Clinical Trials New Jersey2271449449
15
May
08:00 AM ET
May
Clinical Operations
Clinical Operations&
Clinical Trial Supply Chain
Clinical Trial Supply ChainStrategy Meeting East Coast USA 2025
Effective integration of patient outcomes in clinical trial design, Overcoming under-enrollment of ethnic minorities, Employing RBQM and deep learning to your Trial knowledge
Hyatt Regency PrincetonOur Event Starts In
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What makes our strategy meetings unique?
Roundtable Discussions
Intimate discussions led by renowned industry experts. Have your voice heard and debate alongside like-minded life science executives.
Unrivalled Networking
With senior delegation from big pharma and innovative biotech from across the East Coast, you can network with peers from different locations, all in one place.
Personalised Agenda
Choose the topics that matter to you. Reserve your place at the roundtable discussions and ensure your whole day delivers the insights you need to hear.
Solutions to your Problems
We've partnered with the best solution providers to solve your biggest challenges. Engage in pre-arranged, private meetings to address your specific needs and find a tangible solution.
Industry Researched Topics
We guarantee our agenda is up-to-date and mission critical because its designed by you. We speak to our extended network of senior decision makers to ensure the most important topics are discussed.
Senior Decision Makers
The entire strategy meeting is specifically tailored to the needs and challenges of senior life science professionals. Discover how your peers are dealing with the same challenges as you.
Meet Our Past Facilitators
Our panel of facilitators play a key role in shaping the agenda for the day.See who will be bringing their expertise to the table at Clinical Operations and Clinical Trial Supply Chain Strategy Meeting.
Jim DiCesare
Vice President, Financial Management Solutions IQVIA Technologies
Kevin Landells
Vice President, Business Head for IRT IQVIA Technologies
KK Rumrill
Senior Director, Site Suite IQVIA Technologies
Murray Aitken
Executive Director, Senior Vice President IQVIA Institute for Human Data Science, IQVIA
Naouel Baili
Director, AI Scientist IQVIA Technologies
Amit Gulwadi
Vice President, Head of Transformation Alexion Pharmaceuticals, Inc.
Barry Moore
Head, Randomization and Trial Supply Management GSK
Brian Dole
Vice President, Global Clinical Supply Chain Bristol Myers Squibb
Eve Dryer
Vice President, Patient Advocacy Emerita Travere Therapeutics
Kathy Machuzak
Former Director, Patient Advocacy Travere Therapeutics
Jackie Foster
Senior Director, Clinical Supplies PTC Therapeutics, Inc.
James Kirwin
COO and Head, Clinical Development Operations SFA Therapeutics
Karrie Hilsinger
Senior Director, Head of Clinical Operations UroGen Pharma
Rose Satz
Founder & CEO AIP
Paresh Patel
Global Head, Clinical Intelligence Otsuka Pharmaceutical Companies (U.S.)
Uday Harle
Assistant Vice President and Head, Global Clinical Research Kashiv BiosciencesOur Past Agenda
See Which Topics Are Discussed at the Strategy Meeting
08:30 - 09:00
Is technology delivering on its promise to improve clinical development productivity?
Murray Aitken
Executive Director, IQVIA Institute for Human Data Science
Senior Vice President, IQVIA
09:00 - 10:00
Roundtable Tracks
1
Patient Recruitment / Decentralized u0026 Hybrid Trials And Emergingbiopharma / Outsourcing
Patient Recruitment 2.0: Strategies And Approaches For Success In Decentralized Hybrid Trials
-Amit Gulwadi
Vice President, Head of Transformation
Alexion Pharmaceuticals, Inc.
Clinical Technologies u0026 Innovation
Innovating Novel Approaches to Enrollment Prediction and Tracking within Clinical Operations can Significantly Enhance the Efficiency and Success of Clinical Trials
-Paresh Patel
Global Head, Clinical Intelligence
Otsuka Pharmaceutical Companies (U.S.)
Global Site Selection and Feasibility Study
What Are the Prevailing Challenges in Global Site Selection and Feasibility, and How Can Innovations Shape the Future Landscape
-James Kirwin
COO and Head, Clinical Development Operations
SFA Therapeutics
Diversity, Equity and Inclusion In Patient Recruitment u0026 Engagement
Implementing Diversity, Equity, and Inclusion (DEI) Initiatives: Insights from Company Case Studies and Exemplary Practices
-Erinne Wasalski
Global Head, Regional Site Engagement
Daiichi Sankyo, Inc.
Clinical Supplies / Storage u0026 Global Networks
A Strategic Discussion on Decentralized Trials and the impact on Clinical Supplies
-Jackie Foster
Senior Director, Clinical Supplies
PTC Therapeutics, Inc.
Patient Recruitment 2.0: Strategies And Approaches For Success In Decentralized Hybrid Trials
-Amit Gulwadi
Vice President, Head of Transformation
Alexion Pharmaceuticals, Inc.
Clinical Technologies u0026 Innovation
Innovating Novel Approaches to Enrollment Prediction and Tracking within Clinical Operations can Significantly Enhance the Efficiency and Success of Clinical Trials
-Paresh Patel
Global Head, Clinical Intelligence
Otsuka Pharmaceutical Companies (U.S.)
Global Site Selection and Feasibility Study
What Are the Prevailing Challenges in Global Site Selection and Feasibility, and How Can Innovations Shape the Future Landscape
-James Kirwin
COO and Head, Clinical Development Operations
SFA Therapeutics
Diversity, Equity and Inclusion In Patient Recruitment u0026 Engagement
Implementing Diversity, Equity, and Inclusion (DEI) Initiatives: Insights from Company Case Studies and Exemplary Practices
-Erinne Wasalski
Global Head, Regional Site Engagement
Daiichi Sankyo, Inc.
Clinical Supplies / Storage u0026 Global Networks
A Strategic Discussion on Decentralized Trials and the impact on Clinical Supplies
-Jackie Foster
Senior Director, Clinical Supplies
PTC Therapeutics, Inc.
11:10 - 12:10
Roundtable Tracks
2
Patient Recruitment / Decentralized u0026 Hybrid Trials And Emergingbiopharma / Outsourcing
Financial Empowerment:
Fueling Site and Patient Engagement for Suc cessful Clinical Trials
Effective financial management is the backbone of successful clinical trials. In this discussion, we’ll explore how strategic financial practices empower trial sites and engage participants, ultimately driving superior trial outcomes for sponsors. By aligning financial processes with trial objectives, we can enhance collaboration, transparency, and overall trial efficiency.
-Aligning financial stakeholders—sponsors, CROs, sites, and patients
-Understanding the financial impact on patients and sites
-Integrating financial decisions with trial objectives
-Jim DiCesare
Vice President, Financial Management Solutions
IQVIA Technologies
The Future Of Clinical Trials Embracing Early Signal Prediction And Simulations For Enhanced Outcomes
This theme captures the essence of our vision for a more efficient, secure, and ethically grounded approach to clinical trials.
- Integration of multiple data sources - the importance of leveraging diverse data sets to build predictive models that enhance safety, assess trial feasibility, and simulate trial arms with precision
-Security and privacy in data utilization - strategies to maintain high standards of data security and privacy while fostering the development of robust predictive models
- Human-machine synergy - the critical role of integrating medical reviews and human insights to refine predictive models, enhancing their reliability and ethical standards
-Future trajectory and practical use cases - exploration of real-world applications and the prospective impact of signal prediction and SIM models on clinical trial planning, monitoring, and execution
-Naouel Baili
Director, AI Scientist
IQVIA Technologies
Making Progress in Study Start-Up in The Face of Industry Headwinds
- What sub-processes have you identified to be slowing down study start-ups?
-Is the situation with site capacity improving yet, or are budgets continuing to increase?
- What process and technology solutions for site activation have been successful and what hasn’t been as effective as hoped?
-KK Rumrill
Senior Director, Site Suite
IQVIA Technologies
Navigating The Future Involves Pioneering Strategies For Diversity, Equity And Inclusion In Patient Recruitment And Engagement Through Comprehensive Demographic Data Collection
Supply Chain Initiatives that Improve Accountability, Optimization, and Sustainability in IP Management
Discussion Points:
- Improving supply chain optimization and cost efficiencies through intelligent integrations & automation
- Ensuring quality control and assurance in cold chain management
- Tools and strategies to improve drug accountability and facilitate the move to remote monitoring.
- Optimizing trial processes for sites and patients with the right data and integration strategies
-Kevin Landells
Vice President, Business Head for IRT
IQVIA Technologies
Financial Empowerment:
Fueling Site and Patient Engagement for Suc cessful Clinical Trials
Effective financial management is the backbone of successful clinical trials. In this discussion, we’ll explore how strategic financial practices empower trial sites and engage participants, ultimately driving superior trial outcomes for sponsors. By aligning financial processes with trial objectives, we can enhance collaboration, transparency, and overall trial efficiency.
-Aligning financial stakeholders—sponsors, CROs, sites, and patients
-Understanding the financial impact on patients and sites
-Integrating financial decisions with trial objectives
-Jim DiCesare
Vice President, Financial Management Solutions
IQVIA Technologies
IQVIA Technologies
Clinical Technologies u0026 InnovationThe Future Of Clinical Trials Embracing Early Signal Prediction And Simulations For Enhanced Outcomes
This theme captures the essence of our vision for a more efficient, secure, and ethically grounded approach to clinical trials.
- Integration of multiple data sources - the importance of leveraging diverse data sets to build predictive models that enhance safety, assess trial feasibility, and simulate trial arms with precision
-Security and privacy in data utilization - strategies to maintain high standards of data security and privacy while fostering the development of robust predictive models
- Human-machine synergy - the critical role of integrating medical reviews and human insights to refine predictive models, enhancing their reliability and ethical standards
-Future trajectory and practical use cases - exploration of real-world applications and the prospective impact of signal prediction and SIM models on clinical trial planning, monitoring, and execution
-Naouel Baili
Director, AI Scientist
IQVIA Technologies
Sponsor
Global Site Selection and Feasibility StudyMaking Progress in Study Start-Up in The Face of Industry Headwinds
- What sub-processes have you identified to be slowing down study start-ups?
-Is the situation with site capacity improving yet, or are budgets continuing to increase?
- What process and technology solutions for site activation have been successful and what hasn’t been as effective as hoped?
-KK Rumrill
Senior Director, Site Suite
IQVIA Technologies
IQVIA Technologies
Diversity, Equity and Inclusion In Patient Recruitment u0026 EngagementNavigating The Future Involves Pioneering Strategies For Diversity, Equity And Inclusion In Patient Recruitment And Engagement Through Comprehensive Demographic Data Collection
SPONSOR
Clinical Supplies / Storage u0026 Global NetworksSupply Chain Initiatives that Improve Accountability, Optimization, and Sustainability in IP Management
Discussion Points:
- Improving supply chain optimization and cost efficiencies through intelligent integrations & automation
- Ensuring quality control and assurance in cold chain management
- Tools and strategies to improve drug accountability and facilitate the move to remote monitoring.
- Optimizing trial processes for sites and patients with the right data and integration strategies
-Kevin Landells
Vice President, Business Head for IRT
IQVIA Technologies
IQVIA Technologies
12:15 - 13:15
Roundtable Tracks
3
Patient Recruitment / Decentralized u0026 Hybrid Trials And Emergingbiopharma / Outsourcing
How Are Emerging Biopharma Firms Tackling Infrastructure Challenges To Expedite Drug Development?
-Karrie Hilsinger
Senior Director, Head of Clinical Operations
UroGen Pharma
Clinical Technologies u0026 Innovation
AI and ML In 2024:
Innovations Reshaping Clinical Trial Supply Chains
-Barry Moore
Head, Randomization and Trial Supply Management
GSK
Global Site Selection and Feasibility Study
Embarking on the Pinnacle of Clinical Trial Success in 2024: Unveiling Global Site Selection Strategies, Where Patient Population Precision Aligns with Study Criteria, and Ethical and Cultural Considerations Illuminate the Path to Ethical and Culturally Sensitive Trials
-Erinne Wasalski
Global Head, Regional Site Engagement
Daiichi Sankyo, Inc.
Diversity, Equity and Inclusion In Patient Recruitment u0026 Engagement
Involving Patients In Decision Making Exploring A Scope Of Strategies Statements And Transformations For Engaging Underrepresented Communities And Patient Engagement
-Eve Dryer
Vice President, Patient Advocacy Emerita
Travere Therapeutics
-Kathy Machuzak
Former Director, Patient Advocacy
Travere Therapeutics
Clinical Supplies / Storage u0026 Global Networks
Mastery Of Clinical Logistics:
Unleashing The Power Of Quality Control And Assurance In Clinical Supplies Storage
How Are Emerging Biopharma Firms Tackling Infrastructure Challenges To Expedite Drug Development?
-Karrie Hilsinger
Senior Director, Head of Clinical Operations
UroGen Pharma
Clinical Technologies u0026 Innovation
AI and ML In 2024:
Innovations Reshaping Clinical Trial Supply Chains
-Barry Moore
Head, Randomization and Trial Supply Management
GSK
Global Site Selection and Feasibility Study
Embarking on the Pinnacle of Clinical Trial Success in 2024: Unveiling Global Site Selection Strategies, Where Patient Population Precision Aligns with Study Criteria, and Ethical and Cultural Considerations Illuminate the Path to Ethical and Culturally Sensitive Trials
-Erinne Wasalski
Global Head, Regional Site Engagement
Daiichi Sankyo, Inc.
Diversity, Equity and Inclusion In Patient Recruitment u0026 Engagement
Involving Patients In Decision Making Exploring A Scope Of Strategies Statements And Transformations For Engaging Underrepresented Communities And Patient Engagement
-Eve Dryer
Vice President, Patient Advocacy Emerita
Travere Therapeutics
-Kathy Machuzak
Former Director, Patient Advocacy
Travere Therapeutics
Clinical Supplies / Storage u0026 Global Networks
Mastery Of Clinical Logistics:
Unleashing The Power Of Quality Control And Assurance In Clinical Supplies Storage
14:00- 14:40
Your Pre-Selected Private Meetings
15:10 - 16:10
Roundtable Tracks
4
Patient Recruitment / Decentralized u0026 Hybrid Trials And Emergingbiopharma / Outsourcing
The Role of AI/ML in Enhancing Efficiency for Emerging Biopharma
-James Kirwin
COO and Head, Clinical Development Operations
SFA Therapeutics
Clinical Technologies u0026 Innovation
Harnessing The Power Of Digital Platforms For Enhanced Monitoring (EMC), Communication, And Decision Making Across The Clinical Trial Ecosystem In Global Clinical Trials
-Amit Gulwadi
Vice President, Head of Transformation
Alexion Pharmaceuticals, Inc.
Global Site Selection and Feasibility Study
How Can Sponsors and Researchers Harness the Power of Global Site Selection and Feasibility Studies to Anticipate Challenges and Optimize Conditions for Successful Global-Scale Trials?
-Uday Harle
Assistant Vice President and Head, Global Clinical Research
Kashiv Biosciences
Diversity, Equity and Inclusion In Patient Recruitment u0026 Engagement
Eliminating Health Inequities: How Can We Improve The Diverse Representation Of Clinical Trial Programs To Drive Health Equity?
-Lisa Coleman
Senior Vice President, Global Inclusion and Strategic Innovation
New York University
Clinical Supplies / Storage u0026 Global Networks
Strategies And Approaches For Seamless Integration Of Clinical Supplies Storage Global Networks And Regulatory Compliance Through Dynamic Partnerships And Supplier Networks
-Brian Dole
Vice President, Global Clinical Supply Chain
Bristol Myers Squibb
The Role of AI/ML in Enhancing Efficiency for Emerging Biopharma
-James Kirwin
COO and Head, Clinical Development Operations
SFA Therapeutics
Clinical Technologies u0026 Innovation
Harnessing The Power Of Digital Platforms For Enhanced Monitoring (EMC), Communication, And Decision Making Across The Clinical Trial Ecosystem In Global Clinical Trials
-Amit Gulwadi
Vice President, Head of Transformation
Alexion Pharmaceuticals, Inc.
Global Site Selection and Feasibility Study
How Can Sponsors and Researchers Harness the Power of Global Site Selection and Feasibility Studies to Anticipate Challenges and Optimize Conditions for Successful Global-Scale Trials?
-Uday Harle
Assistant Vice President and Head, Global Clinical Research
Kashiv Biosciences
Diversity, Equity and Inclusion In Patient Recruitment u0026 Engagement
Eliminating Health Inequities: How Can We Improve The Diverse Representation Of Clinical Trial Programs To Drive Health Equity?
-Lisa Coleman
Senior Vice President, Global Inclusion and Strategic Innovation
New York University
Clinical Supplies / Storage u0026 Global Networks
Strategies And Approaches For Seamless Integration Of Clinical Supplies Storage Global Networks And Regulatory Compliance Through Dynamic Partnerships And Supplier Networks
-Brian Dole
Vice President, Global Clinical Supply Chain
Bristol Myers Squibb
16:30 - 17:00
Challenges and Opportunities in Biologics Clinical Trials
PRESENTER: Uday Harle, Assitant Vice President and Head, Global Clinical Research, Kashiv Biosciences
See the agenda and facilitator line-up. Download the strategy meeting brochure for full details.
Reasons To Attend Our Strategy Meetings
Fully Interactive Format
There's only so much you can learn from presentations and lectures. Instead our interactive Roundtable Discussions let you debate the topics that really matter
Senior Decision Makers
All our Strategy Meetings are aimed at director level and above. Discover how your peers are tackling the industries biggest challenges and have your thoughts heard
Personalised Agendas
Pick the roundtable discussions that you want to be part of. Simply choose your sessions and we'll create a personalised agenda just for you
Private and Intimate Networking
Small group discussions, private meetings, networking drinks - however you choose to make those important connections our Strategy Meetings have the solution
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Become an official strategy meeting partner. Whatever your business needs, we can help. Get in touch for partnering opportunities
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Hotel & Venue
Hyatt Regency Princeton
Hyatt Regency Princeton hotel is conveniently located near corporate offices and attractions, as well as the Mercer County Airport.
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