Outsourcing in Clinical Trials Southeast 2023

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

28 - 29

March

2023
  • Embassy Suites Raleigh-Durham Research Triangle, Cary, NC
  • Complimentary
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Why attend?

WHAT TO EXPECT FOR 2023?

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.

100+

Attendees

20+

Exhibitors

20+

Speakers

75%

Attendees at Director+ level

100+

Attendees

20+

Exhibitors

20+

Speakers

75%

Attendees at Director+ level

See What It's All About

Agenda

  • 28 Mar 2023
  • 29 Mar 2023
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8 AM

Registration and Refreshments

8:55 AM

Chairman’s Opening Remarks

9 AM

Measure, Map, Mobilize: Recruitment plans that ensure diversity

  • The urgency of now: movements in patient and community outreach and how the entire industry needs to adapt
  • Setting and measuring goals for diversity that include, not target, patients and communities
  • Mapping goals to study designs, advisory groups, thought leaders, technologies, and protocols that ensure success
  • Mobilizing with tactics and strategies that work for partners and participants and meet goals

Speakers

9:30 AM

Reserved for ICON

10 AM

Exploring the rising use of AI in every phase of drug development, from discovery through to commercialization

  • Preclinical: target discovery, drug design, hit to lead optimization
  • Enrollment of trials and how AI can boost the process.
  • Addressing patient biomarkers to smooth out the trial process.
  • Using AI to enhance and streamline protocol design.
  • Enhancing health and safety measures by using sophisticated AI driven techniques.
  • Drug repurposing, finding alternative uses for already approved drugs.

Speakers

10:30 AM

Morning Refreshments & Networking

11 AM

Reserved for Worldwide Clinical Trials

11:30 AM

Navigating operational challenges for Cell & Gene Therapy trials

  • Expanding on the real challenges that arise when designing and running a cell & gene therapy trial.
  • Which technologies were essential in creating a smooth and easy to run trial.
  • Things to keep in mind when organising the supply chain of a cell and gene therapy trial.

Speakers

12 PM

Reserved for Novotech

12:30 PM

Lunch

1:30 PM

Identifying the approaches and challenges to improving diversity in clinical research

  • Identifying the approaches and challenges to improving diversity in clinical research
  • How patient and community partnership is key to improving diversity
  • Fostering collaboration to build public and community trust and engagement
  • How regulatory and cross-disciplinary guidance can guide your efforts
  • Review concrete examples of diversity initiatives and projects

Speakers

2 PM

Reserved for Viedoc

2:30 PM

How a strong Sponsor / Clinical Site collaboration can improve clinical trial performance

  • Highlighting the role in the team that the clinical site plays and how to work with the site during the planning phase.
  • How a sponsor’s study can stand out at a clinical site.
  • Site centricity vs patient centricity, how patient care can actually be impacted by a lack of foresight.
  • Focus points moving forwards, how both CRO’s and sponsors can work with a site to improve the quality of a trial.

Speakers

3 PM

Reserved for eClinical Solutions

3:15 PM

Afternoon Networking & Refreshments

3:45 PM

Data security and the impacts on the clinical world, is it really a worthwhile investment?

  • Regulations versus reality, what are the reasonable guard rails to keep in place.
  • Investing in security as a small team, the needs to have versus the nice to have.
  • Handling your image in the public eye in the worst-case scenario.
  • Moving to virtual trials puts more cogs in motion, do we need to take extra precaution.

Speakers

4:15 PM

Working with a deal that hasn’t gone quite the way you expected, pragmatic solutions for traditional CRO execution

  • How to approach a negotiation to ensure you’re getting the best deal.
  • When a partner is underdelivering what are your best paths to take.
  • Relationship management and how to handle projects with multiple CRO’s.
  • Giving back to the CRO, constructive feedback helps but it goes both ways.

Speakers

4:45 PM

Case Study: Virtual drug development from concept through to FDA approval with one full-time employee: challenges and learnings.

  • Fund raising from a concept without initial clinical data.
  • Conducting drug development virtually with only one employee.
  • Interactions with the FDA
  • Progression throughout the different clinical phases through to approval as a small team of consultants.

Speakers

5:15 PM

Chairman’s Closing Remarks & Drinks Reception

8 AM

Registration and Refreshments

9 AM

Panel: Movements in patient engagement, what we as an industry need to change to promote trust.

  • Collaboration is key when it comes to promoting the reputation of the industry.
  • Key focus areas to work on to improve how we are keeping patients engaged in trials.
  • Tackling patient education, understanding is the real key to engagement.
  • Working alongside technology, do patients receive a higher quality or do they feel frustrated working with screens.
  • Involving the site and patient perspective, what are their thoughts on movements within the industry.

Speakers

9:30 AM

Reserved for Trialcard

10 AM

Panel: What are our current biggest industry challenges at the moment in small biotech and how are we dealing with them?

  • Dealing with staffing shortages across the industry and how it affects the smaller firms.
  • Timescale issues that affect everything from supply to patient engagement, what we as a smaller team can do to make this easier.
  • Managing slow turnaround from the FDA and how it impacts trials.
  • Working with CRO’s as a small biotech, how to keep the costs down when the budgets remain small

Speakers

10:30 AM

Reserved for Pro-ficiency World HQ

11 AM

Morning Refreshments & Networking

11:30 AM

Looking into relationship management with vendors small scale and large from a small start-up perspective:

  • Establishing the foundations is a key start to a good relationship with your vendors
  • Managing your communication with a vendor, from conferences like this to regular meet ups.
  • When and where to work on protocols with your vendors as a small company, can you ask too much?

Speakers

12 PM

Reserved for Calyx

12:30 PM

Case Study: Running a successful cell therapy trial in a non-oncology indication, the key takeaways and most successful methods.

  • An in depth discussion of a successful trial run with a novel autologous cellular therapy.
  • Sharing insight into the positive steps taken to help with recruitment, engagement and enrolment.
  • A focus on the real pain points of a logistically complex trial and what surprising obstacles we came across.

Speakers

1 PM

Networking Lunch

2 PM

Funding, how to get the most funding as a startup and to enhance your current funding.

  • Covering the biggest challenges you will face with a start-up
  • Looking into the milestones you need to cross on your funding journey.
  • How to manage fund raising for a novel product and promote it to the right people.

Speakers

2:30 PM

Running a trial outside of the US, how to secure FDA approval for your drug

  • Discussing the current advantages and pitfalls with hosting trials outside of the US.
  • Planning a path from the start to ensure you get the right dataset from your trials that will be approved.
  • Dealing with differing standards of care in other countries.
  • A case study of how we approved a drug with the FDA with 100% non US patients.

Speakers

3 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 session lasts for 30 minutes, and delegates may attend up to 2 roundtables

 

RT1 A critical discussion of novel technology that is out there, how do bring something from concept through to clinical trials.

Charlene Knape, Vice President, Clinical Affairs, NecteroMedical Inc

 

RT2 Sharing ideas about diversity in trials, what ideas have we tried and how much impact has it had.

 

RT3 Patient reported outcomes are still changing the world of clinical trials, how can we trust them?

Speakers

4 PM

Close of Conference

Speakers

Select a speaker to learn more

Back
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:

Panel: What are our current biggest industry challenges at the moment in small biotech and how are we dealing with them?

2023-03-29, 10:00 AM

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Behtash Bahador
Director, Health Literacy, CISCRP

Behtash Bahador is the Director of Health Literacy 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.

Session Details:

Identifying the approaches and challenges to improving diversity in clinical research

2023-03-28, 1:30 PM

Session Details:

PANEL DISCUSSION: Challenges related to Diversity, Equity and Inclusion for Clinical Research

2023-03-29, 10:30 AM

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Michael Hickey
Director, Clinical Program Management , Bio-Path Holdings

Session Details:

Looking into relationship management with vendors small scale and large from a small start-up perspective:

2023-03-29, 11:30 AM

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Lauren Neighbours
PhD, RAC, Senior Vice President, Product Development and Regulatory Affairs, Checkpoint Therapeutics, Inc

Session Details:

Running a trial outside of the US, how to secure FDA approval for your drug

2023-03-29, 2:30 PM

Session Details:

Panel: What are our current biggest industry challenges at the moment in small biotech and how are we dealing with them?

2023-03-29, 10:00 AM

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Om Dhingra
Vice-Chair And Co-Founder, Marius Pharmaceuticals

Session Details:

Case Study: Virtual drug development from concept through to FDA approval with one full-time employee: challenges and learnings.

2023-03-28, 4:45 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:

Panel: Movements in patient engagement, what we as an industry need to change to promote trust.

2023-03-29, 9:00 AM

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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:

How a strong Sponsor / Clinical Site collaboration can improve clinical trial performance

2023-03-28, 2:30 PM

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Barb Geiger
Sr VP Clinical Operations, Mana Therapeutics

Clinical Research and Development management professional for over 25 years. Full development experience from clinical coordinator to Phase I NHV unit to monitor to Global Project Manager in pharma and CROs and an oncology nurse by training. Entrepreneur who founded a CRO specializing in oncology clinical services, and acquired by Clinipace in 2009 to form a full service global CRO.

Session Details:

Panel: What are our current biggest industry challenges at the moment in small biotech and how are we dealing with them?

2023-03-29, 10:00 AM

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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:

Speaker Hosted Roundtables

2023-03-29, 3:00 PM

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David Dworaczyk
CEO, Bryn Pharma

Dr. Dworaczyk has done extensive work with numerous Healthcare, Pharma, Biotech, Healthcare, Informatics, Diagnostic and CRO companies as well as life and health science focused Venture and Private Equity investment groups assessing/evaluating investment opportunities from an operational, strategic and business perspective.

Session Details:

Funding, how to get the most funding as a startup and to enhance your current funding.

2023-03-29, 2:00 PM

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Megan Liles
Vice President Clinical Operations, ProKidney

Session Details:

Case Study: Running a successful cell therapy trial in a non-oncology indication, the key takeaways and most successful methods.

2023-03-29, 12:30 PM

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Liz Presson
Founder & Chief Strategist, PursuitOf

Session Details:

Panel: Movements in patient engagement, what we as an industry need to change to promote trust.

2023-03-29, 9:00 AM

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

Session Details:

Working with a deal that hasn’t gone quite the way you expected, pragmatic solutions for traditional CRO execution

2023-03-28, 4:15 PM

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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:

Data security and the impacts on the clinical world, is it really a worthwhile investment?

2023-03-28, 3:45 PM

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Deborah Covington
Global Director Clinical Outsources Management, Grifols
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Jennifer Cook
Clinical Research Patient Engagement, DCRI

Jennifer Cook is an Associate Director in the Research Communications & Engagement group at the Duke Clinical Research Institute. In her role she leads teams that are designing and implementing communications and stakeholder engagement strategies that ensure diversity in clinical research studies and national research networks. She brings more than 25 years of experience in health care communications and engagement working for universities, consulting firms, and professional associations and has a master’s degree in public heath from the University of North Carolina, Chapel Hill.

Session Details:

Measure, Map, Mobilize: Recruitment plans that ensure diversity

2023-03-28, 9:00 AM

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Ed Addison
Co Founder, 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:

Exploring the rising use of AI in every phase of drug development, from discovery through to commercialization

2023-03-28, 10:00 AM

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Matthew Barnes
Director Portfolio Management, Virpax Pharmaceuticals

Matthew Barnes is a clinical researcher specializing in project management, operational efficiency, and drug development. He has over 28 years of experience providing support for clinical trials in a variety of roles in both small to mid-sized pharmaceutical/biotech companies and Clinical Research Organizations (CROs). He is currently serving as the Director of Portfolio Management of Virpax Pharmaceuticals, where he is responsible for leading and coordinating cross-functional activities to advance non-clinical and clinical development programs, manufacturing activities, and the implementation and management of the Quality Management System and SOPs.

Session Details:

Panel: Movements in patient engagement, what we as an industry need to change to promote trust.

2023-03-29, 9:00 AM

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Michael Karg
Sr. Director, Clinical Operations, Precision Biosciences

Michael is a 20+ year veteran of the pharmaceutical industry. He has spent the majority of his career working across major Clinical Research Organizations in Clinical Operations, Project and Program Management and Therapeutic Strategy development. He currently Heads Clinical Operations and CAR-T Program Management at Precision Biosciences.

Session Details:

Navigating operational challenges for Cell & Gene Therapy trials

2023-03-28, 11:30 AM

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James Bernstein
President, Live Oak®, Pharmaceutical Consulting, Inc

Session Details:

Case Study: Virtual drug development from concept through to FDA approval with one full-time employee: challenges and learnings.

2023-03-28, 4:45 PM

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Plan Your Visit

Venue

Embassy Suites by Hilton, Raleigh Durham Research Triangle

201 Harrison Oaks Boulevard Cary, North Carolina 27513 USA

Sponsors

Select a sponsor to learn more

FEATURED SPONSOR

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EXHIBITORS

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Enquiry

Contact Us

SPONSORSHIP ENQUIRIES

Nicholas McCudden

Head of OCT Events

+61 280 978 126

SPEAKING OPPORTUNITIES

Douglas Webber

Conference Producer

+44 (0) 20 7866 9411

MARKETING ENQUIRIES

Moona Popal

Marketing 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:

 

Douglas Webber

Conference Producer


+44 (0) 20 7866 9411