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8th CROWN Congress -

8th CROWN Congress
January 22 - 24, 2019
Orlando, FL

An Elite Gathering of Clinical Decision-Makers Ready to Learn, Network and Engage on Topics Critical to the Effective Development, Execution and Management of Clinical Trials

Agenda – 8th CROWN Congress




Seminars

 Tuesday, January 22

 

CNS SEMINAR

8:30AM – 8:45AM
Chairperson’s Opening Remarks            

Atul Mahableshwarkar, M.D., DFAPA, Vice President, Clinical Development, BLACKTHORN THERAPEUTICS

8:45AM – 9:30AM
Improve CNS Clinical Trials Through Recent Trends and Strategies

Atul Mahableshwarkar, M.D., DFAPA, Vice President, Clinical Development, BLACKTHORN THERAPEUTICS

9:30AM – 10:15AM
Dynamic Morphological Brain Changes and Their Potential Role in Therapy Refractory Depression

Harald Murck, Adjunct Professor, UNIVERSITY OF MARBURG

IMMUNO-ONCOLOGY SEMINAR

8:30AM – 8:45AM
Chairperson’s Opening Remarks            

Dr. Bhanu Bahl, Director, Clinical and Translational Science Center, HARVARD MEDICAL SCHOOL

8:45AM – 9:30AM
Moving Forward With New Analytical Technology

Manny Lazaro, Vice President, Head of Clinical Operations, JOUNCE THERAPEUTICS

9:30AM – 10:15AM
Recruiting Patients for Clinical Trials            

Dr. Bhanu Bahl, Director, Clinical and Translational Science Center, HARVARD MEDICAL SCHOOL

 

 

10:45AM – 11:15AM
Enhancing Recruitment and Retention in Rare Disease Populations: Lessons Learned From ALS Trials

Sabrina Paganoni, Assistant Professor, Massachusetts General Hospital, SPAULDING REHAB HOSPITAL

11:15AM – 12:00PM
Ambulant Service Model: Optimizing Patient Recruitment and Retention in CNS Trials

Gail Adinamis, CEO, GLOBALCARE CLINICAL TRIALS, LTD

 

12:00PM – 1:00PM

Luncheon


 

1:00PM – 1:45PM
Current Challenges and Pitfalls in Developing Antidepressants

Stephen Brannan, Chief Medical Officer, KARUNA PHARMACEUTICALS

1:45PM – 2:30PM
Understand How to Streamline and Improve Study Start-Up

Amanda Moore, Associate Director Clinical Operations and Development, SAGE THERAPEUTICS

1:00PM – 2:30PM
Adjust the Standard of Your Clinical Development Operating Model

Franco Davi, Senior Clinical Program Leader, gRED Clinical Operations, GENENTECH, INC









 

2:30PM – 3:15PM

Networking Break


 

3:15PM – 4:45PM
Panel: Patient-Centered Trials and Patient Advocacy Groups

Atul Mahableshwarkar, M.D., DFAPA, Vice President, Clinical Development, BLACKTHORN THERAPEUTICS
Stephen Brannan, Chief Medical Officer, KARUNA PHARMACEUTICALS

 


Day One

 Wednesday, January 23

8:45AM – 9:00AM

Opening Remarks Presented by IQVIA


Costa Panagos, President, Clinical Operations, IQVIA?

9:00AM – 9:30AM

Keynote: The Future of Technology and Quality in Clinical Trials and How It Affects Quality and Compliance


Federico Feldstein, Vice President, Head of Quality and Compliance, JOHNSON & JOHNSON

9:30AM – 10:15AM

Presented by IQVIA


10:45AM – 11:15AM

Patient Perspective During a Clinical Trial: Metastatic Lung Cancer “Kept Alive” by Clinical Trials


Janet Freeman, Stage IV Lung Cancer Survivor, PATIENT ADVOCATE

11:15AM – 12:15PM

Explore Clinical Operations and Resources: Where Are Clinical Trials Headed for 2019?


Moderator
Dennis Salotti, Chief Operating Officer, THE AVOCA GROUP, INC.

Panelist
Mitchell Katz, Vice President, Development Operations, FERRING PHARMACEUTICALS
Rajneesh Patil, BDS., MBA., FPH., Senior Director, Head - Process, Technology and Analytics, Clinical Operations, IQVIA

12:15PM – 1:15PM

Luncheon


 

TRACK A
OPERATIONAL EXCELLENCE

1:15PM – 1:30PM
Track Chair Opening Remarks

Stella Stergiopoulos, Senior Project Manager, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT


1:30PM – 2:15PM
Simplifying Vendor Selection and Qualification With Standards and Centralized Approaches

Jay A. Turpen, Senior Consultant, THE AVOCA GROUP ?

2:15PM – 3:00PM
Decentralized Trials: Moving From Concept to Reality



Gail Adinamis, CEO, GLOBALCARE CLINICAL TRIALS, LTD

TRACK B
TECHNOLOGY AND INNOVATION

1:15PM – 1:30PM
Track Chair Opening Remarks

Joshua Rubin, J.D., MBA, MPP, MPH, Program Officer for Learning Health System Initiatives, UNIVERSITY OF MICHIGAN MEDICAL SCHOOL DEPARTMENT OF LEARNING HEALTH SCIENCES

1:30PM – 2:15PM
AI Augments Clinical Trials With In-Home 24/7 Patient Monitoring

Dina Katabi, Ph.D., MacArthur Fellow, Andrew and Erna Viterbi Professor, Director of MIT Center for Wireless Networks and Mobile Computing, MIT

2:15PM – 3:00PM
Leverage New Technologies That Are Improving Clinical Trials for the Future


Michelle Shogren, Head of Innovation, Portfolio and Operations, BAYER

TRACK C
PARTNERSHIPS WITH STAKEHOLDERS

1:15PM – 1:30PM
Track Chair Opening Remarks

Leesa Gentry, Director, Clinical Management, OTSUKA PHARMACEUTICAL


1:30PM – 2:15PM
Clinical Trial Diversity: Improve Patients During a Clinical Trial

Madeline Geday, Associate Director, Patient and Stakeholder Engagement Lead, Global Operations, MERCK

 

3:00PM – 3:30PM

Networking Break


 

3:30PM – 4:15PM
Outsource and Collaborative Research in Clinical Trials, Patient Centricity

Dominique Duchesne, Director, Clinical Operations Lead, BRISTOL-MYERS SQUIBB





4:15PM – 5:00PM
Overcoming Crisis in Clinical Trials

Jennifer Sheller, AVP, Regional Head, N. America - Trial Operations, MERCK

5:00PM – 5:45PM
Patient Centricity and Making the Needs of a Patient a Priority

Reginald Hooks, Associate Director, Clinical Operations, ACADIA PHARMACEUTICALS
Janet Freeman, Stage IV Lung Cancer Survivor; Patient Advocate

3:30PM – 4:15PM
PANEL: Explore Blockchain Technology and Data Integrity Assurance

David Vulcano, Vice President, Research Compliance and Integrity, HCA HEALTHCARE
Atul Mahableshwarkar, M.D., DFAPA, Vice President, Clinical Development, BLACKTHORN THERAPEUTICS
Dany DeGrave, Senior Director Innovation Programs and External Networks, SANOFI

4:15PM – 5:00PM
PANEL: Impact of AI and Machine Learning in Clinical Research

Alex (Wen-Yaw) Hsieh, Director - Clinical Development Quality, PFIZER

5:00PM – 5:45PM
Technologies: Patient-Centric in Clinical Trials

Atul Mahableshwarkar, M.D., DFAPA, Vice President, Clinical Development, BLACKTHORN THERAPEUTICS

3:30PM – 4:15PM
CASE STUDY: Explain the Tools, Processes, and Systems Enabling the Operation of Roche’s Clinical Trials Globally, Across Multiple Study Phases

Michael Rosenblatt, Global Head, Clinical Operations Systems and Processes, GENENTECH, INC



 

5:45PM – 6:45PM

Cocktail Reception



Day Two

 Thursday, January 24

8:00AM – 8:45AM

Continental Breakfast


 

OPERATIONAL EXCELLENCE

8:45AM – 9:00AM
Track Chair Recap of Day One

Stella Stergiopoulos, Senior Project Manager, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT


9:00AM – 9:30AM
Using Metrics to Achieve Oversight and Operational Excellence

Randy Krauss, Head Clinical Performance and Analytics, MERCK



9:30AM – 10:15AM
Keynote Session Disruptive Innovation — The Impact on Clinical Trials

Karrie A. Hilsinger, Director, Global Development Operations, MALLINCKRODT PHARMACEUTICALS

TECHNOLOGY AND INNOVATION

8:45AM – 9:00AM
Track Chair Recap of Day One

Joshua Rubin, J.D., MBA, MPP, MPH, Program Officer for Learning Health System Initiatives, UNIVERSITY OF MICHIGAN MEDICAL SCHOOL DEPARTMENT OF LEARNING HEALTH SCIENCES

9:00AM – 9:30AM
CASE STUDY: Health IT and Patient Learning Capturing Data — Real-World Experience Experience

Joshua Rubin, J.D., MBA, MPP, MPH, Program Officer for Learning Health System Initiatives, UNIVERSITY OF MICHIGAN MEDICAL SCHOOL DEPARTMENT OF LEARNING HEALTH SCIENCES

9:30AM – 10:15AM
Analyze Clinical Trial Data Through the Use of AI and Blockchain

Danny DeGrave, Senior Director Innovation Programs and External Networks, SANOFI

PARTNERSHIPS WITH STAKEHOLDERS

8:45AM – 9:00AM
Track Chair Recap of Day One

Leesa Gentry, Director, Clinical Management, OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION, INC.

9:00AM – 9:30AM
Collaboration on How to Ensure Inspection Readiness and Quality Oversight

Ann Hegarty, Exec. Director GSMO - Head of CRO Oversight and Phase I, ALLERGAN
Alana Wriggins, Head, Global Clinical Site Management, Acquisition Assessments and Clinical records Management, ALLERGAN

9:30AM – 10:15AM
RBM, Best Practices and Advancements

Mitchell Katz, Vice President, Development Operations, FERRING PHARMACEUTICALS

 

10:15AM – 10:45AM

Networking Break


 

10:45AM – 11:30AM
Integrating Research and Healthcare: Short-Term Challenges and Opportunities

David Vulcano, Vice President, Research Compliance and Integrity, HCA HEALTHCARE

11:30AM – 12:15PM
Clinical Trial Protocol Design: Review Current Trends and Strategies


Stella Stergiopoulos, Senior Project Manager, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT

10:45AM – 11:30AM
Discuss the Science behind Clinical Trials to Determine Failure and Success Factors

Paul Chew, M.D., Chief Medical Officer, PHESI

10:45AM – 11:30AM
PANEL: Improve the Working Relationship Between the Site, CRO and Sponsor

Reginald Hooks, Associate Director, Clinical Operations, ACADIA PHARMACEUTICALS

Janis Hall, MBA, Senior Consultant, THE AVOCA GROUP, INC.

11:30AM – 12:15PM
Attract top-level CROs, Understanding How to Foster a Good Reputation to Facilitate CRO Interest in Your Company Trials

Leesa Gentry, Director, Clinical Management, OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION, INC.

 

12:15PM – 1:15PM

Luncheon


1:15PM – 2:00PM

Leadership in Clinical Trial Management: How Strong Clinical Trial Managers Enable Successful Trials


Kristen Perkins, Clinical Trial Manager, TESARO, INC.
Aubri Lang, Clinical Trial Manager, TESARO, INC

2:00PM – 2:45PM

Innovative Platform: Deliver, Transform, and Leverage Unified Patient Data


Manny Lazaro, Vice President, Head of Clinical Operations, JOUNCE THERAPEUTICS

2:45PM – 3:30PM

Quality Trends That Impact Clinical Development


Liza Brienza, Director, GCP Inspection Management, MERCK


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