15th Annual Outsourcing in Clinical Trials East Coast 2024

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

21 - 22

May

2024
  • Valley Forge Casino Resort, King of Prussia, PA, USA
  • Complimentary
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2024 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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Clario is a leading healthcare research and technology company that generates the highest 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. Clario’s science, technology, and operational experts have helped deliver over 26,000 trials and contributed to over 800 regulatory approvals in more than 100 countries. For more than 50 years, we have provided deep scientific expertise and the broadest endpoint technologies to help transform lives around the world. clario.com

Company Website

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

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PCM TRIALS screens, hires, trains and manages all of our own Certified Mobile Research Nurses who conduct clinical trial visits in the subject’s homes. Each nurse is trained, tested, and certified as a Certified Mobile on an annual basis in the principles of clinical trial research, GCP, Nurse Guidelines and IATA.  Services are available in U.S., Canada and ROW.

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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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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Medidata is leading the digital transformation of life science, with the world’s most used platform for clinical development, commercial, and real-world data. Rave RTSM is the only fully pre-validated randomization and trial supply management solution that can be configured in minutes and enables mid-study changes with minimal downtime and no change orders. RTSM is built on Rave EDC, so there is no double data entry and minimal reconciliation expediting study start-up and study-close out. Rave RTSM streamlines your operations and provides real-time visibility for your study teams. https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/

Company Website

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

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

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

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

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

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

Company Website

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

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Company Website

To learn more , please visit our website - atreo.io

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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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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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Datacubed Health is a pioneering technology company making better science and healthier communities a reality. Datacubed applies innovative solutions for the capture of active and passive data for engagement with patients in in-person, hybrid, or fully virtual clinical studies. Focusing on life sciences, Datacubed offers software and services driven by behavioral science to improve patient retention and compliance, resulting in better data and positive health outcomes.

Company Website

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

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Deep 6 AI is the leader in precision research software, connecting all research stakeholders in an AI-powered, real-time, data-driven, collaborative ecosystem.  Our Precision Matching software mines millions of patient records, including “unstructured” physician notes, to pin-point eligible study patients in real-time. Deep 6 eliminates months of manual data validation, to de-risk and accelerate clinical trials, because clinical trials should be a gatekeeper (accelerator), not a bottleneck to innovation.

Company Website

To learn more , please visit our website - deep6.ai

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Endpoint Clinical is an interactive response technology (IRT) solutions provider that supports the life sciences industry. Our innovative, high-quality randomization and clinical trial management technologies are backed by over a decade of award-winning experience and expertise. Endpoint is headquartered in Wakefield, MA, with offices across the US, EU, and Asia.

Company Website

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

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MaxisIT’s clinical data analytics platform is a purpose-fit solution developed to improve clinical trial performance, mitigate risk, and optimize clinical outcomes. This holistic self-service platform provides faster data access and intelligent analytics, empowering clinical trial teams to think innovatively.

Company Website

To learn more , please visit our website - www.maxisit.com/ctos/

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Mural Health is a participant management platform that helps manage & streamline the trial experience for patients and caregivers. Using modern payment, transportation, and communication solutions we help drive retention, compliance, and data quality.

Company Website

To learn more , please visit our website - https://www.muralhealth.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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Jumo Health develops age-appropriate, culturally sensitive, and relatable educational resources for patients and caregivers. We have experience serving diverse populations, covering more than 160 health topics across 75+ countries and 90+ languages – and we’re always expanding!

Our multicultural offerings are designed to explain the latest in evidence-based literature using highly visual elements so that everyone can understand complex medical topics. We use familiar mediums to ensure this – from comic books and Pixar®-style animation, to virtual reality experiences and authentic documentary-style patient stories – all tailored based on age and audience.

Jumo Health collaborates globally with more than 180 advocacy groups and community organizations to ensure an authentic patient experience is accurately represented.

Company Website

To learn more , please visit our website - www.jumohealth.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.

    This year alongside talks from industry leaders Pfizer, Bristol Myers Squibb, Otsuka and Endo Pharmaceuticals, we have a keynote presentation from Craig Lipset, Advisor and Founder at Clinical Innovation Partners. Craig will be discussing “Can patients out innovate pharma?”

     

    WHAT TO EXPECT FOR 2024?

    450+

    Attendees

    		70+

    Exhibitors

    		30+

    Speakers
    450+

    Attendees

    		70+

    Exhibitors
    30+

    Speakers

    Testimonials

    See What It's All About

    Agenda

    • 21 May 2024
    • 22 May 2024
    Expand All

    Streams

    Stream one

    Clinical Operations and Outsourcing

    Stream two

    Clinical Technology and Innovation

    10:30 AM

    Morning Refreshments & Networking

    11 AM

    PANEL DISCUSSION: AI and digitalization in clinical trials

    • How AI can improve and streamline clinical operations: opportunities and real use cases
    • AI as a tool to support thinly stretched clinical operations teams: where can this be utilized to minimize workloads and increase overall output?
    • How are clinical trial sponsors implementing tools such as Generative AI and ChatGPT?
    • FDA perspectives on AI in clinical trials: are there limitations to its use?

    Speakers

    Judyth Zahora
    Senior Director, Global Quality Systems and Process Improvement, Agenus
    Blake Edward Wilson
    Partner (FDA Regulatory), Hogan Lovells
    Derek Shannon
    Director, Statistical Project Management, Madrigal Pharmaceuticals
    Jeannette Villabon
    Associate Director, Outsourcing Management, Bristol Myers Squibb

    11:30 AM

    Reserved for Saama Technologies

    12 PM

    AI 101: the opportunities of AI for clinical trials

    • An overview of different types of AI and machine learning and where there are opportunities to use these in clinical trials
    • Assessing easy ways to incorporate and implement AI into your clinical study
    • Where is AI being utilized in other industries and how can this be applied to clinical trials?

    Speakers

    Derek Shannon
    Director, Statistical Project Management, Madrigal Pharmaceuticals

    12:30 PM

    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:

    • 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

    12:45 PM

    Reserved for Acolad

    1 PM

    Lunch and networking

    2 PM

    CASE STUDY: Targeting Alzheimer’s Disease and Dementia in Parkinson’s Disease with Blarcamesine (ANAVEX®2-73)

    Clinical efficacy is associated with biomarker expression and restoration of neurodegenerative pathways

    • Blarcamesine (ANAVEX®2-73) treatment result in significant improvements in patients with Alzheimer’s Disease and in Parkinson’s Disease Dementia
    • Analysis demonstrates predictive biomarker of efficacy in Alzheimer’s Disease and in Parkinson’s Disease Dementia
    • Whole blood transcriptomics analysis (RNAseq) identifies treatment impact on pathways impaired in neurodegenerative diseases

    Speakers

    Daniel Klamer
    Vice President, Business Development & Scientific Strategy, Anavex Life Sciences

    2:30 PM

    A holistic approach to Parkinson’s disease endpoint data collection: efficacy, safety and quality of life

    • Wearable digital endpoint solutions and their pivotal role in providing quantitative gait assessment for detection of disease progression
    • eCOA solutions for assessing efficacy and quality of life, leveraging clinical rating scales, symptom diaries, and other patient-reported outcome measures
    • Medical imaging modalities focused on accurately characterizing PD status biologically, paving the way for biomarker-guided drug development
    • Cardiac monitoring in this unique population, collecting high-quality blood pressure and cardiac rhythm data to characterize PD-associated autonomic dysfunction

    Speakers

    Todd Rudo, MD
    EVP & Chief Medical Officer, Clario

    3 PM

    The impact of high turnover of site staff on data collection and what sponsor companies can do to help

    • How to deal with high turnover of staff as a sponsor company: what issues are caused by this?
    • Assessing available technology and processes to alleviate pressure and workload on site staff
    • The importance of maintaining a strong relationship with sites when it comes to data entry and collection

    Speakers

    Rosanne Petros
    PMP, Associate Director, Clinical Research, Merck Research Laboratories

    3:30 PM

    Afternoon refreshments, networking

    4 PM

    Critical to quality factors: a simple but powerful framework for risk-based quality management

    The Quality by Design (QbD) and Critical to Quality (CTQ) Factor concepts were introduced by the Clinical Trials Transformation Initiative (CTTI) in 2015 and included in ICH E8(R1) (General Considerations for Clinical Trials) in 2021.  The current draft of ICH E6(R3) integrates the QbD and CTQ Factor concepts with RBQM.  Despite Health Authority and Industry endorsement and support, Sponsors and CROs aren’t taking full advantage of CTQ Factors in the clinical trial process. This presentation will explain how a CTQ Framework can be implemented simply and flexibly – to align RBQM activities from the protocol to the risk assessment to the operationalization of mitigation activities in the functional plans and more. 

    Speakers

    Jehan Poco
    Associate Director, BDM Planning and Functional Excellence, Biostatistics & Data Management, Daiichi Sankyo, Inc
    Kevin Douglass
    Associate Director, RBQM Center of Excellence, Global Clinical Operations, Daiichi Sankyo, Inc

    4:30 PM

    Digitalization in clinical trials: a 360 view

    • Presenting on how to digitalize clinical trials in e.g. endpoints, and study designs
    • Highlighting the possibilities that digital trials bring, whilst moving away from the common brick-and-mortar sites
    • Discussing the rigorous standards and scientific integrity required by regulators, whether a regular brick-and-mortar trial or a digital trial
    • 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 digital 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

    GREG TULLO
    VP Professional Services North America, Viedoc Technologies

    7:30 AM

    Registration & Refreshments

    8:20 AM

    Chairperson’s opening remarks

    Speakers

    Rosalie Filling
    Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

    8:30 AM

    PATIENT ADVOCACY KEYNOTE: A caregiver’s story: supporting children participating in a clinical trial

    • What do patients and caregivers experience when participating in a clinical trial, from start to finish?
    • Understanding patients’ motivations for choosing and staying in a clinical trial
    • Hurdles and barriers to patients’ participation in pediatric clinical trials: what can pharma companies do to improve this and relieve burden on patients and caregivers?

    Speakers

    Kelly Franchetti
    Patient Advocate

    9 AM

    Reserved for featured sponsor

    9:30 AM

    PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

    • Weighing up pros and cons of different outsourcing models: which is best for your trial?
    • When is mixing and matching better than fully outsourcing or keeping trials fully in house?
    • Developing an outsourcing strategy as a small to medium sized biotech with limited resources
    • Why is FSP becoming a popular choice among sponsor companies and how can this support meeting trial timelines?

     

    MODERATOR:

    John J. Seman, Chief Executive Officer, REVITALE Pharma

     

    PANELLISTS:

    Terry Katz, Senior Director, Biostatistics and Data Management Planning and Functional Excellence, Daiichi Sankyo

    Jessica King, Head of Clinical Operations, Sonnest

    Maria Metzger, Executive Director, Supplier Relationship Management and Performance, Clinical Development Operations, Eikon Therapeutics

    Priya Marreddy, Vice President, Clinical Operations, Context Therapeutics

    Speakers

    John J. Seman
    Chief Executive Officer, REVITALE Pharma
    Terry Katz
    Sr. Director, Biostatistics and Data Management Planning and Functional Excellence, Daiichi Sankyo, Inc.
    Jessica King
    Head of Clinical Operations, Sonnest
    Maria Metzger
    , Executive Director, Supplier Relationship Management and Performance, Clinical Development Operations, Eikon Therapeutics
    Priya Marreddy
    Vice President, Clinical Operations, OnCusp Therapeutics

    10 AM

    Reserved for ICON

    10:30 AM

    Morning refreshments and networking break

    11 AM

    Site management: building a strong partnership with sites to ensure you are a sponsor of choice

    • Creating a partnership that is built on reciprocity and providing a voice for site feedback
    • Collaboration and training to ensure sites are confident and equipped to successfully complete trial
    • Reducing the burden on sites financially and operationally
    • Supporting sites individual needs from established clinics to naïve sites

    Speakers

    Suzy Montanye
    Site Relationship Manager, Endo Pharmaceuticals

    11:30 AM

    How a consultative approach from a CRO could add value to your development program

    • How to unlock the full power of your CRO partner
    • How a CRO partner helps you navigate the interface between science and operations and why that improves your study
    • Why early engagement can be key to your study’s success

    Speakers

    MarieElena Cordisco
    MA, NP-C, Senior Director, Therapeutic Strategy Lead, Metabolic, Worldwide Clinical Trials

    12 PM

    Insights into barriers to care in the rare disease community

    • Challenges and nuances of rare disease patients’ journey to receive a diagnosis
    • Recognizing the pivotal role insurance plays in accessing healthcare services
    • Assessing adequacy of healthcare coverage, affordability of services, and the extent to which patients utilize available healthcare resources
    • Exploring overall experiences individuals have had within the healthcare system: strengths and areas for improvement
    • Mental health and well-being: the emotional toll rare diseases take on patients and caregivers

    Speakers

    Jenifer Waldrop
    Executive Director, Rare Disease Diversity Coalition

    12:30 PM

    Access for all: how mobile visits help sponsors meet new diversity goals

    Speakers

    Tajuana Barron
    Vice President, Project Management, PCM Trials

    1 PM

    Lunch and networking

    2 PM

    Effective patient education to increase enrolment and retention

    • Making trial participation easy for patients: what is effective and what isn’t?
    • Ensuring communications with patients are pitched at the right level in order to maximize understanding and thus increase retention
    • Innovative ways to create resources for patients using new technology and digital content

    Speakers

    Susan Neal
    Director, Clinical Operations, Novavax

    2:30 PM

    Reserved for TecEx

    3 PM

    PANEL DISCUSSION: Diversity and inclusion in patient recruitment

    • How can expanding into diverse geographies support meeting DEI regulations for trials?
    • DEI in rare diseases: how to ensure your trial participants represent the overall population in trials with limited patient numbers
    • Navigating FDA regulations and devising a strategy for diversity and inclusion
    • Building trust and relationships with communities who may not traditionally participate in clinical trials
    • Working with advocacy groups to increase trial diversity and patient numbers

    MODERATOR:

    Rosalie Filling, Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

    PANELLISTS:

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

    Dija Atta, Senior Director, Clinical Operations, Incyte

    Jenifer Waldrop, Executive Director, Rare Disease Diversity Coalition

    Mohammed Ali, M&D Head of Reporting, Analytics and Insights, Astellas Pharma

    Speakers

    Rosalie Filling
    Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals
    Ram Raju
    Senior Vice President and Community Health Investment Officer, Northwell Health
    Dija Atta
    Senior Director, Clinical Operations, Incyte
    Jenifer Waldrop
    Executive Director, Rare Disease Diversity Coalition
    Mohammed Ali
    M&D Head of Reporting, Analytics and Insights, Astellas Pharma

    3:30 PM

    Afternoon refreshments, networking

    3:50 PM

    EXHIBITION APPLE PRIZE DRAW

    Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

    4 PM

    CASE STUDY: Targeting Alzheimers: rationale and clinical trial plans at Neurotez

    Speakers

    Dr Nikolaos Tezapsidis
    President and Chief Executive Officer, Neurotez

    4:30 PM

    Reserved for session sponsor

    5 PM

    CLOSING KEYNOTE PRESENTATION: Can patients out innovate pharma?

    While pharma struggles to adopt clinical trial innovations at scale, another stakeholder has demonstrated the urgency, will and creativity to disrupt clinical research: patients. 

    This keynote will explore ways in which patients have already "out-innovated" pharma and will provide clues to a power shift that may be in our future.

    Speakers

    Craig Lipset
    Advisor and Founder, Clinical Innovation Partners

    5:30 PM

    Chairperson’s closing remarks

    Speakers

    Rosalie Filling
    Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

    5:50 PM

    NETWORKING DRINKS RECEPTION AND END OF DAY 1

    Streams

    Stream one

    Clinical Operations and Outsourcing

    Stream two

    Clinical Technology and Innovation

    9 AM

    Site selection for increased patient recruitment and retention

    • Highlighting discrepancies in the distance between clinical trial sites and the disease prevalent populations using case studies
    • Exploring the impact of appropriate and inappropriate site selection on a trial’s success through case studies
    • Showcasing how patient accrual has been affected in clinical trials utilizing virtual components

    Speakers

    Sonnika Lamont
    Analyst, Clinical Trials Intelligence, GlobalData Plc

    9:30 AM

    Technology spotlight reserved for Diligent Pharma

    9:45 AM

    Technology spotlight reserved for Egnyte

    10 AM

    Topic TBC

    Speakers

    Blake Edward Wilson
    Partner (FDA Regulatory), Hogan Lovells

    10:30 AM

    Morning Refreshments & Networking

    11 AM

    PANEL DISCUSSION: Has DCT passed its peak in popularity?

    • Was DCT just a COVID buzzword or does it still have practical applications?
    • How can elements of decentralization be applied to clinical trials in order to maximize patient engagement?
    • Does DCT still have a future in a post-COVID world or has the clinical trial industry returned to ‘normal’?
    • Are there therapeutic areas where elements of decentralization or hybridization are essential to success?
    • Where are the main technological and practical hurdles to DCT taking off?

    MODERATOR:

    Judyth Zahora, Senior Director, GCP Quality Risk Management and Process Improvement, Agenus

     

    PANELLISTS:

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

    Rosanne Petros, PMP, Associate Director, Clinical Research, Merck Research Laboratories

    Kristen Olszyk, Senior Director, Clinical Scientist, Neuraptive Therapeutics

    Speakers

    Judyth Zahora
    Senior Director, Global Quality Systems and Process Improvement, Agenus
    RAM RAJU
    Former CEO, NYC Health & Hosptials Corporation
    Rosanne Petros
    PMP, Associate Director, Clinical Research, Merck Research Laboratories
    Kristen Olszyk
    Senior Director, Clinical Scientist, Neuraptive Therapeutics

    11:30 AM

    Reserved for uMotif

    12 PM

    FIRESIDE CHAT: Managing talent and resources to ensure the success of your clinical trial

    • Training and inducting staff with technology and systems in order to ensure a smooth transition
    • The importance of your staff when it comes to clinical trial efficiency: why you need to avoid overlooking this
    • Ensuring your new staff training programs are as effective as possible: what should you consider?

    Speakers

    Carrie Lewis
    Executive Director, Clinical Program Optimization, Endo Pharmaceuticals
    Deanna Lutte
    Senior Clinical Trial Manager, Clinical Operations, Endo Pharmaceuticals

    8 AM

    Registration and Refreshments

    8:50 AM

    Chairperson’s opening remarks

    Speakers

    Rosalie Filling
    Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

    9 AM

    PANEL DISCUSSION: Fostering a strong relationship with your CRO

    • Technology and new developments when it comes to managing CRO relationships
    • How to ensure your study is prioritized
    • Maintaining a strong relationship with vendors in remote and hybrid work settings
    • How to blend a CRO team with your internal team in order to foster communication and overall success of your trial

    MODERATOR:

    John J. Seman, Chief Executive Officer, REVITALE Pharma

     

    PANELLISTS:

    Hal J. Mann, Chapter Lead Clinical Support Solutions, Roche Diagnostics Solutions

    Kathleen Cohen, Vice President, Clinical Development, Marinus Pharmaceuticals

    Douglas Kling, Chief Operating Officer, NewAmsterdam Pharma

    Patti O’Malley, Associate Director, Strategic Relationship Management, Incyte

    Speakers

    John J. Seman
    Chief Executive Officer, REVITALE Pharma
    Hal J. Mann
    Chapter Lead Clinical Support Solutions, Roche Diagnostics Solutions
    Kathleen Cohen
    Head of Clinical Operations, Marinus Pharma
    Douglas Kling
    Chief Operating Officer, NewAmsterdam Pharma
    Patti O’Malley
    Associate Director, Strategic Relationship Management, Incyte

    9:30 AM

    Reserved for TRI

    10 AM

    Selecting vendors and CRO partners: what are the most important considerations?

    • Balancing cost alongside other considerations when selecting a CRO
    • Should trial partners always need expertise in your therapeutic area or are there other factors to consider?
    • Advantages and disadvantages of choosing a small CRO vs a global CRO for your trial

    Speakers

    Laurie Taraborrelli
    Clinical Programs and Compliance Specialist, Fujirebio Diagnostics

    10:30 AM

    Morning refreshments and networking

    11 AM

    CASE STUDY: Designing and running a trial for pediatric diseases: overcoming challenges when working with younger patients

    • Working with and supporting caregivers throughout the clinical trial process, and where sponsors can relieve burden
    • Additional considerations when designing a pediatric study: best practice when working with children and teenagers
    • Regulatory guidance in the USA around enrolling under 18s in a clinical trial and how to navigate this

    Speakers

    Gurdyal Kalsi
    Chief Medical Officer, Asklepion Pharmaceuticals

    11:30 AM

    Reserved for session sponsor

    12 PM

    PANEL DISCUSSION: Running clinical trials in different geographic regions: assessing opportunities and challenges

    • Advantages and disadvantages of regions including APAC, Latin America and Asia for running clinical trials
    • Regulatory hurdles to overcome when running trials outside of the USA
    • Key factors to consider in selection of sites and geographies for your clinical trials
    • Sourcing CROs, vendors and partners overseas
    • Analyzing cost and benefit of keeping your trial in the US vs taking it overseas

    Speakers

    Judyth Zahora
    Senior Director, Global Quality Systems and Process Improvement, Agenus
    Susan Neal
    Director, Clinical Operations, Novavax
    Aki Ko
    Chief Executive Officer, Co-Founder and Board Chairman, Elixirgen Therapeutics

    12:30 PM

    Lunch and Networking

    1:30 PM

    Developing a cell therapy for patients with telomere biology disorders: challenges and lessons learned

    • An overview of Elixirgen’s lead EXG-34217 program from a clinical operations perspective
    • Running a clinical trial with patients with a rare disease: what do you need to consider?
    • Key challenges faced during Phase I/II trials on EXG-34217 and future opportunities uncovered

    Speakers

    Aki Ko
    Chief Executive Officer, Co-Founder and Board Chairman, Elixirgen Therapeutics

    2 PM

    Available for session sponsor

    2:30 PM

    CLOSING KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

    • What more should sponsors, sites and CROs be doing in order to ensure clinical trials are as patient centric as possible?
    • Innovative strategies for working with patients and advocacy groups from early on in your trial design
    • Engaging groups and communities who would not typically participate in trials in order to achieve targets around diversity and inclusion
    • Reducing the burden on patients participating in clinical trials

    MODERATOR:

    Judyth Zahora, Senior Director, GCP Quality Risk Management and Process Improvement, Agenus

     

    PANELLISTS:

    Rosanne Petros, PMP, Associate Director, Clinical Research, Merck Research Laboratories

    Harsha K. Rajasimha, MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases

    Laurie Taraborrelli, Clinical Programs and Compliance Specialist, Fujirebio Diagnostics

    Kelly Franchetti, Patient Advocate

    Speakers

    Judyth Zahora
    Senior Director, Global Quality Systems and Process Improvement, Agenus
    Rosanne Petros
    PMP, Associate Director, Clinical Research, Merck Research Laboratories
    Harsha K. Rajasimha
    MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases
    Laurie Taraborrelli
    Clinical Programs and Compliance Specialist, Fujirebio Diagnostics
    Kelly Franchetti
    Patient Advocate

    3 PM

    Afternoon refreshments and networking

    3:20 PM

    EXHIBITION APPLE PRIZE DRAW

    Visit our exhibitors’ booths throughout the day and collect stamps in order to enter our Prize Draw and be in for a chance of winning Apple devices or Amazon vouchers. The Prize Draw will take place in the Exhibition Hall, make sure you don’t miss out!

    3:30 PM

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    During the roundtable discussion session, the conference hall will be divided into four ‘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 clinical operations.

    ROUNDTABLE 1: Topic TBC
    Laurie Taraborrelli, Clinical Programs and Compliance Specialist, Fujirebio Diagnostics

    ROUNDTABLE 2: Working with patient advocacy groups to design a patient centric clinical trial 
    Speaker TBC

    ROUNDTABLE 3: Using an FSP model for your clinical outsourcing strategy
    Hal J. Mann, Chapter Lead Clinical Support Solutions, Roche Diagnostics Solutions

    ROUNDTABLE 4: Operational challenges when running a rare disease clinical trial
    Harsha K. Rajasimha, MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases

    ROUNDTABLE 5: Lessons from the pandemic: are there any DCT technologies which are here to stay?
    Ram Raju, Senior Vice President and Community Health Investment Officer, Northwell Health

    Speakers

    Laurie Taraborrelli
    Clinical Programs and Compliance Specialist, Fujirebio Diagnostics
    Hal J. Mann
    Chapter Lead Clinical Support Solutions, Roche Diagnostics Solutions
    Harsha K. Rajasimha
    MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases
    Ram Raju
    Senior Vice President and Community Health Investment Officer, Northwell Health

    End of conference

    END OF CONFERENCE – SEE YOU NEXT YEAR!

    Speakers

    Select a speaker to learn more

    Back
    Judyth Zahora
    Senior Director, Global Quality Systems and Process Improvement, Agenus

    Session Details:

    PANEL DISCUSSION: AI and digitalization in clinical trials

    2024-05-21, 11:00 AM

    Session Details:

    PANEL DISCUSSION: Running clinical trials in different geographic regions: assessing opportunities and challenges

    2024-05-22, 12:00 PM

    Session Details:

    PANEL DISCUSSION: Has DCT passed its peak in popularity?

    2024-05-22, 11:00 AM

    Session Details:

    CLOSING KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

    2024-05-22, 2:30 PM

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    Daniel Klamer
    Vice President, Business Development & Scientific Strategy, Anavex Life Sciences

    Dr Daniel Klamer, Vice President of Business Development and Scientific Strategy of Anavex, has more than 15 years of experience in neuroscience and the orphan disease space, with acquisition, partnering and R&D experience in Europe and the USA. Prior to Anavex he worked at Retrophin and Neurosearch Sweden. At Neurosearch Sweden, Dr Klamer led and evaluated multiple discovery-phase neuropharmacological research products with an emphasis on strategic evaluation of preclinical and clinical development.

    Dr. Klamer earned his PhD in Pharmacology at The Sahlgrenska Academy at University of Gothenburg, Sweden, his MBA at Fordham Gabelli School of Business, and his Post-Doctoral training at the Department of Psychiatry, Yale University School of Medicine. In addition, Dr. Klamer holds a position as an Associate Professor at the Department of Pharmacology at The Sahlgrenska Academy at the University of Gothenburg.

    Session Details:

    CASE STUDY: Targeting Alzheimer’s Disease and Dementia in Parkinson’s Disease with Blarcamesine (ANAVEX®2-73)

    2024-05-21, 2:00 PM

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    Gurdyal Kalsi
    Chief Medical Officer, Asklepion Pharmaceuticals

    Session Details:

    CASE STUDY: Designing and running a trial for pediatric diseases: overcoming challenges when working with younger patients

    2024-05-22, 11:00 AM

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    Mohammed Ali
    M&D Head of Reporting, Analytics and Insights, Astellas Pharma

    Session Details:

    PANEL DISCUSSION: Diversity and inclusion in patient recruitment

    2024-05-21, 3:00 PM

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    Jeannette Villabon
    Associate Director, Outsourcing Management, Bristol Myers Squibb

    Session Details:

    PANEL DISCUSSION: AI and digitalization in clinical trials

    2024-05-21, 11:00 AM

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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:

    A holistic approach to Parkinson’s disease endpoint data collection: efficacy, safety and quality of life

    2024-05-21, 2:30 PM

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    Craig Lipset
    Advisor and Founder, Clinical Innovation Partners

    Session Details:

    CLOSING KEYNOTE PRESENTATION: Can patients out innovate pharma?

    2024-05-21, 5:00 PM

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    Terry Katz
    Senior Director, Biostatistics, Data Management Planning, Functional Excellence, Daiichi Sankyo

    Terry Katz is Senior Director of Biostatistics and Data Management Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA International, and a Statistician at Schering-Plough. He holds Accreditation as a Professional Statistician and Certifications as a Quality Engineer and a Six Sigma Green Belt. He is Chair of DIA's GCP-QA Community; formerly he was a Core Committee member for NJ CDISC User Group and Chair of the Statistical Taskforce for the Animal Health Institute. Terry also completed a 3-month Fellowship in Kenya to improve capacity and capability for the local hospitals to run oncology clinical trials.

    Next speaker
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    Jehan Poco
    Associate Director, BDM Planning and Functional Excellence, Biostatistics & Data Management, Daiichi Sankyo, Inc

    Jehan, Associate Director, Functional Excellence, Biostatistics & Data Management (BDM), Daiichi Sankyo, Inc.

     

    Jehan is an Associate Director in the Biostatistics & Data Management Functional Excellence at Daiichi-Sankyo.  In this role, Jehan partners with BDM and R&D teams on functional initiatives, system roll outs, and committee as well as supporting key partners like the RBQM COE as a member.

     

    Jehan has 18+ years of industry experience working for numerous companies in various positions (TMF, Clinical Monitoring, Quality & Compliance, Operational Excellence/Change Management, Metrics/Benchmarking and RBQM).  He received a BA in Cell Biology & Neuroscience from Rutgers College, an MBS in Biomedical Science from the University of Medicine and Dentistry NJ (UMDNJ), and is certified Auditing and Change Management methodologies.

     

    Jehan can be contacted at jpoco@dsi.com

    Session Details:

    Critical to quality factors: a simple but powerful framework for risk-based quality management

    2024-05-21, 4:00 PM

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    Kevin Douglass
    Associate Director, RBQM Center of Excellence, Global Clinical Operations, Daiichi Sankyo, Inc

    Kevin Douglass, Associate Director, RBQM Center of Excellence, Biostatistics & Data Management (BDM), Daiichi Sankyo, Inc.

     

    Kevin is an Associate Director in the Risk-Based Quality Management Center of Excellence (RBQM COE) at Daiichi-Sankyo.  The RBQM COE partners within BDM, with cross-functional stakeholders, and CRO partners to optimize RBQM processes and tools.  The RBQM COE has central (e.g., as process owners developing and delivering tools and training) and Program/Study-level responsibilities (providing guidance to study teams).

     

    Kevin has 40+ years of industry experience working for numerous companies in various positions (Data Management, Quality & Compliance, Operational Excellence/Change Management, and RBQM).  He received a BS in Biology from Ursinus College, an MS in Biology from Villanova University, and is certified in Lean Six Sigma and multiple Change Management methodologies.

     

    Kevin can be contacted at kdouglass@dsi.com.

    Session Details:

    Critical to quality factors: a simple but powerful framework for risk-based quality management

    2024-05-21, 4:00 PM

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    Maria Metzger
    , Executive Director, Supplier Relationship Management and Performance, Clinical Development Operations, Eikon Therapeutics

    Session Details:

    PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

    2024-05-21, 9:30 AM

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    Aki Ko
    Chief Executive Officer, Co-Founder and Board Chairman, Elixirgen Therapeutics

    Session Details:

    Developing a cell therapy for patients with telomere biology disorders: challenges and lessons learned

    2024-05-22, 1:30 PM

    Session Details:

    PANEL DISCUSSION: Running clinical trials in different geographic regions: assessing opportunities and challenges

    2024-05-22, 12:00 PM

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    Rosalie Filling
    Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

    In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

     

    Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

     

    Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

     

    Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

     

    Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

    Session Details:

    Chairperson’s closing remarks

    2024-05-21, 5:30 PM

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    Carrie Lewis
    Executive Director, Clinical Program Optimization, Endo Pharmaceuticals

    Session Details:

    FIRESIDE CHAT: Managing talent and resources to ensure the success of your clinical trial

    2024-05-22, 12:00 PM

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    Suzy Montanye
    Site Relationship Manager, Endo Pharmaceuticals

    Session Details:

    Site management: building a strong partnership with sites to ensure you are a sponsor of choice

    2024-05-21, 11:00 AM

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    Deanna Lutte
    Senior Clinical Trial Manager, Clinical Operations, Endo Pharmaceuticals

    Session Details:

    FIRESIDE CHAT: Managing talent and resources to ensure the success of your clinical trial

    2024-05-22, 12:00 PM

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    Laurie Taraborrelli
    Clinical Programs and Compliance Specialist, Fujirebio Diagnostics

    Session Details:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2024-05-22, 3:30 PM

    Session Details:

    Selecting vendors and CRO partners: what are the most important considerations?

    2024-05-22, 10:00 AM

    Session Details:

    CLOSING KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

    2024-05-22, 2:30 PM

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    Revati Tatake
    Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Plc

    Revati Tatake currently serves as a Global Director of Databases and Analytics at GlobalData, where her primary responsibilities are to lead the development and continuous enhancement of integrated databases and analytical tools for providing competitive and business intelligence for pharmaceutical and biotechnology sectors Revati has more than 20 years’ experience, both in academic research and the healthcare industry, during which time she focused on basic and clinical research, drug discovery and competitive intelligence projects across many therapeutic areas. After academic career at Tata Cancer Research Institute and the University of Connecticut Health Center, she began her healthcare industry career at Boehringer Ingelheim Pharmaceuticals, where she led drug discovery projects involving small molecules, gene therapy and cell therapy for cardiovascular diseases, Rheumatoid arthritis and Diabetes. In addition to leading drug discovery projects, Revati co-chaired novel target identification group, scouted novel technologies for enhancing drug discovery efforts, established collaborations with experts in academic institutions to complement internal projects and evaluated in-licensing opportunities for their scientific and technical merit. She is a co-inventor on several issued US patents and applications related to the projects on cell and gene therapies. Before joining GlobalData, Revati worked at Citeline, where she was involved in competitive intelligence and analytics of clinical trials and pharmaceutical products. Revati holds a PhD in Tumor Immunology from Tata Cancer Research Institute. She was a post-doctoral fellow at the University of Connecticut Health Center.

    Session Details:

    Chairperson’s closing remarks

    2024-05-21, 5:30 PM

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    Sonnika Lamont
    Analyst, Clinical Trials Intelligence, GlobalData Plc

    Sonnika Lamont, MRes, is a a Clinical Trials Analyst at GlobalData, where her primary responsibilities include the review and update of clinical trial information presented on GlobalData’s Trials Intelligence Platform, the production of analytical reports and insights, testing database releases, and providing comprehensive conference coverage. She has a firm understanding of all aspects of clinical research, and the drug development process. Prior to joining GlobalData, Sonnika worked as a Clinical Trials Research Assistant at University College London’s Cancer Institute. Sonnika holds a Master of Research in Drug Design with a concentration in rare diseases from University College London, and a Bachelor of Science in Biochemistry from Nottingham Trent University.

    Session Details:

    Site selection for increased patient recruitment and retention

    2024-05-22, 9:00 AM

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    Blake Edward Wilson
    Partner (FDA Regulatory), Hogan Lovells

    Blake Wilson is a Partner in Hogan Lovells’ FDA Regulatory group.  He holds a juris doctorate from the University of Pennsylvania and a master’s degree in biostatistics from Columbia University.  Prior to becoming an attorney he managed Phase I and II pharmaceutical trials at Brown University.  His legal practice focuses on FDA’s premarket approval process for drugs/biologics/devices, oversight of clinical trials including BIMO audits, as well as navigating changes in laws or regulations that govern the life sciences industry.  He also guides sponsors through the special designation programs available at the premarket stage, like RMAT, accelerated approval, and breakthrough.  In this capacity, Blake advises extensively on novel products, study design considerations, and the use of clinical data in FDA-related matters.  By stress testing clinical materials through the lens of an FDA reviewer, Blake helps sponsors avoid pitfalls that can delay or derail a project.

    Session Details:

    PANEL DISCUSSION: AI and digitalization in clinical trials

    2024-05-21, 11:00 AM

    Session Details:

    Topic TBC

    2024-05-22, 10:00 AM

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    Dija Atta
    Senior Director, Clinical Operations, Incyte

    Session Details:

    PANEL DISCUSSION: Diversity and inclusion in patient recruitment

    2024-05-21, 3:00 PM

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    Patti O’Malley
    Associate Director, Strategic Relationship Management, Incyte

    Session Details:

    PANEL DISCUSSION: Fostering a strong relationship with your CRO

    2024-05-22, 9:00 AM

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    Harsha K. Rajasimha
    MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases

    Session Details:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2024-05-22, 3:30 PM

    Session Details:

    CLOSING KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

    2024-05-22, 2:30 PM

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    Derek Shannon
    Director, Statistical Project Management, Madrigal Pharmaceuticals

    Session Details:

    PANEL DISCUSSION: AI and digitalization in clinical trials

    2024-05-21, 11:00 AM

    Session Details:

    AI 101: the opportunities of AI for clinical trials

    2024-05-21, 12:00 PM

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    Kathleen Cohen
    Vice President, Clinical Development, Marinus Pharmaceuticals

    Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

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    Rosanne Petros
    PMP, Associate Director, Clinical Research, Merck Research Laboratories

    Rosanne Petros is a US Sr. Clinical Research Manager currently working in the vaccine therapy area.  She has 35 years of experience in Clinical Research primarily in clinical project management and is a PMP.   She has been at Merck for 18 years.  Prior to Merck, Rosanne had her own clinical research consulting company and began her career in clinical research at Pharmaco (then PPD).  Rosanne received her degree in Chemistry from University of Virginia and was a bench chemist prior to moving into clinical research. She lives outside of Washington DC with Kevin, her husband of 35 years and 4 of her 5 children (one moved out!) and two shih tzu mix dogs.  Her children range in age from 30 to 13 years old. Rosanne enjoys cooking, crafting and being with her family.  She also enjoys collecting and restoring Victorian and Art Deco jewelry and collecting and repairing vintage quilts.

    Session Details:

    The impact of high turnover of site staff on data collection and what sponsor companies can do to help

    2024-05-21, 3:00 PM

    Session Details:

    PANEL DISCUSSION: Has DCT passed its peak in popularity?

    2024-05-22, 11:00 AM

    Session Details:

    CLOSING KEYNOTE PANEL: Looking forward to 2025 and beyond: patient centricity in clinical trials

    2024-05-22, 2:30 PM

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    Kristen Olszyk
    Senior Director, Clinical Scientist, Neuraptive Therapeutics

    Kristen Olszyk joined Neuraptive in March 2020 and is the Acting Head of Clinical Operations.  She brings with her 20 years in the pharmaceutical industry.  Kristen’s areas of expertise include data science, clinical development, clinical operations and regulatory affairs, and she has been involved with several successful regulatory submissions in multiple therapeutic areas.  Prior to joining Neuraptive, Kristen held positions at Wyeth Pharmaceuticals/Pfizer, Endo Pharmaceuticals and Paratek Pharmaceuticals.

     

    Kristen earned her Bachelor of Science degree in Biochemistry from The Pennsylvania State University and her Master of Science degree in Quality Assurance and Regulatory Affairs from Temple University School of Pharmacy.

    Session Details:

    PANEL DISCUSSION: Has DCT passed its peak in popularity?

    2024-05-22, 11:00 AM

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    Dr Nikolaos Tezapsidis
    President and Chief Executive Officer, Neurotez

    Session Details:

    CASE STUDY: Targeting Alzheimers: rationale and clinical trial plans at Neurotez

    2024-05-21, 5:00 PM

    Session Details:

    CASE STUDY: Targeting Alzheimers: rationale and clinical trial plans at Neurotez

    2024-05-21, 4:00 PM

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    Douglas Kling
    Chief Operating Officer, NewAmsterdam Pharma

    Session Details:

    PANEL DISCUSSION: Fostering a strong relationship with your CRO

    2024-05-22, 9:00 AM

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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:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2024-05-22, 3:30 PM

    Session Details:

    PANEL DISCUSSION: Diversity and inclusion in patient recruitment

    2024-05-21, 3:00 PM

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    Susan Neal
    Director, Clinical Operations, Novavax

    Session Details:

    Effective patient education to increase enrolment and retention

    2024-05-21, 2:00 PM

    Session Details:

    PANEL DISCUSSION: Running clinical trials in different geographic regions: assessing opportunities and challenges

    2024-05-22, 12:00 PM

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    Priya Marreddy
    Vice President, Clinical Operations, OnCusp Therapeutics

    Session Details:

    PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

    2024-05-21, 9:30 AM

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    Kelly Franchetti
    Patient Advocate

    Kelly has over 25 years of experience in obtaining and discerning the patient and caregiver experience as well as developing strong relationships with advocacy groups on a global scale. She has extensive experience in multiple therapeutic areas such as oncology, cardiovascular, endocrinology, orthopedics, infectious disease, neurology, pediatrics, and critical care. This depth and breadth of experience translate into a keen understanding of how patients think regarding their treatment giving her a singular perspective on the best way to approach patients with their treatment options, and an understanding that proves invaluable to her pharmaceutical and clinical research stakeholders.

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    Tajuana Barron
    Vice President, Project Management, PCM Trials

    Session Details:

    Access for all: how mobile visits help sponsors meet new diversity goals

    2024-05-21, 12:30 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:

    Insights into barriers to care in the rare disease community

    2024-05-21, 12:00 PM

    Session Details:

    PANEL DISCUSSION: Diversity and inclusion in patient recruitment

    2024-05-21, 3:00 PM

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    John J. Seman
    Chief Executive Officer, REVITALE Pharma

    John Seman is the CEO and Founder of REVITALE Pharma.  He began his career working in Big Pharma - Johnson & Johnson and Bristol Myers Squibb - in sales, marketing and business development.  The second half of his career was spent as a serial entrepreneur having Founded a half dozen companies that provided either products or services for the pharmaceutical industry.  John earned his bachelor's and master's degrees from the Massachusetts College of Pharmacy.

    Session Details:

    PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

    2024-05-21, 9:30 AM

    Session Details:

    PANEL DISCUSSION: Fostering a strong relationship with your CRO

    2024-05-22, 9:00 AM

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    Hal J. Mann
    Chapter Lead Clinical Support Solutions, Roche Diagnostics Solutions

    I am a Clinical Research Professional with more than 30 years of experience ranging in perspective from the Study Site, small and large CRO’s, large Pharma, and large Diagnostics companies.  During my 15 years with GlaxoSmithKline, I spent my early years designing and conducting Clinical Trials before focusing on supplier management and strategic outsourcing.  In 2013, I joined Roche Molecular in Pleasanton, CA, where I currently lead a chapter in Clinical Development and Medical Affairs delivering Clinical Contracts & Outsourcing, Clinical Supplies Management, Functional Excellence / Clinical Quality, Clinical IT Solutions and Analytics, and sample management and testing from our internal Clinical Trial Support Lab.

    Session Details:

    PANEL DISCUSSION: Fostering a strong relationship with your CRO

    2024-05-22, 9:00 AM

    Session Details:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2024-05-22, 3:30 PM

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    Jessica King
    Head of Clinical Operations, Sonnest

    Session Details:

    PANEL DISCUSSION: Choosing an outsourcing model: FSO vs FSP vs inhouse

    2024-05-21, 9:30 AM

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    GREG TULLO
    VP Professional Services North America, Viedoc Technologies

    Greg is an expert at designing innovative data collection plans, managing quality control of collected data, and creating custom tools and databases for end users, leveraging expertise in clinical software applications including SAS, DataFax, OpenClinica, Excel, and Access.

    Session Details:

    Digitalization in clinical trials: a 360 view

    2024-05-21, 4:30 PM

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    MarieElena Cordisco
    MA, NP-C, Senior Director, Therapeutic Strategy Lead, Metabolic, Worldwide Clinical Trials

    MarieElena has been active in both research and clinical care through her career.  She brings more than ten years of leadership experience in clinical research sites management to the Worldwide team. She is also a clinically active nurse practitioner with more than 17 years of experience and a specialty in endocrinology. She has served as principal and sub-investigator for cardiometabolic trials and holds publications in peer-reviewed and high-impact journals. She is passionate about bringing her understanding of the patient journey to the Worldwide team.

    Session Details:

    How a consultative approach from a CRO could add value to your development program

    2024-05-21, 11:30 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:

    Oversight for all: achieve data transparency with elluminate

    2024-05-21, 12:30 PM

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    Steve Rosenberg
    Chief Executive Officer, uMotif
    Next speaker

    Plan Your Visit

    Venue

    Valley Forge Casino Resort

    1160 1st Ave King of Prussia PA 19406 United States

    Book Your Stay

    Accommodation

    Arena International Events Group “(Arena”) is aware of numerous third party agencies which are contacting Arena’s customers and purporting to have access to hotel room bookings and events attendee lists. For the avoidance of doubt, Arena will only share attendee lists with carefully selected third party partners for event registration purposes. Whilst Arena International Events Group pursues third party agencies for their potentially illicit activity, Arena encourages you to be cautious in engaging with such third party agencies and Arena shall not accept any responsibility for any losses incurred by you should you choose to engage with third parties that have no affiliation to Arena International Events Group..

    Sponsors

    Select a sponsor to learn more

    FEATURED SPONSORS

    SESSION SPONSORS

    TECHNOLOGY SPOTLIGHT SPONSORS

    DRINKS RECEPTION SPONSOR

    Lanyard Sponsor

    Tote Bag Sponsor

    EXHIBITORS

    Co-Sponsor

    Why partner?

    Contact us to become a partner

    Partnership Opportunities

    We work with you to design a bespoke package to meet your business needs, where you could:

    • Demonstrate your expertise on the agenda – have the attention of the entire audience. For greatest impact, why not position your talk before a networking break and immediately conduct follow up conversations with highly engaged attendees
    • Showcase your business and its services at an exhibition booth, which provides a perfect meeting place for prospective new clients
      Present the value proposition of your offering over your competitors, in front of an audience of active, engaged potential customers
    • Speak with key decision makers as part of our intimate, interactive roundtable style workshop sessions with over 8 hours allowed for networking

    Event reach

    • 150+ attendees each year
    • 80% attendees C-suite level

     

    Take a look at our current sponsors

    Media Centre

    MEDIA PARTNERS

    Enquiry

    Contact Us

    SPONSORSHIP ENQUIRIES

    Nick McCudden

    Head of OCT Events

    SPEAKING OPPORTUNITIES

    Louisa Manning

    Programme Director

    +44 (0)20 766 10552

    MARKETING ENQUIRIES

    Moona Popal

    Senior Marketing Manager

    DELEGATE ENQUIRIES

    Sunny Saikia

    VIP Delegate Manager

    Sponsorship Enquiries

    To enquire about sponsorship opportunities for the conference, please contact:

     

    Nick McCudden

    Head of OCT Events


    Speaker Enquiries

    To enquire about sponsorship opportunities for the conference, please contact:

     

    Louisa Manning

    Programme Director


    +44 (0)20 766 10552