14
November

08:00 AM EST

Clinical Operations

Name: Clinical Operations & Clinical Trial Supply Chain Strategy Meeting East Coast 2024 (Boston)
Start: 2024-11-14T08:00
End: 2024-11-14T18:00
Location: Crowne Plaza, London Docklands

&

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 enhance your trial knowledge

Le Meridien Cambridge Boston

Our Event Starts In

–
days

–
hours

–
minutes

–
seconds

A MEETING EXPERIENCE UNLIKE ANY OTHER

Fresh Clinical Operations 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 Boston MA, 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 2024 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 our Clinical Operations strategy meeting.

Abhishek Gupta

Senior Director, Research & Development | Quality Capabilities BlueRock Therapeutics

Allison Kemner

Vice President, Clinical Sciences and Operations Tyra Biosciences

Amy McCagg

Executive Director and Head, Patient Innovation Sarepta Therapeutics

AnneMarie Winkler

Associate Director, Clinical Trial Optimization and Innovation Genmab

Bill Jackson, Ph.D

Founder & CEO Base Pair Biotechnologies, Inc.

Caroline Potts

General Manager – MRN Site and Patient Services Medical Research Network

Charlie Pattrell

Associate Director, Solution Engineering IQVIA

Ed Carneglia

Business Development Manager Peli BioThermal USA

Frank Leu

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

George Naumov

Chief Operations Officer & Chief Business Officer RS Oncology

Graham Wylie

Executive Chairman Medical Research Network

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.

Jamie Morisco

Vice President, Sales, Marketing & Operations Glemser Technologies

Justin Buie

Clinical Program Manager Candel Therapeutics

Maria Margarita Corvez

Global Program Director Hematology AstraZenca

Meredith Frank-Molnia

Vice President, Clinical Affairs Vericel Corporation

Michael Kleinrock

Senior Research Director, IQVIA Institute for Human Data Science IQVIA

Michael Kleinrock serves as Research Director for the IQVIA Institute for Human Data Science, setting the research agenda for the Institute, leading the development of reports and projects focused on the current and future role of human data science in healthcare in the United States and globally. Kleinrock leads the research development included in Institute reports published throughout the year. The research is focused on advancing the understanding of healthcare and the complex systems and markets around the world that deliver it.
Throughout his tenure at IMS Health, which began in 1999, he has held roles in customer service, marketing, product management, and in 2006 joined the Market Insights team, which is now the IQVIA Institute for Human Data Science.
He holds a B.A. degree in History and Political Science from the University of Essex, Colchester, UK, and an M.A. in Journalism and Radio Production from Goldsmiths College, University of London, UK.

Michael Tolentino

Co-Founder, Chief Innovation Officer Aviceda Therapeutics

ML Ujwal

Associate Director, Data Science Johnson & Johnson

Nancy Dubois

Head, Global Patient Safety, US Region EMD Serono, Inc.

Naouel Baili

Director, AI Scientist IQVIA Technologies

Pawan Gandhi

Director, R&D Glemser

Rakibou Ouro-Djobo

Global Clinical Supply Chain & Logistics Leader Bill & Melinda Gates Medical Research Institute

Seshu Tyagarajan

Chief Technical and Development Officer Candel Therapeutics

Yuyi Shen

Vice President, Technical Operations Abcuro,Inc.

Yuyi Shen is an inspirational CMC thought leader with management experience in biopharmaceutical development, manufacturing, and clinical supply chain. She is an accomplished program leader in the early to late phase development and commercialization of a wide range of recombinant proteins for immuno-oncology, infectious and rare disease drug platforms. She brings extensive expertise in CDMO selection and oversight, facility/team build- out, technology transfer, budget planning, partner collaboration, and CMC strategic direction of global regulatory filings. She is also an industry-recognized innovation-driven CMC expert on disruptive technology implementation, including process modeling, to deliver with high efficiency and better quality under an accelerated timeline.
She served various leadership roles in CMC at large pharma to emerging biotech companies, including Bolt, XOMA, Bayer, BioMarin, and Grifols. She holds a Ph.D. degree in Chemical Engineering from the University of California, Davis.

Uday Harle

Assistant Vice President and Head, Global Clinical Research Kashiv Biosciences

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

DOWNLOAD BROCHURE

Who Should Attend the Event?

Clinical Operations

Clinical Project/ Program Leads

Clinical Quality Assurance

Clinical Research

Clinical Outsourcing

Data Management

Vendor Management

Medical/Scientific Officers

Biometrics

Medical Affairs

Patient affairs

Global study

Site management/ selection

Digital health

TMF/eTMF

Data monitoring

Patient recruitment

Patient engagement

Clinical investigation

Study optimisation

Patient insights

Clinical systems

See Which Topics Are Discussed at the Strategy Meeting

09:00 - 10:00

Roundtable Tracks

Patient Recruitment / Decentralized & Hybrid Trials
Data Security and Privacy in the Era of Decentralized Trials: A 2024 Perspective

Emerging Biopharma / Outsourcing
Managing the Complications of Collaborations: Obstacles and Resolutions in Outsourcing for Developing Biotech/ Pharma Companies

-Nancy Dubois
Head, Global Patient Safety, US Region
EMD Serono, Inc.

Clinical Technologies & Innovation
The Latest Trends in Electronic Data Capture (EDC) Systems and eClinical Solutions for Digital Transformation in Clinical Operations

-Abhishek Gupta
Senior Director, Research & Development | Quality Capabilities
BlueRock Therapeutics

Global Site Selection & Feasibility Study
An In-Depth Exploration of Emerging Trends and Cutting-Edge Best Practices in Elevating Clinical Trial Awareness and Revolutionizing Recruitment Strategies (TOPIC TBC)

-Michael Tolentino
Co-Founder, Chief Innovation Officer
Aviceda Therapeutics

Diversity, Equity & Inclusion In Patient Recruitment & Engagement
Implementing Diversity, Equity, and Inclusion (DEI) Initiatives: Insights from Company Case Studies and Exemplary Practices(TOPIC TBC)

-Luis Aguilar
Vice President, Business and Clinical Operations
Candel Therapeutics

Clinical Supplies / Storage & Global Est Networks
A Strategic Discussion on Clinical Supplies, Storage Innovation, and Global Networks Reshaping the Landscape of CTM, Storage Facilities, Packaging, and Labeling in Clinical Trials

-Rakibou Ouro-Djobo
Global Clinical Supply Chain & Logistics Leader
Bill & Melinda Gates Medical Research Institute

11:10 - 12:10

Roundtable Tracks

Patient Recruitment / Decentralized & Hybrid Trials
Expanding Trial Access into New Communities for New Sites, Patients, and Researchers

-Caroline Potts
General Manager – MRN Site and Patient Services
Medical Research Network

MRN

Emerging Biopharma / Outsourcing
Protocol Designs Balancing Safety, Endpoints, and Cost

-Graham Wylie
Executive Chairman
Medical Research Network

MRN

Clinical Technologies & Innovation
Transforming Clinical Data Analytics with Generative AI: The Next Frontier in Trial Efficiency and Precision

-Naouel Baili
Director, AI Scientist
IQVIA Technologies

IQVIA TECHNOLOGIES

Global Site Selection & Feasibility Study
Redefining “AI” in Feasibility: Authentic Intelligence through Sponsor-Site Partnerships

-Aruna Adhikari Thapa
Senior Director, Product Management
IQVIA Technologies

IQVIA TECHNOLOGIES

Diversity, Equity & 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

Clinical Supplies / Storage & Global Est Networks
Supply Chain Initiatives that Improve Accountability, Optimization, and Sustainability in IP Management

-Charlie Pattrell
Associate Director, Solution Engineering
IQVIA

IQVIA TECHNOLOGIES

12:15 - 13:15

Roundtable Tracks

Patient Recruitment / Decentralized & Hybrid Trials
Is Patient Recruitment Keeping Pace with Technological Advances in the Future Years?

-ML Ujwal
Associate Director, Data Science
Johnson & Johnson

Emerging Biopharma / 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
AI and ML in 2024: Innovations Reshaping Clinical Trial Supply Chains

-Meredith Frank-Molnia
Vice President, Clinical Affairs
Vericel Corporation

Global Site Selection & Feasibility Study
How Can Global Site Selection Evolve to Optimize Assessments of Site Infrastructure, Ensuring Facilities, Equipment, and Resources Meet the Demands of Modern Clinical Trials?

Diversity, Equity & 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

-Amy McCagg
Executive Director and Head, Patient Innovation
Sarepta Therapeutics

Clinical Supplies / Storage & Global Est Networks
The Challenge and Opportunities of Sustainable Temperature Controlled Packaging for Pharmaceuticals

-Ed Carneglia
Business Development Manager
Peli BioThermal USA

Peli Biothermal

15:10 - 16:10

Roundtable Tracks

Patient Recruitment / Decentralized & Hybrid Trials
Patient Recruitment 2.0: Strategies And Approaches for Success in Decentralized/Hybrid Trials

-AnneMarie Winkler
Associate Director, Clinical Trial Optimization and Innovation
Genmab

Emerging Biopharma / Outsourcing
A Decentralized Trial Under Rapidly Evolving Standards Requires Disruptive Tech Adoption (Topic TBC)

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

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

-Seshu Tyagarajan
Chief Technical and Development Officer
Candel Therapeutics

Global Site Selection & 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?

Diversity, Equity & Inclusion In Patient Recruitment & Engagement
Eliminating Health Inequities: How Can We Improve The Diverse Representation Of Clinical Trial Programs To Drive Health Equity?

-Maria Margarita Corvez
Global Program Director Hematology
AstraZenca

Clinical Supplies / Storage & Global Est Networks
Strategies and Approaches for Seamless Integration of Clinical Supplies, Storage, Global Networks, and Regulatory Compliance through Dynamic Partnerships and Supplier Networks

-Yuyi Shen
Vice President, Technical Operations
Abcuro,Inc.

16:15 - 16:45

Overcoming clinical labeling challenges with automation

PRESENTER: Jamie Morisco, Vice President, Sales, Marketing & Operations and Pawan Gandhi, Director, R&D, Glemser PRESENTER: Pawan Gandhi, Director, R&D, Glemser

Reasons To Attend the Strategy Meeting

Our unique closed door round-table discussion format is exclusively designed to engage 10-15 CxO, VP and director-level individuals from pharma, biotech and thought leaders from academia, to address and find solutions to industry challenges from a strategic perspective within the Clinical community

Bespoke networking opportunities to help streamline your procurementrnprocesses, meaning the impetus for your peers attending is solely based around making business decisions at the highest level

To gain practical insight with Good Clinical Practice and Risk Based QualityrnManagement strategies

Improve diversity through patient-centric approaches, decentralized trials and new digital technologies

Event Gallery

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

Hotel & Venue

Le Méridien Boston Cambridge

Le Méridien Cambridge-MIT’s elegant guest rooms and suites offer a place of luxurious sanctuary and unmatched comfort. Explore unique programs inspired by the brand’s European heritage. Born in a glamorous era of travel, Le Méridien believes everyone should explore the world in style.

Hotel Details Maps & Direction Parking

Quick Links

Want to find out more?

Find out more details about our Strategy Meetings and other news and events.

Here To Help

Want to know more? Interested in sponsoring the event? Need help registering your team?rnrnJust get in touch and a member of the team will be happy to help.

Europe

USA East

USA West

Webinars

Dinners & Spotlights

R&D

Clinical Trials Boston

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

&

Strategy Meeting East Coast USA 2024

<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" >Le Meridien Cambridge Boston

Fresh Clinical Operations 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 2024 Facilitators

Abhishek Gupta

Allison Kemner

Amy McCagg

AnneMarie Winkler

Bill Jackson, Ph.D

Caroline Potts

Charlie Pattrell

Ed Carneglia

Frank Leu

George Naumov

Graham Wylie

James Kirwin

Jamie Morisco

Justin Buie

Maria Margarita Corvez

Meredith Frank-Molnia

Michael Kleinrock

Michael Tolentino

ML Ujwal

Nancy Dubois

Naouel Baili

Pawan Gandhi

Rakibou Ouro-Djobo

Seshu Tyagarajan

Yuyi Shen

Uday Harle

Who Should Attend the Event?

Clinical Operations

Clinical Project/ Program Leads

Clinical Quality Assurance

Clinical Research

Clinical Outsourcing

Data Management

Vendor Management

Medical/Scientific Officers

Biometrics

Medical Affairs

Patient affairs

Global study

Site management/ selection

Digital health

TMF/eTMF

Data monitoring

Patient recruitment

Patient engagement

Clinical investigation

Study optimisation

Patient insights

Clinical systems

See Which Topics Are Discussed at the Strategy Meeting

Breakfast & Registration

Opening Keynote Presentation

Roundtable

Roundtable Tracks

REFRESHMENT BREAK

NETWORKING / 1-1 MEETINGS

NETWORKING / 1-1 MEETINGS

NETWORKING / 1-1 MEETINGS

Roundtable

Roundtable Tracks

Le Meridien Cambridge Boston