16th Annual Outsourcing in Clinical Trials East Coast 2025

Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget

20 - 21

May

2025
  • King of Prussia, PA, USA
  • Complimentary
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  • 2024
  • 2024 Speakers
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  • Event Gallery
  • 2024 Sponsors
  • Media Centre
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Why attend?

WHAT TO EXPECT FOR 2024?

450+

Attendees

70+

Exhibitors

30+

Speakers

450+

Attendees

70+

Exhibitors

30+

Speakers

See What It's All About

2024

  • 20 May 2025
  • 21 May 2025
Expand All

Streams

Stream one

Clinical Operations and Outsourcing

Stream two

Clinical Technology and Innovation

10:30 AM

Morning Refreshments & Networking

11 AM

FIRESIDE CHAT: AI and digitalization in clinical trials

  • How AI can improve and streamline clinical operations: opportunities and real use cases
  • AI as a tool to support thinly stretched clinical operations teams: where can this be utilized to minimize workloads and increase overall output?
  • How are clinical trial sponsors implementing tools such as Generative AI and ChatGPT?
  • FDA perspectives on AI in clinical trials: are there limitations to its use?

Speakers

Judyth Zahora
Senior Director, Global Quality Systems and Process Improvement, Agenus
Blake Edward Wilson
Partner (FDA Regulatory), Hogan Lovells
Derek Shannon
Director, Statistical Project Management, Madrigal Pharmaceuticals

11:30 AM

AI: revolutionizing clinical development

The landscape of clinical development is rapidly evolving as R&D leaders explore how to leverage Artificial Intelligence (AI) and Generative AI (GenAI) capabilities. AI has the ability to automate study team tasks from creating data and medical review listings, defining study risks to issuing easy to understand queries for site resolution. All of this is now possible without the need for programming experts. Join Saama to see how we have embedded GenAI into clinical applications that help Study Managers, Data Managers, and Medical Reviewers get time back in their day using AI-enabled solutions.

Speakers

Aamir Jaka
Global Vice President, Customer Experience and Success, Saama

12 PM

AI 101: the opportunities of AI for clinical trials

  • An overview of different types of AI and machine learning and where there are opportunities to use these in clinical trials
  • Assessing easy ways to incorporate and implement AI into your clinical study
  • Where is AI being utilized in other industries and how can this be applied to clinical trials?

Speakers

Derek Shannon
Director, Statistical Project Management, Madrigal Pharmaceuticals

12:30 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

12:45 PM

Innovations in patient recruitment, powered by AI

  • Understand how AI is revolutionizing how content is rated and qualified by enhancing precision and accelerating the speed of communication
  • Experience a real-life AI application used to optimize patient recruitment materials
  • Gain insights into future trends and opportunities in AI-powered translation for the life sciences sector, including regulatory compliance for labeling

Speakers

Stephane Millet
Director, Clinical and Patient Engagement Solutions, Acolad Life Sciences
Kathleen O’Brien
Head of Sales, Acolad Life Sciences

1 PM

Lunch and networking

2 PM

CASE STUDY: Targeting Alzheimer’s Disease and Dementia in Parkinson’s Disease with Blarcamesine (ANAVEX®2-73)

Clinical efficacy is associated with biomarker expression and restoration of neurodegenerative pathways

  • Blarcamesine (ANAVEX®2-73) treatment result in significant improvements in patients with Alzheimer’s Disease and in Parkinson’s Disease Dementia
  • Analysis demonstrates predictive biomarker of efficacy in Alzheimer’s Disease and in Parkinson’s Disease Dementia
  • Whole blood transcriptomics analysis (RNAseq) identifies treatment impact on pathways impaired in neurodegenerative diseases

Speakers

Daniel Klamer
Vice President, Business Development & Scientific Strategy, Anavex Life Sciences

2:30 PM

A holistic approach to Parkinson’s disease endpoint data collection: efficacy, safety and quality of life

  • Wearable digital endpoint solutions and their pivotal role in providing quantitative gait assessment for detection of disease progression
  • eCOA solutions for assessing efficacy and quality of life, leveraging clinical rating scales, symptom diaries, and other patient-reported outcome measures
  • Medical imaging modalities focused on accurately characterizing PD status biologically, paving the way for biomarker-guided drug development
  • Cardiac monitoring in this unique population, collecting high-quality blood pressure and cardiac rhythm data to characterize PD-associated autonomic dysfunction

Speakers

Todd Rudo, MD
EVP & Chief Medical Officer, Clario

3 PM

The impact of high turnover of site staff on data collection and what sponsor companies can do to help

  • How to deal with high turnover of staff as a sponsor company: what issues are caused by this?
  • Assessing available technology and processes to alleviate pressure and workload on site staff
  • The importance of maintaining a strong relationship with sites when it comes to data entry and collection

Speakers

Rosanne Petros
PMP, Associate Director, Clinical Research, Merck Research Laboratories

3:30 PM

Afternoon refreshments, networking

4 PM

Critical to quality factors: a simple but powerful framework for risk-based quality management

The Quality by Design (QbD) and Critical to Quality (CTQ) Factor concepts were introduced by the Clinical Trials Transformation Initiative (CTTI) in 2015 and included in ICH E8(R1) (General Considerations for Clinical Trials) in 2021.  The current draft of ICH E6(R3) integrates the QbD and CTQ Factor concepts with RBQM.  Despite Health Authority and Industry endorsement and support, Sponsors and CROs aren’t taking full advantage of CTQ Factors in the clinical trial process. This presentation will explain how a CTQ Framework can be implemented simply and flexibly – to align RBQM activities from the protocol to the risk assessment to the operationalization of mitigation activities in the functional plans and more. 

Speakers

Jehan Poco
Associate Director, BDM Planning and Functional Excellence, Biostatistics & Data Management, Daiichi Sankyo, Inc
Kevin Douglass
Associate Director, RBQM Center of Excellence, Global Clinical Operations, Daiichi Sankyo, Inc

4:30 PM

Digitalization in clinical trials: a 360 view

  • Presenting on how to digitalize clinical trials in e.g. endpoints, and study designs
  • Highlighting the possibilities that digital trials bring, whilst moving away from the common brick-and-mortar sites
  • Discussing the rigorous standards and scientific integrity required by regulators, whether a regular brick-and-mortar trial or a digital trial
  • How we tend to focus too much on technology when it’s actually the processes for the patients and the sites that matter even more
  • Major points to consider in designing digital trials; building blocks and practical examples to best prepare you to meet the needs of regulators whilst keeping the patient and sites front of mind

Speakers

GREG TULLO
VP Professional Services North America, Viedoc Technologies

7:30 AM

Registration & Refreshments

8:20 AM

Chairperson’s opening remarks

Speakers

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

8:30 AM

A caregiver’s story: supporting children participating in a clinical trial

  • What do patients and caregivers experience when participating in a clinical trial, from start to finish?
  • Understanding patients’ motivations for choosing and staying in a clinical trial
  • Hurdles and barriers to patients’ participation in pediatric clinical trials: what can pharma companies do to improve this and relieve burden on patients and caregivers?

Speakers

Kelly Franchetti
Patient Advocate

9 AM

Can patients out innovate pharma?

While pharma struggles to adopt clinical trial innovations at scale, another stakeholder has demonstrated the urgency, will and creativity to disrupt clinical research: patients. 

This keynote will explore ways in which patients have already "out-innovated" pharma and will provide clues to a power shift that may be in our future.

Speakers

Craig Lipset
Advisor and Founder, Clinical Innovation Partners

9:30 AM

Maximizing the consultative partnership between CRO and pharma/biotech partners

  • How early engagement can improve outcomes
  • How do we speak the same language, no one size fits all approach
  • Simplifying the complex, in a world of overwhelming amount of outsourcing options and models

Speakers

Lynn Adams
Senior Director, Product Delivery, ICON Biotech

10 AM

PANEL DISCUSSION: 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
Terry Katz
Senior Director, Biostatistics, Data Management Planning, Functional Excellence, Daiichi Sankyo
Jessica King
Head of Clinical Operations, Sonnest
Maria Metzger
Executive Director, Supplier Relationship Management and Performance, Clinical Development Operations, Eikon Therapeutics
Priya Marreddy
Vice President, Clinical Operations, OnCusp Therapeutics

10:30 AM

Morning refreshments and networking break

11 AM

Site management: building a strong partnership with sites to ensure you are a sponsor of choice

  • Creating a partnership that is built on reciprocity and providing a voice for site feedback
  • Collaboration and training to ensure sites are confident and equipped to successfully complete trial
  • Reducing the burden on sites financially and operationally
  • Supporting sites individual needs from established clinics to naïve sites

Speakers

Suzy Montanye
Site Relationship Manager, Endo Pharmaceuticals

11:30 AM

How a consultative approach from a CRO could add value to your development program

  • How to unlock the full power of your CRO partner
  • How a CRO partner helps you navigate the interface between science and operations and why that improves your study
  • Why early engagement can be key to your study’s success

Speakers

MarieElena Cordisco
MA, NP-C, Senior Director, Therapeutic Strategy Lead, Metabolic, Worldwide Clinical Trials

12 PM

Insights into barriers to care in the rare disease community

  • Challenges and nuances of rare disease patients’ journey to receive a diagnosis
  • Recognizing the pivotal role insurance plays in accessing healthcare services
  • Assessing adequacy of healthcare coverage, affordability of services, and the extent to which patients utilize available healthcare resources
  • Exploring overall experiences individuals have had within the healthcare system: strengths and areas for improvement
  • Mental health and well-being: the emotional toll rare diseases take on patients and caregivers

Speakers

Jenifer Waldrop
Executive Director, Rare Disease Diversity Coalition

12:30 PM

Access for all: how mobile visits and community sites help sponsors meet new diversity goals

  • Understand the importance of diversity in clinical trials and its influence on research outcomes
  • Examine the challenges traditional clinical models face in recruiting and retaining diverse participant populations
  • Discover the benefits of mobile visits and community-based sites, supported by new data highlighting their positive impact on accessibility and inclusivity in clinical trials
  • Identify strategies for the effective implementation of mobile visits and community-based sites

Speakers

Tajuana Barron
Vice President, Project Management, PCM Trials
Kris Booth
Director of Strategic Partnerships, EmVenio

1 PM

Lunch and networking

2 PM

Effective patient education to increase enrolment and retention

  • Making trial participation easy for patients: what is effective and what isn’t?
  • Ensuring communications with patients are pitched at the right level in order to maximize understanding and thus increase retention
  • Innovative ways to create resources for patients using new technology and digital content

Speakers

Susan Neal
Director, Clinical Operations, Novavax

2:30 PM

Outsourcing Importer of Record (IoR) requirements and a deep dive into the operational pitfalls

  • Basics of an Importer of Record (IOR): definition, responsibilities and when an IOR (or EOR) is required
  • Common pitfalls associated with an outsourced IOR: identifying these common pitfalls with practical solutions for each
  • Roadmap to a successful outsourced IOR solution: practical items for a successful IOR solution
  • Benefits of an outsourced Importer of Record (IOR)

Speakers

Louisa Carlse
Director of Partnerships, TecEx Medical

3 PM

PANEL DISCUSSION: Diversity and inclusion in patient recruitment

  • How can expanding into diverse geographies support meeting DEI regulations for trials?
  • 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:

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

PANELLISTS:

Ram Raju, Senior Vice President and Community Health Investment Officer, Northwell Health

Dija Atta, Senior Director, Clinical Operations, Incyte

Jenifer Waldrop, Executive Director, Rare Disease Diversity Coalition

Mohammed Ali, M&D Head of Reporting, Analytics and Insights, Astellas Pharma

Speakers

Ram Raju
Senior Vice President and Community Health Investment Officer, Northwell Health
Dija Atta
Senior Director, Clinical Operations, Incyte
Jenifer Waldrop
Executive Director, Rare Disease Diversity Coalition
Mohammed Ali
M&D Head of Reporting, Analytics and Insights, Astellas Pharma

3:30 PM

Afternoon refreshments, networking

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

CASE STUDY: Targeting Alzheimers: rationale and clinical trial plans at Neurotez

Speakers

Dr Nikolaos Tezapsidis
President and Chief Executive Officer, Neurotez

4:30 PM

Digitalization in clinical trials: a 360 view

  • Presenting on how to digitalize clinical trials in e.g. endpoints, and study designs
  • Highlighting the possibilities that digital trials bring, whilst moving away from the common brick-and-mortar sites
  • Discussing the rigorous standards and scientific integrity required by regulators, whether a regular brick-and-mortar trial or a digital trial
  • How we tend to focus too much on technology when it’s actually the processes for the patients and the sites that matter even more
  • Major points to consider in designing digital trials; building blocks and practical examples to best prepare you to meet the needs of regulators whilst keeping the patient and sites front of mind

Speakers

GREG TULLO
VP Professional Services North America, Viedoc Technologies

5 PM

Critical to quality factors: a simple but powerful framework for risk-based quality management

The Quality by Design (QbD) and Critical to Quality (CTQ) Factor concepts were introduced by the Clinical Trials Transformation Initiative (CTTI) in 2015 and included in ICH E8(R1) (General Considerations for Clinical Trials) in 2021.  The current draft of ICH E6(R3) integrates the QbD and CTQ Factor concepts with RBQM.  Despite Health Authority and Industry endorsement and support, Sponsors and CROs aren’t taking full advantage of CTQ Factors in the clinical trial process. This presentation will explain how a CTQ Framework can be implemented simply and flexibly – to align RBQM activities from the protocol to the risk assessment to the operationalization of mitigation activities in the functional plans and more. 

Speakers

Jehan Poco
Associate Director, BDM Planning and Functional Excellence, Biostatistics & Data Management, Daiichi Sankyo, Inc
Kevin Douglass
Associate Director, RBQM Center of Excellence, Global Clinical Operations, Daiichi Sankyo, Inc

5:30 PM

Chairperson’s closing remarks

Speakers

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

NETWORKING DRINKS RECEPTION AND END OF DAY 1

Streams

Stream one

Clinical Operations and Outsourcing

Stream two

Clinical Technology and Innovation

9 AM

Site selection for increased patient recruitment and retention

  • Highlighting discrepancies in the distance between clinical trial sites and the disease prevalent populations using case studies
  • Exploring the impact of appropriate and inappropriate site selection on a trial’s success through case studies
  • Showcasing how patient accrual has been affected in clinical trials utilizing virtual components

Speakers

Sonnika Lamont
Analyst, Clinical Trials Intelligence, GlobalData Plc

9:30 AM

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

  • Exposing inefficiencies of current vendor qualification practices: challenging the industry to adopt a proven process innovation to help sponsors onboard providers 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 you become inspection ready
  • Uncover benefits of a centralized approach to vendor qualification that provides unique benefits to both sponsors and providers globally

Speakers

Anthea Dransfield
Head of Quality, Diligent Pharma

9:45 AM

TECHNOLOGY SPOTLIGHT: Establishing data governance as a best practice in your clinical eco-system

Join for an insightful session on the world of data governance and security for the modern biotech. In this session, we will provide invaluable insights and practical strategies to help you optimize your clinical trial operations while ensuring the security of your sensitive data. Gain insight into areas such as mastering your data, the role of data governance in life sciences, and solving challenges in implementing data governance within your organization.

Speakers

Cat Hall
Head of GXP Assurance, Egnyte

10 AM

Revolutionizing clinical trials with accelerating clinical evidence models

  • Novel approaches for drug approvals with accelerated approval pathway to streamline processes
  • Enhancing collaboration between the FDA and CMS in developing new payment methods for drugs approved via accelerated approval
  • Improving patient access to post-market safety and efficacy data

Speakers

Blake Edward Wilson
Partner (FDA Regulatory), Hogan Lovells

10:30 AM

Morning Refreshments & Networking

11:15 AM

PANEL DISCUSSION: Has DCT passed its peak in popularity?

  • Was DCT just a COVID buzzword or does it still have practical applications?
  • How can elements of decentralization be applied to clinical trials in order to maximize patient engagement?
  • Does DCT still have a future in a post-COVID world or has the clinical trial industry returned to ‘normal’?
  • Are there therapeutic areas where elements of decentralization or hybridization are essential to success?
  • Where are the main technological and practical hurdles to DCT taking off?

MODERATOR:

Judyth Zahora, Senior Director, GCP Quality Risk Management and Process Improvement, Agenus

PANELLISTS:

Ram Raju, Senior Vice President and Community Health Investment Officer, Northwell Health

Rosanne Petros, PMP, Associate Director, Clinical Research, Merck Research Laboratories

Kristen Olszyk, Senior Director, Clinical Scientist, Neuraptive Therapeutics

Speakers

Judyth Zahora
Senior Director, Global Quality Systems and Process Improvement, Agenus
RAM RAJU
Former CEO, NYC Health & Hosptials Corporation
Rosanne Petros
PMP, Associate Director, Clinical Research, Merck Research Laboratories
Kristen Olszyk
Senior Director, Clinical Scientist, Neuraptive Therapeutics

11:45 AM

Start expecting more from eCOA and ePRO

  • Describe why a legacy eCOA/ePRO system will not deliver the same results as a system developed with modern, digital technology
  • Examine how eCOA/ePRO technologies should promote compliance by giving patients apps that are akin to apps they use in daily life, on their own devices
  • Discuss how eCOA/ePRO will not become a strategic component of sponsor and CROs technology portfolios unless vendors embrace continuous innovation

Speakers

Steve Rosenberg
Chief Executive Officer, uMotif

8 AM

Registration and Refreshments

8:50 AM

Chairperson’s opening remarks

Speakers

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

9 AM

PANEL DISCUSSION: Fostering a strong relationship with your CRO

  • 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

MODERATOR:

John J. Seman, Chief Executive Officer, REVITALE Pharma

Speakers

John J. Seman
Chief Executive Officer, REVITALE Pharma
Hal J. Mann
Chapter Lead Clinical Support Solutions, Roche Diagnostics Solutions
Douglas Kling
Chief Operating Officer, NewAmsterdam Pharma
Patti O’Malley
Associate Director, Strategic Relationship Management, Incyte
Lynn Adams
Senior Director, Product Delivery, ICON Biotech

9:30 AM

How RBQM creates trust between sponsors and CROs

  • The big communication and trust challenges we see from hundreds of projects
  • What do the ultimate customers (regulatory authorities) want to see?
  • What is RBQM, what are the challenges, and how can it help?
  • How technology makes all the difference

Speakers

Duncan Hall
Chief Executive Officer, TRI

10 AM

Selecting vendors and CRO partners: what are the most important considerations?

  • Balancing cost alongside other considerations when selecting a CRO
  • Should trial partners always need expertise in your therapeutic area or are there other factors to consider?
  • Advantages and disadvantages of choosing a small CRO vs a global CRO for your trial

Speakers

Laurie Taraborrelli
Clinical Programs and Compliance Specialist, Fujirebio Diagnostics

10:30 AM

Morning refreshments and networking

11:15 AM

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
Deanna Lutte
Senior Clinical Trial Manager, Clinical Operations, Endo Pharmaceuticals

11:45 AM

CASE STUDY: Designing and running a trial for pediatric diseases: overcoming challenges when working with younger patients

  • Working with and supporting caregivers throughout the clinical trial process, and where sponsors can relieve burden
  • Additional considerations when designing a pediatric study: best practice when working with children and teenagers
  • Regulatory guidance in the USA around enrolling under 18s in a clinical trial and how to navigate this

Speakers

Gurdyal Kalsi
Chief Medical Officer, Asklepion Pharmaceuticals

12:15 PM

PANEL DISCUSSION: Running clinical trials in different geographic regions: assessing opportunities and challenges

  • Advantages and disadvantages of regions including APAC, Latin America and Asia for running clinical trials
  • Regulatory hurdles to overcome when running trials outside of the USA
  • Key factors to consider in selection of sites and geographies for your clinical trials
  • Sourcing CROs, vendors and partners overseas
  • Analyzing cost and benefit of keeping your trial in the US vs taking it overseas

Speakers

Judyth Zahora
Senior Director, Global Quality Systems and Process Improvement, Agenus
Susan Neal
Director, Clinical Operations, Novavax
Aki Ko
Co-Founder & Chief Executive Officer, Elixirgen Therapeutics

12:45 PM

Lunch and Networking

1:45 PM

Developing a cell therapy for patients with telomere biology disorders: challenges and lessons learned

  • An overview of Elixirgen’s lead EXG-34217 program from a clinical operations perspective
  • Running a clinical trial with patients with a rare disease: what do you need to consider?
  • Key challenges faced during Phase I/II trials on EXG-34217 and future opportunities uncovered

Speakers

Aki Ko
Co-Founder & Chief Executive Officer, Elixirgen Therapeutics

2:15 PM

KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

  • What more should sponsors, sites and CROs be doing in order to ensure clinical trials are as patient centric as possible?
  • Innovative strategies for working with patients and advocacy groups from early on in your trial design
  • Engaging groups and communities who would not typically participate in trials in order to achieve targets around diversity and inclusion
  • Reducing the burden on patients participating in clinical trials

MODERATOR:

Judyth Zahora, Senior Director, Global Quality Systems and Process Improvement, Agenus

Speakers

Judyth Zahora
Senior Director, Global Quality Systems and Process Improvement, Agenus
Rosanne Petros
PMP, Associate Director, Clinical Research, Merck Research Laboratories
Harsha K. Rajasimha
MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases
Laurie Taraborrelli
Clinical Programs and Compliance Specialist, Fujirebio Diagnostics
Kelly Franchetti
Global Head of Growth and Insights, Savvy Cooperative

2:45 PM

Afternoon refreshments and networking

3:05 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!

3:15 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.

ROUNDTABLE 1: AI in clinical trials: unlocking new opportunities

Laurie Taraborrelli, Clinical Programs and Compliance Specialist, Fujirebio Diagnostics

ROUNDTABLE 2: Using an FSP model for your clinical outsourcing strategy

Hal J. Mann, Chapter Lead Clinical Support Solutions, Roche Diagnostics Solutions

ROUNDTABLE 3: Operational challenges when running a rare disease clinical trial

Harsha K. Rajasimha, MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases

ROUNDTABLE 4: Lessons from the pandemic: are there any DCT technologies which are here to stay?

Ram Raju, Senior Vice President and Community Health Investment Officer, Northwell Health

Speakers

Laurie Taraborrelli
Clinical Programs and Compliance Specialist, Fujirebio Diagnostics
Hal J. Mann
Chapter Lead Clinical Support Solutions, Roche Diagnostics Solutions
Harsha K. Rajasimha
MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases
Ram Raju
Senior Vice President and Community Health Investment Officer, Northwell Health

4:15 PM

End of conference

END OF CONFERENCE – SEE YOU NEXT YEAR!

Additional topic suggestions:

Adaptive study design: creating a trial that is flexible and responsive to change

  • Assessing the advantages of adaptive design over traditional fixed designs and how this can improve your clinical trial efficiency
  • Key considerations for adaptive design
  • What additional flexibility is available when using adaptive design?

CASE STUDY: Overcoming operational challenges for a CAR-T trial: learnings and best practice

  • How are CAR-T trials unique from an operational standpoint: what do you need to consider?
  • Designing KPIs and other metrics to measure the efficiency of your CAR-T trial
  • Best practice in collaboration with CROs, vendors and other partners to make your CAR-T trial a success

Creating a budget that works for hybrid trials

  • Introducing elements of decentralization into your trial while remaining cost-conscious
  • Maximizing ROI on investment in new technology to support hybrid trials
  • Where can hybridization of trials help to minimize costs and reduce timelines?

Leveraging AI to design a cutting-edge patient recruitment strategy

  • Utilizing AI to minimize patient recruitment costs and maximize speed of enrolment
  • An overview of how data driven technology is able to enhance patient recruitment in trials
  • Leveraging AI and ML to reach a wider population when recruiting for a clinical study 

CASE STUDY: 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

Using data and information from electronic medical records in order to shorten patient recruitment timelines

  • What are the benefits of electronic medical records and how can they enhance patient recruitment processes?
  • Navigating challenges and overcoming hurdles when using electronic medical records
  • Using electronic medical records in conjunction with other methods of identifying and screening patients in order to shorten timelines and reduce overall costs 

Risk based quality management systems: an overview of solutions available in the market

  • Best practice in processes for risk based management
  • Tools available to streamline risk based management and how to best leverage these
  • How can risk based quality management be used effectively in order to maximize trial success

Utilizing technology to maximize patient engagement and retention

  • Increasing patient touchpoints without increasing burden through the use of technology
  • The importance of having lighter, more frequent touchpoints in order to increase communications and improve relationships with patients
  • Assessing technologies available for supporting patient engagement and retention

Real world data in clinical trials: how can you utilize this effectively?

  • Navigating FDA and international regulations around the use of RWE in clinical trials
  • Understanding the full potential of RWE and how this can benefit your trial
  • Collecting and analyzing RWE effectively: how to address and overcome challenges

CASE STUDY: Practical challenges when running a rare disease trial in the US

  • The regulatory landscape for rare disease trials in the US: what do you need to be aware of?
  • Learnings and outcomes from running a rare disease trial: where were the main hurdles
  • Working with CROs and vendors in order to deliver a successful orphan drug clinical trial 

Forecasting and budgeting for your clinical trial

  • 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

2024 Speakers

Select a speaker to learn more

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Stephane Millet
Director, Clinical and Patient Engagement Solutions, Acolad Life Sciences

Session Details:

Innovations in patient recruitment, powered by AI

2024-05-21, 12:45 PM

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Kathleen O’Brien
Head of Sales, Acolad Life Sciences

A 15-year veteran of the translation industry with a background in linguistics, Kathleen has held various roles in the translation business: vendor, project and account management, as well as new business development. Her experiences have  positioned her with a unique perspective into both translation operations and how translation impacts the globalization needs of clients in the pharmaceutical and medical device industries.​ Kathleen proactively collaborates with her Life Sciences client partners on a daily basis to help them set their localization strategies.

Session Details:

Innovations in patient recruitment, powered by AI

2024-05-21, 12:45 PM

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Judyth Zahora
Senior Director, Global Quality Systems and Process Improvement, Agenus

Session Details:

FIRESIDE CHAT: AI and digitalization in clinical trials

2024-05-21, 11:00 AM

Session Details:

KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

2024-05-22, 2:15 PM

Session Details:

PANEL DISCUSSION: Running clinical trials in different geographic regions: assessing opportunities and challenges

2024-05-22, 12:15 PM

Session Details:

PANEL DISCUSSION: Has DCT passed its peak in popularity?

2024-05-22, 11:15 AM

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Daniel Klamer
Vice President, Business Development & Scientific Strategy, Anavex Life Sciences

Dr Daniel Klamer, Vice President of Business Development and Scientific Strategy of Anavex, has more than 15 years of experience in neuroscience and the orphan disease space, with acquisition, partnering and R&D experience in Europe and the USA. Prior to Anavex he worked at Retrophin and Neurosearch Sweden. At Neurosearch Sweden, Dr Klamer led and evaluated multiple discovery-phase neuropharmacological research products with an emphasis on strategic evaluation of preclinical and clinical development.

Dr. Klamer earned his PhD in Pharmacology at The Sahlgrenska Academy at University of Gothenburg, Sweden, his MBA at Fordham Gabelli School of Business, and his Post-Doctoral training at the Department of Psychiatry, Yale University School of Medicine. In addition, Dr. Klamer holds a position as an Associate Professor at the Department of Pharmacology at The Sahlgrenska Academy at the University of Gothenburg.

Session Details:

CASE STUDY: Targeting Alzheimer’s Disease and Dementia in Parkinson’s Disease with Blarcamesine (ANAVEX®2-73)

2024-05-21, 2:00 PM

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Gurdyal Kalsi
Chief Medical Officer, Asklepion Pharmaceuticals

Session Details:

CASE STUDY: Designing and running a trial for pediatric diseases: overcoming challenges when working with younger patients

2024-05-22, 11:45 AM

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Mohammed Ali
M&D Head of Reporting, Analytics and Insights, Astellas Pharma

Session Details:

PANEL DISCUSSION: Diversity and inclusion in patient recruitment

2024-05-21, 3:00 PM

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Todd Rudo, MD
EVP & Chief Medical Officer, Clario

As Clario’s Chief Medical Officer, Dr. Todd Rudo provides medical and scientific leadership across the organization. Passionate about leveraging our scientific expertise to support our customers’ success, Dr. Rudo has focused efforts on optimizing our solutions across the therapeutic areas. His team supports Clario’s clients by providing expert consulting services on scientific and regulatory strategy, and ensures our product portfolio is scientifically robust, generating high quality data to support clinical trial endpoints. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials, while maintaining focus on the customer experience, including minimizing patient and site burden. With nearly 20 years of clinical cardiology and pharmaceutical research experience, Dr. Rudo has focused his career predominantly on drug safety. He has worked within therapeutic areas including oncology, immuno-inflammatory diseases, urology, and cardiometabolic diseases, and has achieved board certifications in internal medicine, cardiology, cardiac electrophysiology, nuclear cardiology, and adult echocardiography.

Session Details:

A holistic approach to Parkinson’s disease endpoint data collection: efficacy, safety and quality of life

2024-05-21, 2:30 PM

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Craig Lipset
Advisor and Founder, Clinical Innovation Partners

Session Details:

Can patients out innovate pharma?

2024-05-21, 9:00 AM

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Terry Katz
Senior Director, Biostatistics, Data Management Planning, Functional Excellence, Daiichi Sankyo

Terry Katz is Senior Director of Biostatistics and Data Management Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA International, and a Statistician at Schering-Plough. He holds Accreditation as a Professional Statistician and Certifications as a Quality Engineer and a Six Sigma Green Belt. He is Chair of DIA's GCP-QA Community; formerly he was a Core Committee member for NJ CDISC User Group and Chair of the Statistical Taskforce for the Animal Health Institute. Terry also completed a 3-month Fellowship in Kenya to improve capacity and capability for the local hospitals to run oncology clinical trials.

Session Details:

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

2024-05-21, 10:00 AM

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Jehan Poco
Associate Director, BDM Planning and Functional Excellence, Biostatistics & Data Management, Daiichi Sankyo, Inc

Jehan, Associate Director, Functional Excellence, Biostatistics & Data Management (BDM), Daiichi Sankyo, Inc.

 

Jehan is an Associate Director in the Biostatistics & Data Management Functional Excellence at Daiichi-Sankyo.  In this role, Jehan partners with BDM and R&D teams on functional initiatives, system roll outs, and committee as well as supporting key partners like the RBQM COE as a member.

 

Jehan has 18+ years of industry experience working for numerous companies in various positions (TMF, Clinical Monitoring, Quality & Compliance, Operational Excellence/Change Management, Metrics/Benchmarking and RBQM).  He received a BA in Cell Biology & Neuroscience from Rutgers College, an MBS in Biomedical Science from the University of Medicine and Dentistry NJ (UMDNJ), and is certified Auditing and Change Management methodologies.

 

Jehan can be contacted at jpoco@dsi.com

Session Details:

Critical to quality factors: a simple but powerful framework for risk-based quality management

2024-05-21, 4:00 PM

Session Details:

Critical to quality factors: a simple but powerful framework for risk-based quality management

2024-05-21, 5:00 PM

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Kevin Douglass
Associate Director, RBQM Center of Excellence, Global Clinical Operations, Daiichi Sankyo, Inc

Kevin Douglass, Associate Director, RBQM Center of Excellence, Biostatistics & Data Management (BDM), Daiichi Sankyo, Inc.

 

Kevin is an Associate Director in the Risk-Based Quality Management Center of Excellence (RBQM COE) at Daiichi-Sankyo.  The RBQM COE partners within BDM, with cross-functional stakeholders, and CRO partners to optimize RBQM processes and tools.  The RBQM COE has central (e.g., as process owners developing and delivering tools and training) and Program/Study-level responsibilities (providing guidance to study teams).

 

Kevin has 40+ years of industry experience working for numerous companies in various positions (Data Management, Quality & Compliance, Operational Excellence/Change Management, and RBQM).  He received a BS in Biology from Ursinus College, an MS in Biology from Villanova University, and is certified in Lean Six Sigma and multiple Change Management methodologies.

 

Kevin can be contacted at kdouglass@dsi.com.

Session Details:

Critical to quality factors: a simple but powerful framework for risk-based quality management

2024-05-21, 4:00 PM

Session Details:

Critical to quality factors: a simple but powerful framework for risk-based quality management

2024-05-21, 5:00 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:

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

2024-05-22, 9:30 AM

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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

2024-05-21, 12:30 PM

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Cat Hall
Head of GXP Assurance, Egnyte

Session Details:

TECHNOLOGY SPOTLIGHT: Establishing data governance as a best practice in your clinical eco-system

2024-05-22, 9:45 AM

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Maria Metzger
Executive Director, Supplier Relationship Management and Performance, Clinical Development Operations, Eikon Therapeutics

Session Details:

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

2024-05-21, 10:00 AM

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Aki Ko
Co-Founder & Chief Executive Officer, Elixirgen Therapeutics

Aki Ko has served as Chief Executive Officer and Chair of the Board of Directors since May 2017, when he co-founded the company. Previously, Mr. Ko served as Chief Operating Officer for Elixirgen, LLC, the parent company of Elixirgen Therapeutics, and President of Elixirgen Scientific, LLC, a provider of stem cell reagent kits and related services. In his previous roles, Mr. Ko was responsible for operations and business development at Elixirgen, LLC and Elixirgen Scientific. Mr. Ko earned a Bachelor of Science degree from the University of Virginia, where he cultivated his interest in biology.

Session Details:

Developing a cell therapy for patients with telomere biology disorders: challenges and lessons learned

2024-05-22, 1:45 PM

Session Details:

PANEL DISCUSSION: Running clinical trials in different geographic regions: assessing opportunities and challenges

2024-05-22, 12:15 PM

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Kris Booth
Director of Strategic Partnerships, EmVenio

Session Details:

Access for all: how mobile visits and community sites help sponsors meet new diversity goals

2024-05-21, 12:30 PM

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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.

Session Details:

Chairperson’s opening remarks

2024-05-21, 8:20 AM

Session Details:

Chairperson’s closing remarks

2024-05-21, 5:30 PM

Session Details:

Chairperson’s opening remarks

2024-05-22, 8:50 AM

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Carrie Lewis
Executive Director, Clinical Program Optimization, Endo Pharmaceuticals

Session Details:

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

2024-05-22, 11:15 AM

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Suzy Montanye
Site Relationship Manager, Endo Pharmaceuticals

Session Details:

Site management: building a strong partnership with sites to ensure you are a sponsor of choice

2024-05-21, 11:00 AM

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Deanna Lutte
Senior Clinical Trial Manager, Clinical Operations, Endo Pharmaceuticals

Session Details:

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

2024-05-22, 11:15 AM

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Laurie Taraborrelli
Clinical Programs and Compliance Specialist, Fujirebio Diagnostics

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-05-22, 3:15 PM

Session Details:

KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

2024-05-22, 2:15 PM

Session Details:

Selecting vendors and CRO partners: what are the most important considerations?

2024-05-22, 10:00 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.

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Sonnika Lamont
Analyst, Clinical Trials Intelligence, GlobalData Plc

Sonnika Lamont, MRes, is a a Clinical Trials Analyst at GlobalData, where her primary responsibilities include the review and update of clinical trial information presented on GlobalData’s Trials Intelligence Platform, the production of analytical reports and insights, testing database releases, and providing comprehensive conference coverage. She has a firm understanding of all aspects of clinical research, and the drug development process. Prior to joining GlobalData, Sonnika worked as a Clinical Trials Research Assistant at University College London’s Cancer Institute. Sonnika holds a Master of Research in Drug Design with a concentration in rare diseases from University College London, and a Bachelor of Science in Biochemistry from Nottingham Trent University.

Session Details:

Site selection for increased patient recruitment and retention

2024-05-22, 9:00 AM

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Blake Edward Wilson
Partner (FDA Regulatory), Hogan Lovells

Blake Wilson is a Partner in Hogan Lovells’ FDA Regulatory group.  He holds a juris doctorate from the University of Pennsylvania and a master’s degree in biostatistics from Columbia University.  Prior to becoming an attorney he managed Phase I and II pharmaceutical trials at Brown University.  His legal practice focuses on FDA’s premarket approval process for drugs/biologics/devices, oversight of clinical trials including BIMO audits, as well as navigating changes in laws or regulations that govern the life sciences industry.  He also guides sponsors through the special designation programs available at the premarket stage, like RMAT, accelerated approval, and breakthrough.  In this capacity, Blake advises extensively on novel products, study design considerations, and the use of clinical data in FDA-related matters.  By stress testing clinical materials through the lens of an FDA reviewer, Blake helps sponsors avoid pitfalls that can delay or derail a project.

Session Details:

FIRESIDE CHAT: AI and digitalization in clinical trials

2024-05-21, 11:00 AM

Session Details:

Revolutionizing clinical trials with accelerating clinical evidence models

2024-05-22, 10:00 AM

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Lynn Adams
Senior Director, Product Delivery, ICON Biotech

Session Details:

Maximizing the consultative partnership between CRO and pharma/biotech partners

2024-05-21, 9:30 AM

Session Details:

PANEL DISCUSSION: Fostering a strong relationship with your CRO

2024-05-22, 9:00 AM

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Dija Atta
Senior Director, Clinical Operations, Incyte

Session Details:

PANEL DISCUSSION: Diversity and inclusion in patient recruitment

2024-05-21, 3:00 PM

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Patti O’Malley
Associate Director, Strategic Relationship Management, Incyte

Session Details:

PANEL DISCUSSION: Fostering a strong relationship with your CRO

2024-05-22, 9:00 AM

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Harsha K. Rajasimha
MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-05-22, 3:15 PM

Session Details:

KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

2024-05-22, 2:15 PM

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Derek Shannon
Director, Statistical Project Management, Madrigal Pharmaceuticals

Session Details:

FIRESIDE CHAT: AI and digitalization in clinical trials

2024-05-21, 11:00 AM

Session Details:

AI 101: the opportunities of AI for clinical trials

2024-05-21, 12:00 PM

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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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Rosanne Petros
PMP, Associate Director, Clinical Research, Merck Research Laboratories

Rosanne Petros is a US Sr. Clinical Research Manager currently working in the vaccine therapy area.  She has 35 years of experience in Clinical Research primarily in clinical project management and is a PMP.   She has been at Merck for 18 years.  Prior to Merck, Rosanne had her own clinical research consulting company and began her career in clinical research at Pharmaco (then PPD).  Rosanne received her degree in Chemistry from University of Virginia and was a bench chemist prior to moving into clinical research. She lives outside of Washington DC with Kevin, her husband of 35 years and 4 of her 5 children (one moved out!) and two shih tzu mix dogs.  Her children range in age from 30 to 13 years old. Rosanne enjoys cooking, crafting and being with her family.  She also enjoys collecting and restoring Victorian and Art Deco jewelry and collecting and repairing vintage quilts.

Session Details:

The impact of high turnover of site staff on data collection and what sponsor companies can do to help

2024-05-21, 3:00 PM

Session Details:

KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

2024-05-22, 2:15 PM

Session Details:

PANEL DISCUSSION: Has DCT passed its peak in popularity?

2024-05-22, 11:15 AM

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Kristen Olszyk
Senior Director, Clinical Scientist, Neuraptive Therapeutics

Kristen Olszyk joined Neuraptive in March 2020 and is the Acting Head of Clinical Operations.  She brings with her 20 years in the pharmaceutical industry.  Kristen’s areas of expertise include data science, clinical development, clinical operations and regulatory affairs, and she has been involved with several successful regulatory submissions in multiple therapeutic areas.  Prior to joining Neuraptive, Kristen held positions at Wyeth Pharmaceuticals/Pfizer, Endo Pharmaceuticals and Paratek Pharmaceuticals.

 

Kristen earned her Bachelor of Science degree in Biochemistry from The Pennsylvania State University and her Master of Science degree in Quality Assurance and Regulatory Affairs from Temple University School of Pharmacy.

Session Details:

PANEL DISCUSSION: Has DCT passed its peak in popularity?

2024-05-22, 11:15 AM

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Dr Nikolaos Tezapsidis
President and Chief Executive Officer, Neurotez

Session Details:

CASE STUDY: Targeting Alzheimers: rationale and clinical trial plans at Neurotez

2024-05-21, 4:00 PM

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Douglas Kling
Chief Operating Officer, NewAmsterdam Pharma

Session Details:

PANEL DISCUSSION: Fostering a strong relationship with your CRO

2024-05-22, 9:00 AM

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Ram Raju
Senior Vice President and Community Health Investment Officer, Northwell Health

Dr. Ram Raju has a distinguished career over 40 years as a healthcare provider, teacher, researcher and community organizer. In his role at Northwell Health, Dr. Raju set the strategic vision to improve population health by finding ways to meet the needs of its most vulnerable communities, by examining the existing programs aimed at improving the health system's response to the community's needs and working with local organizations to address them. Northwell Health is the largest healthcare provider in the state of New York, is a system with 23 hospitals and 830 outpatient facilities that sees 2 million people every year in the New York metro area and beyond.

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-05-22, 3:15 PM

Session Details:

PANEL DISCUSSION: Diversity and inclusion in patient recruitment

2024-05-21, 3:00 PM

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Susan Neal
Director, Clinical Operations, Novavax

Session Details:

Effective patient education to increase enrolment and retention

2024-05-21, 2:00 PM

Session Details:

PANEL DISCUSSION: Running clinical trials in different geographic regions: assessing opportunities and challenges

2024-05-22, 12:15 PM

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Priya Marreddy
Vice President, Clinical Operations, OnCusp Therapeutics

Session Details:

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

2024-05-21, 10:00 AM

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Kelly Franchetti
Patient Advocate

Kelly has over 25 years of experience in obtaining and discerning the patient and caregiver experience as well as developing strong relationships with advocacy groups on a global scale. She has extensive experience in multiple therapeutic areas such as oncology, cardiovascular, endocrinology, orthopedics, infectious disease, neurology, pediatrics, and critical care. This depth and breadth of experience translate into a keen understanding of how patients think regarding their treatment giving her a singular perspective on the best way to approach patients with their treatment options, and an understanding that proves invaluable to her pharmaceutical and clinical research stakeholders.

Session Details:

A caregiver’s story: supporting children participating in a clinical trial

2024-05-21, 8:30 AM

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Tajuana Barron
Vice President, Project Management, PCM Trials

Session Details:

Access for all: how mobile visits and community sites help sponsors meet new diversity goals

2024-05-21, 12:30 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.

Session Details:

Insights into barriers to care in the rare disease community

2024-05-21, 12:00 PM

Session Details:

PANEL DISCUSSION: Diversity and inclusion in patient recruitment

2024-05-21, 3:00 PM

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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 DISCUSSION: Fostering a strong relationship with your CRO

2024-05-22, 9:00 AM

Session Details:

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

2024-05-21, 10:00 AM

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Hal J. Mann
Chapter Lead Clinical Support Solutions, Roche Diagnostics Solutions

I am a Clinical Research Professional with more than 30 years of experience ranging in perspective from the Study Site, small and large CRO’s, large Pharma, and large Diagnostics companies.  During my 15 years with GlaxoSmithKline, I spent my early years designing and conducting Clinical Trials before focusing on supplier management and strategic outsourcing.  In 2013, I joined Roche Molecular in Pleasanton, CA, where I currently lead a chapter in Clinical Development and Medical Affairs delivering Clinical Contracts & Outsourcing, Clinical Supplies Management, Functional Excellence / Clinical Quality, Clinical IT Solutions and Analytics, and sample management and testing from our internal Clinical Trial Support Lab.

Session Details:

PANEL DISCUSSION: Fostering a strong relationship with your CRO

2024-05-22, 9:00 AM

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-05-22, 3:15 PM

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Aamir Jaka
Global Vice President, Customer Experience and Success, Saama

Session Details:

AI: revolutionizing clinical development

2024-05-21, 11:30 AM

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Jessica King
Head of Clinical Operations, Sonnest

Session Details:

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

2024-05-21, 10:00 AM

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Louisa Carlse
Director of Partnerships, TecEx Medical

Proven success in supporting the Health and Lifesciences industry as Partnership Director.   Fostering B2B partnerships, and driving customer success initiatives for overall efficiency across clinical trials in support of timely delivery of supplies to sites and patients. Recognized for implementing key projects, reducing compliance risks, and leading Importer of Record initiatives. Leader with a visionary and strategic mindset, fostering innovation, inclusivity, and continuous improvement.

Session Details:

Outsourcing Importer of Record (IoR) requirements and a deep dive into the operational pitfalls

2024-05-21, 2:30 PM

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Duncan Hall
Chief Executive Officer, TRI

Session Details:

How RBQM creates trust between sponsors and CROs

2024-05-22, 9:30 AM

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Steve Rosenberg
Chief Executive Officer, uMotif

Session Details:

Start expecting more from eCOA and ePRO

2024-05-22, 11:45 AM

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GREG TULLO
VP Professional Services North America, Viedoc Technologies

Greg is an expert at designing innovative data collection plans, managing quality control of collected data, and creating custom tools and databases for end users, leveraging expertise in clinical software applications including SAS, DataFax, OpenClinica, Excel, and Access.

Session Details:

Digitalization in clinical trials: a 360 view

2024-05-21, 4:30 PM

Session Details:

Digitalization in clinical trials: a 360 view

2024-05-21, 4:30 PM

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MarieElena Cordisco
MA, NP-C, Senior Director, Therapeutic Strategy Lead, Metabolic, Worldwide Clinical Trials

MarieElena has been active in both research and clinical care through her career.  She brings more than ten years of leadership experience in clinical research sites management to the Worldwide team. She is also a clinically active nurse practitioner with more than 17 years of experience and a specialty in endocrinology. She has served as principal and sub-investigator for cardiometabolic trials and holds publications in peer-reviewed and high-impact journals. She is passionate about bringing her understanding of the patient journey to the Worldwide team.

Session Details:

How a consultative approach from a CRO could add value to your development program

2024-05-21, 11:30 AM

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Louisa Manning

Programme Director

+44 (0)20 766 10552

MARKETING ENQUIRIES

Moona Popal

Senior Marketing Manager

DELEGATE ENQUIRIES

Sunny Saikia

VIP Delegate Manager

Sponsorship Enquiries

To enquire about sponsorship opportunities for the conference, please contact:

 

Nick McCudden

Head of OCT Events


 

Speaker Enquiries

To enquire about sponsorship opportunities for the conference, please contact:

 

Louisa Manning

Programme Director


+44 (0)20 766 10552