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Welcome to the SmartLab Exchange February 16-18, 2015 in Philadelphia, PA Maximizing the opportunities of laboratory informatics to increase your R&D productivity and streamline operations Speakers Leading Case Studies, Panels and Discussion Sessions in 2015 Include: Dimitris Agrafiotis VP, Chief Data Officer Covance Cramen Nitsche Executive Director Pistoia Alliance Stuart Miller Senior Director, IS Quality Applications Genzyme/Sanofi Vijay Bulusu Director Informatics & Innovation Pfizer William Telford Director Security & Information Protection Sanofi Peter Boogaard Chief Executive Officer Industrial Lab Automation Tony Williams VP, Head of Cheminformatics Royal Society of Chemistry Steve Thomas Principal Investigator GSK Dana Vanderwall Associate Director of Cheminformatics Bristol-Myers Squibb Robert Boland Directing Sr. Manager, External Innovation R&D IT Johnson & Johnson Eric Milgram Director, Quality Systems Informatics PepsiCo Stuart Merdian Associate Director – Global Quality Assessments and Digitization Systems Procter & Gamble Andrew Porter Director of Enterprise Architecture Merck Yan Song Associate Director, Bioanalysis Operations Abbvie Brett Yeager Special Agent, Cyber Investigations Federal Bureau of Investigation (FBI) Jeffrey Kriseman Chief Public Health Informatics Officer Tennessee Department of Health Evan Guggenheim Principal Scientist Biogen Idec Julie Spirk Principal Scientist Pfizer Patrick Chin IT Specialist, Research Lab Platforms Merck Jeff Hurst Principal Scientist Hershey’s Dr. Lloyd Colegrove Data Services Director, Fundamental Problem Solving Director Dow Chemical Anthony Tahl Project Manager Hologic Wolfgang Colsman Chief Technology Officer OSTHUS Natasja Castro Kreder Senior Business Consultant OSTHUS Ryan Sasaki Director of Global Strategy ACD/Labs Gene Tetreault Sr. Director, Products and Marketing for the Laboratory Informatics Portfolio BIOVIA Louis Hendriks Managing Director Global Value Web

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Page 1: Welcome to the SmartLab Exchange - Home | IQPC …Welcome to the SmartLab Exchange February 16-18, 2015 in Philadelphia, PA Maximizing the opportunities of laboratory informatics to

Welcome to the SmartLab Exchange

February 16-18, 2015 in Philadelphia, PA

Maximizing the opportunities of laboratory informatics to increase your R&D productivity and streamline operations

Speakers Leading Case Studies, Panels and Discussion Sessions in 2015 Include:

Dimitris Agrafiotis VP, Chief Data Officer Covance

Cramen Nitsche Executive Director Pistoia Alliance

Stuart Miller Senior Director, IS Quality Applications Genzyme/Sanofi

Vijay Bulusu Director Informatics & Innovation Pfizer

William Telford Director Security & Information Protection Sanofi

Peter Boogaard Chief Executive Officer Industrial Lab Automation

Tony Williams VP, Head of Cheminformatics Royal Society of Chemistry

Steve Thomas Principal Investigator GSK

Dana Vanderwall Associate Director of Cheminformatics Bristol-Myers Squibb

Robert Boland Directing Sr. Manager, External Innovation R&D IT Johnson & Johnson

Eric Milgram Director, Quality Systems Informatics PepsiCo

Stuart Merdian Associate Director – Global Quality Assessments and Digitization Systems Procter & Gamble

Andrew Porter Director of Enterprise Architecture Merck

Yan Song Associate Director, Bioanalysis Operations Abbvie

Brett Yeager Special Agent, Cyber Investigations Federal Bureau of Investigation (FBI)

Jeffrey Kriseman Chief Public Health Informatics Officer Tennessee Department of Health

Evan Guggenheim Principal Scientist Biogen Idec

Julie Spirk Principal Scientist Pfizer

Patrick Chin IT Specialist, Research Lab Platforms Merck

Jeff Hurst Principal Scientist Hershey’s

Dr. Lloyd Colegrove Data Services Director, Fundamental Problem Solving Director Dow Chemical

Anthony Tahl Project Manager Hologic

Wolfgang Colsman Chief Technology Officer OSTHUS

Natasja Castro Kreder Senior Business Consultant OSTHUS

Ryan Sasaki Director of Global Strategy ACD/Labs

Gene Tetreault Sr. Director, Products and Marketing for the Laboratory Informatics Portfolio BIOVIA

Louis Hendriks Managing Director Global Value Web

Page 2: Welcome to the SmartLab Exchange - Home | IQPC …Welcome to the SmartLab Exchange February 16-18, 2015 in Philadelphia, PA Maximizing the opportunities of laboratory informatics to

The SmartLab Exchange Network Includes:

The Exchange Format: Learn. Engage. Network.

Page 3: Welcome to the SmartLab Exchange - Home | IQPC …Welcome to the SmartLab Exchange February 16-18, 2015 in Philadelphia, PA Maximizing the opportunities of laboratory informatics to

SMARTLAB EXCHANGE Pre-Event Evening – Monday, February 16, 2015

6.45 PM (open until 8pm)

Event Registration

You will be greeted at registration by dedicated SmartLab Exchange team members who will run through your personal schedule for the Exchange. You will also receive a “Top Projects” sheet, which includes a list of challenges each registered delegate is looking to overcome. This is a great tool to help ‘break the ice’ when networking with your fellow lab informatics professionals and helps you identify which of your peers in attendance are facing similar challenges to you, helping you to maximize your time at the Exchange.

7.00 PM

Ice-breaker Networking Session & Welcome Drinks Reception

Branded as “the best networking session I’ve ever attended” by a number of past Exchange delegates, this structured networking session is the ideal opportunity for you to capitalise on time out of the office by speaking to each of your peers in attendance.

How does it work? It’s easy. You spend five minutes on one table, and when the bell rings you’ll be directed to the next one to start another round of networking. At the end of the session you’ll have met most of your peers, and if you haven’t, you can continue into the drinks reception at the end of the day.

SMARTLAB EXCHANGE Day One – Tuesday, February 17, 2015

7.30 AM

Event Registration You will be greeted at registration by dedicated SmartLab Exchange team members who will run through your personal schedule for the Exchange. You will also receive a “Top Projects” sheet, which includes a list of challenges each registered delegate is looking to overcome. This is a great tool to help ‘break the ice’ when networking with your fellow lab informatics professionals and helps you identify which of your peers in attendance are facing similar challenges to you, helping you to maximize your time at the Exchange.

8.15 AM

Welcome From The SmartLab Exchange

Laila Sienne, Head of Production, SmartLab Exchange

8.20 AM

Chairman’s Welcome

Carmen Nitsche , Executive Director at Pistoia Alliance Peter Boogaard, Chief Executive Officer at Industrial Lab Automation

Big Data Science: Driving Productivity. Enabling Collaboration

8.40 AM

Keynote Introduction Driving Quality And Productivity Through Intelligent Use Of Laboratory Data: Why Market Leadership Matters As a market leader in central laboratory and pre-clinical services and top 5 provider of phase III clinical trial management services, Covance has assembled the most comprehensive investigator knowledge-base in the pharmaceutical industry, spanning >11,000 protocols, >600 indications, >175,000 unique investigators, and >14 million patient visits over the past 10 years. Here, Dimitris describes how Covance leverage this historical data to optimize the selection of sites for new clinical trials using tailored optimization algorithms, a normalization strategy for investigator performance, and a set of dynamic visualization displays that enable clinical trial planners to understand the impact of their choices and make more informed decisions.

Dimitris Agrafiotis, VP & Chief Data Officer at Covance

9.00 AM

Panel Discussion Transform Your Data Into Knowledge: How To Use Data To Drive Intelligence And Improve R&D Productivity Accessing, aggregating, mining and sharing scientific data in a productive way is essential to every business, but with concerns of system integration, data produced in disparate format and collaboration, the journey from simple data management to knowledge and, ultimately business critical insight is paved with many obstacles. Our experts will share their views and success stories on how to drive an efficient data management strategy and generate competitive business intelligence.

Panellists:

Dimitris Agrafiotis, VP & Chief Data Officer at Covance

Eric Milgram, Director, Quality Systems Informatics at PepsiCo

Jeffrey Kriseman, Chief Public Health Informatics Officer at Tennessee Department of Health

Anthony Williams, VP Strategic Development, Head of Cheminformatics at Royal Society of Chemistry

Vijay Bulusu, Director Informatics & Innovation at Pfizer

10.00 AM

One-to-One Business Meetings

10.35 AM

Think Tank Enabling Collaborative Data Improvement And Analytics Driving Global Operational Collaboration through Better Data

Louis Hendriks, Managing Director at Global Value Web

One-to-One Business Meetings & Coffee Break

Page 4: Welcome to the SmartLab Exchange - Home | IQPC …Welcome to the SmartLab Exchange February 16-18, 2015 in Philadelphia, PA Maximizing the opportunities of laboratory informatics to

11.10 AM

Case Study Building Your Laboratory Informatics Strategy: The benefit of reference architectures & data standardization Modern laboratory processes have to deal with a multitude of data sources originating from different instruments, systems, sites and external resources. As a consequence data analytics is severely limited by incomplete or inconsistent metadata and different data formats. This complexity leads to inefficient processes and high costs due to insufficient data integration and accessibility.

Showing different use cases, we will present a successful data and systems integration approach using reference architectures and data standardization, resulting in increased cost efficiency and improved decision making.

Dana Vanderwall, Associate Director, Cheminformatics at Bristol-Myers Squibb Wolfgang Colsman, Chief Technology Officer at OSTHUS Natasja Castro Kreder, Senior Business Consultant at OSTHUS

11.40 AM

One-to-One Business Meetings

12.15 PM

Think Tank Improving Data Quality How to clean up your legacy R&D data?

Wolfgang Colsman, Chief Technology Officer at OSTHUS Natasja Castro Kreder, Senior Business Consultant at OSTHUS

One-to-One Business Meetings & Coffee Break

12.50 PM

One-to-One Business Meetings

1.20 PM

Like and Like Strike Together: Interactive Networking Lunch During this lunch break, take the opportunity to network with those attendees who share your interests, challenges and expertise to maximise your time at the Exchange.

How does it work? Each table will be labelled with a different theme e.g. collaboration, LIMS, cloud computing, change management, and so on. You then sit at the table you feel is most relevant to you. So whether you’re a seasoned expert with war stories galore, or completely new to the area, you’ll be surrounded with people who have been, or soon will be in your shoes. Objective: To meet as many people as you can who are able to help now and in the future.

Lab Automation and New Technologies

2.20 PM

Trend Watch LIMS & ELN: Overlap And Restructuring Of The Vendor Market The growth of the ELN market over the past years has also triggered an evolution in the software’s capabilities. Extended functionalities and the generalization of requirements of more flexibility, agility and customization have brought up the question of the similarities between LIMS and ELN. This session will look at LIMS and ELN in the data management scene, their evolution and expectations for the future.

Stuart Miller, Senior Director, IS Quality Applications at Genzyme

Peter Boogaard, Chief Executive Officer at Industrial Lab Automation

Julie Spirk, Principal Scientist at Pfizer Inc.

2.50 PM

One-to-One Business Meetings

3.25 PM

One-to-One Business Meetings

4.00 PM

One-to-One Business Meetings & Coffee Break

4.35 PM

Case Study Simplifying Analytical Knowledge Transfer In An Externalized World As externalization and research virtualization continues to evolve, the task of mining these legacy analytical chemistry datasets and methods to help monitor and identify raw materials, impurities, and metabolites will be ever more difficult based on deficiencies in knowledge exchange mechanisms. This session will present a use case for a new laboratory informatics external collaboration model that highlights: • A collaborative workspace to create an analytical knowledge package that can include ‘live’ analytical data, metadata, and chemistry information independent of the instrument source for seamless knowledge sharing. • The value and importance of fingertip access to this ‘live’ information and knowledge that can be searched, shared, re-processed, re-purposed, and re-analyzed. • A system that is easily accessed via web or mobile client interfaces and is amenable to integration and cloud-based deployments.

Ryan Sasaki, Director of Global Strategy at ACD/Labs

Enabling Innovation Through Change Management

4.55 PM

Entrepreneurship Session Drive Success Through Innovation: Change Management And Adoption Has your laboratory informatics strategy been implemented successfully? Adoption is one of the key measures to answer this question. Defining a change management process should be at the origin of every new implementation and will determine the success of your investment.

In this session our experts will provide key take-aways on:

How to identify the vital steps of your change management process

How to adapt your change management strategy to the scope of your deployment

How to embed cultural-differences to your approach in global projects

Yan Song, Associate Director, Bioanalysis Operations at Abbvie

Page 5: Welcome to the SmartLab Exchange - Home | IQPC …Welcome to the SmartLab Exchange February 16-18, 2015 in Philadelphia, PA Maximizing the opportunities of laboratory informatics to

5.30 PM

Round Table Discussions

How does it work? All roundtables will take place at the same time and each will be led be an industry expert. Simply choose the roundtable topic of most interest to you and join in the discussion! These sessions are open, informal and a great opportunity to really gauge what your peers are planning and to share ideas and lessons learned. You will walk away with tangible ideas on how to solve your biggest challenges. There is an opportunity to attend 2 roundtables, as they are all repeated at the same time on day 2!

Quality By Design VS Quality Control: Are We moving Away From Traditional QC Laboratories?

Strategies For An ‘Inspection Ready Environment’ In The Lab

Facilitator

Stuart Merdian, Associate Director, Global Quality Assessments and Digitization Systems at Procter & Gamble

Drive Success Through Innovation: Change Management And Adoption

Facilitator Yan Song, Associate Director Bioanalysis Operations at Abbvie

Digital Lab And Security: Keeping Control Over Your Data

Facilitator William Telford, Director Security and Information Protection at Sanofi

6.30 PM

Live Lab Demos: Vote For Your Favourite Vendor Demonstration and Win a Prize! Followed by Networking Drinks Reception

SMARTLAB EXCHANGE Day Two – Wednesday, February 18, 2015

7.45 AM

Registration

8.30 AM

Chairman’s Opening Address

Scientific Data Management: Visualize. Capture. Integrate. Share.

8.40 AM

Opening Keynote Data Visualization And Capture In The Lab: From Big Data To Useable Data The volume of data and metadata produced by disparate systems/software is the haystack in which lab workers consistently have to find needles.

Eliminating the long winded manual process often required to extract, use and share relevant data is an underlying challenge for laboratories.

In this session our expert will present a use case of how automated processes can help you build an efficient data framework to capture, analyse and surgically access scientific data.

Dr. Lloyd Colegrove, Data Services Director, Fundamental Problem Solving Director at Dow Chemical

9.10 AM

One-to-One Business Meetings

9.45 AM

One-to-One Business Meetings & Coffee Break

10.20 AM

Best Practice Session Building Your Smart Laboratory: Automation, Data Management, Compliance And New Technologies

Our speakers will each have 15 minutes to present their perspective on Laboratory Automation and strategic recommendation to creating a “smarter lab”.

They will look at, new technologies, system validation and regulation, integration etc… . Delegates will have 15 minutes to ask questions before they break into groups for our workshop session.

Jeff Hurst, Principal Scientist at Hershey’s

Steve Thomas, Study Director, Principal Investigator at GSK

Evan Guggenheim, Principal Scientist at Biogen Idec

Robert Boland, Sr. Manager Translational Informatics & External Innovation R&D IT at Janssen

11.20 AM

Data Security Masterclass How To Manage Cyber Security And Privacy In Your Projects

Based on actual investigations, Brett will share key findings and advice on how to manage:

Cyber threats to trade secret and sensitive data

Insider threats to trade secret and sensitive data with an actual example of an adjudicated case

Risk of “outsourcing” data to cloud providers or third parties You will have the opportunity to ask specific questions to our speaker in an open discussion at the end of the presentation.

Special Agent Brett Yeager – Cyber Security Unit at The FBI

William Telford, Director Security and Information Protection at Sanofi

Page 6: Welcome to the SmartLab Exchange - Home | IQPC …Welcome to the SmartLab Exchange February 16-18, 2015 in Philadelphia, PA Maximizing the opportunities of laboratory informatics to

Risk Assessment And Compliance

12.05 AM

One-to-One Business Meetings

12.40 PM

One-to-One Business Meetings

1.10 PM

Like and Like Strike Together: Interactive Networking Lunch During this lunch break, take the opportunity to network with those attendees who share your interests, challenges and expertise to maximise your time at the Exchange.

How does it work? Each table will be labelled with a different theme e.g. collaboration, LIMS, cloud computing, change management, and so on. You then sit at the table you feel is most relevant to you. So whether you’re a seasoned expert with war stories galore, or completely new to the area, you’ll be surrounded with people who have been, or soon will be in your shoes. Objective: To meet as many people as you can who are able to help now and in the future.

2.00 PM

Case Study Regulatory Compliance: How to Create And Maintain An “Inspection Ready Environment” Laboratories operating in a GxP environments face the additional challenge of regulatory compliance. Remaining compliant often means costly, tedious procedures that need to be understood and performed accurately to create an inspection ready environment. Questions such as how to keep SOP’s and training records up to date, how to ensure an effective quality and risk management approach in line with FDA guidelines, how to implement a well documented validation plan, are all part of the daily endeavour of quality and manufacturing professionals.

This session will demonstrate how to achieve higher quality, better compliance and increased productivity to address regulatory audit pressures.

Anthony Tahl, Project Manager at Hologic

The Cloud Era: The Impacts On Your Science

2.30 PM

360⁰ Focus Session The Emerging Importance Of The Cloud In SmartLabs

The cloud might have opened a new door for laboratory informatics.

With an ever increasing demand for more agility and scalability from lab systems, as well as a growing need for open collaboration in, the cloud seems to offer new capabilities for research.

This presentation will discuss how the cloud will impact the future of your laboratory infrastructure. We will then hand the microphone over to you for your questions!

Andrew Porter, Director Enterprise Architecture at Merck

3.15 PM

Case Study Accelerating Innovation

Gene Tetreault, Sr. Director, Products and Marketing for the Laboratory Informatics Portfolio at BIOVIA

3.45 PM

Coffee Break & Live Lab Competition Results

4.00 PM

Fireside Chat Towards A Fully Integrated Lab: Update On The Allotrope Foundation The Allotrope Foundation has for mission to create a framework enabling standardization and integration making data more accessible, of better quality and more productive. Our guests from the Foundation will give an overview of their project and what has been achieved so far. The scope of the framework includes:

Simplifying access to raw data across instrument platforms

Cut costs by eliminating the need for custom integration of heterogeneous laboratory software platforms

Enable regulatory compliance by creating a better access to and management of knowledge across the full lifecycle

Patrick Chin, Executive Director, R&D Informatics at Merck

Dana Vanderwall, Associate Director, Cheminformatics at Bristol-Myers Squibb

5.00 PM

Chairman’s Closing Remarks & Exchange Ends

Page 7: Welcome to the SmartLab Exchange - Home | IQPC …Welcome to the SmartLab Exchange February 16-18, 2015 in Philadelphia, PA Maximizing the opportunities of laboratory informatics to