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
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • 2025 Sponsors
  • Media Centre
  • Presentations
  • Why partner?
  • Resources
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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

Worldwide is changing how the world experiences CROs – in the best possible way. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence, Worldwide Clinical Trials provides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies.

Company Website

To learn more, please visit our website - https://www.worldwide.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 innovative site and sponsor technology, and the pioneer in clinical research experience software. Our depth of technology and people expertise combine to deliver solutions that enable the collaboration, transparency, and speed required to optimize trial operations and ensure patient safety.

Company Website

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/

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    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

    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

    9:45 AM

    Reserved for featured sponsor

    10:15 AM

    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

    10:45 AM

    Morning Refreshments & Networking

    11:15 AM

    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

    Deborah Waltz
    Vice President, Head of Quality, Cullinan Therapeutics
    Sharri Adams-Edwards
    Senior Director, Clinical Operations, Adverum Biotechnologies, Inc

    12 PM

    Reserved for event sponsor

    12:30 PM

    Journey to Better Health Mobile Education Unit

    • Sustaining community outreach and engagement to align with FDA Diversity Action Plan (DAP) requirements
    • 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

    1 PM

    Lunch and Networking

    2 PM

    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?

    Moderator: Gabriela Feldberg, Head of Portfolio Strategy, Evinova part of AstraZeneca

    Speakers

    Gabriela Feldberg
    Head of Portfolio Strategy, Evinova part of AstraZeneca
    Bianca Green
    Senior Manager, Diversity Equity & Inclusion in Clinical Trials, Takeda
    Ros Cheetham
    Vice President of Clinical Operations, MacroGenics

    2:45 PM

    TECHNOLOGY SPOTLIGHT

    3 PM

    Clinical Data Management: Ensuring Quality and Integrity in Clinical Trials

    Effective clinical data management (CDM) is essential for the success of clinical trials, ensuring that data is accurate, complete, and timely. This session will explore the key components of clinical data management, best practices for data collection and analysis, challenges faced by data managers, and emerging trends that are shaping the future of clinical data management.

    • Understand the key principles and processes of clinical data management in clinical trials.
    • Identify best practices for ensuring data quality and integrity throughout the trial lifecycle.
    • Explore common challenges faced in clinical data management and strategies to overcome them.
    • Discuss emerging trends and technologies impacting clinical data management, including data integration and real-time analytics.

     

    3:30 PM

    TECHNOLOGY SPOTLIGHT

    3:45 PM

    Afternoon Networking & Refreshments

    4:30 PM

    Reserved for event sponsor

    5 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
    Senior Manager, Diversity Equity & Inclusion in Clinical Trials, Takeda

    5:30 PM

    Chair’s Closing Remarks & Drinks Reception

    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 to Ensure Study Success
    Stacey Curelop, Director of Clinical Operations, Mycovia Pharmaceuticals

    RT2 - DEI
    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
    Senior Manager, Diversity Equity & Inclusion in Clinical Trials, Takeda
    Ros Cheetham
    Vice President of Clinical Operations, MacroGenics

    10 AM

    Morning Refreshments & Networking

    10:30 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

    Moderator: Robert Loll, SVP, Business Development, Praxis Communications

    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 AM

    Reserved for event sponsor

    11:30 AM

    FIRESIDE CHAT Integration of Data science into clinical trial execution

    • Trial planning
    • Productivity – planning clinical trials through the lens of productivity
    • Site distribution planning; considering costs

    Moderator: Robert Loll, SVP, Business Development, Praxis Communications

    Speakers

    Robert Loll
    SVP, Business Development, Praxis Communications
    Nicole Turner
    Senior Director, Oncology Data Science and Digital Health, The Janssen Pharmaceutical Companies of Johnson & Johnson

    12 PM

    Reserved for event sponsor

    12:30 PM

    Networking Lunch

    1:30 PM

    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
    • Creating a meaningful path forward to promote seamless outsourcing

    Speakers

    Jennifer D. Hart
    Executive Director, Operations, Evecxia Therapeutics

    2 PM

    Reserved for event sponsor

    2:30 PM

    US Biosecure Act and its impact on the Pharmaceutical Industry

    • History of and rationale for the Biosecure act
    • Chinese companies potentially affected
    • BioSecure Act Scope and impact
    • US pharma industry reliance on Chinese CROs and CDMOs to advance research
    • Risk assessment for companies with ongoing drug development activities with a Chinese CRO/CDMO

    Speakers

    Matthew Barnes
    Director Portfolio Management, Virpax Pharmaceuticals

    3 PM

    Afternoon Networking & Refreshments with Prize Draw at 3:30

    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 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?

    Moderator:
    Robert Loll, SVP, Business Development, Praxis Communications

    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

    5 PM

    Chair’s Closing Remarks

    Close of Conference

    Speakers

    Select a speaker to learn more

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    Bianca Green
    Senior Manager, Diversity Equity & Inclusion in Clinical Trials, Takeda

    Session Details:

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

    2025-04-01, 2:00 PM

    Session Details:

    Speaker Hosted Roundtables

    2025-04-02, 9:00 AM

    Session Details:

    Diversity and Inclusion in Clinical Trials

    2025-04-01, 5:00 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:

    Journey to Better Health Mobile Education Unit

    2025-04-01, 12:30 PM

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    Deborah Waltz
    Vice President, Head of Quality, Cullinan Therapeutics

    Session Details:

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

    2025-04-01, 11:15 AM

    Session Details:

    Site Selection and Setting Them up for Success

    2025-04-01, 10:15 AM

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    Gabriela Feldberg
    Head of Portfolio Strategy, Evinova part of AstraZeneca

    Session Details:

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

    2025-04-02, 10:30 AM

    Session Details:

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

    2025-04-01, 2:00 PM

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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, 1:30 PM

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

    Session Details:

    PANEL Choosing an outsourcing model: FSO vs FSP vs inhouse

    2025-04-02, 4:15 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

    2025-04-02, 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, 10:30 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:

    US Biosecure Act and its impact on the Pharmaceutical Industry

    2025-04-02, 2:30 PM

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

    Session Details:

    PANEL Choosing an outsourcing model: FSO vs FSP vs inhouse

    2025-04-02, 4:15 PM

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    Nicole Turner
    Senior Director, Oncology Data Science and Digital Health, The Janssen Pharmaceutical Companies of Johnson & Johnson

    Session Details:

    FIRESIDE CHAT Integration of Data science into clinical trial execution

    2025-04-02, 11:30 AM

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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, 4:15 PM

    Session Details:

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

    2025-04-02, 10:30 AM

    Session Details:

    Chair’s Opening Remarks

    2025-04-01, 8:50 AM

    Session Details:

    FIRESIDE CHAT Integration of Data science into clinical trial execution

    2025-04-02, 11:30 AM

    Session Details:

    Chair’s Opening Remarks

    2025-04-02, 8:50 AM

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    Sharri Adams-Edwards
    Senior Director, 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, 11:15 AM

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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, 4:15 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, 2:00 PM

    Session Details:

    Speaker Hosted Roundtables

    2025-04-02, 9:00 AM

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

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

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

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    We work with you to design a bespoke package to meet your business needs, where you could:

    • Demonstrate your expertise on the agenda – have the attention of the entire audience. For greatest impact, why not position your talk before a networking break and immediately conduct follow up conversations with highly engaged attendees
    • Showcase your business and its services at an exhibition booth, which provides a perfect meeting place for prospective new clients
      Present the value proposition of your offering over your competitors, in front of an audience of active, engaged potential customers
    • Speak with key decision makers as part of our intimate, interactive roundtable style workshop sessions with over 8 hours allowed for networking

    Event reach

    • 150+ attendees each year
    • 80% attendees C-suite level

     

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    SPONSORSHIP ENQUIRIES

    Nicholas McCudden

    Head of OCT Events

    +61 280 978 126

    SPEAKING OPPORTUNITIES

    Maya Hudson

    Deputy Head of Production

    +44 204540 7766

    MARKETING ENQUIRIES

    Moona Popal

    Marketing Manager

    DELEGATE ENQUIRIES

    Sunny Saikia

    VIP Delegate Manager

    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

    Deputy Head of Production


    +44 204540 7766