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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

9:00AM – 9:15AM
Chairperson’s Opening Remarks            

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

9:15AM – 9:45AM
Improve CNS Clinical Trials Through Recent Trends and Strategies

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

9:45AM – 10:15AM
Dynamic Morphological Brain Changes and Their Potential Role in Therapy Refractory Depression

Harald Murck, Adjunct Professor, UNIVERSITY OF MARBURG

IMMUNO-ONCOLOGY SEMINAR

9:00AM – 9:15AM
Chairperson’s Opening Remarks            

Dr. Bhanu Bahl, Director, Senior Director, Head Research and Development Information Sciences, FORMA THERAPEUTICS

9:15AM – 10:15AM
Moving Forward With New Analytical Technology

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

 

 

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
Adoptive NK Cell Therapy for Cancer Treatment

Robert Igarashi, Ph.D., Co-Founder, Chief Science Officer, CYTOSEN THERAPEUTICS, 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

9:00AM – 9:15AM

Opening Remarks Presented by IQVIA


Costa Panagos, President, Clinical Operations, IQVIA

9:15AM – 10:00AM

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


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

10:00AM – 10:45AM

Bringing the Trial to the Patient: Virtual Trials and the Promise of Patient Engagement


Josh Rose, VP, Global Head of Strategy, Research and Development Solutions, IQVIA

11:15AM – 12:00PM

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


Janet Freeman-Daily, Metastatic Lunch Cancer Patient/Activist, GRAYCONNECTIONS.NET

12:00PM – 12:45PM

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


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

Panelists:
Karim Damji, SVP Product Management and Marketing, Saama
Jim Kremidas, Executive Director, THE ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS
Manny Lazaro, Vice President, Head of Clinical Operations, JOUNCE THERAPEUTICS
Michelle Shogren, Director of Innovation – Pharma R&D Clinical Operations, BAYER

12:45PM – 1:45PM

Luncheon


 

TRACK A
OPERATIONAL EXCELLENCE

1:45PM – 2:15PM
Track Chair Opening Remarks

Stella Stergiopoulos, MS-MPH, Assistant Director of Statistics and Analytics, Research Instructor, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT


2:15PM – 2:45PM
Simplifying Vendor Selection and Qualification With Standards and Centralized Approaches

Jay A. Turpen, Senior Consultant, THE AVOCA GROUP

2:45PM – 3:15PM
Decentralized Trials: Moving From Concept to Reality



Gail Adinamis, CEO, GLOBALCARE CLINICAL TRIALS, LTD

TRACK B
TECHNOLOGY AND INNOVATION

1:45PM – 2:15PM
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

2:15PM – 2:45PM
AI Augments Clinical Trials With In-Home 24/7 Patient Monitoring

Hariharan Rahul, Ph.D., Visiting Researcher, The Massachusetts Institute of Technology

2:45PM – 3:15PM
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

1:45PM – 2:15PM
Track Chair Opening Remarks

Leesa Gentry, Senior Vice President, Infectious Disease, EVOTEC (US), INC.


2:15PM – 2:45PM
Ensure a Successful Partnership With a CRO by Understanding to CRO Engagement and for a Long- Lasting Relationship

Supriya Shoroff, Associate Director, Head of TMF Operations, AMAG PHARMACEUTICALS

2:45PM – 3:15PM
Pharma-Academia Collaboration for Enhancing Drug Development

Steven E. Cohen, M.D., Executive Director, Search and Evaluation, Global Business Development, and Translational Medicine, Daiichi Sankyo, Inc

 

3:15PM – 3:30PM

Networking Break


 

3:30PM – 4:00PM
Outsource and Collaborative Research in Clinical Trials, Patient Centricity

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





4:00PM – 4:30PM
SOPs: They Must Be Compliant BUT Do They Have to Be Painful?

Betsy Fallen, Special Topics Consultant, SAFE-BioPharma Association

4:30PM – 5:00PM
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 – 4:00PM
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

4:00PM – 4:30PM
PANEL: Impact of AI and Machine Learning in Clinical Research

Alex (Wen-Yaw) Hsieh, Director - Clinical Development Quality, PFIZER
Jean-David Zeitoun, Chief Medical Officer, INATO

4:30PM – 5:00PM
Technologies: Patient-Centric in Clinical Trials

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

3:30PM – 4:00PM
How Artificial Intelligence and Machine Learning with Advanced Analytics are Driving New Levels of RBM Efficiencies

Zabir Macci, Centralized Monitoring Manager — Process, Technology and Analytics, IQVIA

4:00PM – 4:30PM
Breaking the Mold in Study Start-Up: Embracing Innovation Through Partnerships

Amanda Moore, Associate Director, Clinical Operations and Development, SAGE THERAPEUTICS
Kelly Koziol, Client Services Lead, 4G CLINICAL

 

5:00PM – 6:00PM

Cocktail Reception



Day Two

 Thursday, January 24

8:00AM – 9:15AM

Continental Breakfast


 

OPERATIONAL EXCELLENCE

9:15AM – 9:30AM
Track Chair Recap of Day One

Stella Stergiopoulos, MS-MPH, Assistant Director of Statistics and Analytics, Research Instructor, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT


9:30AM – 10:00AM
Using Metrics to Achieve Oversight and Operational Excellence

Randy Krauss, Head Clinical Performance and Analytics, MERCK



10:00AM – 10:45AM
Integrating Research and Healthcare: Short-Term Challenges and Opportunities

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

TECHNOLOGY AND INNOVATION

9:15AM – 9:30AM
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

9:30AM – 10:00AM
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

10:00AM – 10:45AM
Analyze Clinical Trial Data Through the Use of AI and Blockchain

Danny DeGrave, Founder, Unconventional Innovation

PARTNERSHIPS WITH STAKEHOLDERS

9:15AM – 9:30AM
Track Chair Recap of Day One

Leesa Gentry, Senior Vice President, Infectious Disease, EVOTEC (US), INC.

9:30AM – 10:00AM
Outsourcing and Inspection Readiness in the E6 (R2) World

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

10:00AM – 10:45AM
PANEL: Improve the Working Relationship Between the Site, CRO and Sponsor

Moderator:
Janis Hall, MBA, Senior Consultant, THE AVOCA GROUP, INC.
Reginald Hooks, Associate Director, Clinical Operations, ACADIA PHARMACEUTICALS
Gloria I-Hsuan Jen, M.S., PMP, Director of Clinical Operations, SRI Biosciences, Clinical Trials and Strategic Development Services
Jim Kremidas, Executive Director, The Association of Clinical Research Professionals
Aryn Knight, Clinical Research Oversight Specialist; Assistant Administrative Director, TEXAS HEART INSTITUTE

 

10:45AM – 11:15AM

Networking Break


 

11:15AM – 12:00PM
Clinical Trial Protocol Design: Review Current Trends and Strategies

Stella Stergiopoulos, MS-MPH, Assistant Director of Statistics and Analytics, Research Instructor, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT

12:00PM – 12:30PM
Track Chair Closing (Transition to Lunch and General Sessions)

Stella Stergiopoulos, MS-MPH, Assistant Director of Statistics and Analytics, Research Instructor, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT

11:15AM – 12:00PM
Discuss the Science behind Clinical Trials to Determine Failure and Success Factors

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

12:00PM – 12:30PM
Track Chair Closing (Transition to Lunch and General Sessions)

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

11:15AM – 12:00PM
Attract top-level CROs, Understanding How to Foster a Good Reputation to Facilitate CRO Interest in Your Company Trials

Leesa Gentry, Senior Vice President, Infectious Disease, EVOTEC (US), INC.

12:00PM – 12:30PM
Track Chair Closing (Transition to Lunch and General Sessions)

Leesa Gentry, Senior Vice President, Infectious Disease, EVOTEC (US), INC.

 

12:30PM – 2:00PM

Luncheon


2:00PM – 2:45PM

How to Destroy Clinical Data Silos


Karim Damji, SVP Product Management and Marketing, Saama

2:45PM – 3:30PM

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

3:30PM – 4:15PM

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


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

4:15PM – 5:00PM

Quality Trends That Impact Clinical Development


Liza Brienza, Director, GCP Inspection Management, MERCK


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