Outsourcing in Clinical Trials East Coast 2023

Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget

23 - 24

May

2023
  • Valley Forge Casino Resort, King of Prussia, PA, USA
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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 - http://www.iconplc.com/

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Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 33,000 trials and 10 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across 2,200+ customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster.

Company Website

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

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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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Clario is a leading healthcare research and technology company that generates high quality clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence generation solutions that combine eCOA, cardiac safety, medical imaging, precision motion, and respiratory endpoints. Since our founding more than 50 years ago, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported clinical trials over 26,000 times in more than 100 countries.  Our global team of science, technology, and operational experts have supported over 60% of all FDA drug approvals since 2019.

Company Website

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

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PCM Trials has been at the forefront of decentralized clinical research since 2008, leading mobile visits and recently introducing community-based research sites. We are driving the shift to patient-centric clinical trials, giving individuals the flexibility to engage in research studies in ways that work best for them. Our approach expands opportunities for participation, resulting in greater patient diversity, reduced patient dropout, and faster study results.

Company Website

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

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Saama Technologies is the advanced clinical data and analytics company, unleashing wisdom from data to deliver better actionable business outcomes for the life sciences industry. Saama’s unified, AI-driven clinical data analytics cloud platform seamlessly integrates, curates, and animates unlimited sources of structured, unstructured, and real-world data to deliver actionable insights across all therapeutic areas. The award-winning platform gives unprecedented real-time visibility into clinical data, enabling sponsors to file New Drug Applications (NDAs) more efficiently to bring drugs to market faster and at lower costs. For more information, visit http://www.saama.com.

Company Website

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

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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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WCG measurably improves the quality and efficiency of clinical trials, helping biopharmaceutical companies, CROs, and institutions facilitate the development of new treatments and therapies for patients.

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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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YPrime’s cloud-based technology streamlines clinical trial data collection and management. Electronic clinical outcome assessments (eCOA) and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone.

We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. We’re doing more than streamlining your processes. We’re streamlining your research, helping you get to your next milestone faster.

Company Website

To learn more , please visit our website - http://www.yprime.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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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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BSI Life Sciences offers smart eClinical software for CTMS, eTMF and more. BSI makes life science software for people – and has done so for over 25 years. BSI’s software solution is made in Switzerland, Germany, USA and anywhere else clients need to be, and focused on being innovative and user-friendly. They focus on staying ahead of the industry trends and delivering a functional, compliant, and leading edge eClinical solution. This way, BSI helps its customers continuously optimize and accelerate the clinical development process. And that’s what they love! www.bsi-lifesciences.com

Company Website

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

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With over 40 years’ experience, 600 beds and locations in NA, EU and Asia, Celerion conducts First-in-Human, clinical Proof-of-Concept and patient dose response studies, cardiovascular safety and NDA-enabling clinical pharmacology research. Celerion provides full study services including statistics, data management and biostatistics (including PK/PD analysis), and bioanalytical services.

Company Website

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

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ClinChoice is a leading full-service clinical CRO offering high-quality solutions to pharmaceutical, biotechnology, medical device and consumer products clients. We contribute to a safer and better world by helping our sponsor clients accelerate drug and device approvals to market. We do this by combining our 25 years of proven quality and results with expertise in 30+ therapeutic areas, a flexible approach, and dedicated teams who enable rapid startups and fast timelines.

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ClinOne, a leader in virtual clinical trial management, provides a single platform technology experience to accelerate clinical trial enrollment and remote patient care, compliance and retention. Featuring solutions for automated referrals, eConsent, patient engagement, connected devices, eCOA, and eSource, ClinOne makes participating in a clinical trial a little easier, every day. Learn more at www.clinone.com.

Company Website

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

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    Why attend?

    Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget  

    Join us for a two day event filled with case studies, panel discussion and face to face networking opportunities around clinical operations, technology and innovation, and data management.

    Last year alongside talks from industry leaders Pfizer, Bristol Myers Squibb, Otsuka and Endo Pharmaceuticals, we had a keynote presentation from Craig Lipset, Advisor and Founder at Clinical Innovation Partners. Craig was discussing the event with a talk on “Democratizing Decentralised Trials: How Innovative Solutions Can be Accessible for All” – this session will discuss real life tips on innovating clinical trials and future trends for the industry.

     

    WHAT TO EXPECT FOR 2023?

    450+

    Attendees

    		70+

    Exhibitors

    		30+

    Speakers
    450+

    Attendees

    		70+

    Exhibitors
    30+

    Speakers

    Testimonials

    See What It's All About

    Agenda

    • 23 May 2023
    • 24 May 2023
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    Streams

    Stream one

    Outsourcing and Clinical Operations

    Stream two

    Clinical Innovation & Technology

    7:30 AM

    Registration & Refreshments

    8:20 AM

    Chairperson’s opening remarks

    Speakers

    Peter O’Neill
    Senior Director, Clinical Operations, Cellectis

    8:30 AM

    Keynote We Are All At-Risk of Being Obsolete: Earning Our Place in the Future of Clinical Research

    Clinical research is a crucial part of delivering a healthy society, and no stakeholder involved in the process today has a "right" to be here tomorrow. There are futures where every entity in research is at risk of being made obsolete. How can we best avoid complacence and ensure we are all earning the right to be at this table?

    Speakers

    9 AM

    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

    Alex Ireland
    Associate Director Business Development, Novotech

    9:30 AM

    Artificial Intelligence & the future of clinical trials: the potential of AI to help with study planning

    • Identify and assess the possibilities for AI in your clinical trial
    • Understanding the technologies behind AI such as machine learning, deep learning, neural networks, and algorithms
    • Social and ethical implications of Artificial Intelligence
    • A contextual understanding of AI, its history, and evolution, helping you to make relevant predictions for its future trajectory.
    • Looking at how to successfully implement AI into your clinical trial

    Speakers

    Venkat Sethuraman, Ph.D MBA
    Head of Global Biometrics and Data Sciences, Bristol Myers Squibb

    10 AM

    Optimize Your Trial Execution with the Strategic Use of an Experienced Technology Solutions Team

    It takes more than reading a protocol to design and implement technology for a successful clinical trial. It takes years of knowledge and experience to fully understand the risks and provide meaningful insights into best practices that ensure all stakeholders achieve their goals. Before and during a clinical trial, planning decisions across many complex processes is required.

    Areas of discussion will include how an expert and experienced team can set up your organization for success in all phases, including.

    • study design
    • recommendations
    • blinding concerns
    • mid-study changes
    • supply management

     

    Speakers

    Kevin Collier
    VP, Medidata

    10:30 AM

    Morning Refreshments & Networking

    11 AM

    Strengthening patient relationships authentically to enhance the therapeutic development process

    Abstract: Gain a comprehensive understanding of a patient’s journey to advocacy highlighting important pillars of successful patient engagement directly from a patient advocate’s experiences. Understanding and recognizing the barriers, burdens, knowledge gaps, and needs of patients allows for strengthened patient relationships and optimizes long term gains in patient engagement strategies

    • Treating the patient as more than a consumer builds the foundation for patient relationships
    • Recognizing and mitigating the barriers patient trial participation and retention
    • Understanding the value of incorporating the patient voice from the inception and design of research and trials through drug development
    • Improving health literacy and ensuring transparency builds trust
    • Maintaining patient relationships through a feedback loop of dissemination of trial results and co-creation in design strengthens future research

    Speakers

    Ella Balasa
    Patient Advocate, speaker, published writer, and health engagement consultant

    11:30 AM

    The Last Millimeter is Everything: Essential Guide for Home Visits

    • Home visits have evolved since their inception in 2003
    • Services possible in 2023 – an overview of what is possible today
    • Sourcing the right professionals for visits is essential to success

    Speakers

    Ellen Weiss
    Vice President, In-Home Solutions, Decentralized Clinical Trials, PCM Trials

    12 PM

    Panel: Reversing the Conversation: What the clinical trial industry really wants from its service providers

    We’ve all had to sit through several pitches from vendor companies telling us what they can do for us, but now it’s time to reverse the conversation! Hear from the trial industry as they discuss the services, they would like to see from their solution providers, including:

    • What they like to see in an outsourced partner organization
    • What they would like a partner to know about them / how they work
    • What things do they need a partner to do and what they don’t need!
    • What things can be best done in house?

    Speakers

    Adam Kinsey
    Associate Vice President, Global Clinical Trial Operations (GCTO), Head of GCTO North America, Merck Novotech
    Alex Ireland
    Associate Director Business Development, Novotech

    12:30 PM

    Clinical Trial Liaisons’ Support of Psychedelic Clinical Trials

    • Psychedelic-assisted therapy has shown potential in the treatment of severe mood and anxiety disorders, including major depressive disorder (MDD) and post-traumatic stress disorder (PTSD)
    • Worldwide is a leader in psychedelics and understands the importance of selecting sites that have the appropriate support services as well as specialized training
    • Worldwide Clinical Trial Liaisons (CTL) provide support to sites as they navigate psychedelic clinical trials, helping sites integrate psychedelic clinical studies into their practice and manage expectations

    Speakers

    Alison Bedenkop
    Senior Director, Patient Recruitment and Retention, Worldwide Clinical Trials

    1 PM

    Lunch and networking

    2 PM

    Protecting our planet: Sustainable drug development

    • Understanding the environmental and social impacts of clinical trials
    • Collaborating with supplier ecosystems to drive sustainability goals
    • Sustainability by design: innovation and changing behaviours

    Speakers

    Anthony Fuller
    Global Head of Sourcing, Mitsubishi Tanabe Pharma Development America

    2:30 PM

    A Clinical Outsourcing Model That’s As Agile As Your Development Program

    The clinical development landscape is entering a phase of accelerated innovation. Is your clinical outsourcing strategy ready to evolve and adapt to the new trial designs, skills, geographies and technologies to deliver on those needs? This session will explore outsourcing models and trends, as well as emerging models and metrics to consider

    Speakers

    Neil Berger
    Vice President, FSP Commercial and Operational Strategy, Parexel

    3 PM

    Encouraging public health literacy, patient education and engagement; informing and empowering patients and the public as partners in clinical research

    • Focusing on nurturing our established relationships, building new ones, and on identifying and developing new opportunities.
    • Discussing how to serve patient communities and clinical research stakeholders throughout the world with the highest quality educational and advocacy services

    Speakers

    Jill McNair
    Chief Growth Officer, CISCRP

    3:30 PM

    Afternoon refreshments, networking and Apple prize draw

    4 PM

    How CRO’s can help sponsors be the sponsor of choice, a partnership with CRO’s population of sites and conducting clinical trials

    • Removing the bias for sites to engage with CROs in the same way as sponsors
    • The ability to leverage a CRO’s global reach for clinical trial site footprint

    Speakers

    Adam Barrows
    Executive Director - Solid Tumour TA Head, Bristol Myers Squibb

    4:30 PM

    Innovative Processes to Better Address Today’s Trial Dynamics

    • Supply Chain Efficiency
    • Why do extra work and spend more money than necessary?

     

    • Payment Process Efficiency
    • Leverage an existing workflow process that sites use everyday

     

    • Understanding the Total Value a Vendor Can Provide
    • Select a vendor that can demonstrate its total value (and make you look good in the eyes of your company)

    Speakers

    5 PM

    Chairperson’s closing remarks followed by Drinks Reception

    END OF DAY 1 AND NETWORKING DRINKS

    10:30 AM

    Morning Refreshments & Networking

    11 AM

    Data Management in Oncology; the importance of using suitable technology in your clinical trial, leading to a manageable data structure

    • Challenges: How we collect data – number of data forms and adverse effects in oncology
    • Using the right technology
    • Understanding the importance of data
    • Looking at how to manage your data structure

    Speakers

    Narayan Lebaka
    Senior Director, Clinical Data Management, Inspirna

    11:30 AM

    Advancements in AI: turning big data into actionable intel for optimal site identification

    Despite advancing technologies, trials still struggle to meet patient enrolment goals. Slow enrollment directly impacts schedule and budget, with each day of delay carrying cripplingly high costs. Successful, timely patient recruitment is directly linked to effective site selection. Conversely, selecting the wrong site can negatively impact recruitment or result in total failure to enroll patients.  Join us to learn how advancements in AI can help the pharma industry identify the best sites for their clinical trials through the harnessing of big data. Topics include:

    • Transitioning from data overload to data driven decision-making
    • The role of Artificial Intelligence in optimizing site identification and selection
    • Expected and unexpected downstream benefits of an AI-enabled site selection strategy

    Speakers

    Travis Caudill
    Vice President Feasibility, Site Identification & Clinical Informatics Feasibility & Site Identification Integration Workstream Lead, ICON

    12 PM

    FIRESIDE CHAT Are We Committed to Not Going Back?

    Are We Committed to "Not Going Back"?

    The rapid introduction of new approaches to sustain clinical trials during the COVID-19 pandemic drove substantial early enthusiasm that there was "no going back"

    But with the convergence of the end of the pandemic along with a challenging economic environment, can we sustain this promise? How do we mitigate the risk of sliding backward and losing the positive changes introduced during the last two years?

    • Discuss the factors bringing new challenges to the adoption of innovative approaches in clinical trials
    • Explore how some organizations may be "over the crest" in change and adoption while others may "slide back"
    • Consider strategies to sustain forward momentum and progress despite new organizational challenges

    Speakers

    Hassan Kadhim
    Senior Director, Head of Clinical Trial Business Capabilities, Bristol Myers Squibb

    12:30 PM

    The Digital-First Future of Clinical Trials

    Technologies for life sciences were initially problem-solving solutions designed to streamline the management of clinical trials, speed up processes, and make data collection more accurate. Now, the industry is embracing a digital transformation enabled by widespread communication networks, proliferation of mobile devices, modern software approaches, and consumer industries.

     

    Digital technologies are now viewed as solutions that can reduce site and patient burdens in clinical trials, improve access to trials, increase clinical trial diversity, and collect higher-quality data that can be used in more powerful ways to aid research.

     

    In this session, we will discuss the importance of user-focused design when implementing digital health technologies such as eCOA, eConsent, telemedicine, wearables and more, to help create a better user experience and provide better quality data throughout a clinical trial.

    Speakers

    Donna M. Mongiello, RN, BSN
    Senior VP, Strategic Solutions, YPrime
    Joseph Im
    Director, Digital Health Technologies Operations, Regeneron

    1 PM

    Lunch and networking

    2 PM

    Leveraging study participants’ Real-World Data to enable researchers to confirm the representativeness of the baseline

    A patient enrols in a trial, is administered test drug, and has an outcome.  Post-treatment results are compared to pre-treatment to claim a change from baseline.  That is the classic method to establish a drug effect, whether it’s a positive treatment outcome or an adverse effect. But, this absolute dependence on the single baseline measurement may be unsubstantiated.

    • Looking at the reliability of baseline values
    • Leveraging real world data for that participant from their Electronic Medical Record

    Speakers

    2:30 PM

    Decentralization through Centralization: Thinking the Unthinkable in Clinical Trials

    Decentralized clinical trials (DCTs) and centralized monitoring (CM) are two buzz words which appear contradictory to each other prima facie, bur are in fact very much symbiotic.
    There is a consensus amongst most clinical trial stakeholders that DCTs are the future of clinical trials. It is a disruptive approach with immense potential to make clinical trials “Patient-centric”. However, as is true for any innovation, DCTs also comes with unique set of risks and require innovative monitoring model to mitigate the same.
    DCTs collect data from multiple heterogenous sources and in high volumes which increases the risks related to data integrity, interpretation, and even patient safety.
    The traditional method of 100% source data verification (SDV) is inefficient to match the speed and complexity of DCTs, which requires a more proactive and structured approach as provided by CM. The focus of CM is the critical data points and critical processes

    which are likely to have maximum impact on data integrity. CM is concerned less with how the data looks like in an individual Case report Form (CRF), but more on the aggregated data through metadata driven harmonization across different modalities. Also, it can be much more proactive than traditional SDV. Hence, it will be wise to conclude that CM can provide the best required support for DCTs. Modern clinical trial implementation process and innovative digital solutions will be discussed to increase study access, reduce patient burden, improve data quality, integrity and management.

    Speakers

    Dr Atul Gupta, MD
    Vice President, Medical Services and Client Solutions, Navitas life Sciences

    2:45 PM

    Running Up That Hill: Accelerate Cycle Times & Reach Patients Faster with elluminate

    Operational oversight within outsourced models has become increasingly complex for teams who are tasked with managing trials amid a rapidly changing landscape of partners, technologies, and global regulations. Data proliferation along with dwindling resources has made it a top priority for clinical development teams to look to technology to improve cycle times and the overall experiences of data managers, medical monitors, and clinical operations leaders.

    This presentation will highlight how the elluminate Clinical Data Cloud and Biometrics Services can reshape your data architecture by automating data flows to keep up with the pace of data evolution and speed time to insights.

    Learn how elluminate and eClinical’s Biometrics Services deliver:

    • Operational insights across numerous data sources that provides definitive answers and analytics on enrollment, protocol compliance and safety
    • Improved study oversight with a holistic view of risk across all data sources
    • 50 out-of-the-box visualizations to support supports cross-study analysis for deeper insights with self-service access to clinical and operational analytics
    • Increased productivity across data management, medical monitoring, clinical operations, clinical programming and statistical analysis roles

    Speakers

    Jason Konn
    Solution Consultant, eClinical Solutions

    3 PM

    FIRESIDE CHAT: Clinical Trials. What the Changing Social, Political and Economic Landscape Means for Evidence

    The US and countries around the globe are in the midst of shifts in their demographic and political systems.  This has significant implications for developing and applying evidence. Research systems, clinical trial recruitment and retention, and even data analysis must change to ensure new technologies and therapeutics are effective for as many people as possible. This fireside chat will explore several important questions:

     

    • Is diversity in clinical trials possible?
    • What diversity practices can be applied to clinical trials in order to operate smoothly and within budget?
    • What are the consequences of leaving people out?
    • How can we ensure that newly created evidence is applicable for everyone?

    Moderator: Rosalie Filling, Vice President, Clinical Operations & Biometrics, Endo Pharmaceuticals

    Speakers

    Linda Blount
    President, The Black Women's Health Imperative

    3:30 PM

    Afternoon refreshments, networking and Apple prize draw

    4 PM

    Featured New Technology Presentation: Administration of Respiratory Therapeutics with a Device and Fixed Dose Drug Combination Using Portable Medical Vaporizers

    • First usage of Portable Therapeutic Vaporizers as a new delivery modality for prescription drugs arising out of technologies originally developed as electronic nicotine delivery systems (ENDS)
    • Advantages in safety and efficacy of delivering respiratory drug regimens directly to sinus, throat and lung tissue in gas vapor form
    • Likely regulation of a new therapeutic delivery modality
    • Clinical trial challenges for therapeutic vape device and drug systems

    Speakers

    John Gregg
    Chairman and CEO at BalinBac Therapeutics, Inc.

    4:30 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

    Streams

    Stream one

    Outsourcing and Clinical Operations

    Stream two

    Clinical Innovation & Technology

    8:15 AM

    Registration and Refreshments

    9 AM

    What does it really take to achieve global IDEA in clinical trials?

    • Inclusion, Diversity, Equity, and Access
    • Major barriers to achieving IDEA for sponsors and investigator teams
    • Recent regulatory guidelines
    • Strategies for achieving IDEA in clinical trials

    Speakers

    9:30 AM

    Work smarter, not harder: Fulfilling your cardiac safety requirements without a Thorough QT (TQT) study

    • Recent updates to the ICH guidance enable several pathways to a TQT waiver
    • High quality ECG data in phase I can enable early decision making
    • Save time and substantial cost compared to a dedicated TQT study
    • Not just for oncology; applicable for all TAs

    Speakers

    Todd Rudo, MD
    EVP & Chief Medical Officer, Clario

    10 AM

    Interactive Session: The Elephant in the room – what is holding you back from developing key relationships when managing your trials? Are you in your own way?

    How do you relate and interact with:

    • Your Study Team
    • Your Vendors
    • Your Manager
    • Yourself
    • Are you willing to face others’ perceptions of you?

    This will be a brief presentation followed by an Open discussion on some barriers to communication that Clinical Operations professional experience.

    Speakers

    Jenny Wakefield
    Senior Director- Quality Development Operations, Incyte

    10:30 AM

    Morning refreshments and networking

    11 AM

    Population Health & Diversity in Clinical Trials

    • Highlighting the importance of inclusion
    • Focusing on the opportunities within Decentralised Clinical Trials to encourage enhanced enrolment of minority and diverse populations into research
    • Understanding why we struggle to recruit a varied patient population; how improving our recruitment can improve our study results
    • Looking into the best step forward

    Speakers

    Ram Raju
    Senior Vice President and Community Health Investment Officer, Northwell Health

    11:30 AM

    Outsourcing independent committees: benefits, operational considerations, and best practices

    From mitigating risk to ensuring independent expert committee success, proper management and setup is crucial. During this session, we will discuss outsourcing independent committees, industry best practices, and operational strategies that drive meaningful results.

    Speakers

    David Cutler
    Director, Project Management, WCG

    12 PM

    PANEL DISCUSSION: What are the different outsourcing relationships and how do you manage them?

    • What are the categories and the driving needs for 2023?
    • How has this changed over the years?
    • Key strategies that sponsor companies have – how has this changed?
    • Did the pandemic effect these strategies?

     

    Speakers

    Kevin Shipe
    Director, Head of Strategic Sourcing and Study Start-up, INOVIO Pharmaceuticals
    Adam Barrows
    Executive Director - Solid Tumour TA Head, Bristol Myers Squibb
    Sherin Abdel-Meguid
    President, Shifa Biomedical Corporation
    Lauren Colfer
    Former Vice President, Clinical Operations at Aceragen Pharmaceuticals

    12:45 PM

    Lunch and Networking

    1:45 PM

    Collaborating across Functions to Improve the Forecasting, Budgeting, and Accruals Process

    This fireside chat will focus on the accrual/forecasting process for Clinical trial budgets. Specifically, the processes for working with vendors to obtain current accruals and forecasts. We will also discuss coordination with the internal functions at the Sponsor to ascertain the most accurate and current timelines, enrollment rates, screen failure and drop out rates. Aligning all expectations with both the operations teams as well as Finance and Senior Management.

    Speakers

    Rick O’Hara
    Director of R&D Business Operations, Endo Pharmaceuticals

    2:15 PM

    PANEL DISCUSSION: Diversity & Inclusion in Clinical Trials

    • Increasing diversity in clinical trials; overcoming critical barriers
    • Focusing on the application of diverse populations
    • Action for increasing diversity
    • Regulatory Updates

    Speakers

    Linda Blount
    President, The Black Women's Health Imperative
    Jenifer Waldrop
    Executive Director, Rare Disease Diversity Coalition
    Jen Horonjeff
    CEO, Savvy Cooperative
    Ram Raju
    Senior Vice President and Community Health Investment Officer, Northwell Health

    3 PM

    Afternoon refreshments and Apple prize draw

    3:30 PM

    ROUNDTABLE SESSIONS

    During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

    Roundtable 1 - Strategies for Country and Site Selection 

    Kelly Ragins, Global Head of Portfolio Delivery Office, Novartis

    Roundtable 2 Implementing effective vendor management tools and communication strategies to avoid the failure of clinical trials 

    Kathleen Cohen, Head of Clinical Operations, Marinus Pharma

    Roundtable 3 Top Tips in Effective Budget Management, Forecasting and Contracting: Ensuring Your Resources Are Allocated Correctly 

    Kevin Shipe, Director, Head of Strategic Sourcing and Study Start-up, INOVIO Pharmaceuticals

    Roundtable 4 Decentralised Clinical Trials; a discussion on transforming clinical trial development

    Candice Estes, Clinical Trial Manager, Clinical Operations, Incyte

    Roundtable 5 Discussing intersections with rare diseases, health disparities and clinical trial research

    Jenifer Waldrop, Executive Director, Rare Disease Diversity Coalition

    Speakers

    Kelly Ragins
    Global Head of Portfolio Delivery Office, Novartis
    Kevin Shipe
    Director, Head of Strategic Sourcing and Study Start-up, INOVIO Pharmaceuticals
    Candice Estes
    Clinical Trial Manager, Clinical Operations, Incyte
    Jenifer Waldrop
    Executive Director, Rare Disease Diversity Coalition

    4:30 PM

    Chairman’s closing remarks

    END OF DAY TWO

    9 AM

    Digital and telehealth; remote monitoring in clinical trials

    • Integrating apps and wearables into your clinical study: what additional benefits can this bring?
    • Combining remote monitoring with risk-based monitoring to deliver a successful decentralised trial
    • How consumer-wearables can provide enhanced access to clinical trials
    • Compiling data from wearables to contribute toward clinical trials
    • Overcoming common issues around using data collected remotely

    Speakers

    Jen Horonjeff
    CEO, Savvy Cooperative

    9:30 AM

    From Concept to Breakthrough: The Case for AI/ML in Clinical Development

    The industry is facing significant challenges finding the right resources to deliver operational best practices. There is also an expectation to move at the “speed of Covid” for every trial. It feels like an either/or.

     However, you can have both. You can accelerate times with fewer resources - by applying artificial intelligence (AI) and machine learning (ML) to key clinical development processes.

     Join this exciting session to learn how you can use AI/ML - and other advanced technologies - to:

    • Centralize and standardize your trial data
    • Accelerate the data review and cleaning process
    • Understand how patients are responding to treatment
    • Prevent early withdrawals, screen failures, and even potential adverse events
    • Automate raw data transformation for regulatory submissions

    Speakers

    Ted Kirby
    Senior Director, Product Marketing, Saama

    10 AM

    Blockchain comes before Artificial Intelligence – Exploring the Implications for the Future In this session Frank Leu, CEO at BioPharMatrix explores where he sees Blockchain going in the future, its implications and whether we should all be investing in it.

    • What is blockchain?
    • How can it be adapted in the Clinical Trial?
    • Why do we need to reach a consensus platform as soon as possible?  Who gets to decide this, will it be FDA or the Pharma industry?
    • What would be its cost impact on drug development?
    • Why does the C-suite need to engage in blockchain use immediately?

    Speakers

    Frank Leu
    CEO, BioPharMatrix

    10:30 AM

    Morning Refreshments & Networking

    11 AM

    Fireside Chat: Leveraging global trial footprint to accelerate clinical development

    Clinical trial conduct is facing multiple challenges from budget pressure, patient recruitment difficulties, to regulatory uncertainties. At the beginning of each development program, companies need to plan for global trial capabilities by utilizing multiple geographic locations for clinical trials to accelerate the development process. This approach allows for larger and more diverse patient populations to be enrolled, leading to faster completion of trials and ultimately getting treatments to market faster. A global trial footprint also enables the collection of data in different regions and across different populations, providing valuable insights into the efficacy and safety of treatments. By leveraging a global trial footprint, biotech and pharmaceutical companies can overcome barriers to clinical development and bring life-saving treatments to patients more quickly.

    Speakers

    YuFeng Li
    Executive Director, Clinical Development Qilu Pharmaceuticals
    Will Newton
    Senior Healthcare Reporter, Clinical Trials Arena, GlobalData Healthcare

    11:30 AM

    Leveraging predictive analytics to improve patient retention, data quality, and enrollment outcomes in clinical trials

    Clinical trial data complexity has tripled in the past decade, leading to fragmented data, insights, and stakeholder collaboration. These data complexities pose significant inefficiencies in the research and drug development process and are exacerbated as clinical operations teams become leaner and cost-constrained. 

    In this presentation, you will gain insight to real world case studies that use Lokavant to radically improve clinical trial outcomes, as well as overall successes for leaner study teams.

    Speakers

    Rohit Nambisan
    CEO & Co-Founder, Lokavant

    12 PM

    PANEL: Addressing the issues with Decentralised Clinical Trials and how we may work collaboratively to overcome them; addressing the pitfalls & challenges

    • There are varied viewpoints on the success of DCT’s, we are therefore using this panel as a platform to discuss issues raised within processes
    • Are timelines actually increasing? Taking into consideration site staff turnover and knowledge base
    • It is said DCT’s will enhance patient recruitment, is this the truth in practice? Looking into patient’s ability to par-take and keep to trial timelines considering factors beyond our control
    • Site Perspective; their involvement with sponsors and the differences with their involvement of the trial

    Moderator: Peter O'Neill, Senior Director, Clinical Operations, Cellectis
    Panelists:
    Anka G. Ehrhardt, Director, Cell-Based Sciences, AR&D, Merck
    Dominique Duchesne, VP Global Head of Clinical Operations, Ichnos Sciences

    Speakers

    Peter O’Neill
    Senior Director, Clinical Operations, Cellectis
    Anka G. Ehrhardt
    Director, Cell-Based Sciences, AR&D, Merck
    Dominique Duchesne
    VP Global Head of Clinical Operations, Ichnos Sciences
    Susan Maloney
    Former Associate Vice President, Head Clinical Operations, PhaseBio
    Keith Kennedy
    Principal and Team Lead, Patient Cloud, Medidata
    Candice Estes
    Clinical Trial Manager, Clinical Operations, Incyte

    2023 Speakers

    Select a speaker to learn more

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    Session Details:

    Keynote We Are All At-Risk of Being Obsolete: Earning Our Place in the Future of Clinical Research

    2023-05-23, 8:30 AM

    Session Details:

    FIRESIDE CHAT Are We Committed to Not Going Back?

    2023-05-23, 12:00 PM

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    Session Details:

    Panel: Reversing the Conversation: What the clinical trial industry really wants from its service providers

    2023-05-23, 12:00 PM

    Session Details:

    PANEL DISCUSSION: What are the different outsourcing relationships and how do you manage them?

    2023-05-24, 12:00 PM

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    Peter O’Neill
    Senior Director, Clinical Operations, Cellectis

    "Work Hard, Stay Calm, and Cure Cancer! This is Peter O'Neill's motto while conducting oncology clinical trials at Cellectis, where he is Senior Director of Clinical Operations. Peter was named to PharmExec’s list of "2020 Emerging Pharma Leaders” and has been conducting clinical trials for over 24 years, formerly at Incyte, Sanofi, and Beth Israel Deaconess Medical Center. He is passionate about developing new therapies for patients, with a focus on innovative strategies to enhance the clinical trial experience for participants, caregivers, and care teams.

    Session Details:

    Chairperson’s opening remarks

    2023-05-23, 8:20 AM

    Session Details:

    PANEL: Addressing the issues with Decentralised Clinical Trials and how we may work collaboratively to overcome them; addressing the pitfalls & challenges

    2023-05-24, 12:00 PM

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    John Gregg
    Chairman and CEO at BalinBac Therapeutics, Inc.

    John Gregg, Pharmaceutical industry executive, John Gregg, has extensive experience in worldwide clinical development and commercialization of new anti-infective drugs. He has spent much of his career in senior roles directing the development and commercialization efforts for a large number of antibiotic, anti-protozoal, anti-fungal and anti-viral drugs. He is a veteran of new product development leadership positions at Pfizer, Novartis, J&J, BMS, and more recently his start-ups, Symbiomix Therapeutics, LifeQual Pharmaceuticals, and AkaRx. He is now the CEO of a BalinBac Therapeutics, Inc., a specialty infectious disease and microbiome modulation company. He was trained as a microbiologist and has led multi-disciplinary anti-infective drug development teams at the largest pharmaceutical companies, as well as small, private specialty firms directing the work of colleagues and contract laboratories

    Session Details:

    Featured New Technology Presentation: Administration of Respiratory Therapeutics with a Device and Fixed Dose Drug Combination Using Portable Medical Vaporizers

    2023-05-23, 4:00 PM

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    Session Details:

    What does it really take to achieve global IDEA in clinical trials?

    2023-05-24, 9:00 AM

    Session Details:

    PANEL DISCUSSION: Diversity & Inclusion in Clinical Trials

    2023-05-24, 2:15 PM

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    Jill McNair
    Chief Growth Officer, CISCRP

    Jill has worked in the industry for over 25 years. She is the Chief Growth Officer at the Center for Information and Study on Clinical Research Participation (CISCRP) where she has worked since 2007. I joined CISCRP in 2007 to advance our mission to inform and empower patients and the public as partners in clinical research. Throughout my tenure, I have led a variety of teams and functions in delivering on our mission and advocating for public health literacy, patient education and engagement.

    In my new role as Chief Growth Officer, I focus on nurturing our established relationships, building new ones, and on identifying and developing new opportunities. As a non-profit innovator, CISCRP is uniquely positioned to serve patient communities and clinical research stakeholders throughout the world with the highest quality educational and advocacy services. I’m so excited about the trajectory of CISCRP’s growth and welcome the opportunity to nurture current and new relationships and collaborations.

    As a non-profit innovator, Jill serves patient communities and clinical research stakeholders throughout the world with the highest quality educational and advocacy services.

    Jill received her MBA from the Fox School of Business at Temple University, and she resides in Bucks County, PA with her husband, three children and three dogs.

    Session Details:

    Encouraging public health literacy, patient education and engagement; informing and empowering patients and the public as partners in clinical research

    2023-05-23, 3:00 PM

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    Narayan Lebaka
    Senior Director, Clinical Data Management, Inspirna

    Narayan has and ten (10)+ years of award-winning and progressive experience delivering the highest standards of clinical data management at Bayer and Bristol Myers Squibb (BMS). Bayer Gold Award 2017, Bronze Award 2016, and Pinnacle Award 2015; BMS Performance Award. In-depth knowledge of all aspects of clinical data management, reporting, reconciliation, study reviews, and standards development that drive pharmaceutical businesses forward. 

    Session Details:

    Data Management in Oncology; the importance of using suitable technology in your clinical trial, leading to a manageable data structure

    2023-05-23, 11:00 AM

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    Rick O’Hara
    Director of R&D Business Operations, Endo Pharmaceuticals

    Session Details:

    Collaborating across Functions to Improve the Forecasting, Budgeting, and Accruals Process

    2023-05-24, 1:45 PM

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    Anthony Fuller
    Global Head of Sourcing, Mitsubishi Tanabe Pharma Development America

    Passionate sustainability and procurement leader with the mission to put ESG at the heart of all supplier relationships. 15+ years' senior level experience, driving strategic partnerships and embedding sustainability goals into supply network. Collaboration catalyst, initiative builder, and speaker, I put responsible sourcing front and center in business and procurement strategy.

    Session Details:

    Protecting our planet: Sustainable drug development

    2023-05-23, 2:00 PM

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    Ram Raju
    Senior Vice President and Community Health Investment Officer, Northwell Health

    Dr. Ram Raju has a distinguished career over 40 years as a healthcare provider, teacher, researcher and community organizer. In his role at Northwell Health, Dr. Raju set the strategic vision to improve population health by finding ways to meet the needs of its most vulnerable communities, by examining the existing programs aimed at improving the health system's response to the community's needs and working with local organizations to address them. Northwell Health is the largest healthcare provider in the state of New York, is a system with 23 hospitals and 830 outpatient facilities that sees 2 million people every year in the New York metro area and beyond.

    Session Details:

    PANEL DISCUSSION: Diversity & Inclusion in Clinical Trials

    2023-05-24, 2:15 PM

    Session Details:

    Population Health & Diversity in Clinical Trials

    2023-05-24, 11:00 AM

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    Frank Leu
    CEO, BioPharMatrix

    Session Details:

    Blockchain comes before Artificial Intelligence – Exploring the Implications for the Future In this session Frank Leu, CEO at BioPharMatrix explores where he sees Blockchain going in the future, its implications and whether we should all be investing in it.

    2023-05-24, 10:00 AM

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    Session Details:

    Collaborating across Functions to Improve the Forecasting, Budgeting, and Accruals Process

    2023-05-24, 1:45 PM

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    Adam Barrows
    Executive Director - Solid Tumour TA Head, Bristol Myers Squibb

    Adam joined Bristol Myers Squibb in 2016 and has held various roles in Oncology Clinical Protocol Operations, Oncology Clinical Development and Global Clinical Trial Strategy & Operations.  Adam is currently the Global Development Operations Therapeutic Area Head for Solid Tumor Oncology leading a team of Operation Portfolio Leads with Full Development.  Before joining BMS, Adam worked for several other sponsors (Wyeth, Merck) and CRO partners across all phases of development and multiple indications including Metabolism, cardiovascular, CNS and Oncology.   Having started his clinical career as a Clinical Nurse Assistant he built upon this experience at the patient bedside and started in industry with a role in data management but has spent the bulk of his time in clinical trial management (project and portfolio management).  Adam holds his Bachelor of Science in Biology and French and a Master of Business Administration.  Adam lives in Pennsylvania, with his wife, Marci, and two children, Vivienne and Oliver.  He is an avid morning runner and usually starts his day with a few miles run and the obligatory few cups of coffee.

    Session Details:

    How CRO’s can help sponsors be the sponsor of choice, a partnership with CRO’s population of sites and conducting clinical trials

    2023-05-23, 4:00 PM

    Session Details:

    PANEL DISCUSSION: What are the different outsourcing relationships and how do you manage them?

    2023-05-24, 12:00 PM

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    Session Details:

    Panel: Reversing the Conversation: What the clinical trial industry really wants from its service providers

    2023-05-23, 12:00 PM

    Session Details:

    ROUNDTABLE SESSIONS

    2023-05-24, 3:30 PM

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    Ella Balasa
    Patient Advocate, speaker, published writer, and health engagement consultant

    Ella Balasa is a patient advocate, consultant, and a person living with cystic fibrosis. She has committed her time to empowering patients and advancing healthcare strategies. She speaks publicly about the value of patient perspective and has a passion for distilling clinical information for patient communities. Through opportunities working with healthcare organizations on content strategy, writing, speaking, clinical trial development, and sharing the patient experience she aims to affect the healthcare landscape by raising awareness of rare diseases, promoting self-advocacy to patients, and valuable insights to organizations. More of her work and experiences can be found at www.ellabalasa.com.

    Session Details:

    Strengthening patient relationships authentically to enhance the therapeutic development process

    2023-05-23, 11:00 AM

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    Kelly Ragins
    Global Head of Portfolio Delivery Office, Novartis

    Session Details:

    ROUNDTABLE SESSIONS

    2023-05-24, 3:30 PM

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    Anka G. Ehrhardt
    Director, Cell-Based Sciences, AR&D, Merck

    Dr. Ehrhardt is a biophysicist with a Ph.D. in human physiology. Throughout her career, she focused on driving biomedical research through efficient application of innovative technologies and strategies. She built and led successful teams in industry, including at Merck, where she headed a laboratory providing leading technologies for cell-based research from early discovery through manufacturing; and at BMS where Dr. Ehrhardt led and grew an international clinical assay team to robustly cover large scale registrational and translational clinical analysis generating clinical decision-driving data and mechanistic insights for immuno-oncology, cardiovascular, immunology, metabolic and rare disease studies. Before returning to Merck, Dr. Ehrhardt fulfilled one of her scientific aspirations at CHDI Foundation, designing and implementing successful clinical biomarker discovery and development strategies for Huntington’s disease. Currently, at Merck, Dr. Ehrhardt is providing strategic and technical leadership for the development and implementation of industry-leading and QC-friendly cell-based assays and models for potency determination that reflect the unique mechanisms of biologics products in clinical studies and beyond.

    Session Details:

    PANEL: Addressing the issues with Decentralised Clinical Trials and how we may work collaboratively to overcome them; addressing the pitfalls & challenges

    2023-05-24, 12:00 PM

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    Venkat Sethuraman, Ph.D MBA
    Head of Global Biometrics and Data Sciences, Bristol Myers Squibb

    Venkat Sethuraman is currently the Global Head of Biometrics and Data Sciences at Bristol Myers Squibb, where he is accountable for the biostatistics/quantitative support to R&D Global Development and Medical organization. In addition, Venkat leads the Innovation Pillar for the Global Drug Development.

    Prior to BMS, Venkat was a partner at a management consulting firm, where he led the R&D clinical development and operations. While there, he worked closely with R&D leaders of top 10 pharma companies in driving data-driven clinical decision-making, leveraging advanced analytics and data science. Venkat has held various leadership roles at BMS, Novartis Oncology and GSK leading quantitative and biometrics organization. Venkat has diverse research interests and consulting experience in industry that includes clinical trials design, innovative trial models, data science, and most recently, digital efforts in clinical research.

    Venkat received a PhD in statistics from Temple University and an MBA from the Wharton School of the University of Pennsylvania. He currently serves on the Board of Association for Women in Science (AWIS) and has served on the board of the Biopharmaceutical Section of the American Statistical Association.

     

    Session Details:

    Artificial Intelligence & the future of clinical trials: the potential of AI to help with study planning

    2023-05-23, 9:30 AM

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    Adam Kinsey
    Associate Vice President, Global Clinical Trial Operations (GCTO), Head of GCTO North America, Merck Novotech

    Adam Kinsey is currently Associate Vice President and Regional Head of North America for Global Clinical Trial Operations (GCTO) at Merck Research Laboratories. He has over 25 years of clinical research experience, with the last 8 at Merck. He has been a key leader within GCTO, most recently serving as Executive Director, GCTO Clinical Sciences & Study Management (CSSM) and Therapeutic Area Section (TAS) Head: Melanoma, Hepatobiliary Cancers, and Innovative Strategies. Previously, Adam was Clinical Research Director (CRD) Oncology where he served as Director of country clinical operations activities in the United States for Merck’s oncology pipeline. Adam started his career as a CRA and has traversed through various roles in clinical operations of increasing responsibility and scope. He also has experience across a wide array of therapeutic areas and with companies of different sizes and operating models. Adam has a bachelor’s degree in biology from Rice University in Houston. He completed post-baccalaureate course work at Houston Baptist University and coursework toward a Master of Public Health (MPH) degree at the University of Texas School of Public Health in Houston.

    Session Details:

    Panel: Reversing the Conversation: What the clinical trial industry really wants from its service providers

    2023-05-23, 12:00 PM

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    Susan Maloney
    Former Associate Vice President, Head Clinical Operations, PhaseBio

    Session Details:

    PANEL: Addressing the issues with Decentralised Clinical Trials and how we may work collaboratively to overcome them; addressing the pitfalls & challenges

    2023-05-24, 12:00 PM

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    Linda Blount
    President, The Black Women's Health Imperative

    Linda Goler Blount, MPH, is the President and CEO of the Black Women’s Health Imperative, the only national organization focused on Black women’s emotional, physical and financial health. Since joining the organization in 2014, Ms. Blount has overseen more than $20 million invested in Black women and research to prevent chronic disease and HIV, ensure reproductive justice and healthy maternal outcomes, and advocate for health promoting policies. Ms. Blount, an epidemiologist, edited IndexUS, the first research on Black women’s health based on healthy Black women. Her career includes successful tenures at CDC, the Coca-Cola Company and consulting with health ministries in countries in Europe, Africa and the Caribbean.

    Session Details:

    FIRESIDE CHAT: Clinical Trials. What the Changing Social, Political and Economic Landscape Means for Evidence

    2023-05-23, 3:00 PM

    Session Details:

    PANEL DISCUSSION: Diversity & Inclusion in Clinical Trials

    2023-05-24, 2:15 PM

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    Jenifer Waldrop
    Executive Director, Rare Disease Diversity Coalition

    Jenifer Ngo Waldrop joined the Black Women’s Health Imperative (BWHI) as Executive Director of the Rare Disease Diversity Coalition (RDDC) in October 2022. Before joining the leadership team of RDDC, she developed models and programs for diversity, equity, and inclusion initiatives to support multiple business units with Fortune 500 companies and organizations in Asia, Canada, and the US.

    Jenifer has led initiatives at non-profit organizations where she recruited local community members to participate in numerous health-related fundraising events and developed programs to target disparities and underrepresented groups. In addition to facilitating development and fundraising, Jenifer developed a reputation for successful coalition building.

    Jenifer received her undergraduate degree from Colby College and her Master of Human Resources Development from Villanova. As the Professional Development Director of the National Association of Asian-American Professionals (NAAAP) of Colorado, Jenifer continues her outreach in society. Through this organization, she mentors formally and informally.

    Session Details:

    ROUNDTABLE SESSIONS

    2023-05-24, 3:30 PM

    Session Details:

    PANEL DISCUSSION: Diversity & Inclusion in Clinical Trials

    2023-05-24, 2:15 PM

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    Evan Tzanis
    Chief Operating Officer and Executive Vice President, Head of R&D, Neuraptive Therapeutics
    Next speaker
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    Dominique Duchesne
    VP Global Head of Clinical Operations, Ichnos Sciences

    Dynamic leader in clinical operations with over 25 years of experience across various therapeutics areas.  After obtaining her master's degree in microbiology and immunology from a Canadian university, she joined the pharmaceutical industry where she held positions of increasing responsibility, most recently leading the clinical operations team at a small biotech company.  She has worked on programs in all phases of clinical development, in small and large organizations, and is recognized for building highly successful teams.  Her focus is providing guidance and removing obstacles to enable the team to execute efficiently while maintaining a strong sense of teamwork and enthusiasm.  She is passionate about helping others grow and develop and places a high priority on working with the members of her team to achieve their goals.

    Session Details:

    PANEL: Addressing the issues with Decentralised Clinical Trials and how we may work collaboratively to overcome them; addressing the pitfalls & challenges

    2023-05-24, 12:00 PM

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    Kevin Shipe
    Director, Head of Strategic Sourcing and Study Start-up, INOVIO Pharmaceuticals

    Session Details:

    ROUNDTABLE SESSIONS

    2023-05-24, 3:30 PM

    Session Details:

    PANEL DISCUSSION: What are the different outsourcing relationships and how do you manage them?

    2023-05-24, 12:00 PM

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    Jen Horonjeff
    CEO, Savvy Cooperative

    Jen Horonjeff, PhD, is a patient advocate and the Founder & CEO of Savvy Cooperative. She was named one of the 50 Most Daring Entrepreneurs by Entrepreneur Magazine, alongside Elon Musk and Reese Witherspoon, for her work at Savvy, which helps companies equitably gather input and insights from diverse patients. Jen is passionate about patient co-design as she grew up with juvenile idiopathic arthritis, and survived a brain tumor as an adult. She also holds a PhD in Environmental Medicine, and previously worked as a health outcomes researcher, a human factors engineer and user-centered designer, and an advisor to the FDA. Jen serves on the Board of Directors for The Sequoia Project, a non-profit focused on health data exchange, the Advisory Board of Trialbee, a clinical trial recruitment company, and numerous other committees to ensure the patient voice is included.

    Session Details:

    Digital and telehealth; remote monitoring in clinical trials

    2023-05-24, 9:00 AM

    Session Details:

    PANEL DISCUSSION: Diversity & Inclusion in Clinical Trials

    2023-05-24, 2:15 PM

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    Jenny Wakefield
    Senior Director- Quality Development Operations, Incyte

    Jenny Wakefield is an Adult and Pediatric Oncology and Critical Care Registered Nurse, ACRP-CP and CCRA Certified. Jenny graduated with her BSN from Florida International University in Miami, Florida, and has worked in Clinical Research since 1997 in a variety of roles, at the Site, CRO and Sponsor levels in all Phases of Global Clinical Trials and multiple disease indications. With her diverse experience, Ms. Wakefield brings a unique level of insight to the challenges faced in the management of Clinical Trials. Jenny currently is the Senior Director of Quality and Clinical Operations at Incyte. Ms. Wakefield’s specific focus is delivering Quality Programs with a humanistic approach, blending what’s expected from Clinical Research Professionals with what the real world presents.

    Session Details:

    Interactive Session: The Elephant in the room – what is holding you back from developing key relationships when managing your trials? Are you in your own way?

    2023-05-24, 10:00 AM

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    Sherin Abdel-Meguid
    President, Shifa Biomedical Corporation

    Dr. Abdel-Meguid has extensive experience in drug discovery. He built and managed a number of successful departments and drug discovery programs. He founded Shifa Biomedical Corporation (Shifa), a company dedicated to the treatment of cardiovascular diseases. He also founded ProXyChem, a company focused on providing drug discovery solutions to the biotech and pharmaceutical sector. Prior to this, he was Chief Scientific Officer and Co-Founder of Suntory Pharmaceutical Research Laboratories (SPRL), a structure-based drug discovery company dedicated to the treatment of cardiovascular and immune disorders. Before the formation of SPRL, he was Worldwide Director of Structural Biology and Director of Macromolecular Sciences at SmithKline Beecham (SB), now Glaxo SmithKline (GSK). He also served as Director of several therapeutic programs. Prior to SB, he was head of Biophysical Sciences and Protein Engineering at Monsanto. He has a PhD in Physical Chemistry and MS and BS in Biochemistry.

    Session Details:

    PANEL DISCUSSION: What are the different outsourcing relationships and how do you manage them?

    2023-05-24, 12:00 PM

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    Candice Estes
    Clinical Trial Manager, Clinical Operations, Incyte

    Candice Estes is as a Clinical Trial Manager at Incyte and works extensively in the decentralized trial space. She holds her Masters of Public Health in Epidemiology from the University of Alabama at Birmingham and has worked in Clinical Research since 2013 in a variety of roles including a Data Manager, Biostatistician, Oncology Research Coordinator, Clinical Trials Specialist and multiple levels of Clinical Research Associate. Ms. Estes’ specific focus lies in pushing dermatologic products forward, bridging the gap between clinical operations and global monitoring and operationalizing decentralized trials.

    Session Details:

    ROUNDTABLE SESSIONS

    2023-05-24, 3:30 PM

    Session Details:

    PANEL: Addressing the issues with Decentralised Clinical Trials and how we may work collaboratively to overcome them; addressing the pitfalls & challenges

    2023-05-24, 12:00 PM

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    Hassan Kadhim
    Senior Director, Head of Clinical Trial Business Capabilities, Bristol Myers Squibb

    Multilingual professional with 15+ years experience with informatics & digital technology in the pharmaceutical / biotechnology industry. With university degrees in Bioinformatics and in Clinical R&D, Hassan has a great mix of pharmaceutical industry Drug Discovery and Clinical Operations knowledge and Informatics. He has contributed in driving forward the vision of patient centricity and digital health at BI by promoting the Remote Clinical Trial model, and implementing several innovative digital health technologies in Clinical Trials to drive Patient Centricity. A great communicator with superb interpersonal skills, Hassan regularly interacts with key stakeholders to provide innovative solutions to critical problems. He is highly motivated in constantly seeking to improve processes and efficiency while driving innovation, and acts as a key contributor to multiple projects. Over the years, he has developed experience working in a global organization that requires collaboration with multidisciplinary international partners and is an invited guest speaker in several global Pharmaceutical and Clinical R&D conferences. Hassan is an active contributor to Transcelerate and the Clinical Trials Transformation Initiative (CTTI).

    Session Details:

    FIRESIDE CHAT Are We Committed to Not Going Back?

    2023-05-23, 12:00 PM

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    Session Details:

    Leveraging study participants’ Real-World Data to enable researchers to confirm the representativeness of the baseline

    2023-05-23, 2:00 PM

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    Keith Kennedy
    Principal and Team Lead, Patient Cloud, Medidata

    Keith Kennedy is a subject matter expert in eCOA/ePRO, eConsent, tele visits, wearables and other decentralized clinical trial tools. For over 15 years, Keith has consulted pharmaceutical, medical device and biotech companies on the best strategy to collect patient facing data in clinical trials in order to maximize patient compliance, increase data quality and decrease patient burden. A distinguished career in healthcare sales leadership, talent development and product education.

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    PANEL: Addressing the issues with Decentralised Clinical Trials and how we may work collaboratively to overcome them; addressing the pitfalls & challenges

    2023-05-24, 12:00 PM

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    Ellen Weiss
    Vice President, In-Home Solutions, Decentralized Clinical Trials, PCM Trials

    Ellen Weiss is the Vice President, In-Home Solutions, Decentralized Clinical Trials at PCM Trials. Ellen brings decentralized clinical trial visits to patients with PCM Trials experienced Certified Mobile Research Nurses. She is mastering the logistics of dosing and testing clinical trial participants where they live, work, and study. With nearly a decade of home visits learnings, Ellen has a unique perspective on how decentralized clinical trials have changed over the years and what the future looks like.

    Session Details:

    The Last Millimeter is Everything: Essential Guide for Home Visits

    2023-05-23, 11:30 AM

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    Travis Caudill
    Vice President Feasibility, Site Identification & Clinical Informatics Feasibility & Site Identification Integration Workstream Lead, ICON

    In my role, I am responsible for leading ICON’s country and site selection strategy ensuring that every project ICON undertakes benefits from a data-driven approach, optimized to reflect customer priorities, and with a probability of success calibrated to each customer’s risk preferences.

     

    I started my journey working for a local health insurance company supporting actuarial (claims data) analysis, and then joined a local CRO to help them develop a data-driven site identification strategy to support their late phase studies.  Since then I’ve held a number of Feasibility, Site Identification, and Study Start-up focused roles across midsize and large CROs.

     

    I’m an expert in trial modelling and leveraging artificial intelligence to inform country and site selection. I have really enjoyed helping to develop ICON’s OneSearch platform as well as leading initiatives to deliver next-generation scenario planning capabilities.  As we work to bring the best of both organizations together I’m excited about exploring new opportunities to excite and delight our customers through data-driven delivery.

     

    Session Details:

    Advancements in AI: turning big data into actionable intel for optimal site identification

    2023-05-23, 11:30 AM

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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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    Rohit Nambisan
    CEO & Co-Founder, Lokavant

    Trained as a neuroscientist, Rohit Nambisan is a product executive with experience leading product development organizations in pharma, medical devices, personalized medicine, health IT, healthcare data and analytics, and AI. Prior to co-founding and leading Lokavant, Rohit was most recently the Head of Digital Product at Roivant and the Head of Product at Prognos Health. Rohit holds an M.S in Management and Engineering from MIT, an M.A. in Neuroscience from Boston University, and a B.A in Cognitive Neuroscience from UC Berkeley.

    Session Details:

    Leveraging predictive analytics to improve patient retention, data quality, and enrollment outcomes in clinical trials

    2023-05-24, 11:30 AM

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    Kevin Collier
    VP, Medidata

    Kevin is Vice President of Product with global responsibility for product strategy and delivery of
    Medidata's RTSM solution. Kevin has spent his entire 30 year career in the Life Sciences arena
    working in clinical research, medical devices, systems and software delivery, and project
    management. Kevin has a well-rounded background that is technology focused and includes a deep
    understanding of the Pharmaceutical industry and clinical trial life-cycle. Kevin first started in
    IRT/RTSM at ICON Clinical Research in 2002 where he led the Project Management team responsible
    for large clients and was instrumental in unique and innovative design initiatives.

    Session Details:

    Optimize Your Trial Execution with the Strategic Use of an Experienced Technology Solutions Team

    2023-05-23, 10:00 AM

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    Alison Bedenkop
    Senior Director, Patient Recruitment and Retention, Worldwide Clinical Trials

    Alison Bedenkop is a Senior Director, Patient Recruitment and Retention at Worldwide Clinical Trials. Alison has been in clinical trial research for over 20 years, with the past 13 years focusing on global patient recruitment and retention.  Alison is passionate about diversity and inclusion and works towards building greater awareness of clinical trial opportunities in the local community.

    Session Details:

    Clinical Trial Liaisons’ Support of Psychedelic Clinical Trials

    2023-05-23, 12:30 PM

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    Ted Kirby
    Senior Director, Product Marketing, Saama

    Ted Kirby is currently the Head of Product and Brand Marketing at Saama. Prior to Saama, Ted served as Senior Director, Product Marketing at Medidata, where he oversaw product marketing for Medidata's platform. He was previously Director of Account Management at Medable, where he oversaw commercial relationships with Medable’s key Pharmaceutical and CRO accounts. His previous experience also includes stints at AiCure, a VC-backed startup using visual artificial intelligence for medication adherence in clinical trials, Deloitte and IQVIA. Ted earned his undergraduate degree in business administration from the University of North Carolina at Chapel Hill and his MBA from Columbia Business School.

    Session Details:

    From Concept to Breakthrough: The Case for AI/ML in Clinical Development

    2023-05-24, 9:30 AM

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    Neil Berger
    Vice President, FSP Commercial and Operational Strategy, Parexel

    As Vice President, FSP Commercial and Operational Strategy, Neil Berger is an operational and commercial strategist for clinical development outsourcing solutions at Parexel. Bringing 20 years of commercial and research operations experience, he is a recognized expert in holistic and cross-functional approaches to talent development – integrating acquisition, development and retention to meet long-term portfolio needs for biopharmaceutical sponsors.

     

    Prior to joining Parexel in 2015 as a commercial account leader, Neil held a range of positions of increasing responsibility in project management and client services for Pharma Medica Research, a contract research organization based in Canada.

    Neil earned a Master of Business Administration degree from Schulich School of Business, and holds a master’s and bachelor’s degree in science from McGill University.

    Session Details:

    A Clinical Outsourcing Model That’s As Agile As Your Development Program

    2023-05-23, 2:30 PM

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    Dr Atul Gupta, MD
    Vice President, Medical Services and Client Solutions, Navitas life Sciences

    Atul is a physician with over 18 years’ experience in Clinical Research, Drug Development, and clinical practice, after getting education from top medical schools of India. Atul joined Navitas in February 2021, and prior to that he has worked with leading organizations like Ranbaxy, Panacea Biotec, Max Neeman International and Apcer Life Sciences. Atul has rich leadership experience in providing end to end scientific guidance in drug development (Phase 1-IV) across multiple therapeutic area portfolios, in diverse regulatory environments including FDA, EMA, MHRA, ANVISA and DCGI. Atul has been extensively involved in defending clinical strategy proposals with respect to scientific rationale, timelines and budget with senior executives. He has worked as Global Medical Lead (USA, Europe and Asia Pacific) in more than 50 studies across the continents for both drugs and devices. Atul has been involved extensively in developing complex innovative trial designs for complex protocols reducing the huge costs and time associated with standard clinical randomized controlled trials.

    Apart from being a medical lead, atul has multifaceted experience in diverse clinical research domains including medical writing (Protocol, IB, CSR, eCTD etc), medico-regulatory (IND, NDA, BLA), drug safety and operations. Atul has been actively involved in multiple DSMBs and SRCs. He has been involved in negotiating clinical plans with FDA during pre-IND and type C meetings.  He has been the part of successful marketing authorization approval of breakthrough therapies including PD-1 inhibitors, V2 antagonist, multiple biosimilars, vaccines and several repurposed therapies (for MDD, narcolepsy, psoriasis)

    Session Details:

    Decentralization through Centralization: Thinking the Unthinkable in Clinical Trials

    2023-05-23, 2:30 PM

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    Todd Rudo, MD
    EVP & Chief Medical Officer, Clario

    As Clario’s Chief Medical Officer, Dr. Todd Rudo provides medical and scientific leadership across the organization. Passionate about leveraging our scientific expertise to support our customers’ success, Dr. Rudo has focused efforts on optimizing our solutions across the therapeutic areas. His team supports Clario’s clients by providing expert consulting services on scientific and regulatory strategy, and ensures our product portfolio is scientifically robust, generating high quality data to support clinical trial endpoints. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials, while maintaining focus on the customer experience, including minimizing patient and site burden. With nearly 20 years of clinical cardiology and pharmaceutical research experience, Dr. Rudo has focused his career predominantly on drug safety. He has worked within therapeutic areas including oncology, immuno-inflammatory diseases, urology, and cardiometabolic diseases, and has achieved board certifications in internal medicine, cardiology, cardiac electrophysiology, nuclear cardiology, and adult echocardiography.

    Session Details:

    Work smarter, not harder: Fulfilling your cardiac safety requirements without a Thorough QT (TQT) study

    2023-05-24, 9:30 AM

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    Lauren Colfer
    Former Vice President, Clinical Operations at Aceragen Pharmaceuticals

    Lauren joins us with over 25 years of pharmaceutical development experience in both large and small pharmaceutical company settings.  Her career started as a clinical monitor with Covance which eventually led to oversight of clinical and medical affairs operations teams at Wyeth, Pfizer, Cephalon and Teva across multiple therapeutic areas.  Her biotech experience includes Head of Clinical Operations and Project Management at Recro Pharmaceuticals and, most recently, Head of Clinical Operations at Aceragen Pharmaceuticals (formerly Idera Pharmaceuticals).

    Lauren holds a BS in Biology from the University of Scranton and an MBA in Biotechology and Health Industry Management from Pennsylvania State University.

    Session Details:

    PANEL DISCUSSION: What are the different outsourcing relationships and how do you manage them?

    2023-05-24, 12:00 PM

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    Donna M. Mongiello, RN, BSN
    Senior VP, Strategic Solutions, YPrime

    Donna’s diverse career began in healthcare as a registered nurse and evolved to focus on technologies that support patients in clinical research.  Donna has published articles in trade journals and presented at pharmaceutical industry conferences on topics including patient centricity, improving enrollment success, eCOA, BYOD, and more.  With over 18 years in the clinical trials space, Donna currently serves as Senior Vice President, Strategic Solutions at YPrime, where she is responsible for developing and growing strategic partnerships.  Donna earned her Bachelor of Science degree in nursing from Thomas Jefferson University.

    Session Details:

    The Digital-First Future of Clinical Trials

    2023-05-23, 12:30 PM

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    Joseph Im
    Director, Digital Health Technologies Operations, Regeneron

    Joe Im is currently the head of digital health technology operations at Regeneron.  He has 15 years of experience within the clinical trial space, where he’s been able to exercise his interest in cutting-edge technologies and his passion to improve the lives of patients. He has held positions on the supplier and sponsor sides within the COA project management function, as well as in imaging category management.  In his current role, he leads a team responsible for deploying and operating digital health technologies such as eCOA, sensor devices, digital apps, medical devices, and eClinical solutions in clinical trials. Joe has successfully led initiatives at Regeneron including the COA operations team development, adoption of eCOA BYOD as a standard modality, and development of a decentralized trial operating strategy.

    Session Details:

    The Digital-First Future of Clinical Trials

    2023-05-23, 12:30 PM

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    David Cutler
    Director, Project Management, WCG

    David Cutler is the Director of Project Management at WCG for the EAC service line. David provides leadership to the WCG EAC organization and serves as a subject matter expert for management of endpoint adjudication committees. In his current role, David leads WCG’s EAC Project Management group with a focus on developing and managing expert committees in alignment with industry and regulatory best practices.

     

    David has over 15 years industry experience and prior to joining WCG David worked in a variety of leadership roles in healthcare, academic, and nonprofit organizations building healthcare delivery programs and managing research teams. David spent the early part of his career developing and managing operations for NEURO-NET, a program aimed at improving long term outcomes for patients with catastrophic injuries. Prior to his focus on EACs, David’s work in clinical research was at a large public hospital building clinical research infrastructure enabling underserved patient populations to gain access to industry sponsored clinical trials and public/private grant funded research initiatives.

     

    David holds a Bachelor of Arts in Psychology from the University of California Santa Cruz and a Master of Arts in Counseling, Health Psychology from Santa Clara University.

    Session Details:

    Outsourcing independent committees: benefits, operational considerations, and best practices

    2023-05-24, 11:30 AM

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    Alex Ireland
    Associate Director Business Development, Novotech

    Alex Ireland is Associate Director Business Development at Novotech, the leading Asia Pacific centered global biotech CRO.  During her tenor, she has worked with 125+ biotech companies on 400+ studies in preparation for their upcoming Ph 1-3 clinical trials. Prior to joining Novotech, she worked for a small biotech company in a variety of business development and operational roles. Alex graduated from Boston University with a Master of Public Health.

     

    Session Details:

    Panel: Reversing the Conversation: What the clinical trial industry really wants from its service providers

    2023-05-23, 12:00 PM

    Session Details:

    State of the Global Biotech Landscape: Where the opportunities lie

    2023-05-23, 9:00 AM

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    Session Details:

    Innovative Processes to Better Address Today’s Trial Dynamics

    2023-05-23, 4:30 PM

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