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
  • Why attend?
  • Agenda
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
  • Contact Us

Why attend?

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

See What It's All About

Agenda

  • 9 Jul 2024
  • 10 Jul 2024
Expand All

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

Beyond Informed Consent:  Bridging the patient education gap to improve the clinical trial experience

  • Reviewing the past and current barriers to improving patient enrollment and retention amidst the unique complexities of today’s oncology clinical trials
  • Researching the research:  Exploring key takeaways from patient educational support case studies
  • Employing multimodal educational approaches and varied communication channels to enhance patients’ informed engagement

Speakers

Bob Bauer
Executive Director Operational Strategy, Precision For Medicine

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
Elizabeth Barksdale
Senior Director of Regulatory Affairs and Scientific Policy, Lungevity

1 PM

TECHNOLOGY SPOTLIGHT: Driving drug exposure, accuracy, and speed in clinical trials through SMART-digital solutions

  • Enhanced Drug Exposure Evidence through Innovative Digital Adherence Solutions
  • Introduce innovative SMART-Digital Solutions to drive Speed, Accuracy and Drug Exposure across Clinical Trials
  • Improving Data-Quality to provide real world data to support intervention & improve drug efficacy through SMART measure and Monitor digital Solutions

Speakers

Brian Sheridan
Vice President Global Adherence & Clinicals, Smurfit Westrock
Bernard Vrijens, PhD
Chief Executive Officer & Scientific Lead, AARDEX Group

1:15 PM

Lunch and networking

2:15 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
  • Considerations of the patient treatment experience and minimizing burden of and barriers to care
  • 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

2:45 PM

Hybrid trial design: Expanding trial access and reducing burden through patient-centric solutions in home and at site

  • Hybrid trials offer sponsors, sites and patients options, reduce participation challenges, and create trial efficiencies.
  • Bringing trials to patients in their own homes eliminates travel burden, creates convenience, flexibility and choice, and delivers more accessible clinical trials.
  • Supporting sites through trial participation can increase trial success in recruitment, enrollment and retention and can build stronger relationships for all stakeholders.
  • A patient-centric strategy from the start is foundational for successful, hybrid trial and will deliver efficiencies for sponsors.

Speakers

Caroline Potts, MSc
General Manager, Site and Patient Services, MRN

3:15 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

8 AM

Registration and refreshments

8:35 AM

Chairperson’s opening remarks

Speakers

Keya Watkins
SVP - Catalyst Oncology, Catalyst Clinical Research

8:45 AM

The crucial role of communication for clinical trial drug management

  • Foundation of Success: How effective communication is the cornerstone of successful clinical trial drug management
  • Cross-functional Collaboration: The importance of seamless communication across various functional areas
  • Mitigating Risks: Strategies for using communication to identify and mitigate risks early in the trial
  • Best Practices: Implementing communication best practices to enhance coordination, efficiency, and successful outcomes in clinical trials.

Speakers

Francesco Santo
Associate Director Global Clinical Supply Chain, HUYABIO

9:15 AM

Aligning Clinical Supply Strategies with Sustainability Goals

Increasingly pharmaceutical companies are committing to reduce their carbon footprints
in the execution of clinical trials.

This session will cover how implementing innovative clinical trial supply technologies and sustainable processes can.

  • result in a more efficient use of human resources
  • reduce the number of logistical resources required
  • reduce waste
  • save money
  • lower the carbon footprint impact

Speakers

Tom Gottschalk
Vice President, Business Development, Mercalis

10:15 AM

Why so slow? Insider insights from the clinic floor to speed up the startup and execution of proof-of-concept patient trials

How to:

  • Harness regulatory dynamics for strategic advantages.
  • Obtain feasibility figures true to delivery.
  • Employ innovative study designs to expedite the development program.
  • Customize efficient patient recruitment tactics!

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

Navigating the Landscape of Complex and Adaptive Clinical Trials: Key Challenges and Solutions

  •  Practical solutions for regulatory hurdles, statistical design challenges, and data integration
  • Adaptive randomization, interim analysis, and effective patient recruitment
  • FDA’s push for two doses into Phase 2 (Project Optimus)
  • Increase in BOIN trial designs
  • Requirements of PK & PD data to serve the cohort review committees
  • Cohort planning and practicalities of running this across multiple sites/countries

Speakers

Jim Eamma
Senior Director, Project Management US, Worldwide Clinical Trials

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 be 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

Danny Lu
Associate Director, Site Management GCO Americas, BeiGene

1 PM

TECHNOLOGY SPOTLIGHT: Oversight for All: Achieve data transparency with elluminate Learn how the elluminate Clinical Data Cloud provides seamless access to comprehensive trial data across systems and sources. This presentation will showcase:

  • How a centralized data workbench eradicates data silos and provides near real-time access to data for optimized oversight and more efficient, data-driven decision making
  • AI/ML capabilities to ensure data quality, automated data review processes, and increased productivity across the clinical development lifecycle with eIQ Review
  • Proactive trial oversight and management with increased automation, comprehensive analytics, and custom visualizations in elluminate Operational Insights
  • Mitigating risk with efficiency, accuracy, and ease with holistic Risk-Based Quality Management

Speakers

Jason Konn
Solution Consultant, eClinical Solutions

1:15 PM

Lunch and networking

2:15 PM

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

2:45 PM

Implement a Lean Methodology for More Efficient Clinical Trial Operations

  • Best use of Lean methodology to drive continuous improvement
  • How use of Lean methodology better informs feasibility
  • What can make Lean your ‘silver bullet’

Speakers

Julie Martin
President & CEO, Scimega Research

3:15 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
Senior Consultant, Tufts Center for the Study of Drug Development
Abigail S Dirks
Data Scientist, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

3:45 PM

Afternoon refreshments and networking

4:15 PM

Respecting patient and site voices: Practical steps to streamline clinical technologies

  • Examine the oncology clinical trial journey from patient and site perspectives, identifying current stressors and opportunities to solve challenges.
  • Dive in on specific practices and technologies that can remove friction from the trial experience for patients and reduce workloads for sites.
  • Identify future innovation spaces to streamline the trial experience and how that can lead to better care for patients and better trial outcomes for sponsors. 

Speakers

Amanda Howley
Director, Services Solutions, Suvoda
Andrés Escallón
Vice President, eCOA Solutions Strategy, Suvoda

4:45 PM

Panel Discussion: 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 and Scientific Board Member, Biond Biologics and HiFi Bio
Filip Janku
Chief Medical Officer, Monte Rosa Therapeutics
Sally Wang Liang
Partner, Highlight Capital

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

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, Head of Oncology & Hematology, TFS CRO

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 and 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

Select a speaker to learn more

Back
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, 2:15 PM

View In Agenda
Next speaker
Back
Giovanni Abbadessa
Vice President, Head of Oncology Early Development, Sanofi and Scientific Board Member, Biond Biologics and HiFi Bio

Session Details:

Panel Discussion: Geopolitical, regulatory and financial factors influencing oncology trials

2024-07-09, 4:45 PM

View In Agenda
Next speaker
Back
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

View In Agenda
Next speaker
Back
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, 2:15 PM

View In Agenda
Next speaker
Back
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

Session Details:

Interactive Speaker-Hosted Roundtable Discussions

2024-07-10, 9:00 AM

View In Agenda
Next speaker
Back
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

View In Agenda
Next speaker
Back
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

View In Agenda
Next speaker
Back
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, 3:15 PM

View In Agenda
Next speaker
Back
Rosemary Conway
Patient Advocate

Session Details:

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

2024-07-09, 12:15 PM

View In Agenda
Next speaker
Back
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.

Next speaker
Back
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

View In Agenda
Next speaker
Back
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, 2:15 PM

View In Agenda
Next speaker
Back
Maria Florez
Senior Consultant, Tufts Center for the Study of Drug Development

Maria Florez is involved in research looking at the impact of digital transformation in clinical research and organizational strategies and practices driving improvement in development operations and economics. Maria has been a researcher and strategist in the healthcare sector for 15 years. She has held positions at Cleveland Clinic and at New York-Presbyterian Hospital of Columbia and Cornell Universities and has published articles in trade and peer-reviewed journals. She holds a B.S. in economics and an M.A. in international economics from The Fletcher School of Law and Diplomacy at Tufts University.

Session Details:

Measuring RBQM Adoption: Insights and Opportunities

2024-07-09, 3:15 PM

View In Agenda
Next speaker
Back
Abigail S Dirks
Data Scientist, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

Abigail Dirks is a Data Scientist 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, 3:15 PM

View In Agenda
Next speaker
Back
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:

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, 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

View In Agenda
Next speaker
Back
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

View In Agenda
Next speaker
Back
Elizabeth Barksdale
Senior Director of Regulatory Affairs and Scientific 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

View In Agenda
Next speaker
Back
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.

Next speaker
Back
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:

Why so slow? Insider insights from the clinic floor to speed up the startup and execution of proof-of-concept patient trials

2024-07-09, 10:15 AM

Session Details:

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

2024-07-10, 11:30 AM

View In Agenda
Next speaker
Back
Amanda Howley
Director, Services Solutions, Suvoda

As Director, Services Solutions at Suvoda, Amanda brings more than 10 years of experience working in client services.  Prior to joining Suvoda,  she held positions in science and consulting, operations, product development, and technical implementation with various technology vendors and CROs. With her extensive experience in decentralized trials, Amanda also serves as an eConsent expert at Suvoda. Amanda holds a master’s in Organizational Learning and Development from Suffolk University and a master’s in Health Sciences: Clinical Research Administration from George Washington University.

 

Session Details:

Respecting patient and site voices: Practical steps to streamline clinical technologies

2024-07-09, 4:15 PM

View In Agenda
Next speaker
Back
Julie Martin
President & CEO, Scimega Research

Julie Martin, MSc, Lean Certified - CEO & co-Owner is a 17-year industry veteran who has led Scimega as CEO for 5 years. Her passion for Scimega’s business and team stems from knowing its expert oncology clinical development services add distinct value to industry stakeholders at a time when it’s needed most. As CEO, Julie’s vision is to secure the company’s long-term success by leveraging her in-depth industry expertise and business acumen. She equates that success with setting a clear vision for the organization’s continued sense of purpose. Her leadership, and collaboration with the managing Board of Directors, combined ensure the business excellence upon which Scimega has built its reputation. Julie plays a vital role in promoting Scimega’s expertise and showcasing Canada’s attributes as a formidable partner in global oncology drug development with an evolving Lean methodology.

Session Details:

Implement a Lean Methodology for More Efficient Clinical Trial Operations

2024-07-09, 2:45 PM

View In Agenda
Next speaker
Back
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

View In Agenda
Next speaker
Back
Bob Bauer
Executive Director Operational Strategy, Precision For Medicine

Bob Bauer is Executive Director of Operational Strategy at Precision for Medicine.   He is a 23-year clinical operations professional with extensive tenures in both the pharmaceutical sponsor and contract research organization (CRO) sectors. His diverse experience spans across all phases of clinical research, encompassing a wide range of study designs and therapeutic indications. Bob has played key roles in several programs involving rare and challenging to recruit populations and has implemented creative and cost-effective approaches to ensure successful patient engagement and recruitment.

Session Details:

Beyond Informed Consent:  Bridging the patient education gap to improve the clinical trial experience

2024-07-09, 11:45 AM

View In Agenda
Next speaker
Back
Jason Konn
Solution Consultant, eClinical Solutions

As a Solution Consultant, Jason works with Sponsor organizations to understand their challenges and come up with creative solutions leveraging the elluminate platform. Jason has lead design & development for several products ranging from a Data Management Workbench, Data Integrations, Clinical Operations Platform, Clinical Analytics, and Risk Based Quality Management.  Jason has been in the clinical trials industry for over 15 years and his prior experience includes, global central laboratory, eCOA design, process improvement, and building an automated workforce.

Session Details:

TECHNOLOGY SPOTLIGHT: Oversight for All: Achieve data transparency with elluminate Learn how the elluminate Clinical Data Cloud provides seamless access to comprehensive trial data across systems and sources. This presentation will showcase:

2024-07-09, 1:00 PM

View In Agenda
Next speaker
Back
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

View In Agenda
Next speaker
Back
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

View In Agenda
Next speaker
Back
Filip Janku
Chief Medical Officer, Monte Rosa Therapeutics

Dr. Filip Janku is the Chief Medical Officer of Monte Rosa Therapeutics. Previously, he served as an Associate Professor of Investigational Cancer Therapeutics and Medical Director of the Clinical and Translational Research Center at MD Anderson Cancer Center. His experience includes many years in early-stage development of new cancer treatments with a focus on proof-of-concept studies of personalized cancer therapies. He has received multiple awards for his research efforts, including the Sabin Family Fellow Award, the Sidney Kimmel Scholar award, Khalifa Scholar Award, several ASCO Merit Awards and an American Association for Cancer Research Scholar-in-Training Award. He is the coauthor of more than 250 scientific articles that have appeared in peer-reviewed journals.

Dr. Janku earned his Ph.D. in Pathobiochemistry and his M.D. from Charles University in Prague. He completed his medical training at Charles University and The University of Texas MD Anderson Cancer Center.

Session Details:

Panel Discussion: Geopolitical, regulatory and financial factors influencing oncology trials

2024-07-09, 4:45 PM

View In Agenda
Next speaker
Back
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

View In Agenda
Next speaker
Back
Brian Sheridan
Vice President Global Adherence & Clinicals, Smurfit Westrock

Brian joined, the then WestRock, in 2018 as Vice President Global Adherence & Clinicals - the business unit focused on providing Adherence focused, patient centric and Child Resistant Senior Friendly (CR-SF) packaging & service solutions to the Pharmaceutical, Biotech & Clinical Trial industries.

Having majored in marketing, business studies and finance Brians key expertise has been developing packaging solutions supplied to these key markets. Holding a wide range of increasingly elevated positions within companies such as Cardinal Health, Catalent and across several other packaging entities, Brian has gained invaluable insights and a thorough understanding of the demanding requirements, operating systems and ethos of the various market sectors that Smurfit Westrock support today.

Within the last number of years Brian's focus, together with his globally based team, has been to strategically develop a bespoke, best in class global supply infrastructure within the Smurfit Westrock specialized field of Adherence, Clinical Trial and SMART digital & electronic platforms. These cutting-edge solutions encompass electronically enhanced SMART measure and monitor packaging solutions, such as Cere®Pak, together with developing the vision and capabilities of Cere®Screen Digital Display Labels within the Clinical Trial Supplies arena..

Session Details:

TECHNOLOGY SPOTLIGHT: Driving drug exposure, accuracy, and speed in clinical trials through SMART-digital solutions

2024-07-09, 1:00 PM

View In Agenda
Next speaker
Back
Bernard Vrijens, PhD
Chief Executive Officer & Scientific Lead, AARDEX Group

Bernard Vrijens is Chief Executive Officer at Advanced Analytical Research on Drug Exposure (AARDEX Group). He is also Invited Professor of Biostatistics at Liège University, Belgium.

Dr. Vrijens holds a PhD from the Department of Applied Mathematics and Informatics from Ghent University, Belgium.

Dr Vrijen’s currently leads a research programme investigating (a) the most common errors in dosing using a simple but robust taxonomy, (b) particular dosing errors that can jeopardise the efficacy of a drug, and (c) the optimal measurement-guided medication management programme that can enhance adherence to medications and maintain long-term persistence.

Dr. Vrijens is a co-author of seven book chapters, over 100 peer-reviewed scientific papers, and named as inventor on 6 patents. He is a founding member of the International Society for Patient Adherence (ESPACOMP), and an active member of several EU- and US-funded collaborative projects around the theme of adherence to medications.

Dr. Vrijens is a highly-accomplished public speaker, having presented lectures at over 200 industry events and scientific conferences around the world over the past 20 years. Public speaking experience includes the NIH Adherence Network Distinguished Speaker Webinar Series, CDER Drug Packaging Summit at FDA, European Society of Cardiology Congress, American Society on Pharmacometrics, WHO Global Forum on Innovation for Aging Populations, among many others.

Session Details:

TECHNOLOGY SPOTLIGHT: Driving drug exposure, accuracy, and speed in clinical trials through SMART-digital solutions

2024-07-09, 1:00 PM

View In Agenda
Next speaker
Back
Jim Eamma
Senior Director, Project Management US, Worldwide Clinical Trials
  • BSc in biology from Saint Andrew’s Presbyterian College, US. MSc in Biology from Texas Christian University
  • Oncology project-management specialist with almost 25 years of experience in academic, clinical site, and contract research organization (CRO) settings.
  • Experience in all phases of reseach (Phase I-III) including Phase IV across multiple study designs such as basket and umbrella studies, 3+3 dose escalation, expansion, accelerated titration, modified toxicity-probability interval, and Bayesian logistic-regression model

Session Details:

Navigating the Landscape of Complex and Adaptive Clinical Trials: Key Challenges and Solutions

2024-07-09, 11:45 AM

View In Agenda
Next speaker
Back
Bin Pan
Executive Director, Head of Oncology & Hematology, TFS CRO

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

View In Agenda
Next speaker
Back
Andrés Escallón
Vice President, eCOA Solutions Strategy, Suvoda

Andrés Escallón, the Vice President of eCOA Solutions Strategy at Suvoda, boasts over 18 years of expertise in the eCOA industry. With roots at PHT Corporation and subsequent leadership roles at ERT, Andrés has been a driving force in eCOA project and program management. Recognized as an eCOA Subject Matter Expert, he joined Suvoda in 2021 as the Vice President of eCOA Practice, building a team and seamlessly integrating eCOA functions into Suvoda’s successful IRT delivery framework. In his current role, Andrés guides Suvoda’s eCOA product and commercial strategy, provides consultative support to industry stakeholders, and serves as the face of the eCOA product, showcasing his strategic leadership in the dynamic eCOA landscape.

Session Details:

Respecting patient and site voices: Practical steps to streamline clinical technologies

2024-07-09, 4:15 PM

View In Agenda
Next speaker
Back
Francesco Santo
Associate Director Global Clinical Supply Chain, HUYABIO

A highly experienced and passionate Clinical Supplies Project Manager, Francesco has dedicated the past 17 years to ensuring the seamless execution of clinical trials by optimizing supply chain operations. His deep commitment to this field is driven by a relentless pursuit of excellence in delivering life-saving treatments to patients worldwide.  Throughout his career, he has honed a diverse skill set, encompassing:

  • Strategic Supply Chain Management
  • Regulatory Compliance
  • Cross-Functional Collaboration
  • Risk Management
  • Innovative Problem-Solving

Francesco’s dedication to the clinical supplies industry is rooted in a profound understanding of the critical role it plays in advancing medical research and improving patient outcomes. He is committed to continuing his journey in this field, always striving to contribute to the betterment of global health.

Session Details:

The crucial role of communication for clinical trial drug management

2024-07-09, 8:45 AM

View In Agenda
Next speaker
Back
Danny Lu
Associate Director, Site Management GCO Americas, BeiGene

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

View In Agenda
Next speaker
Back
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

View In Agenda
Next speaker
Back
Luis A. Aguilar
Vice President, Business and Clinical Operations, Candel Therapeutics

Session Details:

Interactive Speaker-Hosted Roundtable Discussions

2024-07-10, 9:00 AM

View In Agenda
Next speaker
Back
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

View In Agenda
Next speaker
Back
Tom Gottschalk
Vice President, Business Development, Mercalis

Tom has worked in the life sciences industry for over 26 years, with the first 10 as a pharmaceutical representative and marketing product manager for Bertek, Merck and GSK.

Tom joined Mercalis 16 years ago, created the RxStudy Card offering in 2009 and for the past 14 years has been focused on changing the paradigm of the traditional clinical trial supply process to one of greater efficiency through the RxStudy Card.

Session Details:

Aligning Clinical Supply Strategies with Sustainability Goals

2024-07-09, 9:15 AM

View In Agenda
Next speaker
Back
Caroline Potts, MSc
General Manager, Site and Patient Services, MRN

Caroline Potts, MSc Health Sciences, MSc Healthcare and Design

General Manager – MRN Site and Patient Services, Medical Research Network

Before joining MRN, Caroline worked in the public sector for 15 years supporting research in hospitals and the primary care setting as well as providing support to research academics by writing funding applications, making submissions to regulatory authorities and running a large portfolio of studies to ICH-GCP requirements in clinical specialties such as stroke medicine, Parkinson’s disease, orthopaedics, gastrointestinal medicine and respiratory medicine. During this time, Caroline was one of the founding members of the UKRD group as well as an Executive member of the RD Forum providing R&D Directors and research staff working in the public sector with strategic guidance in supporting high quality research in the NHS. In her current role, Caroline leads the development and expansion of MRN's global site network, site training programs, and on-site support services.

Session Details:

Hybrid trial design: Expanding trial access and reducing burden through patient-centric solutions in home and at site

2024-07-09, 2:45 PM

View In Agenda
Next speaker
Back
Sally Wang Liang
Partner, Highlight Capital

Harvard educated (BA Biology, JD, MPH), exceptionally well-rounded, and award winning life sciences venture capitalist with operating, entrepreneurial, legal (IP & FDA) and pharmaceutical management consulting experience and a science background. An entrepreneurial journey as a female founder and CEO “growing up” on the tech side (digital health) makes me a unique biotech investor with a founder friendly bent and a lean startup mindset.

20 years of biopharma and healthcare industry experience. Board Director or Observer of 8 biotechs with 3 exits in 2 years. Led/Shepard 3 large pharma deals (AZ, Pfizer, Takeda).

Skilled in life sciences and healthcare venture investing, board governance, BD, strategy, management, fundraising/startup operations, IP law, Food & Drug regulation, tech transfer, and cross-border international business with Asia.

Session Details:

Panel Discussion: Geopolitical, regulatory and financial factors influencing oncology trials

2024-07-09, 4:45 PM

View In Agenda
Next speaker

Plan Your Visit

Venue

Boston Marriott Burlington

One Burlington Mall Road Burlington MA 01803 United States

Accommodation

Arena International Events Group “(Arena”) is aware of numerous third party agencies which are contacting Arena’s customers and purporting to have access to hotel room bookings and events attendee lists. For the avoidance of doubt, Arena will only share attendee lists with carefully selected third party partners for event registration purposes. Whilst Arena International Events Group pursues third party agencies for their potentially illicit activity, Arena encourages you to be cautious in engaging with such third party agencies and Arena shall not accept any responsibility for any losses incurred by you should you choose to engage with third parties that have no affiliation to Arena International Events Group.

Sponsors

Select a sponsor to learn more

FEATURED SPONSORS

Session Sponsors

ROUNDTABLE SPONSOR

Technology Spotlight Sponsor

Exhibitors

Co-Sponsors

Media Centre

Media Partner

Become A Media Partner

A fantastic network of your peers and colleagues!

 

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.

See What It's All About

Press releases

  • 14 May -Clinical Operations In Oncology Trials Press release

    Download download press release

Enquiry

Contact Us

SPONSORSHIP ENQUIRIES

Conor Taylor

Sponsorship Sales Manager

+44 (0)20 7936 6870

SPEAKING OPPORTUNITIES

Niki Khoshkbary

Senior Conference Producer

+44 (0)20 4540 7545

MARKETING ENQUIRIES

Moona Popal

Marketing Manager

+44 (0) 20 7936 6656

DELEGATE ENQUIRIES

Sunny Saikia

VIP Delegate Manager

Sponsorship Enquiries

To enquire about sponsorship opportunities for the conference, please contact:

 

Conor Taylor

Sponsorship Sales Manager


+44 (0) 20 7936 6870

Speaker Enquiries

To enquire about speaking opportunities for the conference, please contact:

 

Niki Khoshkbary

Senior Conference Producer


+44 (0)20 4540 7545