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DETAILED AGENDA:
The executive speaking faculty for iiBIG’s Spring 2014 CLINICAL STUDY TEAMWORK: Building Effective Partnerships is currently being organized. To apply to become a member of our faculty, please submit your application on our JOIN OUR FACULTY page; or contact our conference organizer:

Kathy Lenhard, RN, EVP, Clinical Programs, iiBIG
Tel: 224-655-2968 • Email: info@iibig.com

DAY ONE: APRIL 10, 2014

8:00 – 8:50
Networking & Registration


8:50 – 9:00
Welcome to Raleigh-Durham/RTP – Opening Remarks

Don Buford, CEO,
International Institute for Business Information & Growth LLC (iiBIG)
Kathy Lenhard, RN, EVP, Clinical Programs,
International Institute for Business Information & Growth LLC (iiBIG)

9:00 – 9:45 (OPENING PLENARY SESSION 101):
KEYNOTE PRESENTATION: Clinical Collaborations: Driving a More Efficient R&D Paradigm

Ken Getz, Founder and Owner, CenterWatch
Director, Sponsored Research Programs, Tufts CSDD
Chairman, CISCRP

Course learning objectives:
Characterize the changing drug development landscape
• Summarize key trends and their expected impact
Describe new opportunities to improve drug development performance and efficiency


9:45 – 10:30 (PLENARY SESSION 102)
A Moderated Panel Discussion: Building Effective Partnerships
Immediately following the opening keynote address above, this roundtable discussion, featuring industry leaders will:

  • Review primary characteristics and trends defining the current drug development operating environment
  • Explore collaboration models that hold the potential to profoundly impact more efficient and effective drug development
  • Engage downstream assets including investigative sites and study volunteers to support collaboration performance

Moderator:

Ken Getz, Founder and Owner, CenterWatch
Director, Sponsored Research Programs, Tufts CSDD
Chairman, CISCRP

Panelists:

Jennifer Byrne, President & CEO,
PMG Research, Inc.
Jeffrey A. Spaeder, M.D., Chief Medical and Scientific
Officer, Quintiles

Course learning objectives:
Highlight trends that are of greatest concern to R&D leaders
• Discuss opportunities and approaches to address those concerns
Describe specific strategies and tactics of organizations looking to improve their quality and performance


10:30 – 11:00
AM Refreshments & Networking Break


 

BREAKOUT TRACK A:
Clinical Research Site Operations/Site Management
Training for CRA/CRC and Investigators

11:05 – 11:50

(Breakout Session A101)
Exceptional Clinical Sites-What is the Recipe?

Moderator:

Brenda Atchison, Executive Director,
The Alliance for Multispecialty Research (AMR)

Panelists:

Dan Diaz, VP, Business Development,
SPRI Clinical Trials
William B. Smith, MD, FACC,
President and Principal Investigator,
New Orleans Center for Clinical Research and Volunteer Research Group (NOCCR and VRG)
Adam Larrabee, Director of Business Development & Patient Recruitment,
Rochester Clinical Research

Course learning objectives:
• Key things to highlight when marketing your center’s “exceptionality”
• How to maintain consistent “exceptionality” across multiple centers
• Understanding the fundamentals of social media recruitment
• How to use case studies to market exceptional successes

(Breakout Session B101)
Strategies for building an effective Partnership between Sponsor and CRO

Moderator:

Anna McBride, Sr. Research Manager, CATO

Panelists:

Jane Green, President,
Morley Research Consortium
Greg Fiore, MD, Founder,
SSI Strategy
Keri Urwin, MBA, Consultant II, Halloran Consulting Group, Inc.

Course learning objectives:
• Examine the ways to establish a collaborative environment
• Learn tips on how to maintain transparency
• Learn ways to share compliance responsibilities


11:55 – 12:50

(Breakout Session A102)
Proxy Consent-Children and The Cognitively Impaired

Moderator:

Mitchell Parrish, JD, RAC, CIP, Regulatory Attorney,
Quorum Review IRB

Panelists:

Bonnie Brookshire, Director QA and Education, Aspire IRB
Troy Brinkman, JD, MA, CIP,
Manager of Consulting Services,
WIRB-Copernicus Group

Course learning objectives:
• Learn how to identify the issues and implement methods to successfully consent vulnerable subjects.
• Identify important strategies for working with special populations.
• Identify the roles and responsibilities of the PI and IRB when consenting children and special populations.

(Breakout Session B102)
Managing Risks in Outsourcing Clinical Trials

Moderator:

Peter Sullivan, VP & Principal,
Sullivan Group

Panelists:

Sonali Gunawardhana,
OF Counsel FDA Practice Group, Wiley Rein LLP

Michelle Michela, Leader Consulting Services, Boston BioMedical Associates

Course learning objectives:
• Understand ways to share risk (i.e. provider penalties for missing milestones)
• Identify “What “Risks should be assessed
• Identify ways to establish absolute clarity in roles and responsibilities from the outset


12:55 – 2:00
PLATED LUNCHEON FOR CONFERENCE ATTENDEES


2:05 – 2:50

(Breakout Session A103)
How Sites Can Track Their Own Performance Metrics to Be Successful

Moderator:

Patricia Larrabee, RN, NP, Site Director, Founder and Chief Executive Officer, Rochester Clinical Research

Panelists:

Derek Grimes, Vice President, Clinical Operations, TKL Research, Inc.
Brian Wulff, VP Marketing & Sales,
Forte Research Systems

Course learning objectives:
• Identify essential approaches taken by a dedicated research site to monitor it performance
• Learn how self-monitoring performance at the site level adds value
• Learn how to set goals for workload of research nurses and ancillary staff

(Breakout Session B103)
Improving the Study Start-up process with the clinical sites

Moderator:

Karen Massand, Co-founder, Board Member and President, Litéra®

Panelists:

Amanda Wright, Director,
Marketing & Business Development,
PMG Research, Inc.
Cathy White, VP Operations,
Novella, a Quintiles Company
Dan Diaz, VP, Business Development,
SPRI Clinical Trials

Course learning objectives:
• Identify key ways to improve the site selection process
• Identify hold-ups in CTA and budget negotiations
• Learn smarter recruitment strategies


2:50 – 3:20
PM Refreshments & Networking Break


3:25 – 4:10

(Breakout Session A104)
It’s all about the Data: Source Documentation

Moderator:

Sandra “Sam” Sather,MS, BSN, CCRA, CCRC, Vice President, Clinical Pathways

Panelists:

Nanci Hook-Seid, CEO, Co-Founder and Executive Director, Research & Business Development, SDS Clinical Trials

Course learning objectives:
• Learn why Source Documentation is the second most commonly cited deficiency in US-FDA inspections of clinical investigator sites.
• Identify the words attributable and contemporaneous in Source Documentation
• Understand why the reality of source documents as “working documents” is imperfect

(Breakout Session B104)
CTA / Budget Development and Negotiation with the Clinical Sites

Moderator:

Sonali Gunawardhana,
OF Counsel FDA Practice Group, Wiley Rein LLP

Panelists:

Jane Green, President,
Morley Research Consortium

Course learning objectives:
• Identify the budget needs of the sponsor and clinical sites
• Discuss now to negotiate fair Clinical Trial contracts
• Identify Best Practices for cooperation at Clinical Sites


4:15 – 5:00

(Breakout Session A105)
Silos in Recruitment-Breaking Down the Barriers Between Sponsor/CRO/Sites

Moderator:

Adam Larrabee, Director of Business Development & Patient Recruitment, Rochester Clinical Research

Panelists:

Tim Richardson, Site Operations Manager, GuideStar Clinical Trials Management
Matt Gibson, VP Business Development, IRC Clinics, Inc.

Course learning objectives:
• Learn the various approaches to maximize recruitment of patients.
• Identify effective techniques used in the recruitment process.
• Learn how to deal successfully with the key challenges with Sponsor/CRO/Sites as they relate to efficient recruitment.

(Breakout Session B105)
How to Implement Risk Based Monitoring into your Clinical Program, i.e. How to Implement it for all your Trials

Moderator:

Melissa Becker, Senior Project Manager, SPRI Clinical Trials Global

Panelists:

Amy Rigney, COO,
SPRI Clinical Trials Global

Course Objectives:
Learn when Risk Based Monitoring (RBM) should be implemented.
Learn how to implement RBM across your program.
• Understand the key things to consider in RBM.


5:00 – 6:30

GALA EVENING RECEPTION

 


DAY TWO: APRIL 11, 2014

8:30 – 9:00
Networking & Registration


 

BREAKOUT TRACK A:
Clinical Research Site Operations and Site Management Training for CRA and CRC and Investigators

9:00 – 9:45

(Breakout Session A206)
Working Together in the Interest of Patients

Moderator:

Robert Romanchuk, Principal,
Clinical Research Advisors, LLC

Panelists:

Becca Chase, Executive Director,
Greater Gift Initiative
Allison Kelly, Marketing Manager,
PMG Research, Inc.
Charlotte Stewart, CIP, Chief Operating Officer, Aspire IRB

Course learning objectives:
• Identify key ways patients and clinicians are working together to shape therapeutic research
• Learn how to determine what patients know and identify patients’ unique expertise to share with research clinicians

(Breakout Session B206)
International Clinical Research, Challenges & Solutions

Moderator:

Mauro Martinelli, Business Development, Quintiles

Panelists:

Kathy Lenhard RN, EVP, Clinical Programming, iiBIG and Principal,
SMO PanAmerican Clinical Research
Dr. Eulises Franco, CEO/ President,
SMO PanAmerican Clinical Research (Mexico City, Mexico)
Kim Ribeiro, Senior Patient Recruitment Specialist, PAREXEL International

Course learning objectives:
• Identify solutions for fast track regulatory submissions
• Identify the benefits of International Clinical Research
• Identify opportunities to educate Sponsors and CROs on the advantages of International Clinical Research


9:50 – 10:35

(Breakout Session A207)
Sponsor Audits and FDA Inspections at the Clinical Site

Moderator:

MarthaLee Reynolds, President,
Service Matters

Panelists:

Elizabeth Robinson, Executive Director, Compliance and Quality,
Advanced Clinical

Course learning objectives:
• Better understand FDA approach to clinical site inspections in past two years.
• Identify Trends noted during Inspections.
• Identify How this tracks with Audit Outcomes.

(Breakout Session B207)
Partnership Considerations for the Small Virtual Company

Moderator:

Lisa Sanders Ph.D., Sr. Clinical Strategy Scientist, Cato Research

Panelists:

Roger Nolan, President,
BioKier
Christine Warrington, President,
EvalStar

10:35 – 11:05
AM Refreshments & Networking Break


11:10 – 12:30
(PLENARY SESSION 202)
Overcoming Clinical Trial Challenges

Nicki Norris, CEO,
Symphony Clinical Research
Keri Urwin, MBA, Consultant II,
Halloran Consulting Group, Inc.
Greg Fiore, MD, Founder,
SSI Strategy

12:35 – 1:00
(PLENARY SESSION 203)
Conference Wrap-Up: Interactive Q&A with Audience Regarding Topics for Future Conferences


1:00
Conference Concludes
Thanks for Supporting your fellow Clinical Research Professionals


EARN UP TO
8 CNE CREDITS

ATTENDING THIS CONFERENCE

Nurse
The Institute for Advancement of Human Behavior is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.

This course is co-provided by IAHB and iiBIG International Institute for Business Information & Growth, LLC. Maximum of 8 contact hours.

Satisfactory completion
Participants must complete an attendance/evaluation form in order to receive a certificate of completion/ attendance. Your chosen sessions must be attended in their entirety. Partial credit of individual sessions is not available.

Target Audience
Global clinical research leaders and trial practitioners from pharma, biotech, medical device, for- profit and non-profit hospitals, public and private academic sites, independent research sites,
CROs, IRBs and others involved in:

  • Clinical Research
  • Clinical Operations
  • Strategy
  • Nursing
  • Planning
  • Business Development
  • Regulatory Affairs
  • Site Management
  • Contracts/Budgeting
  • Drug Development
  • Financial Management