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
  • Contact Us
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Why attend?

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

See What It's All About

Agenda

  • 1 Apr 2025
  • 2 Apr 2025
Expand All

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 - Team dynamics; recruitment & retention

 

Speakers

Stacey Curelop
Director of Clinical Operations, Mycovia Pharmaceuticals
Bianca Green
Senior Manager, Diversity Equity & Inclusion in Clinical Trials, Takeda

10 AM

Morning Refreshments & Networking

10:30 AM

Panel Discussion Clinical Partnerships; transition and growth post pandemic

  • 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

View In Agenda
Next speaker
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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

View In Agenda
Next speaker
Back
Gabriela Feldberg
Head of Portfolio Strategy, Evinova part of AstraZeneca

Session Details:

Panel Discussion Clinical Partnerships; transition and growth post pandemic

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

View In Agenda
Next speaker
Back
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

View In Agenda
Next speaker
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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

View In Agenda
Next speaker
Back
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

View In Agenda
Next speaker
Back
Marina Acosta Enslen
Director, Clinical Operations, Grifols

Session Details:

Panel Discussion Clinical Partnerships; transition and growth post pandemic

2025-04-02, 10:30 AM

View In Agenda
Next speaker
Back
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

View In Agenda
Next speaker
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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

View In Agenda
Next speaker
Back
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

View In Agenda
Next speaker
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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

View In Agenda
Next speaker
Back
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 post pandemic

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

View In Agenda
Next speaker
Back
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

View In Agenda
Next speaker
Back
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

View In Agenda
Next speaker
Back
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 enhancing diversity in clinical trials and she has worked closely with Advocacy groups in both Rare Diseases and Oncology. 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

View In Agenda
Next speaker

Advisory Board

Select a member to learn more

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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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Plan Your Visit

Venue

Embassy Suites by Hilton Raleigh Durham Research Triangle

201 Harrison Oaks Boulevard, Cary, NC 27513 USA

Accommodation

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2025 Sponsors

Select a sponsor to learn more

Featured Sponsor

Session Sponsors

Drinks Reception Sponso

Associate Sponsor

Exhibitors

Presentations

Why partner?

Contact us to become a partner

Partnership Opportunities

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

 

Take a look at our current sponsors

Resources

       
       
   

Media Centre

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A FANTASTIC NETWORK OF YOUR PEERS AND COLLEAGUES

Simply register, login on the day and get ready to connect and learn.

See What It's All About

Enquiry

Contact Us

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