15th Annual Outsourcing in Clinical Trials Southeast 2026

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

10 - 11

March

2026
  • Embassy Suites by Hilton, Durham/Raleigh Research Triangle, NC, USA
  • Complimentary
  • Agenda
  • Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • 2026 Sponsors
  • Media Centre
  • Presentations
  • Why partner?
  • Resources
  • Contact Us
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2026 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 - https://www.iconplc.com/sectors/biotech

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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

Almac Group is a global leader in providing a range of expert services and support across the drug development lifecycle.

We are trusted experts in R&D, diagnostic services, API manufacture, formulation development, clinical trial supply services and technologies through to commercial-scale manufacture and distribution.

We are recognised as an industry leader in client service, providing understanding, experience and knowledge to our clients as we work together to advance human health.

Almac is trusted by the leading global biopharma companies to provide crucial services across their drug development projects. In the last 5 years alone, we have contributed to over 50% of all FDA approved New Molecular Entities (NMEs) and are currently supporting 30% of EU approved /pre-registered Gene therapy products.

A privately owned organisation, Almac has grown organically over the past five decades, employing over 7,700 highly skilled employees across 18 facilities in Europe, North America, and Asia. Learn more about us at https://www.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 breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials. Advarra is number one in research review services, a leader in site and sponsor technology, and is trusted by the top 50 global biopharma sponsors, top 20 CROs, and 50,000 site investigators worldwide. Advarra solutions enable collaboration, transparency, and speed to optimize trial operations, ensure patient safety and engagement, and reimagine clinical research while improving compliance.

For more information, visit – 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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    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

    • 10 Mar 2026
    • 11 Mar 2026
    Expand All

    8 AM

    Registration & Refreshments

    8:50 AM

    Chair’s Opening Remarks

    9 AM

    Improving efficiency and quality of clinical trials with support of multi agent AI systems

    • Highlighting the fast-evolving development of multi-agent AI tools available
    • Using humanoid robots to carry out motion-based tasks in the laboratory and the workplace
    • Understanding how multi-agentic systems can support and improve different phases, operations, and processes of clinical trials
    • Improving the design, enrolment, execution, analysis, results, and reporting in clinical trials with multi-agent systems

    Speakers

    Ed Addison
    Co-Founder and Chairman, Cloud Pharmaceuticals

    9:30 AM

    Reserved for event sponsor

    10 AM

    Transforming sponsor-CRO partnerships for clinical trial success

    • Defining evolving relationships between sponsors and CROs
    • Highlighting challenges and hurdles and how to overcome them
    • Creating trust and transparency to enhance partnerships
    • Outlining governance and oversight structures, working towards shared goals and KPIs

    Speakers

    DeAnn Hyder
    Associate Director, Clinical Data Management And Programming, Kronos Bio

    10:30 AM

    Morning refreshments and networking break

    11 AM

    Exploring outsourcing models to assess and determine best fit per trial

    • Reviewing outsourcing models from FSO, FSP and fully inhouse
    • Determining the best outsourcing model: pros, cons and assessment tips to consider
    • Selecting the right model and partners to fit your needs, optimizing cost and efficiency

    Speakers

    Ros Cheetham
    Vice President of Clinical Operations, MacroGenics

    11:30 AM

    Reserved for event sponsor

    12 PM

    Selecting the right vendor and negotiating the best deal for your study

    • Creating comparison process
    • Deciding and prioritising the most important criteria for study success
    • Negotiating the best deal to ensure only paying for what you need

    Speakers

    Marla Mills-Wilson
    Head of Clinical Operations, EmitBio

    12:30 PM

    Reserved for event sponsor (tech spotlight)

    12:45 PM

    Lunch and Networking

    2 PM

    Sharing insights to improve patient outreach and experience

    • Ensuring patient understanding of rights and informed consent
    • Reaching underserved communities and reducing enrolment stigma
    • Running trials more efficiently and effectively with patient burden in mindFatiha Adams

    Speakers

    Fatiha Adams
    Independent Patient Advocate

    2:30 PM

    Reserved for event sponsor (tech spotlight)

    2:45 PM

    Contracting sites for clinical trials: accelerating timelines

    • Creating site selection criteria and streamlining feasibility
    • Attracting an academic organization’s attention to prioritize your need
    • Considerations for contract negotiations and speeding up processing time scales
    • Building relationships and providing two-way support

    Speakers

    Jamie Kime
    Vice President, Clinical Operations & Procurement, Locus Biosciences

    3:15 PM

    Afternoon Networking & Refreshments

    3:45 PM

    Panel Discussion: Optimizing patient recruitment strategies

    • Selecting recruitment partners and collaborating with advocacy groups, patient organizations and care givers to extend patient reach
    • Communicating effectively and working together with sites to assist in recruitment
    • Complying with regulation across differing therapeutic areas
    • Finding innovative solutions to reduce patient burden

    Moderator: TBC

    Speakers

    Kimberly Futch
    Senior Director Clinical Operations, Mitsubishi Tanabe
    Charlene Knape
    Vice President, Clinical Affairs, NecteroMedical Inc

    4:30 PM

    Panel Discussion: Integrating AI and technology into clinical trials from different size company perspectives

    • What are key blockers and decision-making factors preventing or accelerating the use of AI
    • Where is it currently being used within the clinical trial lifecycle and how has it been implemented
    • What tools and systems are being used and how to select the right service provider
    • Overcoming barriers, sharing challenges and successes
    • Where do we see the evolvement of AI within clinical trials in 5-10 years time?

    Moderator: TBC

    Speakers

    Ed Addison
    Co-Founder and Chairman, Cloud Pharmaceuticals

    5:15 PM

    Chairperson’s closing remarks

    Networking drinks reception

    8 AM

    Registration and Refreshments

    8:50 AM

    Chair’s Opening Remarks

    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

    Roundtable 1: Creating effective clinical vendor strategies and partnerships
    Amanda Hovda, Director, Clinical Vendor Strategy and Partnerships, Agios Pharmaceuticals

    Roundtable 2: Sharing thoughts on diversity in clinical trials: how much focus remains on this?
    Deborah Waltz, Vice President Quality Assurance, Cullinan Therapeutics

    Roundtable 3: Running clinical trials inside or outside the USA: benefits and challenges
    Ros Cheetham, Vice President Clinical Operations, MacroGenics

    Roundtable 4: Creating a robust clinical trial design
    Nicole Leedom, VP Head of Clinical Operations, SpringWorks Therapeutics

    Roundtable 5: Discussing how individuals are utilizing AI in clinical trials
    Katherine Neblett, Global Program Director, AstraZeneca

     

     

    Speakers

    Amanda Hovda
    Director, Clinical Vendor Strategy and Partnerships, Agios Pharmaceuticals
    Deborah Waltz
    Vice President, Head of Quality, Cullinan Therapeutics
    Ros Cheetham
    Vice President of Clinical Operations, MacroGenics
    Nicole Leedom
    Vice President, Head of Clinical Operations, Spring Works Therapeutics
    Katherine Neblett
    Global Program Director, AstraZeneca

    10 AM

    Sharing a quickfire summary from each roundtable discussion

    10:10 AM

    Morning refreshments and networking break

    11:25 AM

    Collaborating with quality assurance to improve efficiency and compliance

    • Reducing barriers and highlighting benefit of QA cross departmental collaboration
    • Embedding QA input into outsourcing strategy, contracting and oversight
    • Working together with QA for risk mitigation and inspection readiness
    • Vendor selection audit strategy

    Speakers

    Kyle Davis
    GCP Quality Assurance, Peptilogics

    11:55 AM

    Case Study: Delivering and managing oversight of global clinical trials (Topic TBC)

    • Defining a global operational model aligned with program and regulatory objectives
    • Managing vendor oversight and fostering collaborative relationships
    • Ensuring delivery resilience amid complexity, variability and disruption
    • Embedding quality and compliance to ensure inspection readiness

    Speakers

    Matthew Failor
    Director, Head of Clinical Operations, MAIA Biotech

    12:25 PM

    Lunch, networking and prize draw

    1:40 PM

    Fireside Chat: Incorporating patient perspective in clinical development

    • Sharing patient experience through clinical trial case study examples
    • Considering hurdles and barriers for participants and what could be improved
    • Streamlining patient involvement, communication and processes to remove patient burden
    • Using technology within trials: when it helps or hinders

    Moderator: Rich Pelt, Senior Director Global Regulatory Sciences, Pfizer

    Speakers

    Rich Pelt
    Senior Director, Global Regulatory Sciences, Vaccines CMC, Pfizer
    Xaviette Pointer-Kincy
    Patient Advocacy Expert

    2:10 PM

    Fireside Chat: Managing vendor oversight successfully as a small company

    • Ensuring study goals and expectations are agreed and aligned
    • Monitoring budgets and dealing with additional costs
    • Sharing processes for managing oversight with limited resource

    Moderator: TBC

    Speakers

    Sharri H. Adams-Edwards
    Executive Director Clinical Operations, Adverum Biotechnologies
    Jesselle Simeon
    Director, Clinical Operations and Contracts Management, Adverum Biotechnologies, Inc

    2:40 PM

    Reimagining outsourcing models for radiopharmaceutical trials: Beyond the traditional CRO

    Speakers

    Fran Newark
    Senior Director Clinical Operations, Perspective Therapeutics

    3:10 PM

    Chairperson’s closing remarks

    3:15 PM

    END OF CONFERENCE

    Speakers

    Select a speaker to learn more

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    Sharri H. Adams-Edwards
    Executive Director Clinical Operations, Adverum Biotechnologies

    Session Details:

    Fireside Chat: Managing vendor oversight successfully as a small company

    2026-03-11, 2:10 PM

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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:

    Fireside Chat: Managing vendor oversight successfully as a small company

    2026-03-11, 2:10 PM

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    Amanda Hovda
    Director, Clinical Vendor Strategy and Partnerships, Agios Pharmaceuticals

    Session Details:

    Speaker Hosted Roundtables

    2026-03-11, 9:00 AM

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    Katherine Neblett
    Global Program Director, AstraZeneca

    Session Details:

    Speaker Hosted Roundtables

    2026-03-11, 9:00 AM

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    Ed Addison
    Co-Founder and Chairman, Cloud Pharmaceuticals

    For 30 years, I have been a serial entrepreneur, starting multiple tech companies. Today, I am adviser to startup companies and venture capital funds, including startups originating at universities. I am a partner in Spectacular Health Ventures, a newly forming venture firm and fund in 2020 that applies advanced technology and modern trends to disruptive health ventures. I am active on the boards of startup companies. I am Chairman of Cloud Pharmaceuticals, a leader in Artificial Intelligence based drug development, located in Research Triangle Park.

    I am also a part-time adjunct professor/lecturer of Entrepreneurship, Product Management and Engineering. To that end, my goal is to motivate engineering students to find their passion and create breakthrough products and ventures.

    I advise a number ventures including Drug Logic, Parallel Profile, and PolarisQB, as well as some emerging new starts that are under wraps. My approach to venture work is unique. I work for long periods of time incubating new venture projects, but I only work on high quality, promising opportunities.

    With a technical background in Artificial Intelligence, Bioinformatics and Software, and a business background in Life Sciences, Healthcare and SaaS, I started 7 companies, funded 5 of them and exited 3. I have twice been named "Entrepreneur of the Year" by different organizations. I have advised 7 venture capital funds and over 20 early stage ventures. I am a frequent public speaker on entrepreneurship, innovation and new venture work, as well as on Artificial Intelligence in Healthcare. I have an interdisciplinary technical background acquired through grad school, teaching at universities and advising technical startups. It includes AI, IT, bioinformatics and genomics, HPC, parallel and distributed computing, quantum computing, IoT and drug discovery. The Covid-19 period has shifted my focus to telemedicine, more AI-based drug discovery, and new methods of capital raising.

    I hold a BSEE from Virginia Tech, two MS degrees from Johns Hopkins, an MBA from Duke University, and an 'online' law degree from Concord Law School at Perdue University. I completed a sabbatical year at MIT in Artificial Intelligence. This eclectic educational background along with my multi-industry experience is uniquely suited to the entrepreneurship, innovation, startup and venture capital worlds, as well as university and industry roles in managing design, innovation programs, and partnerships. I stay current by reading approximately 500 pages per day.

    Session Details:

    Panel Discussion: Integrating AI and technology into clinical trials from different size company perspectives

    2026-03-10, 4:30 PM

    Session Details:

    Improving efficiency and quality of clinical trials with support of multi agent AI systems

    2026-03-10, 9:00 AM

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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:

    Speaker Hosted Roundtables

    2026-03-11, 9:00 AM

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    Marla Mills-Wilson
    Head of Clinical Operations, EmitBio

    Session Details:

    Selecting the right vendor and negotiating the best deal for your study

    2026-03-10, 12:00 PM

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    Jamie Kime
    Vice President, Clinical Operations & Procurement, Locus Biosciences

    Jamie Kime is the Vice President of Clinical Operations & Procurement at Locus Biosciences. Jamie is an experienced leader focused on the operational delivery of Phase 1 – 4 clinical studies through clinical service partnerships and providers. Prior to joining Locus, he spent 18+ years at UCB Pharma in multiple leadership positions including the Global Head of Clinical Project Management and the Global Head of Outsourcing, Contracts, and Strategic Partnerships. Over the course of his career, Jamie has held positions at the Sponsor, CRO and Clinical Site providing for a well-rounded approach to operational implementation and execution of clinical studies.

    Session Details:

    Contracting sites for clinical trials: accelerating timelines

    2026-03-10, 2:45 PM

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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:

    Speaker Hosted Roundtables

    2026-03-11, 9:00 AM

    Session Details:

    Exploring outsourcing models to assess and determine best fit per trial

    2026-03-10, 11:00 AM

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    Matthew Failor
    Director, Head of Clinical Operations, MAIA Biotech

    Session Details:

    Case Study: Delivering and managing oversight of global clinical trials (Topic TBC)

    2026-03-11, 11:55 AM

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    Kimberly Futch
    Senior Director Clinical Operations, Mitsubishi Tanabe

    Session Details:

    Panel Discussion: Optimizing patient recruitment strategies

    2026-03-10, 3:45 PM

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    Charlene Knape
    Vice President, Clinical Affairs, NecteroMedical Inc

    Charlene Knape is currently Vice President, Clinical Affairs at Nectero Medical. Charlene has more than 30 years of experience and leadership in key areas including Clinical Trials, Regulatory Affairs, Quality and Program Management. Along her career path Charlene has previously held various key positions including executive roles at both start-up and large corporations, including Inivata, Kiyatec, Becton Dickinson, Micell Technologies, LabCorp, EndoTex, Somnus covering a vast array of technologies focused on vascular medical device/drug combination products and the oncology personalized medicine diagnostic space.

    Session Details:

    Panel Discussion: Optimizing patient recruitment strategies

    2026-03-10, 3:45 PM

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    Fatiha Adams
    Independent Patient Advocate

    Session Details:

    Sharing insights to improve patient outreach and experience

    2026-03-10, 2:00 PM

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    Xaviette Pointer-Kincy
    Patient Advocacy Expert

    Session Details:

    Fireside Chat: Incorporating patient perspective in clinical development

    2026-03-11, 1:40 PM

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    Kyle Davis
    GCP Quality Assurance, Peptilogics

    Session Details:

    Collaborating with quality assurance to improve efficiency and compliance

    2026-03-11, 11:25 AM

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    Fran Newark
    Senior Director Clinical Operations, Perspective Therapeutics

    Session Details:

    Reimagining outsourcing models for radiopharmaceutical trials: Beyond the traditional CRO

    2026-03-11, 2:40 PM

    View In Agenda
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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:

    Fireside Chat: Incorporating patient perspective in clinical development

    2026-03-11, 1:40 PM

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    Nicole Leedom
    Vice President, Head of Clinical Operations, Spring Works Therapeutics

    Nicole Leedom has over 20 years of experience in clinical research with her primary focus being rare disease indications. She is currently VP, Head of Clinical Operations at SpringWorks Therapeutics, a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer. She joined this start-up biotech company at its inception in August of 2017 where she has spent the last five and half years building out and leading the clinical operations team, executing multiple clinical trials across many different programs. Prior to joining SpringWorks, Nicole had lengthy tenures at United Therapeutics and CROs working in positions of increasing responsibilities within clinical operations, also focusing in rare diseases.

    Session Details:

    Speaker Hosted Roundtables

    2026-03-11, 9:00 AM

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    DeAnn Hyder
    Associate Director, Clinical Data Management And Programming, Kronos Bio

    DeAnn is a thought leader in the application of analytics to support innovative clinical trial processes. She also has special experience in customer engagement, process models, data use, privacy and governance across therapeutic areas

    Session Details:

    Transforming sponsor-CRO partnerships for clinical trial success

    2026-03-10, 10:00 AM

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    Advisory Board

    Select a member to learn more

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    Dr Alison McMorn
    PH.D – VP, CLINICAL DEVELOPMENT, AMO PHARMA LTD

    Dr. McMorn is an experienced clinical development researcher with over 25 years of industry experience and has a strong focus in CNS and paediatric drug development. She has worked for both Pharmaceutical Companies and Contract Research Organisations including holding positions at SAR Monitoring Services Ltd, Mundipharma International Ltd and Shire Development Inc. Starting her career at SAR as a Clinical Research Associate (CRA) she subsequently moved to Mundipharma where she was responsible for initiating the first paediatric clinical research program for the company. At Shire Dr. McMorn led, planned and managed global paediatric and adult clinical development programs for a wide variety of indications including psychiatry, pain, gastrointestinal and hepatology across all phases of development (Phase 0 to Phase 4). In addition she was responsible for harmonizing Clinical Trial Administrator (CTA) working practices across all regions for the company. In 2015 Dr. McMorn joined AMO Pharma Ltd, a virtual pharmaceutical company focused predominantly on paediatric neurodevelopmental rare diseases, as VP of Clinical Development. She holds an undergraduate degree in Pharmacology and a PhD in Psychology from the University of Leeds, UK.

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    Behtash Bahador
    Senior Director, Community Engagement & Partnerships, CISCRP

    Behtash Bahador is the Senior Director of Community Engagement & Partnerships at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

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    Kathleen Cohen
    Vice President, Clinical Development, Marinus Pharmaceuticals

    Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

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    Aditya Kotta
    Head of Business Development, Novotech

    Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. He has extensive experience helping sponsor companies make their trials a reality across a range of projects from first in human to phase iv.

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    Martin Rodriguez
    Consumer Safety & Evidence Global Quality & Excellence Head, Sanofi

    Senior executive Leader in Life Science (Biochemist) and Lean/Six Sigma Green-belt certified, with more than 20 year of experience in clinical operations, Operational Excellence (i.e., operational strategy, performance management, process optimization, risk management, Quality-by-Design and team performance), clinical quality, and Service Providers / Outsourcing management.

    I developed, reengineered, automated, and optimized business processes with a risk-based and approach to produce high quality outputs and to ensure regulatory compliance. I led the development, implementation and monitoring of different operational and quality strategies and models including Outsourcing as well as new/ innovative clinical capabilities to fulfill consumers/ patients needs .

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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.

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    Edwin van Vulpen
    Executive Director and Head of Clinical Business Development Euro-Asia
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    SPONSORSHIP ENQUIRIES

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    Nicholas McCudden

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    +61 280 978 126

    SPEAKER ENQUIRES

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    Maya Hudson

    Head of Production


    +44 204540 7766