15
May

08:00 AM ET

Clinical Operations

Name: Clinical Operations & Clinical Trial Supply Chain Strategy Meeting East Coast 2025
Start: 2024-05-16T08:00
End: 2024-05-16T18:00
Location: Hyatt Regency Princeton

&

Clinical Trial Supply Chain

Strategy 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 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 plays a key role in shaping the agenda for the day. See who will be bringing their expertise to the table at the Clinical Operations and Clinical Trial Supply Chain Strategy Meeting.

Amber Roberts

Head, Regional Clinical Compliance & Risk Management Bristol Myers Squibb

Ashok Kadian

Senior Client Partner Quantiphi

Ashok Srivastava

Chief Clinical Officer Autolus Therapeutics

Carl Spana

Chief Executive Officer & President Palatin Technologies

Carl Spana, Ph.D., Co-Founder of Palatin, has been the Chief Executive Officer and President since June 14, 2000. He has been a director of Palatin since June 1996 and has been a director of our wholly owned subsidiary, RhoMed Incorporated, since July 1995. From June 1996 through June 14, 2000, Dr. Spana served as an executive vice president and chief technical officer of Palatin. From June 1993 to June 1996, Dr. Spana was vice president of Paramount Capital Investments, LLC, a biotechnology and biopharmaceutical merchant banking firm, and of The Castle Group Ltd., a medical venture capital firm. Through his work at Paramount Capital Investments and The Castle Group, Dr. Spana co-founded and acquired several private biotechnology firms. From July 1991 to June 1993, Dr. Spana was a Research Associate at Bristol-Myers Squibb, a publicly held pharmaceutical company, where he was involved in scientific research in the field of immunology. Dr. Spana received his Ph.D. in molecular biology from Johns Hopkins University and his B.S. in biochemistry from Rutgers University.

Erinne Wasalski

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

Frank Leu

Founder & Managing Member/ Managing Member BioPharMatrix LLC/ Novapeutics LLC

Irena Maksimovic

Senior Director, Strategy & Business Operations-Clinical Supply Chain Bristol Myers Squibb

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.

Kenneth Locke

Senior Vice President, Technical Operations Carisma Therapeutics

Louis Smikle

Executive Director, Global Strategic Partnership Arensia

Marisa Ehinger

Senior Director, Head Clinical Supply Operations Cross-TA Johnson & Johnson Innovative Medicine

Mohit Ahuja

Engagement Manager – Healthcare and Life Sciences Quantiphi

Pankaj Patel

Innovation Capability Head – Clinical Trial Diversity, Equity and Inclusion Novartis

Paresh Patel

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

Robert Gabriel

Board Member, Managing Partner Ashur Capital

Savita Bharathy

Global Clinical Operations Program Director – Community Lead Novartis

Soumaya Abdel-Rahman

Global Head, Clinical Project Management Eisai US

Sunil Joshi

President & CEO Protelis Bio

Tatiana Eidus

Director, Corporate Development North America Arensia

Vidhya Gedela

Head, Patient & Site Engagement Products, Drug Development IT Bristol Myers Squibb

Zena Muzyczenko

Vice President, Clinical Operations CNS Pharmaceuticals, Inc

Our Agenda

See Which Topics Are Discussed at the Strategy Meeting

08:30 – 09:00

PRESENTER: Ashok Srivastava, Chief Clinical Officer, Autolus Therapeutics

09:00 – 10:00

Roundtable Tracks

DEI In Patient Recruitment / Decentralized & Hybrid Trials

Emerging Biopharma / Outsourcing
The Path to Performance: Navigating Complexities of Emerging Biopharma

-Zena Muzyczenko
Vice President, Clinical Operations
CNS Pharmaceuticals, Inc

Clinical Technologies & Artificial Intelligence
AI-Driven Patient Matching and Recruitment

-Vidhya Gedela
Head, Patient & Site Engagement Products, Drug Development IT
Bristol Myers Squibb

Global Site Selection And Feasibility Study
Optimizing Feasibility Assessments for Effective Strategies in Global Site Selection and Management

-Savita Bharathy
Global Clinical Operations Program Director – Community Lead
Novartis

Early Phase Clinical Trials
Balancing Risk and Innovation in Early Phase Clinical Trials for New Drug Candidates

-Ashok Srivastava
Chief Clinical Officer
Autolus Therapeutics

Clinical Supplies Global Networks Storage & Distribution
Overcoming Global Logistics Challenges in Clinical Trial Supply Chains Across Borders

-Marisa Ehinger
Senior Director, Head Clinical Supply Operations Cross-TA
Johnson & Johnson Innovative Medicine

-Carl Spana
Chief Executive Officer & President
Palatin Technologies

11:10 – 12:10

Roundtable Tracks

DEI In Patient Recruitment / Decentralized & Hybrid Trials
Promoting Data Integrity and Decentralized Clinical Trials: Key Elements and Patient-Centric Approaches

-Catherine Jervis
General Manager Integrated Trial Services
MRN

MRN

Emerging Biopharma / Outsourcing

Sponsor

Clinical Technologies & Artificial Intelligence
Advanced AI Agents in Clinical Operations: Enabling Autonomous Decision-Making at Scale

-Mohit Ahuja
Engagement Manager – Healthcare and Life Sciences
Quantiphi

-Ashok Kadian
Senior Client Partner
Quantiphi

Quantiphi

Global Site Selection And Feasibility Study

Early Phase Clinical Trials
Patient Recruitment Strategies for Early Clinical Trials: A Site Perspective on What Works and What Doesn’t in Europe vs. the US

-Louis Smikle
Executive Director, Global Strategic Partnership
Arensia

-Tatiana Eidus
Director, Corporate Development North America
Arensia

ARENSIA

Clinical Supplies Global Networks Storage & Distribution
Building Resilient Supply Chains to Manage Global Distribution and Mitigate Delays in Clinical Trials

-Irena Maksimovic
Senior Director, Strategy & Business Operations-Clinical Supply Chain
Bristol Myers Squibb

Sponsor

12:15 – 13:15

Roundtable Tracks

DEI In Patient Recruitment / Decentralized & Hybrid Trials
Operational Challenges in Diversity Action Plan (DAP) Development and Delivery

-Pankaj Patel
Innovation Capability Head – Clinical Trial Diversity, Equity and Inclusion
Novartis

Emerging Biopharma / Outsourcing
Flexible and Modular Clinical Operations Solutions: The Future of Biopharma Partnerships

-James Kirwin
COO and Head, Clinical Development Operations
SFA Therapeutics

Clinical Technologies & Artificial Intelligence
Leveraging Adaptive AI Systems to Transform Compliance and Workflow Automation in Clinical Trial Design

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

Global Site Selection And Feasibility Study
Leveraging Data Science for Enhanced Global Site Selection and Feasibility Studies

-Sunil Joshi
President & CEO
Protelis Bio

Early Phase Clinical Trials
Integrating Patient-Reported Outcomes into Early Phase Clinical Trials: Enhancing Data, Patient Experience, and Long-Term Follow-Up

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

Clinical Supplies Global Networks Storage & Distribution

14:00- 14:40

Your Pre-Selected Private Meetings

14:40 – 15:10

Proof-of-Concept: Bold moves, big wins, and lessons learned

CHAIRPERSION: Tatiana Eidus, Director, Corporate Development North America, Arensia

15:10 – 16:10

Roundtable Tracks

DEI In Patient Recruitment / Decentralized & Hybrid Trials

Emerging Biopharma / Outsourcing
The Role of AI and Leveraging Blockchain in Emerging Biopharma Trials

-Frank Leu
Founder & Managing Member/ Managing Member
BioPharMatrix LLC/ Novapeutics LLC

Clinical Technologies & Artificial Intelligence
Enhancing Efficiency and Compliance in Modern Trials Through Quality Management

-Amber Roberts
Head, Regional Clinical Compliance & Risk Management
Bristol Myers Squibb

Global Site Selection And Feasibility Study
Mitigating Site Overload and Addressing Capacity Constraints in Research Sites

-Ashok Srivastava
Chief Clinical Officer
Autolus Therapeutics

Early Phase Clinical Trials

Clinical Supplies Global Networks Storage & Distribution
Ensuring Cold Chain Integrity: Navigating Temperature-Controlled Logistics in Global Clinical Trials

-Kenneth Locke
Senior Vice President, Technical Operations
Carisma Therapeutics

16:30 – 17:00

CHAIRPERSON: Carl Spana, Chief Executive Offier & President, Palatin Technologies PANELIST: Paresh Patel, Former Global Head, Clinical Intelligence, Otsuka Pharmaceutical Companies (U.S.) Robert Gabriel, Board Member, Managing Partner, Ashur Capital

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

&

Strategy Meeting East Coast USA 2025

<img class="lazy" decoding="async" src="data:image/svg+xml,%3Csvg%20xmlns='http://www.w3.org/2000/svg'%20viewBox='0%200%201%201'%3E%3C/svg%3E" data-src="https://proventainternational.com/wp-content/uploads/2020/12/location.png" >Hyatt Regency Princeton

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

Amber Roberts

Ashok Kadian

Ashok Srivastava

Carl Spana

Erinne Wasalski

Frank Leu

Irena Maksimovic

James Kirwin

Kenneth Locke

Louis Smikle

Marisa Ehinger

Mohit Ahuja

Pankaj Patel

Paresh Patel

Robert Gabriel

Savita Bharathy

Soumaya Abdel-Rahman

Sunil Joshi

Tatiana Eidus

Vidhya Gedela

Zena Muzyczenko

Our Agenda

See Which Topics Are Discussed at the Strategy Meeting

Breakfast & Registration

Opening Keynote Presentation

Roundtable ( Pharma/Biotech )

Roundtable Tracks

Refreshment Break

Networking/1-1 Meetings

Roundtable ( Solutions )

Roundtable Tracks

MRN

Sponsor

Quantiphi

ARENSIA

Sponsor

Roundtable ( Pharma/Biotech )

Roundtable Tracks

Networking Lunch

Networking/1-1 Meetings

Keynote Presentations

Proof-of-Concept: Bold moves, big wins, and lessons learned

Roundtable ( Pharma/Biotech )

Roundtable Tracks

Afternoon Refreshment Break

Panel Discussion

Drinks & Canapes Reception

Reasons To Attend Our Strategy Meetings

Fully Interactive Format

Senior Decision Makers

Personalised Agendas

Private and Intimate Networking

Our 2025 Sponsors

Co-Host

Partnering Sponsor

Key Opinion Leader

Media Partners

Explore Highlight From The Past Events

Press play to hear what your colleagues had to say…

Hotel & Venue

Hyatt Regency Princeton