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

Day 1, 18 February


Trends and strategies for the future

Alain Bernard


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


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


Day 2, 19 February


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

Lance Minor
VP, Operations Strategy and Network Performance

stream 1

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

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

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

Younok Dumortier Shin
Director, Large Molecule Technology Platform
Johnson & Johnson


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

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



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

stream 1

Strategy Development


  • Commercial Manufacturing and Global Supply Chain

  • Use of CMO partnerships to enhance current capabilities and to expand future capacity

  • Creating 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 organizationIntegration 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

Ray Kaczmarek
Vice President, Manufacturing & Supply Operations
Pacira Pharmaceuticals

stream 2
quality and regulatory

Understanding the different stages of process validation as per the FDAs revised (2011) guidance to achieve compliance

  • Adopting a science and risk-based approach to process validation supported by sound statistical analysis of process data
  • Deeply investigating current process efficiencies to fully understand which future improvements are needed
  • Using the investigations to create more robust, cost effective processes in order to achieve overall manufacturing improvement

Ran Zheng
Biopharma Leader and Change Agent Transforming Business for Sustained Growth

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

stream 1

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

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

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

stream 1

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
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
Senior Director, Operational Excellence
Baxter Bioscience

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


Theme: New technologies improving manufacturing processes 

  • Analysing single use technologies such as: 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

This session brings you five of the newest and best innovations addressing your technical needs, as voted by our advisory board (pharm / biopharm representatives). At the end of session you have the opportunity to cast your vote and choose who you think is ahead of the pack. 


Day 2, 19 February


  • 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
VP Biopharmaceutical Operations USA
Boehringer Ingelheim


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

stream 1

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

Mireli Fino
Protein Sciences
Vice President Manufacturing operations

stream 2
quality and regulatory

Supporting external biotech manufacturers in meeting regulatory requirements for auditing

  • Generating an audit report that can be accepted by regulatory authorities worldwide
  • Creating a flexible strategy for auditing to maintain product quality and consistency
  • Incorporating risk assessment in decision making by breaking it down to several different processes: risk control, risk acceptance and executing risk reduction activities 

Andre Dumez
Principle Investigator

stream 3
supply chain

Preparing biotech operations for emerging legislations

  • Understanding the strategy between the industry and the FDA commission: input and response
  • Clarifying any uncertainties of technical details to date filling industry data, concerns and queries
  • Efficiently preparing for the unknown, creating a strategy without full legislative information and requirements
  • Using case study examples from China: understanding about the additional requirements of the East and preparing global suppliers

lunch & learn roundtables

lunch & learn roundtables

lunch & learn roundtables

stream 1

“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

  • Overcoming the sole supplier issue and how it affects the product by establishing best practices for successful transfer
  • Taking holistic approaches to all tech transfer scenarios
  • Establishing the boundary between development and tech transfer from the start: avoiding taking steps backwards
  • Ensuring third parties are equipped with the proper facilities for manufacturing 

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

panel discussion

Using the success stories from last year to identify the major cost drivers for commercialization

  • Understanding how to cut costs and optimize future modelling strategies
  • Identifying the most profitable areas to invest in and overcoming the initial hurdles of production
  • Improving the total costs of producing and the development of value streams
  • Successfully overcoming the future challenges of products becoming commercialized