Improving Speed and Quality within Clinical Trial Operations Using Process Improvement Tools

1. Register
by January 21st
for Increased
Latin America
Savings!
The 6th
Presents
Clinical Trials Conference
Improving Speed and Quality within Clinical Trial
Operations Using Process Improvement Tools
March 1st – 2nd, 2011 | Hyatt Regency Miami | Miami, Florida
Novavax Case study: Kathy Lenhard
Director, Clinical Operations
examination of a Clinical trial
KeyNote Conducted in Mexico City
Novavax, iNC.
Constantino López-Macías, Ph.D.
PreseNtatioN: which enrolled 4,550 subjects Medical Research Unit on Immunochemistry
Christy Vaughn HosPitaL oF tHe NatioNaL
Preventing the spread of H1N1 Senior Project Manager MediCaL CeNtre
iCoN
PRE-CONFERENCE Featured Sessions:
WORKSHOP UPDATES FROM MEXICO, BRAZIL AND ARGENTINA
Examining the Current Issues Facing Clinical Research in Traditional
Latin America Countries including Regulatory Requirements and Timelines
Mapping Critical Questions
in R&D - Creating Strategic Pedro Garbes-Netto,
Moderated By: Regional Director, Clinical Development, Latin America,
Direction and Flexible, SANOFI-PASTEUR
Fast Learning Structures to
Support Clinical Research Panelists Include:
Gabriela Dávila-Loaiza MD Carlos Sanmarco Dr. Daniel Ciriano
Workshop Leader: Head of Clinical Operations, Clinical Operations Medical Director /
Mexico, PFIZER Manager,LILLY PDO Country Operation
Terry Barnhart, Manager, ROCHE
Senior Director of
Strategy and Platinum Sponsors &
Continuous Sponsor: Exhibitors:
Improvement,
PFIZER
To Register Call 866-207-6528 or visit www.exlpharma.com/6thlatin

2. A History of Success
Miami
March 2008 February 2009 August 2009 February 2010 August 2010
Brazil
Argentina
14%
Associate, Coordinator Level
Attendee 37%
Experience Level Senior Manager, Manager Level
49%
Vice President, Director Level
This Summit is specifically designed for
C-Level, Department Heads, Vice Presidents,
Hyatt Regency Miami Directors and Managers at pharmaceutical,
wholesaler, and pharmacies from the follow-
400 South East Second Avenue, Miami, Florida ing departments:
Tel: +1 305 358 1234 | Fax: +1 305 358 0529 • Scientific and Medical Directors/Affairs
• Regulatory Affairs and Liasons
Move with the rhythm of the city at this downtown Miami hotel. the striking white • Clinical/R&D Operations, Research
towers of hyatt Regency Miami overlook Biscayne Bay and connect to the Conven- • Clinical Quality Assurance/Control
tion Center providing effortless access to everything from Brickell and Coral Gables to • Clinical Outsourcing – Planning and Vendor
Coconut Grove and world-famous white sand beaches. Our newly updated hyatt hotel Management
in downtown Miami offers an outstanding array of amenities - including the city’s largest • Strategic Business Development/Operations
meeting space, dramatic bayside or skyline views from spacious guestrooms, and a lively
bar and restaurant. Discover this exclusive setting among downtown Miami florida hotels • Project/Study Management/Project Planning
and experience the excellence you’ve come to expect from hyatt. • Clinical Trial Capacity Planning/Management
• Clinical Trial Process Improvement/Enhance-
Room Reservations:
ment
If you require overnight accommodations, please contact the hyatt Regency Miami at 305-
358-1234 and mention our discounted room rates. We encourage conference partici- • Clinical Compliance
pants to make reservations by Wednesday, February 3rd with our designated • Clinical Safety
venue as our discount room rates are limited. • Patient Recruitment/Clinical Trial Enrollment
Sponsorship and Exhibit Opportunities
Do you want to spread the word about your organization’s solutions and services to potential clients who attend this event? take advantage of the opportunity to exhibit, pres-
ent an educational session, host a networking event, or distribute promotional items to attendees. ExL works closely with you to customize a package that suits all of your needs.
to learn more about these opportunities, contact Jayson Mercado, Business Development Division head, by calling 212-400-6236 or by emailing jmercado@exlpharma.com.
To Register Call 866-207-6528 or visit www.exlpharma.com/6thlatin

3. Pre-Conference Workshop Day One – Tuesday, March 1st, 2011
Interactive Networking Workshop Session: Mapping Critical Questions
8:00 Registration Opens and Continental Breakfast is Served for Workshop Attendees
9:00 Mapping Critical Questions in R&D - Creating Strategic Direction and Flexible, Fast Learning Structures
Pre-Conference Workshop
to Support Clinical Research
Workshop Leader:
terry Barnhart, Arnoud h.J. herremans PhD
Senior Director of Strategy and Behavioral Pharmacologists, Local Unit Manager,
Continuous Improvement, PFIZER Preclinical Candidate Selection Unit, ABBOTT
Full contact mapping session:
• The audience will identify several strategic issues they’d like to explore
• Selecting an issue 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
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 team
• How to map critical questions for your business needs
• How to convert critical question maps into fit for purpose value streams
Take-Aways:
• Practice a new technique to:
• Define direction across multiple functions
• Identify the right 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
12:30 Lunch for Workshop Attendees
Main Conference
12:30 Registration Opens for Main Conference
1:30 Chairperson’s Welcome and Opening Remarks
Clinical Improvement
1:35 Using Process Improvement to Improve Study Start-Up in the 2:15 Increasing Patient Recruitment Success and Regulatory Submission
Latin America and Other Regions Efficiency of a Difficult Trial Using Process Improvement
Alister thomson, Director, Strategic Process Optimization, terry Barnhart, Senior Director of Strategy and Continuous Improvement,
BRISTOL-MYERS SQUIBB PFIZER
• Study start-up - similarities & differences with other regions of the • Critical success factors for optimizing enrollment including protocol
world development, site performance, study planning and governance
• Recent experiences in using Lean Sigma projects to improve study • Initiate submissions on a global basis as rapidly as possible to begin
start-ups in Latin America enrollment in all selected countries
• Observations on fostering a continuous improvement culture in a • Focus on company controlled activities and influencers such as docu-
multinational clinical development organization ment preparation and relationships with investigators
To Register Call 866-207-6528 or visit www.exlpharma.com/6thlatin

4. Main Conference Continued Day One – Tuesday, March 1st, 2011
3:00 Networking & Refreshment Break
Removing Waste From Clinical Operations
3:30 Deconstructing a Clinical Process to Identify Applications of Lean: A Before-and-After Look at a Wasteful and Lean Clinical Operations Framework
Bob Moroz, Associate Director, David Rodin, Head of Business Performance Management,
Global Clinical Research Operations, MERCK Global Clinical Trial Operations, MERCK
• Identifying process improvement tools and which ones work best for a desired function
• Defining waste and solutions for removing it – why it exists and how it builds in a clinical process
• Applying process improvement to a real clinical process to show how it removes waste
5:00 Close of Day One
5:00 Cocktail Reception Sponsored By
Day Two – Wednesday, March 2nd 2011 Regulatory Timelines (Continued)
Panelists Include:
9:00 Chairperson’s Day Two Welcome and Recap
Novavax Case Study
9:05 KEYNOTE CASE STUDY Gabriela Dávila-Loaiza Carlos Sanmarco, Dr. Daniel Ciriano,
Examination of a Clinical Trial Conducted in Mexico City which MD, Head of Clinical Clinical Operations Medical Director / PDO
Enrolled 4,450 Subjects During the Pandemic of 2009 Preventing Operations, Mexico, Manager, Country Operation
the Spread of H1N1 PFIZER LILLY Manager, ROCHE
Constantino López-Macías, Ph.D., Medical Research Unit on This session will provide guidance for working with regulatory agencies
Immunochemistry, HOSPITAL OF THE NATIONAL MEDICAL CENTRE within different LATAM countries.
Kathy Lenhard, R.N., Director Clinical Operations, NOVAVAX • Current regulatory authority and ethical committee procedures and timelines
• Local expertise and disease state prevalence
Christy Vaughn,
• Restrictions for study protocols
Senior Project Manager, ICON
• Current trends
BACKGROUND 11:45 Networking & Refreshement Break
In April of 2009, the H1N1 influenza pandemic began in a small Mexican
town and by June 11, 2009 the WHO had declared a global pandemic. Panel Discussion With Latam Regional Heads
APPROACH 12:05 Quality Oversight of Strategic Outsourced Partners: Defining Roles,
Researchers in Mexico City contacted Novavax, Inc. a Rockville, Mary- Ensuring Integration and Overcoming Challenges
land vaccine based company to see if they could assist in the Mexico
Crisis and provide H1N1 vaccine.
STUDY DESIGN
4,550 subjects, 18 to 64 years old were enrolled at a single site in Enrique Isola, Luis Rios-Nogales, felipe Rodriguez-Davidson,
Mexico City, between Oct 19, 2009 and March 5, 2010 in a Phase 2 Medical Director, Regional Medical Director, Regional Medical Director,
randomized, double-blind placebo-controlled study. Latin America Region, Head of Latin America Latin America,
NOVARTIS Clinical Research Region, HOSPIRA
10:10 Networking & Refreshement Break ASTRAZENECA
Regulatory Timelines • Defining deliverables within a strategic partnership to ensure inte-
10:30 Examining the Current Issues Facing Clinical Research in grated expertise and resources
Traditional Latin America Countries including Regulatory/Ethical • Clearly defining roles, responsibilities and trust in valuable collaboration
Requirements and Timelines • Creating a feedback process on cost, speed, and quality to measure
Moderated By: the success of the partnership
Pedro Garbes-Netto, Clinical Research Director, • Overcoming issues and bottlenecks with roles, workload, risk and
SANOFI PASTEUR responsibilities
To Register Call 866-207-6528 or visit www.exlpharma.com/6thlatin

5. Main Conference Continued Day Two – Wednesday, March 2nd, 2011
1:00 Lunch 2:45 Risk Management Plans and the Impact on the Quality of Clinical
Research
Avenues For Regional Growth Rodrigo Pimentel, Senior Medical Director, Latin America Region,
2:00 Opportunities for Success in “Non-Traditional” Latin America CELGENE
Markets • Examination of various scenarios for a risk management plan
Luis Rios-Nogales, Regional Medical Director, Head of Latin America, • Keys for a successful RMP implementation in clinical trials
Clinical Research Region, ASTRAZENECA • Strategies and variations for avoiding or accepting risk
• Unique characteristics of non-traditional countries that make them
attractive for clinical research 3:30 Close of Conference
• Cost-effectiveness
• Patient availability
• Enrollment speed Questions? Comments?
• Reliability Do you have a question or comments that you would like to be ad-
• Quality dressed at this event? Would you like to get involved as a speaker or
• Regulatory environment discussion leader? Please email Conference Director, Matt Millman at
• Increased involvement with investigators within each country mmillman@exlpharma.com
• Study planning and room for growth
Media Partners
Registration Fees for Attending ExL’s Five Ways to Register:
6th Latin America Clinical Trials Conference: Mail: Phone: Email:
ExL Events, Inc. 866-207-6528 registration@exlpharma.com
EARLY BIRD PRICING: Register by Friday, January 21st
555 8th Ave, Ste 310 Fax: Online:
to Take Advantage of Early Bird Pricing:
New York, NY 10018 888-221-6750 www.exlpharma.com/6thlatin
Conference + Workshop $1795
Conference Only $1595 Group Discount Program: Cancellations:
Save 25% per person when Registering Four If you need to cancel your registration for an upcom-
STANDARD PRICING: Register After January 21st: For every three simultaneous registrations from your ing ExL conference, please note the following policies
company, you will receive a fourth complimentary regis- derived from the Start Date of the event:
Conference + Workshop $1995 tration to the program (must register 4 at one time) this • Four weeks or more: A full refund (minus a $95
Conference Only $1795 is a savings of 25% per person. processing fee), or a voucher to another ExL event
Save 15% per person when Registering Three valid for two years from the voucher issue date.
ONSITE PRICING Can only send three? You can still save 15% off of every • Four weeks or Less: A voucher to another ExL
registration. event valid for two years from the voucher issue
Conference + Workshop $2195 date.
To find out more on how you can take advantage of these
Conference Only $1995 group discounts, please call 866-207-6528. • To receive a refund or voucher, please fax your re-
quest to 888-221-6750.
Make checks payable to ExL Events, Inc. and write code
P737 on your check. You may also use Visa, MasterCard, • There will be an administrative charge of $300 to
Flying in from Discover or American Express. Payments must be received substitute, exchange and/or replace attendance
badges with a colleague occurring within five busi-
Latin America? in full prior to the commencement of the conference.
*Offers may not be combined, Early Bird rates do not apply*
ness days of the conference.
Ask about our special Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancella-
discounts! tion, every effort to find a suitable replacement will be made.
* The opinions of this faculty do not necessarily reflect those of the companies they represent or ExL Events, Inc.*
To Register Call 866-207-6528 or visit www.exlpharma.com/6thlatin

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Improving Speed and Quality within Clinical Trial
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Operations Using Process Improvement Tools
March 1st – 2nd, 2011 | Hyatt Regency Miami | Miami, Florida
MEthOD Of PAYMENt:
Name on Card:
Novavax Case study:
Card Number:
Kathy Lenhard,
CARD tYPE:
Director, Clinical Operations,
examination of a Clinical
Signature:
Novavax, iNC.
KeyNote trial Conducted in Mexico Constantino López-Macías, Ph.D.
PreseNtatioN: City which enrolled 4,550 Medical Research Unit on
Immunochemistry
subjects Preventing the Christy Vaughn
HosPitaL oF tHe NatioNaL
Senior Project Manager
spread of H1N1 iCoN MediCaL CeNtre
PRE-CONFERENCE Featured Sessions:
Zip:
866-207-6528
888-221-6750
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UPDATES FROM MEXICO, BRAZIL AND ARGENTINA
Examining the Current Issues Facing Clinical Research
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Mapping Critical Questions in Traditional Latin America Countries including
in R&D - Creating Strategic Regulatory Requirements and Timelines
State:
Fax:
Direction and Flexible, Pedro Garbes-Netto,
www.exlpharma.com/6thlatin
Moderated By: Regional Director, Clinical Development,
Fast Learning Structures to Latin America, SANOFI-PASTEUR
Support Clinical Research
555 8th Avenue, Suite 310
Panelists Include:
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Senior Director Gabriela Dávila-Loaiza MD Carlos Sanmarco Dr. Daniel Ciriano
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of Strategy and
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Mexico, PFIZER Manager,LILLY Operation Manager, ROCHE
Continuous
Improvement, Platinum Sponsors &
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