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13th Annual Clinical Trials in Oncology East Coast 2024

Discover effective strategies for oncology trial operations to ensure trials run smoothly and within budget.

9 - 10

July

2024

Boston Marriott Burlington, Boston, USA
Complimentary

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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

IQVIA Biotech delivers flexible clinical development solutions designed for the specific needs of biotech and emerging biopharma companies. When you partner with our clinical development team you gain expertise from more than two decades of running clinical trials exclusively for biotech companies plus access to IQVIA’s unparalleled data and technology. From drug development strategy to trial design and execution, we draw on this experience to put together the right solution, and the right team, for you.

Company Website

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

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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 for oncology trial operations to ensure trials run smoothly and within budget.

Arena International is delighted to announce Clinical Trials in Oncology East Coast will take place in Boston in July 2024! 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 brand 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 2024?

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.

150+ Attendees	20+ Exhibitors	25+ Speakers
150+ Attendees	20+ Exhibitors
25+ Speakers

Testimonials

See What It's All About

Agenda

9 Jul 2024
10 Jul 2024

Expand All

Streams

Stream one

STREAM A: Clinical Operations

5:15 PM

The Next Frontier in Early Phase Oncology Trials

Optimizing Study Protocols: Discover tools to streamline study protocols, alleviating patient burden and minimizing the need for future amendments.
Project Optimus Impact: Understand how Project Optimus influences early phase oncology operations.
Diversity and Compliance: Explore strategies to enhance clinical trial diversity while adhering to the FDA’s DEPICT Act.

Speakers

Rashmi Chandra

Clinical Project Management Director, Immuno-Oncology and Cell and Gene Therapy, IQVIA Biotech

5:45 PM

Chair’s closing remarks

END OF DAY 1 AND NETWORKING DRINKS

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

Annlouise Assaf

Senior Director, Global Medical Patient Impact Assessment, Worldwide Medical and Safety, Pfizer

Shawn Keogan

Director of Patient Advocacy and Professional Relations, GenMab

1 PM

Available for event sponsor

1:30 PM

Lunch and networking

2:30 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

3 PM

Available for event sponsor

3:30 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

4 PM

Afternoon refresments and networking

4:30 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

Annlouise Assaf

Senior Director, Global Medical Patient Impact Assessment, Worldwide Medical and Safety, Pfizer

8 AM

Registration and refreshments

8:35 AM

Chair’s opening remarks

8:45 AM

PANEL: What does the new administration mean for oncology trials in the US? An overview of the impact

6 months in: evaluating the impact of a new administration on clinical trials
Navigating and implementing new regulation effectively
Understanding how the geopolitical landscape is affecting oncology trials inside and outside of the US

Speakers

Fatima Scipione

Vice President, Global Patient Affairs, Blueprint Medicines

Giovanni Abbadessa

Chief Medical Officer, ModeX Therapeutics

9:15 AM

Available for featured sponsor

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.

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

1 PM

Available for event sponsor

1:30 PM

Lunch and networking

2:30 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

3 PM

Available for event sponsor

3:30 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

4 PM

Afternoon refreshments and networking

4:30 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

8 AM

Registration and refreshments

8:50 AM

Chair’s opening remarks

Speakers

Keya Watkins

SVP - Catalyst Oncology, Catalyst Clinical Research

9 AM

Interactive Speaker-Hosted Roundtable Discussions

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Each discussion will be led by a table moderator and will focus on a different challenge within oncology clinical trials. Roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

RT 1
Vendor selection – Managing the matrix of incorporating these platforms
Hosted by Yolanda Wan, Head of Clinical Operations, Orna Therapeutics

RT 2
Allowing revolutionary innovative technologies to prosper in the pre-existing CRO ecosystem
Hosted by Kevin Stephenson, Executive Director, Data Management, Karyopharm Therapeutics

RT 3
Achieving successful integration of clinical operations, medical affairs, and clinical research groups to better develop protocols that support patient care and reduce patient, site and sponsor burden
Hosted by Luis A. Aguilar, Vice President, Business and Clinical Operations, Candel Therapeutics

RT 4
Live reads in cancer trials
Hosted by Rick Patt, MD, Co-Founder and Director of Medical and Scientific Affairs, RadMD

Speakers

Yolanda Wan

Head of Clinical Operations, Orna Therapeutics

Kevin Stephenson

Executive Director, Data Management, Karyopharm Therapeutics

Luis A. Aguilar

Vice President, Business and Clinical Operations, Candel Therapeutics

Rick Patt

MD, Co-Founder and Director, Medical and Scientific Affairs, RadMD

10 AM

Building success together: a reflection on oncology trial management

This presentation will use a real-life event as an analogy to explore the Sponsor's involvement and oversight in clinical operations, focusing on strategies to maximize success.

Balancing Involvement: How Little is Too Little and How Much is Too Much?
Evaluating Industry Standards
Adopting a Consultative Approach to Problem-Solving

Speakers

Bin Pan

Executive Director, Operational Strategy, Ergomed

10:30 AM

Morning refreshments and networking

11 AM

Forging strong partnerships: The “why” behind its importance in cancer research

Leveraging Relationships
Quality Vendor Management Principles
Strong Focus on Forecasting Accuracy/Dependability
Proactively Managing Scope
Truly Living these Values (Flexibility, Listening, Collaboration, Learning, Commitment)

Speakers

Troy DeSelms

Associate Director, Project Finance, Catalyst Clinical Research

Kate Lai

Director, Program Management, Mythic Therapeutics

11:30 AM

Panel Discussion How your outsourcing strategy will shape the success of your clinical research in oncology

Exploring what is driving the increasing costs of running your study
Aligning the CRO and sponsor ecosystem to be operationally efficient and reduce the chaos of vendor overload in research
Taking control of your outsourcing strategy to deliver seamless trials and getting products approved quicker
Uncovering whether your vendors’ offerings are competitive and a good value for the money

Speakers

Keya Watkins

SVP - Catalyst Oncology, Catalyst Clinical Research

Mick Ribeiro

Vice President Clinical Operations at Ribon Therapeutics

David Sherris, Ph.D.

Board Member, SiVEC Biotherapeutics, Inc.

Kevin Stephenson

Executive Director, Data Management, Karyopharm Therapeutics

Dr. Claudia Hesselmann

Founder & CEO, ARENSIA Exploratory Medicine

12 PM

Driving Success: Strategies for Optimal Site Support

Evolving landscape of clinical trials and the need for more engaged sites
- Trial complexity
- Trial competition/saturation
- Turnover of site staff
How the CRO fits into addressing site support as a focal point
The Sponsor role in site support
Methods of addressing site support/the road forward

Speakers

Dylan Stoy

Director Therapeutic Strategy, PSI CRO

1 PM

Lunch, networking and prize draw

2:15 PM

Data matters: How improved data management is set to further revolutionize the design, conduct, and analysis of oncology trials

Data
- Amount of Data Collected
- Data Availability
- Data Collection Cost
- The 80/20 Rule
- How good is good enough
Real World Data and Oncology
- FDA – Oncology Real World Evidence Program
- Society Support
Data Timelines
Resourcing
Picking a vendor
Vendor Options

Speakers

Colleen M. Cox, CCDM

Senior Director, Clinical Data Management, Editas Medicine

2:45 PM

Ensuring oncology trial integrity through effective Clinical Quality Oversight: Prioritize your efforts to achieve compliance

Holding your CRO accountable to deliver their services at the level of quality and compliance required by FDA
Including CRO performance in your risk management strategy
Is the quest for quality and the approach taken to achieve it justified?

Speakers

Krishna Singh

Director, Clinical Quality (GCP), Regulatory Affairs and Quality Assurance, Olema Oncology

3:15 PM

A case study: overcoming challenges and optimizing a phase 3 oncology trial using data and technology

Geographic feasibility for country selection
Benchmarking timelines, trial costs and recruitment rates
DCT complications
Site selection process including e-feasibility questionnaires

Speakers

Amanda Murphy

Senior Director, Data Intelligence & Solutions,
GlobalData

3:45 PM

Chair’s closing remarks

Speakers

Keya Watkins

SVP - Catalyst Oncology, Catalyst Clinical Research

END OF CONFERENCE

Speakers

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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, 2:30 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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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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Annlouise Assaf

Senior Director, Global Medical Patient Impact Assessment, Worldwide Medical and Safety, Pfizer

Session Details:

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

2025-07-08, 4:30 PM

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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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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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: What does the new administration mean for oncology trials in the US? An overview of the impact

2025-07-08, 8:45 AM

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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:

PANEL: What does the new administration mean for oncology trials in the US? An overview of the impact

2025-07-08, 8:45 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, 2:30 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, 3:30 PM

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Session Details:

Designing an effective patient recruitment strategy for a rare cancer trial

2025-07-08, 3:30 PM

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Holly Huang

Vice President, Head of Biometrics, Denovo Biopharma

Session Details:

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

2025-07-08, 4:30 PM

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Rashmi Chandra

Clinical Project Management Director, Immuno-Oncology and Cell and Gene Therapy, IQVIA Biotech

Rashmi Chandra, Project Director, Immuno-Oncology and Cell and Gene Therapy, holds a doctorate in Biochemistry and a PMP certification from Project Management Institute. Dr. Chandra worked as a biomedical researcher for many years prior to transitioning to clinical research. As a result, she has a broad and fundamental understanding of cellular and molecular pathways interrogated during drug development. Dr. Chandra's clinical research experience includes serving as a Research Coordinator, remote Site Monitor and Project Manager for domestic and global studies. Dr. Chandra has start-to-finish project management experience in early phase trials. She has demonstrated strong team leadership and consistently managed high quality clinical trials. Dr. Chandra has cardiac device and stem cell trial experience, along with significant oncology, immuno-oncology and CAR-T cell experience in both solid and liquid tumors across several indications.

Session Details:

The Next Frontier in Early Phase Oncology Trials

2024-07-09, 5:15 PM

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Keya Watkins

SVP - Catalyst Oncology, Catalyst Clinical Research

Keya brings 25 years of experience in building and leading high-functioning teams in drug development inclusive of clinical operations, data sciences and trial support services. An executive in operational and commercial roles, she has extensive experience in implementing strategies and delivering excellence for complex, global Oncology trials.

Session Details:

Panel Discussion How your outsourcing strategy will shape the success of your clinical research in oncology

2024-07-10, 11:30 AM

Session Details:

Chair’s opening remarks

2024-07-10, 8:50 AM

Session Details:

Chair’s closing remarks

2024-07-10, 3:45 PM

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Mick Ribeiro

Vice President Clinical Operations at Ribon Therapeutics

For more than 20 years, Mick Ribeiro, MSc., PMP, has been a leader in clinical research, managing and overseeing the development of various compounds and vaccines from Phase 1 to Phase 4 studies. He has worked with biotechs and Fortune 500 companies, bringing perspective and balance to an industry that thrives on discovery.

As the Vice President Clinical Operations at Ribon Therapeutics, he is responsible for the strategic planning, execution, and oversight of the company's clinical programs, ensuring quality, compliance, and efficiency. He also runs his own consulting business, Biotech Clinical Consulting LLC, providing services to start-ups and early stage biotech companies in clinical operations, business operations, vendor selection and management, and inspection support. Multi-lingual and globally minded, he coordinates operations across diverse regions and cultures, applying his expertise in Good Clinical Practice (GCP) and Project Management.

Session Details:

Panel Discussion How your outsourcing strategy will shape the success of your clinical research in oncology

2024-07-10, 11:30 AM

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David Sherris, Ph.D.

Board Member, SiVEC Biotherapeutics, Inc.

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.

Session Details:

Panel Discussion How your outsourcing strategy will shape the success of your clinical research in oncology

2024-07-10, 11:30 AM

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Kevin Stephenson

Executive Director, Data Management, Karyopharm Therapeutics

Experienced Data Manager having worked in the following therapeutic areas:
* Oncology
* CNS
* Diabetes
* Infectious Diseases
* Respiratory

Also, experience in Phase I, II, III and IIIb studies in both the EDC environment (primarily in OC RDC and Medidata) and the paper CRF environment.

Provides process development and evaluation.
Develops training for data manager in areas from GCP and the CDM role to query writing and CRF development.
Provides mentoring and general consulting to the DM group.

Specialties: Vendor Management
Risk Analysis & Management
Problem Solving
Team Building and Communication
Training
Mentoring
GCDMP
SQL and SAS Programming
Tableau

Session Details:

Panel Discussion How your outsourcing strategy will shape the success of your clinical research in oncology

2024-07-10, 11:30 AM

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Interactive Speaker-Hosted Roundtable Discussions

2024-07-10, 9:00 AM

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Dr. Claudia Hesselmann

Founder & CEO, ARENSIA Exploratory Medicine

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:

Panel Discussion How your outsourcing strategy will shape the success of your clinical research in oncology

2024-07-10, 11:30 AM

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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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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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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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Yolanda Wan

Head of Clinical Operations, Orna Therapeutics

Yolanda is the Vice-President of Clinical Operations at Accutar Biotechnology. She brings along 17 years of experience in Clinical Development, with focus on both Clinical Operations and Clinical Project Management. Her areas of expertise include strategic operations planning at the compound-level; first-in-human study planning & adaptive execution in therapeutic areas of oncology and ophthalmology. Leadership with cross-functional teams has included the development and implementation of governance and operational strategy, optimizing processes and building dynamic teams to exceed business objectives. Prior to joining Accutar, she held various positions at Bayer in the US and a number of countries within Asia. This attributes to her extensive knowledge of bridging-strategy between the two continents.

Session Details:

Interactive Speaker-Hosted Roundtable Discussions

2024-07-10, 9:00 AM

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Luis A. Aguilar

Vice President, Business and Clinical Operations, Candel Therapeutics

Session Details:

Interactive Speaker-Hosted Roundtable Discussions

2024-07-10, 9:00 AM

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Rick Patt

MD, Co-Founder and Director, Medical and Scientific Affairs, RadMD

Dr. Patt is Co-Founder and Principal in RadMD. He has a broad prior experience in medical imaging: this includes research and development of contrast agents: design and manage site and central reviews and trained reviewers for over 300 oncology trials; and has expertise in cardiovascular device, infectious disease, and pulmonary fibrosis trials. He has performed blinded reads and adjudications in a variety of trial types. He has held positions as both an academic and private practice radiologist.

After his fellowship at Georgetown University and the National Institutes of Health (NIH), he served as Chief of Body MRI, then Director of MRI, at Georgetown University Medical Center, where he was both an investigator and blinded reader in numerous pharmaceutical and medical device clinical trials.

He subsequently joined Berlex Labs as Associate Director, followed by Director of Medical Imaging Clinical Development. where he managed an experienced team in all phases of clinical development of radiological contrast agents.

Dr. Patt also served as Medical Director for HealthHelp, a radiology management services organization. He founded Foresight Consulting, working with pharmaceutical and medical device companies on the utilization of medical imaging into clinical development programs.

He has numerous publications, has served on an NCI Advisory Panel, is a reviewer for major radiology journals, and has been an invited lecturer across the US and Europe on the use of medical imaging in clinical trials.

Session Details:

Interactive Speaker-Hosted Roundtable Discussions

2024-07-10, 9:00 AM

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Bin Pan

Executive Director, Operational Strategy, Ergomed

Bin Pan has 23 years of experience in clinical research with a strong focus on early-phase oncology trial strategy and execution. She has a scientific background in biochemistry and molecular biology with postdoctoral research in cellular signaling pathways.

Throughout her career, Bin has supported numerous oncology studies through an evolving therapeutic landscape from the early days of mAb drugs such as trastuzumab and cetuximab to the current immuno-oncology revolution with checkpoint inhibitors such as CAR-T and TCR-T.

She maintains a broad knowledge of current oncology therapeutics and the competitive clinical landscape. She provides strategic guidance and operational leadership to internal cross-functional teams as well as a consultative approach to developing novel solutions.

Session Details:

Building success together: a reflection on oncology trial management

2024-07-10, 10:00 AM

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Troy DeSelms

Associate Director, Project Finance, Catalyst Clinical Research

Troy brings a combination of financial expertise, risk assessment/mitigation, clinical research knowledge, leadership skillset, and excellent project management skills to ensure the financial success of clinical research projects. He truly is honored to work for a company that delivers industry-leading specialized clinical development solutions while still ensuring a culture that coupled with our expertise and technology brings out the best in our team members, our clients, and our partners.

Session Details:

Forging strong partnerships: The “why” behind its importance in cancer research

2024-07-10, 11:00 AM

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Kate Lai

Director, Program Management, Mythic Therapeutics

Kate brings 20 years of experience in the research and development of Antibody-Drug Conjugates (ADCs) to her role as Director, Program Management at Mythic Therapeutics. As a cross-functional matrix team leader, she has remarkable experience in not only communication, risk management, and problem-solving skills but also aligning to corporate goals.

Session Details:

Forging strong partnerships: The “why” behind its importance in cancer research

2024-07-10, 11:00 AM

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Colleen M. Cox, CCDM

Senior Director, Clinical Data Management, Editas Medicine

Colleen has worked in Clinical Data Management since 1989 working at biotech, pharma and CROs. She has held roles ranging from data processing to data programming to data management. She has been responsible for the implementation and maintenance of global Data Management strategy for both clinical trials and programs. Provided day to day leadership support for Data project management, medical coding, data systems and quality, and is accountable for overall project delivery. Participated in clinical and corporate project team interactions on the development of internal data management processes, cross-departmental procedures. Defined, maintained, and updated metrics and other performance measurements, as well as review of external vendor procedures to ensure compliance with corporate expectations.

Session Details:

Data matters: How improved data management is set to further revolutionize the design, conduct, and analysis of oncology trials

2024-07-10, 2:15 PM

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Krishna Singh

Director, Clinical Quality (GCP), Regulatory Affairs and Quality Assurance, Olema Oncology

Experienced Clinical Quality Assurance with a demonstrated history of working in the pharmaceuticals industry. Skilled in Oncology trials, Endocrinology, U.S. Food and Drug Administration (FDA), Quality Assurance, Audits, CAPA & GCP compliance. Strong quality assurance professional with a Master of Business Administration (M.B.A.) focused in Health/Health Care Administration/Management from Ashford University.

Session Details:

Ensuring oncology trial integrity through effective Clinical Quality Oversight: Prioritize your efforts to achieve compliance

2024-07-10, 2:45 PM

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Dylan Stoy

Director Therapeutic Strategy, PSI CRO

Dylan Stoy, PSI’s Therapeutic Strategy Director, is dedicated to conducting and executing better clinical studies in PSI’s core therapeutic areas. Dylan has a wealth of experience in the oncology indication, with research interests in targeted drug delivery systems and optimizing the design and conduct of studies. Dylan has overseen clinical research from various roles including onsite research, design and trial conduct, clinical operations oversight, project management, and therapeutic strategy.

Dylan and his team are devoted to making participation for sites and patients in complex oncology studies more attainable and ensuring that both PSI’s teams and your study sites are highly trained and properly supported to handle any challenges your program might encounter. Dylan works closely with the core business units within PSI, overseeing research throughout the study lifecycle, providing strategic leadership to our teams and collaborators (both internally and externally), and delivering corporate-wide trainings to make PSI your full-service CRO for all things oncology.

Session Details:

Driving Success: Strategies for Optimal Site Support

2024-07-10, 12:00 PM

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Amanda Murphy

Senior Director, 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:

A case study: overcoming challenges and optimizing a phase 3 oncology trial using data and technology

2024-07-10, 3:15 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

2025-07-08, 9:45 AM

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