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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Why attend?

WHAT TO EXPECT FOR 2023?

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

See What It's All About

Agenda

  • 9 Jul 2024
  • 10 Jul 2024
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Streams

Stream one

STREAM A: Clinical Operations

Stream two

STREAM B: Patient Recruitment and Engagement

11:15 AM

Patient perspective: Bringing the patient voice to clinical trial development

  • Hear firsthand patient experience and how ‘research saved Irisaida’s life’
  • How to innovatively move patient-centric trials forward in 2024
  • Streamlining patient involvement, communication and cumbersome processes in your trial to reduce patient burden
  • Sharing best practice to ensure an engaged patient journey, and guaranteeing retention

Speakers

Irisaida Méndez
Patient Advocate, IMKahlo

11:45 AM

Session reserved for event sponsor

12:15 PM

Panel Discussion: Innovatively moving patient-centric trials forward in 2024

  • Patient Perspective: Highlighting the importance of incorporating the patient voice into clinical trial development.
  • Innovative Progress: Strategies for advancing patient-centric trials in 2024, focusing on innovative approaches to enhance trial design and execution.
  • Streamlining Patient Involvement: Improving patient involvement, communication, and the simplification of processes in trials to minimize patient burden.
  • Best Practices for Engagement: Sharing best practices to foster an engaged patient journey, ensuring patient retention throughout the trial process.

Moderator: Fatima Scipione, Vice President, Global Patient Affairs, Blueprint Medicines

Speakers

Fatima Scipione
Vice President, Global Patient Affairs, Blueprint Medicines
Rosemary Conway
Patient Advocate
Brian McMahon
CEO & Founder, SparkCures
Dr Elizabeth Barksdale
Senior Director of Regulatory Affairs and Science Policy, Lungevity

12:45 PM

Spotlight session reserved for technology spotlight

1 PM

Lunch and networking

2 PM

FIRESIDE CHAT: Incorporating the patient voice throughout the drug development process to help transform patient experience

  • Hear about MorphoSys’ latest initiatives in including the patient perspective from the start of the trial process
  • Drawing parallels and highlighting universal considerations between the patient treatment process in Gene Therapy and oncology
  • Looking backwards to look forwards: What to do differently to make the process more inclusive
  • Optimizing community outreach programs and patient advocacy groups

Speakers

Elsa Wilson LaVita
Director, Patient Advocacy, MorphoSys
Fatima Scipione
Vice President, Global Patient Affairs, Blueprint Medicines

2:30 PM

Session reserved for event sponsor

3 PM

Strengthening clinical trial diversity to reduce inequities in cancer trials and delving into the humanitarian aspects of patient care

  • Working with unrepresented communities to help patients globally and sharing best practice how to recruit and integrate these populations into oncology trials
  • What is your humanitarian responsibility as it relates to clinical trial recruitment?
  • Meeting FDA expectations: Guidance on the DEPICT Act compliance and how to write, implement and report on Diversity Plans
  • Working effectively with sites: What strategies CROs, patient advocacy firms and pharmaceutical companies can design and support to encourage sites to implement these for a diverse patient population
  • Educating patients to reduce fear and knowing what to ask for from your doctor regarding off label usage and black box warnings from the patient advocacy perspective

Speakers

Christina DiArcangelo
Chief Executive Officer, Affinity Patient Advocacy

3:30 PM

Session reserved for event sponsor

8 AM

Registration and refreshments

8:35 AM

Chairperson’s opening remarks

Speakers

Keya Watkins
Global Head, Clinical Development

8:45 AM

Protecting vulnerable trials by navigating operational challenges in an unstable global economy

  • Thinking strategically to change the current paradigm of what’s being done industry-wide so that trials do not face roadblocks
  • What is affecting investors’ willingness to invest in drug discovery and how can we combat this?
  • Current trends and future directions for 2024 in a tough market

Speakers

Sergio Santillana
Chief Medical Officer, Ikena Oncology

9:45 AM

Navigating the complexities of insufficient resources to allow your trial to succeed in an increasingly competitive landscape

  • Battling site competitiveness to reduce delays on study start-up: what can you do differently to tackle these operational challenges?
  • When there are immense pressures on the trial ecosystem, how can we build quality and ensure quantity in an innovative way
  • Developing an optimized strategy as a small to medium-sized biotech with limited resources to stay afloat
  • Discussing the importance of protocol optimization and specialized statistical support to reduce the pressure on sites and relieve bottlenecks

Speakers

Alison Duhamel
Senior Director, Clinical Operations, Strand Therapeutics

10:15 AM

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

  • Global Challenges & Industry Trends
  • Research Clinics dedicated to early patient trials
  • Key elements to consider when planning a phase IB/IIA Patient Trials
  • Case Studies

Speakers

Dr. Claudia Hesselmann
Founder and CEO, ARENSIA Exploratory Medicine

10:45 AM

Morning refreshments and networking

11:15 AM

Consider, collaborate and communicate: Help sites to help you

  • Including sites in the planning and implementation of clinical trials to promote trial enrolment and overall study conduct efficiency
  • Equipping sites with the resources and tools they need so they can spend more time working directly with patients
  • Ensuring harmony between sites, CROs and biotechs to accelerate trial timelines and quality
  • How to best incorporate new technology to reduce the burden on sites?

Speakers

Steve Dunlap
Senior Director, Oncology Global Clinical Development, GSK

11:45 AM

Session reserved for event sponsor

12:15 PM

Deconstructing and evolving the role of the CRA to better suit the needs of the biotechs and CROs and add value to safer, stronger clinical trials

  • Leveraging the skills and knowledge of the CRA to beshfsfh consistent with modern approaches
  • Call for a new and improved workforce management: can a CRA do it all or must we redefine the nature of the role to succeed in drug development
  • Empowering CRAs by appropriate training in latest technology to ensure competent and confident workforce
  • Is a standardization of the CRA role across board a realistic and suitable response?

Speakers

Maria de Assis
Senior Director, Clinical Operations, OriCell Therapeutics

12:45 PM

Spotlight session reserved for technology spotlight

1 PM

Lunch and networking

2 PM

How to leverage CRO’s FSP model

  • Country/Region-specific considerations
  • What functions can be brought in house?
  • How to leverage CRO organization with showcase“ BBT’s DIBO model in BBT-207 clinical trial”

Speakers

Agnes Jung
VP, Head of Clinical Development and Operations, Bridge Biotherapeutics

2:30 PM

Session reserved for event sponsor

3 PM

Measuring RBQM Adoption: Insights and Opportunities

  • Learn about a new comprehensive approach to assessing RBQM adoption.
  • See recent data on current levels of RBQM adoption among industry sponsors and CROs.
  • See recent data on expected future levels of use of RBQM components.
  • Discuss perceived challenges associated with the implementation of RBQM components.
  • Discuss opportunities and benefits of RBQM implementation.
  • Discuss implications of these findings for the future of RBQM.

Speakers

Maria Florez
Research Consultant, Tufts University School of Medicine
Abigail S Dirks
Research Data Analyst, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

3:30 PM

Session reserved for event sponsor

4 PM

Afternoon refreshments and networking

4:30 PM

Geopolitical regulatory and financial factors influencing oncology trials

  • Discussion of global financial markets and how to adapt to them for oncology trials
  • FDA’s Project Optimus: Key considerations for cancer drug development
  • Solutions to promote oncology trial collaboration between regulators and healthcare systems
  • Dealing with companies’ lack of willingness to invest in small molecule development

Speakers

Giovanni Abbadessa
Vice President, Head of Oncology Early Development, Sanofi

5 PM

Session reserved for event sponsor

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

Speakers

Keya Watkins
Global Head, Clinical Development

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 45 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

RT3

Balancing patient, development and investor priorities in clinical trial design

Hosted by Bryan Song, Head of Corporate Development, Bicara Therapeutics

RT4

Reserved for Rick Patt, MD, Co-Founder and Director of Medical and Scientific Affairs, RadMD

Speakers

Kevin Stephenson
Executive Director, Data Management, Karyopharm Therapeutics
Yolanda Wan
Head of Clinical Operations, Orna Therapeutics
Rick Patt, MD
Co-founder and Director of Medical and Scientific Affairs, RadMD
Bryan Song
Head of Corporate Development, Bicara Therapeutics

10:30 AM

Morning refreshments and networking

11 AM

Strategically designing your oncology study for commercial success

  • Sharing insight from two perspectives: how the commercial and clinical units collaborate to bring safe and effective medicines to patients in a timely manner
  • Key capabilities for success and how to measure them
  • Analyzing dynamic market environments to understand drug impact on patient population
  • How do you define the structure of your oncology trial?

Speakers

Sashka Dimitrievska
Global Therapeutic Area Head Oncology Clinical Insights, AstraZeneca
Juliet Cronin
US Commercial Lead, Lung Immuno-Oncology, AstraZeneca

11:30 AM

Session reserved for event sponsor

12 PM

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
Global Head, Clinical Development
Dr. Markus Vallaster
VP, Clinical Development, Affini-T Therapeutics
Mick Ribeiro
Vice President Clinical Operations at Ribon Therapeutics

12:30 PM

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

  • Amount of data collected
    • Operations, Data Collection and Analysis
  • How good is good enough?
  • Real world data
  • Data timeliness
    • Decisions
    • Safety signals
  • Resourcing
    • Internal vs External
    • Level of Commitment (% FTE)

Speakers

Colleen Cox
Director, Clinical Data Management, Mersana Therapeutics

1 PM

Lunch, networking and prize draw

2:15 PM

How to align financial incentives between CROs and biotechs so that both sides win

  • Fine-tuning the partnership and incentivizing CROs to be more thoughtful in proposals
  • Reconsidering PM involvement and responsibilities
  • Encouraging data system investment
  • Building better budgets on the known

Speakers

David Murcar
Associate Director Procurement, Immunocore

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

Session reserved for GlobalData

3:45 PM

Chairperson’s closing remarks

END OF CONFERENCE

Speakers

Select a speaker to learn more

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Sergio Santillana
Chief Medical Officer, Ikena Oncology

Sergio Santillana is a medical oncologist with more than 25 years of oncology drug development and clinical practice experience. Prior to providing strategic consultancy services to a variety of life science companies, including Ikena Oncology, he was Chief Medical Officer for Merrimack Pharmaceuticals, focused on developing biologics and nanotherapeutics for solid tumors. Before joining Merrimack, he was Chief Medical Officer for ARIAD Pharmaceuticals, a commercial-stage biotechnology company that was acquired by Takeda. Under Sergio’s leadership, ARIAD obtained US regulatory approval of Brigatinib for the treatment of ALK+ NSCLC, and had continued growth of its portfolio of targeted agents in solid tumors. Preceding his executive role at ARIAD, he served in various oncology clinical development leadership roles at Takeda, GlaxoSmithKline and Eli Lilly. Before entering the biopharma industry, he was a practicing board-certified medical oncologist for 15 years, including tenure at the National Cancer Institute of Peru (INEN) where his research focus was in clinical studies of novel agents. He holds an M.D. and B.S. from the Universidad Nacional Federico Villarreal School of Medicine in Lima, Peru and a M.Sc. in Experimental Therapeutics from Kellogg College at the University of Oxford. He also holds an MBA from the MIT Sloan School of Management.

Session Details:

Protecting vulnerable trials by navigating operational challenges in an unstable global economy

2024-07-09, 8:45 AM

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Giovanni Abbadessa
Vice President, Head of Oncology Early Development, Sanofi

Session Details:

Geopolitical regulatory and financial factors influencing oncology trials

2024-07-09, 4:30 PM

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Steve Dunlap
Senior Director, Oncology Global Clinical Development, GSK

Steve has 20 years of clinical research experience and has spent the majority of that time working within oncology.  He is driven to help patients by developing new therapies that improve outcomes.  He started his career as a Study Coordinator in the Neuroimaging Center at a McLean Hospital before moving to his first industry position at Genzyme where he worked in various roles within clinical operations and has worked in small biotechs, as well as big pharma.  Steve has spent the last 7 years at GSK working as a Clinical Operations Program lead, and helped the team move an asset from a first-in-human trial through numerous phase II and III trials which have resulted in multiple marketing authorizations around the globe within endometrial cancer and dMMR solid tumors.  He takes a pragmatic approach while focusing on quality, timely delivery, and efficiency.

Session Details:

Consider, collaborate and communicate: Help sites to help you

2024-07-09, 11:15 AM

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Sashka Dimitrievska
Global Therapeutic Area Head Oncology Clinical Insights, AstraZeneca

Session Details:

Strategically designing your oncology study for commercial success

2024-07-10, 11:00 AM

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Juliet Cronin
US Commercial Lead, Lung Immuno-Oncology, AstraZeneca

Session Details:

Strategically designing your oncology study for commercial success

2024-07-10, 11:00 AM

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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 Discussion: Innovatively moving patient-centric trials forward in 2024

2024-07-09, 12:15 PM

Session Details:

FIRESIDE CHAT: Incorporating the patient voice throughout the drug development process to help transform patient experience

2024-07-09, 2:00 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, 12:00 PM

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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:

Interactive Speaker-Hosted Roundtable Discussions

2024-07-10, 9:00 AM

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Dr. Markus Vallaster
VP, Clinical Development, Affini-T Therapeutics

Dr. Markus Vallaster currently serves as the Vice President and Head of Clinical Development at Affini-T Therapeutics, Inc. an immune-oncology company focused on TCR T cell therapies that target oncogenic driver mutations such as KRAS and TP53 in patients with solid cancers.  Prior to joining Affini-T, he held clinical development positions of increasing responsibility at major pharmaceutical companies.  Dr. Vallaster’s expertise lies in stem cell transplant, cell therapies, and hemato-oncology.

Session Details:

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

2024-07-10, 12:00 PM

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Irisaida Méndez
Patient Advocate, IMKahlo

Irisaida is a seasoned Multicultural Communications and Development consultant and has worked with renowned corporations looking to penetrate the LATAM and US Hispanic markets.

During her 20 years’ experience, Irisaida has led crisis communications and public relations efforts for disaster relief initiatives with the American Red Cross, FEMA, and United Way. These include first response, deployment, and media messaging of very sensitive issues under high pressure environments for hurricanes Georges, Charles, Jean, Katrina, Irma and Maria. She also developed Spirit Airlines’ Communications Emergency Response Plan and its Emergency Action Team Protocol. She has acted as liaison between FEMA, city mayors, and other government officials during the implementation of FEMA’s intergovernmental communications efforts in South Florida.

She holds a BA in Communications from Seton Hill University and an MA in Employee Relations from the Interamerican University of Puerto Rico. Her additional training includes Managing Communications During a Major Crisis (by the NTSB), Spokesperson training for Crisis Communications, and First Responder’s Emergency Management Certification (by FEMA’s National Training and Education Division).

Session Details:

Patient perspective: Bringing the patient voice to clinical trial development

2024-07-09, 11:15 AM

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Alison Duhamel
Senior Director, Clinical Operations, Strand Therapeutics

Clinical research professional with over 25 years in the biotech/pharma industry. Educated in organizational development and change management and enjoys using both work experience and education to help individuals, teams, and organizations become better versions of themselves. Skilled in cross functional training, process improvement and management, communication, and collaboration.

Session Details:

Navigating the complexities of insufficient resources to allow your trial to succeed in an increasingly competitive landscape

2024-07-09, 9:45 AM

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Maria de Assis
Senior Director, Clinical Operations, OriCell Therapeutics

Session Details:

Deconstructing and evolving the role of the CRA to better suit the needs of the biotechs and CROs and add value to safer, stronger clinical trials

2024-07-09, 12:15 PM

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Colleen Cox
Director, Clinical Data Management, Mersana Therapeutics

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, 12:30 PM

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Christina DiArcangelo
Chief Executive Officer, Affinity Patient Advocacy

A Global, Award-Winning Entrepreneur and CEO with more than two decades of experience in the medical cannabis, biotechnology, pharmaceutical, nutraceutical, and medical device industries, Christina’s dedication to revolutionizing patient care is unprecedented. Through her roles as CEO, Spectral Analytics Precision Tele-Monitoring, Founder and CEO of Affinity Bio Partners, Board President and CEO of Affinity Patient Advocacy, Christina has been involved with revolutionary projects and global clinical studies that positively impact patients including formulating new products. Christina has spoken at many events including delivering Keynote addresses as well as organizing her own education events for her multiple companies.

Christina has a personal brand, I am Christina DiArcangelo with a podcast channel (I am Christina DiArcangelo) where she speaks to many exciting, thought-provoking guests. Christina has also developed merchandise under Affinity Patient Advocacy and Christina DiArcangelo and launched a merchandise company called Sparkle Sisters.

Christina has launched an e-magazine called The DiArc. The DiArc is a lifestyle magazine that shines a spotlight on all topics that apply to Christina DiArcangelo.

As an award winning global clinical research pioneer, and Christina is also an Opinion Columnist for CEO WorldBiz, she has utilized the tools at her disposal to champion patient care and provide best-in-class patient advocacy services. For Christina, patient care and safety come first.

As an active Bahai’ and mother to her one son, Christian, she believes that listening, learning, and growing are everyday values that can change the world by impacting our own hearts, homes, and communities.

Session Details:

Strengthening clinical trial diversity to reduce inequities in cancer trials and delving into the humanitarian aspects of patient care

2024-07-09, 3:00 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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Rosemary Conway
Patient Advocate

Session Details:

Panel Discussion: Innovatively moving patient-centric trials forward in 2024

2024-07-09, 12:15 PM

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Agnes Jung
VP, Head of Clinical Development and Operations, Bridge Biotherapeutics

Agnes Jung is a Regulatory/Project/Team management expert with over 17 years of experience in the clinical trials industry.

Extensive experience with coordinating and managing Phase I ~IV clinical trials through Study Start-up, Conduct, and Close-down, with a keen focus on the ICH-GCP guidelines and country-specific regulations in Asia-Pacific, Canada and Europe countries. Customer-oriented and professional team player with demonstrated capacity to lead cross-functionally between sites/CROs/vendors/internal study teams for process management and issue resolution. Results-oriented professional realizing a successful US-FDA site inspection in 2017 and successful coordination of a HSA inspection in 2021. Strong professional with a Master's degree focused in outcomes research and regulatory science from Chung-Ang University.

Session Details:

How to leverage CRO’s FSP model

2024-07-09, 2:00 PM

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David Murcar
Associate Director Procurement, Immunocore

Experienced biotech leader in contract operations and contract life cycle management with a demonstrated history of working in both CROs and pharma. Skilled in RFP design, proposal process and management, business development and revenue operations.

Session Details:

How to align financial incentives between CROs and biotechs so that both sides win

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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Elsa Wilson LaVita
Director, Patient Advocacy, MorphoSys

Elsa LaVita has grown her patient advocacy career rooted in rare disease and oncology.  Elsa is the Director of Patient Advocacy at MorphoSys where she is responsible for ensuring the patient perspective is integrated into the development and commercialization of the company’s cancer medicines. She acts as the bridge between the company and patient communities.  Elsa holds an MBA from Boston University and a BS from Cornell University.

Session Details:

FIRESIDE CHAT: Incorporating the patient voice throughout the drug development process to help transform patient experience

2024-07-09, 2:00 PM

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Maria Florez
Research Consultant, Tufts University School of Medicine

Session Details:

Measuring RBQM Adoption: Insights and Opportunities

2024-07-09, 3:00 PM

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Abigail S Dirks
Research Data Analyst, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

Abigail Dirks is a Data Analyst at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to industry drug development performance, including clinical research associate (CRA) performance, impact of decentralized clinical trials (DCT), and investigative site burden. She recently received her Master’s in Health Informatics and Analytics from Tufts University and has a BS in Data Science and Mathematics from St. Michael’s College. She also has experience in web development for North Shore Nurse Practitioner Associates, a psychopharmacology practice.

Session Details:

Measuring RBQM Adoption: Insights and Opportunities

2024-07-09, 3:00 PM

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Keya Watkins
Global Head, Clinical Development

Session Details:

Chairperson’s opening remarks

2024-07-09, 8:35 AM

Session Details:

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

2024-07-10, 12:00 PM

Session Details:

Chair’s opening remarks

2024-07-10, 8:50 AM

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Brian McMahon
CEO & Founder, SparkCures

Brian McMahon is the founder of SparkCures and a four-time cancer caregiver. The search for clinical trials is personal for him, because his mother was diagnosed with multiple myeloma. She received a poor prognosis due to genetic factors and a late diagnosis. Within three weeks, she was enrolled in a clinical trial. Participating in the trial gave his family two additional years with his mother that his doctors never thought would be possible. Since then, he’s cared for family members and friends who were diagnosed with cancer. As a caregiver, he’s had clinical trial conversations with doctors for the University of Arkansas to Dana-Farber and a half-dozen hospitals in between. He’s used dozens of advocacy groups and websites to search for clinical trials—and he knows how difficult it is to find them, to understand them and to have the conversations. He also knows there is a better way to help patients and caregiver understand and discover eligible clinical trials.

Session Details:

Panel Discussion: Innovatively moving patient-centric trials forward in 2024

2024-07-09, 12:15 PM

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Dr Elizabeth Barksdale
Senior Director of Regulatory Affairs and Science Policy, Lungevity

Elizabeth (Libby) Barksdale, PhDis the Senior Director of Regulatory Affairs and Scientific Policy for LUNGevity Foundation. In her role she guides the development and execution of LUNGevity’s regulatory strategy as well as the organization’s Transforming Clinical Trials Initiative, a multi-stakeholder effort to streamline clinical trials and make them more patient-centric.

Previously, Libby served as the Assistant Director for Regulatory Science and Policy at the American Association for Cancer Research (AACR), where she led efforts aimed at increasing understanding of the regulatory ecosystem and enhancing the development of oncology products. Before joining the AACR, she was with the Federation of American Societies for Experimental Biology, where she focused on policies related to clinical research and biomedical research training.

Libby received her BS in Biology from Hope College and PhD in Molecular Medicine from The George Washington University. She sought out experiences in science policy while conducting postdoctoral research at the National Institute of Child Health and Human Development.

 

 

Session Details:

Panel Discussion: Innovatively moving patient-centric trials forward in 2024

2024-07-09, 12:15 PM

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Rick Patt, MD
Co-founder and Director of Medical and Scientific Affairs, RadMD

Dr. Patt is co-founder and principal of RadMD, and is an acknowledged expert in the field of applying medical imaging to new drug development.

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.

Dr Patt’s experience includes design and management of site and central reviews for over 500 oncology trials with a focus on early-phase efficiency for better decision-making.

Session Details:

Interactive Speaker-Hosted Roundtable Discussions

2024-07-10, 9:00 AM

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Bryan Song
Head of Corporate Development, Bicara Therapeutics

Session Details:

Interactive Speaker-Hosted Roundtable Discussions

2024-07-10, 9:00 AM

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Dr. Claudia Hesselmann
Founder and 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:

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

2024-07-09, 10:15 AM

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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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