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
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Featured Speakers

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Rich Pelt​

Senior Director, Global Regulatory Sciences, Vaccines CMC, Pfizer

Rich has over 25 years of CMC Regulatory Affairs with positions of increasing responsibility with GSK, PDL Biopharma, Wyeth Pharmaceuticals and currently with Pfizer, Inc as a senior director for vaccines CMC regulatory affairs.  Rich currently leads a team of 30 CMC Regulatory professionals responsible for supporting the development and production of various vaccines for the prevention of Sars-CoV-2 (Covid 19), C. Difficile, RSV, Group B Streptococcus, and Influenza.  Since the beginning of the pandemic, he has been one of the global leaders responsible for developing the BioNtech/Pfizer mRNA Covid-19 Vaccine.  Rich has been responsible for CMC Regulatory leadership on various vaccine programs over the last 25 years including the Prevnar 13 Vaccine global market submissions and approvals, coral snake antivenin production restart as well as various development programs including Staphylococcus aureus and RSV.

 

Rich has been an educator and guest speaker at various industry seminars and forums including The World Vaccine Congress, The American Association of Pharmaceutical Scientists National Biotechnology Conference, The International Society for Bioprocess Technology Nucleic Acids Conference, CASSS WCBP Conference, Academy for Institutional Investors Investment Forums, IBC Life Sciences programs, Regulatory Affairs Professional Society, and several other educational organizations.  Rich is also the Author of CMC Regulatory Affairs 101:  What does CMC Regulatory Affairs Do? (American Pharmaceutical Outsourcing:  Nov./Dec. 2007), and a contributing reviewer for the 5th edition of Fundamentals of US Regulatory Affairs (Chapter 15 on Biologics submission 2007) for the Regulatory Affairs Professionals Society.

 

Rich received a Bachelor of Science degree in Chemical Engineering from NC State University.  Rich is a 7-Time Ironman Triathlon finisher and was a division one swimmer for NC State University.  When Rich is not working on vaccine development, he enjoys playing golf and spending quality time at the beach in Oak Island, NC with his family.

 

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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 how to improve trial outcomes and success including enhancing diversity in clinical trials. 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.

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Pooja Mankani​

Director of Cloud and Software Engineering, Bristol Myers Squibb

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Michael J. Benecky​

PhD, Senior Director, Global Regulatory Affairs – Devices, UCB Pharma

2023 Sponsors Include:

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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 - https://www.iconplc.com/sectors/biotech

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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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Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory partner for biotech and small- to mid-sized pharmaceutical companies seeking to advance drug development. With deep therapeutic and regulatory expertise and an expansive global footprint across the Asia-Pacific region, North America, and Europe, Novotech offers clients an accelerated path to bring life-changing therapies to market.

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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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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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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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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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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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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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

Why attend?

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

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 maximize their effort to get drugs to patients in a timely fashion.

Key topics to be presented and discussed include exploring the shift to technological advancements including innovative trends such as: generative AI and LLM in CT and decentralized trials. Along with current trends such as diversity, equity and inclusion, patient centricity, recruitment, regulatory standpoints and more.

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

Testimonials

It was very interesting, both the presentations and the meeting opportunities.

IBSA Institut Biochimique SA

A great networking opportunity.

Medigene AG

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
SVP, Business Development, Praxis Communications

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
Head of Clinical Program Diversity, UCB

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
Vice President, Quality Assurance, MindMed
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
SVP, Business Development, Praxis Communications

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
Vice President, Quality Assurance, MindMed

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
SVP, Business Development, Praxis Communications

9 AM

Speaker Hosted Roundtables

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables.

RT1 - 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
SVP, Business Development, Praxis Communications
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, Global Regulatory Sciences, Vaccines CMC, 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

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Rich Pelt
Senior Director, Global Regulatory Sciences, Vaccines CMC, Pfizer

Rich has over 25 years of CMC Regulatory Affairs with positions of increasing responsibility with GSK, PDL Biopharma, Wyeth Pharmaceuticals and currently with Pfizer, Inc as a senior director for vaccines CMC regulatory affairs.  Rich currently leads a team of 30 CMC Regulatory professionals responsible for supporting the development and production of various vaccines for the prevention of Sars-CoV-2 (Covid 19), C. Difficile, RSV, Group B Streptococcus, and Influenza.  Since the beginning of the pandemic, he has been one of the global leaders responsible for developing the BioNtech/Pfizer mRNA Covid-19 Vaccine.  Rich has been responsible for CMC Regulatory leadership on various vaccine programs over the last 25 years including the Prevnar 13 Vaccine global market submissions and approvals, coral snake antivenin production restart as well as various development programs including Staphylococcus aureus and RSV.

 

Rich has been an educator and guest speaker at various industry seminars and forums including The World Vaccine Congress, The American Association of Pharmaceutical Scientists National Biotechnology Conference, The International Society for Bioprocess Technology Nucleic Acids Conference, CASSS WCBP Conference, Academy for Institutional Investors Investment Forums, IBC Life Sciences programs, Regulatory Affairs Professional Society, and several other educational organizations.  Rich is also the Author of CMC Regulatory Affairs 101:  What does CMC Regulatory Affairs Do? (American Pharmaceutical Outsourcing:  Nov./Dec. 2007), and a contributing reviewer for the 5th edition of Fundamentals of US Regulatory Affairs (Chapter 15 on Biologics submission 2007) for the Regulatory Affairs Professionals Society.

 

Rich received a Bachelor of Science degree in Chemical Engineering from NC State University.  Rich is a 7-Time Ironman Triathlon finisher and was a division one swimmer for NC State University.  When Rich is not working on vaccine development, he enjoys playing golf and spending quality time at the beach in Oak Island, NC with his family.

 

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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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 how to improve trial outcomes and success including enhancing diversity in clinical trials. 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

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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

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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

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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

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Lysa Triantafillou
Vice President, Quality Assurance, MindMed

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

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Robert Loll
SVP, Business Development, Praxis Communications

Robert Loll is the SVP of Business Development & Strategic Planning at Praxis, a full service patient recruitment & retention agency that specializes in optimizing study enrollment for research studies with award-winning creative and superior execution.  Designing and deploying effective patient recruitment campaign strategies since 2004, Robert’s clinical background includes 16+ years providing patient care for top collegiate, Olympic and disabled athletes around the world and working for outpatient rehabilitation companies including Baxter, Caremark and NovaCare.  Robert is an Advisory Board member for The Center for Information and Study on Clinical Research Participation (CISCRP), an independent non-profit organization dedicated to educating and informing the public and patients about clinical research.

Session Details:

Panel 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

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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

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Michael Hickey
Vice President, Clinical Operations, Bio-Path Holdings Inc

Michael Hickey is the VP of Clinical Operations at Bio-Path Holdings, LLC, a small biotech focused on developing liposomal antisense oligonucleotides in leukemia, lymphoma and solid tumors.  With over 26 years of experience at large and small sponsors including 6 years on the CRO side, Michael brings a truly collaborative approach and broad expertise in oncology and rare disease clinical drug development.  His clinical experience has focused on challenging indications such as head-and-neck cancer, colorectal cancer, breast cancer with BRCA mutations as well as chemotherapy induced myelosuppression, hemophilia, and Battens Disease.

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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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

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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

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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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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 since 1997, with the first 10 years spent as a
pharmaceutical representative and marketing product manager for Bertek, Merck and GSK.

Tom joined Mercalis in 2008, created the RxStudy Card offering in 2009 and since then has been focused
on changing the paradigm of the traditional clinical trial supply process to one of greater efficiency.

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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