Outsourcing in Clinical Trials Texas 2022

A unique event for the vibrant biopharmaceutical cluster in the region to network, collaborate and refine outsourcing strategies.

7 - 8

December

2022
  • Hilton Houston Plaza/Medical Center
  • Complimentary
  • Why attend?
  • Agenda
  • Speakers
  • Plan Your Visit
  • Sponsors
  • Media Centre
  • Contact Us

Why attend?

WHAT TO EXPECT FOR 2022?

The Outsourcing in Clinical Trials Texas event aims to be a solution-driven conference that allows Clinical Operations professionals to network with innovative vendors, hear cutting-edge content, and participate in interactive discussions. This year, expect to hear from industry leaders learn about future trends, and gain the most up-to-date information on new and upcoming disruptors.

100+

Attendees

10+

Exhibitors

18+

Speakers

75%

Attendees at Director+ level

100+

Attendees

10+

Exhibitors

18+

Speakers

75%

Attendees at Director+ level

See What It's All About

Agenda

  • 7 Dec 2022
  • 8 Dec 2022
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8 AM

Registration & Refreshments

8:50 AM

Chairman’s Opening Remarks

Speakers

9 AM

Keynote Address: Designing and developing trials that appeal to a wider patient population

  • Enhancing clinical research through government, industry, and advocacy efforts
  • Strengthen diversity and inclusion through engagement and collaboration with patients and their communities
  • Promoting strategies that connect with patients from various backgrounds and implementing health literacy principles to improve patient retention
  • Collaborating with patient advocacy groups and using their voices to engage others
  • Understanding the role decentralized trials play in patient recruitment; are they a help or hindrance?

Speakers

9:30 AM

Decentralized clinical trials and hybrid trials: What you need to understand to run these successfully

  • Key learnings from running DCT/hybrid trials so far
  • Points to consider designing your coming clinical trials using DCT processes and technologies
  • The building blocks in your DCT/hybrid trials

Speakers

10 AM

Looking to the Texas biopharma landscape: What does Texas lack in comparison to other biotech hotspots?

  • Is Texas equipped to support early and late drug development?
  • Is Texas too focused on the local community?
  • Should we look further afield, both nationally and globally to outsource?

Speakers

10:30 AM

Morning Refreshments & Networking

11 AM

Identify how rare disease studies are operationally different

  • Reviewing challenges associated with initiating rare diseases studies:

-Protocol development                                           -Study start up; regulatory and contracting                     -Workforce and staffing

  • Discussing expectation during study conduct and at closure

Speakers

11:30 AM

Biotech Market Performance and the Impact on Clinical Trials and Operations

  • Trends in clinical development across the globe over the last 5 years
  • Pre and post covid impact on the clinical trial global economy
  • Patterns in investment and clinical trial equity
  • Where do the opportunities lie for further acceleration in clinical development?

Speakers

12 PM

Panel Discussion: Optimizing trial success with your CRO: Relationship, management, and development

  • Ensuring that initial contact with CROs is clear and concise to confirm project specifications and deadline requirements
  • Investigating effective enrolment and retention techniques when collaborating with a CRO, as well as implementing consistent KPIs
  • Unlocking strategies for managing vendor and trial sponsor teams toward a common goal
  • Highlighting methods for getting back on track and re-building site relationships when commitments are not met
  • Exploring strategies for CRO selection; should we be outsourcing globally or locally?

Speakers

12:45 PM

Lunch

1:40 PM

Innovation Afternoon

1:45 PM

Disrupt or be disrupted: Embracing digital transformation in pharma

  • Why has digital transformation become a necessity
  • Current and future investment trends
  • Technologies to address clinical trials disruption
  • Barriers and obstacles to digital transformation
  • Necessities for digital transformation

Speakers

2:15 PM

Fireside Chat Hybrid vs decentralized trials: Considerations for a successful study

  • Navigating the challenges of retaining patients in innovatively designed virtual trials
  • Implementing wearable devices to hybrid and virtual trials and understanding the key considerations
  • How can we overcome the potential for missing reverse reactions while conducting fully virtual trials?
  • Do paperless trials have any technological flaws that need to be addressed?
  • Are hybrid trials and home health the future?

Speakers

3 PM

Afternoon Networking & Refreshments

3:30 PM

CASE STUDY: Harnessing the power of machine learning in identifying patient’s therapeutic reactions

  • Presenting a case study of bionformations and machine learning in immuno-oncology clinical trials
  • Looking at machine learning to improve targeted delivery
  • Accelerating the global understanding of the connections between cell and tissue organisation through general analysis and community-based projects/resources like HuBMAP
  • Understanding the interactions between cells in order to impact human health

Speakers

4 PM

Medical device spotlight: Recognising changes and guidelines

  • Understanding considerations needed when devising a clinical program
  • Navigating EUMDR and regulatory uncertainty
  • Exploring best practices for conforming to standards

Speakers

4:30 PM

Chairman’s Closing Remarks & Drinks Reception

8 AM

Registration and Refreshments

9 AM

Keynote Panel Discussion: How can we as a biotech community attract people and talent to the region?

  • Investigating strategies for attracting a diverse talent pool in manufacturing, pre-clinical and clinical research
  • Engaging with the local talent pipeline and focusing on employee development strategies
  • Highlighting the benefits of the Texas Biotech community in the recruitment process
  • Has Texas' business-friendly image been tainted by recent politics?

Speakers

10 AM

Women’s health fireside chat

This session will discuss the rise of Femtech, treatment development, and women’s underrepresentation in clinical trials. Covering:

  • Access to healthcare and clinical trials for women of all races and ethnicities
  • Accelerating patient recruitment for women in trial areas with higher disease prevalence
  • Supporting women’s health and rights prior and throughout the trial
  • How can we keep the momentum going and accelerate change and innovation in women’s health?

Speakers

10:30 AM

Morning Refreshments & Networking

11 AM

Navigating the supply chain within clinical studies

  • Examining the supply chain more thoroughly and understanding the significance of scaling up and early supply chain involvement
  • How can we use blockchain and technology in the supply chain?
  • What changes will be required in the supply chain to support the growth of decentralised clinical trials?

Speakers

11:30 AM

Q&A: Pediatric clinical trial and drug development spotlight

  • Looking at the history of pediatric drug development
  • A recap of the three key laws governing pediatric medication research
  • • Exploring mapping tools discussed in the US and EU

Speakers

12 PM

Lunch & Networking

1:15 PM

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 runs for 45 minutes and delegates have an opportunity to take part on 2 roundtables

RT1 – A discussion of the issues in the clinical trial landscape post-COVID: How long will the pandemic’s effects be felt?

Aryn Knight, BS, CCRP – Associate VP Clinical Research – Clinical Innovation and Research Institute

RT2 – Oncology clinical trials: Considerations when choosing and working with a CRO

Anastasia Gutierrez – Vice President Clinical Operations – Immuneering Corporation

RT3 – Building a clinical program strategy for your medical device

Tien Dang – Manager of Clinical Affairs – Aerin Medical

RT4 – How do we move from clinical to commercial?

Dave Malenfant – Director, Outreach & Partnerships – Center for Supply Chain Innovation, Neeley School of Business

2:45 PM

Close of Conference

Speakers

Select a speaker to learn more

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HEATHER GILES
CSO & CEO, Vapogenix

Dr. Giles has been President, CEO and Director of Vapogenix since July 2017. She joined Vapogenix in 2009 as Chief Scientific Officer and has provided scientific and drug development leadership, in addition to making significant contributions to overall company strategy and to successful fundraising. Dr. Giles has held international leadership positions in large and small pharmaceutical companies and has wide experience in drug discovery and development from target validation, through clinical studies to final regulatory submission. She recently led Vapogenix through the successful completion of a Phase II clinical trial in Australia.

Session Details:

Session reserved for Novotech

2022-12-07, 11:30 AM

Session Details:

Panel Discussion: Optimizing trial success with your CRO: Relationship, management, and development

2022-12-07, 12:00 PM

Session Details:

Session reserved for Sponsorship

2022-12-07, 11:45 AM

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Bonnie Bain, PhD
Global Head And Executive Vice President Of Healthcare Operations And Strategy, GlobalData Healthcare

Bonnie Bain, PhD, is the Global Head and EVP of Healthcare Operations and Strategy. Bonnie has over 20 years’ experience in the healthcare sector and a proven track record of developing innovative solutions on both the client and agency sides of the business. Bonnie was GlobalData Healthcare’s first Western analyst, and under her leadership, the company launched a number of premium syndicated reports, analytical tools, and databases in the pharmaceuticals and medical devices space. Prior to GlobalData, Bonnie was Vice President and Global Research & Analysis Director for Informa’s Pharma Division, which includes Datamonitor Healthcare, Scrip Group, and Business Insight. Bonnie also worked for several years at Decision Resources as an Analyst and Project Manager. On the client side of the industry, Bonnie worked for several years as a Senior Manager in Marketing Strategy and Analytics at Boston Scientific, where her work contributed to the successful commercialization of the first ever Access and Visualization Platform at the company. Bonnie has a PhD in Biochemistry and Molecular Biology from Purdue University and completed a Post-Doctoral Fellowship in Molecular Pharmacology at the University Of Miami School Of Medicine. She also has a graduate certificate in Applied Management Principles from Purdue University Krannert School of Management.

Session Details:

Chairman’s Opening Remarks

2022-12-07, 8:50 AM

Session Details:

Disrupt or be disrupted: Embracing digital transformation in pharma

2022-12-07, 1:45 PM

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ANASTASIA GUTIERREZ
Director, Clinical Operations, Bellicum Pharmaceuticals

Anastasia Gutierrez is a Director, Clinical Program Management at Bellicum Pharmaceuticals, where she is managing the execution of Adaptive Cell Therapy programs including timelines, deliverables, scope, risks and budget. Anastasia has almost 20 years of clinical research experience, with a focus on early phase oncology studies. Prior to joining Bellicum, Anastasia spent a number of years on the CRO side of industry where she managed a number of global Phase I-IV studies across Americas, Europe, Middle East, Africa and Asia/Pacific Rim. She is a native of Russia and has her medical degree from Smolensk State Medical Academy. She came to the US in 2003 and settled in the Houston area, where she currently lives with her family

Session Details:

Session reserved for Novotech

2022-12-07, 11:30 AM

Session Details:

Panel Discussion: Optimizing trial success with your CRO: Relationship, management, and development

2022-12-07, 12:00 PM

Session Details:

Session reserved for Sponsorship

2022-12-07, 11:45 AM

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DR IKE OGBAA
US Medical Affairs Lead, Sanofi,

Ike Ogbaa, MD is currently the US Medical Affairs Lead for New Products and Integrated Diabetes Care at Sanofi. His current role is to develop the US medical affairs strategy for Sanofi’s pipeline of New Diabetes Drugs, Devices and Digital health Solutions. He has extensive experience throughout the Pharmaceutical value chain in Clinical Pharmacology, Drug Development, Field-based Medical Affairs and Home-Office Medical affairs. He has worked for a CRO, small biotech and 2 large Pharma companies.

Session Details:

Keynote Address: Designing and developing trials that appeal to a wider patient population

2022-12-07, 9:00 AM

Session Details:

Registration and Refreshments

2022-12-07, 8:00 PM

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RICARDO JIMENEZ
Senior Vice President, Technical Operations, Neurogene

Experienced Operations Management with a background in Quality Assurance in the pharmaceutical and biotech industry with a focus on Regenerative Medicines.

Session Details:

Keynote Panel Discussion: How can we as a biotech community attract people and talent to the region?

2022-12-08, 9:00 AM

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AUNDRIETTA DUNCAN
Director, Non-Clinical Development, Salarius Pharmaceuticals

Session Details:

Looking to the Texas biopharma landscape: What does Texas lack in comparison to other biotech hotspots?

2022-12-07, 10:00 AM

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ASHLEY INNES
Regional Director-HIV Community, Gilead Sciences

Motivated and passionate leader with a proven ability to build relationships, lead and develop people, manage projects, and produce outcomes. Creates opportunities to further drive business and improve lives through public health education and resources. Extensive experience in HIV/AIDS, mental health, and community engagement. In addition is highly skilled in public speaking and persuasive writing. Passionate about social justice and creating a diverse and inclusive environment for all people. Consistent history of top performance and excellence in leadership as shown through my various career achievements and awards.

Session Details:

Keynote Address: Designing and developing trials that appeal to a wider patient population

2022-12-07, 9:00 AM

Session Details:

Registration and Refreshments

2022-12-07, 8:00 PM

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KELLI L. JONES, MS
Senior Local Trial Manager , Janssen Pharmaceuticals

Kelli is a dynamic and skilled Clinical Trial Manager with 12 years of Pharmaceutical/CRO industry experience with extensive knowledge of clinical monitoring, trial management (regionally and globally), and trial operations from start-up to close out. Talents include exceptional leadership, organizational and analytic skills, highly adaptable to multiple demands and shifting priorities, collaborative with cross-functional teams and key stakeholders, and exhibit keen oversight of external vendors.

Session Details:

Keynote Panel Discussion: How can we as a biotech community attract people and talent to the region?

2022-12-08, 9:00 AM

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TIEN DANG
Manager Of Clinical Affairs, Aerin Medical

Passionate clinical researcher experienced in biopharmaceutical, IVD and medical device industries. Therapeutic Areas: CNS, Infectious Diseases, Aesthetics/Dermatology, Neurovascular, ENT.

Next speaker
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EZINNEKA IMOH
Senior Manager, Scientific Communications, Karyopharm Therapeutics

Session Details:

Keynote Panel Discussion: How can we as a biotech community attract people and talent to the region?

2022-12-08, 9:00 AM

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SOMER BABUREK
MBA - CEO, Hera Biotech

Somer is the CEO of Hera Biotech developing and commercializing the world's 1st non-surgical test for definitive diagnosis and staging of endometriosis. An achievement oriented strategic thinker with strong communication, presentation and interpersonal skills. Adept at building and maintaining close relationships with key stakeholders. Ability to work in all levels of an organization with a desire to find opportunities for improvement.

Session Details:

Women’s health fireside chat

2022-12-08, 10:00 AM

Session Details:

Session reserved for Sponsorship

2022-12-08, 9:45 AM

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Dave Malenfant
Executive Vice-President, Industry Liaison | Director, Center For Supply Chain Innovation, BSMA (Biotech Supply Management Alliance) | Neeley School Of Business, TCU (Texas Christian University)

Dave is recognized for the creative development of standardized systems and business processes, and for developing enabling technology throughout the entire supply chain. During his career, Dave has implemented over 30 different computer systems – WMS, ERP, Finite Scheduling, Product Launch, and Order Entry, among others. Dave is past Chairman of the Supply Chain Council and past member of the Executive Committee of NASSTRAC. Dave is currently Executive Vice President of Industry Liaison and Talent Development for the BSMA (Biotech Supply Management Alliance). In 1993, Dave joined Alcon Laboratories where he steadily advanced through leadership roles such as Purchasing Manager, Materials Operation Manager, and Global Supply Chain Director before becoming the Vice President of Global Supply Chain in 2005. In this role, Dave provided strategic direction for the company’s Global Supply Chain initiatives and created global centers of excellence for Purchasing, Distribution, Transportation, Customer Service, Sales and Operations Management, Data Management, Graphic Design and Artwork Development, and Product Launches. Dave retired from Alcon in 2014.

Session Details:

Navigating the supply chain within clinical studies

2022-12-08, 11:00 AM

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ARYN KNIGHT BS, CCRP
Associate VP Clinical Research, Memorial Hermann Health System

A certified clinical research professional with more than 20 years of direct experience in clinical research within a large Academic Medical Center, private practice and hospital environments. Aryn's experience includes: clinical research operations and administration, research compliance and oversight, protocol development, IRB submission and all regulatory maintenance, research coordination, grant writing and submissions, budget development, supervision and training of other research coordinators, site perspective of TMF and proficient knowledge of research regulations in FDA/GCP/ICH guidelines. Aryn possess excellent project, regulatory management and coordination skills; effective management proficiency of multi-protocol research from development to finalization. Aryn have great enthusiasm for my chosen field, pride in work standards, and the ability to translate enthusiasm into concrete, positive results.

Session Details:

Fireside Chat Hybrid vs decentralized trials: Considerations for a successful study

2022-12-07, 2:15 PM

Session Details:

Speaker Hosted Roundtables

2022-12-07, 2:15 PM

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INSIYA JAFFERJI
Senior Research Scientist, MD Anderson Cancer Center

Insiya has a PhD from the University of Cambridge, England (Immunology NK cell research), Postdoctoral, Biotech and Clinical Research experience. Over 10 years of laboratory experience and strong research background and knowledge in the fields of virology, immunology (NK and T cell research) and oncology research with 8 peer reviewed published papers. Experience in coordinating clinical trials and overseen the startup and continuation of 15 clinical trial protocols simultaneously in a Phase I Cancer Program. Strong communication skills and the ability to explain complex technical information in simple language in order to facilitate user understanding and learning.

Session Details:

CASE STUDY: Harnessing the power of machine learning in identifying patient’s therapeutic reactions

2022-12-07, 3:30 PM

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ANDREA WILEY
Senior Scientist, Ridgeline Therapeutics

Session Details:

Session reserved for Novotech

2022-12-07, 11:30 AM

Session Details:

Panel Discussion: Optimizing trial success with your CRO: Relationship, management, and development

2022-12-07, 12:00 PM

Session Details:

Session reserved for Sponsorship

2022-12-07, 11:45 AM

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CARLOS RODRIGUEZ-GARCIA
Director Of Operations Support, AstraZeneca

Results-oriented Professional in Medical Device & Pharmaceutical industries with experience in ERP, Lean-Six Sigma, Configuration Specification and Integration Testing, Investigations (CAPA System), Complaints Investigations and Management, Regulatory Agency Audits, Technology Transfer and Startups, Design Controls, Customer Field Support, Operations and Validation focusing on compliance withwith FDA and International regulations and voluntary standards in an environment of continuous improvement and safety.

Session Details:

Keynote Panel Discussion: How can we as a biotech community attract people and talent to the region?

2022-12-08, 9:00 AM

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SERPIL TUTAN, MBA
Director, Clinical Research , Baylor College Of Medicine

Serpil Tutan is a Director of Clinical Research at the Research Resources Office, Baylor College of Medicine/Texas Children’s Hospital. She has more than 24 years of nursing and clinical research experience. Some of her current responsibilities include, protocol development, feasibility reviews, budget negotiations, and direct oversight of the clinical trial finance, regulatory and QA/QC teams. She had successfully completed institutional launch of the Clinical Trial Management System, financial module at Texas Children’s Hospital. One of her passions is protocol development and project management for all aspects of investigator initiated and/or rare disease trials.

Session Details:

Bringing ideas into action: Transforming therapeutics and through innovation

2022-12-07, 4:15 PM

Session Details:

Identify how rare disease studies are operationally different

2022-12-07, 11:00 AM

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ALEXIS MOBLEY
Global Regulatory Affairs, Janssen Pharmaceuticals

Dr. Alexis S Mobley completed her PhD in Neuroscience and Immunology at the University of Texas MD Anderson Cancer Center UTHealth Graduate School of Biomedical Sciences. She is currently a postdoctoral fellow at Janssen Pharmaceuticals in Global Regulatory Affairs, where she supports the Immunology therapeutic area focused on pediatric studies, combination devices, and novel cytokine inhibitors. Alexis is also President, Treasurer, and a co-founder of Black in Immuno, a non-profit organization focused on celebrating, amplifying, and supporting Black voices in immunology. Alexis enjoys mentoring students, working on effective scientific communication, and advocating for underrepresented groups. Outside of the work, she serves on the Board of Directors and sings for International Voices Houston, a non-profit organization that uses choral singing to “create global harmony by celebrating and giving voice to human difference.” As hobbies, Alexis likes to read, play video and board games, and spend time with her family comprising her child and rescue dog, Izzy.

Session Details:

Q&A: Pediatric clinical trial and drug development spotlight

2022-12-08, 11:30 AM

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RUBA SARRIS SAWAYA
Former Executive Vice President Clinical Affairs , DJO

High performance executive with extensive experience leading the development & execution of effective strategies across the healthcare sector.

Session Details:

Medical device spotlight: Recognising changes and guidelines

2022-12-07, 4:00 PM

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Casey Kappenman
Administrative Director Texas Heart Institute

Casey Kappenman an Administrative Director who works with physicians, scientists and visionary leaders who push the boundaries of medicine through clinical research. Today’s clinical trials are more complex, making efficient research operations essential. To run an efficient research enterprise, interactions between the people, processes, and technologies are key, as operational transformation cannot be achieved through technology alone. It takes a holistic approach to ensure technology improves the processes employees depend on to get work done. With 15+ years of clinical research operations experience, Casey strategically addresses today’s research business challenges by applying methods such as workflow analysis and change management to new operational research technologies (CTMS, eRegulatory, ePayments, databases, etc). Casey holds a B.S. in Applied Health and a M.S. in Applied Biomedical Informatics from the University of Texas Health Science Center in Houston. He is certified by the Association of Clinical Research Professionals and is a member of the American Medical Informatics Association.

Session Details:

Fireside Chat Hybrid vs decentralized trials: Considerations for a successful study

2022-12-07, 2:15 PM

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Sverre Bengtsson
Co-Founder Viedoc Technologies

Sverre Bengtsson started in the clinical trials industry over 30 years ago. He started as a statistician/statistical programmer, later into data management and since over 20 years into business development. He has been working in both CRO’s as well as in clinical trials technology companies, including the global first ePRO company. Sverre is very interested in making clinical trials efficient, in both study design but also in the processes and technologies used. Sverre co-founded Viedoc Technologies 19 years ago and is responsible for some of the major accounts but also the vision around the company. He’s on the board of both some industry organisations and in clinical technology companies.

Session Details:

Decentralized clinical trials and hybrid trials: What you need to understand to run these successfully

2022-12-07, 9:30 AM

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Craig Leach
Senior Business Development Manager, West Coast Novotech

Session Details:

Biotech Market Performance and the Impact on Clinical Trials and Operations

2022-12-07, 11:30 AM

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TRACY R. WILSON, DNP, MSN.ED., RN, FNP-C
Director, Field Medical, Anti-Infectives, Southwest Region , Pfizer

Tracy is an accomplished Health Equity Advocate, Diversity and Inclusion Champion, and highly driven Field Medical Director . Tracy is passionate about reducing health care disparities & improving patient outcomes by developing marketing strategies & educational tools to enhance the knowledge of HCPs & patients for BIPOC communities. Tracy experience includes almost 6 years in medical affairs and a 20 + year nursing/NP career which has allowed her to excel at leveraging scientific and clinical expertise to serve as a value-added resource for cross-functional teams such as sales, training, and marketing.

Session Details:

Session reserved for Novotech

2022-12-07, 11:30 AM

Session Details:

Panel Discussion: Optimizing trial success with your CRO: Relationship, management, and development

2022-12-07, 12:00 PM

Session Details:

Fireside Chat Hybrid vs decentralized trials: Considerations for a successful study

2022-12-07, 2:15 PM

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Next speaker
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Shirley Asemota
Clinical Monitoring Lead Ipsen Bioscience

Session Details:

Women’s health fireside chat

2022-12-08, 10:00 AM

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Plan Your Visit

Hilton Houston Plaza/Medical Center

Hilton Houston Plaza/Medical Center, 6633 Travis St, Houston, TX 77030, Houston, United States of America

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Hilton Houston Plaza/Medical Center

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Exhibitors

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What to Expect for 2022?

The Outsourcing in Clinical Trials Texas event aims to be a solution-driven conference that allows Clinical Operations professionals to network with innovative vendors, hear cutting-edge content, and participate in interactive discussions.

 

This year, expect to hear from industry leaders learn about future trends, and gain the most up-to-date information on new and upcoming disruptors.

See What It's All About

Enquiry

Contact Us

SPONSORSHIP ENQUIRIES

Nick McCudden

Head of OCT Events

+61 280 978 126

SPEAKER ENQUIRIES

Megan Gleave

Conference Producer

+44 20 4540 7727

MARKETING ENQUIRIES

Katie Giorgadze

Marketing Manager

+44 (0) 207 936 6521

SPONSORSHIP ENQUIRIES

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

Nick McCudden

Head of OCT Events


+61 280 978 126

SPEAKER ENQUIRES

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

Megan Gleave

Senior Conference Producer


+44 20 4540 7727