Program

6th Annual Biomanufacturing Summit 2014 – January 29-31, 2014

The 6th Annual Biomanufacturing Summit program is under development. If you would like to submit a paper, recommend a speaker, or be considered for our Advisory Board, please contact Mark Blendheim, Portfolio Manager, Pharma Summits, by calling 416 214 9060 or by emailing: mark.blendheim@wtgevents.com

Below you can review the current 2014 program.


Day 1, 29th January 2014 (Wednesday)

08:30-12:00

FACILITY TOUR: STONE BREWING CO.

Expanding production capacity through leveraging existing assets and building new sites

Featured in Inc. Magazine's 2013 List of the fastest-growing private companies in America

Looking for inspiration outside the industry? In addition to being a vibrant center for biotech, San Diego is a nationwide leader in craft beer. Stone is the largest brewery in Southern California and the 10th largest craft brewery in the U.S. As an exclusive offering to the Biomanufacturing Summit, the company’s Chief Operating Officer will take you through the heart of the custom-designed facility and on-site bottling line to discuss its lean, customer-centric operations, product and process development, business transformations and growth strategy. Discussion points include:

  • Improving manufacturing capacity and supply operations to accommodate 3-year growth of 114%
  • Cutting-edge automation, controls and supply chain lines to advance line production and profitability
  • Assessing the latest yield improvement processes and QA lab technologies
  • Increasing your global manufacturing footprint and market access by establishing new facilities

Pat Tiernan
Chief Operating Officer
Stone Brewing Co.

FACILITY TOUR: ORGANOVO

Examining process translations from development to manufacturing for engineered human tissues

Featured in MIT Technology Review’s 2012 TR50 List of World’s Most Innovative Companies

Located in a 15,000 sq. ft. facility in San Diego, Organovo’s Vice President of Technical Operations and Product Development will lead the company’s first-ever manufacturing-oriented tour of all operations, workstations and labs used to design functional human tissues. This personalized tour allows you to see Organovo’s 3D proprietary bio-printing technology and process teams in action. It will be followed by discussion on the scalability and manufacturing opportunities for the company’s first set of commercial products. Discussion points include:

  • Preparing cellular materials compatible with the proprietary printing processes
  • Managing and scaling of human cells in culture
  • Assessing the maturation and conditioning of printed tissues into the final differentiated form and function
  • Qualify “in vivo” like performance and stated claims with functional and analytical QC testing
  • Reviewing the opportunities and scalability of 3D bio-printing technology for wider application

This tour has reached capacity and is currently sold out.

Craig Halberstadt, Ph.D.
VP, Technical Operations and Product Development
Organovo

12:00-12:30

Registration and light lunch

12:30-12:45

Manufacturing Chair’s Welcome Address

Andrew Ramelmeier, Ph.D.
VP, Manufacturing and Facilities
BioMarin

QUALITY CHAIR

Ronald C. Branning
VP, Quality
Gilead Sciences

12:45-13:20

Keynote: Leadership, production, quality and people

 Delivering the next era of innovation and global growth in bio industries

  • Generating an optimistic mindset when it comes to a biomanufacturing future
  • Grasping the challenges and the opportunities new markets and rising economies offer
  • Taking an honest inventory of capabilities and competitive advantages
  • What do we need to do as individual companies and as an industry to build the next decade of prosperity?

Patrick Yang, Ph.D.
Retired EVP and Global Head, Technical Operations; Member - Board of Directors, Tesoro Corporation
Genentech

13:20-13:55

Creating an Uncompromising Quality Culture

Best strategies for defining, instituting and maintaining a culture of quality

 
  • Placing quality and compliance as the core strength of your organization and the industry
  • Ensuring a strong quality focus with CMOs, partners and suppliers
  • Improving supply chain integrity through continuous improvement, on-going training and audits

Greg Guyer, Ph.D
SVP, Global Quality
Merck & Co.

13:55-14:30

Workshop: Manufacturing Excellence

Optimizing the quality of your CMO choice based on their quality and regulatory capabilities

  • How understanding the nuances between agencies leads to successful outcomes
  • Tips on systems and planning to manage successful audits
  • Ensuring collaboration and communication between the sponsor and CMO
  • Achieving supply reliability

Laura Parks, Ph.D.
President
DSM Pharmaceuticals

Warren Horton
VP, Quality Operations
DSM Pharmaceuticals

Workshop: Manufacturing technology

Enabling consistent product quality and richer scientific understanding with on-line analytics

  • Developing innovative solutions to overcome long-standing challenges
  • Accelerating the process development cycle
  • Streamlining scale-up and technology transfer activities
  • Using real-time analysis to increase production pace, quality and process intensity

Scott Samojla
Senior Director, Process Analytics
Waters Corporation

14:30-15:00

Networking and refreshments

15:00-15:35

Keynote: Creating proactive models for technical lifecycle management

Simplifying SOPs and improving operational performance by increasing process controls and automation

  • Reconfiguring bioproduction systems to produce biologics faster and at a lower cost
  • Examining complex process architecture for areas of improvement and new operations technology
  • Rethinking routine operations and attitudes to create a roadmap for change
  • Knowing when to invest in new bioreactors, purification equipment and facility upgrades

Alain Pralong, Ph.D.
VP, New Product Introduction and Technical Life Cycle Management
GlaxoSmithKline

15:35-16:10

Workshop: Manufacturing excellence

Ensuring state of the art reliable global supplies

  • Addressing the reliability of commercial supply in the current global regulatory environment and complex international supply chain demands
  • Devising a manufacturing strategy for constantly changing market requirements:
    • Personalized medicine concepts
    • Emerging markets and access requirements
    • Introduction of new product formats and biosimilars
  • Supplementing large volume stainless steel equipment with disposables to enable a flexible supply of biopharmaceuticals
  • Managing multi-product operations to cope with an increasing number of products and more diverse manufacturing technologies

Uwe Bücheler, Ph.D.
SVP, Global Biopharmaceutical Operations
Boehringer Ingelheim

Workshop: Manufacturing technology

Advancing your biologics upstream development through fully automated process analytics

 
  • Assessing regulatory agencies reasoning for implementing PAT in pharmaceutical development and production
  • Obtaining a solid process understanding of QbD initiatives to determine different conditions
  • Providing high quality data and reliable on-line sampling
  • Enabling robust, long-term sampling and analysis of upstream bioprocesses
  • Case study: Presenting results from BaychroMAT® systems and analyzers in fed-batch or perfusion processes in a variety of different bioreactors

Jens Traenkle, Ph.D.
Head, PAT Biotechnology
Bayer Technology Services GmbH

16:10-16:45

Workshop: Manufacturing excellence

Assessing the climate of single-use technologies: Niche play or mainstream potential?

  • Analyzing real world transfer and scalability data for mammalian cell culture in stainless steel
  • Reviewing game changing downstream technologies: ATF, disposable centrifugation, pre-packed chromatography disposable column technology
  • Addressing the need for standardization: How can we as an industry accelerate this?
  • Exploring how Acceleron, Amgen and Merck have achieved success with single-use systems

Kimball Hall
VP, Corporate Manufacturing
Amgen

Mark Petrich, Ph.D.
Associate Director, Engineering
Merck & Co.

Mark R. Bamforth
President and CEO
Gallus BioPharmaceuticals

Robert Steininger
SVP, Manufacturing
Acceleron

Workshop: Manufacturing technology

Using Next Generation Genomics for profitable bioprocess optimization

  • Making the case for the use of hypothesis-driven experimentation and analysis
  • Applying genomics tools to increase process stability and improve bioproduction efficiencies
  • How efficient cell line development and predictable scalability dovetail into production process optimization
  • Assessing other applications of Next Generation Genomics for understanding and optimizing complex biologics systems

Len van Zyl, Ph.D.
CEO and Chief Scientific Officer
ArrayXpress

16:45-17:20

Manufacturing Spotlight

3D Bio-printing: Is it the next wave of biomanufacturing?

  • Proven examples of how Organovo's bio-printer is being applied to engineer therapeutic tissues
  • What potential does 3D bio-printing have for clinical and commercial manufacturing?
  • Demonstrating the scalability of 3D bio-printing technology to be used more widely
  • Exploring the use of decellularized scaffolding as a medium to manufacture full scale implantable human organs
  • Navigating the regulatory pathway and the roadblocks to success
  • How will 3D bio-printers contribute to the future of biologic drug products and regenerative medicine?

Keith Murphy
Chairman and CEO
Organovo

17:20-17:30

Manufacturing Chair’s closing remarks

Andrew Ramelmeier, Ph.D.
VP, Manufacturing and Facilities
BioMarin

QUALITY CHAIR

Ronald C. Branning
VP, Quality
Gilead Sciences


Day 2, 30th January 2014 (Thursday)

07:15-08:15

Delegate registration and light breakfast

08:15-08:20

MANUFACTURING CHAIR'S WELCOME ADDRESS AND REVIEW OF DAY ONE

Andrew Ramelmeier, Ph.D.
VP, Manufacturing and Facilities
BioMarin

SUPPLY CHAIN CHAIR

Timothy Redmond
Director, Business Development
World Courier

QUALITY CHAIR

Ronald C. Branning
VP, Quality
Gilead Sciences

08:20-09:20

Keynote: Capacity management

Looking at the big picture: Applying a risk-based approach to global product supply management

  • Debating the merits of nimble and flexible facilities versus manufacturing battleships
  • Preparing your pilot plants and manufacturing facilities to move forward with Phase II-III approvals
  • Forecasting requirements for optimizing manufacturing equipment, facilities and partners to increase speed to market

Case study: Using cross-functional metrics to drive a flexible manufacturing network

  • Achieving business goals to better manage times of product and economic uncertainty
  • Putting theory into practice: Implementing key metrics to improve manufacturing flexibility
  • Establishing a baseline within your network to help gauge operational performance
  • Limiting idle space and using data-driven models to better plan for capacity
  • Examining a case of when to build new or renovate existing facilities
  • Managing capital investments to support global product growth over the next 2-3 years

Andrew Skibo
EVP, Operations
MedImmune

Lance Minor
VP, Operations Strategy and Network Performance
MedImmune

09:20-09:55

KEYNOTE: BIOMANUFACTURING UNDER PRESSURE

Embracing manufacturing complexity to build manufacturing capability and competitive advantage

  • Introducing a systems framework to manage manufacturing complexity and drive performance improvements
  • Highlighting the evolution of a manufacturing system through an industry case study of Genzyme's Allston Landing facility
  • Meeting the challenges within a complex system: Contamination crisis, supply shortage and consent decree
  • Translating lessons learned at the manufacturing network level

Sandra Poole
SVP, Biologics Operations
Genzyme, a Sanofi company

09:55-11:15

PRE-ARRANGED 1-2-1 MEETINGS AND REFRESHMENTS

11:15-11:50

Manufacturing Excellence

Keeping up with the changes in demand for vaccines by managing production flexibility

  • Addressing the benefits and drawbacks of single-use bioreactors and flexible facilities
  • Increasing flexibility in manufacturing processes and facilities with disposable technologies
  • Implementing single-use systems in downstream purification and F&F operations of clinical vaccine products
  • Our journey in the flexibility and ease in facility changeover: Explaining the roadblocks and solutions

Tony D'Amore, Ph.D.
VP, BioProcess R&D, North America
Sanofi Pasteur

SUPPLY CHAIN

Developing joint and shared audit programs to ensure the quality of raw materials used in biomanufacturing

  • Establishing strong operational control and quality processes to drive supply chain transparency
  • Mitigating supply chain risk through the application of regulatory guidance from the FDA, EU and ICH
  • Striking the balance between cost and security of materials manufacturing at suppliers and CMOs
  • Assessing internal and external contractor's capabilities to build a culture of quality across complex global supply chains
  • Case study: Improving supply chain reliability through the standards and mechanisms of Rx-360 in conjunction with regulatory guidance

Wes Schmidt
VP, Operations Quality Assurance
AbbVie

Quality and compliance

Establishing quality agreements and increasing oversight in your contract manufacturing operations

  • Enhancing quality operations and agreements with CMOs in emerging markets
  • How can you add value and efficiency to quality teams at third party manufacturing networks?
  • What are the best practices and greatest challenges?
  • Working collaboratively to implement the right quality system and leadership
  • Building from a strong internal culture to ensure effective transfer of quality standards

Jaspreet Gill
VP, Global Quality and Compliance
Baxter Healthcare

11:50-12:25

Workshop: Manufacturing excellence

Establishing an effective quality focus to improve bioprocessing operations

  • Creating a quality focus early in the product lifecycle to ease the path to product realization and a state of control
  • Balancing phase appropriate applications of:
    • Quality systems
    • Knowledge and risk management
    • Product control
  • Practically embedding a quality focus into the product lifecycle

Mark J. Kuenzi, Ph.D.
Director, Quality Assurance
Fujifilm Diosynth Biotechnologies

Workshop: Supply chain

Principles of good distribution practices and the influences on a full service chemical management model

  • Contrasting modern distribution models with the future of full service chemical management
  • Ensuring supply chain security through competent chemical management services
  • Building reliable and auditable business processes
  • Uncovering new ways to do business and find innovative supply chain solutions

Spencer Todd
VP, Production and General Manager
Doe & Ingalls

Workshop: Quality and compliance

Strengthening your organization’s quality and compliance capabilities

  • Establishing quality as a strategic competitive advantage across your global operations
  • Developing robust quality systems and metrics
  • Driving the continuous improvement of established quality procedures
  • Applying pharmaceutical risk management principles
  • Creating synergies with suppliers and CMO partners to create a two-way street to improve quality

Zena Kaufman
SVP, Global Quality
Hospira

12:25-12:50

Pre-arranged 1-2-1 meetings

12:50-13:50

Themed lunch

Benefit from some additional networking and ask your questions about specific topics at themed lunches hosted by our commercial partners. Places are limited so sign up in the registration area during Day One and in the morning of Day Two. Choose from:

  • Doe & Ingalls: Outsourcing supply chain management
  • DSM Pharmaceuticals: Take advantage of the Australian R&D Tax Credit, 45cts to the $, and the latest technologies for flexible processing
  • Kinaxis: How do you balance network planning with manufacturing effectiveness?
  • Roche Diagnostics: Supporting QbD initiatives using consolidated bioanalytical platforms
  • World Courier: Evolving requirements for the distribution of pharmaceuticals supplies in Europe and beyond

13:50-14:25

Manufacturing Excellence

Licensing the facility of the future now: Doubling production capacity to respond to increasing customer needs

  • Maximizing closed processing while minimizing human intervention to improve quality operations
  • Developing unique process technologies to achieve Operational Excellence
  • Optimizing modularization to achieve aggressive project schedules while minimizing lifecycle cost
  • Selecting the best owner/contractor teams for project execution

Detlef Kehm, Ph.D.
VP, Project and Site Engineering
Grifols

Supply chain

Case study: Transforming from a company with local processes towards a truly integrated company fit for the future

  • Examining our journey to decrease time in the chain
  • Improving end-to-end time management in the chain with the support of ERP and MES systems
  • Merging your manufacturing technologies with business management in building an optimum organizational architecture
  • Assessing MES and EBR systems: Which are the most efficient and why?

Jérôme Repiton
Head, Lean Six Sigma Program
Ferring Pharmaceuticals

QUALITY AND COMPLIANCE

Creating a clear governance model in your organization to successfully implement new processes and quality systems

  • What can manufacturing teams do to enhance quality assurance and control?
  • Which attributes can quality teams bring to process engineering and design?
  • Managing manufacturing complexity through:
    • Opening communication lines in plant operations
    • Aligning strategic decision making across the business
    • Improving governance standards
  • Case study: Quantifying the impact of improving governance standards at the South San Francisco site

Ashley Taylor
Head, Drug Substance CMO Operations
Genentech

14:25-15:00

Workshop: Manufacturing excellence

Assessing the latest advances in single-use bioreactor control strategies for process optimization

 

  • Overcoming challenges to scale-up, process development and technical transfer from single-use or traditional bioreactors
  • Demonstrating dual sparger designs for more predictable process development and scale-up
  • Achieving a well-characterized hydrodynamic environment
  • Employing key scale-up parameters:
    • Power input per unit volume
    • Mixer tip speed
    • Oxygen transfer coefficient
  • Enhancing cell growth and productivity by balancing the need for CO2 stripping and O2 delivery

Michael Goodwin
Director, R&D
Thermo Scientific (Part of Thermo Fisher Scientific)

Workshop: Process Monitoring and Control

Transforming biopharmaceutical operations through process control monitoring and real-time data aggregation

  • Reducing operational variability and simultaneous need for high service levels
  • Exploring a different paradigm to designing, scheduling and responding to the changing needs of manufacturing facilities
  • Using real-time data to enable robust process monitoring and control

Rick Johnston Ph.D.
Principal
Bio-G

Workshop: Quality and compliance

Modularity in biomanufacturing: Is it of value or not?

  • Riding the wave of the future: How modularity can help minimize facilities cost and timelines
  • Applying modularity to existing facilities and best strategies during new construction
  • Investigating applications of modularity in other manufacturing sectors, such as CPG and electronics 
  • Case studies on clients who use modularity to truly add value to their projects

George Wiker
VP, Technology and Facilities Engineering
M+W Group

15:00-15:30

PRE-ARRANGED 1-2-1 MEETINGS AND REFRESHMENTS

15:30-16:05

CASE STUDY: PACKAGING INNOVATION

Improving collaboration to optimize the product: Balancing the expectations of brand and design teams with manufacturing capabilities and cost controls

  • Understanding patient needs in partnership with brand and design teams
  • Manufacturing perspectives in bringing new packaging innovation to market
  • Defining the role of packaging development as a key integrator of patient needs and manufacturing expectations with the formulation and delivery device
  • Evaluating emerging primary and secondary packaging technologies: What are the pros and cons of standard vs. more patient-focused options?
  • Integrating both the patient and technical drivers for product and packaging innovation while managing the expectations of the marketing organization

Travis White
Director, New Product Planning, Drug Delivery and Packaging
Eli Lilly and Company

CASE STUDY: POST-MERGER INTEGRATION

Addressing the issues of plant comparability and facility fit during M&As

  • What are the crucial considerations for manufacturing and quality departments before the M&A process?
  • Understanding the effects of a shrinking biopharmaceutical universe
  • Which technical aspects of M&A and facilities expansion impact the Board of Directors most?
  • How do you develop an effective program and risk mitigation strategy for facility switch?
  • Which logistical considerations are different vs. the same for M&As and capacity expansions?
  • Coming out on top: Managing manufacturing complexities to execute M&A quickly and efficiently

Paul Marshall
President
Marshall Biopharm Associates

CASE STUDY: VIRAL SAFTEY

Implementing a viral safety procedure to correct apparent viral contamination in perfusion bioreactors and commercial product 

  • What do you do when you've received a contamination report?
  • Examining the technical requirements and evaluation tools required to conduct investigations
  • Outlining the response plan to improve adventitious virus assay (AVA) after investigation revealed a false positive out of specification (OOS) result
  • Processes for discussing information with health authorities
  • Developing a global viral approach to prevent similar problems in the future
  • Exploring the limitations and drawbacks of current risk assessment tools and detection assays
  • Qualifying new analytical technologies to improve viral safety: PCR technology, screening tests and more

Linda Hendricks, Ph.D.
Scientific Director, Analytical Development and CMC Strategist
Janssen

16:05-16:40

MANUFACTURING SPOTLIGHT

Developing a robust technology transfer system at the NIAID/NIH Vaccine Production Program Laboratory to efficiently translate a candidate HIV vaccine for clinical trials

  • Developing robust tech transfer processes from the lab to the clinic under strict timelines
  • Improving monitoring for loss and yield, resins and flow to produce a high pure product for clinical trails
  • Establishing purification processes for highly unstable VLPs from upstream cell line production to downstream products
  • Deploying new technologies to streamline downstream processing: Single-use systems and novel chromatography
  • Overseeing the operations and scale-up at contract manufacturing partners
  • Reviewing the next steps to move from clinical scales to production scales

Xun Liu, Ph.D.
Associate Director, Downstream Process Development – Vaccine Production Program Laboratory, Vaccine Research Center
National Institutes of Health

16:40-16:45

MANUFACTURING Chair’s closing remarks

Andrew Ramelmeier, Ph.D.
VP, Manufacturing and Facilities
BioMarin

SUPPLY CHAIN CHAIR

Timothy Redmond
Director, Business Development
World Courier

QUALITY CHAIR

Ronald C. Branning
VP, Quality
Gilead Sciences

16:45-17:45

Networking drinks reception

Sponsored by: Bio-G


Day 3, 31st January 2014 (Friday)

08:00-08:30

Delegate registration and light breakfast

08:30-08:40

MANUFACTURING CHAIR'S WELCOME ADDRESS AND REVIEW OF DAY TWO

Andrew Ramelmeier, Ph.D.
VP, Manufacturing and Facilities
BioMarin

SUPPLY CHAIN CHAIR

Timothy Redmond
Director, Business Development
World Courier

QUALITY CHAIR

Ronald C. Branning
VP, Quality
Gilead Sciences

08:40-09:15

Keynote: Examining plant and network parameters to improve current performance

Making smart investments in manufacturing and supply chain technology: Which will be most relevant in the future?

  • Assessing industry trends affecting biologics production and technology procurement:
    • Competitive production costs
    • Commoditization of technologies
    • Expanding global footprints
  • Is there an advantage to purchasing a facility in an emerging market?
  • Meeting emerging technology needs for multi-product operations and new product innovations

Alison Moore, Ph.D.
SVP, Operations Technology
Amgen

09:15-09:50

Keynote: Developing a world-class continuous improvement program

Driving transformational change across your global supply chain by applying leadership and people enablement strategies

  • Applying lean principles to encourage teams to work at their full capability
  • Rethinking years of cultural inertia and uniformity to improve lead time and flexibility
  • Exploring how leading automotive and technology companies are capitalizing on best practices: What can the pharmaceutical industry learn from them?

Craig Kennedy
SVP, Global Supply Chain Management, Merck Manufacturing Division
Merck & Co.

09:50-11:10

Pre-arranged 1-2-1 business meetings and refreshments

11:10-11:45

Manufacturing excellence

Examining the scientific and technical requirements for harmonizing fermentation and microbial systems within a complex biologics portfolio

  • Assessing production systems opportunities and routes for improving early manufacturing of proteins
  • Tackling the challenges of fermentation, mediums, non-harmonized and complex feeds
  • Case study: Developing effective assays for production

Henrik Andersen, Ph.D.
Executive Director, Bio-Process Development
ZymoGenetics, a Bristol-Myers Squibb company

Supply chain

Boosting traceability and security in the supply chain with serialization: Understanding expectations to ensure compliance with new legislation on serialization standards for 2015

  • Where are we in moving toward global agreements for serialization?
  • What are the preferred software and hardware technologies for customization?
  • Assessing the level of systems sophistication and infrastructure required for compliance with standards
  • Developing and implementing systems with packaging and CMO partners:
    • Exception handling
    • Production requirements
    • Data capture
  • Looking forward: Examining legislation to determine where serialization is heading

Claude Durepo
Director, Serialization and e-Pedigree
Gilead Sciences

Paul Seaback
Head, Global Supply Chain
Gilead Sciences

QUALITY AND COMPLIANCE

Case study: Assessing QbD considerations, validation and regulatory approval for the manufacture of Flucelvax®, a cell culture based influenza vaccine

  • Understanding how QbD techniques can help to adapt the production process to strain to strain variability
  • Using the latest aseptic technologies and meeting safety requirements of large-scale flu vaccine manufacturing
  • Successfully using a fully closed manufacturing system to enable propagation of biosafety level III wild-type virus
  • Efficiently gaining licenses for seasonal vaccines in Europe and the U.S. meeting regulatory requirements of both markets
  • Learning about the validation strategy and concept of the flu cell culture production process
  • Fast response to pandemic situation including the latest improvements to accelerate the availability of the vaccine

Manfred Brunen, Ph.D.
Manager, Flu Cell Culture Projects and Training
Novartis Vaccines and Diagnostics

11:45-12:20

Workshop: Manufacturing excellence

Streamlining recombinant protein manufacturing with secretion of biologically active proteins from bacteria

  • Addressing the common challenges with recombinant protein production from E. coli:
    • Improving protein aggregation
    • Reducing timelines of lengthy purification
    • Correcting inefficient refolding processes 
  • Creating scalable, high cell-density, endotoxin-free fermentation processes to manufacture commercially valuable proteins
  • Developing alternative systems to eliminate multiple purification steps
  • Eliminating the need for cell lysis and protein refolding
  • Reducing the number of difficulties, lowering costs and speed to market

Kristin DeFife, Ph.D.
Director, Biologics
Ajinomoto Althea Inc.

Workshop: Process Monitoring and Control

Leveraging coupled bioreactor analytics, automated sampling and applied mathematics to improve cell culture and bioreactor operations

  • Enhancing process development methods through the application of novel and existing bioreactor monitoring technologies and processes
  • Maximizing big data and data-integration to generate real-time high quality data sets to meet the dynamic requirements of cell cultures
  • Developing robust processes with a multi-disciplinary approach to:
    • Molecular biology
    • Engineering
    • Advanced process controls
    • Modeling
  • Employing dielectric spectroscopy (DS), process-analytical technology (PAT) and cell-based bioreactor models with a simple, compact device that automatically obtains samples aseptically at specified intervals for off-line analysis
  • Achieving process improvements, meeting QbD requirements and shortening development timelines
  • Case study: Linking on-line data with applied-mathematics techniques to increase process understanding cell performance and productivity

Lisa Graham, Ph.D.
SVP, Biotherapeutics and New Technology
Bend Research

Workshop: Quality and Compliance

Case study: Implementing the Continued Process Verification (CPV) program at Baxter BioScience

  • Accessing process and quality data stored in electronic and paper systems
  • Improving data analysis and understanding process variability
  • Defining the essential element of a collaborative CQV program
  • Overcoming challenges to making comparisons across the global manufacturing network
  • Changing the culture and adapting participants to new habits
  • Capitalizing on the business benefits and expectations for future expansion

Justin O. Neway, Ph.D.
Chief Science Officer
Accelrys

Marco Arocha Jr.
Manager, Information Systems
Baxter BioScience

12:20-13:20

LUNCH AND LEARN ROUNDTABLE

Benefit from additional thought leadership and networking during lunch. Join other delegates at speaker-led roundtables:

LUNCH AND LEARN ROUNDTABLE

Quality risk management

Jaspreet Gill
VP, Global Quality and Compliance
Baxter Healthcare

LUNCH AND LEARN ROUNDTABLE

Addressing the business drivers and needs to develop the facility of the future

Ken Hamilton, Ph.D.
Director, Process Engineering
Genentech

12:25-13:20

LUNCH AND LEARN ROUNDTABLE

Strategies for technology transfer: Getting the most from your investment

Mark Fromhold, Ph.D.
Director, Biologics Outsourcing
Gilead Sciences

LUNCH AND LEARN ROUNDTABLE

Capacity management and sharing: Establishing your manufacturing asset base as a variable

Darren Dasburg
VP, Capacity Utilization
MedImmune

LUNCH AND LEARN ROUNDTABLE

Providing leadership to validations, regulatory and quality aspects during technology transfer to emerging markets

Rakesh Kakkar, Ph.D.
Director, Technical Operations, Emerging Markets
Pfizer

13:20-13:55

KEYNOTE: Efficient, effective and compliant biomanufacturing

Assessing future trends in bioprocess development and manufacturing

  • What are the tolls for designing product quality?
  • Applying cutting-edge technologies to improve process control and predictability
    • Sophisticated spectrometry and probing tools
    • Real time on-line and in-line monitoring technologies
  • Weighing QbD and biology and where they fit into a larger spectrum

Rohin Mhatre, Ph.D.
VP, Biopharmaceutical Development
Biogen Idec

13:55-14:30

Manufacturing excellence

Examining a complete process fit for end-to-end single-use commercial production of monoclonal antibodies

  • Evaluating the sensitivity of single-use equipment at lab and commercial scale
  • What are the timelines, struggles and hurdles in implementing disposable systems in clinical and commercial capacities?
  • Comparing stainless to single-use options for CHO mAb platform:
    • Reviewing layout and capital investments
    • Cost analysis at full and partial capacity
    • Total cost of ownership/NPV assessments
    • NPV modeling
  • Best examples of single-use vs. traditional stainless steel process fits and facility designs
  • Envisioning modular 2kL, multi-product facilities for hybrid process fit options

Mark Petrich, Ph.D.
Associate Director, Engineering
Merck & Co.

Supply chain

Improving network effectiveness: Assessing the latest processes and toolkits to help drive significant improvements in your global operations

  • Overcoming challenges to high product values, regulated operations and limited product shelf-lives
  • Reducing waste in biologics supply chain operations
  • What industry best practices can help you achieve enhanced visibility, efficiency and robustness?

Elisabeth Kaszas
Director, Supply Chain Management
Amgen

Quality and compliance

Aligning quality systems: Identifying the critical needs of quality based on Lean Six Sigma to create a strong framework for ICH implementation

  • Transitioning from a traditional to an enhanced approach by developing project-based activities
  • Improving process performance and product quality monitoring systems
  • Restructuring and rethinking the responsibilities of QA departments
  • Capitalizing on the benefits of reduced process redundancies
  • Measuring the efficiency of manufacturing and quality teams through quality metrics and KPIs
  • Exploring new opportunities ICH offers to CAPA, complaint handing and product lifecycle management

Rudolf Frank, Ph.D.
VP and Head, Global Quality Management
Actelion Pharmaceuticals

14:30-15:00

Pre-arranged 1-2-1 meetings and refreshments

15:00-15:35

THOUGHT LEADERSHIP: Overcoming institutional inertia and short-term standards in the industry

Integrating R&D and manufacturing to create a roadmap for accelerating biotech development

  • Taking a cross-disciplinary approach to foster and leverage innovation in drug substance, drug product and analytical
  • Decentralizing manufacturing to increase flexibility:
    • How could it impact the supply chain and plant network?
    • What are the impacts on testing and quality assurance oversight?
  • Improving process understanding using in-line and on-line analytics
  • Demonstrating new technologies that can speed-up upstream and downstream processes
  • Taking a beginning to end development approach to improve product quality and performance

Timothy Charlebois, Ph.D.
VP, Technology and Innovation Strategy, BioTherapeutics Pharmaceutical Sciences
Pfizer

15:35-16:20

Panel discussion: Building the facility of the future

Selecting breakthrough technologies poised to revolutionize the industry

   
  • What technologies are needed to address market demands for personalized medicines, orphan products and niche busters?
  • Assessing new opportunities to improve bioprocess development and manufacturing
  • Exploring the next frontier of biomanufacturing innovation:
    • Moving from batch processing to continuous manufacturing
    • Expanding validation capabilities and network capacity
    • Reviewing game changing technology and facility design
  • What can we do to communicate with suppliers to help bring the latest innovations to market?
  • Responding to FDA requirements: Pushing for bigger and better technologies

Alain Pralong, Ph.D.
VP, New Product Introduction and Technical Life Cycle Management
GlaxoSmithKline

Dave Nichols
Senior Director, Process Development
Shire

Detlef Kehm, Ph.D.
VP, Project and Site Engineering
Grifols

Jonathan Sowerbutts
Director, Technical Operations
Janssen

Rob Wright
Chief Editor
Life Science Leader

16:20-16:25

QUALITY CHAIR'S CONCLUDING REMARKS AND CLOSE OF SUMMIT

Ronald C. Branning
VP, Quality
Gilead Sciences

SUPPLY CHAIN CHAIR

Timothy Redmond
Director, Business Development
World Courier

Manufacturing Chair

Andrew Ramelmeier, Ph.D.
VP, Manufacturing and Facilities
BioMarin