14th Annual Clinical Trials in Oncology East Coast 2025

Discover effective strategies to ensure your oncology trial operations run smoothly and within budget, while improving the experience for patients.

8 - 9

July

2025
  • The Westin Waltham Boston, Boston, USA
  • Complimentary
  • Why attend?
  • Agenda
  • Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • 2025 Sponsors
  • Media Centre
  • Contact Us
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Featured Speakers

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Giovanni Abbadessa​

Chief Medical Officer, ModeX Therapeutics

Giovanni was born in Naples, Italy. While studying Medicine, he volunteered on projects for the poor, sick and lepers in Italy, Albania, India. He was a subinvestigator on 4 oncology clinical trials during his Clinical Oncology in Milan since 2001; moved to Philadelphia, PA, USA in 2005 where enrolled in a PhD program in Genetic Oncology, performing in vitro and in vivo gene therapy studies in cancer models. In 2007 he moved to Boston to lead cancer drug development programs in small biotech companies; at ArQule he led lab research, clinical development and medical affairs and brought 7 molecules to Ph1-3 clinical development. In 2017 he joined Sanofi, where as VP and Head of Oncology Early Development he oversaw development of over 20 clinical experimental drugs, as many preclinical, through teams of ~300 people, besides helping with Business Development and Investor Relations. In addition, Giovanni consulted for a couple of dozen companies and VC funds, scientific societies, and Governments. In 2008 Giovanni founded the nonprofit Professionisti Italiani a Boston, which has hosted 100+ cultural and networking events; in 2014 he founded Scuola PIB, a nonprofit Italian Saturday school with over 170 pupils in 2025

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Leena Gandhi​

Chief Medical Officer, NextPoint Therapeutics, Inc

Leena is a board-certified thoracic oncologist and physician-scientist in immuno-oncology with an academic and industry background in translational research and early and late clinical development. She have developed multiple investigator-initiated trials with associated correlative studies to help define biomarkers of response with a focus on immunotherapeutics in lung cancer. Leena has led phase I-III pivotal trials in lung cancer defining the role of PDL1 in the use of immunotherapy and immunotherapy combinations in NSCLC. Leena has led academic clinical and clinical research programs in immuno-oncology development and oversaw translational and clinical aspects of development of a portfolio that spanned early pre-clinical to late-phase compounds . Leena has also developed the Center for Therapeutic Innovation at DFCI-- an integrated clinical/translational research center focused on early drug development.

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Tomasz Adamusiak​

Chief Scientist, Clinical Quality and Data Science, MITRE

Tomasz Adamusiak, MD PhD, serves as the Chief Scientist for Clinical Quality and Data Science at MITRE, where he leads initiatives to improve healthcare outcomes through AI and real-world evidence. Previously, as Head of Data Science at the Pfizer Innovation Research Lab, he led work on digital endpoints and decentralized clinical trials. He has held leadership positions within the American Medical Informatics Association and SNOMED International, and has published extensively in peer-reviewed journals.

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    2025 Sponsors Include:

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    Company Information

    Philips BioTel Research is an industry leader in medical imaging and cardiovascular safety testing for clinical trials.

    Philips BioTel Research offers global operational support for cardiovascular monitoring in all therapeutic areas, and advances imaging services in oncology, cardiovascular, metabolic, musculoskeletal, neurologic, and medical device studies. Their experienced research team comprises key opinion leaders, board-certified cardiologists and radiologists, sub-specialty scientists, and highly trained technicians – who acquire, evaluate, and report high-quality data through an efficient, cloud-based infrastructure. Many biopharmaceutical trial sponsors rely on or scientific leaders to help design and optimize their protocols and statistical analysis plans. We have conducted clinical trials contributing to the market approval of nearly 100 new drugs to date.

    Company Website

    To learn more, please visit our website - www.gobio.com/clinical-research/

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    Company Information

    eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. The elluminate® Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. elluminate software and data driven services have been used by more than 100 life sciences companies on over 500 clinical trials to reduce cycle time and improve data quality. For more information, visit www.eclinicalsol.com, or contact us at info@clinicalsol.com.

    Company Website

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

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    Company Information

    Worldwide is changing how the world experiences CROs – in the best possible way. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence, Worldwide Clinical Trials provides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies.

    Company Website

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

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    Company Information

    Scimega is a niche Canadian Oncology CRO with a singular focus on promoting and contributing to the successful conduct of cutting-edge oncology clinical trials in Canada. With a permanent, Lean-coached operations team our proven track record assisting mid-size and smaller US biotech/biopharma sponsors to undertake global oncology studies in Canada is bundled with 25 years of lessons learned!

    Company Website

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

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    Company Information

    ARENSIA Exploratory Medicine, a German-based company, is a leader in “first-in-patient” Phase IB and II/Proof-of-Concept clinical trials across a wide range of disease areas. With 14 proprietary research clinics and cutting-edge Phase I infrastructure, ARENSIA accelerates the early detection of efficacy signals for new therapies at an unparalleled speed. Its streamlined, highly efficient approach reduces patient recruitment time and costs by over 50% compared to conventional trial sites, which are often overcrowded and understaffed. This exceptional performance has resulted in a 93% repeat business rate and robust growth through collaborations with top pharmaceutical companies, biotechs, and global CROs. Headquartered in Düsseldorf, ARENSIA operates with a team of 600 professionals across 8 countries.

    Company Website

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

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    Company Information

    You need an Imaging Strategy that’s designed and customized for your oncology clinical trial. RadMD, a Medica Group Company, is your full service imaging core lab solution. Imaging endpoints are often used to support go/no-go decision-making in early phase trials. This is also a critical time to determine the development strategy for later study phases. https://www.rad-md.net/

    Company Website

    To learn more, please visit our website - www.rad-md.net

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    Company Information

    IDDI optimizes the clinical development of drugs, biomarkers and IVD using a unique combination of advanced biostatistics and innovative data collection technology.

    IDDI covers the full spectrum of trial design, clinical data collection, management, analysis and reporting for Phase I- IV clinical trials.

    – IDDI’s services include: Clinical Development Plans, Protocol Development, Randomization (IWRS/IRT) with Drug Supply Management, EDC, Medical Coding, Data Management, Biostatistics, IDMC Support, Biomarker/Diagnostics Validation, Medical Writing.

    – IDDI’s therapeutic areas of expertise include oncology, ophthalmology, infectious diseases and cardiology.
    – Experience: 27+ years – 980+ trials (630+ in oncology) – 20 FDA/EMA approvals to-date
    – HQ in Belgium with offices in the USA ( Raleigh, NC, Boston, MA and San Francisco, CA).

    Company Website

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

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    Company Information

    Simply sourcing comparators – we offer a unique blend of small company flexibility and speed, backed with the large-scale buying power of the Orifarm Group, which is one of the largest pharmaceutical suppliers in Europe. With over €1.4B products sold in 2021 and more than 4,000 unique product lines sourced on a monthly basis, we have unparalleled access to “out of market” and manufacturer direct buying capability, both in the US and Europe.

    Company website: www.Orifarm-CTS.com

    Company Website

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

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    Company Information

    LabConnect is the world’s most agile central laboratory solutions partner supporting clinical trials of all sizes and complexity. With modern operations and strategic alliances with world-leading laboratories, LabConnect is uniquely positioned to provide access to the latest innovation and automation. LabConnect is the trusted partner for biotechnology, pharmaceutical, and clinical research organizations.

     

    Follow LabConnect on LinkedIn

    Learn more at labconnect.com

    Company Website

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

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    Company Information

    Precision medicine is in our blood, our cells, our genes, and our name. Precision for Medicine (PFM), the full-service global CRO, is purpose-built to accelerate clinical research and development processes to bring life-changing therapeutics to those who need them most. We integrate clinical operations excellence, laboratory expertise, and advanced data sciences to deliver on the promise of personalized therapy; translating research into real-world results and forever reimaging how to get there.

    Company Website

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

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    Company Information

    Biorasi is a global contract research organization (CRO) delivering fast and flexible solutions across clinical trials to maximize speed-to-market for its sponsors. As the leader in clinical trials for dermatology, neurology, and oncology, Biorasi sets new benchmarks for speed, agility, and quality in patient enrollment, decentralized trials, and data sciences.

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    Company Information

    We’re more than a supplier: we’re a partner that can deliver consistent quality and superior service, a partner that fuel innovation for foster real and sustainable results. A deep understanding of healthcare industry and our customers’ needs is critical to ensure our range of packaging products and services deliver value through the entire product lifecycle. These insights and the experience of the WestRock Adherence team enable us to work in tune with regulations and clients to provide a service solution underpinned by an innovative and unparalleled range of packaging products including Clinical Trial Packaging, specialty labels, literature & booklets, Adherence packaging, multiple component kits and SMART Digital Adherence Technology.

    Company Website

    To learn more, please visit our website - www.westrock.com/markets/healthcare

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    Company Information

    Myonex provides tailored services and solutions to advance medicine through clinical to commercial stages with tailored drug sourcing and ancillary supply, to packaging, labeling, and distribution. With ten global locations, we offer flexible, efficient, and cost-effective support for clients across the pharmaceutical and biotech sectors.

     

    Company Website

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

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    Company Information

    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.

    Company Website

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

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      Why attend?

      Discover effective strategies to ensure your oncology trial operations run smoothly and within budget, while improving the experience for patients. 

      Arena International is delighted to announce Clinical Trials in Oncology East Coast will be returning to Boston in July 2025! Bringing together clinical operations experts from oncology pharma and biotech sponsor companies on the East Coast alongside technology vendors, CROs and patient advocates, this will provide a perfect platform to uncover new technologies, processes and solutions to operational challenges when running an oncology trial.

      The programme will look at the latest challenges and innovations in oncology operations including fostering relationships with clinical sites, innovating data management processes and navigating new regulations impacting oncology trials in the US. Featuring a new track on Patient Recruitment and Engagement, the conference will be the platform for innovative case studies and break out discussions to connect and enhance your knowledge in the oncology space.

      Join us for a two-day event and register now!

      WHAT TO EXPECT FOR 2025?

      Clinical Trials in Oncology is the meeting place for leading pharmaceutical companies and biotechnology institutes. Discover how to excel in oncology operations and clinical supply strategy as well as form key connections for long-term success for your clinical trial.

      150+

      Attendees

      		20+

      Exhibitors

      		25+

      Speakers
      150+

      Attendees

      		20+

      Exhibitors
      25+

      Speakers

      Testimonials

      See What It's All About

      Agenda

      • 8 Jul 2025
      • 9 Jul 2025
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      Streams

      Stream one

      STREAM A: Clinical Operations

      Stream two

      STREAM B: Patient Centricity

      11:15 AM

      Keeping patients at the heart of clinical trials: how to incorporate patient centricity throughout oncology studies

      • Maintaining patient centricity in your trial to positively impact recruitment and engagement
      • Working with patients, caregivers and advocacy groups to establish better patient support systems throughout trial participation
      • Best practice in prioritizing patient needs in clinical trial design

      Speakers

      T.J Sharpe
      Patient Advocate

      11:45 AM

      Available for event sponsor

      12:15 PM

      PANEL: Boosting recruitment in oncology trials by incorporating patient friendly language that effectively conveys information

      • Equipping patients with a better understanding of your trial to increase recruitment
      • Modifying communication strategies to ensure patients feels fully informed with decision making and giving consent
      • Incorporating health literacy in all stages of patient communication to ensure fully transparent clinical trials

      Speakers

      Irisaida Méndez
      Patient Advocate, IMKahlo
      T.J Sharpe
      Patient Advocate
      Shawn Keogan
      Director of Patient Advocacy and Professional Relations, GenMab

      12:45 PM

      Available for tech spotlight

      1 PM

      Lunch and networking

      2 PM

      Utilizing emerging technologies to enhance patient experience during oncology trials

      • Analyzing the latest trends in technology that assist in delivering a better patient experience
      • Utilizing technologies that enhance patient experience and efficiency of study
      • Understanding how to successfully incorporate new technology to improve patient trial experience

      Speakers

      Lisa La
      Early Development Project & Team Leader, Oncology, Sanofi
      Rebecca Jacob
      Early Development Clinical Operations Project Team Leader, Sanofi

      2:30 PM

      Keeping Patients Connected: The Role of Virtual Support Centers in Long-Term Follow-Up

      • Review the challenges of long-term patient engagement and why ongoing communication is crucial
      • Explore the role of virtual call centers in bridging patients and research teams
      • Understand how virtual centers can alleviate burden on clinical sites and streamline patient management
      • Highlight the impact on patient retention, data quality, and timely adverse event reporting

      Speakers

      Elaina Haeuber
      M.S. Senior Vice President, Oncology, Premier Research

      3 PM

      Designing an effective patient recruitment strategy for a rare cancer trial

      • Patient identification: how to find patients who are eligible to participate in trials for rare forms of cancer
      • Collaborating with patient advocacy groups to facilitate and boost recruitment
      • What makes recruiting for a rare cancer trial unique?

      Speakers

      Chris Adams
      Founder & CEO, Andarix

      3:30 PM

      Afternoon refreshments and networking

      4 PM

      Raising community awareness of oncology trials to reach target patient populations and boost numbers of participants

      • Exploring ways to effectively communicate information about your trial to wider patient populations
      • Learning how to target eligible patients through increased awareness
      • Connecting with communities to address patient worries in trial participation

      Speakers

      Kelly Schlemm
      Vice President, Head of Corporate Affairs, Servier Pharmaceuticals

      4:30 PM

      Available for event sponsor

      5 PM

      Oncology patient perceptions and experiences in clinical research: Review of results from a large global survey

      Speakers

      Emily Clifford
      Senior Project Manager, Research Services, CISCRP

      8 AM

      Registration and refreshments

      8:35 AM

      Chairperson’s opening remarks

      8:45 AM

      PANEL: Evolving Oncology landscapes for trials in the US: adapting to a changing environment

      • Evaluating regulation and the impact on oncology clinical
      • Navigating the evolving regulatory landscape effectively
      • Understanding how the geopolitical landscape is affecting oncology trials inside and outside of the US

      Speakers

      Giovanni Abbadessa
      Chief Medical Officer, ModeX Therapeutics
      Fatima Scipione
      Vice President, Global Patient Affairs, Blueprint Medicines
      Shaily Arora
      Executive Director, Oncology Regulatory Strategy, AstraZeneca
      Holly Huang
      Vice President, Head of Biometrics, Denovo Biopharma

      9:15 AM

      Available for featured sponsor

      9:45 AM

      Forecasting and managing budgets to ensure financial feasibility throughout your oncology trial

      • Mapping out trial budgets to ensure financial feasibility throughout your study
      • Securing VC funding through communication and forecasting budgets
      • Strategies to avoid overspending by tracking finances during trials

      Speakers

      Giovanni Abbadessa
      Chief Medical Officer, ModeX Therapeutics

      10:15 AM

      Available for featured sponsor

      10:45 AM

      Morning refreshments and networking

      11:15 AM

      Discovering new approaches to protocol design in oncology trials that shorten study timelines and decrease cost

      • Designing a protocol that adapts to increased complexities in trials to shorten timelines
      • Creating adaptable designs that allows flexibility during trials for increased efficiency
      • Strengthening foundations of your trial with a clearly defined protocol ensuring the collection of valid data

      Speakers

      Leena Gandhi
      Chief Medical Officer, NextPoint Therapeutics, Inc

      11:45 AM

      Available for event sponsor

      12:15 PM

      PANEL: Exploring developments in AI to identify how your oncology clinical trial can be enhanced

      • Evaluating current trends in AI technology
      • Understanding how AI can enhance areas of clinical studies
      • Identifying where AI can be incorporated and how to implement this effectively in your company

      Speakers

      Tomasz Adamusiak
      Chief Scientist, Clinical Quality and Data Science, MITRE
      Irena Webster
      Senior Vice President, Development & Operations, Incendia Therapeutics
      Ayat Alsaraby
      Sr. Manager, Clinical Biomarker Operations, Repare Therapeutics
      Rebecca Jacob
      Early Development Clinical Operations Project Team Leader, Sanofi

      12:45 PM

      Available for tech spotlight

      1 PM

      Lunch and networking

      2 PM

      Effectively navigating vendor relationships: how to maintain communication to ensure your oncology trial is prioritized

      • Tips and tricks for stakeholders to maintain relationships throughout study
      • Establishing strong communication patterns that convey information effectively for smooth running of trials
      • Learning tactics that will capture vendor attention throughout study timelines

      Speakers

      Irena Webster
      Senior Vice President, Development & Operations, Incendia Therapeutics

      2:30 PM

      How to Measurably Increase Operational Efficiency in Clinical Trials

      There is an urgency to speed up clinical trial processes. To identify and eliminate operational inefficiencies that cause bottlenecks. To ensure concerted efforts from investigators and study teams, sponsors, and other key operational partners combine to conserve resources and time, and, most importantly, accelerate progress in cancer research.

      • This presentation explores just how to do so with key insights that look at how to:
      • Identify and eliminate operational inefficiencies that cause bottlenecks in clinical trials
      • Organize, implement and maintain the coordination between investigators and study teams, sponsors, and other key operational partners to conserve resources and time to accelerate progress in cancer research
      • Implement continuous examination and optimization

      Speakers

      Julie Martin
      President & CEO, Scimega

      3 PM

      Breaking down silos in teams and encouraging collaboration across your company for increased efficiency

      • Exploring communication methods that encourage a collaborative culture across a company
      • Implementing a strategy that breaks down silos and redefines how teams work together
      • How working closely with other teams can foster collaboration when working towards shared goals

      Speakers

      Michelle Joseph
      Associate Director, Data Management, Alkermes

      3:30 PM

      Afternoon refreshments and networking

      4 PM

      Data aggregation in oncology trials: ensuring your sites are collecting data in a timely and efficient manner

      • Incorporating site-friendly technology to facilitate data collection and decrease errors or delays
      • Methods to increase efficiency in data collection at sites
      • Working closely with site staff to ensure data is gathered

      Speakers

      Holly Huang
      Vice President, Head of Biometrics, Denovo Biopharma

      4:30 PM

      Available for event sponsor

      5 PM

      Leveraging FDA expedited programs: enhancing drug development and review

      • Exploring the eligibility requirements and specific advantages of the expedited programs
      • Incorporating expedited programs to streamline development timelines

       

      Speakers

      Shaily Arora
      Executive Director, Oncology Regulatory Strategy, AstraZeneca

      5:30 PM

      Chair’s closing remarks

      END OF DAY 1 AND NETWORKING DRINKS

      8 AM

      Registration and refreshments

      8:50 AM

      Chair’s opening remarks

      9 AM

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the running of an oncology trial in the US.

      ROUNDTABLE 1: Weighing up the pros and cons of different trial designs to enhance your clinical study
      ROUNDTABLE 2: Optimizing site budgets and minimizing cost through clinical study strategies
      ROUNDTABLE 3: Breaking down distrust of AI to effectively implement new technology in your company
      ROUNDTABLE 4: Analyzing opportunities to include decentralized and hybrid elements in your clinical trial

      Speakers

      Giovanni Abbadessa
      Chief Medical Officer, ModeX Therapeutics
      Lisa La
      Early Development Project & Team Leader, Oncology, Sanofi
      Ayat Alsaraby
      Sr. Manager, Clinical Biomarker Operations, Repare Therapeutics

      10 AM

      From setback to success: The art of clinical trial rescue

      In the complex world of clinical research, even meticulously planned trials can face unexpected hurdles that threaten to derail progress and encounter obstacles beyond the capabilities of a small-scale Clinical Research Organization (CRO). When studies falter, a well-executed rescue strategy with an experienced global CRO becomes crucial. Drawing from Parexel's extensive rescue-trial experience, this presentation unveils the blueprint for successful clinical trial transitions, focusing on four key phases:

      • Strategic Initiation & Planning - establishing a robust framework and standardized processes
      • Comprehensive Preparation & Due Diligence - ensuring stakeholder alignment on transition plans and timelines  - Conducting thorough documentation review and gap analysis
      • Adaptive Execution & Transfer - How to operationalize a study transfer - Anticipating challenges and employing agile governance for real-time course corrections
      • Effective Closure & Delivery - defining clear transition thresholds and success metrics  - Ensuring continuity and maintaining data integrity throughout the process

      Parexel

      10:30 AM

      Morning refreshments and networking

      11 AM

      Going paperless: Overcoming the challenges and reaping benefits of implementing digital solutions in oncology trials

      • Pre-implementation data and workflow challenges – A look at the inefficiencies and pain points in paper-based workflows and the impact on data management
      • Navigating the implementation process – Key steps, challenges, and site engagement strategies for successfully transitioning to fully digital workflows
      • Post-implementation impact: A transformative shift – How real-time oversight has reshaped workflows, improved data accuracy, and enhanced site operation

      Speakers

      Ayat Alsaraby
      Sr. Manager, Clinical Biomarker Operations, Repare Therapeutics

      11:30 AM

      Available for event sponsor

      12 PM

      Investigating new initiatives for study start up to keep ahead of the competition in oncology trials

      • Evaluating new initiatives to speed up study start up and site activation
      • Streamlining trial start up and site activation by establishing strong communication
      • Implementing and executing new processes across your company for easy and effective study start up

      Speakers

      Tatiana Kolesnikova
      Director, Oncology and Hematology, GlobalData

      12:30 PM

      Available for event sponsor

      1 PM

      Lunch and networking

      2 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!

      2:15 PM

      Using the Budget to Facilitate Improved Alignment Between CROs and Sponsors in Oncology Trials

      • Utilizing trial budgets to increase efficiency between CROs and Sponsors
      • Establishing trial expectations by conveying budget outlines effectively
      • Ensuring your trial stays within budget throughout the full timeline

      Speakers

      David Murcar
      Associate Director, Procurement, Immunocore Limited

      2:45 PM

      From day one to data: How strong regulatory-clinical operations collaboration can chart a course for success

      • Establishing clear communication pathways between clinical operations and regulatory teams
      • Proactive integration of regulatory, development, and clinical operations strategies in a dynamic environment
      • Synchronizing clinical operations and regulatory activities to expedite the execution of protocols and amendments

      Speakers

      Brian Caselli, MS,
      Senior Director, Regulatory Affairs, Sumitomo Pharma America
      Reyna Bishop, MS, RD
      Associate Director, Clinical Operations, Sumitomo Pharma America

      3:15 PM

      Case study: How to successfully pick the right CRO for increased efficiency and better oncology trial results

      • Identifying and creating criteria that addresses exactly what your study needs to make the selection process easier
      • Strengthening relationships with CROs by communicating effectively throughout your study
      • Understanding and assessing CROs capabilities tailored to your specific trial needs to avoid running into roadblocks

       

      Speakers

      Andrea Bottkova
      Director, Senior Director of Procurement and Vendor Management, Karyopharm Therapeutics Inc.

      3:45 PM

      Characterizing the transition from legacy, on-site to centralized and risk-based monitoring

      Speakers

      Hana Do
      Research Analyst, Tufts Center for the Study of Drug Development

      4:15 PM

      Chair’s closing remarks

      END OF CONFERENCE

      Speakers

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      Fatima Scipione
      Vice President, Global Patient Affairs, Blueprint Medicines

      Fatima is passionate about elevating the patient voice on a global scale.

      She believes that understanding patient experiences and challenges is essential to speeding up the development of life-changing medicines. Further, she advocates in support of patients gaining the skills, courage, and knowledge to navigate through a cancer diagnosis, to make informed decisions, and to ensure they can advocate for and achieve the best care possible.

      This fierce passion and commitment to putting the needs of patients first is evident in her decades-long career where she is recognized as an influential global advocate thought leader focused on patient centered research, policy, access, and regulatory impact.

      She has held multiple senior management positions in healthcare and is a respected member of the biopharma and cancer communities. Fatima has contributed to numerous publications in partnership with the advocacy community and key academic researchers to advance patient-centered care, as well as being included in the PharmaVOICE 100 in 2014 and receiving the Trailblazer Brand Champion Award from PM3670 in 2015

      Session Details:

      PANEL: Evolving Oncology landscapes for trials in the US: adapting to a changing environment

      2025-07-08, 8:45 AM

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      Holly Huang
      Vice President, Head of Biometrics, Denovo Biopharma

      Session Details:

      PANEL: Evolving Oncology landscapes for trials in the US: adapting to a changing environment

      2025-07-08, 8:45 AM

      Session Details:

      Data aggregation in oncology trials: ensuring your sites are collecting data in a timely and efficient manner

      2025-07-08, 4:00 PM

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      Michelle Joseph
      Associate Director, Data Management, Alkermes

      Session Details:

      Breaking down silos in teams and encouraging collaboration across your company for increased efficiency

      2025-07-08, 3:00 PM

      View In Agenda
      Next speaker
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      Shawn Keogan
      Director of Patient Advocacy and Professional Relations, GenMab

      Shawn Keogan, Ph.D., is the Director of Patient Advocacy and Professional Relations at Genmab, where she leads efforts to build strategic partnerships with advocacy organizations, professional societies, and patients. She is responsible for advancing patient engagement initiatives to gather patient perspectives and ensure they are integrated into development and commercialization strategies. Shawn holds a Ph.D. in Microbiology and Immunology from Drexel University College of Medicine.

      Session Details:

      PANEL: Boosting recruitment in oncology trials by incorporating patient friendly language that effectively conveys information

      2025-07-08, 12:15 PM

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      Irena Webster
      Senior Vice President, Development & Operations, Incendia Therapeutics

      Session Details:

      Effectively navigating vendor relationships: how to maintain communication to ensure your oncology trial is prioritized

      2025-07-08, 2:00 PM

      Session Details:

      PANEL: Exploring developments in AI to identify how your oncology clinical trial can be enhanced

      2025-07-08, 12:15 PM

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      David Murcar
      Associate Director, Procurement, Immunocore Limited

      Mr Murcar has worked in the CRO industry for 25 years, primarily managing proposal and contract development. He has a particular background in the development of Phase II/III budgeting tools. For the last five years he has worked in biotech helping to facilitate the selection and financial management of CROs related to oncology and infectious disease studies.

      Session Details:

      Using the Budget to Facilitate Improved Alignment Between CROs and Sponsors in Oncology Trials

      2025-07-09, 2:15 PM

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      Irisaida Méndez
      Patient Advocate, IMKahlo

      : Irisaida Mendez is a seasoned multicultural communications expert with a unique ability to weave compelling narratives that transcend geographic boundaries. She is passionate about raising awareness for global issues through highlighting acculturation and modeling methods that bridge language and cultural divides. Her expertise in multicultural communications and crisis management makes her a leading figure in impactful transmedia projects, seamlessly integrating quantitative and qualitative research. Her contributions span a diverse range of fields, from clinical trial development and end-of-life care to microbusiness empowerment and global training initiatives.

      Her storytelling work has taken her impact to Ghana, Ethiopia, Haiti, Colombia, Puerto Rico, Albania, and South Korea, where she has used her skills to amplify the voices of marginalized communities and advocate for social change.

      Under Univision Foundation, Irisaida spearheaded a trauma-informed parenting campaign in Spanish, providing crucial support to families navigating the difficult aftermath of disasters like Hurricanes Helene and Milton and the LA Fires. This initiative helped families cope with the emotional challenges of these devastating events. Also, La fuerza STEM, a multi-platform edutainment initiative designed to empower caregivers to cultivate a love for science in children, has earned widespread recognition. This project, which garnered multiple awards including an Emmy Award and a Silver Anthem Award, inspires the next generation of STEM leaders by providing a multigenerational approach to informal science.

      Having navigated her own journey as a Stage 4 cancer survivor who is now NED (no evidence of disease), Irisaida is a sought-after Patient Advocate speaker, using her powerful voice to empower others and advocate for their needs at state and national conferences. Her ability to craft and share impactful narratives, born from personal experience, has earned her widespread recognition.

      Session Details:

      PANEL: Boosting recruitment in oncology trials by incorporating patient friendly language that effectively conveys information

      2025-07-08, 12:15 PM

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      Andrea Bottkova
      Director, Senior Director of Procurement and Vendor Management, Karyopharm Therapeutics Inc.

      I currently work as Senior Director of Procurement and Vendor Management at Karyopharm Therapeutics Inc. I have been negotiating contracts for little over fifteen years. Working 10 years in the biotech industry I have gained an excellent Understanding of all areas of research and development. In 2019 I helped establish Karyopharm’ s vendor management and procurement department to support vendor oversight, strategic sourcing maximizing financial savings. I am passionate about building partnerships and negotiating business terms of contracts resulting in several million dollar savings annually. I believe that I have perfected my negotiations skills while learning from my very curious 7-year-old son Barton.

      Session Details:

      Case study: How to successfully pick the right CRO for increased efficiency and better oncology trial results

      2025-07-09, 3:15 PM

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      Tomasz Adamusiak
      Chief Scientist, Clinical Quality and Data Science, MITRE

      Tomasz Adamusiak, MD PhD, serves as the Chief Scientist for Clinical Quality and Data Science at MITRE, where he leads initiatives to improve healthcare outcomes through AI and real-world evidence. Previously, as Head of Data Science at the Pfizer Innovation Research Lab, he led work on digital endpoints and decentralized clinical trials. He has held leadership positions within the American Medical Informatics Association and SNOMED International, and has published extensively in peer-reviewed journals.

      Session Details:

      PANEL: Exploring developments in AI to identify how your oncology clinical trial can be enhanced

      2025-07-08, 12:15 PM

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      Giovanni Abbadessa
      Chief Medical Officer, ModeX Therapeutics

      Giovanni was born in Naples, Italy. While studying Medicine, he volunteered on projects for the poor, sick and lepers in Italy, Albania, India. He was a subinvestigator on 4 oncology clinical trials during his Clinical Oncology in Milan since 2001; moved to Philadelphia, PA, USA in 2005 where enrolled in a PhD program in Genetic Oncology, performing in vitro and in vivo gene therapy studies in cancer models. In 2007 he moved to Boston to lead cancer drug development programs in small biotech companies; at ArQule he led lab research, clinical development and medical affairs and brought 7 molecules to Ph1-3 clinical development. In 2017 he joined Sanofi, where as VP and Head of Oncology Early Development he oversaw development of over 20 clinical experimental drugs, as many preclinical, through teams of ~300 people, besides helping with Business Development and Investor Relations. In addition, Giovanni consulted for a couple of dozen companies and VC funds, scientific societies, and Governments. In 2008 Giovanni founded the nonprofit Professionisti Italiani a Boston, which has hosted 100+ cultural and networking events; in 2014 he founded Scuola PIB, a nonprofit Italian Saturday school with over 170 pupils in 2025

      Session Details:

      Forecasting and managing budgets to ensure financial feasibility throughout your oncology trial

      2025-07-08, 9:45 AM

      Session Details:

      PANEL: Evolving Oncology landscapes for trials in the US: adapting to a changing environment

      2025-07-08, 8:45 AM

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2025-07-09, 9:00 AM

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      Leena Gandhi
      Chief Medical Officer, NextPoint Therapeutics, Inc

      Leena is a board-certified thoracic oncologist and physician-scientist in immuno-oncology with an academic and industry background in translational research and early and late clinical development. She have developed multiple investigator-initiated trials with associated correlative studies to help define biomarkers of response with a focus on immunotherapeutics in lung cancer. Leena has led phase I-III pivotal trials in lung cancer defining the role of PDL1 in the use of immunotherapy and immunotherapy combinations in NSCLC. Leena has led academic clinical and clinical research programs in immuno-oncology development and oversaw translational and clinical aspects of development of a portfolio that spanned early pre-clinical to late-phase compounds . Leena has also developed the Center for Therapeutic Innovation at DFCI-- an integrated clinical/translational research center focused on early drug development.

      Session Details:

      Discovering new approaches to protocol design in oncology trials that shorten study timelines and decrease cost

      2025-07-08, 11:15 AM

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      Ayat Alsaraby
      Sr. Manager, Clinical Biomarker Operations, Repare Therapeutics

      Ayat is a leading expert in biospecimen management, solutions, and chain of custody, with over a decade of experience advancing best practices in clinical and research settings. She has a proven track record of developing and implementing innovative strategies for the collection, storage, and utilization of biospecimens while ensuring compliance with the highest regulatory and quality standards.

      Passionate about driving progress in the field, Ayat has pioneered solutions that enhance efficiency, integrity, and precision in biospecimen management. Her expertise plays a critical role in supporting scientific discoveries and healthcare advancements. A trusted thought leader, she continues to shape the future of biospecimen management through advocacy and innovative solutions that drive medical breakthroughs and better patient care.

      Session Details:

      PANEL: Exploring developments in AI to identify how your oncology clinical trial can be enhanced

      2025-07-08, 12:15 PM

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2025-07-09, 9:00 AM

      Session Details:

      Going paperless: Overcoming the challenges and reaping benefits of implementing digital solutions in oncology trials

      2025-07-09, 11:00 AM

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      Lisa La
      Early Development Project & Team Leader, Oncology, Sanofi

      Session Details:

      Utilizing emerging technologies to enhance patient experience during oncology trials

      2025-07-08, 2:00 PM

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2025-07-09, 9:00 AM

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      T.J Sharpe
      Patient Advocate

      Session Details:

      PANEL: Boosting recruitment in oncology trials by incorporating patient friendly language that effectively conveys information

      2025-07-08, 12:15 PM

      Session Details:

      Keeping patients at the heart of clinical trials: how to incorporate patient centricity throughout oncology studies

      2025-07-08, 11:15 AM

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      Shaily Arora
      Executive Director, Oncology Regulatory Strategy, AstraZeneca

      Shaily Arora, PharmD, is an Executive Regulatory Science Director, Oncology at AstraZeneca, where she orchestrates the regulatory strategy concerning tumor drivers and resistance-related clinical research endeavors. She established and co-leads the AstraZeneca Dose Optimization Working Group to support the dose optimization paradigm across the oncology portfolio. Additionally, she serves as the regulatory lead for several patient-centric initiatives, underscoring her commitment to advancing healthcare outcomes.

      Prior to her current role, Dr. Arora served as an Associate Director in the Office of Oncologic Diseases at the U.S. Food and Drug Administration (FDA), where she spearheaded initiatives and projects spanning from pre-IND stages through post-marketing phases. Before assuming this role, Dr. Arora served as a clinical reviewer within the Breast and Gynecologic Malignancies Team at the FDA. Notably, she was instrumental in shaping FDA’s Project Orbis and was a founding member of the Project Optimus initiative. She provided strategic input in the development of various FDA guidances, policy initiatives, and authored impactful publications.

      A frequent public speaker at national and international forums, Dr. Arora adeptly represents her organization at external forums, scientific societies, and global conferences. She is the recipient of distinguished accolades, including the 40 under 40 Award from California State University, East Bay (CSUEB) and the Alumni Early-Career Award from the University of California, San Francisco (UCSF), that underscores her dedication, excellence, and multifaceted contributions to the professional, philanthropic, and personal spheres.

      Session Details:

      PANEL: Evolving Oncology landscapes for trials in the US: adapting to a changing environment

      2025-07-08, 8:45 AM

      Session Details:

      Leveraging FDA expedited programs: enhancing drug development and review

      2025-07-08, 5:00 PM

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      Chris Adams
      Founder & CEO, Andarix

      Mr. Adams has been a founder or co-founder of life science and technology based companies in Massachusetts for the past several years. Mr. Adams has been instrumental in developing new proprietary therapeutic and medical device technologies and bringing the technologies to commercialization. The companies he has founded include, Compellis Pharmaceuticals, a developer of therapeutics to treat obesity and its co-morbidities, diabetes and hypertension and Mosaic Technologies, a venture backed MIT spin-out genomics company that developed patented technologies for genetic analysis and detection.
      Chris is the holder of more than 20 issued US and international patents for medical devices and pharmaceuticals.

      Session Details:

      Designing an effective patient recruitment strategy for a rare cancer trial

      2025-07-08, 3:00 PM

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      Tatiana Kolesnikova
      Director, Oncology and Hematology, GlobalData

      Session Details:

      Investigating new initiatives for study start up to keep ahead of the competition in oncology trials

      2025-07-09, 12:00 PM

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      Rebecca Jacob
      Early Development Clinical Operations Project Team Leader, Sanofi

      Session Details:

      PANEL: Exploring developments in AI to identify how your oncology clinical trial can be enhanced

      2025-07-08, 12:15 PM

      Session Details:

      Utilizing emerging technologies to enhance patient experience during oncology trials

      2025-07-08, 2:00 PM

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      Hana Do
      Research Analyst, Tufts Center for the Study of Drug Development

      Session Details:

      Characterizing the transition from legacy, on-site to centralized and risk-based monitoring

      2025-07-09, 3:45 PM

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      Emily Clifford
      Senior Project Manager, Research Services, CISCRP

      Emily is a Senior Project Manager for the Research Services Department at the Center for Information and Study on Clinical Research Participation (CISCRP). She is responsible for planning, executing, and moderating patient advisory boards and various other patient engagement activities, which provide insights to support recommendations in the design and/or improvement of clinical trials. She holds a B.S. in Biochemistry and Molecular Biology from University of Massachusetts Amherst and a MSPH in Global Disease Epidemiology and Control from Johns Hopkins University.

      Session Details:

      Oncology patient perceptions and experiences in clinical research: Review of results from a large global survey

      2025-07-08, 5:00 PM

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      Kelly Schlemm
      Vice President, Head of Corporate Affairs, Servier Pharmaceuticals

      Kelly is a communications leader with more than 15 years of experience across all facets of pharmaceutical communications. In her current role as Head of Communications & Public Affairs for Servier Pharmaceuticals - she devises, manages and implements communications strategies across a range of internal and external channels and vehicles in support of corporate initiatives, pipeline and marketed products. She strives daily to meet patient needs and ensure their voice is heard.

      Session Details:

      Raising community awareness of oncology trials to reach target patient populations and boost numbers of participants

      2025-07-08, 4:00 PM

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      Elaina Haeuber
      M.S. Senior Vice President, Oncology, Premier Research

      Elaina has more than 20 years of leadership and project management experience in the biotechnology, pharmaceutical, and CRO industries. She is passionate about driving innovation and bringing new treatments to patients.

      In this role Ms. Haeuber oversees a team of oncology/hematology experts in the delivery of tailored and strategic clinical development programs. Along with her team, Ms. Haeuber is dedicated to understanding the acute needs of both patients and sponsors to create impactful project plans, mindful of risk, budget, and time to market.

      Ms. Haeuber gained her clinical research operations and project management experience in the biopharmaceutical industry through positions at large pharma, small biotech, and CROs. Programs she supported have led to marketing approval in both the US and EMA. Ms. Haeuber earned a B.A. from Boston University and an M.S. from the University of Illinois at Chicago.

      Session Details:

      Keeping Patients Connected: The Role of Virtual Support Centers in Long-Term Follow-Up

      2025-07-08, 2:30 PM

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      Brian Caselli, MS,
      Senior Director, Regulatory Affairs, Sumitomo Pharma America

      Session Details:

      From day one to data: How strong regulatory-clinical operations collaboration can chart a course for success

      2025-07-09, 2:45 PM

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      Reyna Bishop, MS, RD
      Associate Director, Clinical Operations, Sumitomo Pharma America

      After Reyna completed a Master's in Nutrition in 1998, and  a short stint at a Endocrinology clinic and Research center she was recruited by Ilex Oncology, and got a crash course in clinical research. During her career she had run the gambit of clinical research, working as a CRA, Project Manager, and later Independent Consultant. After a 4 year hiatus from corporate and contractor life that included staying home with young kids, pursuit of some food/nutrition related entrepreneurial interests and a position on the Wheatsville Food Coop Board of Directors, she answered the siren call of research and again joined the ranks of pharmaceutical professionals.

      Session Details:

      From day one to data: How strong regulatory-clinical operations collaboration can chart a course for success

      2025-07-09, 2:45 PM

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      Advisory Board

      Select a member to learn more

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      Cesare Spadoni

      Cesare is co-founder and Chief Operating Officer of Oncoheroes Biosciences Inc., a Boston-based biotech company focused on pediatric oncology drug development. Cesare has more than 20 years of experience in the drug development field, in both scientific and commercial roles. Previously, he held senior positions at AMRI, Aptuit Laurus, ThalesNano and Auxiliis. Cesare started his career as research scientist in a pharmaceutical company (Eisai, London) and in academia (Institute of Enzymology, Budapest).

      Following the death of his first daughter Laura to cancer, Cesare set up aPODD Foundation, a London-based charity focused on accelerating paediatric oncology drug development. As aPODD’s chairman he is actively involved on a pro-bono basis in drug repurposing projects, advocacy efforts and research collaborations.

      Cesare holds an MSc in Applied Molecular Biology and a PhD in Neurosciences from UCL, University of London, as well as an MBA from the Central European University, Budapest.

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      Frank Richard

      Frank Richard, MD, MBA is a seasoned medical doctor and has over 20 years of development experience in R&D. In his current role as VP Medical at Heidelberg Pharma AG, Germany, he is providing medical strategy and oversight for the preparation and conduct of phase I-III clinical studies using antibody-drug conjugates (ADCs). Additionally, he supports modelling &simulation activities to understand how to effectively use preclinical data from in vivo studies, mechanistic modeling, and bioanalysis to improve dose prediction and determine the optimal dose when introducing an ADC into clinical trials in various cancer indications.

      Frank has been working in the past in Immune-Oncology, Immunology& Respiratory, Rare Hematology Diseases and Iron Metabolism across big pharma and biotech.

      Frank holds a MD from Charité Medical University, Berlin, an MBA from University of Applied Sciences, Neu-Ulm, and is a board-certified Clinical Pharmacologist.

      Additionally, he exerts an unique expertise and interest in Bayesian Statistics and machine learning in Pharma and Biotech.

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      Stefano Ferrara

      Stefano Ferrara is a Clinical Development Expert and Director of Clinical Science at BeiGene, specializing in oncology clinical development with a focus on innovative cancer treatments. With over 20 years of leadership in global oncology clinical trials, he has played key roles at Celgene Corp, Novartis Pharma, and Sanofi-Aventis, specializing in GI, Lung, GU, and Pediatric cancers. Stefano is passionate about increasing accessibility to cancer treatment globally. He holds a strong commitment to humanitarian efforts as a supporter of Save the Children. Stefano brings his expertise in both science and advocacy to his role on the advisory board

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      Fatima Scipione

      Fatima serves as the Vice President of Global Patient Affairs at Blueprint Medicines, a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology.

      In her role, Fatima leads transformative collaborations with external advocacy groups, empowering and educating those affected by systemic mastocytosis. She has led the launch of significant initiatives such as GRTY Health’s SM patient platform, MastoConnect (https://mastoconnect.com), and Colors of SM (https://www.colorsofsm.com/), in partnership with the advocacy community, and actively chairs the Equity, Diversity, and Inclusion (ED&I) patient committee, which looks to address the needs of marginalized and underrepresented communities.

      With over two decades of experience in the biopharma sector, Fatima is a dedicated and passionate advocate for patients. Celebrated by PharmaVoice 100 as one of the most inspiring leaders in patient advocacy, her work focuses on amplifying patient voices and harnessing the collective power of individuals to make a positive impact. Fatima is committed to enhancing patient engagement in the development of transformative medicines, ensuring that the patient perspective is integral to every stage of the process.

      She inspires her colleagues to foster a culture of purpose-driven advocacy, ensuring that patient welfare remains at the forefront of their mission. Beyond her professional role, Fatima is deeply involved in civic activities, continually dedicating herself to enhancing patient welfare and advocacy on a broader scale.

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      Clinical Operations in Oncology is the meeting place for leading pharmaceutical companies and biotechnology institutes. Discover how to excel in oncology operations and clinical supply strategy as well as form key connections for long-term success for your clinical trial.

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