Home » C.R.O.W.N. Agenda at a Glance

C.R.O.W.N. Agenda at a Glance

CROWN AGENDA-AT-A-GLANCE
	3rd Patient Engagement Summit	3rd Clinical Site Feasibility, Selection, and Start-Up	6th Forecasting & Optimization of the Clinical Supply Chain	5th Lean Sigma & Kaizen for Pharma R&D		8th Latin America Clinical Trials Conference
Monday, March 19th – Pre-Conference Workshop Day Pick the Workshop Session that Best Fits Your Interests
8:00am	Registration and Continental Breakfast			Registration and Continental Breakfast
9:00am	Electronic Health Records: Leveraging Pre-Engagement Technologies to Optimize Your Patient Recruitment Strategies Led By: Joseph Kim, MBA, Clinical Operations Director, SHIRE PHARMACEUTICALS			Lean Kaizen Certification: Lean Six Sigma Yellow Belt Class Led By: David Asher, President and CEO, ASHER ASSOCIATES
10:30am	Networking and Refreshement Break			Networking and Refreshement Break
12:00pm	Workshop Concludes	Registration Opens	Registration Opens	Lunch for Certification Participants
1:00pm		Site Contracts, Activation, Delays and Timelines Led By: Deena Bernstein, Director of Clinical Research, SHERIDAN CLINICAL RESEARCH, INC. David Knepper, MS, MBA, Head of Continuous Improvement, FOREST LABORATORIES Thomas D. Meulbroek, J.D. Associate Consultant, Contracts Management, LILLY	Successfully Dealing with the Challenges of Forecasting and Managing Global Trials Led By: Steve Jacobs, Chair, GLOBAL CLINICAL SUPPLIES GROUP	Certification Concludes at 3:00pm
5:00pm		Workshop Concludes	Workshop Concludes
Tuesday, March 20th – Main Conference Day One Pick the Session and Customize Your Agenda
8:00am	Registration and Continental Breakfast
9:00am	Chairperson’s Welcome and Introduction Chaired By: Joseph Kim, MBA, Clinical Operations Director, SHIRE PHARMACEUTICALS	Chairperson’s Welcome and Introduction Chaired By: Kelly Willenberg, MBA, BSN, CHC, CHRC, President, SYNERGISM, LLC	Chairperson’s Welcome and Introduction Chaired By: Steve Jacobs, Chair, GLOBAL CLINICAL SUPPLIES GROUP	Chairperson’s Welcome and Introduction Chaired By: Terence Barnhart, Senior Director, Strategy and Continuous Improvement, PFIZER		Chairperson’s Welcome and Introduction
9:15am	PANEL DISCUSSION: Using Mobile Technology to Keep Patients Motivated and Engaged in the Trial Process Moderated By: Jordan Lateiner, MS, MBA, Assistant Director, Clinical Development, FOREST RESEARCH INSTITUTE	Risk Based Strategies for Mitigating Site Quality Issues Theresa (Tre) Ruth Eisenberg, Senior Manager, Process Management, Standards and Training, ASTELLAS	Building a Clinical Supply Chain Project Management Core Competency Scott Wong, Senior Systems Analyst, CELGENE	LEAN IMMERSION MINI-WORKSHOP Building and Managing Through A3s Workshop Leaders: Terence Barnhart, Senior Director, Strategy and Continuous Improvement, PFIZER Bella Englebach, Senior Director Strategic Business Improvement, CENTOCOR R&D		LATAM RISK MINI-WORKSHOP CONDUCTING CLINICAL TRIALS IN LATIN AMERICA FROM A LEGAL PERSPECTIVE: Structuring, Contracting, and Mitigating Risk Stacie Switzer, Assistant General Counsel, TAKEDA PHARMACEUTICALS
10:00am	Developing Study Protocol and Recruiting Patients Using Existing Online Communities Heather Almonte, Associate Director, Clinical Operations, OCTAPHARMA	Changing Site Selection Requirements: How New Guidance and EMA Inspections are Changing How Sites are Selected David Knepper, MS, MBA, Head of Continuous Improvement, FOREST LABORATORIES	Developing an Effective Site Supply Strategy from Demand Forecasting Techniques Brad Graves, Manager, Clinical Research Pharmacy Services, MEDIMMUNE
10:45am	Networking and Refreshment Break
11:15am	How a Monte Carlo Simulation can Help Establish Expectations of Recruitment Campaigns Susie Kim, MPH, Global Trial Optimization Specialist, MERCK	PANEL DISCUSSION: Streamlining Activation through Proper Planning for IRB Requirements PANELISTS: Lynn Meyer, President, INTEGREVIEW ETHICAL REVIEW BOARD Dr. Joan Shapiro, Associate Dean for Research, UNIVERSITY OF ARIZONA COLLEGE OF MEDICINE, PHOENIX Sharon R. O’Brien, Regulatory Associate, PENN STATE HERSHEY MEDICAL CENTER	Examining Quality by Design (QbD) & Quality Risk Management Approaches for the Clinical Supply Chain Ken Schiff, Director, Quality Assurance/Quality Risk Management, F. HOFFMANN LA ROCHE	LEAN IMMERSION MINI-WORKSHOP CONTINUES		LATAM RISK MINI-WORKSHOP
12:00pm	Engaging Patients and Physicians in Clinical Research Through Electronic Health Records Joris van Dam, Ph.D., TS Strategic Projects Leader, NOVARTIS INSTITUTE FOR BIOMEDICAL RESEARCH	Clinical Trial Training: Investigator, Delegate And Sponsor Responsibility Pamela Nelson, RN, MS, President & CEO, BRACANE COMPANY	Factoring and Mitigating Risk Regarding the Sustainability of Conducting Global Clinical Studies within Emerging Markets Mark Walls, Director, Clinical Pharmacy, HUMAN GENOME SCIENCES	LEAN IMMERSION MINI-WORKSHOP CONTINUES		LATAM RISK MINI-WORKSHOP
12:45pm	Luncheon
1:45pm	Leveraging Health Tracking Apps for Clinical Trial Recruitment Elizabeth Mascherino, Associate Clinical Operations Director, SHIRE PHARMACEUTICALS	PANEL DISCUSSION: How Trial Budgets and Standard-of-Care Impact CRO’s, Sites and Sponsors During Negotiations Moderated By: Kelly Willenberg, MBA, BSN, CHC, CHRC, President, SYNERGISM, LLC	Overcoming the Challenges of Conducting Clinical Trials in Latin America for Orphan Diseases: Huntington’s Disease Perspective Joseph Giuliano, Director, Clinical Operations, CHDI FOUNDATION	ORGANIZATIONAL SPOTLIGHT: ELI LILLY & CO Utilization of Lean Six Sigma to Speed Innovation Martin Hynes III, PhD, Senior Director, Product Research & Development, and Six Sigma Champion, ELI LILLY Trafford Clarke, PhD, Executive Director, Six Sigma, ELI LILLY		KEYNOTE PRESENTATION – Latin America and the Relationship Between Clinical Advantages and Market Access Luis Rios-Nogales, Regional Medical Director, Head of Latin America Clinical Research Region, ASTRAZENECA AMERICAS
2:30pm	Site Networks Case Study: Leveraging Web Sites Managed Within a Network of Investigators Rodney Butt, MSc, MBA, Principal, HAMILTON MEDICAL CONSULTANTS GROUP	“New” Sites and “New” Investigators, How Do You Choose Them? Kerri Mallory, Site Development Manager, GLAXOSMITHKLINE (BIOLOGICALS) VACCINES	CAST STUDY: Maintaining an Efficient and Balanced Supply Strategy Through The Use of IWR Data William Hillman, Associate Director, Clinical Supply Systems, JOHNSON AND JOHNSON	ORGANIZATIONAL SPOTLIGHT: ASTRAZENECA The Purple Path to Operational Excellence Patricia Hayes, Continuous Improvement Leader, R&D, ASTRAZENECA		Regulatory Update for the Major Latin American Markets: Brazil, Argentina, Mexico, Columbia, Chile, Peru Renato Piemonte Ribeiro, Clinical Research Manager, MERCK
3:15pm	Networking and Refreshment Break
3:45pm	Online Recruitment Case Study: Abbott Canada Web Site Dedicated to Clinical Trial Participants Sandra Gazel, Associate Director of Clinical Operation, ABBOTT LABORATORIES	How Sites Can Leverage EHR Data For Site Startup and Associated Implications For Sponsor and CRO’s Christy Gilchrist, PhD, CRA, Health Director of Research, WELLSPAN	PANEL DISCUSSION: Complying with United States Prerequisites for Importing Clinical Trial Materials Moderator: Frank J. Reale, Associate Director, Global Regulatory Operations Global Regulatory, Strategy, Policy & Safety, MERCK & CO.	ORGANIZATIONAL SPOTLIGHT: LEO PHARMACEUTICALS Becoming Patient Centric: Reducing Development Time in Order to Reach the Patients Faster – The Patients are Waiting! Joergen Ahm Petersen, Senior LEAN Project Manager, Financial Development & Strategic Planning, LEO PHARMA		Benefits and Risks of Conducting Clinical Trials in Latin America Pedro Garbes-Netto, Clinical Research Director, SANOFI PASTEUR INC.
4:30pm	Reaching Populations that May Not be Connected Online and with Mobile Devices Tim Verfaillie, International Project Manager, ABBOTT VASCULAR	Non- Physician Provider As Private Investigators – A Change in Tradition Not Guidelines Nancy K. Durham, MSN, APRN, C-FNP, CDE, President and Chief Clinician, MOUNTAIN VIEW CLINICAL RESEARCH Amy Santaniello, Pharm D, Regional Scientific Associate Director, NOVARTIS	CASE STUDY: Identifying and Eliminating Waste while Maximizing Resources within Your Clinical Supply Chain Daniel Kropas, Senior Manager, Clinical Drug Supply and Logistics, Clinical Development & Regulatory Affairs, REGENERON	PANEL DISCUSSION: Not Only Changing Culture, But Sustaining Improvement & Optimizing Workforces Alister Thomson, Director, Strategic Process Optimization, BRISTOL-MYERS SQUIBB COMPANY Martin Hynes III, PhD, Senior Director, Product Research & Development, and Six Sigma Champion, ELI LILLY Heike Roeder, Global SOP & Training Management, UCB Patricia Hayes, Continuous Improvement Leader, R&D, ASTRAZENECA		Overcoming the Challenges of Conducting Clinical Trials in Latin America for Orphan Diseases: Huntington’s Disease Perspective Joseph Giuliano, Director, Clinical Operations, CHDI FOUNDATION
5:15pm	Close of Day One
	Cocktail Reception Sponsored By:
Wednesday, March 21st – Main Conference Day Two
8:00am	Continental Breakfast
9:00am	Chair’s Day Two Welcome and Recap Joseph Kim, MBA, Clinical Operations Director, SHIRE PHARMACEUTCALS	Chair’s Day Two Welcome and Recap Kelly Willenberg, MBA, BSN, CHC, CHRC, President, SYNERGISM, LLC	Chair’s Day Two Welcome and Recap Steve Jacobs, Chair, GLOBAL CLINICAL SUPPLIES GROUP	Chair’s Day Two Welcome and Recap Terence Barnhart, Senior Director, Strategy and Continuous Improvement, PFIZER		Chair’s Day Two Welcome and Recap
9:15am	KEYNOTE PRESENTATION: How Do Patients View Pharma Companies’ Efforts to Use Social Media to Involve them in Clinical Trials? Jenni Prokopy, Editrix, CHRONICBABE.COM	A Private Investigator’s Perspective on Selection and Start-Up – What Are the Roadblocks Investigators are Facing when Conducting Industry Sponsored Research? Cristina Truica MD, Associate Professor of Medicine, Penn State College of Medicine, Director, Breast Medical Oncology, PENN STATE HERSHEY CANCER INSTITUTE	Enhancing the Relationship Between You and Your CRO to Optimize Your Clinical Supply Chain Adam Sabouni, Ph.D, Chief Development Officer, NOVAN THERAPEUTICS, INC.	Track A: Clinical Improvement BUILDING QUALITY INTO CLINICAL TRIALS USING LEAN SIX SIGMA PRINCIPLES: An Integrated Quality Management Plan (IQMP) Ken Sprenger, MD, MBBCh, Medicine Team Leader, Primary Care BU, PFIZER	Track B: Research Improvement FOLLOW UP PRESENTATION: Workload Leveling in a Biologics Research Discovery Lab Jill Carton, Director, Biologics Research, CENTOCOR R&D	Chair’s Day Two Welcome and Recap
10:00am	Risks Involved when Patients are Socially Engaged During a Clinical Trial Bonnie Brescia, Co-Founding Principal, BBK WORLDWIDE	CASE STUDY: Mitigating Risks and Variance when Budgeting and Contracting for a Complex Global Clinical Trial Allison Burmeister, MBA, Senior Analyst, Clinical Business Operations, JANSSEN AI R&D, LLC	PANEL DISCUSSION: Minimizing Drug Supply Issues During a Global Clinical Trial Brad Graves, Manager, Clinical Research Pharmacy Services, MEDIMMUNE Carol Haddad, Manager, Oncology Therapeutic Area, Global Clinical Supply, MERCK & CO. Rick Mann, Associate Director, Product Development, Clinical Supplies And Logistics, SUNOVION Ram Narayanan, Associate Director, Planning And Development Operations, BIOGEN IDEC Wendy Xia, Senior Program Manager, MERCK & CO.	Track A: Clinical Improvement THE ROLE OF THE PROCESS OWNER: Comparing the Theory of the Process Owner to Real Life Experiences Mariana Sacchi, Latin America Site Monitor Manager, Latin America Clinical Data Quality Manager, BRISTOL-MYERS SQUIBB	Track B: Research Improvement VARIATION REDUCTION IN THE LAB: Using Statistical Tools to Discover and Eliminate Variation in R&D Joel Smith, Statistician, MINITAB	PANEL DISCUSSION: Strategies for Improving Site Selection Pedro Garbes-Netto, Clinical Research Director, SANOFI PASTEUR INC. Joseph Giuliano, Director, Clinical Operations, CHDI FOUNDATION Paul Lupo, Clinical Project Manager, ETHICON, INC.
10:45am	Networking and Refreshement Break
11:15am	PANEL DISCUSSION: Creating Metrics to Measure Online Interactions Russell Sobel, Director of Clinical Research, CHUGAI PHARMACEUICALS Lisa Kaufman, MS, RN, ACNP-BC, Independent Consultant Tim Verfaillie, International Project Manager, ABBOTT VASCULAR	Increasing Enrollment Vs. Inappropriate Incentivizing Practices: Getting Studies Up-And-Running Fast Using Incentives John O’Reilly, Senior Corporate Counsel, SANOFI-AVENTIS	IRT and GMP: Using Technology to Optimize the GMP Processes of Production and Distribution in Clinical Trials Anthony Frankland, Global Head Of Sales And Marketing, CENDUIT, LLC	Track A: Clinical Improvement EMEA-CLINICAL OPERATIONS CASE STUDY: Improving the Site Opening Process During the Start-Up of a Clinical Trial Tim Verfaillie, International Clinical Project Manager, ABBOTT VASCULAR	Track B: Research Improvement QUALITY CONTROL FOR AN R&D LAB CASE STUDY: HPLC Cleaning and Maintenance Sally McGouran, Scientific Services Analyst, MCNEIL CONSUMER HEALTHCARE	Enhance Training On-site to Ensure Investigator Compliance and Data Integrity Paul Lupo, Clinical Project Manager, ETHICON, INC.
12:00pm	The Newest Advances in Cutting Edge Technology for Recruitment, Compliance, and Retention Leaders: Matthew Stumm, Creative Director, BBK WORLDWIDE	CASE STUDY: Determining The Viability For Clinical Trial Success At The Site Level Damon R. Michaels, CCRP, Director – Clinical Trials Research Department of Anesthesiology, VANDERBILT UNIVERSITY MEDICAL CENTER	CASE STUDY: Assessing and Using a Novel Payer-Design Model for Clinical Enrollment Activities Karen Shaver, Clinical Director, INTERLEUKIN GENETICS	Track A: Clinical Improvement IMPLEMENTING AND SUSTAINING CONTINUOUS IMPROVEMENTS IN REGULATORY SUBMISSIONS Patrick McCann, Associate Director of R&D Operations, BRISTOL-MYERS SQUIBB	Track B: Research Improvement VIRTUAL PHARMACEUTICAL FACTORY CASE STUDY: How to Handle “Added Failure” in Pharmacological Drug Development Gyorgy Bathori, Head of the Applied Liposome Research Laboratory, NANOMEDICINE RESEARCH AND EDUCATION CENTER	Improving Clinical Research Training and Education- Brazilian Perspective Yukie Kawasaki, MBA, MSc, Clinical Research Manager, Global Clinical Trial Operations – Brazil, MERCK
12:45pm	Luncheon
1:45pm	Constructing an Online Community for Study Participants Russell Sobel, Director of Clinical Research, CHUGAI PHARMACEUTICALS	How To Motivate Your Sites To Increase Study Enrollment Dr. Joan Rankin Shapiro, Associate Dean for Research, UNIVERSITY OF ARIZONA COLLEGE OF MEDICINE, PHOENIX	Evaluating Sourcing, Packaging and Using of Comparator Products Peter Orosz, Ph.D, Head Of Clinical Supply Chain Management, Oncology, BOEHRINGER INGELHEIM	EFFECTIVELY USING STATISTICS: Visualizing and Communicating Results with Non-Statisticians Christina Gilchrist, Director of Research, WELLSPAN HEALTH		Overcoming the Challenges with Patient Recruitment in LATAM Mariana Sacchi, Site Monitor, Clinical Data Quality Manager, BRISTOL-MYERS SQUIBB
2:30pm	ARE NEW STRATEGIES WORKING: Rethinking Recruitment in Terms of Overall Study Execution Lisa Kaufman, MS, RN, ACNP-BC, Independent Consultant	Building Productive Sponsor – CRO Relationships Speaker TBD	Streamlining Review and Approval of Label Text for Clinical Studies Sashin Bhuta, R.PH, MBA, Drug Supply Manager, BRISTOL-MYERS SQUIBB	LEAN SIGMA PROJECT SELECTION IN R&D Jacqueline Jones, Associate Project Engineer II, NESTLE		Improve the Functionality and Structure of Operations during Clinical Trials in Latin America Matilde Damian, Clinical Research Director BRISTOL-MYERS SQUIBB COMPANY
3:15pm	Conference Concludes