Event Schedule

Have a look at Schedule

08:00 - 08:50

Welcome Coffee, Registration & Itinerary Collection

08:50 - 09:00

Co-Chair Welcome Address

JOHN J SEMAN

CEO

REVITALE Pharma

Jennifer C. Smith-Parker

Independent PR and Communications Consultant

09:00

Presentation 1: Modernizing Bioinformatics Exploration in Clinical Trials

OhKyu Yoon, PhD, MBA

Director, Clinical Bioinformatics and Exploratory Analytics

Gilead Sciences
09:25

Presentation 2: Do Not Dispense and Do Not Ship

James Hartford

Senior Principal Design Consultant

Oracle Life Sciences
09:50

Presentation 3: Using Digital Innovation in Clinical Trials: The Function of Advanced Modeling and Data Science

Zhaoling Meng

AVP, Global Head Clinical Modeling & Evidence Integration, Digital and Data Sciences

Sanofi
10:15

Coffee Break & Networking Session

11:05

Presentation 4: Recruitment and retention tactics based on data we gathered at Tufts CSDD from Top 17 pharma companies

Mary Jo Lamberti

Director and Research Associate Professor

Tufts Center for the Study of Drug Development
11:30

Presentation 5: Streamlining Clinical Data Collection and Analysis in Real World Settings

Milos Todorovic, Ph.D

Director, Biomedical and Clinical Engineering

Analog Devices Inc
11:55

Presentation 6: Diversity by Design: Setting Data-Driven Recruitment Goals

Beth Brooks, MPH, LSSBB

Head, Patient Insights and Behavioral Sciences

Sanofi
12:20

Lunch Break

13:20

Give and Take Chat: Enhancing Patient Retention and Engagement in Trials: A Data-Driven Approach

Moderator:-

Beth Brooks, MPH, LSSBB

Head, Patient Insights and Behavioral Sciences

Sanofi

Panelist:-

Sarah Small

Associate Director, Patient Centricity

Moderna
13:45

Give and Take Chat: Digital Display Labeling in Clinical Supplies for Clinical Trials

Moderator:-

Brian Sheridan

Vice President Global Adherence & Clinicals

WestRock

Panelist:-

Martina Marauli

Director Clinical Supply Innovation

MSD International Business GmbH, Lucerne (Switzerland)
14:20

Presentation 7: Why rare diseases are an important medical issue: The Next generation rarity

Jenifer Ngo Waldrop

Executive Director

Rare Disease Diversity Coalition
14:45

Presentation 8: Clinical trial trends for medication development in rare diseases

JOHN J SEMAN

CEO

REVITALE Pharma
15:10

Presentation 9: LLS/BAML Master Trial

Len Rosenberg

Head, Clinical Operations

Beat AML, a division of The Leukemia & Lymphoma Society
15:35

Fire-side Chat: Future outcomes of empowering clinical trials with digital technology

Moderator:-

Len Rosenberg

Head, Clinical Operations

Beat AML, a division of The Leukemia & Lymphoma Society

Panelist:-

Zhaoling Meng

AVP, Global Head Clinical Modeling & Evidence Integration, Digital and Data Sciences

Sanofi

Stan Kachnowski PHD MPA

Director, Digital Health Program, Columbia Business School

Columbia University in the City of New York
16:00

Co-Chair Closing Remarks with End of Day 1

JOHN J SEMAN

CEO

REVITALE Pharma

Jennifer C. Smith-Parker

Independent PR and Communications Consultant

16:05

Happy Hour Session

08:00 - 08:50

Welcome Coffee, Registration & Itinerary Collection

08:50 - 09:00

Chair Welcome Address

Jennifer C. Smith-Parker

Independent PR and Communications Consultant

09:00

Presentation 10: D&I in clinical trials

Shreya Badhrinarayanan, MD, FRSPH

Lead Medical Director

Genentech - Roche
09:25

Presentation 11: Understanding the safety profiles of drugs

Peter V. Henstock

Harvard Lecturer: Teach Graduate Advanced AI/ML & Software Engineering Courses

Harvard University Extension School
09:50

Data Driven Presentation: Regulatory aspects of digital health technology use in clinical trials

SARAH BILALI

Director, Global Regulatory Affairs Devices

UCB
10:15

Coffee Break & Networking Session

11:05

Presentation 12: Creating a Clinical Supply Chain Playbook for Onboarding Acquired Assets

Reid Tonik

Senior Director of Clinical Supply Chain

Eikon Therapeutics
11:30

Presentation 13: Optimizing Vendor Management in Clinical Trials: Strategies for Efficiency and Collaboration

Mundayat Jyoti R

Independent Consultant Medical Affairs and Clinical Operations

11:55

Presentation 14: Ensuring Compliance and Safety: The Role of Clinical Quality Assurance in Clinical Trials

Jeanna Julo, BA, BA, CHRC, CCRP

Quality Improvement & Compliance Officer, Office of Clinical Trial Activation

University of California, San Francisco (UCSF)
12:20

Give and Take Chat: Clinical Safety and Quality Management: Good clinical, laboratory and manufacturing practices

Moderator:-

Jeanna Julo, BA, BA, CHRC, CCRP

Quality Improvement & Compliance Officer, Office of Clinical Trial Activation

University of California, San Francisco (UCSF)

Panelist:-

Chidi Umeh, MBA, ASQ-CQA

Director of Quality

Telios Pharma, Inc
12:45

Lunch Break

13:45

Give and Take Chat: Navigating Complexities in Global Clinical Trial Operations: Challenges and Best Practices

Moderator:-

Greg Dombal

President, DLRC Inc

DLRC Regulatory Consultancy

Panelists:-

Mundayat Jyoti R

Independent Consultant Medical Affairs and Clinical Operations

Tina (Weldt) Karunaratne

Independent Consultant (Pharma/Biotech)

14:15

Chair Closing Remarks

Jennifer C. Smith-Parker

Independent PR and Communications Consultant

14:20

End of Day 2