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

First name	Last name	Job title	Company name	Photo URL	Bio Position
Amber	Roberts	Head, Regional Clinical Compliance & Risk Management	Bristol Myers Squibb	https://proventainternational.com/wp-content/uploads/2025/05/Amber-Roberts.jpg
Ashok	Kadian	Senior Client Partner	Quantiphi	https://proventainternational.com/wp-content/uploads/2025/05/Ashok-Kadian.jpg	With 15 years of experience in the Healthcare and Life Sciences (HCLS) service area, Ashok Kadian has built a strong track record across clinical trials, regulatory affairs, biomedical research, and P&L management. In life sciences, he has played a pivotal role in managing Trial Master Files (TMFs), ensuring regulatory compliance, supporting biomedical research deliverables, and managing P&L. Now, as a Senior Client Partner at Quantiphi, Ashok leverages this deep domain expertise to help pharmaceutical companies adopt AI and GenAI solutions, driving greater efficiency and faster results in R&D space.
Ashok	Srivastava	Chief Clinical Officer	Autolus Therapeutics	https://proventainternational.com/wp-content/uploads/2025/03/Ashok-Srivastava.jpg
Carl	Spana	Chief Executive Officer & President	Palatin Technologies	https://proventainternational.com/wp-content/uploads/2025/05/Carl-Spana.jpg	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.	https://proventainternational.com/wp-content/uploads/2024/04/Erinne-Wasalski-1.jpg	Erinne Wasalski is the Senior Group Director of Clinical Programs in Early Oncology at AstraZeneca, where she leads teams responsible for close-out strategy and post-trial patient access across global early oncology programs. A strategic executive with 20+ years in clinical research and operations, Erinne has a proven track record of driving innovation, diversity, and efficiency in oncology drug development. She has led global teams, accelerated trial timelines, and advanced patient-centric strategies. Erinne is also pursuing a PhD focused on disparities in health-related quality of life in breast cancer trials and has been recognized for her leadership and impact in healthcare.
Frank	Leu	Founder & Managing Member/ Managing Member	BioPharMatrix LLC/ Novapeutics LLC	https://proventainternational.com/wp-content/uploads/2020/08/Frank-Leu-1.jpg	Frank Leu is a Founder & Managing Member/ Managing Member of BioPharMatrix LLC/ Novapeutics LLC located in Philadelphia, developing a first-in-class insulin-producing beta-cell restoration curative for diabetes. Prior, Frank was at a specialty pharma, Verto Institute, developing curatives for a neuroendocrine cancer. Frank received his Pharmacology Ph.D. from Weill Cornell Graduate School of Medical Sciences, postdoc-ed at a HHMI lab at the Rockefeller University, and served as an instructor at the Rutgers Cancer Institute of NJ. Currently, he is an adjunct professor at Thomas Jefferson University, advisor to 1776 for Pennovation Center Labs, founder of BioPharMatrix (life-science ecosystem), and serving on numerous life-sciences advisory boards.
Irena	Maksimovic	Senior Director, Strategy & Business Operations-Clinical Supply Chain	Bristol Myers Squibb	https://proventainternational.com/wp-content/uploads/2025/04/Irena-Maksimovic.jpg	Irena Maksimovic, PhD, is a dynamic and purpose-driven leader with over 15 years of extensive experience in Strategy and Business Operations, Supply Chain and Value Chain Management, CMC Strategy, Project/Portfolio Management and Full Cycle Drug Development. Her expertise lies in optimizing supply chain strategies, reducing costs, improving efficiency, and ensuring the uninterrupted supply of critical medicines to patients. With a PhD in Analytical Chemistry and a CSCP and PMP designation, Irena is renowned for her analytical acumen and strategic planning capabilities. She excels in driving cross-functional collaboration and fostering a culture of innovation and continuous improvement. Irena is adept at solving complex business challenges and delivering sustainable, impactful solutions at scale. Outside of work, she enjoys tennis, basketball, yoga, suspense dramas, history, and gardening.
James	Kirwin	COO and Head, Clinical Development Operations	SFA Therapeutics	https://proventainternational.com/wp-content/uploads/2024/02/James-Kirwin.jpg	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	https://proventainternational.com/wp-content/uploads/2025/05/Kenneth-Locke.jpg
Louis	Smikle	Executive Director, Global Strategic Partnership	Arensia	https://proventainternational.com/wp-content/uploads/2020/06/Louis-Smikle.jpg
Marisa	Ehinger	Senior Director, Head Clinical Supply Operations Cross-TA	Johnson & Johnson Innovative Medicine	https://proventainternational.com/wp-content/uploads/2025/05/Marisa-Ehinger.jpg
Mohit	Ahuja	Engagement Manager – Healthcare and Life Sciences	Quantiphi	https://proventainternational.com/wp-content/uploads/2025/05/Mohit-Ahuja.jpg	With two decades of IT leadership under his belt, Mohit Ahuja has a proven track record of spearheading complex product launches, IT transformations, and AI/ML solutions within the Life Sciences sector. His expertise is well-regarded in the industry for delivering innovative solutions across clinical trials, data migration, analytics, and data sciences. Currently serving as an Engagement Manager at Quantiphi, Mohit is at the forefront of cutting-edge initiatives. This includes the establishment of an AI Center of Excellence for a major Life Science client and the development of one of the largest Agentic frameworks for a leading Contract Research Organization. Mohit’s current roles underscore his continued impact on driving technological advancements in the Life Sciences domain
Pankaj	Patel	Innovation Capability Head – Clinical Trial Diversity, Equity and Inclusion	Novartis	https://proventainternational.com/wp-content/uploads/2024/12/Pankaj-Patel.jpg	Pankaj Patel is the Innovation Capability Head for Clinical Trial Representation at Novartis and leads efforts to drive the incubation of innovative solutions to ensure clinical trial populations robustly inform risk/benefit in the medically indicated population support. Previously he has held several leadership roles in diversity, patient advocacy, and clinical research across multiple organizations. At IQVIA, he led clinical trial representation strategy and initiatives, at Celgene he built a patient advocacy function within global clinical operations and at Bristol Myers Squibb, he managed consumer brand marketing efforts in commercials and helped create a Patient Advocacy Center of Excellence within R&D.
Paresh	Patel	Former Global Head, Clinical Intelligence	Otsuka Pharmaceutical Companies (U.S.)	https://proventainternational.com/wp-content/uploads/2024/02/Paresh-Patel.jpg	Paresh Patel is a visionary in Clinical Data, Systems, and Operations, pioneering advanced technologies for operational excellence. He led global initiatives like enrollment forecasting models and Covid-19 impact assessments. As a Data Science Technologist, he drove efficiency through automation and innovative review processes. His tenure saw the transformation of teams and strategic partnerships for technological advancements. Paresh has championed excellence, revenue growth, and collaborative relationships throughout his career, ensuring the highest standards in clinical research operations
Robert	Gabriel	Board Member, Managing Partner	Ashur Capital	https://proventainternational.com/wp-content/uploads/2025/04/Robert-Gabriel-2.jpg
Savita	Bharathy	Global Clinical Operations Program Director – Community Lead	Novartis	https://proventainternational.com/wp-content/uploads/2024/12/Savita-Bharathy.jpg	Savita Bharathy is an experienced clinical research professional, including 14+ years in the pharmaceutical industry. In her current role, Savita is a clinical operations program director leading the oncology/hematology practice team responsible for early strategic planning and scenario modeling as well as overall delivery of site feasibility and recruitment planning. Savita has a strong professional focus in oncology/hematology, having held leadership positions in trial management and feasibility at Novartis for over 13 years. She is patient-focused and has been involved in numerous process-excellence initiatives and optimization of product delivery. Savita holds a Ph.D. from Rutgers University, New Jersey.
Soumaya	Abdel-Rahman	Global Head, Clinical Project Management	Eisai US	https://proventainternational.com/wp-content/uploads/2024/07/Soumaya-Abdel-Rahman.jpg	Dr. Soumaya Abdel-Rahman is an accomplished project management leader with over 20 years of experience in R&D, scientific research, and management consulting. As the Global Head of Clinical Project Management at Eisai, Inc., she oversees the strategic alignment, integrated planning, and execution across the Neurology and Oncology portfolios. Her team partners with international project leads to guide clinical development from clinical introduction to registration filings. A champion of innovation and process optimization, she led Eisai’s decentralized clinical trials (DCTs) initiative, shaping its DCT strategy and contributing to increased diversity in Alzheimer’s research. Focused on strategic insights and communication, she drives cross-functional initiatives to accelerate drug delivery. She also leads the clinical development of an early Alzheimer’s compound.
Sunil	Joshi	President & CEO	Protelis Bio	https://proventainternational.com/wp-content/uploads/2025/05/Sunil-Joshi.jpg
Tatiana	Eidus	Director, Corporate Development North America	Arensia	https://proventainternational.com/wp-content/uploads/2020/05/Tatiana-Eidus.jpg	Tatiana Eidus received her Master’s Degree in Biophysics from Moscow State University. Entering the industry more than a decade ago, Tatiana has accumulated wide expertise in all the operational aspects of initiating and managing Phase I-III trials across Europe and US. Prior to joining ARENSIA Exploratory Medicine, Tatiana worked for GSK and Merck. Primarily focused on early-stage exploratory programs, she conducted trials in various disease areas. In her current role as Director Corporate Development, Tatiana supports ARENSIA’s partners in the US, supervising cross-functional coordination throughout study planning, start-up and execution.
Vidhya	Gedela	Head, Patient & Site Engagement Products, Drug Development IT	Bristol Myers Squibb	https://proventainternational.com/wp-content/uploads/2024/12/Vidhya-Gedela1.jpg	IT & Life-Sciences Leader enabling technology for Pharma/Biotech in R&D, Global Drug Development, and Clinical Innovation. Pragmatic, big-picture thinker, problem-solver, and hands-on leader. Engages stakeholders to meet high-value needs within budgets and constraints. Passionate about driving change through digital capabilities to optimize patient and site engagement and clinical operations. Experienced in creating and implementing business and technology roadmaps, strategic planning, and integrated business applications. Focused on building effective teams, delivering results, and managing complex enterprise technology with an emphasis on quick value delivery and sustainability. Above all, passionate about serving patients!
Zena	Muzyczenko	Vice President, Clinical Operations	CNS Pharmaceuticals, Inc	https://proventainternational.com/wp-content/uploads/2025/01/Zena-Muzyczenko.jpg

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

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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

<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

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Partnering Sponsor

Key Opinion Leader

Media Partners

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Hotel & Venue

Hyatt Regency Princeton