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

Day 1, 18 February

12:20-13:20
13:20-13:30
13:30-14:00
keynote

 

  •  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 allows for the new capability to be internalized

  • Lessons learned and best practices for success

Joydeep Ganguly
Site Head and General Manager
BIOGEN Idec Inc


14:05-14:35
solution spotlight

  • Achieving maximum transparency of critical Demand and Supply drivers and trigger points
  • Building alignment and resolution around business critical issues
  • Filtering through the “noise” and leveraging tools and processes to get to what really matters

Michael Mastroianni
Executive Director, Global Supply Chain Strategy & Transformation
Bristol-Myers Squibb


14:35-15:50

Check-in and Win!

 

For every meeting you attend on your itinerary you will receive a point - 6 points allows you to go into the draw to win a five night holiday for two to Punta Cana in the Caribbean valued at $2,000.


15:20-15:50
15:50-16:20
solution spotlight

 

  • Industry evolutions outside biopharmaceuticals
  • The case for speed AND robustness
  • Simplifying development and linking to manufacturing
  • Accessing expertise to build product value

Laura Parks, Ph.D.
SVP of Corporate Operations and Strategic Initiatives
Patheon


solution spotlight

 

  • Using Operational Excellence as a starting point for simulations
  • Using real data from your plant historians to build predictive simulations
  • How simulations can help increase throughput by 30% or more with little or no capital investment
  • Case studies with, and without, a simulation model to show the benefit to manufacturers

 

Rick Johnston Ph.D.
Principal
Bio-G


16:25-16:55
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 a state of the art multi-product facility to generate multiple compounds in the same facility

Michael Howaldt
SVP Biopharma Operations and Site Head
Boehringer Ingelheim


16:55-17:00
17:00-18:30

Our champagne speed networking is designed to accelerate your business contacts. You will greet other attendees in a series of brief exchanges during this time. It’s a great opportunity to share your professional background and business goals.

Every 3 minutes a bell will ring prompting attendees to move onto the next meeting.


Day 2, 19 February

07:30-08:00
08:00-08:50

 

  • Developing a manufacturing strategy for BRIC(K)* Countries requires careful consideration of “Everything” (that can impact the size of the local plant and required capacity output over time)
  • For example, modular expansion is tremendously important for profitability while automation is a major protection of company’s profit.
  • Challenges are cost pressures, limited biotech exposure of local regulators, developing infra-structure, and inexperienced plant operations work-force.
  • A SmartFactory is an enabeler of modern and cost effective manufacturing strategies efficiently mitigating those challenges.

*Brazil, Russia, India, China (and Korea)

Philipp Hess PhD
Founder and Managing Partner
PHA - Philipp Hess Associates


08:50-09:00
09:00-09:30
solution spotlight

  • SmartParts: auto-recognition with distributed control
  • SmartSystems: universal controllers, modularity and scalability
  • SmartFactories: resource optimisation, harmonisation and quality

Dr. Barbara Paldus
CEO
Finesse Solutions, Inc


09:35-10:05
solution spotlight

 

  • A decade of derisking major bioprocess facilities
  • Radical capital reduction possibilities: lowering barriers and opening doors
  • Elimination of scale-up and tech transfer unknowns at phase 2 and beyond
  • When and how will continuous bioprocessing become mainstream?


10:05-10:10
10:10-10:40
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

 

 

 

  • 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


10:40-11:55

Check-in and Win!

For every meeting you attend on your itinerary you will receive a point - 6 points allows you to go into the draw to win a five night holiday for two to Punta Cana in the Caribbean valued at $2,000.


11:25-11:55
11:55-12:25
solution spotlight

  • Benefits of single-use technologies
  • Single-use limitations for microbial fermentation
  • Engineering design considerations for a single-use fermentor system
  • Functional performance of a single-use fermentor for E. Coli and Pichia Pastoris organisms  

Heather Kramer
Senior Engineer, Bioprocessing
Thermo Firsher Scientific, Single-Use Technologies Unit


solution spotlight

  • Addressing the common challenges with recombinant protein production from E. coli:
    • Protein aggregation
    • Lengthy purification
    • Inefficient refolding processes
  • Creating  a scalable, high cell-density, endotoxin-free fermentation process 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 reducing time to market

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


12:25-12:30
12:30-13:00
solution spotlight

  • Cytovance introduces the Keystone Expression System™,  an IP-free platform for E. coli strain development.
  • The platform includes custom vectors, host strains, and screening workflow to evaluate many expression techniques in parallel
  • Platform fermentation process that fit the expression systems allow for robust high-cell density screening of candidate strains

April Stanley
Manager, Cell Line & Strain Development
Cytovance


solution spotlight

  • Defining Needs for Specialty Transportation Requirements
  • Chain of Custody
  • Planning & Communication
  • Packaging/Monitoring
  • Understanding Regulatory Requirements
  • Building a Partnership with your Provider

Keegan Moore
Director of Business Development
World Courier Inc.


13:00-13:50

During the networking lunch there will be a limited number of themed lunch roundtables for delegates to participate in hosted by our commercial partners. 

Each roundtable will focus on a different theme which will kick start a discussion amongst your peers. A buffet lunch will be served.

Confirmed themed lunch roundtables hosts:

  • Finesse
  • Althea
  • Biovia


13:50-14:20
stream 1
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
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


14:20-14:25
14:25-14:55
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


14:55-15:00
15:00-15:30
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
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


15:30-16:20
16:20-16:50
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
supply chain

 

  • Single sourcing in the field of biotech manufacturing requires a layered approach per material type/usage. Typical material clusters are:
  • Alternatives not desirable or extremely challenging to qualify (e.g., suppliers of process-specific/unique materials, e.g. chromatography resins)
  • No alternatives pursued (e.g., feasibility of safety stock such as low $/quantity, strong supplier relationship)
  • Secondary alternatives available to be qualified (e.g., for high $, high quantity materials, volatility of supply market)
  • Risk mitigation approach to be developed per (Quality and Regulatory) risk profile:
    • Nature of raw material in question and complexity of market (e.g. customization)
    • Where it is used in the process (criticality of process step)
    • Regulatory considerations
  • Case study: cell culture dry media powder supplier and material qualification program

Yuval Shimoni
Principle Engineer
Bayer


16:50-16:55
16:55-17:25
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
supply chain

 


  • Strategy Development: 2020 and Beyond
  • Internal Manufacturing and Global Supply
  • External Manufacturing, CMO partnerships
  • Creating a strong operations philosophy: Safely, Correctly, On Time, Every Time
  • Using the philosophy to execute the strategy

?     Integration of Operational Excellence

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


Ray Kaczmarek
Vice President, Manufacturing & Supply Operations
Pacira Pharmaceuticals


17:25-17:55
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


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


Salvatore Mascia
Founder
CONTINUUS Pharmaceutical


Younok Dumortier Shin
Director, Large Molecule Technology Platform
Janssen


17:55-18:00
18:00-19:00

 

We are hosting an evening social designed for you to continue networking with summit attendees.

The winner of the Punta Cana, Caribbean holiday will be announced.

Wine and beer will be provided.


18:30-20:30

Over the years, Laguna Beach has established itself as a world-class culinary destination. What this means for you? You are so in for a treat!

The majority of their restaurants are independently owned; there are no large chains or franchises in Laguna Beach. This pride of ownership has served as the foundation for their gourmet renown, and you see it reflected in every type of restaurant, from 5-star Forbes recipients to the small storefront serving up immaculate fish tacos. The restaurateurs here in Laguna Beach are able to create without limit ... and they do.

With more than 90 restaurants in our 8-mile span get out and explore. Experience all of the foodie wonder of Laguna Beach.

 

Coaches will pick up event guests from the Hyatt Regency Orange County at 18:30 and a returning coach from Laguna Beach at 22:30.


Day 2, 19 February

08:15-09:00
09:00-09:10
09:10-09:40
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

Wendy Nelson
Head of Manufacturing
Genentech


09:40-10:10
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


Ronald C. Branning
VP, Quality
Gilead Sciences


Wendy Nelson
Head of Manufacturing
Genentech


10:10-10:40
10:40-11:10
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


11:10-11:15
11:15-11:45
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


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.


11:45-12:15
stream 1
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 2
supply chain

 

  • Planning technology transfer from R&D to commercial Scale-Up – Case Study , protein sciences leverages the BEVS llatform 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


12:15-12:25
12:25-13:30