16th Annual Outsourcing in Clinical Trials New England 2024

This year's Outsourcing in Clinical Trials New England event will boast 4 tracks on Clinical Operations and Outsourcing, Clinical Technology and Innovation, Rare Diseases, and Patient Recruitment and Engagement, meaning for anyone involved in the operational aspects of running a clinical trial, there truly is something for everyone.

23 - 24

October

2024
  • Westin Boston Seaport, Boston, USA
  • Complimentary
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Why attend?

YOUR CHANCE TO MEET AND CATCH UP WITH COLLEAGUES FROM ACROSS THE INDUSTRY

As this event returns to an in-person format, you can look forward to a networking focused event with industry leading presentations, interactive formats and the most innovative solution providers attending. Hear from industry leading speakers, Learn what is round the corner in terms of future trends and get the latest knowledge on new and upcoming disruptors.

  • Keynote presentations on the topics affecting you: from COVID to shipping to disruptive technologies
  • Join in with audience discussions, panel debates and add your voice to the conversation

700+

Attendees

80+

Exhibitors

50+

Speakers

700+

Attendees

80+

Exhibitors

50+

Speakers

See What It's All About

Agenda

  • 23 Oct 2024
  • 24 Oct 2024
Expand All

Streams

Stream one

Stream A: Clinical Outsourcing and Operations

Stream two

Stream B: Clinical Technology and Innovation

Stream three

Stream C: Patient Recruitment and Engagement

10:30 AM

Morning refreshments and networking break

11 AM

Best practice for biopharma and advocacy group collaborations in order to boost recruitment for trials

  • How successful collaboration with advocacy groups can boost recruitment and enrolment
  • Strategies for building effective partnerships with advocacy groups
  • Utilizing patient-centric approaches to enhance trial recruitment efforts
  • The impact of a patient-focused trial design on accelerating timelines

Speakers

Hollie Schmidt
Vice President, Scientific Operations, Accelerated Cure Project for MS

11:30 AM

Diversity Action Plans: preparing, submitting, and receiving regulatory feedback

  • An overview of recent US legislation around diversity in clinical trials
  • Understanding requirements around DAP approval and submission: what should you include?
  • Preparing documentation to demonstrate diversity in your clinical trial
  • Experience with DAPs in view of the received FDA feedback

Speakers

Alicia M. Baker McDowell
Head of Regulatory Strategy and Product Development Consulting, Fortrea

12 PM

PANEL: Achieving diversity and inclusion in patient recruitment

  • DEI in rare diseases: how to ensure your trial participants represent the overall population in trials with limited patient numbers
  • Navigating FDA regulations and devising a strategy for diversity and inclusion
  • Building trust and relationships with communities who may not traditionally participate in clinical trials
  • Working with advocacy groups to increase trial diversity and patient numbers

MODERATOR:

Robert Loll, Senior Vice President, Business Development and Strategic Planning, Praxis

Speakers

Robert Loll
SVP, Business Development, Praxis Communications
Patrick Ezeh
Director, Clinical Trial Diversity Portfolio Lead, Biogen
Tammy Burke
Patient Advocate
Behtash Bahador
Director, Health Literacy, CISCRP
Alicia M. Baker McDowell
Head of Regulatory Strategy and Product Development Consulting, Fortrea

12:30 PM

Patient-guided by design: a framework for successful study start-up, informed protocol design and better outcomes

  • Optimizing study-start up for improved timelines and site performance
  • Integrating patient input into protocol design and the impact of patient motivation assessments
  • Case studies: patient-informed protocol design for successful outcomes

Speakers

Deborah Jakubowski Russ
Director, Launch Excellence Leads, Parexel

1 PM

Lunch and networking break

2 PM

Beyond trial participation: engaging rare disease patients in the long term

  • Biopharma’s role in supporting patients with their disease once no longer study participants
  • Working with advocacy groups on long term patient engagement
  • Where and how can trial sponsors step in to provide long term support for rare disease patients?
  • Bridging the scientific advice gap for patients with rare diseases

Speakers

Kate Tith
Vice President, Head of Clinical Operations, Dyne Therapeutics

2:30 PM

Overcoming the challenges of enrollment in the changing landscape of a rare disease

This presentation delves into dynamics of enrollment challenges and underscores the significance of fostering strong site relationships in rare diseases, which often prove instrumental in driving successful outcomes. Beginning with a compelling case study, we navigate key drivers influencing sponsor decision-making processes, creating innovative strategies that positively impact the study. Emphasizing the paramount importance of timelines, we discuss how sponsor decisions are strategically molded to align with project deadlines. Through the lens of the “one team, one approach” philosophy, we highlight collaborative strategies that surmounted our enrollment hurdles effectively. Key takeaways offer actionable insights for stakeholders navigating the complex terrain of rare disease research, paving the way for enhanced enrollment outcomes.

Speakers

Urania Rappo
Senior Medical Director, Clinical Development, BiomX
Caitlin Hirschman
Executive Director, Project Delivery, Rho

3 PM

PANEL: How minimizing participant burden leads to on-time enrollment and completion

  • Patient reimbursement: how to relieve financial pressures on patients participating in trials
  • Where are the main hurdles patients face and how can these be removed?
  • Addressing low levels of health literacy in the patient population: how to improve communication
  • Engaging patients and advocacy groups early on in the clinical trial design process

 

Speakers

Leticia Tarilonte
Vice President, Global Clinical Operations, Brainstorm Cell Therapeutics
Colleen Graham
Vice President, Head of Clinical Operations, Mediar Therapeutics
Charity Roddy
Associate Director, Patient and Site Experience, Oncology and Rare Disease, Moderna
Tammy Burke
Patient Advocate
G Bernard Wandel
Clinical Trial Patient

3:30 PM

Afternoon refreshments and networking break

3:50 PM

EXHIBITION APPLE PRIZE DRAW

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

4 PM

Utilizing technology to improve patient recruitment and retention

  • Methods to streamline patient recruitment and enrolment processes
  • AI and ML as methods of speeding up enrolment timelines in order to reduce overall trial costs
  • Engaging patients through social media and other digital channels

Speakers

Jenn Curry
Head of Patient Engagement Capabilities, Biogen

4:30 PM

Clinical site support and patient enabling services

  • Everything starts with strategic site selection and feasibility
  • Understand the value of patient engagement and measuring its impact on the trial successful completion
  • Know your sites, know their needs, customize your support
  • Innovative patient centric approach: defining a set of strategies designed to place the needs, preferences, and experiences of patients at the

Speakers

Atalah Haun
Vice President, Global Medical Affairs, WEP Clinical

5 PM

Successful recruitment for a rare disease trial

  • Patient identification: how to find patients who are eligible to participate in your rare disease trial
  • Collaborating with patient advocacy groups to facilitate recruitment
  • How does recruitment in rare diseases differ from other therapeutic areas?

Speakers

Chris Adams
CEO, Andarix Pharmaceuticals

5:30 PM

Chairperson’s closing remarks

Speakers

Robert Loll
SVP, Business Development, Praxis Communications

END OF DAY 1 AND NETWORKING DRINKS

10:30 AM

Morning refreshments and networking break

11 AM

Applying Lean Six Sigma methodology to reduce the lead-time of clinical contracting

  • Clinical contracting is on the critical path to trial start
  • It is a process where bottlenecks and root causes can be identified via data analysis
  • Lean Six Sigma methodology can help to significantly reduce contracting lead-time

Speakers

Alex Bai
Head of Clinical Contracts, Biogen

11:30 AM

Enhancing clinical trial integrity: safeguarding endpoints with patient technology

  • Ensuring data accuracy: utilize eCOA to capture patient-reported outcomes in real-time, reducing errors and enhancing data reliability
  • Streamlining patient enrollment: implement IRT to manage patient randomization and drug supply logistics, ensuring compliance and minimizing risks of bias
  • Enhancing patient compliance: leverage eConsent to provide clear, accessible information to participants, ensuring informed consent and improving retention
  • Strengthening data security: integrate robust encryption and authentication measures across eCOA, IRT, and eConsent platforms to protect sensitive data and maintain trial integrity
  • Facilitating regulatory compliance: ensure all digital tools comply with regulatory standards (eg FDA, EMA) to streamline approval processes and enhance trial credibility

Speakers

Anthony Mikulaschek
VP, Commercial Strategy, IQVIA Technologies

12 PM

Study results: using AI in clinical development

  • Results of a collaborative industry survey on the use of AI and machine learning within clinical research and development
  • Mapping AI usage and level of adoption
  • Examine perceptions and attitudes regarding use of AI and machine learning and challenges to implementation

Speakers

Mary Jo Lamberti
Research Associate Professor and Director, Sponsored Research, Tufts Center for the Study of Drug Development
Maria Florez
Senior Consultant, Tufts Center for the Study of Drug Development

12:30 PM

Accelerating clinical trials with meaningful AI

Explore how artificial intelligence is revolutionizing the speed, quality, and consistency within clinical trials through innovative technologies and real-world applications. This presentation explores:

  • Preparing your organization
  • How to identify AI opportunities and associated value
  • Real life examples of using AI to accelerate clinical trials

Speakers

Brian Wehrle
Vice President, R&D Imaging, Clario

1 PM

Lunch and networking break

2 PM

PANEL: How do we work together to deliver GenAI for clinical trials?

  • How AI and digitalization can support streamlining of clinical operations and improve efficiency
  • Simple ways to implement tools such as GPT and GenAI
  • Where can AI be utilized to minimize workloads and increase overall output?
  • The regulatory landscape in the US for the use of AI in clinical trials: what do you need to know?
  • Key limitations of GenAI and how these impact its potential uses for clinical trials in the US

Speakers

John J. Seman
Chief Executive Officer, REVITALE Pharma
Ankita Deshpande
Head, Digital Health and Experience Innovation, Alexion Pharmaceuticals
Maria Florez
Senior Consultant, Tufts Center for the Study of Drug Development
Jia Chen
Senior Director, Medidata AI, Medidata

2:30 PM

Oversight for all: achieve data transparency with elluminate

Learn how the elluminate Clinical Data Cloud provides seamless access to comprehensive trial data across systems and sources:

  • How a centralized data workbench eradicates data silos and provides near real-time access to data for optimized oversight and more efficient, data-driven decision making
  • AI/ML capabilities to ensure data quality, automated data review processes, and increased productivity across the clinical development lifecycle with eIQ Review
  • Proactive trial oversight and management with increased automation, comprehensive analytics, and custom visualizations in elluminate Operational Insights
  • Mitigating risk with efficiency, accuracy, and ease with holistic Risk-Based Quality Management

Speakers

Jason Konn
Solution Consultant, eClinical Solutions

2:45 PM

Enhancing clinical trial outcomes with a unified eClinical platform

Speakers

Stacey Lasser
Senior Project Manager, Mednet

3 PM

Site activation and study start up: making processes more efficient

  • How early should you begin planning study start up and site activation?
  • Tips and tricks to reduce start up timelines for your trial
  • Fostering a strong relationship with sites to accelerate study start up and reduce overall timelines

Speakers

Jay Russak
Senior Director, Clinical Operations, Keros Therapeutics

3:30 PM

Afternoon refreshments and networking break

3:50 PM

EXHIBITION APPLE PRIZE DRAW

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

4 PM

Assessing patient attitudes to the use of AI in clinical trials

  • Review the results of a public and patient survey on the use of AI to develop clinical trial documents
  • Assess patient level of trust in and comfort with the use of AI to generate patient-facing clinical trial documents
  • Discuss the patient’s views on the importance of human review of AI-generated content and implications for the future

Speakers

Shalome Sine
Senior Manager and Quantitative Insights Specialist, Research Services, CISCRP

4:30 PM

Increase trial agility with our integrated reporting tool

  • High-level study metrics and plan
  • Discover data outliers with intuitive dashboards
  • Deep dive into the data with the Data Browser
  • Standard Reports, including Key Risk Indicator to track site trends
  • Create unlimited custom, user generated reports

Speakers

Kelsey Buhler
Product Specialist, Viedoc Technologies

5 PM

eConsent and the benefits for patients, sites, investigators and sponsors

  • Using eConsent as a tool to speed up recruitment and thus overall trial timelines
  • The regulatory landscape surrounding eConsent: what challenges are there to this?
  • Maintaining a relationship with patients in order to ensure consent is informed in remote settings

Speakers

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

5:30 PM

Chairperson’s closing remarks

Speakers

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

END OF DAY 1 AND NETWORKING DRINKS

7:30 AM

Registration and refreshments

8:20 AM

Chair’s opening remarks

Speakers

Robert Loll
SVP, Business Development, Praxis Communications

8:30 AM

OPENING PANEL: The clinical trial landscape for small to mid sized biopharma in New England

  • Navigating the constantly evolving vendor and CRO landscape as a small to mid sized sponsor company
  • Staff turnover and layoffs: handling changes in the industry in order to ensure success
  • New regulations and guidance around clinical trials in the US: how will this impact you?
  • An overview of technology and innovation in the clinical trial industry: what’s working and what isn’t?

Speakers

Revati Tatake
Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc
Harry Barnett
Executive Chairman And Founder, Lubris BioPharma
Kevin Killeen
Chief Scientific Officer, Matrivax
Nick Pelletier
Head of Clinical Operations and Program Management, Delix Therapeutics
Manny Lazaro
Senior Vice President, Clinical Operations and Data Management, Cerevel Therapeutics

9 AM

Reducing trial start-up time through an innovative approach to vendor qualification

  • Exposing the inefficiencies of current vendor qualification practices and challenging the industry to adopt a proven process innovation that will help sponsors onboard vendors more quickly leading to a real reduction in clinical trial start-up times
  • Learn how embracing innovation, and adopting a risk-based data-driven approach to vendor management can help organizations strength their compliance practices in a heavily regulated industry
  • Uncover the advantages of a centralized approach to vendor qualification that provides unique benefits to both sponsors and vendors across the globe

Speakers

Anthea Dransfield
Head of Quality, Diligent Pharma

9:30 AM

Considerations for successful third party vendor management

  • What degree of oversight should you have over third party vendors?
  • Risks and benefits of handing third party management to CROs
  • Regulatory and quality considerations around outsourcing to third party vendors

Speakers

Leticia Tarilonte
Vice President, Global Clinical Operations, Brainstorm Cell Therapeutics

10 AM

Importance of forecasting clinical trial enrollment: an AI enabled approach to increase confidence in feasibility and execution

  • Learn how to pressure-test site footprint through predictive analytics by forecasting enrollment at the country and site level
  • Discover methods to run re-forecasts based on actual study performance for more accurate tracking and adjustments as necessary
  • Gain competitive advantage thru actionable insights to remain agile and avoid costly enrollment delays
  • Learn how to leverage data to identify low-performing sites earlier in the trial process to implement effective risk mitigation tactics

Speakers

Chloe Ren
Lead Data Scientist, Medidata AI, Medidata

10:30 AM

Morning refreshments and networking break

11 AM

PANEL: Choosing an outsourcing model: FSO vs FSP vs inhouse

  • Weighing up pros and cons of different outsourcing models: which is best for your trial?
  • When is mixing and matching better than fully outsourcing or keeping trials fully in house?
  • Developing an outsourcing strategy as a small to medium sized biotech with limited resources
  • Why is FSP becoming a popular choice among sponsor companies and how can this support meeting trial timelines?

Speakers

John J. Seman
Chief Executive Officer, REVITALE Pharma
Rinaldo Dorman
Associate Director, R&D Global Procurement & Strategic Sourcing, Sarepta Therapeutics
Judith Murphy
Executive Director, Centralized Contracting and Outsourcing, Kura Oncology
Derek Pu
Director, R&D Procurement, Servier Pharmaceuticals

11:30 AM

Maximizing the consultative partnership between CRO and biotech sponsors

  • How early engagement can improve outcomes
  • Unlocking the value of your pipeline
  • Purposeful partnering with bespoke solutions

Speakers

Stacey Flattery
Vice President, General Partner, ICON Biotech

12 PM

FIRESIDE CHAT: Managing talent and resources to ensure the success of your clinical trial

  • Importance of retention and growth for your team
  • Openness to junior clinical team members
  • Openness to bridge programs with vendor partner
  • Navigating these challenges in a hybrid environment

Speakers

Carrie Lewis
Executive Director, Clinical Program Optimization, Endo Pharmaceuticals
Joan Ramella
Associate Director, Clinical Operations, Endo USA, Inc

12:30 PM

Beyond the protocol: crafting expert CRAs for impactful rare disease trials

  • Understanding the role of Key Opinion Leaders beyond data collection
  • Educating CRAs on the impact of safeguarding future customer relationships
  • Prioritizing site satisfaction for patient happiness
  • Enhancing patient outcomes through site relationship building

Speakers

Juliane K Mills
Therapeutic Strategy Lead, Rare Disease, Worldwide Clinical Trials

1 PM

Lunch and networking break

2 PM

From fantasy to function: authentic sponsor-vendor engagement

  • Priorities and strategies for small biotech in partnering with CROs and vendors
  • Breaking down the myths
  • Identifying the right partners
  • Cultivating collaborative relationships
  • Managing the partnership

Speakers

Colleen Graham
Vice President, Head of Clinical Operations, Mediar Therapeutics

2:30 PM

Building your toolkit: how to operationalize FDA guidance on diversity today

  • Understand the key points of recent FDA guidance aimed at enhancing diversity and equity in clinical trials
  • Discuss how recent FDA guidance supports patient optionality in clinical trials, especially for underrepresented populations
  • Identify actionable strategies for integrating FDA guidance into clinical trial designs to achieve diversity and innovation goals
  • Explore the potential impact of FDA guidance on future clinical trials, with an emphasis on patient-centricity and inclusivity

Speakers

Kris Booth
Director of Strategic Partnerships, EmVenio
Stephanie Hitchcock
Associate Director of Project Management, PCM Trials

3 PM

Fostering a productive CRO/Sponsor relationship and factors to consider before undertaking a transition to a new CRO

  • Planning for a successful sponsor/CRO relationship
  • Defining goals, priorities and metrics
  • Considerations when contemplating a CRO transition
  • Overview of common challenges and pitfalls in CRO transitions
  • Developing a detailed transition plan to minimize disruptions and ensure continuity

Speakers

Helen Chalk
Vice President, Clinical Operations, Mythic Therapeutics

3:30 PM

Afternoon refreshments and networking break

3:50 PM

EXHIBITION APPLE PRIZE DRAW

Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

4 PM

PANEL: Funding, investment and budgeting for clinical trials: tips and best practice to ensure success

  • Ensuring your trial is both cost-conscious and efficient without compromising on quality
  • Techniques, processes and technology to improve forecasting and budgeting
  • Avoiding common mistakes to keep your clinical trial budget on track

Speakers

Harry Barnett
Executive Chairman And Founder, Lubris BioPharma
Veronica Ludensky
Director of Procurement, Clinical, Flagship Pioneering
Brenda J Boyle
Senior Director, Clinical Vendor Strategy and Partnerships, Agios
Derek Pu
Director, R&D Procurement, Servier Pharmaceuticals
Jennifer Sydney Goldman
Clinical Business Operations Consultant, Day One Biopharmaceuticals

4:30 PM

Cardiac data matters: keeping patients at the heart of innovation

  • Discover how to achieve unparalleled accuracy and patient compliance through cutting-edge, low-touch technology
  • Dive into the transformative power of AI and explore real-world applications reshaping cardiac care
  • Understand how continuous monitoring ensures precise data collection and enhances patient adherence and safety
  • Uncover the revolutionary role of AI in interpreting cardiac data
  • Review practical examples and case studies demonstrating effectiveness of continuous cardiac monitoring in clinical settings

Speakers

Ana Natera
Director, Clinical Business Strategy, HeartMetrics Cardiac Monitoring, Medtronic

5 PM

The state of the biopharmaceutical industry in 2025

  • Reviewing results from our annual survey: were 2024 predictions correct?
  • Key themes and technology advancements in biopharma
  • Spotlight on clinical trial technologies for drug development
  • Leveraging data to predict the outlook for 2025 clinical trial outsourcing
  • Trends, key players, opportunities and threat in biopharma
  • What the latest investment trends show for small to medium biotechs

Speakers

Revati Tatake
Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc

5:30 PM

Chairperson’s closing remarks

Speakers

Rinaldo Dorman
Associate Director, R&D Global Procurement & Strategic Sourcing, Sarepta Therapeutics

END OF DAY 1 AND NETWORKING DRINKS

Streams

Stream one

Stream A: Clinical Outsourcing and Operations

Stream two

Stream B: Clinical Technology and Innovation

Stream three

Stream C: Rare Diseases

9 AM

Innovation and digital health for rare diseases

  • Challenges and limitations of rare disease research: how new solutions can help to overcome this
  • Embracing a patient centric approach in rare disease trials through digital health
  • Opportunities for innovation for orphan drug trials in the US

Speakers

Ankita Deshpande
Head, Digital Health and Experience Innovation, Alexion Pharmaceuticals

9:30 AM

Exploring the UAE’s clinical research landscape: unlocking opportunities and driving innovation

  • The UAE as a prominent hub for research and clinical trials, driven by a focus on healthcare innovation and patient-centric approaches
  • The UAE’s comprehensive regulatory framework that supports and facilitates clinical research
  • Training and upskilling local researchers and clinicians in research methodologies
  • Prioritizing patient-centric approach, engaging patient communities and advocacy groups

Speakers

Rohan Simon
Associate Director, Business Development, IROS by M42

10 AM

PANEL: How to lay the groundwork for a successful rare disease trial through early patient engagement

  • Working closely with patients, caregivers and advocacy groups in clinical trial design
  • The importance of building a close relationship with patients for trials where patients are the expert in their disease
  • Reducing the financial burden of clinical trial participation on patients
  • How to make trial participation easier on patients: where are the main hurdles impacting enrolment?
  • Building long term relationships with patients post clinical trials

Speakers

Nan Doyle
Patient Advocate
Leticia Tarilonte
Vice President, Global Clinical Operations, Brainstorm Cell Therapeutics
Lily Cappalletti
Director, Patient Experience, Alexion Pharmaceuticals
Janet Peterson
Associate Director, Patient Insights and Clinical Trial Experience, Biogen
Sue Kahn
Board Member, IFOPA

10:30 AM

Morning refreshments and networking break

11 AM

CASE STUDY: Improving patient and site experience for rare disease trials

  • Sponsors’ roles in supporting sites in order to increase trial efficiency and decrease overall timelines
  • Where can clinical trial sponsors better support patients with rare diseases both during trials and in the long term?
  • Lessons learned from Moderna’s experience of site and patient engagement during clinical trials

 

Speakers

Charity Roddy
Associate Director, Patient and Site Experience, Oncology and Rare Disease, Moderna

11:30 AM

Rare disease studies: benefits of a hybrid outsourcing strategy

A look at the pros and cons of various outsourcing models including Full-Service Outsourcing (FSO), Functional Service Provision (FSP), and single service. A discussion of the benefits of a hybrid approach are explored.

Speakers

Ajay Sadhwani
Senior Vice President, Operations, Harbor Clinical

12 PM

Insights into barriers to care in the rare disease community

  • Insights on the differences between represented and underrepresents populations on their barriers to care
  • Challenges and nuances of rare disease patients’ journey to receive a diagnosis
  • Mental health and well-being: the emotional toll rare diseases take on patients and caregivers
  • Exploring overall experiences individuals have had within the healthcare system: strengths and areas for improvement

Speakers

Jenifer Waldrop
Executive Director, Rare Disease Diversity Coalition

12:30 PM

Lunch and networking break

9 AM

Uncovering RBQM adoption levels and mapping implementation: a novel comprehensive assessment

  • Learn about a new comprehensive approach to assessing RBQM adoption
  • See recent data on current and future levels of RBQM adoption among industry sponsors and CROs
  • Discuss a maturity model that characterizes levels of adoption among industry sponsors
  • Discuss perceived challenges associated with the implementation of RBQM components
  • Discuss opportunities and benefits of RBQM implementation

Speakers

Abigail S Dirks
Data Scientist, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

9:30 AM

Biometrics considerations in implementing new technology

  • How to keep up with rapid changes in technology?
  • How do all the systems interact with each other?
  • What is the ultimate goal?

Speakers

David Ng
Vice President, Global Biometrics, Novotech

10 AM

FIRESIDE CHAT: Deploying an effective monitoring strategy

  • Budget considerations
  • In house vs outsourced
  • Site relationship management
  • Effective risk-based approach
  • Remote vs on-site

Speakers

Suzanne Murphy
Director, Clinical Operations, Compliance and Oversight, Editas Med
Matt Weinberg
Director, Clinical Outsourcing and Alliance Management, Intellia Therapeutics

10:30 AM

Morning refreshments and networking break

11 AM

Next generation biotherapeutics: bacteria as a novel drug delivery device

  • Non-pathogenic, non-replicative, immune protected bacteria engineered to safely deliver biologic therapeutic payloads intracellular to targeted tissues
  • Bacteria capable of delivering biologics as in mRNA, siRNA, proteins/nanobodies, and CRISPR/Cas, independent of size
  • Reaches tissues that cannot be targeted by viral vectors or lipid nanoparticles
  • Efficiently target even hard-to-reach tissues and tumors
  • Revolutionizes future of treatment by ensuring better outcomes for patients

Speakers

David Sherris
Board Member, SiVEC Biotherapeutics

11:30 AM

Leveraging technology to ease patient burden: the right solutions for better clinical trials

  • Discover the technology behind patient-centric trials: explore the cutting-edge tools that streamline trial processes and minimize patient burden, improving both retention and outcomes
  • The smart use of tech in clinical trials: learn how to strategically implement technology to enhance patient experiences without compromising data integrity or trial efficiency.
  • Balancing innovation with human touch: understand when technology empowers clinical trials and when human intervention remains critical, ensuring the right blend for successful studies.
  • Practical insights on reducing patient burden: gain actionable insights into how technology can be applied to simplify patient participation, from remote monitoring to decentralized trial designs
  • Where tech truly makes an impact: explore specific phases and aspects of clinical trials where technology transforms patient engagement and drives trial success

Speakers

Kris O’Brien
Vice President, Oncology and Rare Diseases, TFS HealthScience

12 PM

Clinical supply chain procurement challenges in 2024

  • Overview of evolving challenges and solutions in clinical supply chain procurement
  • Examination of the impact of the geopolitical and geoeconomic climate on procurement
  • Regulatory considerations and compliance challenges in clinical supply chain management

Speakers

Heng Liu
Director of Procurement, I-Mab Biopharma

12:30 PM

Lunch and networking break

8 AM

Registration and Refreshments

9 AM

Site relationship management: key ways to develop and maintain effective partnerships with sites

  • How sponsors can support and reduce burden on sites in order to shorten overall trial timelines
  • Top tips for training site staff with new processes and technology
  • Managing relationships with short staffed and under resourced sites to ensure your trial stays on track

Speakers

Marilyn Fontaine
Director of Clinical Operations, Nuvation Bio

9:30 AM

Driving success through well-planned study start-up

  • Defining a start-up plan based on key study objectives
  • Using a data driven approach for effective start-up planning, including data from regulatory intelligence, site intelligence, and KPIs to support start-up planning
  • How effective start-up execution drives a successful trial

Speakers

Ashley Sullivan
Director, Study Start-Up, Allucent

10 AM

Navigating multiple regulatory agencies to help expedite supply chain times

  • Understanding the requirement and options for declaring biological materials to U.S. Customs and Border Protection (CBP)
  • Review of key U.S. regulatory agency authorities, such as CDC, FDA, USDA, and CBP
  • Discovering the latest non-compliant shipment issues for biological materials and pharma products and tips to avoid them
  • Learning about valuable resources and contacts for assistance

Speakers

Sean Smith
Biological Threat Exclusion Coordinator (BTEC), Agriculture Programs and Trade Liaison, Office of Field Operations, U.S. Customs and Border Protection
Baljeet Kaur
Agriculture Operations Manager, US Customs and Border Protection

10:30 AM

Morning refreshments and networking break

11 AM

PANEL: Fostering a strong relationship with your CRO to make your trial a success

  • Technology and new developments when it comes to managing CRO relationships
  • How to ensure your study is prioritized
  • Maintaining a strong relationship with vendors in remote and hybrid work settings
  • How to blend a CRO team with your internal team in order to foster communication and overall success of your trial
  • CRO monitoring and oversight: how to make processes efficient and effective

Speakers

Leonella Seeley
Associate Director Of Vendor Management And Operations, Karyopharm Therapeutics
Yolanda Wan
Head of Clinical Operations, Orna Therapeutics
Molly James
Associate Director, Strategic Sourcing, Beam Therapeutics
Brenda J Boyle
Senior Director, Clinical Vendor Strategy and Partnerships, Agios
Judith Murphy
Executive Director, Centralized Contracting and Outsourcing, Kura Oncology

11:30 AM

Propelling asset development through integrated regulatory, clinical, and medical expertise

  • Discover the benefits this model brings to strategic asset development
  • Understand the optimal timepoints for CRO engagement
  • Discuss tips for maximizing your CRO’s expertise to support a comprehensive development plan
  • Review real-world examples demonstrating the advantages of this approach

Speakers

Elaina Haeuber
Senior Vice President, Oncology, Premier Research

12 PM

Frustrations of a CRO sales guy, or, a guided tour of the clinical trial outsourcing world, from both sides of the negotiation table

Speakers

David Gibboni
Independent Clinical Outsourcing Expert

12:30 PM

Lunch and networking break

1:30 PM

KEYNOTE PRESENTATION: Report Card on the use and impact of patient engagement practices in drug development

  • Overview of the value proposition and expected financial return of patient engagement practices
  • Review of current adoption levels of patient engagement practices
  • Assessment of the impact of patient engagement practices on performance and quality
  • Discussion of opportunities to optimize patient engagement and its impact

Speakers

Ken Getz
Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

2:15 PM

Efficient data orchestration in clinical trials

  • Advantages of using a data-focused CRO and technology to manage data related activities
  • Simplifying process and leveraging efficiencies to reduce risk and cost
  • Understand key gateways to ensure quality and coordination
  • Sponsor perspective and benefits of outsourcing models

Speakers

Amy Manley
Vice President, Clinical and Medical Operations, Paratek Pharmaceuticals
Ben Dudley
Chief Commercial Officer, MMS Holdings Inc
Michelle Gayari
Executive Vice President, Global Operational Excellence and Innovation, MMS Holdings Inc

2:45 PM

KEYNOTE PANEL: Where is the clinical trial industry headed in 2025?

  • Navigating new regulations around clinical trials smoothly and successfully
  • The impact of artificial intelligence: how far can we expect to move forward in the next 12 months?
  • Patient centricity in clinical trials: how can burden be reduced in order to make trials easier for patients to participate in?
  • How may geopolitical and geoeconomic events including the financial crisis, the Inflation Reduction Act and the upcoming election impact clinical trials in the US?
  • Technological developments into 2025 and beyond: what changes can we expect to see in the next 3-5 years?

MODERATOR: Revati Tatake, Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

Speakers

Revati Tatake
Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc
Jay Russak
Senior Director, Clinical Operations, Keros Therapeutics
Harry Barnett
Executive Chairman And Founder, Lubris BioPharma
RINALDO DORMAN, MBA, CPSM
Associate Director, R&D Global Procurement & Strategic Sourcing, Sarepta Therapeutics
Manny Lazaro
Senior Vice President, Clinical Operations and Data Management, Cerevel Therapeutics

3:15 PM

Afternoon refreshments and networking break

3:35 PM

EXHIBITION APPLE PRIZE DRAW

Visit our exhibitors’ booths throughout the conference and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

3:45 PM

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

During the roundtable discussion session, the conference hall will be divided into four ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical operations. Roundtables will take place in the Stream A conference room.

ROUNDTABLE 1: Importing and exporting biological materials to or from the U.S

Sean D. Smith, Biological Threat Exclusion Coordinator (BTEC), U.S. Customs and Border Protection

Baljeet Kaur, Agriculture Operations Manager, U.S. Customs and Border Protection

ROUNDTABLE 2: Pros and cons of different outsourcing models: FSO vs FSP vs inhouse

Yolanda Wan, Head of Clinical Operations, Orna Therapeutics

ROUNDTABLE 3: Enabling the most inclusive approach to patient engagement

Lily Cappalletti, Director, Patient Experience, Alexion Pharmaceuticals

ROUNDTABLE 4: Topic TBC

Kate Tith, Vice President, Head of Clinical Operations, Dyne Therapeutics

ROUNDTABLE 5: Building efficient and effective relationships with sites

Peter Koefler, Director, Study Site Engagement, Takeda

Speakers

Sean Smith
Biological Threat Exclusion Coordinator (BTEC), Agriculture Programs and Trade Liaison, Office of Field Operations, U.S. Customs and Border Protection
Yolanda Wan
Head of Clinical Operations, Orna Therapeutics
Lily Cappalletti
Director, Patient Experience, Alexion Pharmaceuticals
Kate Tith
Vice President, Head of Clinical Operations, Dyne Therapeutics
Peter Koefler
Director, Study Site Engagement, Takeda
Cory Burke
Executive Director, Head of Biometrics and Data Management, Black Diamond Therapeutics
Baljeet Kaur
Agriculture Operations Manager, US Customs and Border Protection

End of Conference

Speakers

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Ken Getz
Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

Ken is the Director of Sponsored Research and Associate Professor at the Tufts Center for the Study of Drug Development, and Chairman of the Center for Information and Study on Clinical Research Participation, a non-profit organization that he founded to raise public and patient awareness of the clinical research enterprise. He is founder and owner of CenterWatch, and an owner and board member of the Metrics Champion Consortium. A well-known speaker at symposia, universities, and corporations, Ken has published extensively in peer-reviewed journals, books and in the trade press.  He has been an active DIA member for 25 years and has held board appointments in the private and public sectors.  Ken earned his MBA from Northwestern University.

Session Details:

KEYNOTE PRESENTATION: Report Card on the use and impact of patient engagement practices in drug development

2024-10-24, 1:30 PM

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Hollie Schmidt
Vice President, Scientific Operations, Accelerated Cure Project for MS

Hollie Schmidt is the VP of Scientific Operations at Accelerated Cure Project for Multiple Sclerosis. She co-chairs the Research Committee of iConquerMS™, a research cohort established to perform and support patient-centered research in MS. She also founded and leads the MS Minority Research Engagement Partnership Network, a multi-stakeholder initiative aimed at increasing racial and ethnic diversity in MS research studies.

Session Details:

Best practice for biopharma and advocacy group collaborations in order to boost recruitment for trials

2024-10-23, 11:00 AM

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Brenda J Boyle
Senior Director, Clinical Vendor Strategy and Partnerships, Agios

Session Details:

PANEL: Funding, investment and budgeting for clinical trials: tips and best practice to ensure success

2024-10-23, 4:00 PM

Session Details:

PANEL: Fostering a strong relationship with your CRO to make your trial a success

2024-10-24, 11:00 AM

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Ankita Deshpande
Head, Digital Health and Experience Innovation, Alexion Pharmaceuticals

Session Details:

PANEL: How do we work together to deliver GenAI for clinical trials?

2024-10-23, 2:00 PM

Session Details:

Innovation and digital health for rare diseases

2024-10-24, 9:00 AM

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Lily Cappalletti
Director, Patient Experience, Alexion Pharmaceuticals

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-10-24, 3:45 PM

Session Details:

PANEL: How to lay the groundwork for a successful rare disease trial through early patient engagement

2024-10-24, 10:00 AM

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Chris Adams
CEO, Andarix Pharmaceuticals

Mr. Adams has been a founder or co-founder of life science and technology based companies in Massachusetts for the past several years. Mr. Adams has been instrumental in developing new proprietary therapeutic and medical device technologies and bringing the technologies to commercialization. The companies he has founded include, Compellis Pharmaceuticals, a developer of therapeutics to treat obesity and its co-morbidities, diabetes and hypertension and Mosaic Technologies, a venture backed MIT spin-out genomics company that developed patented technologies for genetic analysis and detection. Chris is the holder of more than 20 issued US and international patents for medical devices and pharmaceuticals.

Session Details:

Successful recruitment for a rare disease trial

2024-10-23, 5:00 PM

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Marilyn Fontaine
Director of Clinical Operations, Nuvation Bio

Marilyn is currently Director of Clinical Operations at Nuvation Bio. She has dedicated the past 12 years to clinical development and operations, with a sole focus in oncology drugs. She is passionate about executing clinical trials with agile and innovative teams and enjoys working with emerging biotech companies to establish flexible, best practice processes.

Session Details:

Site relationship management: key ways to develop and maintain effective partnerships with sites

2024-10-24, 9:00 AM

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Molly James
Associate Director, Strategic Sourcing, Beam Therapeutics

Molly James is the Associate Director of Strategic Sourcing at Beam Therapeutics. In this role she manages all vendors and leads strategic partnerships for the development organization within Beam. She has over 10 years of experience in strategic sourcing and vendor management within the pharmaceutical industry.

Session Details:

PANEL: Fostering a strong relationship with your CRO to make your trial a success

2024-10-24, 11:00 AM

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Hasim Khorakiwala
Associate Director, Global R&D Sourcing, BeiGene
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Patrick Ezeh
Director, Clinical Trial Diversity Portfolio Lead, Biogen

Session Details:

PANEL: Achieving diversity and inclusion in patient recruitment

2024-10-23, 12:00 PM

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Jenn Curry
Head of Patient Engagement Capabilities, Biogen

Jenn Curry is Head of Patient Engagement Capability at Biogen.  In this role, Jenn is accountable for driving the capabilities optimizes the execution of patient-focused drug development and maximizes the degree of impact on enrollment and the participant experience in Biogen’s clinical studies.  Jenn entered the field of clinical research as a Research Assistant at Massachusetts General Hospital in 2003 and shifted her focus to industry, specifically patient recruitment, in 2006.  Prior to joining Biogen in 2019, she spent 9 years at AES/Acurian Inc., advancing from Project Manager to Director of Operational and Strategic Solutions while honing her expertise in patient recruitment.

Session Details:

Utilizing technology to improve patient recruitment and retention

2024-10-23, 4:00 PM

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Janet Peterson
Associate Director, Patient Insights and Clinical Trial Experience, Biogen

Session Details:

PANEL: How to lay the groundwork for a successful rare disease trial through early patient engagement

2024-10-24, 10:00 AM

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Cory Burke
Executive Director, Head of Biometrics and Data Management, Black Diamond Therapeutics

Cory Burke is the Executive Director Head of Biometrics and Data Management at Black Diamond Therapeutics. Cory has over 25 years of experience in the pharmaceutical industry in both CRO and Sponsor side. She has worked in many aspects of data management, database programming and SAS programming in the industry. She works collaboratively with Clinical Operations, Medical, Translational Medicine and many other cross functional teams. She has worked on a wide range of therapeutic areas (Oncology, Dermatology, Cardiology, Gastrologic,etc) from Phase I-IV.

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-10-24, 3:45 PM

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Leticia Tarilonte
Vice President, Global Clinical Operations, Brainstorm Cell Therapeutics

Leticia has over 25 years of industry experience managing research projects and clinical studies in various roles. She spent many years working for big pharma giants such as Biogen and Merck. Currently Leticia is the Vice-President of Global Clinical Operations at Brainstorm Cell Therapeutics, a biotech company working on cell therapy for ALS. Leticia also serves as an IRB member at Yale University, and is the Chair and President of the New England Chapter of the Association of Clinical Research Professionals (ACRP)

Session Details:

PANEL: How minimizing participant burden leads to on-time enrollment and completion

2024-10-23, 3:00 PM

Session Details:

Considerations for successful third party vendor management

2024-10-23, 9:30 AM

Session Details:

PANEL: How to lay the groundwork for a successful rare disease trial through early patient engagement

2024-10-24, 10:00 AM

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Rebecca Nordland
Senior Project Manager, CISCRP
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Laura Taraboanta
Director, Medical Operations and Strategy, Click Therapeutics

Laura Taraboanta, MS is a clinical strategy and development professional with a demonstrated history in health care and clinical trials. She is currently the of Head Clinical Innovation at Click Therapeutics, with a focus on improving speed, efficiency, and cost of prescription digital therapeutics discovery, development and implementation. Prior to Click, Laura was leading clinical operations at Woebot Health, a mental health company focused on delivering evidence-based treatment through an AI chatbot. Laura has been part of two successful FDA Breakthrough Designations for software as medical devices and has overseen numerous research projects in CNS and oncology, tapping into the potential of virtual trials to empower patients. Laura is keen on tackling health disparities by accelerating digital therapeutic development so that clinically-proven, safe and effective solutions can be universally available to patients and their providers.

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Shaheen Lakhan
Chief Medical Officer, Click Therapeutics
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Manny Lazaro
Senior Vice President, Clinical Operations and Data Management, Cerevel Therapeutics

Session Details:

OPENING PANEL: The clinical trial landscape for small to mid sized biopharma in New England

2024-10-23, 8:30 AM

Session Details:

KEYNOTE PANEL: Where is the clinical trial industry headed in 2025?

2024-10-24, 2:45 PM

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Nick Pelletier
Head of Clinical Operations and Program Management, Delix Therapeutics

Nick is a globally experienced Clinical Operations, Program and Vendor Management professional with greater than 15 years of experience across the biotech/pharmaceutical industry. He is currently the Head of Clinical Operations and Program Management at Delix Therapeutics. Prior to Delix, Nick has spent time at CRO’s and both small and large Biotech, in roles of increasing responsibility across Research and Development. Nick holds both a Bachelor of Science degree and MBA from the University of Massachusetts Amherst.

Session Details:

OPENING PANEL: The clinical trial landscape for small to mid sized biopharma in New England

2024-10-23, 8:30 AM

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Kate Tith
Vice President, Head of Clinical Operations, Dyne Therapeutics

Session Details:

Beyond trial participation: engaging rare disease patients in the long term

2024-10-23, 2:00 PM

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-10-24, 3:45 PM

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Suzanne Murphy
Director, Clinical Operations, Compliance and Oversight, Editas Med

Session Details:

FIRESIDE CHAT: Deploying an effective monitoring strategy

2024-10-24, 10:00 AM

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Veronica Ludensky
Director of Procurement, Clinical, Flagship Pioneering

Veronica Ludensky is the Director of Procurement, Clinical. She is responsible for establishing and growing the procurement function for clinical services to leverage the Flagship ecosystem to advance companies’ clinical development goals.

Veronica has almost two decades of experience in clinical sourcing functions for multiple compounds from Phase 1 through 4, in small biotech, large pharma and CROs. During her career, Veronica was responsible for supporting project teams across multiple therapeutic areas in selecting, negotiating costs, contracting and business oversight of CROs, laboratories and all other vendor types in support of clinical programs at AstraZeneca, Alexion Pharmaceuticals, Millenium Pharmaceuticals and Takeda.

Session Details:

PANEL: Funding, investment and budgeting for clinical trials: tips and best practice to ensure success

2024-10-23, 4:00 PM

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Revati Tatake
Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc

Revati Tatake, PhD, is the Global Head of Pharma Research, Analysis and Competitive Intelligence at GlobalData Healthcare.  Revati has over 25 years of multidisciplinary experience in academic research and the healthcare industry, both on the client and agency sides of the business. Previously she worked as a VP of Databases and Analytics at GlobalData, where she made significant contributions to Pharma Intelligence Center. Before joining GlobalData, Revati worked at Citeline/Informa, where she was involved in competitive intelligence and analytics of clinical trials and drugs in the areas of Autoimmune/Inflammation, Central Nervous System, and Ophthalmology.  Earlier, Revati worked at Boehringer Ingelheim Pharmaceuticals for over 12 years as Senior Scientist to Senior Principal Scientist, where she led drug discovery projects involving traditional high-throughput screening, as well as innovative approaches for gene and cell therapies. She also worked at Boehringer Ingelheim as a Director of Competitive Intelligence for projects in cardiometabolic space and research beyond borders. She is a co-inventor on many issued US patents related cell and gene therapies and has several publications in peer reviewed scientific journals. Revati holds a PhD in Tumor Immunology from the Tata Cancer Research Institute in Mumbai, India. She did her postdoctoral fellowship at the University of Connecticut Health Center and Boehringer Ingelheim.

 

Session Details:

OPENING PANEL: The clinical trial landscape for small to mid sized biopharma in New England

2024-10-23, 8:30 AM

Session Details:

KEYNOTE PANEL: Where is the clinical trial industry headed in 2025?

2024-10-24, 2:45 PM

Session Details:

The state of the biopharmaceutical industry in 2025

2024-10-23, 5:00 PM

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Ajay Sadhwani
Senior Vice President, Operations, Harbor Clinical

Ajay Sadhwani is an executive Life Science Professional with over 25 years of clinical research experience. Proven leader of cross functional teams and people management of large and small functional groups with a track record of successfully leading teams and motivating individuals to perform at their highest level.

Session Details:

Rare disease studies: benefits of a hybrid outsourcing strategy

2024-10-24, 11:30 AM

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Sue Kahn
Board Member, IFOPA

Session Details:

PANEL: How to lay the groundwork for a successful rare disease trial through early patient engagement

2024-10-24, 10:00 AM

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Heng Liu
Director of Procurement, I-Mab Biopharma

Session Details:

Clinical supply chain procurement challenges in 2024

2024-10-24, 12:00 PM

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Matt Weinberg
Director, Clinical Outsourcing and Alliance Management, Intellia Therapeutics

Session Details:

FIRESIDE CHAT: Deploying an effective monitoring strategy

2024-10-24, 10:00 AM

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Leonella Seeley
Associate Director Of Vendor Management And Operations, Karyopharm Therapeutics

Session Details:

PANEL: Fostering a strong relationship with your CRO to make your trial a success

2024-10-24, 11:00 AM

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Jay Russak
Senior Director, Clinical Operations, Keros Therapeutics

Jay has over 17 years of clinical development experience.  He currently is the clinical lead for the PAH program at Keros Therapeutics.  He has been working at smaller biotech companies for the last 8 plus years.  In addition, he is an adjunct faculty member at Northeastern University teaching in the Masters of Regulatory Affairs program.

Session Details:

Site activation and study start up: making processes more efficient

2024-10-23, 3:00 PM

Session Details:

KEYNOTE PANEL: Where is the clinical trial industry headed in 2025?

2024-10-24, 2:45 PM

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Judith Murphy
Executive Director, Centralized Contracting and Outsourcing, Kura Oncology

Session Details:

PANEL: Choosing an outsourcing model: FSO vs FSP vs inhouse

2024-10-23, 11:00 AM

Session Details:

PANEL: Fostering a strong relationship with your CRO to make your trial a success

2024-10-24, 11:00 AM

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Harry Barnett
Executive Chairman And Founder, Lubris BioPharma

Harry Barnett Harry is the co-founder and Executive Chairman of Lubris BioPharma, a clinical-stage biotech company developing a proprietary version of the novel, ubiquitous human protein, PRG4, for use in multiple indications.  Novartis owns rights to Lubris’ technology for ophthalmology. Harry’s two-decade life science career includes: (i) co-founding and executive management roles at three life science companies and two CROs; (ii) incubating, partnering and licensing successfully a wide array of pharmaceutical products and technologies including Pepcid Complete®, the OTC hearburn remedy sold by J&J, and; (iii) innovating multi-center, clinical trial processes using techniques that have been adopted as industry standard.  Prior to his transition to life science and biotech, Harry was a transactional business lawyer in private practice at DLA Piper in San Diego, and later at Faneuil Advisors, Inc., an investment advisory firm based in Boston where he served as General Counsel and Executive Vice President.

Session Details:

OPENING PANEL: The clinical trial landscape for small to mid sized biopharma in New England

2024-10-23, 8:30 AM

Session Details:

PANEL: Funding, investment and budgeting for clinical trials: tips and best practice to ensure success

2024-10-23, 4:00 PM

Session Details:

KEYNOTE PANEL: Where is the clinical trial industry headed in 2025?

2024-10-24, 2:45 PM

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Kevin Killeen
Chief Scientific Officer, Matrivax

Kevin P Killeen, PhD is the Chief Scientific Officer at Matrivax Research & Development Corp.  Dr. Killeen has extensive training in the fields of molecular biology, microbiology, protein chemistry, immunology, and vaccinology.  His undergraduate BS degree is from Stonehill College (biology and chemistry), Ph. D from University of Rhode Island (microbiology), and post-doctoral fellowship at Harvard Medical School (molecular genetics and protein toxin chemistry).  Dr Killeen has more than 30 years of experience in the field of biotechnology at IDEXX Corp., VRI/AVANT-Celldex Inc, and Matrivax Corp.  He has published more than 30 vaccine manuscripts, authored four chapters, written several science reviews, is an inventor on more than ten patent/applications, and served for 12 years as a member of the URI Dean’s Advisory Council.  Dr. Killeen was the principal investigator (PI) on vaccine related grants and contracts exceeding $11 MM and coordinated greater than $13 MM in funding from the Bill & Melinda Gates Foundation.  Career highlights include the commercialization of two diagnostic tests, directing nine (9) vaccine candidates (live-attenuated/oral and subunit/injectable) into Phase 1 and 2 clinical trials, and guiding the clinical development of CholeraGarde®, an oral, single-dose cholera vaccine towards a Phase 3 clinical trial and out-licensing.  Moreover, while at VRI, Dr Killeen identified and performed scientific due diligence on rotavirus vaccine candidate 89-12, advanced through Phase 2b studies and ultimately out-licensed to GSK and commercialized as Rotarix®, a >$1 billion ‘blockbuster’ vaccine.

Session Details:

OPENING PANEL: The clinical trial landscape for small to mid sized biopharma in New England

2024-10-23, 8:30 AM

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Colleen Graham
Vice President, Head of Clinical Operations, Mediar Therapeutics

Colleen Graham has over 20 years of extensive Clinical Research experience. She began her research career at a Clinical Site, and has held a variety of operational positions from an Ethical Review Board to CROs and Pharmaceutical companies, both large and small. Her experience includes Phases I-IV drugs, biologics and device studies across a variety of therapeutic areas working with companies such as Biogen, Pfizer, and Takeda Pharmaceuticals. Her operational experience includes resource management, process development and she has managed large-scale global studies. Colleen is currently Director of Clinical Development Operations at Momenta Pharmaceuticals, where she responsible for clinical development of M281 in rare immune-mediated diseases.

Session Details:

From fantasy to function: authentic sponsor-vendor engagement

2024-10-23, 2:00 PM

Session Details:

PANEL: How minimizing participant burden leads to on-time enrollment and completion

2024-10-23, 3:00 PM

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Eric Harvey
Senior Director, Biometrics and Data Science, MMS

Eric Harvey is the Senior Director of Biometrics and Data Science at MMS. He has over 20 years of experience in pharmaceutical research, spanning pre-clinical through phase IV clinical trials, device and diagnostic studies. Prior to MMS, he led biostatistics, programming, data management, data science and information technology groups at various CROs. He also led a clinical research department at a large hospital system. Eric is a problem solver at heart whose focus is to identify data driven opportunities to increase efficiency and improve quality.

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Helen Chalk
Vice President, Clinical Operations, Mythic Therapeutics

Helen Chalk is a Clinical Development leader who has worked in Clinical and Program Management roles across the pharmaceutical, biotechnology and CRO sectors for over 25 years.  She has a breadth of global industry experience including oversight of Phase 1-4 clinical trials, medical affairs and global managed access programs in indications including oncology, autoimmune disorders, respiratory disorders, cardiovascular and infectious diseases.  Fueled by opportunities to build effective, cohesive teams and processes, Helen enjoys the challenges and daily risk management required to develop drugs and bring them to market.

Beyond work, Helen loves to travel with her family and spend time with her two dogs.  Helen relishes any opportunity to ride horses and to volunteer in a therapeutic riding program in Norfolk, MA.

Session Details:

Fostering a productive CRO/Sponsor relationship and factors to consider before undertaking a transition to a new CRO

2024-10-23, 3:00 PM

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Maria de Assis
Senior Director, Clinical Operations, OriCell Therapeutics
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Yolanda Wan
Head of Clinical Operations, Orna Therapeutics

Yolanda is the Vice-President of Clinical Operations at Accutar Biotechnology. She brings along 17 years of experience in Clinical Development, with focus on both Clinical Operations and Clinical Project Management. Her areas of expertise include strategic operations planning at the compound-level; first-in-human study planning & adaptive execution in therapeutic areas of oncology and ophthalmology. Leadership with cross-functional teams has included the development and implementation of governance and operational strategy, optimizing processes and building dynamic teams to exceed business objectives. Prior to joining Accutar, she held various positions at Bayer in the US and a number of countries within Asia. This attributes to her extensive knowledge of bridging-strategy between the two continents.

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-10-24, 3:45 PM

Session Details:

PANEL: Fostering a strong relationship with your CRO to make your trial a success

2024-10-24, 11:00 AM

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Nan Doyle
Patient Advocate

Nan Doyle is a patient engagement catalyst with a passion to strengthen access to diagnosis and treatment for people living with rare genetic conditions. She has deep roots in medicines development, and is known for building durable relationships based on a foundation of active listening and inquiry.
Most recently, Nan established and built the Rare Disease Patient Engagement function for Takeda Pharmaceuticals. The role required strategy-driven partnerships with patient organizations; and tight, de-siloed collaboration with R&D, Clinical Development, Commercial, Regulatory, Access, and other colleagues around the world.
Nan is also a board-certified genetic counselor, where she developed front-line understanding of patient and care partner practical, emotional, financial and policy needs.

Session Details:

PANEL: How to lay the groundwork for a successful rare disease trial through early patient engagement

2024-10-24, 10:00 AM

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Tammy Burke
Patient Advocate

Session Details:

PANEL: Achieving diversity and inclusion in patient recruitment

2024-10-23, 12:00 PM

Session Details:

PANEL: How minimizing participant burden leads to on-time enrollment and completion

2024-10-23, 3:00 PM

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Robert Loll
SVP, Business Development, Praxis Communications

Robert Loll is the SVP of Business Development & Strategic Planning at Praxis, a full service patient recruitment & retention agency that specializes in optimizing study enrollment for research studies with award-winning creative and superior execution.  Designing and deploying effective patient recruitment campaign strategies since 2004, Robert’s clinical background includes 16+ years providing patient care for top collegiate, Olympic and disabled athletes around the world and working for outpatient rehabilitation companies including Baxter, Caremark and NovaCare.  Robert is an Advisory Board member for The Center for Information and Study on Clinical Research Participation (CISCRP), an independent non-profit organization dedicated to educating and informing the public and patients about clinical research.

Session Details:

Chair’s opening remarks

2024-10-23, 8:20 AM

Session Details:

PANEL: Achieving diversity and inclusion in patient recruitment

2024-10-23, 12:00 PM

Session Details:

Chairperson’s closing remarks

2024-10-23, 5:30 PM

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Jenifer Waldrop
Executive Director, Rare Disease Diversity Coalition

Jenifer Ngo Waldrop joined the Black Women’s Health Imperative (BWHI) as Executive Director of the Rare Disease Diversity Coalition (RDDC) in October 2022. Before joining the leadership team of RDDC, she developed models and programs for diversity, equity, and inclusion initiatives to support multiple business units with Fortune 500 companies and organizations in Asia, Canada, and the US.

Jenifer has led initiatives at non-profit organizations where she recruited local community members to participate in numerous health-related fundraising events and developed programs to target disparities and underrepresented groups. In addition to facilitating development and fundraising, Jenifer developed a reputation for successful coalition building.

Jenifer received her undergraduate degree from Colby College and her Master of Human Resources Development from Villanova. As the Professional Development Director of the National Association of Asian-American Professionals (NAAAP) of Colorado, Jenifer continues her outreach in society. Through this organization, she mentors formally and informally.

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John J. Seman
Chief Executive Officer, REVITALE Pharma

John Seman is the CEO and Founder of REVITALE Pharma.  He began his career working in Big Pharma - Johnson & Johnson and Bristol Myers Squibb - in sales, marketing and business development.  The second half of his career was spent as a serial entrepreneur having Founded a half dozen companies that provided either products or services for the pharmaceutical industry.  John earned his bachelor's and master's degrees from the Massachusetts College of Pharmacy.

Session Details:

PANEL: Choosing an outsourcing model: FSO vs FSP vs inhouse

2024-10-23, 11:00 AM

Session Details:

PANEL: How do we work together to deliver GenAI for clinical trials?

2024-10-23, 2:00 PM

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Rinaldo Dorman
Associate Director, R&D Global Procurement & Strategic Sourcing, Sarepta Therapeutics

Rinaldo leads the Clinical Procurement team at Sarepta Therapeutics; which focuses on the clinical trial outsourcing for phases 1 through 3. His tenure as a Procurement professional includes roles at large and small organizations across both pharmaceuticals as well as biotech organizations. He has an MBA from Northeastern University and is a Certified Professional of Supply Management.

Session Details:

PANEL: Choosing an outsourcing model: FSO vs FSP vs inhouse

2024-10-23, 11:00 AM

Session Details:

Chairperson’s closing remarks

2024-10-23, 5:30 PM

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Derek Pu
Director, R&D Procurement, Servier Pharmaceuticals

Derek is the Director of R&D Procurement in Servier Pharmaceuticals, located in Boston area. Before that Derek worked for Biogen for 5 years managing clinical strategic sourcing.

Session Details:

PANEL: Choosing an outsourcing model: FSO vs FSP vs inhouse

2024-10-23, 11:00 AM

Session Details:

PANEL: Funding, investment and budgeting for clinical trials: tips and best practice to ensure success

2024-10-23, 4:00 PM

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David Sherris
Board Member, SiVEC Biotherapeutics

Dr. Sherris has over 30 years’ experience in translational medicine involving basic research, pharmaceutics and diagnostics.  Dr. Sherris has been a successful serial entrepreneur developing biotechnology companies from the ground up, devising corporate strategy, enacting programs and carrying companies through funding and acquisition with six exits working with venture capital, investment banks and angel investors.  Dr. Sherris has been employed by pharmaceutical and biotechnology companies to manage external (academic groups and contract research organizations) and internal (directly manage, augment and expand internal scientific programs) research and development. Dr. Sherris has been a frequently invited guest speaker at biopharmaceutical business and scientific conferences, a published author and holder of patents in a wide range of therapeutic areas including oncology, ophthalmology, dermatology, neurology, gene therapy and infectious disease.

Session Details:

Next generation biotherapeutics: bacteria as a novel drug delivery device

2024-10-24, 11:00 AM

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Peter Koefler
Director, Study Site Engagement, Takeda

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-10-24, 3:45 PM

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

Meredith Frank-Molnia is currently employed as Vice President of Clinical Affairs at Vericel Corporation. Previously, Meredith held the position of Senior Director Clinical Management, while working at Axiom Real-Time Metrics Inc., where she established and expanded their Clinical Management department. Meredith has been in Clinical Project Management/Operations for 26 years in numerous roles of increasing responsibilities. Meredith has worked managing device/biologic and drug studies.

Session Details:

eConsent and the benefits for patients, sites, investigators and sponsors

2024-10-23, 5:00 PM

Session Details:

Chairperson’s closing remarks

2024-10-23, 5:30 PM

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Mary Jo Lamberti
Research Associate Professor and Director, Sponsored Research, Tufts Center for the Study of Drug Development

Mary Jo Lamberti is a Research Associate Professor at Tufts University Medical School and Director of Sponsored Research at the Tufts Center for the Study of Drug Development. She has extensive experience on benchmarking drug development operating practices. Her research focuses on a variety of areas including outsourcing and partnerships, clinical research workforce issues, investigative site initiation and management, patient recruitment and retention, and the use of technologies and digital solutions in clinical trials. She has been a frequent speaker at global industry conferences and has published extensively. She holds a B.A. from Wellesley College and a Ph.D. from Boston University.

Session Details:

Study results: using AI in clinical development

2024-10-23, 12:00 PM

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Abigail S Dirks
Data Scientist, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

Abigail Dirks is a Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to industry drug development performance, including clinical research associate (CRA) performance, impact of decentralized clinical trials (DCT), and investigative site burden. She recently received her Master’s in Health Informatics and Analytics from Tufts University and has a BS in Data Science and Mathematics from St. Michael’s College. She also has experience in web development for North Shore Nurse Practitioner Associates, a psychopharmacology practice.

Session Details:

Uncovering RBQM adoption levels and mapping implementation: a novel comprehensive assessment

2024-10-24, 9:00 AM

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Maria Florez
Senior Consultant, Tufts Center for the Study of Drug Development

Maria Florez is involved in research looking at the impact of digital transformation in clinical research and organizational strategies and practices driving improvement in development operations and economics. Maria has been a researcher and strategist in the healthcare sector for 15 years. She has held positions at Cleveland Clinic and at New York-Presbyterian Hospital of Columbia and Cornell Universities and has published articles in trade and peer-reviewed journals. She holds a B.S. in economics and an M.A. in international economics from The Fletcher School of Law and Diplomacy at Tufts University.

Session Details:

Study results: using AI in clinical development

2024-10-23, 12:00 PM

Session Details:

PANEL: How do we work together to deliver GenAI for clinical trials?

2024-10-23, 2:00 PM

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Sean Smith
Biological Threat Exclusion Coordinator (BTEC), Agriculture Programs and Trade Liaison, Office of Field Operations, U.S. Customs and Border Protection

Sean Smith is a Biological Threat Exclusion Coordinator (BTEC) for CBP in the Office of Field Operations/ Agriculture Programs and Trade Liaison/ Agro/Bio-Terrorism Countermeasures. As a BTEC, Mr. Smith is charged with supporting and developing U.S. Customs and Border Protection (CBP) operational capacity and capability in preventing tools of agro/bio-terrorism from entering the U.S.

Mr. Smith joined CBP in 2005 as an Agriculture Specialist (CBPAS) and was promoted to Supervisory CBPAS in 2008. He has served CBP in the following ports of entry: San Diego, San Ysidro, Otay Mesa and Boston Logan Airport. From 2011- 2018, Mr. Smith served as the primary Public Affairs Liaison and Border Community Liaison, respectively, for CBP in New England. He has also volunteered to assist in past domestic and international CBP disaster recovery operations, including: Hurricane Ike (2008), 'Operation Safe Return' (Haitian Relief Effort- 2010), and Hurricane Harvey, DHS Surge Capacity Force (2017).

Prior to CBP, Mr. Smith contributed to wildlife conservation for nearly a decade, completing field work on rare endemic Hawaiian birds on the Big Island of Hawaii, and raising rare and endangered birds (in some cases, extinct in the wild) at the San Diego Zoo's Avian Propagation Center. Also, Mr. Smith is a former reserve firefighter and EMT for the City of Borrego Springs in California. He holds a Bachelor of Science degree in Ecology and Systematic Biology from Cal Poly San Luis Obispo, California.

Mr. Smith, his wife, two children, one dog, and one chicken live in an old farmhouse in Massachusetts.

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-10-24, 3:45 PM

Session Details:

Navigating multiple regulatory agencies to help expedite supply chain times

2024-10-24, 10:00 AM

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G Bernard Wandel
Clinical Trial Patient

Session Details:

PANEL: How minimizing participant burden leads to on-time enrollment and completion

2024-10-23, 3:00 PM

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Jennifer Sydney Goldman
Clinical Business Operations Consultant, Day One Biopharmaceuticals

Session Details:

PANEL: Funding, investment and budgeting for clinical trials: tips and best practice to ensure success

2024-10-23, 4:00 PM

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Charity Roddy
Associate Director, Patient and Site Experience, Oncology and Rare Disease, Moderna

Charity Roddy serves as the Director of Patient Engagement for Therapeutics and Oncology at Moderna. In this capacity, she leads patient engagement initiatives, education, and recruitment efforts across oncology and rare disease programs. With over 15 years of diverse experience in the pharmaceutical industry, Charity has held various roles spanning the entire drug development lifecycle. She is deeply committed to enhancing the patient experience in clinical trials and advancing innovative approaches to patient engagement.

Session Details:

PANEL: How minimizing participant burden leads to on-time enrollment and completion

2024-10-23, 3:00 PM

Session Details:

CASE STUDY: Improving patient and site experience for rare disease trials

2024-10-24, 11:00 AM

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Ashley Sullivan
Director, Study Start-Up, Allucent

Ashley Sullivan has more than 13 years’ experience in clinical research. As Director of Study Start-up at Allucent, Ashley is responsible for leading, developing and coordinating activities and staff within Study Start-up & Site Intelligence and developing and implementing business strategies to ensure quality and timely performance of all start-up activities. She guided the overhaul and implementation of a specialized SSU module within CTMS allowing for improved metric tracking and reporting. Ashley also focuses on collaborating across functional areas to ensure a smooth working relationship between Study Start-up and other departments for overall successful trial conduct and delivery for clients.

Session Details:

Driving success through well-planned study start-up

2024-10-24, 9:30 AM

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Rohan Simon
Associate Director, Business Development, IROS by M42

Session Details:

Exploring the UAE’s clinical research landscape: unlocking opportunities and driving innovation

2024-10-24, 9:30 AM

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Urania Rappo
Senior Medical Director, Clinical Development, BiomX

Dr Rappo is Senior Director of clinical development at BiomX, a biotech company developing phage cocktails designed to target and destroy harmful bacteria. Prior to joining BiomX in 2020, Dr Rappo worked on the clinical development of dalbavancin and other anti-infectives at Durata Therapeutics, Actavis and Allergan. As an adult infectious disease physician, she focuses on developing safer and more effective treatment options for difficult to treat infections.

Session Details:

Overcoming the challenges of enrollment in the changing landscape of a rare disease

2024-10-23, 2:30 PM

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Shalome Sine
Senior Manager and Quantitative Insights Specialist, Research Services, CISCRP

Shalome Sine is a Senior Manager and Quantitative Insights Specialist at the Center for Information and Study on Clinical Research Participation (CISCRP).

 

Shalome believes that the patient's voice can be a powerful force toward building inclusive, efficient clinical trials. Through her work, she hopes to help clinical trial sponsors and teams bring actionable patient insights into practice to improve clinical trial operational processes. 

 

Shalome manages both quantitative and qualitative patient voice projects, specializing in quantitative, survey-based patient insights projects. She holds a Master of Public Health from Tufts University and a Bachelor of Science from Penn State University.

Session Details:

Assessing patient attitudes to the use of AI in clinical trials

2024-10-23, 4:00 PM

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Brian Wehrle
Vice President, R&D Imaging, Clario

Brian Wehrle is the Vice President of Research and Development for Medical Imaging at Clario, where he spearheads efforts to push the boundaries of medical imaging technology. With over 25 years of dedicated experience in medical imaging, Brian is passionate about delivering innovative solutions that exceed client expectations. Under his leadership, Clario has seen the successful buildup of its Medical Imaging AI team, significantly enhancing its capabilities in this critical area. Additionally, Brian played a pivotal role in driving the creation of a Generative AI team, further solidifying Clario’s position at the forefront of AI in healthcare. His commitment to innovation and excellence in medical imaging makes him a respected leader and a visionary in the field.

Session Details:

Accelerating clinical trials with meaningful AI

2024-10-23, 12:30 PM

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Kris Booth
Director of Strategic Partnerships, EmVenio

Session Details:

Building your toolkit: how to operationalize FDA guidance on diversity today

2024-10-23, 2:30 PM

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Nina Samra
Executive Director, Project Delivery, ICON

Nina is an experienced executive director of clinical services with over 25 years in the pharmaceutical/biotechnology and clinical research organization industry. She oversees US and EU Project Services teams including project management, client partnerships, team and portfolio management. She has demonstrated success in managing first-in-human through large, international clinical programs with multiple protocols in Phase I-III drug development resulting in several NDAs/BLAs. Before joining ICON, Nina served as Project Director focusing on Neuroscience, Immunology & Infectious Disease at Covance and held several PM roles at Takeda, TAP Pharmaceuticals, Gilead and Genentech. Nina holds a BS in Cellular Molecular Biology and a Masters in Biomedical Laboratory Science.

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Ana Natera
Director, Clinical Business Strategy, HeartMetrics Cardiac Monitoring, Medtronic

Ana Natera is a highly accomplished Clinical Director with extensive experience in clinical research and cardiac monitoring. She has been instrumental in driving innovative solutions and expanding the integration of technology in clinical trials. Her dedication to patient-centered care is evident in her commitment to improving cardiac monitoring through technological advancements. In addition to her professional achievements, she is an advocate for fostering connection within the industry and contributes to advancing technology in clinical trials. She is also passionate about increasing diversity, equity, and inclusion in the clinical space.

Ana holds a Bachelor’s in Biomedical Electrical Engineering, a Master of Science in Forensic Science, and an MBA, bringing a unique blend of technical expertise and business acumen to her role.

Session Details:

Cardiac data matters: keeping patients at the heart of innovation

2024-10-23, 4:30 PM

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David Gibboni
Independent Clinical Outsourcing Expert

Dr David Gibboni has been part of the clinical research community for 15 years, with experience on the vendor side of outsourcing selling services to pharma clients, and on the sponsor side as a senior manager for an oncology-focused global pharma company. His consulting business, DJGibboni Consulting LLC, offers sales. business development, and outsourcing consultation for vendors in the clinical research arena, tapping his vast network of industry connections.

Session Details:

Frustrations of a CRO sales guy, or, a guided tour of the clinical trial outsourcing world, from both sides of the negotiation table

2024-10-24, 12:00 PM

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Caitlin Hirschman
Executive Director, Project Delivery, Rho

Caitlin Hirschman has more than 20 years of clinical research experience across Phase 1-4 studies in a variety of therapeutic areas including pulmonology and has spent the last 12 years working with cystic fibrosis. She has successfully provided oversight and clinical trial management support for more than 14 cystic fibrosis studies, including multiple U.S. and global programs. Ms. Hirschman supports teams to ensure high-quality and timely program delivery, providing extensive knowledge of clinical operations, including trial implementation, monitoring and delivery. Ms. Hirschman has managed trials through the clinical development lifecycle from first-in-human to large 200+ center multinational phase 3 trials.

Session Details:

Overcoming the challenges of enrollment in the changing landscape of a rare disease

2024-10-23, 2:30 PM

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Baljeet Kaur
Agriculture Operations Manager, US Customs and Border Protection

Baljeet Kaur is an Agriculture Operations Manager (AOM) for U.S. Customs and Border Protection (CBP) at the Boston Field Office (BFO) consisting of six New England States (MA, ME, VT, NH, CT, and RI).  As an AOM, Ms. Kaur is charged with providing guidance to personnel within the BFO on various agriculture matters including, but not limited to: regulated garbage compliance, regulation of biological material, and entry requirements for regulated agriculture commodities.  Ms. Kaur has more than 15 years of public service with CBP, and has worked in a variety of environments including, air passenger, air cargo, and maritime.

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-10-24, 3:45 PM

Session Details:

Navigating multiple regulatory agencies to help expedite supply chain times

2024-10-24, 10:00 AM

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Atalah Haun
Vice President, Global Medical Affairs, WEP Clinical

Dr. Haun is an experienced medical doctor, trained in internal medicine and emergency medicine, with 10+ years of clinical practice. He has a high-quality 10+ years’ work history in the drug development and research industry. Among his previous experiences, he was the head of a global medical affairs department for 4 years, acted as primary medical monitor in 30+ clinical trials, mainly in complex studies in a variety of therapeutic areas including oncology, rare diseases, and advanced therapies (gene, cell, chaperone therapies, etc.). He joined WEP Clinical bringing his expertise in applying knowledge and skills in epidemiology, internal medicine and different medical specialties in drug development, clinical trials, and drug safety. He has successfully implemented several techniques to improve site identification and selection and patient centric solutions to ensure timely enrolment and high retention in challenging patient populations with rare and ultra-rare diseases. He is also experienced in elaborating study plans (medical monitoring, clinical monitoring, safety management etc.) and tools (site reference manual, pharmacy manual, treatment manual etc.).

Session Details:

Clinical site support and patient enabling services

2024-10-23, 4:30 PM

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Juliane K Mills
Therapeutic Strategy Lead, Rare Disease, Worldwide Clinical Trials

Juliane K. Mills is a seasoned explorer in the world of clinical research with over 20 years of experience. Juliane's mission is simple but powerful: to make a real difference for people battling rare diseases. At Worldwide, she's the go-to person for creating smart, streamlined plans that help bring new treatments to those in need, without forgetting the real people behind the diagnoses – the patients, their loved ones, and their caregivers. Juliane's work is all about connecting the dots between cutting-edge science and the everyday lives of those affected by rare conditions. She's not just a researcher; she's a champion for better health, working tirelessly to ensure that new, life-changing treatments move from the lab bench to the bedside as smoothly and swiftly as possible.

Session Details:

Beyond the protocol: crafting expert CRAs for impactful rare disease trials

2024-10-23, 12:30 PM

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Carrie Lewis
Executive Director, Clinical Program Optimization, Endo Pharmaceuticals

Carrie Lewis has over 20 years of varied Clinical Research experience.  Carrie is currently an Executive Director, Clinical Program Optimization at Endo USA, Inc. where she oversees Clinical as well Business Operations, eTMF/inspectional readiness, and Training/Oversight.  Prior to Endo, Carrie garnered extensive knowledge in many roles while in academia, at large sponsors, generic sponsor, as well as a global CRO.  She has a Master’s Degree in Clinical Research Administration and has experience in multiple therapeutic areas.

Session Details:

FIRESIDE CHAT: Managing talent and resources to ensure the success of your clinical trial

2024-10-23, 12:00 PM

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Jason Konn
Solution Consultant, eClinical Solutions

As a Solution Consultant, Jason works with Sponsor organizations to understand their challenges and come up with creative solutions leveraging the elluminate platform. Jason has lead design & development for several products ranging from a Data Management Workbench, Data Integrations, Clinical Operations Platform, Clinical Analytics, and Risk Based Quality Management.  Jason has been in the clinical trials industry for over 15 years and his prior experience includes, global central laboratory, eCOA design, process improvement, and building an automated workforce.

Session Details:

Oversight for all: achieve data transparency with elluminate

2024-10-23, 2:30 PM

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David Ng
Vice President, Global Biometrics, Novotech

David Ng is Vice President, Global Biometrics at Novotech, a global CRO.   David has over 30 years of experience in global data management, statistics, and regulatory interactions; and has worked on numerous treatments for rare diseases, from proof of concept to submission and ultimate regulatory approval.   David has also collaborated with various organization and vendors to optimize data access and collection, from early EDC and ePRO systems to the use of EMR in clinical development.

Session Details:

Biometrics considerations in implementing new technology

2024-10-24, 9:30 AM

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Kelsey Buhler
Product Specialist, Viedoc Technologies

Kelsey Buhler has been a Product Specialist at Viedoc Technologies since 2021, and specializes in providing technical demos, support, and project management for Viedoc study builds. Prior to her role at Viedoc, she has 7 years combined experience as a Data Manager/Project Manager at a Medical Device CRO, a Data Entry Specialist, and a Clinical Subjects Associate, where she would obtain consent from subjects in clinical trials. All these experiences drive her passion for user-friendly Electronic Data Capture (EDC) systems that increase efficiencies for the subjects, site, and all other study users.

Session Details:

Increase trial agility with our integrated reporting tool

2024-10-23, 4:30 PM

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Kris O’Brien
Vice President, Oncology and Rare Diseases, TFS HealthScience

Kris joined TFS in August 2024, bringing nearly 40 years of clinical research experience to the Oncology and Rare Diseases business unit. Within her role, Kris manages a global team of experts ranging from physicians to clinical specialists and is responsible for supporting the project delivery of all oncology and rare disease programs.

Kris's diverse experience spans working with CROs, pharmaceutical companies, and academic institutions, with more than half of her career focusing on oncology and rare diseases. Her extensive background includes leadership positions as Vice President of Operations, Executive Director of Strategy, and Head of Project Management, among other clinical roles across the industry.

She is deeply committed to improving the patient's journey, particularly for those seeking life-altering and life-saving therapies through clinical trials. Her expertise in patient recruitment, retention, and study visit design allows her to provide valuable guidance to her team and sponsors, ensuring the highest quality in operational execution and deliverables in these complex therapeutic areas.

Session Details:

Leveraging technology to ease patient burden: the right solutions for better clinical trials

2024-10-24, 11:30 AM

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Stephanie Hitchcock
Director of Project Management, PCM Trials

Stephanie Hitchcock is an Director of Project Management at PCM Trials. Stephanie specializes in adapting trial designs for mobile visit services. She is passionate about expanding the use of high-quality, patient-centric models to drive clinical development. Stephanie is an expert in establishing logistics and procedures on a global scale for complex visit schedules and expanding the scope of what mobile visits can support globally.

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Elaina Haeuber
Senior Vice President, Oncology, Premier Research

Elaina Haeuber, M.S., Senior Vice President, Head of Oncology, has more than 20 years of leadership and project management experience in the biotechnology, pharmaceutical, and CRO industries. She is passionate about driving innovation and bringing new treatments to patients.

In this role Ms. Haeuber oversees a team of oncology/hematology experts in the delivery of tailored and strategic clinical development programs. Along with her team, Ms. Haeuber is dedicated to understanding the acute needs of both patients and sponsors to create impactful project plans, mindful of risk, budget, and time to market.

Ms. Haeuber gained her clinical research operations and project management experience in the biopharmaceutical industry through positions at large pharma, small biotech, and CROs. Programs she supported have led to marketing approval in both the US and EMA. Ms. Haeuber earned a B.A. from Boston University and an M.S. from the University of Illinois at Chicago.

Session Details:

Propelling asset development through integrated regulatory, clinical, and medical expertise

2024-10-24, 11:30 AM

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Alex Bai
Head of Clinical Contracts, Biogen

Session Details:

Applying Lean Six Sigma methodology to reduce the lead-time of clinical contracting

2024-10-23, 11:00 AM

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Behtash Bahador
Director, Health Literacy, CISCRP

Behtash Bahador is the Director of Health Literacy at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

Session Details:

PANEL: Achieving diversity and inclusion in patient recruitment

2024-10-23, 12:00 PM

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Anthea Dransfield
Head of Quality, Diligent Pharma

Anthea has over 30 years of experience within operational and recruitment leadership for clinical sites, technical validation, analytical and manufacturing aspects of cGMP, and quality oversight spanning GxPs.  She advocates for risk-based, phase-appropriate approaches designed to enable compliance, and has a drive for process and attention to detail with a focus on using technology to ease the quality burden.

Session Details:

Reducing trial start-up time through an innovative approach to vendor qualification

2024-10-23, 9:00 AM

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Kristofer Booth
Director, Strategic Partnerships, Emvenio Research
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Joan Ramella
Associate Director, Clinical Operations, Endo USA, Inc

Session Details:

FIRESIDE CHAT: Managing talent and resources to ensure the success of your clinical trial

2024-10-23, 12:00 PM

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Alicia M. Baker McDowell
Head of Regulatory Strategy and Product Development Consulting, Fortrea

Session Details:

PANEL: Achieving diversity and inclusion in patient recruitment

2024-10-23, 12:00 PM

Session Details:

Diversity Action Plans: preparing, submitting, and receiving regulatory feedback

2024-10-23, 11:30 AM

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Anthony Mikulaschek
VP, Commercial Strategy, IQVIA Technologies

As Vice President of Commercial Strategy at IQVIA, Anthony Mikulaschek manages all operations, data management, quality management, training and eCOA project work associated with IQVIA eCOA. Anthony has extensive experience in validated system implementation, systems integration, business process reengineering, IT operations, and consulting. He has successfully led the development, delivery, and management of technology solutions for over 30 years including 26 years in the Pharmaceutical sector.

Session Details:

Enhancing clinical trial integrity: safeguarding endpoints with patient technology

2024-10-23, 11:30 AM

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Stacey Lasser
Senior Project Manager, Mednet

Session Details:

Enhancing clinical trial outcomes with a unified eClinical platform

2024-10-23, 2:45 PM

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Ben Dudley
Chief Commercial Officer, MMS Holdings Inc

Ben Dudley is the Chief Commercial Officer at MMS. He is a seasoned executive with experience gained over a 27-year career in the industry, in both the biopharma and clinical development services sectors. Ben’s deep, broad expertise spans drug development, sales and customer relationship management, operational leadership, and process optimization. His impressive career includes leadership roles at Parexel, Covance and AstraZeneca, where he consistently demonstrated his ability to lead and innovate across various operational, functional, and commercial domains.

Session Details:

Efficient data orchestration in clinical trials

2024-10-24, 2:15 PM

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Amy Manley
Vice President, Clinical and Medical Operations, Paratek Pharmaceuticals

Amy Manley is the Vice President, Clinical and Medical Operations at Paratek Pharmaceuticals.  She has over 25 years of experience in the pharmaceutical industry in roles of increasing leadership.  Prior to joining Paratek, she worked at Wyeth, Pfizer, and Shire.  Amy has worked in numerous therapeutic areas including Neuroscience, GI, Ophthalmology, and Infectious Disease.  She’s been fortunate to have been part of the development and approval of 6 globally marketed products.  She is a solution focused, proven leader who loves working with high performing teams and has thrived in the small biotech environment.

Session Details:

Efficient data orchestration in clinical trials

2024-10-24, 2:15 PM

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Deborah Jakubowski Russ
Director, Launch Excellence Leads, Parexel

Session Details:

Patient-guided by design: a framework for successful study start-up, informed protocol design and better outcomes

2024-10-23, 12:30 PM

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OCT Advisory Board

Select a member to learn more

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Rosalie Filling
Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

 

Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

 

Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

 

Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

 

Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

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Kathleen Cohen
Vice President, Clinical Development, Marinus Pharmaceuticals

Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

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THOMAS M TREMBLAY
Vice President Of Clinical Development, Trefoil Therapeutics, Inc

Thomas is a registered nurse with both clinical and over 30 years pharmaceutical development experience. His pharmaceutical development experience includes clinical operations, clinical science, clinical development, drug safety and quality. He is currently Vice President of Clinical Development at Trefoil Therapeutics and adjunct faculty at San Francisco State University.

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Behtash Bahador
Director, Health Literacy, CISCRP

Behtash Bahador is the Director of Health Literacy at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

Session Details:

PANEL: Achieving diversity and inclusion in patient recruitment

2024-10-23, 12:00 PM

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Bao
Vendor Engagement and Business Operations Leader | Strategic Advisor | Clinical Data Management Expert

With over 15 years of experience in Clinical Data Management, Bao leads business strategy and vendor operations for Takeda’s Clinical Data Management, Clinical Data Engineering, and Clinical Data Standards groups, driving organizational growth, managing global FSP partnerships, and enhancing cross-functional collaboration. As a member of the 2024–2025 OCT Advisory Board, Bao brings expertise in clinical outsourcing, strategic vendor partnerships, and RFP process optimization, providing a fresh vision for the organization.

Beyond professional achievements, Bao is dedicated to fostering collaboration and investing in the local community. As a partner of The Town FC and a Silicon Valley angel investor, Bao champions ventures that advance sustainable growth, youth enrichment, and innovation in technology.’

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