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6th Latin America Clinical Trials Conference, March 2011, Philadelphia
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6th Latin America Clinical Trials Conference, March 2011, Philadelphia

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

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

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  • 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 iCoNPRE-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 TimelinesMapping Critical Questionsin R&D - Creating Strategic Pedro Garbes-Netto, Moderated By: Regional Director, Clinical Development, Latin America,Direction and Flexible, SANOFI-PASTEURFast Learning Structures toSupport Clinical Research Panelists Include: Gabriela Dávila-Loaiza MD Carlos Sanmarco Dr. Daniel CirianoWorkshop 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 LiasonsMove with the rhythm of the city at this downtown Miami hotel. the striking white • Clinical/R&D Operations, Researchtowers of hyatt Regency Miami overlook Biscayne Bay and connect to the Conven- • Clinical Quality Assurance/Controltion Center providing effortless access to everything from Brickell and Coral Gables to • Clinical Outsourcing – Planning and VendorCoconut Grove and world-famous white sand beaches. Our newly updated hyatt hotel Managementin downtown Miami offers an outstanding array of amenities - including the city’s largest • Strategic Business Development/Operationsmeeting space, dramatic bayside or skyline views from spacious guestrooms, and a livelybar and restaurant. Discover this exclusive setting among downtown Miami florida hotels • Project/Study Management/Project Planningand experience the excellence you’ve come to expect from hyatt. • Clinical Trial Capacity Planning/Management • Clinical Trial Process Improvement/Enhance-Room Reservations: mentIf 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 Compliancepants to make reservations by Wednesday, February 3rd with our designated • Clinical Safetyvenue as our discount room rates are limited. • Patient Recruitment/Clinical Trial EnrollmentSponsorship and Exhibit OpportunitiesDo 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, 2011Interactive Networking Workshop Session: Mapping Critical Questions8:00 Registration Opens and Continental Breakfast is Served for Workshop Attendees9:00 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 science12:30 Lunch for Workshop AttendeesMain Conference12:30 Registration Opens for Main Conference1:30 Chairperson’s Welcome and Opening Remarks Clinical Improvement1:35 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, 20113:00 Networking & Refreshment Break Removing Waste From Clinical Operations3:30 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 waste5:00 Close of Day One5:00 Cocktail Reception Sponsored ByDay Two – Wednesday, March 2nd 2011 Regulatory Timelines (Continued) Panelists Include:9:00 Chairperson’s Day Two Welcome and Recap Novavax Case Study9:05 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, HOSPIRA10:10 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, 20111:00 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 growthMedia PartnersRegistration 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
  • 6. Register by January 21st q Amex for Increased Latin America Savings! q Discover Exp. Date: Make checks payable to ExL Events, Inc. The 6th PLEASE MENTION PRIORITY CODE: P737 q Credit Card Clinical Trials Conference q Visa Presents 555 8th Avenue, Suite 310 q MasterCard New York, NY 10018 Improving Speed and Quality within Clinical Trial q Check 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 q I wish to receive email updates on Exl Pharma’s upcoming events WORKSHOP Register Me for the Conference and Workshop UPDATES FROM MEXICO, BRAZIL AND ARGENTINA Examining the Current Issues Facing Clinical Research q I’m interested in marketing opportunities at this event 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: q Register me for the Conference Workshop Leader: New York, NY 10018 Terry Barnhart, ExL Events, Inc. Senior Director Gabriela Dávila-Loaiza MD Carlos Sanmarco Dr. Daniel CirianoTo Register: Head of Clinical Operations, Clinical Operations Medical Director / PDO Country of Strategy and Please contact me: Mexico, PFIZER Manager,LILLY Operation Manager, ROCHE Continuous Improvement, Platinum Sponsors & Telephone: Company: Yes! PFIZER Sponsor: Exhibitors: Address: Name: Dept.: Email: Title: City: To Register Call 866-207-6528 or visit www.exlpharma.com/6thlatin q