Welcome, you can refine the program by selecting an area of interest below:
  • Full Program
  • Focus Day
  • Day 1
  • Day 2
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  • commercial strategy
  • manufacturing excellence
  • supply chain strategy
  • manufacturing
  • quality and regulatory
  • supply chain

DAY 1, 15 October

12:55-13:30

Thriving in challenging conditions of M&As, regulatory requirements and a recovering economic environment

  • Reviewing the growth challenges facing biopharmaceutical companies, including regulatory, IP concerns, shifting demands of customers
  • Creating robust strategies for sustaining growth by interacting with outside advisors
  • Optimizing development to improve commercializations by creating and executing a strategic transformation plan
  • Understanding the impact of M&A and alliances and the role they can play in giving you that competitive edge 


13:30-14:00
stream 1
commercial strategy

Review how key strategies can help in overcoming the difficulties of going into emerging market ventures

 

  • Understanding the governing regulations of your new operational environments
  • Hiring fully trained staff to minimize both costs and risks
  • Choosing a central location for your facilities setup, to avoid having many operational facilities
  • Using disposable technologies to minimize the risks of contaminations
  • Maintaining the quality and integrity of your product


stream 2
manufacturing excellence

Analysing ADCs challenges and creating effective manufacturing solutions  

  • Understanding the complex nature and the unique challenges ADCs present
  • Developing robust and scalable processes that result in the desired product
  • Understanding how facility design can help the process 
  • Overcoming the initial challenges and experiences during ADC manufacturing processes 


stream 3
supply chain strategy

Effectively using third party audits

  • What are the pressures around supply chain and quality?
  • Understanding how to use third party audits to confront supply chain issues
  • Building an effective supplier audit program
  • Reviewing and doing audits of vendor GMP practices
  • Creating an audit process that is consolidated and standardized across the organization 


15:35-16:05

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


16:40-17:10

A look at the current landscape and potential opportunities

  • Overview of the current state of the market, including barriers and regulations
  • What impact will biosimilars have on the biopharmaceutical industry?
  • Considering biosimilars as a business venture

Analysing the established companies and what’s the expected competition


DAY 2, 16 October

09:00-09:30
keynote

Understanding how to align complex biotech manufacturing strategies during pre and post mergers     

  • Assessing the trend and impact of big mergers and acquisitions on the biotech industry
  • Identifying essential components at each stage of the post-merger integration
  • Retaining long-term change management after the formal merger to monitor performance against business goals and objectives to ensure success


10:10-10:40
stream 1
manufacturing

Eliminating risk and implementing a defect free process

  • Managing human error with the increase of automation and technology in plants by setting clear operational standards and reducing human error mistakes
  • Reducing complexity of processes and creating an advanced and reliable way to find the root cause of the issue
  • Quality control approaches to batch processing 


stream 2
quality and regulatory

Submitting new product files to regulatory authorities

  • Identifying what the regulatory bodies require with a new product launch
  • Understanding the key principles behind QbD and PAT and the development of the ICH guidelines
  • Identifying the impact of QbD on change management and understanding how to get regulatory approvals


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


12:15-12:45
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 


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


stream 3
supply chain

Avoiding viral contaminations by selecting the viral clearance methodologies with partners

  • Analysing the new technologies that are available for viral clearance
  • How implementing rigorous testing and control of raw materials can reduce contamination
  • Using a consistent viral clearance methodology during downstream purification processes


13:45-14:15
stream 1
manufacturing

Harnessing the strengths of academia to create a reliable design space

  • Capacity vs pipeline – how do you achieve in this delicate balance
  • Efficiently planning for the uncertainties in pipeline and its impact on planning
  • Using appropriate tools to design an efficient and reliable design space


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


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

 


14:15-14:50
workshop

workshop

workshop

14:50-15:20
stream 1
manufacturing

Maintaining validated states and reviewing success practices   

  • Efficiently creating a  maintain a validation process for a handful of drugs
  • Understanding how much validation process is enough
  • Selecting the right partner and how to form successful collaborations 


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


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 


16:20-16:55
stream 1
manufacturing

The benefits of employing continuous manufacturing in your operations

  • Continuous vs batch production
  • The benefits of employing continuous manufacturing; energy efficient processes, savings in costs, cut in production time, reduction in resources consumed etc.

Increased quality assurance 


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 requir


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


16:55-17:40
keynote

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 3, 17 October

09:00-09:35
keynote

Implementing a flexible manufacturing strategy for a new design space to double production capacity

  • Understanding how to expand capacity quickly and flexibly whilst allowing further expansion in the future
  • Efficiently applying a standardized quality system to obtain FDA approval for the manufacturing facility
  • Creating the state of the art multi-product facility to generate multiple compounds in the same facility


09:35-10:10
keynote

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


11:10-11:40
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


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 


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


11:40-12:15
workshop

workshop

workshop

12:15-13:50
lunch & learn roundtables

lunch & learn roundtables

lunch & learn roundtables

13:50-14:20
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 


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 


14:20-14:50
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


14:50-15:20
15:20-16:20
keynote

 Creating a flexible and robust manufacturing strategy, understanding both the challenges and the opportunities

  • Understanding why single-use makes business sense, to have a flexible manufacturing strategy in place
  • Creating compliant single-use production to achieve low cost of goods whilst ensuring quality and profitability
  • Improving the scalability of disposable technologies  to meet development timeline pressures

Overcoming regulatory challenges in desperate regulatory environments