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09
November

08:00 AM EST

Clinical Operations

Name: Clinical Operations Strategy Meeting Boston
Start: 2023-11-08T08:00
End: 2023-11-08T17:50
Location: Le Méridien Boston Cambridge

Strategy Meeting East Coast USA 2023

New Discoveries in Technology to Enhance Remote & Virtual Approaches, Utilisation of Telemedicine To Optimise Your Clinical Operation Success

Le Meridien Cambridge Boston

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 2023 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.

Brian Schneider

Vice President of Business Development Rosa & Co.

Carrie Melvin

Chief Operating Officer Viridian Therapeutics

Colleen Hoke

Co-founder and CEO Objective Health

Elina Lavit

Vice President of Business Development OncoNano Medicine

Emilio Neto

Head of US Clinical Country & Site Management, Senior Director Biogen

Eyal Ron

Managing Partner Sensei Ventures

Geraldine Briand Brucelle

Head of Clinical Study Operations Management & Academy Novartis Institutes for Biomedical Research (NIBR)

George Naumov

COO & CBO RS Oncology

Jimmy Brown

Senior Vice President, Business Development Parexel

Julia Sundari

Senior Director, Clinical Design and Analytics IQVIA Technologies

Lalit Verma

Head, Artificial Intelligence CoE Indiana University Health

Lalit Verma is an executive leader with 25+ years of progressive experience in the design, development, delivery, and management of digital technology solutions across global life-science corporations, including genomics, human & animal health, and agro-chemical industries. An advocate of human & animal health, Lalit is passionate about advancing healthy living through applied information technology, data science, and machine learning products and services.
Lalit holds postgraduate degrees in Physics and Computer Science. From 1990 to 1999, he taught Electronics Honors undergraduate students at Delhi University and served as the department chair. Since 2002, he has served the life science industry as a bioinformatician and technical leader.
At present, he is leading a global team of engineers, scientists, and project managers as Global Head of the Pre-clinical Sciences & Translational Safety Data Science at Janssen, the pharmaceutical division of Johnson & Johnson. He leads from the front in providing cutting-edge AI/ML/Deep Learning-based pre-clinical safety-related scientific workflow automation and data-driven decision-making, ensuring speedy regulatory submissions, first in human recommendations, and overall R&D pipeline cycle time reduction. He has authored bioinformatics and clinical algorithms, regulatory documents, and articles published in peer-reviewed journals.

Lisa Coleman

Senior Vice President, Global Inclusion and Strategic Innovation New York University

Dr. Lisa M. Coleman is New York University’s (NYU) inaugural senior vice president for global inclusion and strategic innovation. In this role, she works with senior leaders, internal stakeholders, external partners, and constituents to advance, promote, and build capacity for strategies for Global Inclusion, Diversity, Belonging, Equity, and Access (Global IDBEA) and strategic innovation initiatives across NYU. This includes the New York, Shanghai, and Abu Dhabi campuses, as well as NYU’s thirteen global sites, and numerous global research centers. Dr. Coleman is also a faculty member at the NYU Stern School of Business and teaches at NYU Abu Dhabi.
Prior to NYU, Dr. Coleman served as the first chief diversity officer and special assistant to the president at Harvard University for almost a decade, where she and her team developed some of the first initiatives focused on the intersections of technology, disability, and access. Before her appointment at Harvard University, she served as an administrator and faculty member at Tufts University and was later appointed to serve as the institution’s first global inclusion and diversity senior executive.
She earned her doctorate in Social and Cultural Analysis, American Studies from NYU, and three master’s degrees in African and African American Studies; Women’s, Gender, and Sexuality Studies; and Communication Studies from the Ohio State University. She also holds certificates focusing on legal theory and intercultural development and her undergraduate research foci were sociology, anthropology, and computer science. She loves to travel, is an avid photographer, gardener, cook, and soon to be (hopefully) pilot.

ML Ujwal

Associate Director, Data Science Janssen

Nancy Dubois

Head of Global Patient Safety, US Region EMD Serono

Nate Akers

Senior Vice President, Business Development Parexel

Nelio Drumond

Associate Director – Global Manufacturing Sciences Takeda

Nicolas Whitney

Director, Client Services, Feasibility IQVIA Technologies

Paige Bingham

CEO Scout Clinical

Paul Stanley

Vice President, Head of Quality Astria Therapeutics

Paul J. Stanley, member of Beta Gamma Sigma earned his MBA at the Boston College Carroll School of Management. He joined Boston based Astria Therapeutics as Head of Quality in 2021. Paul has lived the biotech experience for over 30 years, growing up at the Genzyme Corp, Framingham MA campus during the 1990s and 2000s before making the switch to clinical stage companies which have included Synageva, Visterra, Catabasis, Frequency and Astria, where product the profiles have included enzyme replacement, monoclonal antibody and small molecule based therapies as well as Class III medical devices. Much of his time has been spent developing, implementing and managing risk based GxP Quality Management Systems designed for sustainability while serving to enable effective and efficient product and clinical development. Along the way his work has simultaneously revolved around the milestones and activities inherent in INDs, BLAs, pre-approval inspections, product launches and commercial product lifecycle management. Through it all, he particularly enjoys the demands and rewards of working closely with his partners both internal and external, executing under a shared vision of bringing life changing therapies to patients in need.

Penny Carlson

Vice President, Head of Innovation & Data Takeda Pharmaceuticals

Siew Tin Gan

Head Of Clinical Operations Acumen Pharmaceuticals

Yolanda Wan

Head of Clinical Operations Orna Therapeutics

Wasfi Alazzam

Director of Operations and Partnerships Takeda

Wendy Morahan

Senior Director, Clinical Data Analytics IQVIA Technologies

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

RISK BASED QUALITY MANAGEMENT/CENTRAL & REMOTE MONITORING
Identifying strategic methods that promote risk-based quality management
-Nancy Dubois
Head of Global Patient Safety, US Region
EMD Serono

DECENTRALIZED/ HYBRID TRIALS/PATIENT RECRUITMENT
Decentralized Clinical Care and Patient Centric Drug Product Design at the forefront of healthcare provision
-Nelio Drumond
Associate Director – Global Manufacturing Sciences
Takeda

EMERGING BIOPHARMA / OUTSOURCING
What future developments and commercial realities businesses with concentrated pipelines or single assets are facing?
-Elina Lavit
Vice President of Business Development
OncoNano Medicine

DIGITAL MEASUREMENTS/ CLINICAL DATA
What strategies can we use to align digital transformation, and leverage data analytics in order to improve clinical trials and encourage growth?

GLOBAL SITE SELECTION AND FEASIBILITY STUDY
Achieving recruitment timeline begins with Site selection and relationship building
-Yolanda Wan
Head of Clinical Operations
Orna Therapeutics

DIVERSITY, EQUITY, AND INCLUSION IN PATIENT EST ENGAGEMENT
Describing the tactics for promoting more community participation and enhancing clinical trial diversity
-Siew Tin Gan
Head Of Clinical Operations
Acumen Pharmaceuticals

11:10 – 12:10

Roundtable Tracks

RISK BASED QUALITY MANAGEMENT/CENTRAL & REMOTE MONITORING
Making the Most of Your RBQM Solution Through the Establishment of Key Risk Indicators And Setting The Appropriate Thresholds

DECENTRALIZED/ HYBRID TRIALS/PATIENT RECRUITMENT
Leveraging Site Selection for Clinical Trial Decentralization

EMERGING BIOPHARMA / OUTSOURCING
The Evolution of Outsourcing Models: What are the Pros and Cons?

DIGITAL MEASUREMENTS/ CLINICAL DATA
How Data Analytics and AI can help you oversee your portfolio of active trials when data are everywhere and insights are inconsistent

GLOBAL SITE SELECTION AND FEASIBILITY STUDY
Redefining “AI” in Feasibility: Authentic Intelligence through Sponsor-Site Partnerships

DIVERSITY, EQUITY, AND INCLUSION IN PATIENT EST ENGAGEMENT
How Can We Recognize And Eliminate Obstacles That Prevent Minority Involvement, Such As Historical Distrust, Accessibility Issues, And A Lack of Awareness?
-Paige Bingham
CEO
Scout Clinical

12:15 – 13:15

Roundtable Tracks

RISK BASED QUALITY MANAGEMENT/CENTRAL & REMOTE MONITORING
A Developed Risk-Based Quality Management Approach To Mitigate Potential Risks and Liabilities
-Penny Carlson
Vice President, Head of Innovation & Data
Takeda Pharmaceuticals

DECENTRALIZED/ HYBRID TRIALS/PATIENT RECRUITMENT
Practical factors to take into account while switching to hybrid or decentralised clinical trials
-Wasfi Alazzam
Director of Operations and Partnerships
Takeda

EMERGING BIOPHARMA / OUTSOURCING
Challenges And Opportunities In Early-Stage Biotech Funding: Understand the strategies startups need to stand out from the competition
-George Naumov
COO & CBO
RS Oncology

DIGITAL MEASUREMENTS/ CLINICAL DATA
How can we use algorithms and other modern methods to clean and interpret data?
-Lalit Verma
Head, Artificial Intelligence CoE
Indiana University Health

GLOBAL SITE SELECTION AND FEASIBILITY STUDY
How can sponsors avoid pitfalls during the feasibility process and what are key steps that can be taken to mitigate them?
-Emilio Neto
Head of US Clinical Country & Site Management, Senior Director
Biogen

DIVERSITY, EQUITY, AND INCLUSION IN PATIENT EST ENGAGEMENT
What obstacles do pharmaceutical and biotech businesses have to overcome in order to adequately represent various populations in clinical trials?
-Carrie Melvin
Chief Operating Officer
Viridian Therapeutics

15:15 – 16:15

Roundtable Tracks

RISK BASED QUALITY MANAGEMENT/CENTRAL & REMOTE MONITORING
Foundational Elements of RBM Steering the Future of Monitoring
-Julia Sundari
Senior Director, Clinical Design and Analytics
IQVIA Technologies

DECENTRALIZED/ HYBRID TRIALS/PATIENT RECRUITMENT
How can we guarantee that the DCT’s many components use patient data in an effective and secure manner?

EMERGING BIOPHARMA / OUTSOURCING
Tackling Key Decisions in Drug Development
-Brian Schneider
Vice President of Business Development
Rosa & Co.

DIGITAL MEASUREMENTS/ CLINICAL DATA
What strategies can we use to align digital transformation, and leverage data analytics in order to improve clinical trials and encourage growth?

GLOBAL SITE SELECTION AND FEASIBILITY STUDY
Assessing technology to accelerate recruitment
-Colleen Hoke
Co-founder and CEO
Objective Health

DIVERSITY, EQUITY, AND INCLUSION IN PATIENT EST ENGAGEMENT
Tactics to promote change and inclusion in clinical research by using strategies that foster diversity in all elements and phases of clinical research

16:30 – 17:30

Roundtable Tracks

RISK BASED QUALITY MANAGEMENT/CENTRAL & REMOTE MONITORING
Choosing The Best Monitoring Method To Improve Patient Compliance And Data Consistency – Centralized Monitoring vs Remote Monitoring

DECENTRALIZED/ HYBRID TRIALS/PATIENT RECRUITMENT
Improving Retention: Supporting decentralized techniques that lessen patient burden and maintain patient engagement
-Nancy Dubois
Head of Global Patient Safety, US Region
EMD Serono

EMERGING BIOPHARMA / OUTSOURCING
Discussing the challenges in limited resources, inadequate infrastructure, delays in manufacturing and clinical supply, and funding concerns emerging biopharma and biotechs face
-Eyal Ron
Managing Partner
Sensei Ventures

DIGITAL MEASUREMENTS/ CLINICAL DATA
Incorporating Digital Health Technologies (DHT) into Clinical Trial Design
-Paul Stanley
Vice President, Head of Quality
Astria Therapeutics

GLOBAL SITE SELECTION AND FEASIBILITY STUDY
What tactics can we employ to successfully choose a site, do precise feasibility assessments and enhance the patient’s experience?
-Geraldine Briand Brucelle
Head of Clinical Study Operations Management & Academy
Novartis Institutes for Biomedical Research (NIBR)

DIVERSITY, EQUITY, AND INCLUSION IN PATIENT EST ENGAGEMENT
Driving Toward Health Equity: Global Diversity, Equity, Inclusion & Access (DEIA) in Patient Outreach and Engagement
-Lisa Coleman
Senior Vice President, Global Inclusion and Strategic Innovation
New York University

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

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

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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 2023 Facilitators

Brian Schneider

Carrie Melvin

Colleen Hoke

Elina Lavit

Emilio Neto

Eyal Ron

Geraldine Briand Brucelle

George Naumov

Jimmy Brown

Julia Sundari

Lalit Verma

Lisa Coleman

ML Ujwal

Nancy Dubois

Nate Akers

Nelio Drumond

Nicolas Whitney

Paige Bingham

Paul Stanley

Penny Carlson

Siew Tin Gan

Yolanda Wan

Wasfi Alazzam

Wendy Morahan

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

Roundtable

Le Meridien Cambridge Boston