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

Beatriz Rocha
Chief Regulatory Liaison Officer, 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
Senior Vice President, Business Development and Strategic Planning, Praxis
Patrick Ezeh
Director, Clinical Trial Diversity Portfolio Lead, Biogen
Tammy Burke
Patient Advocate
Beatriz Rocha
Chief Regulatory Liaison Officer, Fortrea
Hasim Khorakiwala
Associate Director, Global R&D Sourcing, BeiGene
Behtash Bahador
Director, Health Literacy, CISCRP

12:30 PM

Reserved for 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

Reserved for 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

MODERATOR:

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

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
Michele Barber
Former Associate Director, Patient Engagement, Mural Oncology

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

Reserved for 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
Chief Executive Officer, Andarix

5:30 PM

Chairperson’s closing remarks

Speakers

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

END OF DAY 1 AND NETWORKING DRINKS

10:30 AM

Morning refreshments and networking break

11 AM

Reserved for

Speakers

Laura Taraboanta
Director, Medical Operations and Strategy, Click Therapeutics
Shaheen Lakhan
Chief Medical Officer, Click Therapeutics

11:30 AM

Reserved for IQVIA

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

Reserved for 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

MODERATOR:

John J. Seman, Chief Executive Officer, REVITALE Pharma

Speakers

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

2:30 PM

Reserved for eClinical Solutions

2:45 PM

Reserved for 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

Speakers

Rebecca Nordland
Senior Project Manager, CISCRP

4:30 PM

Reserved for Viedoc

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
Senior Director, Clinical Operations, Third Pole Therapeutics

5:30 PM

Chairperson’s closing remarks

Speakers

Meredith Frank-Molnia
Senior Director, Clinical Operations, Third Pole Therapeutics

END OF DAY 1 AND NETWORKING DRINKS

7:30 AM

Registration and refreshments

8:20 AM

Chair’s opening remarks

Speakers

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

8:30 AM

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

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

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
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

Reserved for Diligent Pharma

9:30 AM

KEYNOTE PRESENTATION: An update on utilizing Generative AI in clinical trials

  • An overview of developments in GenAI and how these can be utilized in clinical trials
  • Use cases and examples of effective use of GenAI in Pfizer’s clinical trials
  • Regulatory considerations when implementing GenAI: what do you need to be aware of?
  • Analyzing the potential of GenAI and how this could revolutionize the clinical trial landscape

Speakers

Prasanna Rao
Senior Director, Global Head of AI and ML, Pfizer

10 AM

Reserved for Medidata Solutions

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?

MODERATOR:

John J. Seman, Chief Executive Officer, REVITALE Pharma

Speakers

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

11:30 AM

Reserved for ICON PLC

12 PM

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

12:30 PM

Reserved for Worldwide Clinical Trials

1 PM

Lunch and networking break

2 PM

Choosing CRO and vendor partners as a small biotech sponsor: priorities and key considerations

  • How vital is knowledge of therapeutic area in CRO selection?
  • As a small biotech, is it beneficial to work with a smaller CRO or a large global CRO?
  • Ensuring your CRO and vendor partners prioritize your study

Speakers

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

2:30 PM

Reserved for 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

  • Top tips for sourcing funding and investment in your trial
  • Overcoming challenges when working with angel investors and VCs to source investment in trials
  • 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

MODERATOR:

Harry Barnett, Executive Chairman, Lubris Biopharma

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

Available for event sponsor

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

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

Available for event sponsor

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

MODERATOR:

Nan Doyle, Patient Advocate

Speakers

Nan Doyle
Patient Advocate
Leticia Tarilonte
Vice President, Global Clinical Operations, Brainstorm Cell Therapeutics
Michele Barber
Former Associate Director, Patient Engagement, Mural Oncology
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 Clinic

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

Reserved for 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

Reserved for

Speakers

David Sherris
Board Member, SiVEC Biotherapeutics

11:30 AM

Reserved for 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

Reserved for 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

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

MODERATOR:

Leonella Seeley, Director, Vendor Management and Operations, Karyopharm Therapeutics

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

Reserved for Premier Research

12 PM

Best practices in contracting and budget negotiation in order to minimize cost

  • Sourcing vendors for your trial while remaining cost-conscious
  • Strategies for negotiating with supplier and CRO partners
  • Successful approaches to contracting and budget negotiation in clinical trials
  • Practical tips and tools to minimize cost and maximize value

Speakers

Milica Kakarla
Vendor Contracts Lead, Biogen

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 your clinical trials

  • Understand key gateways to ensure quality and coordination
  • Advantages of using a single CRO to manage all data related activities
  • Simplifying process where achievable to reduce risk and cost

Speakers

Eric Harvey
Senior Director, Biometrics and Data Science, MMS

2:45 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

3:15 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
Associate Director, R&D Global Procurement & Strategic Sourcing, Sarepta Therapeutics
Manny Lazaro
Senior Vice President, Clinical Operations and Data Management, Cerevel Therapeutics

3:45 PM

Afternoon refreshments and networking break

4:10 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!

4:15 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

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

ROUNDTABLE 6: Choosing the right technology vendors for clinical data management

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

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

End of Conference

Speakers

Select a speaker to learn more

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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, 4:15 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
Chief Executive Officer, Andarix

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

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

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

Session Details:

PANEL: Achieving diversity and inclusion in patient recruitment

2024-10-23, 12:00 PM

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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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Milica Kakarla
Vendor Contracts Lead, Biogen

Session Details:

Best practices in contracting and budget negotiation in order to minimize cost

2024-10-24, 12:00 PM

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Jenn Curry
Head of Patient Engagement Capabilities, Biogen

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, 4:15 PM

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

Session Details:

Considerations for successful third party vendor management

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

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

Session Details:

Assessing patient attitudes to the use of AI in clinical trials

2024-10-23, 4:00 PM

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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.

Session Details:

Reserved for

2024-10-23, 11:00 AM

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Shaheen Lakhan
Chief Medical Officer, Click Therapeutics

Session Details:

Reserved for

2024-10-23, 11:00 AM

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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, 3:15 PM

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

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, 4:15 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

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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Beatriz Rocha
Chief Regulatory Liaison Officer, 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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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:

The state of the biopharmaceutical industry in 2025

2024-10-23, 5:00 PM

Session Details:

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

2024-10-24, 3:15 PM

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Ajay Sadhwani
Senior Vice President, Operations, Harbor Clinic

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

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, 3:15 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, 3:15 PM

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Kevin Killeen
Chief Scientific Officer, Matrivax

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:

Choosing CRO and vendor partners as a small biotech sponsor: priorities and key considerations

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

Session Details:

Efficient data orchestration in your clinical trials

2024-10-24, 2:15 PM

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Michele Barber
Former Associate Director, Patient Engagement, Mural Oncology

Session Details:

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

2024-10-23, 3:00 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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Helen Chalk
Vice President, Clinical Operations, Mythic Therapeutics

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

Session Details:

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

2024-10-23, 11:00 AM

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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, 4:15 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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Prasanna Rao
Senior Director, Global Head of AI and ML, Pfizer

Prasanna Rao is an AI practitioner and Industry Thought Leader whose current role is Head of Artificial Intelligence and Data Science for Data Management at Pfizer. He has 30 years of experience in Information technology and Analytics, with 10+ years in Healthcare and Life Sciences. In his previous role as a Watson Solution Architect at IBM, he was instrumental in implementing many different AI systems from idea to implementation with various clients. In his current role, he works with various stakeholders, vendors, business SMEs, Machine Learning developers, and Data Scientists to deliver innovation and drive adoption of AI. He has presented at several industry conferences including SCDM, DIA and SCOPE.

Session Details:

KEYNOTE PRESENTATION: An update on utilizing Generative AI in clinical trials

2024-10-23, 9:30 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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Robert Loll
Senior Vice President, Business Development and Strategic Planning, Praxis

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

2024-10-23, 2:00 PM

Session Details:

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

2024-10-23, 11:00 AM

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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:

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

2024-10-24, 3:15 PM

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Derek Pu
Director, R&D Procurement, Servier Pharmaceuticals

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: Choosing an outsourcing model: FSO vs FSP vs inhouse

2024-10-23, 11:00 AM

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David Sherris
Board Member, SiVEC Biotherapeutics

Session Details:

Reserved for

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, 4:15 PM

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Meredith Frank-Molnia
Senior Director, Clinical Operations, Third Pole Therapeutics

Meredith Frank-Molnia is currently employed at Third Pole Therapeutics as Senior Director of Clinical Operations. Third Pole is a medical device company producing electrically generated nitric oxide for treatment of hypoxic respiratory failure and lung disease.  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

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, 4:15 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
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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

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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+61 280 978 126

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Head of OCT events


+61 280 978 126

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