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
  • Why attend?
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  • Speakers
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  • Event Gallery
  • Sponsors
  • Media Centre
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Why attend?

WHAT TO EXPECT FOR 2025?

450+

Attendees

70+

Exhibitors

30+

Speakers

450+

Attendees

70+

Exhibitors

30+

Speakers

See What It's All About

Agenda

  • 20 May 2025
  • 21 May 2025
Expand All

Streams

Stream one

Clinical Operations and Outsourcing

Stream two

Clinical Technology and Innovation

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

10:30 AM

Morning refreshments and networking break

Streams

Stream one

Clinical Technology and Innovation

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

Streams

Stream one

Clinical Operations and Outsourcing

Stream two

Clinical Technology and Innovation

11 AM

PANEL: Innovation and technology in clinical trials: exploring emerging and upcoming trends

• Is decentralization of clinical trials still relevant in 2025?
• Incorporating remote monitoring tools such as wearables into clinical trials
• An overview of new tools and solutions available on the market
• The growth of GenAI: when will this become widely used in clinical research?
• Balancing new techno

MODERATOR:
Rich Polgar, Managing Director, Danforth Advisors

PANELLISTS:
Ashlyn Jose, Director, Clinical Operations, Kyowa Kirin, Inc
Ram Raju, Senior Vice President and Community Health Investment Officer, Northwell Health
Kristen Olszyk, Vice President, Clinical Operations, Neuraptive Therapeutics
Stefanie Kuhner, Head of Clinical Technology, Innovation and Patient Recruitment, Bristol Myers
Squibb

11:30 AM

Reserved for session sponsor

12 PM

CASE STUDY: Getting a new site up and running: challenges, opportunities and lessons learned

  • Top tips for working with and supporting naïve physicians in order to ensure their success
  • The importance of new study sites as a way of meeting FDA diversity requirements
  • Lessons learned for the future: what should you consider when working with naïve doctors?

Carrie Lewis, Executive Director, Clinical Program
Optimization, Endo
Suzy Montanye, Site Relationship Manager, Endo

Speakers

Carrie Lewis
Executive Director, Clinical Program Optimization, Endo Pharmaceuticals
Suzy Montanye
Site Relationship Manager, Endo Pharmaceuticals

12:30 PM

Reserved for session sponsor

1 PM

Lunch and networking

2 PM

PANEL: AI and machine learning in clinical trials: where are we in 2025?

  • Opportunities for incorporating AI into clinical research: where should the industry be focusing?
  • Why has pharma been relatively slow to utilize AI in clinical research?
  • Understanding limitations of GenAI: what do you need to be wary of?
  • Real case studies on AI in the clinical trial industry: where has there been progress and success?
  • What does the future hold for AI in clinical trials?

MODERATOR:
Judyth Zahora, Senior Director, Clinical QA and Process Improvement, Zentalis Pharmaceuticals

PANELLISTS:
Rosanne Petros, Associate Director, Clinical Research, Merck Research Laboratories
Bryan Clayton, Clinical Systems Consultant, Alnylam Pharmaceuticals
Paresh Patel, Head of Global Clinical Intelligence, Otsuka

Speakers

Rosanne Petros
PMP, Associate Director, Clinical Research, Merck Research Laboratories
Bryan Clayton
Chief Commercial Officer, Endpoint Clinical
Paresh Patel
Head Of Global Clinical Intelligence, Otsuka
Judyth Zahora
Senior Director, Global Quality Systems and Process Improvement, Agenus

2:30 PM

Reserved for session sponsor

3 PM

Topic TBC

Dr Thomas Hopkins, Chief Medical Officer, AccuVein

3:30 PM

Afternoon refreshments, networking

4 PM

Health literacy in clinical trials: ensuring information is clear and accessible to patients

  • Technology and innovation for addressing health literacy and how information is presented to patients
  • Integrating health literacy principles into all phases of clinical research
  • How low health literacy can

Speakers

Lucas Goren
Senior Project Manager, CISCRP

4:30 PM

Reserved for session sponsor

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

8:45 AM

Emerging sourcing needs and models of a new biopharmaceutical company in women’s healthcare

As a newly spun-off biopharma company focusing on unmet medical needs in Women’s Health, our clinical R&D
sourcing needs and models have evolved over the past couple of years. We are transitioning to a function-driven
sourcing model where we can have a set of fit-for-purpose preferred suppliers to bring in flexibility and agility.
Challenges in Women’s Health sourcing, pros and cons of different sourcing models will be discussed.
Mohan Bangalore, PhD, Director, Global R&D Procurement and Supplier Management, Organon

Speakers

Mohan Bangalore
PhD, Director, Global R&D Procurement and Supplier Management, Organon

9:15 AM

Reserved for ICON Plc

9:45 AM

PANEL: Diversity Action Plans: how to ensure your clinical study has diverse representation

• Meeting FDA guidelines around diversity: how will new regulations impact you?
• Addressing historical issues with trial recruitment in certain populations in order to ensure diversity
• Community outreach as a method to reduce distrust around clinical trial participation
• Sourcing new sites in communities with high numbers of under-represented populations
• Language and translation: how to ensure your trial materials are accessible to non English speaking participants

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

PANELLISTS:
Patrick Floody, Executive Director, Global Clinical Trial Services, Regeneron
Lucas Goren, Senior Project Manager, CISCRP
Ram Raju, Senior Vice President and Community Health Investment Officer, Northwell Health

Speakers

Rosalie Filling
Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals
PATRICK FLOODY
Executive Director, Global Clinical Trial Services, Regeneron Pharmaceuticals
RAM RAJU
Former CEO, NYC Health & Hosptials Corporation
Lucas Goren
Senior Project Manager, CISCRP

10:30 AM

Morning refreshments and networking break

11 AM

Innovative approaches to measure your performance and identify areas for improvement in supplier relationships

  • KPIs in clinical research: what should you be measuring to determine your performance?
  • Working collaboratively with your CROs and vendors throughout your clinical trial: where are you falling short?
  • Tools and technology available to facilitate processes around performance measurement

11:30 AM

Reserved for Worldwide Clinical Trials

12 PM

PANEL: Best practice in supplier relationship management: managing evolving needs to foster positive collaboration

• Priorities and considerations when working with vendors and external suppliers
• Cultivating collaborative relationships with vendors and CROs
• Managing procurement and outsourcing during an integration of two companies
• Developing a plan for effective supplier relationship management to ensure your trial runs smoothly

MODERATOR:
Moderator to be confirmed

PANELLISTS:
Albert A Siha, Director, Oncology Unit Management Office, Procurement and Supplier Relationship Manager, Pfizer
Nupur Modi Murali, Director, Clinical Operations, Bausch Health Kathleen Cohen, Head of Clinical Development Operations, Marinus Pharma

Speakers

Albert A Siha
Director, Oncology Unit Management Office, Procurement and Supplier Relationship Manager, Pfizer
Nupur Modi Murali
Director, Clinical Operations, Bausch Health
Kathleen Cohen
Vice President, Clinical Development, Marinus Pharmaceuticals

12:30 PM

Reserved for session sponsor

1 PM

Lunch and networking

2 PM

Marriage counseling: how two nurses from both the hospital and industry side see us resolving the site v sponsor chasm

  • What sites really want and need, and why they don’t understand sponsors
  • What sponsors really want and need, and why they don’t understand sites
  • Areas of common ground
  • How sites and sponsors can reconcile and work together to find success

Speakers

Linda Miller
Senior Clinical Operations Lead, Incyte
Todd Nicklas
Clinical Trial Manager, Incyte

2:30 PM

Reserved for session sponsor

3 PM

PANEL: Handling clinical trial finances: tips for managing funding, investment and budgets

• Ensuring your trial is cost-conscious and efficient without compromising on quality or on patient care
• Forecasting and budgeting in order to accurately predict costs and minimize unforeseen expenses
• Keeping your clinical budget on track
• Negotiating prices and contracts in order to ensure maximum benefit without going over budget

Speakers

Rich Polgar
Director Global Procurement, Bristol-Myers Squibb
Lauren Colfer
Former Vice President, Clinical Operations at Aceragen Pharmaceuticals
Amber Knight
Associate Director, R&D Procurement, Organon
Rick O’Hara
Director, R&D Business Operations, OncoC4

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 gift cards. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

4 PM

What does patient centricity mean in an outsourcing context?

  • Ensuring patients are at the forefront of conversations with CROs and vendors
  • Considering vendor selection processes with the patient in mind: what does this look like?
  • Working closely with patient advocacy groups alongside CROs and vendors to deliver a patientcentric clinical trial

Speakers

Amber Knight
Associate Director, R&D Procurement, Organon

4:30 PM

Reserved for session sponsor

5 PM

KEYNOTE PRESENTATION AND WORKSHOP: Applying AI to our clinical operations challenges

  • What’s stopping us from using AI?
  • How to overcome barriers to AI: creative starter ideas
  • AI case studies, stories and key takeaways

Speakers

Dan Seewald
Co-Founder and COO, LiviWell and Founder and CEO, Deliberate Innovation

5:45 PM

Chairperson’s closing remarks

Speakers

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

5:50 PM

NETWORKING DRINKS RECEPTION AND END OF DAY 1

Streams

Stream one

Clinical Operations and Outsourcing

Stream two

Clinical Technology and Innovation

9 AM

Medically underserved populations and the impact on rare disease clinical trials

  • 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

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

Speakers

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

9:30 AM

Reserved for session sponsor

10 AM

A YEAR ON UPDATE: Critical to quality factors Part 2: operationalization of the concept in a pilot study

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

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

10:30 AM

Morning Refreshments & Networking

11:15 AM

PANEL: Optimizing remote data capture: new trends and technology in data acquisition

  • Incorporating innovative products and tools into your clinical trial for remote data capture
  • FDA regulatory guidance around data acquisition and collecting data in remote settings
  • Easing burden on patients through remote data collection: how to utilize these tools effectively
  • How new tools such as eCOA solve patient issues

MODERATOR:
Terry Katz, Senior Director, Biostatistics and Data
Management Planning and Functional Excellence, Daiichi
Sankyo, Inc
PANELLISTS:
Robert Besthof, Chief Operating Officer, RiboNova
TJ Sharpe, Patient Advocate
Further panellists to be confirmed

Speakers

Terry Katz
Senior Director, Biostatistics, Data Management Planning, Functional Excellence, Daiichi Sankyo
Robert Besthof
Chief Operating Officer, RiboNova
TJ Sharpe
Patient #1, Blogger and Cancer AdvocateJen Horonjeff, CEO

11:45 AM

Analyzing the advantages of using e-requisitions in lab collections

  • How eReqs can improve data accuracy, streamline data flow and reduce errors
    • Compliance with regulatory standards for data handling and reporting, and how eReqs can help
    • Additional benefits of implementing eReqs for lab collections

Bryan Fulop, Associate Director, Laboratory Services, Global R&D Procurement, Teva Pharmaceuticals

Speakers

Bryan Fulop
Associate Director, Laboratory Services, Global R&D Procurement, Teva Pharmaceuticals

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: Ensuring your FSP model is a success: what do you need to know?

• Working closely with FSP vendors: how much oversight do you need?
• Benefits and challenges of moving to an FSP outsourcing model
• Comparing vendor management strategies between pharma and biotechs: do you need a different
approach?
• Why is FSP becoming a popular outsourcing model: what benefits can this offer sponsors?

 

MODERATOR:
Rich Polgar, Managing Director, Danforth Advisors

PANELLISTS:
Melanie Goodwin, Director, Clinical Outsourcing,
Immunocore
Russell Bland, Director, Clinical Outsourcing and
Innovation, Jazz Pharmaceuticals
Terry Katz, Senior Director, Biostatistics and Data
Management Planning and Functional Excellence, Daiichi
Sankyo, Inc

Speakers

Rich Polgar
Director Global Procurement, Bristol-Myers Squibb
Melanie Goodwin
Director, Clinical Outsourcing, Immunocore
Russell Bland
Director, Clinical Outsourcing and Innovation, Jazz Pharmaceuticals
Terry Katz
Senior Director, Biostatistics, Data Management Planning, Functional Excellence, Daiichi Sankyo

9:30 AM

Reserved for session sponsor

10 AM

FIRESIDE CHAT: Achieving diversity in clinical trials

  • The importance of mindset and outlook when it comes to clinical trial diversity
  • How Endo have exceeded diversity goals and beaten timelines: factors for success
  • The role of site selection in enhancing diversity

Carrie Lewis, Executive Director, Clinical Program
Optimization, Endo
Senior representative, ICON

Speakers

Carrie Lewis
Executive Director, Clinical Program Optimization, Endo Pharmaceuticals

10:30 AM

Morning refreshments and networking

11:15 AM

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

11:45 AM

PANEL: Preparing for an FDA inspection: common pitfalls and ensuring your study is ready for approval

  • Reviewing last year’s FDA feedback on audits: what were the main reasons for failure?
  • Tips and tricks to ensure you are ready for inspection
  • Simplifying processes in order to prepare for an FDA inspection

MODERATOR:
Judyth Zahora, Senior Director, Clinical QA and Process
Improvement, Zentalis Pharmaceuticals
PANELLISTS:
Audrey Hill, Associate Director, Data Management, Insmed
Pending confirmation: Cristina N. Monastero, Director of
Clinical Document Management and Inspection Readiness,
Larimar Therapeutics
Further panellists to be confirmed

Speakers

Judyth Zahora
Senior Director, Global Quality Systems and Process Improvement, Agenus
Audrey Hill
Senior Director, Data Management, Advaxis
Samantha Beddows
Director, Data Management, Oncology, AstraZeneca

12:15 PM

KEYNOTE PRESENTATION: Establishing a Center of Excellence for gene therapy and vaccines

Speakers

Gurdyal Kalsi
Chief Medical Officer, Asklepion Pharmaceuticals

12:45 PM

Lunch and Networking

1:45 PM

The state of the biopharmaceutical industry in 2025

  • 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

Amanda Murphy, Senior Director, Data Intelligence and Solutions, GlobalData

Speakers

Amanda Murphy
Senior Director, Data Intelligence & Solutions, GlobalData

2:15 PM

PANEL: Navigating the outsourcing landscape for emerging therapy areas

  • An overview of emerging therapy areas including women’s health, cell and gene therapy and rare diseases
  • Designing a successful patient recruitment strategy: common challenges and how to overcome these
  • Vendor sourcing: key considerations in vendor selection
  • How important is therapeutic area knowledge when choosing CROs and partners?

MODERATOR:
Judyth Zahora, Senior Director, Clinical QA and Process Improvement, Zentalis Pharmaceuticals
PANELLISTS:
Gurdyal Kalsi, Chief Medical Officer, Asklepion Pharmaceuticals
Mohan Bangalore, PhD, Director, Global R&D Procurement and Supplier Management, Organon
Harsha K. Rajasimha, MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases
Priya Marreddy, Vice President, Clinical Operations, OnCusp Therapeutics

Speakers

Judyth Zahora
Senior Director, Global Quality Systems and Process Improvement, Agenus
Gurdyal Kalsi
Chief Medical Officer, Asklepion Pharmaceuticals
Mohan Bangalore
PhD, Director, Global R&D Procurement and Supplier Management, Organon
Harsha K. Rajasimha
MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases
Priya Marreddy
Vice President, Clinical Operations, OnCusp Therapeutics

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 gift cards. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss 0ut!

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 focus on a different challenge within clinical operations.

ROUNDTABLE 1: Developing a successful Diversity Action Plan for your clinical trial
ROUNDTABLE 2: Creating an AI strategy to support clinical research
ROUNDTABLE 3: Key considerations when selecting a CRO
ROUNDTABLE 4: Working with advocacy groups to keep the patient voice at the heart of your trial

 

4:15 PM

End of conference

END OF CONFERENCE – SEE YOU NEXT YEAR!

Speakers

Select a speaker to learn more

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Dr Thomas Hopkins
Chief Medical Officer, AccuVein
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Bryan Clayton
Chief Commercial Officer, Endpoint Clinical

Bryan Clayton is a seasoned global commercial leader with experience across multiple functions including sales and marketing, operations, and software product design. For over 20 years, he has effectively managed cross-functional teams, created new technology solutions, managed contract negotiations, and driven revenue growth for top life sciences technology and solutions providers. Bryan is a sought-after speaker, writer and contributor to industry events and publications, and possesses a range of skills well-suited to boost commercial success and revenue growth.

Bryan joined endpoint Clinical in 2023 as Chief Commercial Officer to lead commercial strategy and business development operations, and to further strengthen endpoint’s expertise in providing agile, patient centric IRT solutions. In his spare time, Bryan coaching and playing baseball.

Session Details:

PANEL: AI and machine learning in clinical trials: where are we in 2025?

2025-05-20, 2:00 PM

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Gurdyal Kalsi
Chief Medical Officer, Asklepion Pharmaceuticals

Session Details:

PANEL: Navigating the outsourcing landscape for emerging therapy areas

2025-05-21, 2:15 PM

Session Details:

KEYNOTE PRESENTATION: Establishing a Center of Excellence for gene therapy and vaccines

2025-05-21, 12:15 PM

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Samantha Beddows
Director, Data Management, Oncology, AstraZeneca

Session Details:

PANEL: Preparing for an FDA inspection: common pitfalls and ensuring your study is ready for approval

2025-05-21, 11:45 AM

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Nupur Modi Murali
Director, Clinical Operations, Bausch Health

Session Details:

PANEL: Best practice in supplier relationship management: managing evolving needs to foster positive collaboration

2025-05-20, 12:00 PM

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STEFANIE KUHNER
Global Head Of Clinical Technology, Innovation & Patient Recruitment – Strategic Sourcing & Procurement, Bristol Myers Squibb
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Lucas Goren
Senior Project Manager, CISCRP

Session Details:

PANEL: Diversity Action Plans: how to ensure your clinical study has diverse representation

2025-05-20, 9:45 AM

Session Details:

Health literacy in clinical trials: ensuring information is clear and accessible to patients

2025-05-20, 4:00 PM

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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: Ensuring your FSP model is a success: what do you need to know?

2025-05-21, 9:00 AM

Session Details:

PANEL: Optimizing remote data capture: new trends and technology in data acquisition

2025-05-21, 11:15 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:

A YEAR ON UPDATE: Critical to quality factors Part 2: operationalization of the concept in a pilot study

2025-05-21, 10:00 AM

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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:

A YEAR ON UPDATE: Critical to quality factors Part 2: operationalization of the concept in a pilot study

2025-05-21, 10:00 AM

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Rich Polgar
Director Global Procurement, Bristol-Myers Squibb

NULL

Session Details:

PANEL: Handling clinical trial finances: tips for managing funding, investment and budgets

2025-05-20, 3:00 PM

Session Details:

PANEL: Ensuring your FSP model is a success: what do you need to know?

2025-05-21, 9:00 AM

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Dan Seewald
Co-Founder and COO, LiviWell and Founder and CEO, Deliberate Innovation

Session Details:

KEYNOTE PRESENTATION AND WORKSHOP: Applying AI to our clinical operations challenges

2025-05-20, 5:00 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:

PANEL: Diversity Action Plans: how to ensure your clinical study has diverse representation

2025-05-20, 9:45 AM

Session Details:

Chairperson’s opening remarks

2025-05-20, 8:20 AM

Session Details:

Chairperson’s closing remarks

2025-05-20, 5:45 PM

Session Details:

Chairperson’s opening remarks

2025-05-21, 8:50 AM

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Carrie Lewis
Executive Director, Clinical Program Optimization, Endo Pharmaceuticals

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

Session Details:

CASE STUDY: Getting a new site up and running: challenges, opportunities and lessons learned

2025-05-20, 12:00 PM

Session Details:

FIRESIDE CHAT: Achieving diversity in clinical trials

2025-05-21, 10:00 AM

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Suzy Montanye
Site Relationship Manager, Endo Pharmaceuticals

Session Details:

CASE STUDY: Getting a new site up and running: challenges, opportunities and lessons learned

2025-05-20, 12:00 PM

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Amanda Murphy
Senior Director, Data Intelligence & Solutions, GlobalData

Amanda Murphy is the Director of Product Management at GlobalData, a company that focuses on research, data analytics and consulting that provide actionable insight into the pharmaceutical and medical device sectors.  She has 10+ years of experience working in pharmaceutical data science and web platform development (including BioPharm Insight, Lead Sheet, and the Pharma Intelligence Center).  She has developed models and solutions to support Clinical Operations & Feasibility teams plan and optimize trials, including an e-feasibility questionnaire tool resulting in 4x faster response rates from sites.  Amanda also has many years of experience supporting business development at CROs through data-driven lead delivery and CRM integration solutions.

Session Details:

The state of the biopharmaceutical industry in 2025

2025-05-21, 1:45 PM

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Melanie Goodwin
Director, Clinical Outsourcing, Immunocore

Session Details:

PANEL: Ensuring your FSP model is a success: what do you need to know?

2025-05-21, 9:00 AM

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Linda Miller
Senior Clinical Operations Lead, Incyte

Session Details:

Marriage counseling: how two nurses from both the hospital and industry side see us resolving the site v sponsor chasm

2025-05-20, 2:00 PM

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Todd Nicklas
Clinical Trial Manager, Incyte

Session Details:

Marriage counseling: how two nurses from both the hospital and industry side see us resolving the site v sponsor chasm

2025-05-20, 2:00 PM

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

Session Details:

PANEL: Navigating the outsourcing landscape for emerging therapy areas

2025-05-21, 2:15 PM

Session Details:

Medically underserved populations and the impact on rare disease clinical trials

2025-05-21, 9:00 AM

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Audrey Hill
Senior Director, Data Management, Advaxis

Session Details:

PANEL: Preparing for an FDA inspection: common pitfalls and ensuring your study is ready for approval

2025-05-21, 11:45 AM

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Russell Bland
Director, Clinical Outsourcing and Innovation, Jazz Pharmaceuticals

Session Details:

PANEL: Ensuring your FSP model is a success: what do you need to know?

2025-05-21, 9:00 AM

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Ashlyn Jose
Director, Clinical Operations, Kyowa Kirin, Inc
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Lauren Colfer
Former Vice President, Clinical Operations at Aceragen Pharmaceuticals

Lauren joins us with over 25 years of pharmaceutical development experience in both large and small pharmaceutical company settings.  Her career started as a clinical monitor with Covance which eventually led to oversight of clinical and medical affairs operations teams at Wyeth, Pfizer, Cephalon and Teva across multiple therapeutic areas.  Her biotech experience includes Head of Clinical Operations and Project Management at Recro Pharmaceuticals and, most recently, Head of Clinical Operations at Aceragen Pharmaceuticals (formerly Idera Pharmaceuticals).

Lauren holds a BS in Biology from the University of Scranton and an MBA in Biotechology and Health Industry Management from Pennsylvania State University.

Session Details:

PANEL: Handling clinical trial finances: tips for managing funding, investment and budgets

2025-05-20, 3:00 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.

Session Details:

PANEL: Best practice in supplier relationship management: managing evolving needs to foster positive collaboration

2025-05-20, 12:00 PM

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Anka G. Ehrhardt
Director, Cell-Based Sciences, AR&D, Merck

Dr. Ehrhardt is a biophysicist with a Ph.D. in human physiology. Throughout her career, she focused on driving biomedical research through efficient application of innovative technologies and strategies. She built and led successful teams in industry, including at Merck, where she headed a laboratory providing leading technologies for cell-based research from early discovery through manufacturing; and at BMS where Dr. Ehrhardt led and grew an international clinical assay team to robustly cover large scale registrational and translational clinical analysis generating clinical decision-driving data and mechanistic insights for immuno-oncology, cardiovascular, immunology, metabolic and rare disease studies. Before returning to Merck, Dr. Ehrhardt fulfilled one of her scientific aspirations at CHDI Foundation, designing and implementing successful clinical biomarker discovery and development strategies for Huntington’s disease. Currently, at Merck, Dr. Ehrhardt is providing strategic and technical leadership for the development and implementation of industry-leading and QC-friendly cell-based assays and models for potency determination that reflect the unique mechanisms of biologics products in clinical studies and beyond.

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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:

PANEL: AI and machine learning in clinical trials: where are we in 2025?

2025-05-20, 2:00 PM

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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.

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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.

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Jim Mordaga
MBA, MA, Senior Director, Medical Platforms and Intelligence, Novartis
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Rick O’Hara
Director, R&D Business Operations, OncoC4

Session Details:

PANEL: Handling clinical trial finances: tips for managing funding, investment and budgets

2025-05-20, 3:00 PM

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Priya Marreddy
Vice President, Clinical Operations, OnCusp Therapeutics

Session Details:

PANEL: Navigating the outsourcing landscape for emerging therapy areas

2025-05-21, 2:15 PM

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Mohan Bangalore
PhD, Director, Global R&D Procurement and Supplier Management, Organon

Session Details:

Emerging sourcing needs and models of a new biopharmaceutical company in women’s healthcare

2025-05-20, 8:45 AM

Session Details:

PANEL: Navigating the outsourcing landscape for emerging therapy areas

2025-05-21, 2:15 PM

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Amber Knight
Associate Director, R&D Procurement, Organon

Session Details:

What does patient centricity mean in an outsourcing context?

2025-05-20, 4:00 PM

Session Details:

PANEL: Handling clinical trial finances: tips for managing funding, investment and budgets

2025-05-20, 3:00 PM

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PARESH PATEL
Director Data Science & Technologies,Otsuka
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TJ Sharpe
Patient #1, Blogger and Cancer AdvocateJen Horonjeff, CEO

Session Details:

PANEL: Optimizing remote data capture: new trends and technology in data acquisition

2025-05-21, 11:15 AM

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Albert A Siha
Director, Oncology Unit Management Office, Procurement and Supplier Relationship Manager, Pfizer

Session Details:

PANEL: Best practice in supplier relationship management: managing evolving needs to foster positive collaboration

2025-05-20, 12:00 PM

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PATRICK FLOODY
Executive Director, Global Clinical Trial Services, Regeneron Pharmaceuticals

Patrick has over 27 years’ experience in new drug development. He joined Regeneron in March 2020. His current role is the Head of the Global Clinical Trial Services group, responsible for global site management, central monitoring, study feasibility and site selection, study/site start up and eCOA and patient technology initiatives. Prior to this, Patrick spent 25 years at Pfizer, with most of his time spent in clinical program operations but also includes GCP Quality (level 1) and Analytics. Patrick has extensive international experience in drug development. He helped establish the Pfizer country office development teams in Latin America, India and other parts of Asia. Subsequently, Patrick spent 10 years in Pfizer’s Development Japan organization as Head of Japan Development Operations and Development Japan Portfolio & Project Management Groups. He was the recipient of the PGRD Achievement Award in 2007. Patrick is a former officer in the U.S. Army and is a veteran of the first Gulf War. He holds a bachelor’s degree in Biology from the University of Rhode Island and a Master of Business Administration from Temple University.

Session Details:

PANEL: Diversity Action Plans: how to ensure your clinical study has diverse representation

2025-05-20, 9:45 AM

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Robert Besthof
Chief Operating Officer, RiboNova

Session Details:

PANEL: Optimizing remote data capture: new trends and technology in data acquisition

2025-05-21, 11:15 AM

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Bryan Fulop
Associate Director, Laboratory Services, Global R&D Procurement, Teva Pharmaceuticals

Session Details:

Analyzing the advantages of using e-requisitions in lab collections

2025-05-21, 11:45 AM

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

Session Details:

PANEL: AI and machine learning in clinical trials: where are we in 2025?

2025-05-20, 2:00 PM

Session Details:

PANEL: Navigating the outsourcing landscape for emerging therapy areas

2025-05-21, 2:15 PM

Session Details:

PANEL: Preparing for an FDA inspection: common pitfalls and ensuring your study is ready for approval

2025-05-21, 11:45 AM

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