one means of recombinant protein production in CHO cells, but lower productivity and longstanding regulatory guidelines have restricted the use of alternative approaches, such as non-clonal stable pools and transient gene expression (TGE), for drug manufacturing. Recently, the performance of stable pool and TGE methods has improved dramatically, making them viable options for producing drug substance for GLP-toxicology, early-phase clinical trials, and other scenarios that demand rapid production timelines. We propose that regulatory guidelines be updated to permit these alternative expression modes as they may enable more rapid and cost-effective clinical evaluation of potentially life-saving drugs.

1:45pm - 2:15pm 30 mins
Late Stage Process Development
Registration Enabling Campaign for Accelerated Development
  • Jessica Wuu, PhD - Senior Engineer, Late Stage Cell Culture, Genentech
1:45pm - 2:15pm 30 mins
Commercial Manufacturing & Beyond
How to Shorten Launch Timelines for New Products
  • Jody Logan - Associate Director of Tech Transfer, Genentech, USA
1:45pm - 2:15pm 30 mins
Viral Safety
Hepatitis A/E Case study
  • Barry Gooch - Associate Director, Grifols
2:15pm - 2:45pm 30 mins
Info
Flexible & Smart Facilities
Plug and Play Automation for Single Use Equipment
  • Eugene Tung - Executive Director of Manufacturing IT,, Merck MSD

The industry’s movement away from large scale, fixed tank facilities to more flexible, single use technologies has demonstrated the desire to move toward flexibility in process equipment.  This has created an equivalent need to move towards more flexible automation systems as well.  The need to quickly and easily build and change process systems is leading to the need for new automation designs that enable the ability to build facilities and change the unit operations inside without the need for large scale development efforts to do so. 

The benefits of flexible, standardized automation designs: 

-   Significantly reduce build times for new facilities (allowing for decisions to build to be placed much later in the product approval cycle) 

-   Significantly reduce development costs by reducing development efforts and making them more of a configuration effort 

-   Significantly reduce the time and cost of change existing facilities 

-   Lower life cycle costs by spreading the cost of maintenance across all users of the standard 

-   Increase flexibility 

-   Increase innovation by reducing barriers to introduction of new technologies 

The presentation describes the implementation of a standard interface that allows a supervisory control system to interface to a process skid.  The standardized interface has been developed for three common unit operations:  a bioreactor, a filtration skid, a chromatography column.  The goal will be to have the supervisory system be able to pass control signals down and collect data up from the unit operations with a minimum of programming effort and to be able to do so independent of controller manufacturer.  A proof-of-concept software demonstration utilizing actual equipment from DCS vendors and equipment suppliers shows the viability of this concept. 

2:15pm - 2:45pm 30 mins
Early Stage Process Development
Case Study: Developing Early Stage Platforms to Accelerate Speed to Market
  • Qinghai Zhao - VP of Technical Development and Manufacturing, FortySeven Inc
2:15pm - 2:45pm 30 mins
Late Stage Process Development
High Speed Late Stage Development to Support Accelerated Launch of Product
2:15pm - 2:45pm 30 mins
Commercial Manufacturing & Beyond
Managing Life Cycle of a Break Through Therapy Designated Product
  • Gargi Maheshwari, PhD - Executive Director, Biologics Process Development and Commercialisation, Merck
2:15pm - 2:45pm 30 mins
Viral Safety
Pathogen safety considerations during ATMP product development
  • Mark Plavsic - Chief Technology Officer, Lysogene, USA
2:45pm - 3:15pm 30 mins
Flexible & Smart Facilities
Technology Workshop
2:45pm - 3:15pm 30 mins
Early Stage Process Development
Technology Workshop
2:45pm - 3:15pm 30 mins
Late Stage Process Development
Technology Workshop
2:45pm - 3:15pm 30 mins
Commercial Manufacturing & Beyond
Technology Workshop
2:45pm - 3:15pm 30 mins
Viral Safety
Technology Workshop
3:15pm - 3:45pm 30 mins
Networking Refreshment Break in Exhibit & Poster Hall
3:45pm - 4:15pm 30 mins
Info
Flexible & Smart Facilities
Automated online MAM, Sizing, Charge Variance, Titer, and Metabolites Quantitation as PAT Tool for In-process Control and Real-time Cell Culture Optimization
  • Becky Chan - Process Development Scientist, Amgen Inc.

Historically, cell culture development was conducted in batch. Bioreactors with varying modulating components were run simultaneously, limited by the number of available bioreactors. In-depth experimental outcome and evaluation were usually done post bioreactor run duration, pending off-line PQA and media consumption results, which may take weeks to months. The turn-around time (TAT) for these analyses significantly delay the re-design and execution of the next phase of development. The online real-time PAT tools we developed, such as online MAM, SEC, CEX, titer, and metabolite analysis, can significantly enhance cell culture development efficiency. Effect of the modulator/lever on PQA will be able to monitor daily with near-real-time feedback. Any adverse or beneficial effect can be mitigated or promoted instantly, saving time, cost, and footprint.

3:45pm - 4:15pm 30 mins
Early Stage Process Development
Panel Discussion: Strategies to Increase Speed from DNA to IND Submission
3:45pm - 4:15pm 30 mins
Late Stage Process Development
Title TBC
  • Dharmesh Kanani, Ph.D. - Senior Scientist, Downstream Development & Operations, Teva Pharmaceutical Inc.
3:45pm - 4:15pm 30 mins
Commercial Manufacturing & Beyond
Life After Launch – Factors to Consider when Navigating Post-Approval Process Optimization
  • Nathan McKnight, Ph.D - Associate Director, Genentech
3:45pm - 4:15pm 30 mins
Viral Safety
Title TBC
  • Dharmesh Kanani, Ph.D. - Senior Scientist, Downstream Development & Operations, Teva Pharmaceutical Inc.
4:15pm - 4:45pm 30 mins
Flexible & Smart Facilities
Data at Your Fingertips: The Benefits of an Integrated Informatics System
  • Carly Cox - Process Informatics Manager, Global Engineering, Pfizer
4:15pm - 4:45pm 30 mins
Early Stage Process Development
Early Development Assessment Strategies to Predict Successful Molecules: A Case Study on Developability Assessment of Bispecific Molecules
  • Duc Nguyen, PhD - Lab Head, Novartis
4:15pm - 4:45pm 30 mins
Late Stage Process Development
Viral Clearance Validation Across Continuous Capture Chromatography
  • Srinivas Chollangi, PhD - Manager, Bristol-Myers Squibb
4:15pm - 4:45pm 30 mins
Commercial Manufacturing & Beyond
Data at Your Fingertips: The Benefits of an Integrated Informatics System
  • Carly Cox - Process Informatics Manager, Global Engineering, Pfizer
4:15pm - 4:45pm 30 mins
Viral Safety
Viral Clearance Validation Across Continuous Capture Chromatography
  • Srinivas Chollangi, PhD - Manager, Bristol-Myers Squibb
4:45pm - 5:15pm 30 mins
Flexible & Smart Facilities
Update on BPOG Technology Roadmap Workstream on Knowledge Management
  • Bert Frohlich, Ph.D., - Director, Strategy and Technology Lifecycle, Manufacturing Sciences & Technology, Shire
4:45pm - 5:15pm 30 mins
Early Stage Process Development
Manufacturing Assessment Strategies and Integration at the Interface of R&D and Early Stage Process Development
4:45pm - 5:15pm 30 mins
Late Stage Process Development
Demonstrating Viral Clearance for a Novel Approach to Continuous Viral Filtration
  • Tarl Vetter, PhD - Senior Scientist, Sanofi
4:45pm - 5:15pm 30 mins
Commercial Manufacturing & Beyond
Update on BPOG Technology Roadmap Workstream on Knowledge Management
  • Bert Frohlich, Ph.D., - Director, Strategy and Technology Lifecycle, Manufacturing Sciences & Technology, Shire
4:45pm - 5:15pm 30 mins
Viral Safety
Demonstrating Viral Clearance for a Novel Approach to Continuous Viral Filtration
  • Tarl Vetter, PhD - Senior Scientist, Sanofi
5:15pm - 6:30pm 75 mins
Cocktail Reception in Exhibit & Poster Hall