15th Annual 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.

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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/

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

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Established in 1997, Novotech is a global CRO recognized for its partnership with sponsors in clinical trial development and management. The Company offers a comprehensive suite of services, including laboratories, Phase I facilities, drug development consulting, and regulatory expertise, Novotech has executed over 5,000 clinical projects, spanning Phase I to Phase IV trials and bioequivalence studies.

With a presence in 34 office locations and a dedicated team of 3,000+ professionals worldwide, Novotech supports clinical trials across Asia Pacific, the United States, and Europe. Leveraging a vast global footprint, deep relationships, and a robust operational framework, Novotech enables small to medium-sized biotech, biopharma, and pharma sponsors to accelerate the speed and scope of their clinical development endeavours.

Discover more at www.novotech-cro.com

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

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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

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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.

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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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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.

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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.

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

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TFS HealthScience is a global Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Bringing together nearly 700 professionals, we deliver tailored clinical research services in more than 40 countries. TFS supports customers with comprehensive solutions including full clinical development services, strategic and flexible resourcing. In partnership, we build solution-driven teams of experienced professionals working together for a healthier future. Our mission is to bring treatments to patients faster. For more information, please visit www.tfscro.com.

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

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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.

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

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Mercalis is an integrated life sciences commercialization partner that provides comprehensive solutions that span the entire healthcare value chain.  The company partners closely with its clients to deliver an end-to-end spectrum of commercial capabilities that work together seamlessly and flexibly.  Backed by proven industry expertise and results-driven technology, Mercalis provides the data and strategic insights, patient support services, and healthcare provider engagement tools to help life sciences companies successfully commercialize new products.  Above all, Mercalis helps navigate the complex life sciences marketplace to accelerate value and enhance patient lives.  Founded in 2000, Mercalis provides commercialization solutions to more than 500 life sciences customers and has provided access and affordability support to millions of patients.  The company is headquartered in Morrisville, North Carolina.  For more information about Mercalis, please visit www.mercalis.com.

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

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

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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

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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.

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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.

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

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IQVIA Technologies help you transform your clinical trials and improve patient safety with SaaS-based applications and tech-enabled services designed to streamline processes, improve workflows, and effectively engage and inform patients. The Orchestrated Clinical Trials (OCT) platform eases the burden on your sites and makes it easier and more appealing for patients to enroll and remain engaged, produces faster trials to database lock, and speeds time to market. For more information visit www.iqvia.com/oct or email us at OrchestrateYourTrials@iqvia.com

 

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

    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

    Speakers

    11:30 AM

    Accelerated performance of complex exploratory patient studies: practical insights from investigational site

    • Global challenges and industry trends
    • Research clinics dedicated to early patient trials
    • Key elements to consider when planning a Phase Ib/IIa patient trial
    • Case studies

    Speakers

    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 TFS HealthScience

    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

    Speakers

    2:30 PM

    How do we make participation in clinical research more patient-friendly

    • Barriers to patient participation in clinical research
    • Pre- and post-pandemic patient expectations
    • Balancing the need for robust data collection and reduced patient burden
    • What does – a potential – future hold?

    Speakers

    3 PM

    Designing patient engagement strategies to inform clinical trial recruitment

    • An overview of frameworks developed around patient recruitment and engagement
    • How to best engage patients, caregivers and advocacy groups in your clinical trial design
    • Key considerations in ensuring your patient recruitment strategy is as patient-centric as possible

    Speakers

    3:30 PM

    Afternoon refreshments and networking break

    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

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

    • Culture shift from the inside out: opportunity to briefly immerse yourself in the clinical trial journey from a patient’s perspective
    • 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

    INTERVIEWER: Robert Loll, Senior Vice President, Business Development and Strategic Planning, Praxis

    Speakers

    4:30 PM

    The innovations of decentralized clinical trials

    Speakers

    5 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

    Speakers

    5:30 PM

    Chairperson’s closing remarks

    Speakers

    END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY KPS LIFE

    11 AM

    Reserved for

    Speakers

    11:30 AM

    TECHNOLOGY SPOTLIGHT: Running up that hill: accelerate cycle times and reach patients faster with elluminate

    Learn how elluminate and eClinical’s Biometrics Services deliver:

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

    Speakers

    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

    Mackenzie Johnson, SM, Patient Centricity, Moderna

    Senior representative, ICON Plc

    Senior representative, Medidata

    Speakers

    12:30 PM

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

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

    Speakers

    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 YPrime

    3 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

    Speakers

    3:30 PM

    Afternoon refreshments and networking break

    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: 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
    • Considerations for medical device trials compared to drug trials in EDC, CTMS and eTMF

    Speakers

    4:30 PM

    Session reserved for

    Speakers

    5 PM

    Key considerations when choosing vendors and partners as a small biotech

    • How specialized should your CRO be in your therapeutic area: is this the most important factor?
    • As a small biotech, what are the benefits of working with a large global CRO vs a small specialized organization?
    • Working with and collaborating with multiple vendors: considerations and best practice

    Speakers

    5:30 PM

    Chairperson’s closing remarks

    Speakers

    END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY KPS LIFE

    7:30 AM

    Registration and refreshments

    8:20 AM

    Chair’s opening remarks

    Speakers

    8:30 AM

    OPENING KEYNOTE: Innovation in the US pharma industry: uncovering challenges and opportunities

    • Harnessing the power of language models such as GPT to revolutionize pharma innovation
    • The potential of advanced technology to drive advancements in drug discovery, optimize clinical trials and enable personalized medicine
    • Practical takeaways: how you can leverage AI and Generative AI to achieve transformative innovation in your clinical trial

    Speakers

    9 AM

    Solving the clinical data challenge

    Patient centricity requires data centricity to integrate and manage a growing variety of data sources. The challenge lies in integrating and managing those sources to deliver high-quality data. How do we overcome this?

    • Moving from manual, reactive data review and cleaning to proactive, risk-based approaches based on integrated data
    • Providing clinical data management and monitoring teams with workflows and analytics that support their day-to-day functions
    • Leveraging technologies that incorporate AI to automate manual tasks and identify potential issues sooner

    Speakers

    9:30 AM

    PATIENT ADVOCACY KEYNOTE: Patient experience in oncology trials: lessons learned from a patient advocacy-driven, decentralized clinical trial

    • How easy and accessible are oncology trials to patients, and where are the main hurdles?
    • What do pharma and biotech sponsors need to be doing in order to ensure a reduced burden on patients participating in clinical trials?
    • Decentralized clinical trials: and what are the benefits and challenges of incorporating elements of decentralization into your clinical trial from a patient perspective?

    Speakers

    10 AM

    Session reserved for Novotech

    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

    Simplifying protocols to enable home-base trial activities

    • How simplification of a protocol for Parkinson’s disease enabled a home-based trial
    • Lean Design approach to radical simplification: results for Merck protocols
    • Overcoming resistance to simplification: common issues

    Speakers

    12 PM

    Choosing the right site for your study: key factors

    • Selection criteria when identifying sites: what should you measure?
    • Transparency around site costs: ensuring you are budgeting and forecasting efficiently
    • Building a strong relationship with your site in order to maximize study success

    Speakers

    12:30 PM

    Assessing risk in your clinical trial using the Pediatric Risk Assessment Map (PRAM):

    • An interactive, reusable, and shareable tool that helps to identify common risks that may exist in a pediatric clinical trial
    • Populates with risk category and mitigation strategies for consideration when risk is identified
    • Tallies and populates key risks and categories identified

    Speakers

    1 PM

    Lunch and networking break

    2 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

    2:30 PM

    Continued evolution of cell and gene therapy development programs

    • Technology-based development trends
    • Driving success in either unexplored settings or in saturated market settings
    • Context-dependent stakeholder engagement

    Speakers

    3 PM

    Biomarker opportunities in FiH and clinical pharmacology studies run in an outsourcing model

    • Introduction: history of “fully outsourced” studies at Novartis
    • Personalized medicine and the shift in clinical trial goals
    • CRO relationships with biomarkers
    • Lessons learned from biomarkers
    • Balancing risks vs benefits

    Speakers

    3:30 PM

    Afternoon refreshments and networking break

    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 and you will need to be physically present to be eligible for a prize. Make sure you don’t miss out!

    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?

    MODERATOR: John J Seman, CEO, Revitale Pharma

    Speakers

    4:30 PM

    Innovative processes to better address today’s trial dynamics

    • Supply chain efficiency: why do extra work and spend more money than necessary?
    • Payment process efficient: leverage an existing workflow process that sites use everyday
    • Understanding the total value a vendor can provide
    • Select a vendor that can demonstrate its total value (and make you look good in the eyes of your company)

    Speakers

    5 PM

    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

    Speakers

    5:30 PM

    Chairperson’s closing remarks

    Speakers

    END OF DAY 1 AND NETWORKING DRINKS SPONSORED BY KPS LIFE

    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

    • 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

    The importance of scientific validation and data integrity when using accessibility features

    • FDA recommendation for accessible features and designs to increase clinical trial inclusivity eg zoom in/zoom out functionality
    • Importance for patients who may have visual impairments, hearing, motor and dexterity, or cognitive difficulties that may impact inclusivity into clinical trials
    • Significance of deploying these functionalities where the drug under study may cause visual impairment such as certain oncology treatments or population under study, eg older adults, may have one or more impairments
    • Results of an industry-first clinical study on the ePRO instrument equivalence across accessibility features and patient communication modality preferences

    Speakers

    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

    Speakers

    10:30 AM

    Morning refreshments and networking break

    11 AM

    Engaging patients in a rare disease clinical trial

    • How rare disease trials are unique when it comes to building and fostering relationships with patients
    • Reasons and tactics to engage longitudinally with rare disease patients
    • Working with patients, carers and advocacy groups for a successful patient engagement strategy

    Speakers

    11:30 AM

    Improving randomization rates with Machine Learning and AI

    • Learn the key differences between Machine Learning and Artificial Intelligence for patient recruiting
    • Find out why study data is more impactful than patient data on predicting recruitment success
    • Discover how to combine your model's results with your business strategy to create reliable recruitment

    Speakers

    12 PM

    Using data intelligence during to optimize geographic feasibility, site selection and patient recruitment

    • Join this session to hear Amanda Murphy speak about GlobalData’s clinical trial data, software solutions and common obstacles our clients face when trying to leverage data in planning clinical trials. She will focus on current needs to plan for very specific patient populations (race/ethnicity, biomarkers, severity, histology, etc.).

    Speakers

    12:30 PM

    Lunch and networking break

    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 Emmes

    Speakers

    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

    CASE STUDY: Introducing and implementing new technologies

    • Understanding and overcoming common challenges around new technology and systems
    • Compliance and support: what do you need to consider?
    • How to introduce and implement new technology smoothly, efficiently and effectively

    Speakers

    11:30 AM

    Session reserved for IQVIA Technologies

    12 PM

    Innovating your data management strategy: how to stay ahead of the curve

    • Developing efficient infrastructures and processes for clinical data management
    • Navigating changing regulatory requirements around data in clinical trials
    • Key drivers for innovation: considerations for 2024

    Speakers

    12:30 PM

    Lunch and networking break

    8 AM

    Registration and Refreshments

    9 AM

    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

    9:30 AM

    Modernizing site management and monitoring roles to meet the dynamic needs of clinical research

    • The purpose of a Site Manager and how they interact with other monitors on the study to avoid duplicate efforts and contain costs
    • When to use a Site Manager for optimal study conduct
    • The benefits a Site Manager can bring to studies with highly complex logistics, such as cell and gene therapies or rare disease trials
    • How technology drives efficiencies and streamlines communications across the various resources on a study

    Speakers

    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

    Leveraging CRO partnerships in effective biomarker development

    • Maintaining and tracking the CRO/sponsor partnership
    • Exploring tools and metrics that can be put in place
    • How best to utilize these in order to strengthen partnerships with CROs to ensure trial success

    Speakers

    11:30 AM

    Session reserved for Cerba Research

    12 PM

    CASE STUDY: Running a clinical trial when repurposing an existing drug

    • An overview of benefits, challenges and key considerations in drug repurposing clinical trials
    • FDA regulations and guidance when it comes to drug repurposing
    • Utilizing existing safety studies to speed up your trial timeline

    Speakers

    12:30 PM

    Lunch and networking break

    1:30 PM

    Operating conditions and trends impacting global clinical trial performance

    • Review macro-level drug development trends
    • Characterize the current operating environment for planning and executing clinical trials
    • Discuss underlying drivers of inefficiency and poor performance
    • Explore new strategies to address and counter the effect of underlying drivers

    Speakers

    2:15 PM

    Forging the future with CTMS

    Clinical trials play a crucial role in medical advancements. With increasing challenges, it is essential for our tools to adapt. CTMS represents a significant step forward in how we manage these trials, and by utilizing it effectively, we can improve the healthcare landscape for everyone.

    Speakers

    2:45 PM

    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?

    MODERATOR:

    Amanda Murphy, Senior Director, Data Intelligence and Solutions, GlobalData

    PANELLISTS:

    Hollie Schmidt, Vice President, Scientific Operations, Accelerated Cure Project for MS

    Prasanna Rao, Senior Director, Global Head of AI and ML, Pfizer

    Rinaldo Dorman, MBA, CPSM, Associate Director, R&D Global Procurement & Strategic Sourcing, Sarepta Therapeutics

    Jasmine Benger, Senior Director, Research Services, CISCRP

    Speakers

    3 PM

    Afternoon refreshments and networking break

    3:35 PM

    EXHIBITION APPLE PRIZE DRAW

    Visit our exhibitors’ booths throughout the conference 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 and you will need to be physically present to be eligible for a prize. Make sure you don’t miss out!

    3:45 PM

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    During the roundtable discussion session, the conference hall will be divided into three ‘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. Roundtables will take place in the Stream B conference room.

    ROUNDTABLE 1: US vs international CROs: which is best for your trial?
    Vikas Agarwal, Vice President, Head of Program Development, Greenfire Bio

    ROUNDTABLE 2: Managing clinical trial budgets effectively
    Marilyn Fontaine, Director, Clinical Operations, AnHeart Therapeutics

    ROUNDTABLE 3: Delivering large and complex clinical trials with cross functional teams
    Jenny Bentsen Gordon, Vice President, Head of Clinical Operations, Editas Medicine

    Speakers

    End of Conference

    5 PM

    Chairperson’s closing remarks

    Speakers

    Select a speaker to learn more

    Back
    Hollie Schmidt
    Vice President, Scientific Operations, Accelerated Cure Project for MS

    Hollie Schmidt is the VP of Scientific Operations at Accelerated Cure Project for Multiple Sclerosis. She co-chairs the Research Committee of iConquerMS™, a research cohort established to perform and support patient-centered research in MS. She also founded and leads the MS Minority Research Engagement Partnership Network, a multi-stakeholder initiative aimed at increasing racial and ethnic diversity in MS research studies.

    Session Details:

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

    2023-11-02, 2:45 PM

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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

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    Adrienne Gaggi
    Associate Director, Clinical Development, Aldeyra Therapeutics

    Session Details:

    Working closely with advocacy groups around clinical trial design

    2023-11-01, 2:00 PM

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    Deborah Howe
    Global Patient Recruitment and Engagement, Alexion Pharmaceuticals

    Session Details:

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

    2023-11-01, 4:00 PM

    Session Details:

    Designing patient engagement strategies to inform clinical trial recruitment

    2023-11-01, 3:00 PM

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    Rohita Sharma
    PhD, Global Senior Director, LEAP Lead, Patient Insights and Solutions, Medical Affairs, Alexion Pharmaceuticals

    Session Details:

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

    2023-11-01, 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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    Dr. Claudia Hesselmann
    Founder and CEO, Arensia

    Dr. Claudia Hesselmann, a chemist by training, with a PhD in molecular biology. Claudia has twenty years of expertise in the early phases of drug development. Her experience includes co-founding and holding management positions in various CROs. Her extensive background and social acumen, along with her first-hand knowledge of the industry, led Claudia to co-found ARENSIA Exploratory Medicine in Düsseldorf, Germany. Her primary aim is the contribution of innovative approaches to bring about substantial acceleration to the drug development process and enable more agile patient access to novel therapeutics.

    Session Details:

    Accelerated performance of complex exploratory patient studies: practical insights from investigational site

    2023-11-01, 11:30 AM

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    TOLA OLORUNNISOLA
    VP, Strategy, Innovation, Marketing And Digital, Avantor

    Ms. Olorunnisola is currently VP – Innovation, Marketing & Digital in the Avantor Services business unit. She leads Innovation, Marketing and Digital Solutions for the Supply Chain (Lab) Services and Clinical Services. She has over 15 years of experience in the Medical Device and Life Science industry developing and executing digital and go-to-market strategies. Additionally, she has led the development and deployment of large-scale enterprise solutions. Ms. Olorunnisola received her BA in Electrical Engineering from the University of Illinois at Chicago.

    Session Details:

    The innovations of decentralized clinical trials

    2023-11-01, 4:30 PM

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    Siddharth Parulkar
    Associate Director, Clinical Operations, Blueprint Medicines

    Session Details:

    Designing a vendor strategy that works for your clinical trial

    2023-11-01, 5:00 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:

    PANEL DISCUSSION: Navigating new regulations around diversity and inclusion

    2023-11-01, 11:00 AM

    Session Details:

    Patient centricity through health literacy

    2023-11-02, 9:00 AM

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    Sarah Tressel Gary
    Ph.D., Senior Scientific Advisor, eCOA Clinical Science and Consulting, Clario

    Session Details:

    The importance of scientific validation and data integrity when using accessibility features

    2023-11-02, 9:30 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, AnHeart Therapeutics

    Marilyn joins us with over 12 years of pharmaceutical development experience focusing small oncology company settings.  Her career started as a Clinical Trial Associate at Sumitomo Pharma Oncology (formerly Boston Biomedical). In her time there, she led a global phase 3 study, managed the TMF department, and supported multiple studies at the program level.  She spent some time at Black Diamond Therapeutics developing process and training for the Clinical Operations department. She is currently Director of Clinical Operations at Compass Therapeutics, where she leads a program with an ongoing phase 2 and phase 2/3 study. Marilyn holds a BS in Anatomy and Cell Biology from McGill University.

    Session Details:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2023-11-02, 3:45 PM

    Session Details:

    PANEL DISCUSSION: Navigating new regulations around diversity and inclusion

    2023-11-01, 11:00 AM

    Session Details:

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

    2023-11-02, 9:00 AM

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    Jodi Coughlin
    Director, Vendor Relationship Management, Deciphera Pharmaceuticals

    Jodi Coughlin, Director of Vendor Relationship Management at Deciphera Pharmaceuticals has over 15 years of industry experience spanning across small to large CRO and Sponsor organizations.  She attributes developing budgets and proposals in her early CRO days to deepening her understanding of the critical relationship between CROs and Sponsors. As she progressed in her career, Jodi transitioned to supporting Sponsor organizations in Outsourcing Management, developing processes and negotiating CRO budgets and contracts for Phase I-IV clinical trials.  Her passion for developing effective communication and governance structures expanded as she discovered a gap in “true strategic partnerships” between cross-functional trial teams.  With the addition of ICH E6 R2, Jodi found her niche as she began to lead and develop strategic and innovative vendor management and performance management oversight solutions between Sponsor and CRO matrix organizations.  She is highly passionate about establishing internal and external cross-functional communication processes and finds joy in building positive strategic partnerships that drive quality performance in support of clinical trial development.

    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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    Kim Ford Festi
    Associate Director, Site Contracts and Budgets, Deciphera Pharmaceuticals

    Session Details:

    Choosing the right site for your study: key factors

    2023-11-01, 12:00 PM

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    Holly Huang
    Vice President, Head of Biometrics, Denovo Biopharma

    Session Details:

    Innovating your data management strategy: how to stay ahead of the curve

    2023-11-02, 12:00 PM

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    Jenny Bentsen Gordon
    Vice President, Head of Clinical Operations, Editas Medicine

    Session Details:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2023-11-02, 3:45 PM

    Session Details:

    CASE STUDY: Recruiting for a rare disease trial

    2023-11-02, 10:00 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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    Neha Ghosh
    Associate Director, Clinical Research, Fresenius Medical Care

    Session Details:

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

    2023-11-01, 5:00 PM

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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:

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

    2023-11-02, 2:45 PM

    Session Details:

    Using data intelligence during to optimize geographic feasibility, site selection and patient recruitment

    2023-11-02, 12:00 PM

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    Vikas Agarwal
    Vice President, Head of Program Development, Greenfire Bio

    Session Details:

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

    2023-11-01, 2:00 PM

    Session Details:

    PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

    2023-11-02, 3:45 PM

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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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    Missy Hansen
    Paediatric Strategy Liaison, ICON Plc

    Session Details:

    Assessing risk in your clinical trial using the Pediatric Risk Assessment Map (PRAM):

    2023-11-01, 12:30 PM

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    Jenny Wakefield
    Senior Director- Quality Development Operations, Incyte

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

    Next speaker
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    Kelsey Miller
    Director, Clinical Development, Intrinsic Therapeutics

    Kelsey started her career in academics with The Boston Spine Group at the renowned New England Baptist Hospital. There she developed and managed their patient registries as well as their investigator and IDE clinical trials.  After 7 years at the Baptist she joined Impliant (a start-up medical device company), where she served as their Clinical Marketing Manager overseeing their US IDE, as well as post-market clinical trials in Brazil, Israel and Belgium. Since 2011 Kelsey has been with Intrinsic Therapeutics in their Clinical department successfully guiding the company’s flagship product through PMA approval.

    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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    Lori Clark
    Senior Director, IT Portfolio and Project Management, Karyopharm Therapeutics

    Session Details:

    CASE STUDY: Introducing and implementing new technologies

    2023-11-02, 11:00 AM

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    Leonella Seeley
    Associate Director Of Vendor Management And Operations, Karyopharm Therapeutics

    Session Details:

    Key considerations when choosing vendors and partners as a small biotech

    2023-11-01, 5:00 PM

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    Judith Murphy
    Executive Director, Centralized Contracting and Outsourcing, Kura Oncology

    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
    Chief Executive Officer, GenAdam Therapeutics

    Dr. Sherris has over 30 years’ experience in translational medicine involving basic research, pharmaceutics and diagnostics. Dr. Sherris has been a successful serial entrepreneur developing biotechnology companies from the ground up, devising corporate strategy, enacting programs and carrying companies through funding and acquisition. Dr. Sherris prides himself as a “roll up your sleeves” CEO, entrepreneur, business development officer, drug developer and scientist, not simply a delegator. Dr. Sherris has worked with venture capital companies, investment banks and angel investors where he has advised and raised well over $100 million for biotech companies. Dr. Sherris has been employed by pharmaceutical and biotechnology companies to manage external (academic groups and contract research organizations) and internal (directly manage, augment and expand internal scientific programs) research and development. Dr. Sherris has been a frequently invited guest speaker at biopharmaceutical business and scientific conferences, a published author and holder of patents in a wide range of therapeutic areas including oncology, ophthalmology, dermatology, neurology, gene therapy and infectious disease. Dr. Sherris has held positions of increasing responsibility in public and private companies. Dr. Sherris has developed drugs from the bench to the clinic, partnered technologies to pharmaceutical companies and raised capital for companies at the triple digit million dollar levels.

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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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    Mackenzie Johnson
    Senior Manager, Patient Centricity, Moderna

    Session Details:

    PANEL DISCUSSION: Is DCT old news?

    2023-11-01, 12:00 PM

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    Rana Said
    Biomarker Study Coordinator, Novartis

    Rana Said is a second year Biomarker Development fellow at Novartis in conjunction with MCPHS. She graduated from Rutgers with her PharmD in May 2022. At Novartis her primary focus is operational support for biomarker sampling on early clinical trials including setting up CRO support for studies. In addition, she works closely on the team that manages the CRO relationship for the Translational Medicine group, with a focus on managing issues.

    Session Details:

    Leveraging CRO partnerships in effective biomarker development

    2023-11-02, 11:00 AM

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    Kathryn Duschean
    Senior Scientist, Laboratory Excellence and Operations, Novartis

    Dr. Kathryn Duschean is a Senior Scientist in Biomarker Development at Novartis Institutes for Biomedical Research in Cambridge, MA, following a 2-year post-doctoral fellowship. She is currently involved in biomarker operational planning, focusing on streamlining fully outsourced studies containing biomarkers. She is also involved in the implementation, and validation of novel patient-centric sampling techniques across a variety of therapeutic areas. Her deep personal passions and former research in autoimmune and related conditions heavily influence and progress her interests and projects in this area. She believes that engaging with internal and external partners is critical to advancing the capabilities of clinical trials, including recruitment and decentralization. Kathryn received both bachelors in English, and in Health Sciences from the University of Iowa, and her PharmD from the University of Colorado.

    Session Details:

    Biomarker opportunities in FiH and clinical pharmacology studies run in an outsourcing model

    2023-11-01, 3:00 PM

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    Nan Doyle
    Patient Advocate

    Session Details:

    Engaging patients in a rare disease clinical trial

    2023-11-02, 11:00 AM

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    Prasanna Rao
    Senior Director, Global Head of AI and ML, Pfizer

    Prasanna Rao is an AI practitioner and Industry Thought Leader whose current role is Head of Artificial Intelligence and Data Science for Data Management at Pfizer. He has 30 years of experience in Information technology and Analytics, with 10+ years in Healthcare and Life Sciences. In his previous role as a Watson Solution Architect at IBM, he was instrumental in implementing many different AI systems from idea to implementation with various clients. In his current role, he works with various stakeholders, vendors, business SMEs, Machine Learning developers, and Data Scientists to deliver innovation and drive adoption of AI. He has presented at several industry conferences including SCDM, DIA and SCOPE.

    Session Details:

    OPENING KEYNOTE: Innovation in the US pharma industry: uncovering challenges and opportunities

    2023-11-01, 8:30 AM

    Session Details:

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

    2023-11-02, 2:45 PM

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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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    Robert Loll
    Senior Vice President, Business Development and Strategic Planning, Praxis

    Robert Loll is the SVP of Business Development & Strategic Planning at Praxis, a full service patient recruitment & retention agency that specializes in optimizing study enrollment for research studies with award-winning creative and superior execution.

    Designing and deploying effective patient recruitment campaign strategies since 2004, Robert’s clinical background includes 15 years providing patient care for top collegiate, Olympic and disabled athletes around the world and working for outpatient rehabilitation companies including Baxter, Caremark and NovaCare.

    Robert received a BA from the University of Iowa and completed the Athletic Training Curriculum Program within the Department of Exercise Science and Physical Education. Post-graduate courses include exercise science and Clinical Pharmacology, Drug Development, and Regulation with the Center for the Study of Drug Development at Tufts University.

    Robert is an Advisory Board member for The Center for Information and Study on Clinical Research Participation (CISCRP) an independent non-profit organization dedicated to educating and informing the public and patients about clinical research.

    Session Details:

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

    2023-11-01, 4:00 PM

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    Nicole Stansbury
    Senior Vice President and Head of Global Clinical Operations, Premier Research

    Nicole Stansbury joined Premier Research in May 2023 as the Senior Vice President and Head of Global Clinical Operations. Prior to joining Premier, Nicole spent 25 years in the CRO industry where she served in leadership roles including Global Head of Clinical Trial Management, Global Head of Central Monitoring, and Head of Global Clinical Performance, a team responsible for SOPs, metrics, training, clinical systems, and clinical quality. Nicole’s 30 years of industry experience has included positions at the site level and other CRO roles such as CRA and Project Manager.

    Nicole’s therapeutic experience has primarily been in Dermatology, Gastroenterology, Urology and Women’s Health; however, Nicole has leadership experience overseeing trials in Oncology, Neuroscience and General Medicine.

    Nicole has a Bachelor’s in Animal Science from Texas A&M University and has a Lean Six Sigma Yellow Belt. Nicole has served as Co-Lead for the Association of Clinical Research Organization’s (ACRO) Risk-Based Monitoring (RBM) Working Group since 2014 where she works with TransCelerate and global regulatory authorities on driving RBM adoption in the industry.

    Nicole is a member of PhUSE, collaborates regularly in industry publications, and is a frequent presenter and panelist at SCOPE, DIA, and other industry conferences.

    Session Details:

    Modernizing site management and monitoring roles to meet the dynamic needs of clinical research

    2023-11-02, 9:30 AM

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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, 2:00 PM

    Session Details:

    PANEL DISCUSSION: Is DCT old news?

    2023-11-01, 12:00 PM

    Session Details:

    PANEL DISCUSSION: How to choose technology vendors for your study

    2023-11-02, 9:00 AM

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    Emily Matthews
    Senior Manager, Clinical Business Operations, Relay Therapeutics

    Session Details:

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

    2023-11-01, 2:00 PM

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    John J Seman
    Chief Executive Officer, Revitale Pharma

    Session Details:

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

    2023-11-01, 4:00 PM

    Session Details:

    CASE STUDY: Running a clinical trial when repurposing an existing drug

    2023-11-02, 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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    Kara Titus
    Head, Clinical Vendor Management, Sage Therapeutics
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    RINALDO DORMAN
    MBA, CPSM, Associate Director, R&D Global Procurement & Strategic Sourcing, Sarepta Therapeutics

    Session Details:

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

    2023-11-02, 2:45 PM

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    Nancy Goodman
    Associate Director, Clinical Operations Program Leader, Takeda

    Nancy Goodman is a Registered Nurse, RN, BSN Nancy has 24 years in Clinical Operations, Ph. 1-4, with a focus in Early Phase, working in multiple therapeutic areas in small, medium and large biotech/pharmaceutical companies in the Boston area.  She has worked on a successful sNDA in Oncology.  Currently, Nancy is at Takeda Pharmaceuticals as an Associate Director, Clinical Operations Program Leader, COPL, Early Clinical Development.  Prior to this remit, she assumed COPL responsibilities in the Neuroscience Therapeutic area working on Neurodegenerative diseases.

    Outside of work, Nancy enjoys spending time with her husband, being outdoors, cycling, hiking, kayaking and playing tennis and travel.  She is located in the Boston area.

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    Jim Palma
    Executive Director, TargetCancer Foundation

    Jim Palma is the Executive Director of TargetCancer Foundation. Since joining TargetCancer Foundation in 2010, Jim has overseen its growth from a small start-up to a nationally recognized foundation supporting comprehensive rare cancer research programs and patient support services. Prior to joining TargetCancer Foundation, he spent eleven years at Fidelity Investments in Boston, MA. Jim is a member of the Board of Directors of the National Organization for Rare Disorders (NORD), and is a founding Co-Chair of the NORD Rare Cancers Coalition. In addition, Jim is a Steering Committee member at the GI Cancers Alliance and the Global Cholangiocarcinoma Alliance. Jim completed studies at the Institute for Nonprofit Management and Leadership at the Questrom School of Business at Boston University, and received his B.A. from Loyola University Maryland.

    Session Details:

    PATIENT ADVOCACY KEYNOTE: Patient experience in oncology trials: lessons learned from a patient advocacy-driven, decentralized clinical trial

    2023-11-01, 9:30 AM

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

    Meredith Frank-Molnia is currently employed at Third Pole Therapeutics as Senior Director of Clinical Operations. Third Pole is a medical device company producing electrically generated nitric oxide for treatment of hypoxic respiratory failure and lung disease.  Previously, Meredith held the position of Senior Director Clinical Management, while working at Axiom Real-Time Metrics Inc., where she established and expanded their Clinical Management department. Meredith has been in Clinical Project Management/Operations for 26 years in numerous roles of increasing responsibilities. Meredith has worked managing device/biologic and drug studies.

    Session Details:

    CASE STUDY: Implementing eClinical technology in a medical device setting

    2023-11-01, 4:00 PM

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    Tom Gottschalk
    Senior Director, Business Development, TrialCard

    Tom Gottschalk has worked in the life sciences industry for over 25 years.  His first 10 years were spent as a Pharmaceutical Representative and Product Manager for Bertek Pharmaceuticals, Merck, and GSK.  He then joined RxSolutions as a commercial services account representative before transitioning into a focused clinical role after creating the RxStudy Card offering.  He joined TrialCard in 2019 via its acquisition of RxSolutions.  For over 12 years, Tom has been committed to changing the paradigm of the traditional clinical trial supply process through the RxStudy Card.

    Session Details:

    Innovative processes to better address today’s trial dynamics

    2023-11-01, 4:30 PM

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    Ken Getz
    Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

    Ken is the Director of Sponsored Research and Associate Professor at the Tufts Center for the Study of Drug Development, and Chairman of the Center for Information and Study on Clinical Research Participation, a non-profit organization that he founded to raise public and patient awareness of the clinical research enterprise. He is founder and owner of CenterWatch, and an owner and board member of the Metrics Champion Consortium. A well-known speaker at symposia, universities, and corporations, Ken has published extensively in peer-reviewed journals, books and in the trade press.  He has been an active DIA member for 25 years and has held board appointments in the private and public sectors.  Ken earned his MBA from Northwestern University.

    Session Details:

    Operating conditions and trends impacting global clinical trial performance

    2023-11-02, 1:30 PM

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    Mary Jo Lamberti
    Research Associate Professor and Director, Sponsored Research, Tufts Center for the Study of Drug Development

    Mary Jo Lamberti is a Research Associate Professor at Tufts University Medical School and Director of Sponsored Research at the Tufts Center for the Study of Drug Development. She has extensive experience on benchmarking drug development operating practices. Her research focuses on a variety of areas including outsourcing and partnerships, clinical research workforce issues, investigative site initiation and management, patient recruitment and retention, and the use of technologies and digital solutions in clinical trials. She has been a frequent speaker at global industry conferences and has published extensively. She holds a B.A. from Wellesley College and a Ph.D. from Boston University.

    Session Details:

    Benchmarking patient enrollment and use of recruitment tactics

    2023-11-01, 12:00 PM

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    Amy Raymond
    Therapeutic Strategy Lead, Gene Therapy Think Tank, Worldwide Clinical Trials

    Amy has been a drug discovery and development professional for 25+ years, including progressive roles in clinical operations and clinical strategy. Her clinical development experience spans all therapeutic areas and all stages of the clinical development lifecycle, from natural history studies through registrational global trials, and Long-Term Follow Up and Post Marketing surveillances. In addition to her deep understanding of the unique dynamics of developing novel treatments for rare and complex diseases, Dr. Raymond also leverages her combination of training and experience leading the Gene Therapy Think Tank at Worldwide Clinical Trials. This experience includes in vivo viral- vectored gene therapies, ex-vivo viral vectored and gene edited treatments for oncology and non-oncology patient communities, and RNA medicine modalities. Her experiences in academia, biotech, and CROs confirm that meeting the needs of all stakeholders – payers, regulators, patients, families, and sites – is a critical success factor for efficient development programs. Dr. Raymond completed her doctoral training in molecular biology at University of California San Diego and post-doctoral training in molecular biology at Memorial Sloan-Kettering in New York City, New York, USA.

    Session Details:

    Continued evolution of cell and gene therapy development programs

    2023-11-01, 2:30 PM

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    Lisa Kang
    Head, Clinical Development Operation, Yoda Pharmaceuticals

    Session Details:

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

    2023-11-01, 2:00 PM

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    Sverre Bengtsson
    Co-Founder, Senior Vice President Strategic Relations, Viedoc

    Sverre Bengtsson started in the clinical trials industry over 30 years ago. He started as a statistician/statistical programmer, later into data management and since over 20 years into business development. He has been working in both CRO’s as well as in clinical trials technology companies, including the global first ePRO company. Sverre is very interested in making clinical trials efficient, in both study design but also in the processes and technologies used. Sverre co-founded Viedoc Technologies 19 years ago and is responsible for some of the major accounts but also the vision around the company. He’s on the board of both some industry organisations and in clinical technology companies.

    Session Details:

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

    2023-11-01, 12:30 PM

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    Evan Hahn
    Senior Vice President, IRT Solutions, YPrime
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    April Mattison-Wolfe
    Senior Solutions Architect, TransPerfect

    Session Details:

    Forging the future with CTMS

    2023-11-02, 2:15 PM

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    Hope Weisser
    Senior Product Manager, TransPerfect

    Session Details:

    Forging the future with CTMS

    2023-11-02, 2:15 PM

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    Ivor Clarke
    Chief Innovation Officer, SubjectWell

    Session Details:

    Improving randomization rates with Machine Learning and AI

    2023-11-02, 11:30 AM

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    Steven Cummings
    Executive Director, San Francisco Coordinating Center at California Pacific Medical Center Research Institute

    Session Details:

    Simplifying protocols to enable home-base trial activities

    2023-11-01, 11:30 AM

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    David Hadden
    President, Founder and Chief Game Changer, Pro-ficiency

    David Hadden is the pioneer of AI-driven Virtual Patient Simulation technology. His last company, TheraSim, trained over 1 million physicians worldwide and was sold to WebMD in 2013. At Pro-ficiency, Dave has transformed clinical research training into a powerful study resource and analytics tool, and Pro-ficiency has become the leader in the proactive, metric-driven approach to training that contradicts the traditional, check-it-off-the-list approach.

    Session Details:

    Session reserved for

    2023-11-01, 4:30 PM

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    Ken Hamill
    Senior Director, Clinical Operations Portfolio, Medidata Solutions

    Ken Hamill is the Senior Director, Clinical Operations Portfolio, at Medidata, a Dassault Systèmes company. Ken works across the organization and with customers in their adoption of clinical operations technologies that help automate trial quality workflows. Ken also leads the development and execution of strategic marketing programs for Clinical Operations at Medidata. Prior to Medidata, Ken had over 15 years of experience in life science product management, most recently at PerkinElmer where he led the strategy team for drug discovery assay development. Ken holds an MBA in Health Sector Management from Boston University, and an BS in Chemistry from Tufts University.

    Session Details:

    Solving the clinical data challenge

    2023-11-01, 9:00 AM

    Session Details:

    Registration and Refreshments

    2022-10-12, 8:15 AM

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    Ching Tian
    Chief Innovation Officer, Emmes

    Session Details:

    Session reserved for Emmes

    2023-11-02, 9:30 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:

    TECHNOLOGY SPOTLIGHT: Running up that hill: accelerate cycle times and reach patients faster with elluminate

    2023-11-01, 11:30 AM

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    Jasmine Benger
    Senior Director, Research Services, CISCRP

    Session Details:

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

    2023-11-02, 2:45 PM

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    Alex Bai
    Head of Clinical Contracts, Biogen

    Session Details:

    Reserved for

    2023-11-01, 11:00 AM

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    Joyce Moore
    Global Head of Patient Engagement, Allucent

    Session Details:

    How do we make participation in clinical research more patient-friendly

    2023-11-01, 2:30 PM

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