16
May

08:30 AM ET

Clinical Operations

Name: Clinical Operations & Clinical Trial Supply Chain Strategy Meeting East Coast 2024
Start: 2024-05-16T08:00
End: 2024-05-16T18:00
Location: Hyatt Regency Princeton

&

Clinical Trial Supply Chain

Strategy Meeting East Coast USA 2024

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 Princeton

A MEETING EXPERIENCE UNLIKE ANY OTHER

Fresh Clinical Operations and Trial Supply Chain Insights

Tired of the same conference experience? Real discussions and genuine networking are often promised, but not always delivered. Proventa International’s Clinical Strategy Meetings are designed to avoid the pitfalls of a typical conference, by providing the right environment to make those important connections through interactive roundtable discussions, exclusive networking and keynote panel debates. Join Clinical Operations professionals from across the East Coast, in Princeton, New Jersey, to discover new insights and take your company’s mission to the next level.

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 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.

Amit is responsible for leading Data Science, Digital and Operating Model Transformation of Alexion’s Development, Regulatory and Safety (DRS) functions which involves use of several cutting edge technology, analytics, partnership programs with a variety of partners and process redesign with a goal to accelerate the execution of the portfolio, drive patient centricity into clinical development, regulatory and safety operations to unlock value of data & strengthen risk posture. Post-acquisition of Alexion by AstraZeneca (AZ), he led a very large and complex integration program to harmonize and secure access to advanced AZ capabilities across technology, analytics, geographic footprint expansion and frameworks such as RBQM to accelerate Alexion’s clinical development pipeline. Amit continues to lead numerous technology and other transformation programs across Alexion and AZ. In addition, he is the Digital lead for rare disease, where he is responsible for the development and execution of innovative digital efforts for heterogeneous use cases in the rare disease. Amit holds a Masters Degree in Neuropharmacology from Massachusetts College of Pharmacy in Boston, Masters in Pharmacognosy from University of Mumbai (India) and Bachelors in Pharmacy from University of Pune (India).

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

Eve Dryer recently retired as Vice President, Patient Advocacy at Travere, and has served as a patient advocacy leader for more than 25 years. She is a founder of the Rare Disease Diversity Coalition, which is actively addressing delays in diagnosis and treatment of rare disease patients of color. Prior to Travere, Eve worked on rare oncology with Lexicon Pharmaceuticals, where she built the Patient Advocacy strategy and team. Working with Sisters Network, the national African American breast cancer association, she launched Teens for Pink, to engage African American teenagers in breast cancer education and family health navigation. She spent 15 years as a partner in a healthcare PR agency, Vox Medica, working with clients including AstraZeneca, GlaxoSmithKline, Eisai and Janssen. She was the Healthcare Businesswomen’s Association’s 2013 international STAR honoree for her efforts in mentoring up-and-coming women healthcare leaders, and was recognized in the PharmaVOICE 100 in 2008, 2016 and 2021 for her innovative work in patient advocacy and her health diversity and equity efforts.

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

James Kirwin is a seasoned pharmaceutical executive with over 20 years industry experience and has been involved in more than 20 NDAs. He has experience at major pharmaceutical companies such as AstraZeneca where he was Clinical Operations Team Lead for the Nexium program. He was VP of Global Clinical Development Operations at Wyeth Pharmaceuticals for the 10 years prior to its acquisition by Pfizer. Since then, he has led Clinical Development Operations at several startups, Intrexon, Intercept Pharmaceuticals, Iterum Therapeutics and Arvinas. He has been responsible for many “firsts” in clinical trial operations. While leading Global Clinical Operations at Wyeth, he was the first to implement Electronic Data Capture across all studies in the company globally. He developed the concept of the Functional Service Provider Model with RPS, implementing a US based monitoring group and also developed back-office data management and Trial Master File support in Bangalore India in partnership with Accenture.

Karrie Hilsinger

Senior Director, Head of Clinical Operations UroGen Pharma

Rose Satz

Founder & CEO AIP

Paresh Patel

Former Global Head, Clinical Intelligence Otsuka Pharmaceutical Companies (U.S.)

Uday Harle

Assistant Vice President and Head, Global Clinical Research Kashiv Biosciences

Our 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

Patient Recruitment / Decentralized & 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 & Innovation
Innovating Novel Approaches to Enrollment Prediction and Tracking within Clinical Operations can Significantly Enhance the Efficiency and Success of Clinical Trials

-Paresh Patel
Former 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 & Engagement
Implementing Diversity, Equity, and Inclusion (DEI) Initiatives: Insights from Company Case Studies and Exemplary Practices

-Erinne Wasalski
Senior Group Director, Clinical Programs in Early Oncology
Daiichi Sankyo, Inc.

Clinical Supplies / Storage & 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

Patient Recruitment / Decentralized & 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

IQVIA Technologies

Clinical Technologies & Innovation
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

Sponsor

Global Site Selection and Feasibility Study
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

IQVIA Technologies

Diversity, Equity and Inclusion In Patient Recruitment & Engagement
Navigating The Future Involves Pioneering Strategies For Diversity, Equity And Inclusion In Patient Recruitment And Engagement Through Comprehensive Demographic Data Collection

SPONSOR

Clinical Supplies / Storage & Global Networks
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

IQVIA Technologies

12:15 – 13:15

Roundtable Tracks

Patient Recruitment / Decentralized & 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 & 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
Senior Group Director, Clinical Programs in Early Oncology
Daiichi Sankyo, Inc.

Diversity, Equity and Inclusion In Patient Recruitment & 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 & 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

Patient Recruitment / Decentralized & 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 & 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 & 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 & 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

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Clinical Operations & Clinical Trial Supply Chain Strategy Meeting East Coast 2024

&

Strategy Meeting East Coast USA 2024

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Fresh Clinical Operations and Trial Supply Chain Insights

What makes our strategy meetings unique?

Roundtable Discussions

Unrivalled Networking

Personalised Agenda

Solutions to your Problems

Industry Researched Topics

Senior Decision Makers

Meet Our Facilitators

Jim DiCesare

Kevin Landells

KK Rumrill

Murray Aitken

Naouel Baili

Amit Gulwadi

Barry Moore

Brian Dole

Eve Dryer

Kathy Machuzak

Jackie Foster

James Kirwin

Karrie Hilsinger

Rose Satz

Paresh Patel

Uday Harle

Our Agenda

See Which Topics Are Discussed at the Strategy Meeting

Breakfast & Registration

Opening Keynote Presentation

Is technology delivering on its promise to improve clinical development productivity?

Roundtable ( Pharma/Biotech )

Roundtable Tracks

Refreshment Break

Networking/1-1 Meetings

Roundtable ( Solutions )

Roundtable Tracks

IQVIA Technologies

Sponsor

IQVIA Technologies

SPONSOR

IQVIA Technologies

Roundtable ( Pharma/Biotech )

Roundtable Tracks

Networking Lunch

Networking/1-1 Meetings

Keynote Presentations

Roundtable ( Pharma/Biotech )

Roundtable Tracks

Afternoon Refreshment Break

Panel Discussion

Challenges and Opportunities in Biologics Clinical Trials

Drinks & Canapes Reception

Reasons To Attend Our Strategy Meetings

Fully Interactive Format

Senior Decision Makers

Personalised Agendas

Private and Intimate Networking

Our 2024 Sponsors

Lead Sponsor

Partnering Sponsors

Key Opinion Leaders

Media Partners

Press play to hear what your colleagues had to say…

Hotel & Venue

Hyatt Regency Princeton

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Hyatt Regency Princeton