2024 Agenda

Amy Bohn, Director, DCT Operations, Bayer

Heidi Johnson, Director, DCT Operations, Bayer

Holly Robertson, PhD, Head of Advisory Services, Medidata Solutions

2:15PM - 2:50PM

Disrupting the Evidence Generation Paradigm: Driving Greater Adoption of DHTs and Endpoints in Clinical Trials

Felix Lee, MBA, US Digital Healthcare Medical Head, Sanofi

Katie Madden, PMP, Director, Digital Health Optimization, Global Clinical Operations, GSK

Kimberly Barnholt, PhD, MS, Executive Director, Evidence Generation Leader, Genentech

2:50PM - 3:15PM

Evaluate Emerging Tech from a Venture Capital /Private Equity Mindset

Cem Behmoaram, MBA, Principal, Warburg Pincus, LLC

Michael Grandfield, Managing Director, Bain Capital Tech Opportunities

James Donohue, MHCI, Senior Digital Health Leader, Digital Medical, Genentech

3:15PM - 3:35PM

Establishing a Pathway for the Seamless Integration of Novel Digital Endpoints in Clinical Trials

Charmaine Demanuele, PhD, Executive Director, AI/ML Quantitative & Digital Sciences, Pfizer Inc.

Carrie Northcott, PhD, Head of Digital Sciences, Pfizer Inc.

3:35PM - 4:15PM

Advancing Scalability and Operationalizing Digital Endpoints in Clinical Trials

Sarah Ernst, Head of Clinical Innovation Strategy and Implementation, Sanofi

Basker Gummadi, Senior Director, Digital Biomarkers, GSK

Carrie Northcott, PhD, Head of Digital Sciences, Pfizer Inc.

Gayle Wittenberg, PhD, VP, Neuroscience Data Science & Digital Health, Johnson & Johnson Innovative Medicine

Rinol Alaj, MS, MPH, Senior Director, Head of Clinical Outcomes Assessment & Patient Innovation, Regeneron

4:15PM - 4:50PM

Panel Session: Tokenization in Clinical Trials: Implementation How-tos, RWD Strategy and Assessing Value

Abigail Alve, Senior Director, Data Management and Engineering, Genentech

Biswajit Kumar, Director, Data Operations and Programming, Novartis

Mike Lu, PharmD, Senior Director, Head of Clinical Design and Data, Gilead Sciences, Inc.

Tom Dougherty, Data Science and AI Innovative Partnership Lead, Novo Nordisk

Showing Events in 1 Track from 04:55pm to 05:00pm

DPHARM 2024 Concludes

4:55PM - 5:00PM

DPHARM 2024 Concludes

Showing Events in 1 Track from 08:00am to 08:20am

Early Riser Session

8:00AM - 8:20AM

Early Wins: Big Pharma and Biotech Innovative Collaborations in Clinical Operations

Christoph Koenen, MD, MBA, Head, Clinical Development and Operations, Pharmaceuticals R&D, Bayer

Doug Schantz, SVP, Clinical Operations, Asklepios BioPharmaceutical, Inc.

Showing Events in 1 Track from 08:25am to 08:40am

Morning General Session

8:25AM - 8:40AM

DPHARM Kicks Off with Idol Winner Announcement

Showing Events in 1 Track from 08:40am to 09:00am

Keynote

8:40AM - 9:00AM

AI and GenAI in Drug Development

Keynote:

Faisal Khan, PhD, Corporate Vice President, AI and Analytics, Novo Nordisk

Showing Events in 1 Track from 09:00am to 09:30am

Leadership Panel

9:00AM - 9:30AM

How Pharma is Shifting Operating Models for More Efficient Clinical Trials

Deirdre BeVard, SVP, R&D Strategic Operation, CSL

Angela DeLuca, MBA, PMP, VP, Head of Oncology & Cell Therapies Clinical Operations, Global Development Office, R&D, Takeda

Candice Fitzgerald, MMedSc, Head of CD&O Regions, Boehringer Ingelheim

Bari Kowal, SVP & Head, Development Operations and Portfolio Management, Regeneron Pharmaceuticals Inc

Showing Events in 1 Track from 09:30am to 10:05am

Special Session

9:30AM - 10:05AM

Keynote TBD

Showing Events in 1 Track from 10:05am to 10:55am

Networking Break

10:05AM - 10:55AM

Networking Break

Showing Events in 3 Tracks from 11:00am to 11:50am

AI Uptake in Clinical Research and Prerequisites for GenAI Adoption in Clinical Operations

11:00AM - 11:20AM

Tufts CSDD Reports on the Uptake of AI In Clinical Research

Mary Jo Lamberti, PhD, Research Associate Professor and Director, Sponsored Research, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

11:20AM - 11:50AM

How Pharma is Adopting GenAI Across Clinical Development

Dave Apfel, MBA, Head, External Innovation, R&D Data Science and Digital Health, Johnson & Johnson Innovative Medicine

Shameer Khader, PhD, MPH, Executive Director, Sanofi

Henry Wei, MD, Head of Development Innovation, Regeneron Pharmaceuticals Inc

Syed Waseem Haider, PhD, Global Head of eClinical Business Intelligent Automation and Life Data Sciences, Merck & Co., Inc.

New Approaches to Scale eSource EHR and Accelerate Clinical Development

11:00AM - 11:25AM

How Do You Make Scaling eSource EHR a Reality?

Nadir Ammour, DDS, MBA, Global Lead, Clinical Innovation & External Partnerships, Sanofi

Joseph Lengfellner, Senior Director, CR Informatics and Technology, Clincial Research Administration, Memorial Sloan Kettering Cancer Center

Amy Cramer, MMCi, BSN, Director, Data Acquisitions, IDAR, Data Management and Central Monitoring, Johnson & Johnson Innovative Medicine

11:25AM - 11:50AM

Leadership on New Thinking to Accelerate Clinical Development

Christoph Koenen, MD, MBA, Head, Clinical Development and Operations, Pharmaceuticals R&D, Bayer

Andy Lee, SVP, Head of Global Clinical Trial Operations, Merck & Co., Inc.

Siân Ratcliffe, PhD, SVP, Head of Global Clinical Operations, Analytics, Technology & Data Sciences, Biogen

Innovative Solutions to Address Sites Burden

11:00AM - 11:50AM

Joint Site and Sponsor Session on Innovative Solutions Addressing Sites Challenges

Brett Bishop, PhD, Global Vice President, Novo Nordisk

Lisa Kiehne, MHA, SVP, Operations, The START Center for Cancer Research

Tracey Robertson, Global CD&O – Head of Patient & Site Engagement Capabilities, Boehringer Ingelheim

Dennis Salotti, MS, MBA, Executive Director & Head, Clinical Outsourcing & Innovation, Jazz Pharmaceuticals

Showing Events in 1 Track from 11:55am to 01:00pm

Today Show at DPHARM

11:55AM - 1:00PM

Today Show at DPHARM

Today Show Host:

Katherine Taylor, MBA, Senior Director, Risk Evaluation and Adaptive Integrated Monitoring (REAIM), Global Clinical Trial Operations (GCTO), Merck & Co., Inc.

Presenting Companies:

Ramil Burden, CEO, Optum Life Sciences

Elisa Cascade, MBA, Chief Product Officer, Advarra

Terttu Haring, MD, President, Sites & Patients, Syneos Health

Ria Westergaard, PharmD, Director Product Strategy, Evernorth Clinical Trial Solutions

Showing Events in 1 Track from 01:00pm to 01:55pm

Networking Luncheon and Facilitated Roundtables

1:00PM - 1:55PM

Networking Luncheon and Facilitated Roundtables

Showing Events in 9 Tracks from 01:20pm to 01:55pm

Roundtable A

Accelerating Action: Reducing The Environmental Impact of Clinical Trials

Facilitators:

Peter Morley, Clinical Sustainability Manager, Novo Nordisk

Susanne Witzke, Senior Director, Clinical Operations Office, Novo Nordisk

Roundtable B

Use of Patient-Centric KPIs in the Design and Execution of Clinical Studies and Organizational Integration for Sustainable, Patient Centric Investments

Ben Geelan, Director, Strategic Operational Intelligence, Roche

Roundtable C

Progressing Towards Data Standards and Protocol Designs for Information Exchange and Data Flow

Bill Illis, Head, Technology and Collaboration, Novartis

Roundtable D

Towards Instantaneous Approvals 2030: Collaborating to Accelerate Patient Access

Antoniu Fantana, PhD, Global Regulatory Affairs Innovation and Technology Lead, Eli Lilly and Company

Roundtable E

Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement

Mitchell Katz, PhD, SVP, Global Clinical Operations, Kyowa Kirin

Roundtable F

Stimulating Industry Uptake in Platform Trials: How Do We Make it Happen?

Nadir Ammour, DDS, MBA, Global Lead, Clinical Innovation & External Partnerships, Sanofi

Roundtable G

The Era of Shiny Objects Is Over: A Pragmatic Approach to Digital Implementation

Aman Thukral, Head of Digital Operations and Clinical Systems, AbbVie

Roundtable H

Navigating EUCTR Impact on Study Start-Up: Overcoming Challenges and Driving Success

David Parker, Senior Director, Clinical Operations Planning & Study Delivery, Immunocore

Roundtable I

Leveraging Smart Packaging Technologies to Reduce Burden and Deliver Better Quality Data from Clinical Trials

Facilitators:

Dan Eversole, PhD, Associate Director, Digital Strategy, Takeda

Jason Williams, Senior Manager, Clinical Trial Tools & Technologies, Takeda

Showing Events in 3 Tracks from 02:00pm to 04:55pm

Track A: Alleviating Patient & Site Burden / Workflow Efficiencies, Data Driven Feasibility, and AI for Patient ID

Track Chair:

Mark Travers, PhD, MBA, VP, Head Global Clinical Trial Operations, Regions and Regional Operations, Merck & Co., Inc.

2:00PM - 2:35PM

Are Site Networks the Solution to the Industry Productivity and Recruitment Challenge?

Mark Travers, PhD, MBA, VP, Head Global Clinical Trial Operations, Regions and Regional Operations, Merck & Co., Inc.

Paul Evans, PhD, President & CEO, Velocity Clinical Research

Mark Scullion, CEO, Atlas Clinical Research

Nick Slack, MBE, Chairman and CEO, The START Center for Cancer Research

2:35PM - 2:45PM

Site Centric Session

2:45PM - 3:05PM

Takeda’s Approach to Adopting “Smart Packaging" at Scale to Address Patient and Site Burden

Speaker:

Sriman Banerjee, Executive Director, Head of Diagnostics, Software Devices and Packaging Development, Takeda

Jordan Brayanov, PhD, Senior Director, Digital Strategy, Takeda

Xuefang Wu, PhD, Associate Director, Digital Strategy, Digital Health Sciences, Takeda

3:05PM - 3:15PM

Site Centric Session

3:15PM - 3:35PM

Merck: Advanced Analytics to Inform Study Planning and Site/Country Selection to Elevate Site Performance

Randy Krauss, PhD, Head of Metrics, Analytics, and Performance, Merck & Co., Inc.

3:35PM - 3:55PM

Novartis: Transitioning to Data Driven Feasibility

Speaker:

Zdenek Zencak, PhD, GCO Development Unit Head, Cardiovascular, Renal and Metabolism, Novartis

3:55PM - 4:15PM

Advancing Data Driven Feasibility: Measuring Impact and Driving Adoption

Sourav Das, Associate Principal, ZS

Mara Kramer, Feasibility Transversal Project Lead, Early Operational Strategy, Sanofi

4:15PM - 4:35PM

Reimagining the Clinical Study Document Creation Workflow with LLMs

Taylor Uttley, MS, Senior Director, Head of Strategy & Operations, Data Strategy & Solutions, Vertex Pharmaceuticals

Lily Xu, PhD, Senior Principal Data Scientist, Data Strategy & Solutions, Vertex Pharmaceuticals

4:35PM - 4:55PM

Leveraging Vocal Digital Biomarkers to Identify Participants for Alzheimer’s Disease Clinical Trials

Katie King, MSHS, Associate Director, PCE DU Lead, Patient Centricity & Engagement, Global Clinical Operations, Biogen

Andrew Vigario, MA, Senior Clinical Country & Site Lead, Biogen

Track B: Advancing DEI: Diversity Action Plan Early Impact, Tools for Risk Mitigation and Data Driven ML Approaches

Track Chair:

Leticia Murray, MBA, Clinical Research Diversity and Patient Recruitment Strategist, Novartis

2:00PM - 2:25PM

Special Session…details to be announced soon

2:25PM - 3:10PM

Panel Session: Examining the Early Impact of Diversity Action Plans and How to Drive Sustainable Momentum

Stacey Bledsoe, RN, MSN, Head of Global Clinical Trial Diversity and Inclusion, Gilead Sciences, Inc

Amanda Bishop, Clinical Trial Diversity Program Lead, Merck & Co., Inc.

Leida Bowen, PharmD, Associate Director, AbbVie

Lorena Kuri, MSMHC, Head, Diversity Strategy for R&D, BMS

Shalini Mohan, MD, Executive Director, Head of Health Equity and Inclusive Research, Genentech

3:10PM - 3:20PM

Patient-centric Session

3:20PM - 3:45PM

Gilead: Applying Machine Learning to Predict Global Site Diversity Outcomes

Kate Luu, PhD, Data Scientist, Advanced Analytics, Clinical Data Science, Gilead Sciences, Inc.

3:45PM - 4:10PM

Repurpose Your RBQM Tool to Mitigate Risk in Diversity Action Plan Monitoring

Lydia Matombo, Director, Risk Evaluation & Adaptive Integrated Monitoring, Merck & Co., Inc.

Alethea Wilson, Director, Risk and Analytics Lead, Merck & Co., Inc.

4:10PM - 4:30PM

Accelerating Patient Enrollment by Deploying a Product Model Approach

Chandeep Kaur, Product Designer, Patient & Site Engagement, Bristol Myers Squibb

Tara Schultz, Associate Director, IT Product Owner Patient Recruitment, Bristol Myers Squibb

4:30PM - 4:55PM

Assessing New Sites Performance Capabilities with a Data Analytics Driven Approach

Marland May, Senior Manager, Clinical Trial Diversity & Inclusion, AbbVie

Erin Reynolds, Associate Director, Data Science & Analytics, AbbVie

Track C: DCT Execution, Adoption of DHTs and Endpoints, Investor Views on Emerging Tech, Novel Digital Endpoints, Advancing Scalability and Tokenization

Track Chair:

Brandon Maggio, Director, Digital & Process Optimization, GSK

2:00PM - 2:15PM

Reflections from a Fully Remote DCT: Maximizing Lessons Learned to Inform Continuous Optimization

Amy Bohn, Director, DCT Operations, Bayer

Heidi Johnson, Director, DCT Operations, Bayer

Holly Robertson, PhD, Head of Advisory Services, Medidata Solutions

2:15PM - 2:50PM

Disrupting the Evidence Generation Paradigm: Driving Greater Adoption of DHTs and Endpoints in Clinical Trials