2nd Euro Lean Sigma and Kaizen for Life Sciences

Day One  Thursday, September 9th, 2010

Pre-Conference Workshop

8:00
Pre-Conference Workshop Registration Opens & Breakfast is Served for Workshop Attendees

9:00
Mapping Critical Questions Workshop Session
Creating Strategic Direction and Flexible, Fast Learning Structures to Support Scientific Quality and Speed from Idea to Launch

Led By:
Arnoud Herremans PhD
Behavioral Pharmacologists, Local Unit Officer, Preclinical Candidate Selecton Unit
ABBOTT

Critical question mapping background:

• What is critical question mapping?
• How critical question mapping can be used to support quality, creativity and speed of science in pharmaceutical R&D
• How mapping works to set strategic direction and gain alignment within the scientific team
• How to map critical questions for your business needs
• How to convert critical question maps into fit for purpose value streams

Full contact mapping session:

• The audience will identify several strategic opportunities they’d like to explore
• Selecting an opportunity of interest, each audience member will gather in teams to map along the walls of the conference room, the critical questions needed to solve that opportunity

Take-Aways:

• Practice a new technique to define scientific direction across multiple functions
• Identify the right scientific problems and set them in sequence and priority
• Define cross-functional dependencies and interactions
• Create management strategy and systems for execution
• Gain cross-functional alignment on strategy
• Learn how to convert that strategic direction into new R&D (or other) value streams
• Define the right experiments to achieve success within cost, time, quality constraints
• Create fast, flexible management systems based on learning
• Ensure on-time delivery of novel science

There will be a networking & refreshment break

12:00
Lunch for Workshop Attendees & Main Conference Registration Begins

Main Conference Begins

13:15
Chairperson’s Welcome and Opening Remarks

13:20
Organizational Alignment and Corporate Culture
Using Lean Sigma as a Vehicle to Drive Organizational Culture within an R&D Organization

• Cultural aspects that are integral to what Lean Sigma is at the core
• Steps to progression of cultural aspects internally within an organization
• Specific experiences from driving culture change through the use of Lean Sigma skills

Speaker
Åsa Ander
Associate Director, Continuous Business Improvement
ASTRAZENECA SWEDEN

14:00
McNeil Case Study
Approach to Lean Implementation and Strategy Development for Roll-Out

• Mission and vision down to tactics via identifying KPIs and establishing measurable objectives
• Creating a well-structured Lean implementation plan
• Internal training on J&J Lean principles within McNeil
• Joint Cultural initiative (R&D and manufacturing)
• Process Mapping and how to address process improvement in a more structured way

Speaker
Filip Frostemark
Director, CProcess Excellence
MCNEIL SWEDEN (A JOHNSON & JOHNSON COMPANY)

 
14:45
Networking and Refreshment Break

15:15
Lean In Research
Separating Transactional and Heuristic R&D Activities as a Key to a Successful Lean Sigma Implementation

• How to balance Lean Sigma efforts in an R&D environment between reducing waste and creating value
• How to improve decision making in an R&D environment using Lean Sigma principles
• Using the Lean Sigma organizational maturity level in R&D as a guideline for the initiation of new improvement initiatives

Speaker
Martin Olander
Development Strategy Leader
VALCON INNOVATION DENMARK

16:00
Accelerating Pure Biological Science Using Lean Principles

• Examining Lean's relationship with the scientific method
• Differences of Lean in manufacturing and R&D
• In manufacturing, Lean applies the scientific method to the value drivers of production, namely, increased perfection and reduced waste. What is it in R&D?

Speaker
Adrienne Motion
Senior Director, Continuous Improvement Lead
PFIZER U.K.

16:45
Organizational Alignment and Corporate Culture
Applying Lean Information Flow Witin a Drug Discovery Environment

• Improving ways of working by maximizing the value of data, information and knowledge
• Optimizing information flow to enable effective decision making
• Identifying common wastes within the information delivery and exploitation process
• Examples of successful, or otherwise, Lean information flow activities within biology

Speaker
Gemma Satterthwaite
Principle Scientist
ASTRAZENECA U.K.

17:30
Close of Day One

Day Two  Friday, September 10th 2010

8:00
Continental Breakfast for Conference Participants

9:00
Chairperson’s Day Two Welcome and Opening Remarks
 

9:05
Lean in Research
Bristol-Myers Squibb Case Study:
Applying Lean Sigma to Improve Administrative Processes in R&D

• Looking at the improvement of administrative processes in a different way
• Unlocking the value of data that describe administrative processes
• Challenges of piloting improvements in administrative processes
• Identifying, predicting and sustaining the gains

Speaker
Nilesh Tailor
Associate Director and Kaizen Leader, Global Development Operations - Data Operations
BRISTOL MYERS-SQUIBB BELGIUM

9:45
How Kaizen Events can Identify Non-Value and Strengthen Clinical Processes

• Unique challenges to deploying Lean Sigma in Pharma R&D
• Prerequisites that need to be in place before Lean Sigma becomes established
• Addressing the concern that rigorous process improvement might limit innovation and creativity

Speaker
Andrew Day
Associate Director, Continuous Business Improvement
ASTRAZENECA U.K.

10:30
Networking & Refreshment Break

11:00
Using Value Stream Mapping and Process Improvement to Reduce Variability in Clinical Cycle Times

• Identifying the steps that slow down progress and increase cycle times
• Standardizing processes despite product differences
• Drawing a future state value map that encourages flow and eliminates waste
• The subsequent implementation process and how to sustain progress

Speaker
Trafford Clarke
Executive Director, Six Sigma Champion
ELI LILLY & CO. U.S.

11:45
Alignment of R&D and Manufacturing
Merck Sharp & Dohme Case Study:
Process Control through Process Understanding - Closing the Gap between R&D and Commercial Production

• Product development using a risk & science based-approach
• Implementation of a Near-Infrared Tool to control, not just monitor, mixing time and allow flexibility in batch size
• Creating a design space, transferring the space to production and dealing with it post-approval

Speaker
Dr. Wim Oostra
Section Head, Oral Dosage Forms
MERCK SHARP & DOHME

12:30
Lunch

13:30
Using Quality Metrics to Drive Direction for Process Improvement Methodologies and Fundamentally Improve the Clinical Drug Development Process

• Using Metrics – how to collect data, report results and common pitfalls
• Examining trial level processes and where key metrics can be generated
• Results from the collection of quality metrics and how measurement can modify clinical team behavior

Speakers
Eli Alford
Director, Operations Management
INC RESEARCH US

Keith Dorricott
Director, Quality Improvement
i3 U.K.

14:15
Process Analytical Technology
Using Process Analytical Technology Versus a Measurement Technology to Create Control-Centric Processes that Do Not Constrain Production

• PAT as a system for designing, analyzing and controlling manufacturing
• Measuring critical quality attributes with the goal of ensuring final product quality
• How R&D can introducing products to manufacturing that can be treated similarly and consistently within the manufacturing process

Speaker
Gawayne Mahboubian-Jones
Program Manager, Excellence in Science and Design
PHILIP MORRIS INTERNATIONAL

15:00
Closing Panel Discussion
Critical Issues in Process Improvement

• Do ‘R&D Only’ Projects Such as Research Innovation Need Special Handling?
• Is there a Lack of Communication between the R&D and Production Silos?
• Are traditional process improvement methodologies able to fit nontraditional learning cycles?
• Closing Q&A

15:45
Close of Conference