13th Annual Outsourcing in Clinical Trials Southeast 2024

The must attend clinical outsourcing event in the Southeast region where industry professional can encounter a platform to explore new solutions to common issues within their clinical trial

16 - 17

April

2024
  • Embassy Suites by Hilton, Durham/Raleigh Research Triangle, NC, USA
  • Complimentary
  • Why attend?
  • Agenda
  • Speakers
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  • Event Gallery
  • Sponsors
  • Media Centre
  • Presentations
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Why attend?

WHAT TO EXPECT FOR 2024?

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

  • 16 Apr 2024
  • 17 Apr 2024
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8 AM

Registration and Refreshments

8:50 AM

Chairman’s Opening Remarks

Speakers

Robert Loll
Senior Vice President, Business Development and Strategic Planning, Praxis

9 AM

Striving for improved education and awareness of patient population to progress trial diversity

  • Identifying community-based organizations that don’t typically participate in clinical trials and helping them to increase their capacity to execute a clinical trial
  • Understanding what mitigations and barriers these communities are experiencing
  • Exploring tactics and strategies to help these patient populations to overcome obstacles
  • Guidance on Diversity Plans to be submitted to FDA

Speakers

Bianca Green
Senior Manager, Diversity in Clinical Trials Lead, Takeda

9:30 AM

Maximizing the consultative partnership between CRO and pharma/biotech partners

  • How early engagement can improve outcomes
  • How do we speak the same language, no one size fits all approach
  • Simplifying the complex, in a world of overwhelming amount of outsourcing options and models

Speakers

Adrienne Stoudenmire
VP of Global Project Delivery, ICON Biotech

10 AM

How implementing innovative processes and technologies results in a more efficient use of human resources, reduces the amount of logistical resources required, saves money and lowers the carbon footprint impact.

  • Increasingly pharmaceutical companies are committing to reducing their carbon footprints in the execution of clinical trials.
  • A more efficient and effective clinical trial supply chain can be created by implementing new clinical supply technologies and sustainable processes.

Speakers

Tom Gottschalk
Vice President, Business Development, Mercalis

10:30 AM

Morning Refreshments & Networking

11 AM

Panel Discussion: Bringing the patient voice to clinical trial development: Current trends and future directions

  • Leveraging patient perspectives to better inform clinical trial design and execution
  • How is the industry approaching diversity and what should the primary focus be?
  • Levelling up relationships with patient advocacy groups
  • Reducing hesitancy and strengthening trust: the drive for strong reciprocal partnerships to improve clinical trial feasibility and efficiency

Speakers

Lysa Triantafillou
Senior Director, Quality Assurance, MindMed,Inc.
Lani Hashimoto
Associate Director, Patient Engagement Management, Novartis
Michael Hickey
Vice President, Clinical Operations, Bio-Path Holdings Inc
Ros Cheetham
Vice President of Clinical Operations, MacroGenics
Adrienne Stoudenmire
VP of Global Project Delivery, ICON Biotech
Robert Loll
Senior Vice President, Business Development and Strategic Planning, Praxis

11:45 AM

Site and Patient Perspectives on Decentralized Trials – How Can They Inform Operational Strategy?

  • We will share data collected from partner sites regarding attitudes towards decentralized trials – both positive and negative
  • We will discuss different patient perspectives on decentralized trials and how these can differ based on a number of factors
  • Finally, we will discuss how we can better operationalize decentralized trials by considering site and patient feedback

Speakers

Scott Palmese
Executive Director, Decentralized Clinical Trials, Worldwide Clinical Trials

12:15 PM

Uncovering the potential impact of large language models and generative AI on clinical trial efficiency to excel in drug development

  • Pushing for better data science, marketplace and aggregation services for improved data-driven decisions and data access
  • How to pick the right AI provider to match your needs?
  • Capitalizing off LLMs: will this be the future of regulatory reporting?
  • Boosting real-time data collection, multiple sites and trial enrollment with AI

Speakers

Ed Addison
Co-Founder and Chairman, Cloud Pharmaceuticals

12:45 PM

Lunch and Networking

1:45 PM

Protect your trials by better managing CRO consolidations

  • Helping small and mid-sized companies to anticipate and plan for CRO consolidation risks to better leverage negotiating agreements
  • Successfully mitigating the M&A risks to reduce impact on trial efficiency and timelines
  • Addressing the challenges consolidation brings for pharmaceutical companies: how to protect the clinical trials?
  • Finding pathways forward to ensure a seamless transition and avoid substantial disruption

Speakers

Jesse Kooker
Head Of Program Leadership & Alliance Management, Dermavant Sciences
Michael McLaughlin
Independent Clinical Program Consultant

2:15 PM

TECHNOLOGY SPOTLIGHT Oversight for All: Achieve data transparency with elluminate

Learn how the elluminate Clinical Data Cloud provides seamless access to comprehensive trial data across systems and sources. This presentation will showcase:

  • How a centralized data workbench eradicates data silos and provides near real-time access to data for optimized oversight and more efficient, data-driven decision making
  • AI/ML capabilities to ensure data quality, automated data review processes, and increased productivity across the clinical development lifecycle with eIQ Review
  • Proactive trial oversight and management with increased automation, comprehensive analytics, and custom visualizations in elluminate Operational Insights
  • Mitigating risk with efficiency, accuracy, and ease with holistic Risk-Based Quality Management

Speakers

Jason Konn
Solution Consultant, eClinical Solutions

2:30 PM

Outsourcing and vendor management from a small/emerging sponsor perspective

  • Grabbing the attention of CROs/key vendors from a small and mid-sized company perspective
  • Establishing criteria to select the best provider(s)/model to match your organization’s needs
  • Effectively managing the ecosystem of multiple vendors: balancing risk vs. ease of control, and driving assurance of delivery
  • What do sponsors need to know (and do) about vendor oversight
  • As biotech/emerging pharma’s needs evolve, so should the model: how to keep up?

Speakers

Ryan Hovda
Vice President, Vendor Strategy & Partnerships, BlueRock Therapeutics
Hilary Partin
CEO, Founder, Allegro Biopharma Associates

3 PM

TECHNOLOGY SPOTLIGHT – Reducing Trial Start-Up Time Through an Innovative Approach to Vendor Qualification

  • Exposing the inefficiencies of current vendor qualification practices and challenging the industry to adopt a proven process innovation that will help Sponsors onboard Providers more quickly leading to a real reduction in clinical trial start-up times.
  • Learn how embracing innovation, and adopting a risk-based data-driven approach to vendor management can help organizations become inspection ready in a heavily regulated industry.
  • Uncover the benefits of a centralized approach to vendor qualification that provides unique benefits to both Sponsors and Providers across the globe.

Speakers

Chris Casazza
Chief Commercial Officer, Diligent Pharma

3:15 PM

Afternoon Networking & Refreshments

3:45 PM

TECHNOLOGY SPOTLIGHT Addressing the Unmet Needs of Clinical Trials: A Senior Investigator’s Perspective

Site team responsibilities need to be less time and effort consuming.

PIs need to be more engaged and involved.

The patient’s HCP needs to be integrated.

Site/CRO/Sponsor communication needs to be improved.

“Underrepresented” patients need to be enrolled

Speakers

Gerald Minuk, MD
President and CEO, Refuah Solutions Ltd.

4 PM

New era of clinical trials in a conservative industry: A hybrid approach to DCTs

  • Evolution of clinical trials and need for decentralization
  • Regulatory compliance in decentralized clinical trials (DCT)
  • Qualification, oversight, and accountability of DCT vendors
  • Assurance of quality and consistency of critical study activities performed remotely
  • Maintaining control, accountability and subject privacy when delivering IP remotely
  • Managing challenges with subject engagement and study compliance
  • Ensuring control when things are out of your direct control

Speakers

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

4:30 PM

Designing trials to reduce patient and site burden

  • How to create a patient-centric clinical protocol to obtain the necessary data and validate your primary objective.
  • The importance of developing/applying tools and managing different stakeholders to pressure test our plans to have less complicated protocols.
  • The importance of creating a collaborative relationship with sites during protocol development targeting reducing patient burden.

Speakers

Jenny Higley
Director, Head of Feasibility CoE, Biogen

5 PM

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

8 AM

Registration and Refreshments

8:50 AM

Chair’s Opening Remarks

Speakers

Robert Loll
Senior Vice President, Business Development and Strategic Planning, Praxis

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 - What’s the best outsourcing model for you?

Hosted by Deborah Covington, Associate Director Global Procurement, Grifols

RT2 - Enabling AI tools to revolutionize the healthcare industry

Hosted by Pooja Mankani, Director of Cloud and Software Engineering, Bristol Myers Squibb

RT3 - Rethinking patient and site engagement to transform patient enrolment and retention

Hosted by Roger Nolan, President and Chief Operating Officer, Biokier

Speakers

Deborah Covington
Director Global Procurement, Grifols
Pooja Mankani
Director of Cloud and Software Engineering, Bristol Myers Squibb
ROGER NOLAN
President, BioKier,

10 AM

Morning Refreshments & Networking

10:45 AM

Panel Discussion Future proofing practice: Are your clinical trials ready for the modern world?

  • The business case for integrating digital technologies into clinical research
  • Elevating the level of patient care and innovative therapies to withstand future threats in the industry
  • Managing unprecedented global socio-economic issues and reducing the impact on trials
  • Innovative approaches to trial design and execution to reduce vulnerability of clinical trials

Moderator: Robert Loll, SVP of Business Development & Strategic Planning, Praxis

Speakers

Robert Loll
Senior Vice President, Business Development and Strategic Planning, Praxis
David Hufner
Senior Director, CVM & Pulmonary Hypertension, Johnson & Johnson Innovative Medicine
DeAnn Hyder
Associate Director, Clinical Data Management And Programming, Kronos Bio

11:15 AM

Development of mRNA Vaccines at Lightspeed… A regulatory perspective CMC Strategy for mRNA-LNP Vaccines: Challenges and Regulatory Considerations

The unprecedented stress that COVID-19 imposed on the global biopharmaceutical supply chain necessitated urgent action to implement flexible, but predictable, regulatory tools and approaches that allowed manufacturers to rapidly increase manufacturing capacity for the production of COVID-19 therapeutics and vaccines to meet global demand and avoid or mitigate drug shortages for non-COVID-19-related products, without compromising patient safety or product quality. This presentation tells the “story” of how the “impossible” was accomplished through rapid development and acceleration of production and global regulatory authorizations of Comirnaty and further suggests opportunities to provide benefits of vaccines earlier and more efficiently.

Speakers

Rich Pelt
Senior Director, Vaccines CMC Regulatory Affairs, Pfizer

11:45 AM

Regulatory aspects of digital health technology use in clinical trials

  • Definition of the Intended Use case is a critical prerequisite for the DHT regulatory assessment
  • DHTs should be fit for purpose -The required level of prior testing is greater for a primary/secondary endpoint compared to an exploratory endpoint
  • Risk mitigation of clinical, cybersecurity and privacy risks are required to ensure patient safety
  • Effective collaboration between the DHT Developer and Pharma Trial Sponsor is critical to ensure project success

Speakers

Michael J. Benecky
PhD, Senior Director, Global Regulatory Affairs – Devices, UCB Pharma

12:15 PM

Gaining confidence from gene therapy: How can we accelerate the development of gene therapies into life-changing treatments for patients

  • What is the long-term durability with gene therapy?
  • Lessons learnt from the DMD case - what’s being done for patient safety?
  • How are we educating sites, doctors and patients to provide the whole ecosystem with improved understanding of gene therapy?
  • Hear about BioMarin case studies focusing on real-world data
  • Choosing the right CRO for successful gene therapy product development

Speakers

Daniel Fitzgerald
Associate Director Global Study Operations, BioMarin Pharmaceutical Inc.

12:45 PM

Networking Lunch & Prize Draw

2 PM

Outsourcing your clinical supply chain and optimizing internal operations

  • Role of clinical supply chain in within the organization
  • Scalability and building an effective internal/external supply chain team
  • Strategies for outsourcing supply chain functions
  • Developing, maintaining, and implementing consistent and streamlined SOPs, business processes and infrastructure to improve departments effectiveness

Speakers

Gerry Crudden
Senior Director of Operations and Supply Chain, Checkpoint Therapeutics

2:30 PM

Clinical operations and inspection readiness considerations in complex gene therapy and rare disease trials

  • Role of clinical operations study lead in managing highly complex logistics of gene therapy and rare disease trials
  • Key considerations in understanding site and patient expectations
  • Best practices and tools for regulatory agency inspections

Speakers

Mohita Changela
Director, Clinical Operations, Ascidian Therapeutics

3 PM

Overview of 2023 Clinical Trials & Trends So Far for 2024

  • Top therapy area and indications for 2023 compared to other years
  • Geographical distribution: Who had the most trials in 2023 and why
  • Top sponsors for 2023 and what they have planned for the near future

Speakers

Scotty Chung-Siu
Senior Analyst, GlobalData Healthcare

3:30 PM

Chair’s Closing Remarks

Close of Conference

Speakers

Select a speaker to learn more

Back
Rich Pelt
Senior Director, Vaccines CMC Regulatory Affairs, Pfizer

Session Details:

Development of mRNA Vaccines at Lightspeed… A regulatory perspective CMC Strategy for mRNA-LNP Vaccines: Challenges and Regulatory Considerations

2024-04-17, 11:15 AM

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Next speaker
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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:

Uncovering the potential impact of large language models and generative AI on clinical trial efficiency to excel in drug development

2024-04-16, 12:15 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 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 Discussion: Bringing the patient voice to clinical trial development: Current trends and future directions

2024-04-16, 11:00 AM

View In Agenda
Next speaker
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Michael J. Benecky
PhD, Senior Director, Global Regulatory Affairs – Devices, UCB Pharma

Session Details:

Regulatory aspects of digital health technology use in clinical trials

2024-04-17, 11:45 AM

View In Agenda
Next speaker
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Ryan Hovda
Vice President, Vendor Strategy & Partnerships, BlueRock Therapeutics

Session Details:

Outsourcing and vendor management from a small/emerging sponsor perspective

2024-04-16, 2:30 PM

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Pooja Mankani
Director of Cloud and Software Engineering, Bristol Myers Squibb

Session Details:

Speaker Hosted Roundtables

2024-04-17, 9:00 AM

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

Session Details:

Panel Discussion Future proofing practice: Are your clinical trials ready for the modern world?

2024-04-17, 10:45 AM

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Deborah Covington
Director Global Procurement, Grifols

Session Details:

Speaker Hosted Roundtables

2024-04-17, 9:00 AM

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ROGER NOLAN
President, BioKier,

Roger has 30 years of management and drug development expertise from his leading roles in preclinical and clinical drug development programs, regulatory strategy and interactions, funding, and outsourcing to specialist service providers. With his experience in basic research, large and small pharma, and CRO settings he provides valuable insight into business and R&D operations for pharma/biotech companies. His specific therapeutic areas of expertise are in diabetes, oncology, gene therapy, and cardiovascular indications. He is currently President and Co-Founder at BioKier and was previously CEO at Plakous Therapeutics and Senior Scientist in Clinical Development at Cato Research. Roger received a PhD in Pharmacology and Biochemistry from Melbourne University and completed Postdoctoral fellowships at the National Institute of Environmental Health Sciences and at Burroughs Wellcome.

Session Details:

Speaker Hosted Roundtables

2024-04-17, 9:00 AM

View In Agenda
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Daniel Fitzgerald
Associate Director Global Study Operations, BioMarin Pharmaceutical Inc.

Session Details:

Gaining confidence from gene therapy: How can we accelerate the development of gene therapies into life-changing treatments for patients

2024-04-17, 12:15 PM

View In Agenda
Next speaker
Back
Lysa Triantafillou
Senior Director, Quality Assurance, MindMed,Inc.

Session Details:

Panel Discussion: Bringing the patient voice to clinical trial development: Current trends and future directions

2024-04-16, 11:00 AM

Session Details:

New era of clinical trials in a conservative industry: A hybrid approach to DCTs

2024-04-16, 4:00 PM

View In Agenda
Next speaker
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Robert Loll
Senior Vice President, Business Development and Strategic Planning, Praxis

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 Discussion: Bringing the patient voice to clinical trial development: Current trends and future directions

2024-04-16, 11:00 AM

Session Details:

Chairman’s Opening Remarks

2024-04-16, 8:50 AM

Session Details:

Panel Discussion Future proofing practice: Are your clinical trials ready for the modern world?

2024-04-17, 10:45 AM

Session Details:

Chair’s Opening Remarks

2024-04-17, 8:50 AM

View In Agenda
Next speaker
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Gerry Crudden
Senior Director of Operations and Supply Chain, Checkpoint Therapeutics

Session Details:

Outsourcing your clinical supply chain and optimizing internal operations

2024-04-17, 2:00 PM

View In Agenda
Next speaker
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Michael Hickey
Vice President, Clinical Operations, Bio-Path Holdings Inc

Session Details:

Panel Discussion: Bringing the patient voice to clinical trial development: Current trends and future directions

2024-04-16, 11:00 AM

View In Agenda
Next speaker
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Lani Hashimoto
Associate Director, Patient Engagement Management, Novartis

Session Details:

Panel Discussion: Bringing the patient voice to clinical trial development: Current trends and future directions

2024-04-16, 11:00 AM

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Michael McLaughlin
Independent Clinical Program Consultant

Mike McLaughlin, MS, MSEd, RAC, has over 20 years of clinical research experience working in various roles at both small and large pharmaceutical companies and in a variety of CRO environments. Since 2017, he has served as Associate Director, Clinical Operations at Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in medical dermatology

Session Details:

Protect your trials by better managing CRO consolidations

2024-04-16, 1:45 PM

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Jesse Kooker
Head Of Program Leadership & Alliance Management, Dermavant Sciences

Session Details:

Protect your trials by better managing CRO consolidations

2024-04-16, 1:45 PM

View In Agenda
Next speaker
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Mohita Changela
Director, Clinical Operations, Ascidian Therapeutics

Session Details:

Clinical operations and inspection readiness considerations in complex gene therapy and rare disease trials

2024-04-17, 2:30 PM

View In Agenda
Next speaker
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Adrienne Stoudenmire
VP of Global Project Delivery, ICON Biotech

Provide delivery oversight for the General Medicine book of business for ICONs Biotech customers, with a primary specialization in Cardiovascular, Metabolic, Hepatology-MASH, and GI.

20 years industry experience, with 11 years in the companies that comprise of ICON, with extensive experience in building operational strategy throughout the people, process, vision, and infrastructure required to successfully to deliver trials across my areas of specialization

Session Details:

Maximizing the consultative partnership between CRO and pharma/biotech partners

2024-04-16, 9:30 AM

Session Details:

Panel Discussion: Bringing the patient voice to clinical trial development: Current trends and future directions

2024-04-16, 11:00 AM

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Next speaker
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Hilary Partin
CEO, Founder, Allegro Biopharma Associates

Session Details:

Outsourcing and vendor management from a small/emerging sponsor perspective

2024-04-16, 2:30 PM

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Scotty Chung-Siu
Senior Analyst, GlobalData Healthcare

Session Details:

Overview of 2023 Clinical Trials & Trends So Far for 2024

2024-04-17, 3:00 PM

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Gerald Minuk, MD
President and CEO, Refuah Solutions Ltd.

Dr. Gerald Y. Minuk, Professor Emeritus at the University of Manitoba in Winnipeg, Canada, is the founder of Refuah Solutions Ltd. Dr. Minuk has over 40 years of experience in the medical field and is highly qualified as an experienced clinical trials investigator and clinician. At Refuah, Dr. Minuk and his global colleagues have applied their vast experience in clinical medicine to assisting other investigators in their efforts to improve patient recruitment/retention, limit screen failures, maximize study awareness and generate high quality data.

Session Details:

TECHNOLOGY SPOTLIGHT Addressing the Unmet Needs of Clinical Trials: A Senior Investigator’s Perspective

2024-04-16, 3:45 PM

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Scott Palmese
Executive Director, Decentralized Clinical Trials, Worldwide Clinical Trials

Scott Palmese is currently Executive Director, Decentralized Clinical Trials at Worldwide Clinical Trials.  He has been in the clinical research industry for almost 15 years and has held a variety of roles in the site and CRO sectors focusing on operations, business development, and strategic direction.  Throughout his career, Scott has consistently been an advocate for sites and patients and is excited about making it easier to access clinical trials across the globe.

Session Details:

Site and Patient Perspectives on Decentralized Trials – How Can They Inform Operational Strategy?

2024-04-16, 11:45 AM

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Jason Konn
Solution Consultant, eClinical Solutions

As a Solution Consultant, Jason works with Sponsor organizations to understand their challenges and come up with creative solutions leveraging the elluminate platform. Jason has lead design & development for several products ranging from a Data Management Workbench, Data Integrations, Clinical Operations Platform, Clinical Analytics, and Risk Based Quality Management.  Jason has been in the clinical trials industry for over 15 years and his prior experience includes, global central laboratory, eCOA design, process improvement, and building an automated workforce.

Session Details:

TECHNOLOGY SPOTLIGHT Oversight for All: Achieve data transparency with elluminate

2024-04-16, 2:15 PM

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Tom Gottschalk
Vice President, Business Development, Mercalis

Tom has worked in the life sciences industry for over 26 years, with the first 10 as a pharmaceutical representative and marketing product manager for Bertek, Merck and GSK.

Tom joined Mercalis 16 years ago, created the RxStudy Card offering in 2009 and for the past 14 years has been focused on changing the paradigm of the traditional clinical trial supply process to one of greater efficiency through the RxStudy Card.

Session Details:

How implementing innovative processes and technologies results in a more efficient use of human resources, reduces the amount of logistical resources required, saves money and lowers the carbon footprint impact.

2024-04-16, 10:00 AM

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Chris Casazza
Chief Commercial Officer, Diligent Pharma

Chris Casazza is an executive team leader with over two decades of experience driving commercial success and R&D excellence in the Pharma and Biotech sectors.  Chris has held pivotal leadership roles at Kantar Health (now part of Oracle Life Sciences), YourEncore, and Advarra.  In his current role as Chief Commercial Officer at Diligent Pharma, Chris manages all commercial aspects of the company's operations and is deeply involved in growing the vision and culture of the company.

Session Details:

TECHNOLOGY SPOTLIGHT – Reducing Trial Start-Up Time Through an Innovative Approach to Vendor Qualification

2024-04-16, 3:00 PM

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Jenny Higley
Director, Head of Feasibility CoE, Biogen

Experienced Associate Director with a demonstrated history of working clinical research and education. Skilled in Analytical Skills, Biotechnology, Feasibility, Mentoring, Proposal Writing, and Leadership. Strong business development professional with a 2005 M.S. focused in Technical Communication from North Carolina State University.

Session Details:

Designing trials to reduce patient and site burden

2024-04-16, 4:30 PM

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Embassy Suites by Hilton Raleigh Durham Research Triangle

201 Harrison Oaks Boulevard, Cary, NC 27513 USA

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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:

 

Niki Khoshkbary

Conference Producer


+44 204540 7545