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  • commercial strategy
  • manufacturing excellence
  • supply chain strategy
  • manufacturing
  • quality and regulatory
  • supply chain

Day 1, 18 February

12:00-12:45
12:45-12:55
12:55-13:30
keynote

Trends and strategies for the future

Alain Bernard
VP
UCB


13:30-14:05
keynote

Overcoming cost pressures at the end of the blockbuster era; keeping an economical advantage without diminishing quality standards of pipeline products to avoid drug recalls

 

  • Keeping expenditures to a minimum despite the  increasing cost of goods without compromising on quality
  • Introducing concrete measures to decrease costs and time to increase productivity and profitability
  • Ensuring quality standardisation during procurement and manufacturing on a global scale

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


14:05-14:10
14:10-14:45
14:45-14:50
14:50-16:05
14:50-15:35

This workshop is to be attend by all delegates in Group 1


15:35-16:05
16:05-16:35
16:35-16:40
16:40-17:10
17:10-17:45

Exploring opportunities for biosimilar development and commercialization vis-a-vis healthcare reform and rising costs

  • Overcoming technical, clinical, and manufacturing challenges of biosimilars
  • Understanding the implications of the healthcare reform on biosimilars
  • Harmonizeing understanding, ensuring safety and not over burdening biosimilar products
  • Exploring FDA's guidelines on biosimilars
  • Understanding regulatory and industry interaction – building a better regulatory setting for the biosimilar industry of tomorrow
  • Efficiently reducing costs and improving patient access

Ronald C. Branning
VP, Quality
Gilead Sciences


17:45-17:55
17:55-19:00

Day 2, 19 February

07:30-08:00
08:00-08:50
08:50-09:00
09:00-09:35

Supply Chain modeling to define risks and drivers of supply shortages

  • Pharma industry continues to seek improvements in gross margin;
  • Operating and fiscal pressures have made inventory a limited solution to mitigate supply risk
  • Outsourcing and consignment stock contracts carry their own risks and costs
  • Rich, multivariate, stochastic supply chain models must be understood to mitigate risk supply shortages
  • What are the next steps that we as an industry can take to build off the FDA Drug Shortage report?

Andrew Skibo
EVP, Operations
MedImmune


Lance Minor
VP, Operations Strategy and Network Performance
MedImmune


09:35-09:40
09:40-10:15
10:15-10:20
10:20-10:55
stream 1
manufacturing

Eliminating risk and error-proofing your process

  • Error-proofing your process before the application of technology or automation
  • Supplementing your error-proofing with automation
  • Identifying behaviors that reduce human error
  • Reducing complexity


Gerard Doyle
Head of Operational Excellence
Shire


stream 2
quality and regulatory

Unique opportunity to think about Quality and Manufacturing

 

  • Adapting to Emerging Market requirements – What we have learned so far?

  • Facing Challenges in Emerging Markets

  • Advice for future emerging markets projects

Eyad Salman
Principal Quality Site Manager
Roche


stream 3
supply chain

Identifying the level of risk of potential contaminations by determining the most critical raw materials

  • Reducing the chances of having contaminations by carefully selecting the right suppliers
  • Carefully analysing the supply and reducing the number of partners to minimize potential risks
  • Ensuring consistent quality in raw materials by setting up short term contracts with suppliers and analysing their products

Bill Scott
Scientist
Biogen Idec


Younok Dumortier Shin
Director, Large Molecule Technology Platform
Janssen


10:55-11:00
11:00-12:15
11:00-11:45

This workshop is to be attended by all delegates in Group 2


11:45-12:15
12:15-12:50
12:50-12:55
12:55-13:30
stream1
manufacturing

Adhering to cGMP requirements and designing the biotech facility of the future

  • Understanding what is expected of process design, future scales and technology requirements
  • Designing the optimal fermentation suites and bio-containment units
  • Creating a water tight strategy to get rid of old equipment and machinery  
  • Overcoming the challenges of contaminations by designing facilities that reduce the risk 

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


stream 2
quality and regulatory

Staying validated throughout manufacturing by deploying hard and soft PAT methodologies

  • Implement CPV to production by analysing both continuous and classical batch process applications
  • Using process verification to ensure a validated state and exploring the necessity of models for multivariate statistical process control
  • Understanding the statistic parameters that could be used to help

Paul Ko
Senior Scientist
Janssen

(h)

stream 3
supply chain

Examining the challenges and opportunities in restructuring your supply chain in the wake of multiple product launches

  • Building up a new manufacturing capability within your supply chain in a cost effective and expedient manner

  • Developing a creative alliance structure that allowed for the new capability to be internalized

  • Lessons learned and best practices for success

Joydeep Ganguly
Site Head and General Manager
BIOGEN Idec Inc


13:30-14:30
14:30-15:05
stream 1
manufacturing

  • Examining the challenges in the commercialization and launch of new products
  • Working with cross-functional teams including supply chain, manufacturing, quality, regulatory and process development
  • Real World case study and best practice recommendations to achieve success

Kimberly Clemenson
Executive Director Global Operations Leader
Amgen


stream 2
quality and regulatory

Pursuing technological, operational and organizational innovations to address today and tomorrow’s challenges in the highly regulated biomanufacturing environment 

  • Employing “Lean Startup” approach to create and capture the values of innovation and improve quality, productivity and speed to market
  • Obtaining strategic advantage by creating an internal and external collaboration ecosystem and embracing sustaining and disruptive innovations

Ran Zheng
Executive Director & Plant Manager
Amgen


stream 3
supply chain

Identifying and securing the most competent and capable partners

  • Identifying the strengths and weakness of partners and monitoring their performance
  • Understanding your partner’s business strategies and aligning them to your biotech organization
  • Forming common goals –with focus on the long term by having a transparent relationship

 

Bernie Huyghe, Ph.D., RAC
Sr. Director, External Supply. Pharmaceutical Sciences, Biotherapeutics & Vaccines Outsourcing, Worldwide Research & Development
Pfizer


15:05-15:10
15:10-15:45
workshop

 

Process and quality data stored in systems like Paper Records, LIMS, LES, EBR, ELN, Historians, ERP, etc., is organized differently in each system to serve the needs of specialized users who focus on different portions of pharmaceutical production processes.  This creates problems for Quality and Process users who need to perform process monitoring, data analysis and reporting on the process as a whole, to understand the sources of variability through initiatives like Quality by Design (QbD).  It also presents needless barriers to identifying Critical Process Parameters (CPP’s) and Critical Quality Attributes (CQA’s) for implementation of automated process monitoring with alerts review-by-exception as part of Continued Process Verification (CPV) initiatives.  These users need an automated way to access, aggregate and contextualize all types of process-related data in a validated environment for analysis and reporting without resorting to labor intensive, error prone spreadsheet methods.  This includes all types of process and quality data, including on-line data from real time (PAT) instruments.  This presentation will describe how pharmaceutical companies have overcome these problems by using a Process Production Operations solution that provides a validated environment for self-service, on-demand access and automated contextualization of data located in disparate source systems without requiring any alterations to the change-controlled sources systems.

Justin O. Neway, Ph.D.
Vice President and General Manager, Operations Intelligence Senior Fellow, BIOVIA Science Council
BIOVIA, a Dassault Systèmes brand


15:45-15:50
15:50-16:25
stream 1
manufacturing

For Commercial Lot Release Activities

Risk based approach (methodology driven by statistical analysis) taken to evaluate the current state of assay performance (analytical system for stability and capability) for the methods which continue to be used for product release

An effective approach to support:

  • Continuous Quality Verification (CQV)
  • Establishing and maintaining a State of Control (Analytical Methods)
  • Facilitate Continual Improvement opportunities

Hemant Kumar PhD
Senior Director, Corporate Quality Operations/Quality Sciences and Analytical Technology
Genzyme


stream 2
quality and regulatory

Fully understanding and satisfying FDAs expectation on QbD implementation

  • Successfully applying regulatory guidance to meet expectations
  • Advancing QbD further than the design space
  • Successfully implementing a total quality concept throughout manufacturing
  • Demonstrating criticality through variant testing
  • Understanding the interactions between CQA’s and material quality
  • Overcoming QbD implementation challenges

Ranjit Deshmukh
Sr. Director, Corporate Technical Science
Medimmune


stream 3
supply chain

  • Watching out for pre-emptive rights
  • Avoiding the unpleasant surprises by having a backup in place
  • Deciding when to establish a second source 

Yuval Shimoni
Principle Engineer
Bayer


16:25-16:30
16:30-17:30
17:30-18:05
stream 1
manufacturing

Why and how is big pharma investing more in continuous manufacturing?

  • Introducing the vision for Integrated Continuous Manufacturing (ICM)
  • Addressing the challenges and benefits of Integrated Continuous Manufacturing
  • Focusing on the future: Breakthrough technologies poised to revolutionize manufacturing of API and dosage forms
  • Ensuring you have fully automated controls to realize true end-to-end processes

Salvatore Mascia
Founder
CONTINUUS Pharmaceutical


stream 2
quality and regulatory

Ensuring crucial compliance quality requirements are met

 

  • Estimating manufacturing costs when you are improving the quality of products
  • Creating and communicating the right strategy regarding product quality management
  • Implementing teaching and training partners on GMP requirements

Michael Teasdale
Former Senior Director, Operational Excellence
Baxter Bioscience


stream 3
supply chain

 


  • Strategy Development
    • Commercial Manufacturing and Global Supply Chain
    • Use of CMO partnerships to enhance current capabilities and to expand future capacityCreating a strong operations cultural philosophy:Safely, Correctly, On Time, Every Time!
  • Using the philosophy to execute the strategy:
    • Establish and enhance goals and objectives for the organization
    • Spark creativity and ownership in employees; development of individual and team scorecards
    • Establish a pathway for process improvement at the lowest level of the organization
  • Integration of Operation Excellence into the commercial manufacturing and supply operations
    • Increasing internal capacity and efficiencies, reducing waste, and ultimately increasing profitability
    • Use of operational excellence to build value for the customer

Heather Young
Senior Director Corporate Manufacturing Strategy and Project Manager
Pacira Pharmaceuticals, Inc.


Ray Kaczmarek
Vice President, Manufacturing & Supply Operations
Pacira Pharmaceuticals


18:05-18:10
18:10-18:45
panel discussion

New technologies improving manufacturing processes

  • Examining new technologies improving manufacturing processes: sensors, software and systems
  • Looking closely into the evolution from PCS to industrial automation and then back again
  • Predicting the development of single use technology in the next 10 years by investing in robust single-use technology
  • Evaluating the the newest and best innovations in the market and what's to come in 2015 and beyond
  • Moving from batch to continuous manufacturing

 

Eyad Salman
Principal Quality Site Manager
Roche


Joydeep Ganguly
Site Head and General Manager
BIOGEN Idec Inc


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


Ran Zheng
Executive Director & Plant Manager
Amgen


Salvatore Mascia
Founder
CONTINUUS Pharmaceutical


Younok Dumortier Shin
Director, Large Molecule Technology Platform
Janssen


18:45-18:55
18:55-20:30

Day 2, 19 February

07:45-08:15
08:15-09:00
09:00-09:10
09:10-09:45
keynote

  • Capacity vs pipeline – how do you achieve this delicate balance
  • Understanding how to expand capacity quickly and flexibly whilst allowing further expansion in the future
  • Creating the state of the art multi-product facility to generate multiple compounds in the same facility

Michael Howaldt
SVP SVP Biopharma Operations and Site Head
Boehringer Ingelheim


09:45-10:20

Bringing  process management and operational excellence to address staff shortage challenges

  • Investing into biotech training programmes to attract talent and promote growth by using talent development and smart planning
  • Successfully creating a programme by using strategic imperatives, cultural attributes and employee engagement drivers
  • Using a new way of thinking to achieve business results and developing an effective pipeline

Wendy Nelson
Head of Manufacturing
Genentech


10:20-10:25
10:25-11:10
11:10-11:45
stream 1
manufacturing

Designing the plant of the future: breaking tradition to reduce complexity, cost and time to production

  • Reducing engineering, commissioning, qualification and validation efforts
  • Efficiently converting to continuous processing to reduce equipment size
  • Identifying the appropriate timelines to upgrade your equipment to stay competitive
  • Using refurbishing to help in the process of expanding manufacturing capacity
  • Applying the latest innovations in manufacturing to operate efficiently and save energy

Joe Revello
Pearl River Core Team, Protein Sciences Corp
Head of Manufacturing


stream 3
supply chain

Understanding the current level of threat and how to best to mitigate it

  • What is the current level of threat?
  • Examining and controlling variability of your raw materials
  • Understanding the full lifecycle of the product
  • Developing strong ties with the supplier to enable transfer of data

Ron Ortiz
Director Six Sigma
Pacira Pharmaceuticals, Inc.


11:45-11:50
11:50-12:25
12:25-13:35
13:35-14:10
stream 1
manufacturing

“Plant-based systems for rapid, inexpensive production of vaccines”

  • Efficiently using alternative manufacturing strategies in biomanufacturing for the production of vaccines
  • Creating a future state of the facility design, evaluating steady operations and using associated benefits
  • Responding to both internal quality and external regulators feedback

Understanding how advances in technology and procedures made change possible

Vidadi Yusibov, Executive Director, Fraunhofer Center for Molecular Biotechnology (CMB) 

Vidadi Yusibov
Executive Director
Fraunhofer Center for Molecular Biotechnology


stream 2
quality and regulatory

Successfully managing process change to achieve regulatory approval

 

  • Understanding regulatory definition of continuous manufacturing to develop a successful strategy
  • Effectively managing process changes  with a worldwide change control system
  • Determining level of change on both validation impact and regulatory impact on the market authorisation process
  • Using CAPA- reducing variability by taking corrective and preventative action for reoccurring problems 
  • Carefully verifying batches are produced, tested and checked in-line with marketing authorisation and cGMP 

Ronald C. Branning
VP, Quality
Gilead Sciences


stream 3
supply chain

Planning technology transfer from R&D to Commercial Scale-Up – Case Study , Protein Sciences Leverages the BEVS Platform to  New Products

  • Establishing principles and best practices for developing new products geared to efficient and expedient transfer to manufacturing
  • Balancing Risk & Time; aligning objectives with deliverables and resources to successfully transfer new products in a small biotech company
  • Managing parallel tracks in Development and Manufacturing, lessons learned and how to we optimized our resources

 

Mireli Fino
Vice President Manufacturing Operations
Protein Sciences Corporation


14:10-14:15
14:15-14:50
panel discussion

  • Overcoming the threat of counterfeit materials entering the supply chain
  • Identifying the most profitable areas to invest in and overcoming the initial hurdles of production
  • Examining new technologies improving manufacturing processes
  • Successfully overcoming the challenges of products becoming commercialized
  • Examining and controlling variability of your raw materials
  • Efficiently planning for the uncertainties in pipeline and its impact on planning

Bill Scott
Scientist
Biogen Idec


Mireli Fino
Vice President Manufacturing Operations
Protein Sciences Corporation


Ran Zheng
Executive Director & Plant Manager
Amgen


Wendy Nelson
Head of Manufacturing
Genentech


14:50-15:00