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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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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.

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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.

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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.

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Megan Liles

Vice President Clinical Operations, ProKidney

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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.

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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.

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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.

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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.

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Company Information

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022.

Company Website

To learn more, please visit our website - http://www.iconplc.com/

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Company Information

Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. With deep expertise in clinical development and more than 25 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day.

Company Website

To learn more, please visit our website - https://www.calyx.ai

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Company Information

Founded in 1997, Novotech is a global full-service clinical Contract Research Organization (CRO) focused on partnering with biotech companies to accelerate the development of advanced and novel therapeutics at every phase.

Recognized for its industry-leading contributions, Novotech has received numerous prestigious awards, including the CRO Leadership Award 2023, the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence 2023, the Asia-Pacific Contract Research Organization Company of the Year Award since 2006.

The Company offers a comprehensive suite of services including laboratories, Phase I facilities, drug development consulting, regulatory expertise, and has experience with over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. With a presence in 34 office locations and a dedicated team of 3,000+ professionals worldwide, Novotech is a trusted end-to-end strategic partner of choice.

For more information or to speak to an expert team member visit www.Novotech-CRO.com

Company Website

To learn more, please visit our website - www.novotech-cro.com

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Company Information

Pro-ficiency converts training from a cost center to a powerful quality improvement system. Our simulation-based protocol training prevents study errors, guarantees timely SIV, and frees up thousands of hours for your study team and site-staff. Pro-ficiency ensures that everyone in your study is compliant with all training requirements.

Company Website

To learn more, please visit our website - www.pro-ficiency.com

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Company Information

Mercalis has a suite of Clinical Trial Support services designed to provide time and cost efficiencies.

RxStudy Card – Pharmacy provides commercially available medications and supplies through retail and specialty pharmacies. This supply strategy reduces supply process steps, requires less employee time, eliminates supply waste, and has fewer risks resulting in an 80% reduction in labor and a 50% reduction in costs.

RxStudy Card – Provider provides reimbursement for site sourced and administered medication and is essential for studies requiring biologics and oncolytics, which are more frequently being sourced directly by a provider and not through a pharmacy.

RxStudy Card – Procurement is an innovative GLOBAL clinical trial supply process that more efficiently provides commercially available medications and supplies. RxStudy Card – Procurement leverages “in country” sourcing and distribution, provides study teams and sites a simple online ordering experience for “just in time” “as needed” delivery, in quantities specific to each site and patients need with direct to site shipments and real time order and shipment status.

Company Website

To learn more, please visit our website - www.mercalis.com

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Company Information

At Viedoc, we design engaging software that modernizes clinical research so that necessary treatments can reach the people who need them faster. We believe in life and science, in people, and in our collective power to change the world and build a healthier future. That unmatched driving force is what pushes us to innovate, accelerate and improve every aspect of modern clinical studies.

Company Website

To learn more, please visit our website - www.viedoc.com

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Company Information

Worldwide is changing how the world experiences CROs – in the best possible way. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence, Worldwide Clinical Trials provides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies.

Company Website

To learn more, please visit our website - https://www.worldwide.com

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Company Information

eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. The elluminate® Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. elluminate software and data driven services have been used by more than 100 life sciences companies on over 500 clinical trials to reduce cycle time and improve data quality. For more information, visit www.eclinicalsol.com, or contact us at info@clinicalsol.com.

Company Website

To learn more, please visit our website - www.eclinicalsol.com

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Company Information

At Praxis, our approach to patient recruitment for clinical trials involves making connections that matter. We connect specialized tools with our team’s talent. Sophisticated data with our insight. And patients with hope. This is how we help the world’s leading pharmaceutical and biotech companies create unique, customized programs to support clinical trial recruitment and patient retention. Learn more at gopraxis.com.

Company Website

To learn more, please visit our website - www.gopraxis.com

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Company Information

KPS is a global, innovative, Clinical Outsourcing Provider delivering clinical trial monitoring, management and quality oversight services to pharmaceutical, biotechnology, medical device, and related industries. Founded and operated as a more customer centric and nimblealternative to traditional CROs, KPS offers a full range of services leveraging the latest clinical technologies.

Company Website

To learn more, please visit our website - http://www.kpslife.com

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Company Information

ACM Global Laboratories is one of the largest global independent central labs in the industry. ACM is certified by the College of American Pathologists (CAP) and the Substance Abuse and Mental Health Services Administration (SAMHSA). The company delivers high-quality laboratory testing and diagnostic lab services in support of both clinical trials research, toxicology and individual patient care. ACM provides a powerful combination of operational excellence, scientific expertise and unsurpassed global service to customers in more than 65 countries. ACM performs more than 20 million laboratory tests each year—spanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more.

Company Website

To learn more, please visit our website - www.ACMGlobalLab.com

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Alcami is a world-class end-to-end CDMO headquartered in North Carolina. Alcami connects its global clients with customizable and innovative solutions for API development and manufacturing, solid state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (oral solid and parenteral), packaging, and stability services.

Company Website

To learn more, please visit our website - www.alcaminow.com

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Company Information

The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com.

Company Website

To learn more, please visit our website - https://www.almacgroup.com

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Company Information

assisTek has been paving the way for integrating technology and data collection in clinical trials for over 25 years. We have earned a solid reputation around the globe by delivering customized solutions used in over 500 clinical research trials, across 90 different languages in 80 different countries. Based outside Philadelphia, Pennsylvania, we pride ourselves on being boutique by design and always customer focused. eCOA is our core focus but not our only service. Our experienced team has been in this niche of clinical research with deep domain experience for decades and client solutions has been our passion for over two decades.

Company Website

To learn more, please visit our website - www.assistek.com

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Company Information

Axiom is celebrating 22 years of delivering hundreds of studies in dozens of countries. Since its founding in 2001, Axiom has delivered data-driven, powerful, and cost-effective eClinical Solutions and Services dedicated to small-to-medium life science companies. Axiom Fusion eClinical Suite is the most adaptable, Unified Platform that serves as the Connected Hub for all your Clinical Trial and operational data and reporting. Choose from 15+ unified modules on a single platform: EDC, DM, RTSM/IRT, CTMS, Inventory Management, ePRO, eConsent, Patient Portal, AE/SAE Tracking, Safety Database, Central/Local Lab, Imaging Management, eTMF, and 24/7 Project and Clinical Data Reporting. We are an embedded partner dedicated to the success of your study, offering managed services such as: Data Management, On-Demand Data Analytics, Biostatistics, Clinical Management, eTMF Management and Pharmacovigilance.

Company Website

To learn more, please visit our website - https://www.axiommetrics.com

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Company Website

To learn more, please visit our website - http://www.bappharma.com/

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Barrington James are a Global specialist recruitment consultancy working across the Healthcare sector. Our structure, with separate divisions and dedicated consultants for the markets we serve ensures a thorough, professional and intelligent approach in both permanent and interim solutions. Our tailored methodologies include Contingency database search and executive search.

Company Website

To learn more, please visit our website - www.barringtonjames.com

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Company Information

Boostcode helps biotech companies to improve the performance of their clinical programs.

We are a small team of dynamic , multi-skills and motivated professionals (quality, CMC, Supply Chain, Procurement, Site engagement, Regulatory, …) available to provide strategic and operational support.

We also provide trainings and business coaching to your staffs.

Company Website

To learn more, please visit our website - https://www.boostcode.eu

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Company Information

Clincierge reduces barriers to trial participation by employing patient-centric strategies to enhance the patient experience, increase patient retention, and improve clinical trial performance. We provide personalized patient logistics management, reimbursement, and convenience services to support clinical trial participants. This enables earlier submissions with the potential of coming to market sooner and recovering R&D investments ahead of projections.

Company Website

To learn more, please visit our website - www.clincierge.com

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Company Information

Since 1997, Clinigen has offered market-leading clinical trial supplies and biological sample management services to meet the most complex clinical supply challenges. Part of Clinigen Group’s global supply chain facility and depot network, we deliver tailored solutions for clients to ensure their clinical trials are a success, regardless of size or scope, from Phase I to Phase IV projects.

Company Website

To learn more, please visit our website - www.clinigencsm.com

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Why attend?

‘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’

The conference has an incredible speaker line-up this year with presidents and directors of regional biopharma organisations and tech innovators. Along with a varied agenda with topics suitable for all size companies. Key topics to be presented and discussed include exploring the shift to technological advancements including innovative trends such as: exploring advanced genomic technology, decentralized trials, remote monitoring and blockchain. Along with current trends such as diversity, equality, & inclusion and health literacy, patient centricity and recruitment, regulatory standpoints and more.

Clinical trial outsourcing South East 2023 is often practiced among online casino enthusiasts. Key topics that will be presented and discussed include studying the transition to technological advances and about Bills’ Damar Hamlin returns to Buffalo | Latest update on cardiac arrest recovery. With current trends such as diversity, earnings in online casinos, equality is often discussed and practiced.

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.

300+ Attendees	20+ Exhibitors	20+ Speakers
300+ Attendees	20+ Exhibitors
20+ Speakers

Testimonials

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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

Jennifer Cook

Clinical Research Patient Engagement, DCRI

9:30 AM

Trends in outsourcing among small/emerging biopharma

Key needs of small/emerging biopharma
Recent trends in outsourcing models in this space
What is the role of CROs in value creation for biotech

Speakers

Brandon Early

Vice President, Project Delivery, ICON Biotech

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

Ed Addison

Co Founder, Cloud Pharmaceuticals

10:30 AM

Morning Refreshments & Networking

11 AM

Leveraging CRO Site Relationships to Drive your Study Forward

- Early engagement to get an early pulse on opportunities and challenges
- The role of strategic sites to meet important milestones
- Ongoing feedback to make needed adjustments and ensure on-time, quality data

Speakers

Steve Chriscoe

Vice President, Project Management - United States, 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

Michael Karg

Sr. Director, Clinical Operations, Precision Biosciences

12 PM

State of the Global Biotech Landscape: Where the opportunities lie

State of Global Clinical Trials Landscape
Lasting COVID Impact
Biotech Economic Landscape
APAC as a Focus for Clinical Development

Speakers

Steve Brandao

Regional Director Business Development, East Coast, US, Novotech

12:30 PM

Networking 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

Behtash Bahador

Director, Health Literacy, CISCRP

2 PM

Hybrid trials using DCT technology and processes; focus on patients and the sites

Highlighting the complexity that Hybrid/DCT brings whilst moving away from the common brick-and-mortar sites.
Discussing the rise in regulator concerns in areas such as investigator oversight, and participant’s safety when face to face contact is limited.
How we tend to focus too much on technology when it’s actually the processes for the patients and the sites that matter even more.
Major points to consider in designing hybrid/DCT trials; building blocks and practical examples to best prepare you to meet the needs of regulators whilst keeping the patient and sites front of mind.

Speakers

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

Jamie Kime

Vice President, Clinical Operations & Procurement, Locus Biosciences

3 PM

Data-Driven Operations and Oversight with elluminate

Operational analytics including enrolment, protocol compliance and safety
Risk-based analyses and insights with elluminate RBQM
Operational knowledge for data-driven development with elluminate CTMS
Centralized issue management across roles in operations, data and medical review
Sample tracking, data forecasting and financial performance indicators

Speakers

Dawn Kaminski

Vice President, Business Development Operations, eClinical Solutions

3:15 PM

Afternoon Networking & Refreshments

3:45 PM

The Intersection of Data Privacy and Improving Diversity in Clinical Trials

Balancing global and US requirements
Challenges and solutions
Practical approach of a start up biotech navigating both needs

Speakers

DeAnn Hyder

Associate Director, Clinical Data Management And Programming, Kronos Bio

4:15 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

Om Dhingra

Vice-Chair And Co-Founder, Marius Pharmaceuticals

James Bernstein

President, Live Oak®, Pharmaceutical Consulting, Inc

4:45 PM

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

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

Nicole Leedom

Vice President, Head of Clinical Operations, Spring Works Therapeutics

Matthew Barnes

Director Portfolio Management, Virpax Pharmaceuticals

Lani Hashimoto

Associate Director, Patient Engagement Management, Novartis

9:30 AM

Innovative Processes To Better Address Todays Trial Dynamics

What you will learn

Supply Chain Efficiency
1. Why do extra work and spend more money than necessary?
Payment Process Efficiency
1. Leverage an existing workflow process sites use everyday.

Understanding The Total Value A Vendor Can Provide
1. Select a vendor that can demonstrate their total value (and make you look good in the eyes of your company)

Speakers

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

ROGER NOLAN

President, BioKier,

Lauren Neighbours

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

Barb Geiger

Sr VP Clinical Operations, Mana Therapeutics

10:30 AM

Innovative Training Strategies

Explore the future-state of performance-based training
Discuss how to interpret and apply learning results to optimize and de-risk your study
Discover how simulation-based training improves study performance

Speakers

Dave Hadden

President and Founder, Pro-ficiency

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

Michael Hickey

Vice President, Clinical Operations, Bio-Path Holdings Inc

12 PM

Why expert partners & staff matter in IRT

Are you moonlighting in IRT?
What does experience look like & who has it
Case study
Why internal experts matter
Platform or Purpose Built

Speakers

Craig Mooney

VP Scientific eTech Enabled Services, 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

Megan Liles

Vice President Clinical Operations, ProKidney

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

David Dworaczyk

CEO, Bryn Pharma

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

Lauren Neighbours

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

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 Addressing the latest budgeting challenges we are facing and sharing cost saving techniques.

RT3 Working alongside CROs, tips and strategies for relationship management.

Speakers

Charlene Knape

Vice President, Clinical Affairs, NecteroMedical Inc

4 PM

Close of Conference

Speakers

Select a speaker to learn more

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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:

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

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Michael Hickey

Vice President, Clinical Operations, Bio-Path Holdings Inc

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, 4:15 PM

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Nicole Leedom

Vice President, Head of Clinical Operations, Spring Works Therapeutics

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

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

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

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Jesse Kooker

Head Of Program Leadership & Alliance Management, Dermavant Sciences

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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:

The Intersection of Data Privacy and Improving Diversity in Clinical Trials

2023-03-28, 3:45 PM

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Deborah Covington

Director Global Procurement, Grifols

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Jennifer Cook

Clinical Research Patient Engagement, DCRI

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

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

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

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, 4:15 PM

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Brandon Early

Vice President, Project Delivery, ICON Biotech

Brandon is a drug developer with deep oncology and immunology experience. He has a particular focus on how CROs can support in expanding the capabilities of small biotech companies. In his current role, he oversees and develops high performance teams to deliver client clinical development portfolios. Prior to his time with ICON, Brandon led global oncology and immuno-oncology programmes in the biotech and CRO sectors. He received his Masters and Undergraduate degrees from the University of Virginia, US.

Session Details:

Trends in outsourcing among small/emerging biopharma

2023-03-28, 9:30 AM

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Steve Chriscoe

Vice President, Project Management - United States, Worldwide Clinical Trials

Mr. Steve Chriscoe, Vice President, Project Management – United States has worked in clinical research since 1995 and has worked for WCT since February 2021.

He began his career as a CRA before moving into a Clinical Research Scientist role at a large pharmaceutical company, where he continued to monitor clinical trials in addition to doing study management and writing. Mr. Chriscoe first became a Project Manager over 20 years ago, and since that time has held a variety of roles in project management, clinical operations and development. He has experience working in larger pharma, small biotech, as well as the CRO industry.

Mr. Chriscoe has served in an oversight role or as Project Manager for a variety of programs in Oncology:

Phase I – IV, with a focus on early phase studies including FIH and dose escalation/expansion
Immuno-oncology as well as CAR-T therapies
Solid tumor types include breast, cervical, prostate, bladder, pancreas, head & neck, liver & lung
Liquid tumor types include NHL, AML, and CLL

Mr. Chriscoe also has project management & clinical development experience in AAV-based gene therapy for rare diseases such as Pompe disease, Huntington’s disease, MMA, muscular dystrophy and Angelman syndrome. This includes experience from pre-clinical through registrational studies.

Mr. Chriscoe holds a Bachelor’s degree in Physical Education from the University of North Carolina-Wilmington, and a Master’s degree in Exercise Physiology from the University of North Carolina.

Session Details:

Leveraging CRO Site Relationships to Drive your Study Forward

2023-03-28, 11:00 AM

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Steve Brandao

Regional Director Business Development, East Coast, US, Novotech

Steve Brandao has spent more than 30 years in research and development. His experience includes time with a major pharmaceutical company, work with two leading SMO’s, and business development positions with large global CRO’s, a medical device CRO, and an EDC technology company. He is currently the US Regional Director of Business Development for Novotech, an Asia-Pacific centered CRO with global capabilities. Steve has a graduate degree in psychology and worked as a psychotherapist before starting his career in biopharma research and development.

Session Details:

State of the Global Biotech Landscape: Where the opportunities lie

2023-03-28, 12:00 PM

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DAVID HADDEN

President And Founder, Pro-Ficiency

Dave is an entrepreneur and technology innovator. He is known for pioneering the fields of A.I.-based medical decision-support, Training Analytics, and Virtual Patient Simulation (VPS). Dave’s last company, TheraSim, launched the world’s first successful online VPS system for physicians and trained over 500,000 doctors in every country on Earth. TheraSim built the world’s largest network of computer-based clinical simulation sites in Africa in support of the USAID and the CDC’s HIV-treatment effort. TheraSim was acquired by WebMD in 2014. Since then, he has focused his passion for technological innovation and learning systems in the field of clinical trials, helping sponsors make their studies more accurate and efficient through finding the right technology mix such as virtualization, performance management and applied behavioral sciences to produce the most effective, lasting, and engaging results for clinical trials. Dave has always valued the interconnectedness of our vastly changing world, and has traveled to over 70 countries for his global health work and for cultural development outreach through music.

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Sverre Bengtsson

Co-Founder, Viedoc

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.

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Dawn Kaminski

Vice President, Business Development Operations, eClinical Solutions

Dawn has over 25 years of experience in the pharmaceutical industry. She has worked within every level of clinical data management, from Data Coordinator to Senior Director where she participated in or had oversight for more than 250 clinical trials. During her time in the industry, she has provided consultation to organizations on clinical trial conduct, best practices in Data Management and data capture as well as developed standardized libraries and templates to support the adoption of CDISC standards. She is an active member of SCDM as a GCDMP SME, course designer and webinar presenter as well as former Co-Chair of the annual conference (2018-2021) and currently serves on the SCDM Board of Trustees. Dawn is involved as a member of the CDISC-CDASH core team, Diabetes sub-team, CDASH CFAST Expanded Leadership Team and former Co-Chair of the CRF Library project. Dawn currently holds the position of Vice President, BD Operations, where she supports business development as a Clinical Subject Matter Expert for both software and Biometrics services as well as overseeing the Proposals and Solution Consulting departments.

Session Details:

Data-Driven Operations and Oversight with elluminate

2023-03-28, 3:00 PM

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Craig Mooney

VP Scientific eTech Enabled Services, CALYX

Craig joined Calyx in 2021 as Vice President Scientific eTech Enabled Services, Craig has nearly 30 years of experience in the clinical trial arena including clinical operations, IMP packaging, labeling & logistics, with a primary focus in Interactive Response Technology (IRT). In his current role Craig’s remit is to: Leverage experience as an IRT business owner & sponsor to drive excellence in product, project management, and commercialization; Consult with clients on IRT best practices and emerging trends in the regulatory landscape; Serve as an advocate for sponsors within Calyx through expanded partnership engagements; And contribute to the industry as an evangelist for IRT and its proper role in clinical trials.

Session Details:

Why expert partners & staff matter in IRT

2023-03-29, 12:00 PM

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