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

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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

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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.

Alex Zisson

Managing Director H.I.G. Capital

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).

Ashok Srivastava Alexander

Chief Clinical Officer Autolus Therapeutics

Barinder Morhok

Global Head Healthcare and Life Sciences

Catherine Jervis

General Manager Integrated Trial Services MRN

Caroline Potts

General Manager – MRN Site and Patient Services Medical Research Network

Cheryl Roche Alexander

Executive Director UCB

Erinne Wasalski

Global Head, Regional Site Engagement Daiichi Sankyo, Inc.

Henry Wei

Head, Development Innovation Regeneron

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

Kiran Bhirangi

Vice President, World Wide Medical Baxter Healthcare Corp

Laura Vessey

Director in Early Development Oncology Janssen

Lee Cooper

Managing Director Delos Capital

Pankaj Patel

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

Paresh Patel

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

Radha Iyer

Chief Quality Officer, VP Quality and Scientific Affairs, Global Developed Markets Dr Reddy's Laboratories

Ms. Radha Iyer is a strategic and transformational leader with 20+ years in the pharma and biopharma industry with extensive North America and international experience. An adaptable executive, she has achieved success in a range of settings, from large, medium, public multinational companies to start-up companies. Her expertise includes strategic development, product and regulatory strategy, Commercial, R&D, supply chain, digitization, pharmacovigilance, Project Management and Quality Compliance.  As Chief Quality Officer, Vice President of Quality at Dr Reddy’s Laboratories Inc., Ms Iyer is accountable for Quality function in Developed Markets. Dr Reddy’s Laboratories Inc is focused on meeting urgently needed affordable and innovative medicines for good health of our patients. In her role, she and her team collaborates with her colleagues and senior leadership to commercialize and provide a safe and ready supply of quality products and services to patients and healthcare providers. Prior to joining Dr Reddy’s she held leadership positions at Acorda Therapeutics, Shire, Johnson and Johnson and Schering Plough. She also served as President of EaglePutt Services LLC. She holds a Bachelor of Science degree in Chemistry, Masters in Organic Chemistry and  Masters in Applied Chemistry.

Raffy Dakessian

Head, Clinical and Regulatory Writing Karyopharm Therapeutics Inc.

Rahul Ganar

Director, Life Sciences AI Solutions QuantiPhi

Sanjay Choubey

Vice President and CIO (North America), Digital & Process Excellence Dr. Reddy’s Laboratories

Savita Bharathy

Global Director, Strategic Planning and Feasibility Novartis

SoumayaAbdel-Rahman

Executive Director, Global Head of Clinical Project Management Eisai US

Tatiana Eidus

Director Corporate Development North America, USA Arensia

Vidhya Gedela

Director - Head of Patient, Site & Medical Engagement Products Bristol Myers Squibb

Zena Muzyczenko

Vice President, Clinical Operations CNS Pharmaceuticals, Inc

Uday Harle

Assistant Vice President and Head, Global Clinical Research Kashiv Biosciences

Our Agenda

See Which Topics Are Discussed at the Strategy Meeting

09:00 - 10:00

Roundtable Tracks

DEI In Patient Recruitment / Decentralized & Hybrid Trials
Addressing Variability in Data Quality: Ensuring Reliable Outputs from Patient-Operated Devices

-Raffy Dakessian
Head, Clinical and Regulatory Writing
Karyopharm Therapeutics Inc.

Emerging Biopharma / Outsourcing
The IPO Slump: Implications for the Future of Emerging Biopharma (Topic TBC)

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

Clinical Technologies & Artificial Intelligence
Wearable Devices and Sensors in Clinical Trials for Revolutionizing Patient Monitoring(Topic TBC)

-Vidhya Gedela
Director - Head of Patient, Site & Medical Engagement Products
Bristol Myers Squibb

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

-Savita Bharathy
Global Director, Strategic Planning and Feasibility
Novartis

Early Phase Clinical Trials
Navigating Regulatory Complexities: Addressing New Guidelines and Optimization of Trial Timelines (Topic TBC)

-Laura Vessey
Director in Early Development Oncology
Janssen

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

-Sanjay Choubey
Vice President and CIO (North America), Digital & Process Excellence
Dr. Reddy’s Laboratories

11:10 - 12:10

Roundtable Tracks

DEI In Patient Recruitment / Decentralized & Hybrid Trials
Sustaining Participant Engagement: Strategies for Adherence in Remote Clinical Trials

MRN

Emerging Biopharma / Outsourcing
Addressing the Economic Challenges in Biopharma Development and Navigating Significant Financial Investments

Sponsor

Clinical Technologies & Artificial Intelligence
Ensuring Ethical Integrity in the Use of Advanced Technologies in Responsible Clinical Trials

Quantiphi

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

MRN

Early Phase Clinical Trials
Optimizing Biomarker Discovery and Validation in Early Phase Clinical Trials

Sponsor

Clinical Supplies Global Networks Storage & Distribution
Balancing Costs and Compliance to Optimize Regional Trial Expenses for Quality Assurance

Sponsor

12:15 - 13:15

Roundtable Tracks

DEI In Patient Recruitment / Decentralized & Hybrid Trials
Overcoming Interoperability Challenges in Digital Clinical Trial Platform(Topic TBC)

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

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

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

Clinical Technologies & Artificial Intelligence
AI and Machine Learning: Driving Innovation in Clinical Trial Design and Analysis(Topic TBC)

-Amit Gulwadi
Vice President, Head of Transformation
Alexion Pharmaceuticals, Inc.

Global Site Selection And Feasibility Study
Leveraging Data Science for Enhanced Global Site Selection and Feasibility Studies (Topic TBC)

-Karrie Hilsinger
Senior Director, Head of Clinical Operations
UroGen Pharma

Early Phase Clinical Trials
Leveraging Real-World Evidence to Enhance Early-Phase Clinical Trial Outcomes (Topic TBC)

-Kiran Bhirangi
Vice President, World Wide Medical
Baxter Healthcare Corp

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

-Cheryl Roche Alexander
Executive Director
UCB

14:00- 14:40

Your Pre-Selected Private Meetings

15:10 - 16:10

Roundtable Tracks

DEI In Patient Recruitment / Decentralized & Hybrid Trials
Overcoming Geographical and Socioeconomic Barriers to Enhance Diversity in Patient Recruitment and Engagement (Topic TBC)

-SoumayaAbdel-Rahman
Executive Director, Global Head of Clinical Project Management
Eisai US

Emerging Biopharma / Outsourcing
Adapting to Market Challenges and Layoff Trends in the Emerging Biopharma Sector (Topic TBC)

-Henry Wei
Head, Development Innovation
Regeneron

Clinical Technologies & Artificial Intelligence
Enhancing Efficiency and Compliance in Modern Trials through Risk-Based Quality Management (Topic TBC)

-Monika Miranda
Head, Clinical Science
BioNTech SE

Global Site Selection And Feasibility Study
Collaborative Approaches to Streamline Global Site Selection and Feasibility Assessments(Topic TBC)

-Uday Harle
Assistant Vice President and Head, Global Clinical Research
Kashiv Biosciences

Early Phase Clinical Trials
Balancing Risk and Innovation in Early Phase Clinical Trials for New Drug Candidates (Topic TBC)

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

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

-Chuan Tian
Executive Director, Biostatistics
Incyte Corporation

16:30 - 17:00

See the agenda and facilitator line-up. Download the strategy meeting brochure for full details.

DOWNLOAD BROCHURE

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

Become an official strategy meeting partner. Whatever your business needs, we can help. Get in touch for partnering opportunities

I'D LIKE TO PARTNER

Explore Highlight From The Past Events

Gain valuable insights, discover innovative solutions and connect with industry leaders through snapshots of our most successful gatherings.

May
2024

May
2023

Press play to hear what your colleagues had to say...

Hotel & Venue

Hyatt Regency Princeton

Hyatt Regency Princeton hotel is conveniently located near corporate offices and attractions, as well as the Mercer County Airport.

Hotel Details Map & Directions Parking

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

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Strategy Meeting East Coast USA 2025

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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

Alex Zisson

Amit Gulwadi

Ashok Srivastava Alexander

Barinder Morhok

Catherine Jervis

Caroline Potts

Cheryl Roche Alexander

Erinne Wasalski

Henry Wei

James Kirwin

Karrie Hilsinger

Kiran Bhirangi

Laura Vessey

Lee Cooper

Pankaj Patel

Paresh Patel

Radha Iyer

Raffy Dakessian

Rahul Ganar

Sanjay Choubey

Savita Bharathy

SoumayaAbdel-Rahman

Tatiana Eidus

Vidhya Gedela

Zena Muzyczenko

Uday Harle

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

MRN

Sponsor

Sponsor

Roundtable ( Pharma/Biotech )

Roundtable Tracks

Networking Lunch

Networking/1-1 Meetings

Keynote Presentations

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

Thought Leader

Co-Host

Hyatt Regency Princeton