Outsourcing in Clinical Trials New England 2023

This year's Outsourcing in Clinical Trials New England event will boast 3 tracks on Clinical Operations and Outsourcing, Clinical Technology and Innovation, and Patient Recruitment and Engagement, meaning for anyone involved in the operational aspects of running a clinical trial, there truly is something for everyone.

1 - 2

November

2023
  • John B. Hynes Veterans Memorial Convention Centre, Boston, USA
  • Complimentary
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2023 Sponsors Included:

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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 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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Novotech is internationally recognized as the leading Asia Pacific centred Biotech Contract Research Organization (CRO) with global execution capabilities.

Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services and FDA regulatory expertise and has experience in over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US and Europe. Novotech has over 3000 staff globally and 34 office locations.”

About Novotech- The Asia Pacific Centred Global Biotech CRO | Novotech CRO (novotech-cro.com)

Company Website

To learn more , please visit our website - https://novotech-cro.com/

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Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. We’re a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients.

Company Website

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

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To support the acceleration of drug development, over the last 12 years, ARENSIA Exploratory Medicine GmbH (www.arensia-em.com) has built up its own research clinics, with full Phase I infrastructure, entirely dedicated to the performance of sophisticated FIRST-in-PATIENT Phase IB, IIA and PROOF OF CONCEPT clinical trials with novel compounds. ARENSIA’s outstanding recruitment performance across numerous disease areas substantially reduces the overall number of sites and countries for any early-phase patient trial. ARENSIA’s speed and data quality provide our Partners/Sponsors with a strategic advantage across the entire lifecycle of a project, as they can progress their novel compounds much faster to later phases of research. ARENSIA is trusted by Leading Pharmaceutical and Biotechnology organizations worldwide. ARENSIA is based with its headquarters in Düsseldorf, Germany, and operates with 400+ talented employees in 7 countries

Company Website

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

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In 2021, ERT and Bioclinica merged to become Clario creating the broadest endpoint technology platform in the industry and enhancing our scientific expertise. With this expertise, global scale and the broadest endpoint technology platform, Clario will continue to lead the way in clinical trial technology that will transform patients’ lives.

Company Website

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

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Emmes is a full service contract research organization collaborating with our clients to produce valued, trusted scientific research. We are known for our superior statistical leadership and data management expertise and proud to have supported  thousands of studies across a diverse range of diseases.  For more than 40 years, Emmes has been dedicated to research for a healthier world.

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

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IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Powered by the IQVIA CORE™, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. Formed through the merger of IMS Health and Quintiles, IQVIA has more than 58,000 employees worldwide. Learn more at www.iqvia.com.

Company Website

To learn more , please visit our website - www.iqvia.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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Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideas into reality. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, CNS, oncology, pediatric, and rare disease.

Company Website

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

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

Company Website

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

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SubjectWell is the risk-free clinical trials marketplace that only charges for patients who randomize. Our unique approach raises awareness of the benefits of clinical research and engages the public when they are not thinking about their conditions. This gives SubjectWell access to tens of millions of patients and when combined with our high-touch approach, allows us to deliver qualified referrals who randomize at three to five times the rate of other sources.

Company Website

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

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TFS HealthScience is a global Contract Research Organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. In partnership with customers, we build solution-driven teams working for a healthier future. Bringing together nearly 700 professionals, TFS delivers tailored clinical research services in more than 40 countries. TFS  demonstrates  scientific  and  medical  competence  across populations and therapeutics, with industry-leading capabilities in:

 

-Dermatology, Immunology and Inflammatory Diseases

-Hematology and Oncology

-Ophthalmology

-Internal Medicine including Neurology & Respiratory

-Pediatrics, Rare Diseases and Orphan Drugs

-Real World Evidence​

Detailed information about TFS, and its business offerings can be obtained through

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TransPerfect Life Sciences specializes in supporting the global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include clinical trial management technology and services (TMF services, eTMF, CTMS, regulated content management, etc.), pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact by driving quality, mitigating compliance risk, and enhancing patient engagement.

Company Website

To learn more , please visit our website - https://lifesciences.transperfect.com/

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TrialCard Incorporated is a full-service life sciences commercialization partner that provides comprehensive solutions that span the entire biopharmaceutical value chain. In addition to a foundation of fully integrated, digitally enabled patient support services, its broader offerings include everything from late-stage clinical trial management to post-marketing HCP engagement services and proprietary data-as-a-service payer intelligence and insights. Founded in 2000, TrialCard provides commercialization needs for more than 160 life science customers and has connected over 35 million patients with more than $18 billion in branded drug savings to date. The company is headquartered in Morrisville, North Carolina.

Company Website

To learn more , please visit our website - http://corp.trialcard.com/

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Viedoc designs engaging software for the life science industry. By accelerating clinical trials on all levels, our solutions support major pharmaceutical, biotech, and medical device companies, as well as renowned research institutions worldwide. Headquartered in Uppsala, Sweden, Viedoc also has offi ces in America, France, Japan, Vietnam, and China. Since our inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. www.viedoc.com

Company Website

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

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Viroclinics-DDL, a Cerba Research Company is a leading specialty contract research organization, serving the biopharmaceutical community with a broad range of non-clinical research, clinical diagnostics, assay development, laboratory, and clinical trial logistic services. It offers its clients a global reach through a network of 38 processing laboratories.

More Info:

www.viroclinics.com

www.ddl.nl

Company Website

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

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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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Yourway is The Biopharma Services Company changing the landscape of clinical supply chain solutions with a unique, single source model. We are the only truly integrated provider premium courier and clinical packager, supported by a global network of GMP facilities. We have the resources, experience and commitment to make your packaging and shipments faster, and management of trials easier and more efficient. For over 20 years, Yourway has guaranteed speed of delivery with highly customized transport and storage solutions for biopharmaceutical companies, CDMOs and anyone needing to move high value and temperature-sensitive materials around the world. By integrating your clinical packaging seamlessly, we provide unified project management and total visibility.

Company Website

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

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    Why attend?

    The 15th Annual Outsourcing in Clinical Trials New England event will bring together clinical trial professionals from big and small biopharma to uncover new technologies and processes, to optimize their clinical and outsourcing operations.

    This two day programme will feature three streams on Clinical Operations and Outsourcing, Clinical Technology and Innovation, and Patient Recruitment and Engagement, with a mixture of case studies, panel discussions and workshops looking at optimizing your clinical trial strategy. We will explore topics including diversity and inclusion in clinical trials, choosing and working with vendors, the potential uses of AI to increase efficiency in clinical trials, and much much more.

    Register now to book your place at the conference.

     

     

    Outsourcing clinical trials can be of particular interest to online casino players. Our Outsourcing in Clinical Trials event in 2023 will consist of 4 tracks, each with something for online casino source link players. In addition, this event will bring together many specialists in clinical trials, who also play in online casinos.

    YOUR CHANCE TO MEET AND CATCH UP WITH COLLEAGUES FROM ACROSS THE INDUSTRY

    As this event returns to an in-person format, you can look forward to a networking focused event with industry leading presentations, interactive formats and the most innovative solution providers attending. Hear from industry leading speakers, Learn what is round the corner in terms of future trends and get the latest knowledge on new and upcoming disruptors.

    • Keynote presentations on the topics affecting you: from COVID to shipping to disruptive technologies
    • Join in with audience discussions, panel debates and add your voice to the conversation

    700+

    Attendees

    		80+

    Exhibitors

    		50+

    Speakers
    700+

    Attendees

    		80+

    Exhibitors
    50+

    Speakers

    Testimonials

    2023 Agenda

    • 1 Nov 2023
    • 2 Nov 2023
    Expand All

    Streams

    Stream one

    Clinical Outsourcing and Operations

    Stream two

    Clinical Technology and Innovation

    Stream three

    Patient Recruitment and Engagement

    11 AM

    PANEL DISCUSSION: Navigating new regulations around diversity and inclusion

    • The importance of ensuring your patient population is diverse
    • Strategies to improve diversity, equity and inclusion in your trial
    • Building trust and relationships with communities who may not traditionally participate in clinical trials
    • Innovative methods of engaging with the wider patient community
    • Best practice in working closely with patient advocacy groups

    MODERATOR:

    Behtash Bahador, Director, Health Literacy, CISCRP

    PANELLISTS:

    Blake E Wilson, Partner, Hogan Lovells LLP

    Cathleen Platt, Vice President, Clinical Operations, Click Therapeutics

    Speakers

    11:30 AM

    Session reserved for event sponsor

    12 PM

    Benchmarking patient enrollment and use of recruitment tactics

    • An overview of Tufts CSDD’s study on study and site level metrics on patient enrollment effectiveness and site activation rates
    • Global recruitment and retention tactics
    • Benchmarking results for enrollment and site activation
    • Differences and similarities in cycle times and performance across therapeutic areas

    Speakers

    12:30 PM

    Session reserved for event sponsor

    1 PM

    Lunch and networking break

    2 PM

    Working closely with advocacy groups around clinical trial design

    • Key considerations in designing a patient-centric clinical trial
    • How to bring the patient voice into your clinical trial design
    • Engaging patient advocacy groups from the beginning of your design process and benefits of this

    2:30 PM

    Session reserved for event sponsor

    3 PM

    Why do patients drop out of clinical trials: increasing your retention rates

    • How to engage patients in order to maximize retention
    • Listening to patients and advocates in order to fully understand burdens and hurdles for patients
    • An overview of the main reasons patients drop out of trials

    3:30 PM

    Afternoon refreshments and networking break

    4 PM

    Reducing the burden of clinical trials on patients: what tools are available?

    • How to lessen the financial impact of clinical trial participation in order to ease pressure on patients
    • What are the main barriers for patients participating in clinical trials and how can these be minimized?
    • Incorporating technology to support patients and increase engagement and retention

    4:30 PM

    Session reserved for event sponsor

    5 PM

    Designing a cutting-edge patient recruitment strategy

    • What opportunities do tools such as AI present for patient recruitment in clinical trials?
    • An overview of technology, tools and devices available to enhance patient recruitment
    • How to use technology to reach a wider population when recruiting for your clinical study

    5:30 PM

    Chairperson’s closing remarks

    Speakers

    END OF DAY 1 AND NETWORKING DRINKS

    11 AM

    2023 update: the state of the biopharmaceutical industry

    Bonnie Bain from GlobalData will join us to give an update and overview of trends and themes in the biopharmaceutical industry for 2023 and 2024. Find out about new technology and innovation in clinical trials, and how to stay ahead of the curve in order to ensure your trial is a success.

    Speakers

    11:30 AM

    Session reserved for event sponsor

    12 PM

    PANEL DISCUSSION: Is DCT old news?

    • How we should be thinking about decentralization in the long term
    • Hybrid vs decentralized vs traditional clinical trial models: the pros and cons of each
    • Which indications and therapeutic areas does DCT have potential in?
    • FDA regulations and guidance around DCT
    • Incorporating elements of DCT into your clinical trial: is this now commonplace or are we moving away from this?
    • Working with vendors and CROs in order to deliver decentralized and hybrid clinical trials

    MODERATOR:

    Christine Hurley, Vice President, Clinical Business Operations and Innovation, Relay Therapeutics

    PANELLISTS:

    Harry Barnett, Executive Chairman, Lubris Biopharma

    Speakers

    12:30 PM

    Session reserved for event sponsor

    1 PM

    Lunch and networking break

    2 PM

    PANEL DISCUSSION: The impact and potential of new AI tools in clinical trials

    • ChatGPT and its potential in supporting clinical trials
    • What risks and potential pitfalls are there when using AI?
    • Does AI eliminate the need for a human, or is it simply a tool?
    • How FDA guidelines impact the use of AI and machine learning in clinical trials

    Speakers

    2:30 PM

    Session reserved for event sponsor

    3 PM

    Leveraging remote monitoring and wearables to increase the effectiveness of your clinical study

    • How incorporating remote monitoring can benefit patients, caregivers and your overall study
    • Building a robust data strategy to support insights from wearables
    • Opportunities to enhance trial efficiency by using wearables and digital tools in your study

    3:30 PM

    Afternoon refreshments and networking break

    4 PM

    Incorporating real world evidence into clinical trials: what new opportunities are created?

    • Tapping into the full potential of real world evidence and incorporating this into your trial
    • Barriers to adopting real world evidence: how to address and overcome these
    • Navigating regulations in the USA in relation to the use of real world evidence in clinical trials

    4:30 PM

    Session reserved for event sponsor

    5 PM

    CASE STUDY: Implementing eClinical technology in a medical device setting

    • Implementing EDC, CTMS and eTMF for a medical device trial and what benefits these can bring
    • Choosing between technology providers: what are the main factors in decision-making?
    • Common challenges and hurdles when introducing new systems to your medical device clinical trial

    Speakers

    5:30 PM

    Chairperson’s closing remarks

    Speakers

    END OF DAY 1 AND NETWORKING DRINKS

    7:30 AM

    Registration and refreshments

    8:20 AM

    Chair’s opening remarks

    Speakers

    8:30 AM

    OPENING KEYNOTE PANEL: What does new technology mean for clinical trials in the US?

    • Managing additional data created by increased use of technology: is this a benefit or a challenge?
    • What does technology mean for the pharma industry and how clinical trials are run?
    • Can tools such as ChatGPT facilitate greater efficiency for clinical trials?
    • Mitigating risks created by increased reliance on technology: what are these, and how can we best manage them?
    • Training and supporting site staff to facilitate smooth transitions to new technology, systems and processes

    9 AM

    Session reserved for featured sponsor

    9:30 AM

    PATIENT ADVOCACY KEYNOTE: Where are biopharma sponsor companies falling short when it comes to supporting patients participating in clinical trials?

    • An overview of key hurdles for patients in clinical trials: where can the burden on patients be reduced?
    • Engaging patients throughout a clinical trial: why do patients drop out of trials, and what can be done to minimize this?
    • Balancing decentralization and physical site visits: what works best for patients?

    10 AM

    Session reserved for featured sponsor

    10:30 AM

    Morning refreshments and networking break

    11 AM

    Choosing a vendor as a small biotech: creating a hierarchy of considerations

    • What are the most important factors when selecting vendors and CROs for your clinical trial?
    • Is it always crucial to have trial partners with expertise in your therapeutic area?
    • Should cost be the primary factor in vendor selection?

    Speakers

    11:30 AM

    Session reserved for event sponsor

    12 PM

    SITE PERSPECTIVE: How can sponsors foster a strong relationship with sites in order to improve efficiency?

    • An overview of challenges faced by sites during a clinical trial: where can sponsors help?
    • How can sponsors relieve the burden on understaffed and overworked sites?
    • Training and supporting site staff on new tools and technology

    12:30 PM

    Session reserved for event sponsor

    1 PM

    Lunch and networking break

    2 PM

    Designing a vendor strategy that works for your clinical trial

    • Choosing between one full service CRO and working with multiple vendors: what are the main advantages and disadvantages?
    • Ensuring sponsors, vendors and sites are aligned under one shared goal
    • Overcoming challenges around communication with vendors in order to create strong relationships

    2:30 PM

    Session reserved for event sponsor

    3 PM

    CASE STUDY: Best practice in managing ongoing relationships with CROs, vendors and other partners

    • Communicating and liaising effectively with CROs: overcoming common challenges
    • Creating and fostering a long term relationship with vendors
    • Balancing levels of vendor oversight in your clinical trial

    Speakers

    3:30 PM

    Afternoon refreshments and networking break

    4 PM

    PANEL DISCUSSION: What degree of oversight should you have over your vendors and CRO partners?

    • Establishing upfront communication on responsibilities and escalation processes
    • What do vendors expect from sponsors in terms of oversight?
    • Best practice in building a strong relationship with vendors
    • Regulatory guidance for sponsors around vendor communications and oversight: what do you need to be doing as a sponsor?

    Speakers

    4:30 PM

    Session reserved for event sponsor

    5 PM

    CASE STUDY: Practical challenges when running an oncology trial as a small biotech organization

    • The regulatory landscape for oncology trials in the US: what do you need to be aware of?
    • Learnings and outcomes from running an oncology trial
    • Working with CROs and vendors in order to deliver a successful cancer clinical trial

    5:30 PM

    Chairperson’s closing remarks

    Speakers

    END OF DAY 1 AND NETWORKING DRINKS

    Streams

    Stream one

    Clinical Outsourcing and Operations

    Stream two

    Clinical Technology and Innovation

    Stream three

    Patient Recruitment and Engagement

    9 AM

    Patient centricity through health literacy

    Easily understandable and accessible clinical trial information empowers and engages the patient community, HCPs and other non-specialist physicians. The value of integrating patient-centric practices extends to more efficient trials, including shorter IRB review and approval cycles, improved patient enrollment, retention, and satisfaction, and greater likelihood of product reaching market. This session will cover:

    • Sponsor funded initiatives that incorporate Health Literacy into the clinical trial lifecycle
    • Beginning patient involvement before the study: building awareness of clinical research
    • The importance of partnership and co-development throughout the research lifecycle
    • Tools and resources available to assist research organizations in effective patient centricity planning

    Speakers

    9:30 AM

    Session reserved for event sponsor

    10 AM

    CASE STUDY: Recruiting for a rare disease trial

    • Identifying eligible patients for an orphan drug trial: designing your recruitment campaign
    • Best practice in collaborating with patient advocacy groups for rare diseases
    • The role of social media and other online tools to drive patient recruitment for a rare disease trial

    10:30 AM

    Morning refreshments and networking break

    11 AM

    Reserved for Amanda Murphy

    Speakers

    11:30 AM

    Session reserved for event sponsor

    12 PM

    CASE STUDY: Working with diverse groups in order to meet achieve DEI in clinical trials

    • How to recruit and engage populations who would not typically participate in clinical trials
    • Ensuring your clinical trial participants are representative of the general population
    • Overcoming common challenges around diversity and inclusion

    12:30 PM

    Lunch and networking break

    9 AM

    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

    9 AM

    PANEL DISCUSSION: How to choose technology vendors for your study

    • Key questions to ask when selecting clinical trial technology
    • Building relationships with vendors in order to deliver a seamless and efficient clinical trial
    • Working with patients and advocacy groups to ensure all new technology is for the ultimate benefit of the patient
    • Making technology and systems easy for sites to adopt
    • Balancing cost and opportunity when weighing up benefits of new technology

    Speakers

    9:30 AM

    Session reserved for event sponsor

    10 AM

    CASE STUDY: Revolutionizing drug delivery devices: paving the way for clinical success

    • Overview: the potential from using nose-to-brain technology to treat complex CNS disorders
    • Learnings and outcomes from running a clinical trial on a drug delivery device
    • Advancing treatment for neurogenerative diseases: how Kurve is reshaping this

    Speakers

    10:30 AM

    Morning refreshments and networking break

    11 AM

    Best practice for engaging sites with new technology

    • Benefits and challenges for site staff when introducing new technology and processes
    • Collaboration and training to ensure sites are confident with new systems
    • Reducing the burden on sites and ensuring processes are easy to follow and adapt to

    11:30 AM

    Session reserved for event sponsor

    12 PM

    Getting buy in from internal and external stakeholders for investment in new clinical trial technology

    • Creating an internal culture of innovation to foster adoption of technology and ideas
    • Maximizing ROI when incorporating new processes
    • Staying ahead of the curve: why investment in technology remains important for clinical trial sponsors

    12:30 PM

    Lunch and networking break

    8 AM

    Registration and Refreshments

    9:30 AM

    Session reserved for event sponsor

    10 AM

    PANEL DISCUSSION: Assessing the potential of different geographical regions for running a clinical trial

    • Benefits and opportunities of running clinical trials outside of the US including Latin America, Europe, Asia and Australia
    • Do the challenges and risks outweigh the benefits of running trials internationally?
    • Understanding and navigating clinical trial regulations in different geographical regions
    • What factors are most important when choosing a location for your clinical trial?

    Speakers

    10:30 AM

    Morning refreshments and networking break

    11 AM

    CASE STUDY: Overcoming operational challenges for a CAR-T trial: learnings and best practice

    • How are CAR-T trials unique from an operational standpoint: what do you need to consider?
    • Designing KPIs and other metrics to measure the efficiency of your CAR-T trial
    • Best practice in collaboration with CROs, vendors and other partners to make your CAR-T trial a success

    11:30 AM

    Session reserved for event sponsor

    12 PM

    Finances and managing your clinical trial budget as a small or medium sized biotech company

    • Cutting down your expenses without compromising on the quality of your trial
    • Forecasting and budgeting costs for your clinical trial
    • Solutions in order to ensure your trial budget stays on track

    Speakers

    12:30 PM

    Lunch and networking break

    1:30 PM

    Reserved for keynote speaker

    2 PM

    Session reserved for event sponsor

    2:30 PM

    CLOSING KEYNOTE PANEL DISCUSSION: Where can we expect clinical trials to be in 2024?

    • How will new and upcoming regulations affect clinical trials, and how can sponsor companies best navigate these?
    • The impact of emerging AI tools such as ChatGPT on clinical trials: are these a challenge or an opportunity?
    • Should we still be discussing decentralization as a long term clinical trial model?
    • Where are the primary opportunities to make clinical trial participation easier on patients and thus improve recruitment, engagement and retention?

    3 PM

    Afternoon refreshments and networking break

    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: Identifying partners and vendors to improve the efficiency of your clinical trial

    ROUNDTABLE 2: Managing clinical trial budgets effectively

    Marilyn Fontaine, Director of Clinical Operations, Compass Therapeutics

    ROUNDTABLE 3: Are decentralized trials here to stay?

    Speakers

    4 PM

    Chairperson’s closing remarks

    Speakers

    End of Conference

    2023 Speakers

    Select a speaker to learn more

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

    Session Details:

    Chair’s opening remarks

    2023-11-01, 8:20 AM

    Session Details:

    Chairperson’s closing remarks

    2023-11-01, 5:30 PM

    Session Details:

    Chairperson’s closing remarks

    2023-11-01, 5:30 PM

    Session Details:

    Chairperson’s closing remarks

    2023-11-01, 5:30 PM

    Session Details:

    Chairperson’s closing remarks

    2023-11-02, 4:00 PM

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    Shelby Abel-Kilmartin
    Director, Data Management Strategic Outsourcing and Vendor Management, Alexion, AstraZeneca Rare Disease

    Session Details:

    PANEL DISCUSSION: What degree of oversight should you have over your vendors and CRO partners?

    2023-11-01, 4:00 PM

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    Behtash Bahador
    Director, Health Literacy, CISCRP

    Behtash Bahador is the Director of Health Literacy at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

    Session Details:

    Patient centricity through health literacy

    2023-11-02, 9:00 AM

    Session Details:

    PANEL DISCUSSION: Navigating new regulations around diversity and inclusion

    2023-11-01, 11:00 AM

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    Cathleen Platt
    Vice President, Clinical Operations, Click Therapeutics

    Former Associate Vice President, Global Clinical Trial Management at Allergan Former Executive Director, Global Clinical Trial Management at Actavis plc Former Executive Director, Clinical Operations at Warner Chilcott Former Senior Director, Technical Services at Consumer Product Testing Company Former Section Head, Toxicology at Leberco Testing A., Biology, Rutgers University

    Session Details:

    PANEL DISCUSSION: Navigating new regulations around diversity and inclusion

    2023-11-01, 11:00 AM

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    Marilyn Fontaine
    Director, Clinical Operations, Compass Therapeutics

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    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2023-11-02, 3:05 PM

    Session Details:

    Finances and managing your clinical trial budget as a small or medium sized biotech company

    2023-11-02, 12:00 PM

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    Jodi Coughlin
    Director, Vendor Relationship Management, Deciphera Pharmaceuticals

    Session Details:

    Choosing a vendor as a small biotech: creating a hierarchy of considerations

    2023-11-01, 11:00 AM

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    Stacey Limauro
    Executive Director, Clinical Operations, Deciphera Pharmaceuticals

    Session Details:

    Choosing a vendor as a small biotech: creating a hierarchy of considerations

    2023-11-01, 11:00 AM

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    Colleen Graham
    Director, Clinical Development Operations

    Colleen Graham has over 20 years of extensive Clinical Research experience. She began her research career at a Clinical Site, and has held a variety of operational positions from an Ethical Review Board to CROs and Pharmaceutical companies, both large and small. Her experience includes Phases I-IV drugs, biologics and device studies across a variety of therapeutic areas working with companies such as Biogen, Pfizer, and Takeda Pharmaceuticals. Her operational experience includes resource management, process development and she has managed large-scale global studies. Colleen is currently Director of Clinical Development Operations at Momenta Pharmaceuticals, where she responsible for clinical development of M281 in rare immune-mediated diseases.

    Session Details:

    PANEL DISCUSSION: How to choose technology vendors for your study

    2023-11-02, 9:00 AM

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    Amanda Murphy
    Senior Director of Data Intelligence & Solutions, GlobalData

    Amanda Murphy is the Director of Product Management at GlobalData, a company that focuses on research, data analytics and consulting that provide actionable insight into the pharmaceutical and medical device sectors.  She has 10+ years of experience working in pharmaceutical data science and web platform development (including BioPharm Insight, Lead Sheet, and the Pharma Intelligence Center).  She has developed models and solutions to support Clinical Operations & Feasibility teams plan and optimize trials, including an e-feasibility questionnaire tool resulting in 4x faster response rates from sites.  Amanda also has many years of experience supporting business development at CROs through data-driven lead delivery and CRM integration solutions.

    Session Details:

    Reserved for Amanda Murphy

    2023-11-02, 11:00 AM

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    Bonnie Bain
    Global Head of Pharma and Executive Vice President of Healthcare Operations and Strategy, GlobalData

    Bonnie Bain, PhD, is the Global Head and EVP of Healthcare Operations and Strategy. Bonnie has over 20 years’ experience in the healthcare sector and a proven track record of developing innovative solutions on both the client and agency sides of the business. Bonnie was GlobalData Healthcare’s first Western analyst, and under her leadership, the company launched a number of premium syndicated reports, analytical tools, and databases in the pharmaceuticals and medical devices space. Prior to GlobalData, Bonnie was Vice President and Global Research & Analysis Director for Informa’s Pharma Division, which includes Datamonitor Healthcare, Scrip Group, and Business Insight. Bonnie also worked for several years at Decision Resources as an Analyst and Project Manager. On the client side of the industry, Bonnie worked for several years as a Senior Manager in Marketing Strategy and Analytics at Boston Scientific, where her work contributed to the successful commercialization of the first ever Access and Visualization Platform at the company. Bonnie has a PhD in Biochemistry and Molecular Biology from Purdue University and completed a Post-Doctoral Fellowship in Molecular Pharmacology at the University Of Miami School Of Medicine. She also has a graduate certificate in Applied Management Principles from Purdue University Krannert School of Management.

    Session Details:

    2023 update: the state of the biopharmaceutical industry

    2023-11-01, 11:00 AM

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    Blake E Wilson
    Partner, Hogan Lovells LLP

    Session Details:

    PANEL DISCUSSION: The impact and potential of new AI tools in clinical trials

    2023-11-01, 2:00 PM

    Session Details:

    PANEL DISCUSSION: Navigating new regulations around diversity and inclusion

    2023-11-01, 11:00 AM

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    Chris Cain
    Vice President, Clinical and Regulatory Affairs, Hyalex Orthopaedics

    Session Details:

    PANEL DISCUSSION: Assessing the potential of different geographical regions for running a clinical trial

    2023-11-02, 10:00 AM

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    David Sherris
    Board Member, Kurve Therapeutics

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    CASE STUDY: Revolutionizing drug delivery devices: paving the way for clinical success

    2023-11-02, 10:00 AM

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    Harry Barnett
    Executive Chairman And Founder, Lubris BioPharma

    Harry Barnett Harry is the co-founder and Executive Chairman of Lubris BioPharma, a clinical-stage biotech company developing a proprietary version of the novel, ubiquitous human protein, PRG4, for use in multiple indications.  Novartis owns rights to Lubris’ technology for ophthalmology. Harry’s two-decade life science career includes: (i) co-founding and executive management roles at three life science companies and two CROs; (ii) incubating, partnering and licensing successfully a wide array of pharmaceutical products and technologies including Pepcid Complete®, the OTC hearburn remedy sold by J&J, and; (iii) innovating multi-center, clinical trial processes using techniques that have been adopted as industry standard.  Prior to his transition to life science and biotech, Harry was a transactional business lawyer in private practice at DLA Piper in San Diego, and later at Faneuil Advisors, Inc., an investment advisory firm based in Boston where he served as General Counsel and Executive Vice President.

    Session Details:

    PANEL DISCUSSION: Is DCT old news?

    2023-11-01, 12:00 PM

    Session Details:

    PANEL DISCUSSION: Assessing the potential of different geographical regions for running a clinical trial

    2023-11-02, 10:00 AM

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    Stacey Oppenheimer
    Imaging Vendor Oversight and Sourcing Strategy Lead, Pfizer

    Session Details:

    PANEL DISCUSSION: What degree of oversight should you have over your vendors and CRO partners?

    2023-11-01, 4:00 PM

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    Christine Hurley
    Vice President, Clinical Business Operations and Innovation, Relay Therapeutics

    Session Details:

    CASE STUDY: Best practice in managing ongoing relationships with CROs, vendors and other partners

    2023-11-01, 3:00 PM

    Session Details:

    PANEL DISCUSSION: Is DCT old news?

    2023-11-01, 12:00 PM

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    Shari Coslett
    Vice President, Clinical Operations, Rhythm Pharmaceuticals

    Session Details:

    PANEL DISCUSSION: What degree of oversight should you have over your vendors and CRO partners?

    2023-11-01, 4:00 PM

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    Meredith Frank-Molnia
    Senior Director, Clinical Operations, Third Pole Therapeutics

    Session Details:

    CASE STUDY: Implementing eClinical technology in a medical device setting

    2023-11-01, 5:00 PM

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