14th Annual Outsourcing in Clinical Trials Southeast 2025

Creating a collaborative environment where pharma & biotech leaders can find solutions to current challenges through innovations and partnerships

1 - 2

April

2025
  • Embassy Suites by Hilton, Durham/Raleigh Research Triangle, NC, USA
  • Complimentary
  • Why attend?
  • Agenda
  • Advisory Board
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  • 2025 Sponsors
  • Media Centre
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Featured Speakers

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Marina Acosta Enslen​

Director, Clinical Operations, Grifols

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Michael Hickey​

Vice President, Clinical Operations, Bio-Path Holdings Inc

Michael Hickey is the VP of Clinical Operations at Bio-Path Holdings, LLC, a small biotech focused on developing liposomal antisense oligonucleotides in leukemia, lymphoma and solid tumors.  With over 26 years of experience at large and small sponsors including 6 years on the CRO side, Michael brings a truly collaborative approach and broad expertise in oncology and rare disease clinical drug development.  His clinical experience has focused on challenging indications such as head-and-neck cancer, colorectal cancer, breast cancer with BRCA mutations as well as chemotherapy induced myelosuppression, hemophilia, and Battens Disease.

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Stacey Curelop​

Director of Clinical Operations, Mycovia Pharmaceuticals

With a distinguished career in the clinical trial industry, Stacey Curelop brings a wealth of expertise in effectively managing clinical programs. Over the past decade, Stacey has successfully planned and executed more than 10 clinical trials, mainly in women’s health and infectious diseases, ensuring patient safety and maintaining data integrity, consistently delivering results within budget, scope, and schedule.

Recently, Stacey concurrently directed three Phase III trials, including two global studies spanning 11 countries. Navigating the complexities of these projects with remarkable precision culminated in FDA approval in 2022—an achievement notably realized amid the challenges posed by the COVID-19 pandemic.

In her role, Stacey has effective oversight of large global teams, expertly coordinating efforts across multiple vendors in clinical monitoring, data management, statistics, safety, medical writing, and central labs. Her comprehensive knowledge of FDA regulations, ICH/GCP guidelines, and professional expertise in Pharmacovigilance, has been instrumental in driving project success.

Stacey's impressive track record and ability to navigate the intricacies of clinical trials make her a compelling speaker and a valuable resource for insights into the ever-evolving landscape of clinical research.

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Matthew Barnes​

Director Portfolio Management, Virpax Pharmaceuticals

Matthew Barnes is a clinical researcher specializing in project management, operational efficiency, and drug development. He has over 28 years of experience providing support for clinical trials in a variety of roles in both small to mid-sized pharmaceutical/biotech companies and Clinical Research Organizations (CROs). He is currently serving as the Director of Portfolio Management of Virpax Pharmaceuticals, where he is responsible for leading and coordinating cross-functional activities to advance non-clinical and clinical development programs, manufacturing activities, and the implementation and management of the Quality Management System and SOPs.

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Deborah Waltz​

Vice President, Head of Quality, Cullinan Therapeutics

Senior quality leader with a proven track record bridging the gaps transitioning from R&D through commercialization and globalization. History of creating efficiencies and agility, minimizing risks, and optimizing competitive edge by developing right sized risk based global quality management systems and building effectiveness through collaborative internal and external partnerships.

Technical expertise includes GCP, GLP, GMP and Drug Safety / Pharmacovigilance quality system, process, program support as well as global and local quality system design, development and implementation on various scales and complexities.

Specialties: Over 35 years in the global pharmaceutical research environment participating in over 30 NDA/BLA/MAA submissions across all therapeutic areas with emphasis in Cardiovascular, Oncology, Anti-Infective/Immunology, Pulmonary/Respiratory, Gene Therapy/Gene Transfer, Nuclear Medicine/Diagnostic Imaging, CNS and Rare Disease. Experience spans complex small molecules, biologics, medical device and drug device combo products as well as transdermal and scheduled products.

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Bianca Green​

Head of Clinical Program Diversity, UCB

2025 Sponsors Include:

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Company Information

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022.

Company Website

To learn more, please visit our website - http://www.iconplc.com/

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Company Information

eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. The elluminate® Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. elluminate software and data driven services have been used by more than 100 life sciences companies on over 500 clinical trials to reduce cycle time and improve data quality. For more information, visit www.eclinicalsol.com, or contact us at info@clinicalsol.com.

Company Website

To learn more, please visit our website - www.eclinicalsol.com

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Company Information

ACM Global Laboratories is one of the largest global independent central labs in the industry. ACM is certified by the College of American Pathologists (CAP) and the Substance Abuse and Mental Health Services Administration (SAMHSA). The company delivers high-quality laboratory testing and diagnostic lab services in support of both clinical trials research, toxicology and individual patient care. ACM provides a powerful combination of operational excellence, scientific expertise and unsurpassed global service to customers in more than 65 countries. ACM performs more than 20 million laboratory tests each year—spanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more.

Company Website

To learn more, please visit our website - www.ACMGlobalLab.com

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Company Information

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com.

Company Website

To learn more, please visit our website - https://www.almacgroup.com

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Company Website

To learn more, please visit our website - http://www.bappharma.com/

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Company Information

SDC delivers top-tier clinical trial services to pharmaceutical, biologic and device/diagnostic companies.  With strategic scientific consulting and clinical data services (biostatistics, data management/EDC, and IRT/WRS) expertise at our core, our services are scalable via our strategic partnerships to provide full-service clinical trial solutions that are The Right Fit For You.

Company Website

To learn more, please visit our website - https://www.sdcclinical.com/

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Company Information

TFS HealthScience is a global Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Bringing together nearly 700 professionals, we deliver tailored clinical research services in more than 40 countries. TFS supports customers with comprehensive solutions including full clinical development services, strategic and flexible resourcing. In partnership, we build solution-driven teams of experienced professionals working together for a healthier future. Our mission is to bring treatments to patients faster. For more information, please visit www.tfscro.com.

Company Website

To learn more, please visit our website - www.tfscro.com.

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Company Information

At Trilogy, medical writing is our passion. As specialists in clinical regulatory documentation, we provide a service that is more than just writing. We proactively plan, coordinate and write clinical documents to meet timelines, with a readability that reduces the time for review and approval.

Company Website

To learn more, please visit our website - https://www.trilogywriting.com/

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Company Information

Greenphire is the industry leader of clinical payment technology, designed to improve the way research professionals work. We leverage our proprietary payments platform and workflow automation to help clients improve operational efficiency, reduce costs, mitigate regulatory risks, improve the patient and site experience and produce quantifiable results that improve clinical operations and strategic planning.

Company Website

To learn more, please visit our website - http://greenphire.com/

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Company Information

IDDI optimizes the clinical development of drugs, biomarkers and IVD using a unique combination of advanced biostatistics and innovative data collection technology.

IDDI covers the full spectrum of trial design, clinical data collection, management, analysis and reporting for Phase I- IV clinical trials.

– IDDI’s services include: Clinical Development Plans, Protocol Development, Randomization (IWRS/IRT) with Drug Supply Management, EDC, Medical Coding, Data Management, Biostatistics, IDMC Support, Biomarker/Diagnostics Validation, Medical Writing.

– IDDI’s therapeutic areas of expertise include oncology, ophthalmology, infectious diseases and cardiology.
– Experience: 27+ years – 980+ trials (630+ in oncology) – 20 FDA/EMA approvals to-date
– HQ in Belgium with offices in the USA ( Raleigh, NC, Boston, MA and San Francisco, CA).

Company Website

To learn more, please visit our website - http://www.iddi.com/

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Company Information

Advarra is number one in trusted research review services, number one in site operations technology, and the pioneer in study collaboration solutions. Our unique portfolio of technology and services reduces friction by decreasing technology burden, improving study visibility, and enabling smarter decisions that advance clinical research.

To learn more, please visit our website – www.advarra.com

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Company Information

PCI is a leading global CDMO, providing integrated end-to-end drug development, manufacturing and packaging solutions to increase product speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the delivery of supply chain healthcare services.  With 30 sites across Australia, Canada, North America, the UK and Europe and over 4,300 dedicated employees, our mission is to bring life-changing therapies to patients. Leading technology and continued investment enable us to deliver development to commercialization solutions throughout the product lifecycle, collaborating with our clients to improve the lives of patients globally.

Company Website

To learn more, please visit our website - http://pciservices.com/

Why attend?

Creating a collaborative environment where pharma & biotech leaders can find solutions to current challenges through innovations and partnerships

This is the leading industry event in the Southeast for outsourcing specialists’ that brings together industry leaders, solution providers and professionals into the same rooms, allowing them to interact in ways which can simplify processes and maximize their effort to get drugs to patients in a timely fashion.

 

WHAT TO EXPECT FOR 2025?

This is the leading industry event in the Southeast for outsourcing specialists’ that brings together industry leaders, solution providers and professionals into the same rooms, allowing them to interact in ways which can simplify processes and maximise their effort to get drugs to patients in a timely fashion.

300+

Attendees

20+

Exhibitors

20+

Speakers
300+

Attendees

20+

Exhibitors
20+

Speakers

Testimonials

It was very interesting, both the presentations and the meeting opportunities.

IBSA Institut Biochimique SA

A great networking opportunity.

Medigene AG

See What It's All About

Agenda

  • 1 Apr 2025
  • 2 Apr 2025
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8 AM

Registration & Refreshments

8:50 AM

Chair’s Opening Remarks

Speakers

Robert Loll
SVP, Business Development, Praxis Communications

9 AM

The Patient’s Perspective: ‘The critical importance of patient voice in clinical development

  • What is patient experience data collection and why does it matter?
  • Mechanisms for patient engagement across the product development lifecycle
  • Demonstrating the value of patient engagement from a variety of perspectives (i.e. biopharmaceutical, patient advocacy, regulatory, and payer)
  • Understanding roles and responsibilities for patient advocacy organizations, patient opinion leaders, pharmaceutical sponsors, etc.

Speakers

Richie Kahn
Clinical Researcher, Patient Advisor, Co-Founder and COO, Canary Advisors

9:30 AM

Reserved for Mercalis

10 AM

PANEL: Considerations for a Patient Centric Trial Design to Increase Trial Success

 

    • Exploring how patients could, and should, be influencing decisions and the R&D process before study start-up.
    • How to optimize collaboration with patient advocacy organizations
    • Discussing recipes for success and the challenges which are still visible.
    • Real-life examples: when has it worked, when hasn’t it and why?

Speakers

Gabriela Feldberg
Head of Portfolio Strategy, Evinova part of AstraZeneca
Bianca Green
Head of Clinical Program Diversity, UCB
Ros Cheetham
Vice President of Clinical Operations, MacroGenics

10:45 AM

Morning Refreshments & Networking

11:30 AM

The value of strategic early engagement to maximize sponsor/CRO partnerships

  • 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 options and models

Speakers

Rick Baransky
Senior Director, Project Delivery, ICON Biotech

12 PM

Site Selection and Setting Them up for Success

  • The paradigm shift, post-pandemic
  • Responsibility of sites, taking ownership
  • How to manage when it goes south, what is persistent non-compliance?
  • Diversity, Equity & Inclusion

Speakers

Deborah Waltz
Vice President, Head of Quality, Cullinan Therapeutics

12:30 PM

TECHNOLOGY SPOTLIGHT by Smurfit Westrock

12:45 PM

Lunch and Networking

2 PM

Community Education, Outreach and Partnership

  • Sustaining community outreach and engagement through CISCRP's Journey to Better Health Mobile Unit
  • The impact on perceptions and behaviors with regards to clinical research
  • Partnering with community educators, drawing attention to the need to be aware of clinical research

Speakers

Corinne Scripps
Account Manager, CISCRP
Barbarajean (BJ) Shaneman-Robinson
Community Educator
Stephanie Stennett
Senior Global Trial Manager, BMS

2:30 PM

TECHNOLOGY SPOTLIGHT: Leveraging Technology for Seamless Collaboration

This session will include demonstrations and case study data illustrating how novel, effective technology-driven strategies can remove workflow friction and improve project delivery across several clinical workflows that are complex and dynamic, requiring multi-stakeholder inputs and timely, complex data exchanges.  In this session, you will learn how to optimize your processes for patient eligibility review, remote monitoring and more – all in one collaboration platform!

Speakers

Catherine Tyner
Head of Clinical Strategy, AG Mednet

2:45 PM

Diversity and Inclusion in Clinical Trials

  • How strategic partnerships can positively impact diversity in clinical trials
  • Leveraging these partnerships to enhance community engagement
  • Planning for diversity at the onset

Speakers

Bianca Green
Head of Clinical Program Diversity, UCB

3:15 PM

Afternoon Networking & Refreshments

3:45 PM

Risky Business: Take Some Chances on Vendor Management

  • Who needs to be risky? - vendor management team
  • What tools are needed to manage risks?
  • What qualification activities are needed? Less audits?
  • How much oversight and management?

Speakers

Kevyn Matijevich
Associate Director, Clinical Quality Assurance, Menarini Stemline

4:15 PM

Panel Discussion Unravelling the impact of ICH E6(R3) on Good Clinical Practice

  • How to implement
  • Different approaches
  • Interpretations
  • Meaningful differences from ICH E6 R2

Speakers

Kristen Prevette
Director Clinical Operations, Global Clinical Studies Division, Scientific and Regulatory Affairs, Reynolds
Sharri Adams-Edwards
Executive Director of Clinical Operations, Adverum Biotechnologies, Inc
Lysa Triantafillou
Senior Director, Quality Assurance, MindMed,Inc.
Brandy Wilcox
Clinical Operations, Rivus Pharmaceuticals

5 PM

Chair’s Closing Remarks & Drinks Reception Sponsored by KPS Life

8 AM

Registration and Refreshments

8:50 AM

Chair’s Opening Remarks

Speakers

Robert Loll
SVP, Business Development, Praxis Communications

9 AM

Speaker Hosted Roundtables

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables.

RT1 - Collaboration on trial design and execution to ensure study success
Stacey Curelop, Director of Clinical Operations, Mycovia Pharmaceuticals

RT2 - Beyond Compliance: Fostering a culture of inclusion in Clinical Trials
Bianca Green, Senior Manager, Diversity Equity & Inclusion in Clinical Trials, Takeda

RT3 - Strategies for Smaller Pharma & Biotech’s to Overcome Financial and Resource Challenges

Ros Cheetham, Vice President Clinical Operations, MacroGenics

 

Speakers

Stacey Curelop
Director of Clinical Operations, Mycovia Pharmaceuticals
Bianca Green
Head of Clinical Program Diversity, UCB
Ros Cheetham
Vice President of Clinical Operations, MacroGenics

10 AM

Morning Refreshments & Networking

10:45 AM

Panel Discussion Clinical Partnerships; transition and growth in an ever changing landscape

  • Addressing the loss of innovative work due to biotechs ceasing to exist
  • Discussing the increase in M&A (Mergers & Acquisitions)
  • CRO hub’s role in managing various entities

 

Speakers

Robert Loll
SVP, Business Development, Praxis Communications
Gabriela Feldberg
Head of Portfolio Strategy, Evinova part of AstraZeneca
Marina Acosta Enslen
Director, Clinical Operations, Grifols

11:15 AM

Interactive Session: Navigating the Impact of New Administration Policies on Clinical Trials

The evolving regulatory landscape following the Trump administration has introduced significant changes that continue to affect clinical trials. This session will explore the lasting impact of policy shifts on trial design, patient recruitment, and data transparency. Industry experts will discuss key regulatory updates, including FDA guidance changes, supply chain implications, and funding adjustments. Attendees are welcome to interact and discuss how these developments are shaping clinical research strategies and what steps organizations can take to ensure compliance and operational efficiency in this new environment.

Speakers

Robert Loll
SVP, Business Development, Praxis Communications
Rich Pelt
Senior Director, Global Regulatory Sciences, Vaccines CMC, Pfizer

11:45 AM

The Broken Business Development/Sponsor Relationship and How to Fix it from Both Perspectives

  • Best and worst business development practices for reaching sponsors
  • Best and worst practices for sponsors working with BD in seeking quotes and outsourced work
  • Understanding and respecting each party’s requirements and pressures

Speakers

Jennifer D. Hart
Executive Director, Operations, Evecxia Therapeutics

12:15 PM

Networking Lunch

1:30 PM

Conducting Clinical Trials in a Complex Geopolitical landscape: Challenges and Strategic

  • Changing foreign relations priorities in US
  • History of the US BioSecure Act, its future, and potential impact on the Pharmaceutical Industry
  • US pharma industry reliance on foreign CROs and CDMOs to advance research
  • Risk assessment for companies with ongoing drug development activities with a foreign CRO/CDMO

Speakers

Matthew Barnes
Director Portfolio Management, Virpax Pharmaceuticals

2 PM

Tactics and eTools for Inspection Readiness in Diagnostics: Lessons learned from US and ROW inspections, and how the preparation differs depending on the auditing body (e.g., FDA vs. TUV)

  • Lessons learned in the Diagnostics space
  • Use of eSystems data / information in Inspection Readiness
  • Understanding the expectations of your Auditor (FDA vs. EU Notified Body)

Speakers

Hal Mann
Senior Director Clinical Affairs & Medical Affairs, Roche Diagnostics

2:30 PM

PANEL Choosing an outsourcing model: FSO vs FSP vs inhouse

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

Speakers

Robert Loll
SVP, Business Development, Praxis Communications
Michael Hickey
Vice President, Clinical Operations, Bio-Path Holdings Inc
Jesselle Simeon
Director, Clinical Operations and Contracts Management, Adverum Biotechnologies, Inc
Stacey Curelop
Director of Clinical Operations, Mycovia Pharmaceuticals

3 PM

Chair’s Closing Remarks

Speakers

Select a speaker to learn more

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Bianca Green
Head of Clinical Program Diversity, UCB

Session Details:

PANEL: Considerations for a Patient Centric Trial Design to Increase Trial Success

2025-04-01, 10:00 AM

Session Details:

Speaker Hosted Roundtables

2025-04-02, 9:00 AM

Session Details:

Diversity and Inclusion in Clinical Trials

2025-04-01, 2:45 PM

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Corinne Scripps
Account Manager, CISCRP

Corinne Scripps is the Account Manager at CISCRP (Center for Information and Study on Clinical Research Participation). Corinne primarily collaborates with industry partners to support patient engagement, clinical research education, and clinical trial participation. She holds a Masters of Public Health from Boston University School of Public Health, and Bachelor's degrees in both Health and Human Services focusing on Gerontology, and Global Gender Studies from The University of Buffalo. Her graduate work primarily focused on the effects of race and quality of maternal healthcare experiences on maternal and infant health outcomes. She is passionate about expanding the availability of healthcare education and creating transparency amongst diverse and underrepresented populations.

Session Details:

Community Education, Outreach and Partnership

2025-04-01, 2:00 PM

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Deborah Waltz
Vice President, Head of Quality, Cullinan Therapeutics

Senior quality leader with a proven track record bridging the gaps transitioning from R&D through commercialization and globalization. History of creating efficiencies and agility, minimizing risks, and optimizing competitive edge by developing right sized risk based global quality management systems and building effectiveness through collaborative internal and external partnerships.

Technical expertise includes GCP, GLP, GMP and Drug Safety / Pharmacovigilance quality system, process, program support as well as global and local quality system design, development and implementation on various scales and complexities.

Specialties: Over 35 years in the global pharmaceutical research environment participating in over 30 NDA/BLA/MAA submissions across all therapeutic areas with emphasis in Cardiovascular, Oncology, Anti-Infective/Immunology, Pulmonary/Respiratory, Gene Therapy/Gene Transfer, Nuclear Medicine/Diagnostic Imaging, CNS and Rare Disease. Experience spans complex small molecules, biologics, medical device and drug device combo products as well as transdermal and scheduled products.

Session Details:

Site Selection and Setting Them up for Success

2025-04-01, 12:00 PM

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Gabriela Feldberg
Head of Portfolio Strategy, Evinova part of AstraZeneca

Create, implement and grow an action oriented portfolio strategy organization ensuring we are accelerating health outcomes for people living with diseases through the delivery of the right human experience driven digital solutions

Session Details:

Panel Discussion Clinical Partnerships; transition and growth in an ever changing landscape

2025-04-02, 10:45 AM

Session Details:

PANEL: Considerations for a Patient Centric Trial Design to Increase Trial Success

2025-04-01, 10:00 AM

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Jennifer D. Hart
Executive Director, Operations, Evecxia Therapeutics

With over 25 years’ experience in the pharmaceutical industry, Ms. Hart has a wide range of experience from working with manufacturing, toxicology and clinical CROs in various roles. An analytical chemist by training, Ms. Hart got her start in the industry performing bench chemistry for analytical CROs such as AAI Pharma (Alcami), and Alpharma (acquired by Pfizer), then migrated into Quality Assurance, responsible for investigations and cGMP compliance. After that, Ms. Hart spent several years at RTI (Research Triangle Institute) in RTP, NC in Quality Assurance overseeing GLP and GMP Quality programs before migrating into commercial business development, where she established short- and long-term partnerships with biotech and pharma companies in support of their programs.  Ms. Hart then became Sr. Director of Business Development at RTI, overseeing a $5M portfolio and 3 Business Development reps.  After spending 6 years at RTI, Ms. Hart became analytical lab director of the new Patheon facility in RTP, NC.  In that role, she managed projects, trained employees, and help set up the lab.  Around 2010, Ms. Hart migrated into the clinical world with a role in business development at Jubilant Clinsys, a boutique CRO based in Raleigh, NC. After her tenure at Jubliant Clinsys, Ms. Hart moved to Duke Clinical Research Institute where she started in business development, but also worked in marketing, project management, cross-functional liaison between Neurology and Psychiatry groups.  During her tenure at DCRI, Ms. Hart created the EEG coordinating center for CNS clinical trials to offer to companies needing EEG central adjudication for clinical endpoints. After leaving DCRI, Ms. Hart became Vice President of Cohortias Intl, a clinical CRO in Monterrey, MX.  During her tenure there, she oversaw the business development groups, creation of the entire QMS (Quality Management System), training, project management, and clinical development groups.  Finally, the last 5 years of experience has been working on the sponsor side at Evecxia Therapeutics as the Executive Director of Operations. In this role, she is responsible for all outsourcing, project management, finance, and quality for nonclinical, clinical, and manufacturing operations of Evecxia’s two main products EVX-101 and EVX-301.

Session Details:

The Broken Business Development/Sponsor Relationship and How to Fix it from Both Perspectives

2025-04-02, 11:45 AM

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Brian Sheridan
Vice President Global Adherence & Clinicals, Smurfit Westrock

Brian joined, the then WestRock, in 2018 as Vice President Global Adherence & Clinicals - the business unit focused on providing Adherence focused, patient centric and Child Resistant Senior Friendly (CR-SF) packaging & service solutions to the Pharmaceutical, Biotech & Clinical Trial industries.

Having majored in marketing, business studies and finance Brians key expertise has been developing packaging solutions supplied to these key markets. Holding a wide range of increasingly elevated positions within companies such as Cardinal Health, Catalent and across several other packaging entities, Brian has gained invaluable insights and a thorough understanding of the demanding requirements, operating systems and ethos of the various market sectors that Smurfit Westrock support today.

Within the last number of years Brian's focus, together with his globally based team, has been to strategically develop a bespoke, best in class global supply infrastructure within the Smurfit Westrock specialized field of Adherence, Clinical Trial and SMART digital & electronic platforms. These cutting-edge solutions encompass electronically enhanced SMART measure and monitor packaging solutions, such as Cere®Pak, together with developing the vision and capabilities of Cere®Screen Digital Display Labels within the Clinical Trial Supplies arena..

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Jesselle Simeon
Director, Clinical Operations and Contracts Management, Adverum Biotechnologies, Inc

Extensive clinical operations experience, with expertise in contracts and forecasting.

Session Details:

PANEL Choosing an outsourcing model: FSO vs FSP vs inhouse

2025-04-02, 2:30 PM

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Kevyn Matijevich
Associate Director, Clinical Quality Assurance, Menarini Stemline

Kevyn Matijevich, RQAP-GCP, is Associate Director, Research and Development (R&D), Clinical Quality Assurance at Menarini Stemline. In this role, Ms. Matijevich is responsible for supporting oncology research trials.  Ms. Matijevich is registered with the Society of Quality Assurance in Good Clinical Practices (RQAP-GCP) and holds a Master’s certificate in regulatory affairs from the University of Georgia. She has more than 20 years of quality experience within the pharmaceutical/life sciences industry. She has extensive experience in quality systems, computer systems validation, risk based quality management, process improvement, change management, auditing, vendor management, and electronic records/signature regulations. Additionally, Ms. Matijevich is the SQA CVIC AVA subcommittee chair and is the past president of the North Carolina Chapter of the Society of Quality Assurance board.

Session Details:

Risky Business: Take Some Chances on Vendor Management

2025-04-01, 3:45 PM

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Marina Acosta Enslen
Director, Clinical Operations, Grifols

Session Details:

Panel Discussion Clinical Partnerships; transition and growth in an ever changing landscape

2025-04-02, 10:45 AM

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Matthew Barnes
Director Portfolio Management, Virpax Pharmaceuticals

Matthew Barnes is a clinical researcher specializing in project management, operational efficiency, and drug development. He has over 28 years of experience providing support for clinical trials in a variety of roles in both small to mid-sized pharmaceutical/biotech companies and Clinical Research Organizations (CROs). He is currently serving as the Director of Portfolio Management of Virpax Pharmaceuticals, where he is responsible for leading and coordinating cross-functional activities to advance non-clinical and clinical development programs, manufacturing activities, and the implementation and management of the Quality Management System and SOPs.

Session Details:

Conducting Clinical Trials in a Complex Geopolitical landscape: Challenges and Strategic

2025-04-02, 1:30 PM

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Michael Hickey
Vice President, Clinical Operations, Bio-Path Holdings Inc

Michael Hickey is the VP of Clinical Operations at Bio-Path Holdings, LLC, a small biotech focused on developing liposomal antisense oligonucleotides in leukemia, lymphoma and solid tumors.  With over 26 years of experience at large and small sponsors including 6 years on the CRO side, Michael brings a truly collaborative approach and broad expertise in oncology and rare disease clinical drug development.  His clinical experience has focused on challenging indications such as head-and-neck cancer, colorectal cancer, breast cancer with BRCA mutations as well as chemotherapy induced myelosuppression, hemophilia, and Battens Disease.

Session Details:

PANEL Choosing an outsourcing model: FSO vs FSP vs inhouse

2025-04-02, 2:30 PM

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Richie Kahn
Clinical Researcher, Patient Advisor, Co-Founder and COO, Canary Advisors

As Co-Founder & COO of Canary Advisors, Richie partners with biopharma, nonprofit, and regulatory stakeholders to better align clinical development programs with patient wants and needs.. A health policy professional by training, clinical researcher by trade and patient advocate by necessity, Richie has spent the last 15 years working across the industry to reduce the time it takes to bring promising new treatments to the patients that need them most.

Session Details:

The Patient’s Perspective: ‘The critical importance of patient voice in clinical development

2025-04-01, 9:00 AM

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Robert Loll
SVP, Business Development, Praxis Communications

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

Session Details:

PANEL Choosing an outsourcing model: FSO vs FSP vs inhouse

2025-04-02, 2:30 PM

Session Details:

Panel Discussion Clinical Partnerships; transition and growth in an ever changing landscape

2025-04-02, 10:45 AM

Session Details:

Chair’s Opening Remarks

2025-04-01, 8:50 AM

Session Details:

Chair’s Opening Remarks

2025-04-02, 8:50 AM

Session Details:

Interactive Session: Navigating the Impact of New Administration Policies on Clinical Trials

2025-04-02, 11:15 AM

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Sharri Adams-Edwards
Executive Director of Clinical Operations, Adverum Biotechnologies, Inc

With 24 years of experience in clinical research, primarily within Clinical Operations, I currently serve as the Executive Director of Clinical Operations at a small biotech firm, a role I've held for over three years. My career spans both big pharma and CRO environments, and I am a long-term owner of Intelligent Clinical Solutions, LLC, and co-owner of TBG Research Consulting. I bring additional expertise in QA, regulations, and inspection readiness, and I am an SME in Diversity and Risk-Based Monitoring (RBM). A former Army Nurse and native of South Carolina, I am deeply committed to continuous learning and growth in my field.

Session Details:

Panel Discussion Unravelling the impact of ICH E6(R3) on Good Clinical Practice

2025-04-01, 4:15 PM

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Stacey Curelop
Director of Clinical Operations, Mycovia Pharmaceuticals

With a distinguished career in the clinical trial industry, Stacey Curelop brings a wealth of expertise in effectively managing clinical programs. Over the past decade, Stacey has successfully planned and executed more than 10 clinical trials, mainly in women’s health and infectious diseases, ensuring patient safety and maintaining data integrity, consistently delivering results within budget, scope, and schedule.

Recently, Stacey concurrently directed three Phase III trials, including two global studies spanning 11 countries. Navigating the complexities of these projects with remarkable precision culminated in FDA approval in 2022—an achievement notably realized amid the challenges posed by the COVID-19 pandemic.

In her role, Stacey has effective oversight of large global teams, expertly coordinating efforts across multiple vendors in clinical monitoring, data management, statistics, safety, medical writing, and central labs. Her comprehensive knowledge of FDA regulations, ICH/GCP guidelines, and professional expertise in Pharmacovigilance, has been instrumental in driving project success.

Stacey's impressive track record and ability to navigate the intricacies of clinical trials make her a compelling speaker and a valuable resource for insights into the ever-evolving landscape of clinical research.

Session Details:

PANEL Choosing an outsourcing model: FSO vs FSP vs inhouse

2025-04-02, 2:30 PM

Session Details:

Speaker Hosted Roundtables

2025-04-02, 9:00 AM

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Ros Cheetham
Vice President of Clinical Operations, MacroGenics

Ros Cheetham is Vice President, Clinical Operations, at MacroGenics. Immediately prior to joining MacroGenics, Ms Cheetham was Senior Vice President, Clinical Solutions and Strategic Partnerships at the WIRB Copernicus Group.

Prior to these roles, Ms Cheetham spent several years as a consultant to the Biotech industry following a varied career within the pharmaceutical industry. Those industry roles included Vice President of Global Clinical Operations at Allergan; several leadership positions at GSK, including Vice President and Medicines Development Leader in both Neurosciences and Rare Diseases, as well as other leadership positions within global clinical operations. Earlier in her career she worked for Janssen Pharmaceutica in the US, Belgium and South Africa and had a pivotal role in the global development and registration of the novel antipsychotic, risperidone (Risperdal®).

Throughout her career, Ms Cheetham has taken a keen interest in how to improve trial outcomes and success including enhancing diversity in clinical trials. She has advised Biotech companies on their DEI strategies and has successfully led the creation of FDA Diversity plans.

Ms Cheetham obtained her undergraduate degree at Imperial College, London and her Master’s degree at the University of the Witwatersrand, Johannesburg.

Session Details:

PANEL: Considerations for a Patient Centric Trial Design to Increase Trial Success

2025-04-01, 10:00 AM

Session Details:

Speaker Hosted Roundtables

2025-04-02, 9:00 AM

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Barbarajean (BJ) Shaneman-Robinson
Community Educator

BJ Shaneman is a positive and strong community nurse advocate. The first Native American/Black female student to attend the nursing program at the University of Virginia, she graduated with honors. She continued her education in nursing, sociology, and psychology by attending Coppin State University and Catonsville Community College with several degrees obtained.

Now retired, BJ volunteers her time, health care skills, and knowledge, providing free health care services and is the accredited developer and/or founder for several community health care programs. She wears many hats to bring and to assure partnerships of health care services will benefit the community residents and clients she serves.

 

Session Details:

Community Education, Outreach and Partnership

2025-04-01, 2:00 PM

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Stephanie Stennett
Senior Global Trial Manager, BMS

Stephanie joined BMS in March 2022 and is currently a Senior Global Trial Manager managing early phase immuno-oncology and hematology studies within the HOCT pillar. She also supports Diversity in Clinical Trials efforts throughout the organization.

Stephanie holds a Master of Public Health in Health Management and Policy, a Bachelor of Science in Biology and a Bachelor of Arts in Chemistry.

Stephanie is a PMP and CCRP Certified Clinical Research Professional with extensive experience in Phase 1-4 trials. She has been in the Clinical Research Industry for over 16 years, beginning as a research assistant at an academic site then transitioning to coordinating trials at the VA for a total of six years. Since moving to sponsor level operations, Stephanie has managed early and late phase trials at both large pharmaceutical companies and small device start-ups. Her experience in this industry as well as within clinical sites has provided her with extensive knowledge in the clinical operations field.

Session Details:

Community Education, Outreach and Partnership

2025-04-01, 2:00 PM

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Lysa Triantafillou
Senior Director, Quality Assurance, MindMed,Inc.

Session Details:

Panel Discussion Unravelling the impact of ICH E6(R3) on Good Clinical Practice

2025-04-01, 4:15 PM

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Catherine Tyner
Head of Clinical Strategy, AG Mednet

Catherine Tyner brings 27 years of clinical research experience with a focus on Oversight Group Management for Clinical Endpoint Committees, Data Monitoring Committees, and other operations. Throughout her career, Ms. Tyner has led and developed oversight departments at Quintiles (now IQVIA), Novella Clinical, and Covance (now Fortrea), providing strategic management for over 500 clinical trials, including complex megatrials across diverse therapeutic areas. A recognized thought leader in endpoint adjudication best practices, Ms. Tyner has authored the industry's seminal guidance on adjudication operations and best practice. In her new role at AG Mednet, Ms. Tyner will work to expand and tailor the value jointly created with new and existing CROs Trial Sponsors, Core Labs, and Academic Research Organizations, working closely to optimize the future of clinical process efficiency.

Session Details:

TECHNOLOGY SPOTLIGHT: Leveraging Technology for Seamless Collaboration

2025-04-01, 2:30 PM

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Rick Baransky
Senior Director, Project Delivery, ICON Biotech

Rick has 23 years of clinical research experience at multiple Clinical Research Organizations (CROs) in various roles, most recently including Sr. Director of Project Delivery, Sr. Director of Site Operations, Head of Just In Time Oncology Business Unit, Sr. Director – Site Collaborations, and Sr. Director of Clinical Management. Rick has 15+ years of Project and Clinical Management oversight, both as Director of Functional Team Leads and Line Management of CRAs. Additionally, Rick has 4+ years of Site Operations/Collaborations experience specializing in Oncology and Pediatrics.

Rick’s vast experience spans all areas of drug development, specializing in CRO delivery and oversight. Rick has global experience in both Project and Clinical Management oversight as well as Site Operations, spanning Phase I First in Human Trials through Phase IV. Rick has experience in multiple therapeutic areas, but has significant expertise in Cardiology, Vaccines, Hematology/Oncology, Pediatrics and Rare Diseases. Rick has a Bachelor’s of Science in Economics from Oswego State University and is currently located in Raleigh, North Carolina.

Session Details:

The value of strategic early engagement to maximize sponsor/CRO partnerships

2025-04-01, 11:30 AM

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Rich Pelt
Senior Director, Global Regulatory Sciences, Vaccines CMC, Pfizer

Rich has over 25 years of CMC Regulatory Affairs with positions of increasing responsibility with GSK, PDL Biopharma, Wyeth Pharmaceuticals and currently with Pfizer, Inc as a senior director for vaccines CMC regulatory affairs.  Rich currently leads a team of 30 CMC Regulatory professionals responsible for supporting the development and production of various vaccines for the prevention of Sars-CoV-2 (Covid 19), C. Difficile, RSV, Group B Streptococcus, and Influenza.  Since the beginning of the pandemic, he has been one of the global leaders responsible for developing the BioNtech/Pfizer mRNA Covid-19 Vaccine.  Rich has been responsible for CMC Regulatory leadership on various vaccine programs over the last 25 years including the Prevnar 13 Vaccine global market submissions and approvals, coral snake antivenin production restart as well as various development programs including Staphylococcus aureus and RSV.

 

Rich has been an educator and guest speaker at various industry seminars and forums including The World Vaccine Congress, The American Association of Pharmaceutical Scientists National Biotechnology Conference, The International Society for Bioprocess Technology Nucleic Acids Conference, CASSS WCBP Conference, Academy for Institutional Investors Investment Forums, IBC Life Sciences programs, Regulatory Affairs Professional Society, and several other educational organizations.  Rich is also the Author of CMC Regulatory Affairs 101:  What does CMC Regulatory Affairs Do? (American Pharmaceutical Outsourcing:  Nov./Dec. 2007), and a contributing reviewer for the 5th edition of Fundamentals of US Regulatory Affairs (Chapter 15 on Biologics submission 2007) for the Regulatory Affairs Professionals Society.

 

Rich received a Bachelor of Science degree in Chemical Engineering from NC State University.  Rich is a 7-Time Ironman Triathlon finisher and was a division one swimmer for NC State University.  When Rich is not working on vaccine development, he enjoys playing golf and spending quality time at the beach in Oak Island, NC with his family.

 

Session Details:

Interactive Session: Navigating the Impact of New Administration Policies on Clinical Trials

2025-04-02, 11:15 AM

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David Hufner
Senior Director, CVM & Pulmonary Hypertension, Johnson & Johnson Innovative Medicine

Advisory Board

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Bao Dinh
Global Development Business Operation, Takeda

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

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

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Nicholas McCudden

Head of OCT Events

+61 280 978 126

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Maya Hudson

Head of Production

+44 204540 7766

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Maya Hudson

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Sunny Saikia

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SPONSORSHIP ENQUIRIES

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

Nicholas McCudden

Head of OCT Events


+61 280 978 126

SPEAKER ENQUIRES

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

 

Maya Hudson

Head of Production


+44 204540 7766