13th Annual Clinical Operations in Oncology Trials East Coast 2024

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

9 - 10

July

2024
  • Boston, MA, 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

2023 Agenda

  • 11 Jul 2023
  • 12 Jul 2023
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Streams

Stream one

Clinical Operations

Stream two

Clinical Technology and Innovation

11:30 AM

Innovating and introducing new technology while ensuring patients remain at the heart of your clinical trial

  • Ensuring that any new technology is for the benefit of the patient: the importance of involving the patient voice and advocacy groups in innovation
  • Where are the main difficulties for patients when participating in a clinical trial, and what technology is available in order to make this easier?
  • Decentralized and remote elements of clinical trials: what can be done remotely to ease the burden on patients?

Speakers

12 PM

eCOA data collection solutions for the unique needs of oncology studies

  • Oncology trials and the need for flexibility
  • Addressing patient fatigue
  • Easing questionnaire response burden
  • Solving for logistical complexities

Speakers

12:30 PM

Assessing opportunities for innovation in oncology trials: what barriers are present?

  • Creating an internal culture of innovation to foster adoption of new technology and ideas
  • What technology is available to make life easier for sponsors, sites and patients alike?
  • Regulatory barriers to new technology and innovation: what do you need to know?

Speakers

1 PM

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

Learn how elluminate and eClinical’s biometrics services deliver:

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

Speakers

1:15 PM

Lunch and networking

2:15 PM

Capturing data from wearables and remote monitoring for early phase oncology studies

  • Drawing additional data from wearables to support your clinical study: what new opportunities are there?
  • Shifting from on-site monitoring to hybrid and decentralized approaches: benefits and challenges
  • Remote monitoring as a method to minimize site workload and increase patient retention

Speakers

2:45 PM

Study design: best practice for increasing your chances of success

  • Striking a balance in inclusion and exclusion criteria in order to maximize recruitment without compromising data
  • Designing objectives and endpoints for an oncology trial: should you be considering surrogate endpoints?
  • With protocol changes far more common in oncology trials, how do you incorporate flexibility from the outset?
  • Involving patients and advocacy groups in study design for oncology trials

Speakers

3:15 PM

PANEL DISCUSSION: Innovating your data management processes when running an oncology trial

  • How is data management and data capture evolving, and how can you be most efficient in using this?
  • Making processes easier for sites from a data management perspective: what tools are available?
  • Overcoming obstacles in order to ensure data is captured and processed in a timely manner

Speakers

3:45 PM

Afternoon refreshments and networking

4:15 PM

Key considerations when choosing vendors and partners as a small oncology biotech

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

Speakers

END OF DAY 1 AND NETWORKING DRINKS

8 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

Speakers

9 AM

OPENING KEYNOTE PRESENTATION: Patient experience in oncology trials: where are pharma and biotech companies falling short?

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

Speakers

9:30 AM

Diversifying Your Site and Patient Population in the Local Community Setting

  • Advantages of local community sites in oncology studies
  • Diverse patient populations
  • Leveraging your CRO's strategic site partnerships with local community hospitals
  • Expanding the advanced clinical trial offering and awareness
  • Easing the financial burden of local clinical trials vs travel to large hospitals

Speakers

10 AM

PANEL DISCUSSION: Navigating the perfect storm as a small biotech company: what you need to know to succeed

  • The impact of FDA Project Optimus, the financial crisis and the Inflation Reduction Act on oncology clinical trials in the US, particularly for early stage trials
  • How macro-political and economic issues affect clinical trials and mitigating risk surrounding this
  • Cutting costs and maximizing resources: the financial consequences of the storm on small biotech organizations
  • Understanding the changing regulatory environment for oncology trials in 2023
  • Keeping the patient at the center of changes to clinical trials: navigating the storm while minimizing patient impact

Speakers

10:30 AM

Getting hard feasibility data: how to do it

  • How do you access current, hard feasibility data?
  • Does your CRO have a stable, permanent clinical team with trial legacy capability and expertise in your domain?
  • Are your sites and vendors audit proof, and how can you enhance continuous improvement by formally adopting Lean?
  • Are you confident your CRO has the capacity to achieve your study milestones on or before deadline?
  • Is your CRO independent, does it act like a SMO with a dedicated site network, and is it well-rounded in regard to systems, with a collaborative vendor team of specialized expertise to support your program?

Speakers

11 AM

Morning refreshments and networking

11:30 AM

A SITE PERSPECTIVE: How can sponsors support sites in order to minimize workload and enhance performance?

  • What can sponsors change internally in order to reduce burden on sites which are stretched for resources?
  • Adapting processes for sites: creative solutions to be more efficient
  • Making processes less complicated and more straightforward for sites without compromising reliability
  • Where are pharma and biotech companies falling short and what more can be done to relieve pressure on sites?

Speakers

12 PM

Decentralized clinical trials in oncology in the post-COVID era

  • Introduction to decentralized clinical trials (DCTs) in oncology
  • Unique challenges in oncology clinical trials
  • Regulatory support and initiatives
  • Benefits of decentralized clinical trials in oncology
  • Future perspectives and opportunities

Speakers

12:30 PM

PANEL DISCUSSION: Looking beyond the USA, which regions offer the best opportunities for early phase oncology trials?

  • With the regulatory and political storm hitting the US, is it best to look abroad for clinical trial opportunities or to stay in the US?
  • Pros and cons of running trials in the US vs looking at international options
  • Assessing opportunities for early stage trials in Africa, Latin America, Europe, Asia and Australia: which offers the best alternative for early stage oncology trials?
  • Which regions are most cost-effective and straightforward to set up an early stage clinical trial in?
  • The impact of European harmonization regulations on running Phase 1 trials in Europe
  • What are the advantages and benefits of keeping trials purely in the US?

Speakers

1:15 PM

Lunch and networking

2:15 PM

Real world evidence: is this key to accelerating approval processes for oncology trials?

  • Tapping into the full potential of real world evidence and incorporating this into your oncology trial
  • Barriers to adopting RWE: how to address and overcome these
  • Navigating regulations in the USA in relation to the use of real world evidence in oncology trials

Speakers

2:45 PM

Imaging considerations for early phase oncology trials

  • Image analyses beyond RECIST to better detect signals
  • What to do with site/central discordant results
  • How early phase reviews should differ from Ph2/3
  • Getting the most out of standard of care imaging

Speakers

3:15 PM

CASE STUDY: Learnings and best practice when running a CAR-T clinical trial in oncology

  • The regulatory environment surrounding CAR-T trials in oncology: what do you need to know from a regulatory perspective in order to run a successful trial?
  • Practicalities of running a CAR-T trial in the US and key considerations
  • Reducing and mitigating against risks in a CAR-T oncology trial from an operational perspective

Speakers

3:45 PM

Afternoon refreshments and networking

4:15 PM

Key considerations when choosing vendors and partners as a small oncology biotech

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

Speakers

4:45 PM

Innovative processes to better address today’s oncology trial dynamics

  • Supply chain efficiency: why do extra work and spend more money than necessary?
  • Payment process efficiency: leverage an existing workflow process that sites use everyday
  • Understanding the total value a vendor can provide: select a vendor that can demonstrate its total value

Speakers

5:15 PM

CLOSING PANEL DISCUSSION: CRO oversight as a pharma or biotech sponsor company: how involved do you need to be?

  • Balancing degrees of oversight with CROs and partners: how often should you check in?
  • Working with CROs in a remote environment and fostering a strong relationship virtually
  • Ensuring you, your vendors and other partners are aligned under one shared goal: best practice in achieving this
  • Achieving a balance to avoid micromanaging CROs
  • Considerations for building efficient working practices with your vendors and partners, and the importance of choosing the right vendors for your clinical trial

Speakers

6 PM

Chairperson’s closing remarks

Speakers

8 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

Speakers

9 AM

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

During the roundtable discussion session, the conference hall will be divided into four ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within oncology clinical trials. After 45 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

ROUNDTABLE 1: Considerations when running clinical trials for rare forms of cancer

George Naumov, Chief Operating Officer, RS Oncology

ROUNDTABLE 2: Preparing data and documents for regulatory submissions: are you ready?

Humphrey Gardner, Chief Medical Officer, Harbour Biomed

ROUNDTABLE 3: Overcoming challenges in clinical development of cell and gene therapies

Rachel Nering, Head, Early Stage Oncology, R&D Clinical Science and Operations, Sanofi

ROUNDTABLE 4: Choosing vendors and partners as a small oncology biotech company: key considerations

Alice Drumheller, Vice President, Clinical Operations, Sensei Bio

ROUNDTABLE 5: Cell therapies for solid tumors

Debora Barton, Chief Medical Officer, TScan Therapeutics

Speakers

10:30 AM

Morning refreshments and networking

11 AM

PANEL DISCUSSION: Innovation and oncology clinical trials: where are the main opportunities in 2023 and beyond?

  • Why is oncology typically slower to adopt new technology and innovate in other therapeutic areas?
  • Understanding patient needs for oncology trials: how can new technology support patients to make participation in trials easier?
  • Decentralized trials and oncology: will it ever be possible to have a fully decentralized oncology trial?
  • What elements of decentralization have or should be incorporated in oncology trials?
  • Assessing new technologies and processes for 2023 and 2024: where are the key areas for opportunity?

Speakers

11:45 AM

The importance of diversity and inclusion in oncology trials and best practice in how to achieve this

  • Working with patient advocacy groups in order to reach out to more patients and increase diversity
  • Improving accessibility to clinical trials: how to engage patients who would not normally participate in clinical trials
  • How having a diverse patient population can increase reliability of data and results from clinical trials

Speakers

12:15 PM

Lunch, networking and prize draw!

1:30 PM

Gene therapy: what’s new in delivering therapeutics in oncology?

Speakers

2 PM

An overview of trends and themes in the clinical trial and healthcare industry in 2023: what’s new for oncology trials?

We welcome Tatiana Kolesnikova from GlobalData to present her research into trends and themes in the clinical trial industry, and what companies need to do to stay ahead of the curve. Join this presentation to hear what has changed since the pandemic, what’s new in 2023, and what to watch out for in 2024

Speakers

2:30 PM

Chairperson’s closing remarks

Speakers

END OF CONFERENCE

2023 Speakers

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Ekatherina Goryachikov
VP and Head of Clinical Operations, Adicet Bio

Session Details:

PANEL DISCUSSION: Looking beyond the USA, which regions offer the best opportunities for early phase oncology trials?

2023-07-11, 12:30 PM

Session Details:

CASE STUDY: Learnings and best practice when running a CAR-T clinical trial in oncology

2023-07-11, 3:15 PM

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Michelle Joseph
Associate Director, Data Management, Alkermes

Session Details:

Capturing data from wearables and remote monitoring for early phase oncology studies

2023-07-11, 2:15 PM

Session Details:

PANEL DISCUSSION: Innovating your data management processes when running an oncology trial

2023-07-11, 3:15 PM

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Chris Adams
Chief Executive Officer, Andarix

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

Session Details:

PANEL DISCUSSION: Navigating the perfect storm as a small biotech company: what you need to know to succeed

2023-07-11, 10:00 AM

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Len Rosenberg
Head Of Clinical Operations, BAML, LLC A Division Of The Leukemia & Lymphoma Society

Dr. Rosenberg is a 30 plus year executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, eclinical and contract research organization sectors. With his diverse background which includes executive management, clinical and regulatory operations, business development, eclinical technology solutions and new product/licensing evaluations, he brings tremendous hands on insights to optimizing the drug development cycle, from the early start-up stage to global product registration across many key therapeutic areas including CNS and oncology.

Dr. Rosenberg is Managing Partner of eP2Consulting, Inc. since 2001. He also currently serves as Head, Clinical Operations at Beat AML, LLC, a division of The Leukemia & Lymphoma Society. Dr. Rosenberg received his Ph.D., from the Kellogg Pharmaceutical Clinical Scientist Program, University of Minnesota, College of Pharmacy and his Bachelor of Science, Pharmacy, from the Philadelphia College of Pharmacy and Science.

Contact Information:
4 Quail Court, Mount Laurel, NJ 08054 (c: 609-923-9443)

Session Details:

Chairperson’s opening remarks

2023-07-11, 8:50 AM

Session Details:

Assessing opportunities for innovation in oncology trials: what barriers are present?

2023-07-11, 12:30 PM

Session Details:

PANEL DISCUSSION: Innovation and oncology clinical trials: where are the main opportunities in 2023 and beyond?

2023-07-12, 11:00 AM

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Leticia Tarilonte
Executive Director, Clinical Operations

Leticia has over 20 years of industry experience managing several research projects and clinical studies in various roles. She started her career in Pharma at Biogen, working collaboratively in an integrated monoclonal antibody research team and then moving to development in clinical operations, where she managed numerous phase I-III clinical trials in diverse therapeutic areas including, gastroenterology, immunology, neurology, and neuropathic pain.

 

She continued her career at Merck/EMD Serono where she served as a Clinical Research Scientist providing strategic and operational expertise in the planning and conduct of Phase I-III clinical studies in oncology and immuno-oncology, contributing to the BLA submission of BAVENCIO®, which led to the FDA accelerated approval in merkel cell carcinoma and in urothelial carcinoma. Later she served as a Chief of Staff to the Head of Development in Oncology, where she partnered with executive sponsors to identify and promote projects that are of strategic importance to the company and translating the function strategy into operational plans.

 

In 2020 Leticia joined Black Diamond Therapeutics, a biotech company addressing the significant unmet need for novel precision oncology therapies for patients with genetically defined cancers. Leticia’s efforts have been widely recognized by promotion to Executive Director of Clinical Operations where she is responsible for ensuring that clinical stage programs achieve objectives within established timelines, budget, and quality standards, while fostering a highly collaborative culture and serving as a leadership role model.

 

Leticia earned her Bachelor’s Degree in Biomedical Laboratory and Clinical Sciences from the School of Medicine at Boston University, followed by a Master’s Degree in Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy and Health Sciences in Boston.

Session Details:

Innovating and introducing new technology while ensuring patients remain at the heart of your clinical trial

2023-07-11, 11:30 AM

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Cory Burke
Senior Director, Head of Biometrics and Data Management, Black Diamond Therapeutics

Cory Burke is the Executive Director Head of Biometrics and Data Management at Black Diamond Therapeutics. Cory has over 25 years of experience in the pharmaceutical industry in both CRO and Sponsor side. She has worked in many aspects of data management, database programming and SAS programming in the industry. She works collaboratively with Clinical Operations, Medical, Translational Medicine and many other cross functional teams. She has worked on a wide range of therapeutic areas (Oncology, Dermatology, Cardiology, Gastrologic,etc) from Phase I-IV.

Session Details:

PANEL DISCUSSION: Innovating your data management processes when running an oncology trial

2023-07-11, 3:15 PM

Session Details:

CLOSING PANEL DISCUSSION: CRO oversight as a pharma or biotech sponsor company: how involved do you need to be?

2023-07-11, 5:15 PM

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Fatima Scipione
Senior Vice President, Strategic Alliances and External 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:

Real world evidence: is this key to accelerating approval processes for oncology trials?

2023-07-11, 2:15 PM

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David Sherris
Chief Executive Officer, GenAdam Therapeutics

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

Session Details:

Gene therapy: what’s new in delivering therapeutics in oncology?

2023-07-12, 1:30 PM

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Tatiana Kolesnikova
Director, Oncology and Hematology, GlobalData

Session Details:

Chairperson’s opening remarks

2023-07-11, 8:50 AM

Session Details:

Chairperson’s closing remarks

2023-07-11, 6:00 PM

Session Details:

Chairperson’s opening remarks

2023-07-12, 8:50 AM

Session Details:

An overview of trends and themes in the clinical trial and healthcare industry in 2023: what’s new for oncology trials?

2023-07-12, 2:00 PM

Session Details:

Chairperson’s closing remarks

2023-07-12, 2:30 PM

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Humphrey Gardner
Chief Medical Officer, Harbour Biomed

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2023-07-12, 9:00 AM

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

Session Details:

Key considerations when choosing vendors and partners as a small oncology biotech

2023-07-11, 4:15 PM

Session Details:

Key considerations when choosing vendors and partners as a small oncology biotech

2023-07-11, 4:15 PM

Session Details:

CLOSING PANEL DISCUSSION: CRO oversight as a pharma or biotech sponsor company: how involved do you need to be?

2023-07-11, 5:15 PM

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Andrea Bottkova
Director, Vendor And Contracts Managemen, Karyopharm Therapeutics

Andrea Bottkova, Director of Vendor Management and Contracts at Karyopharm Therapeutics Inc.  Andrea has been negotiating contracts for little over fifteen years.  In 2019 Andrea has helped established Karyopharm’ s vendor management and procurement department to support vendor oversight, strategic sourcing and maximize financial savings. Andrea is passionate about building partnerships and negotiating business terms of contract resulting in several million dollar saving annually. She believes that she has perfected her negotiations skills while learning from her very curious 5-year-old son Barton.

Session Details:

PANEL DISCUSSION: Navigating the perfect storm as a small biotech company: what you need to know to succeed

2023-07-11, 10:00 AM

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George Naumov
Chief Operating Officer, RS Oncology

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2023-07-12, 9:00 AM

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

Session Details:

PANEL DISCUSSION: Navigating the perfect storm as a small biotech company: what you need to know to succeed

2023-07-11, 10:00 AM

Session Details:

PANEL DISCUSSION: Looking beyond the USA, which regions offer the best opportunities for early phase oncology trials?

2023-07-11, 12:30 PM

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Rachel Nering
Global Head, Early Stage Oncology Clinical Operations, Sanofi

Rachel has spent more than 20 years in Oncology Clinical trials, working in regulatory, clinical operations and project leadership. Spending the majority of her career at smaller biotechs, she has been committed to building dynamic and agile teams across multiple organizations, leveraging the latest technology and process advancements to drive faster and more efficient decision making based on science emerging patient data. She has continued to prioritize a close partnership between research, development and commercial within her current role at Sanofi, transforming the measureable performance of the early oncology clinical operations team within the past 3 years.

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2023-07-12, 9:00 AM

Session Details:

PANEL DISCUSSION: Innovation and oncology clinical trials: where are the main opportunities in 2023 and beyond?

2023-07-12, 11:00 AM

Session Details:

The importance of diversity and inclusion in oncology trials and best practice in how to achieve this

2023-07-12, 11:45 AM

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Alice Drumheller
Vice President Of Clinical Operations, Salubris Bio

Alice Drumheller has over twenty years’ experience in the clinical operations area with the focus on executing clinical trials and works as VP of Clinical Operations at Salubris Bio. Previously, Alice was Senior Director of Clinical Operations at MacroGenics where she executed the company’s clinical strategy. Prior to MacroGenics, Alice was part of the team at Amgen/Micomet where she contributed to the approval of BLINCYTO®. Alice has held positions of increasing responsibility at large pharmaceutical companies, start-up companies and clinical research organizations, including Sensei Bio, Nabi Biopharmaceuticals, Bristol-Myers Squibb, Kendle (now Syneos), British Biotech and Henri Beaufour Institute (a subsidiary of Ipsen). Alice holds a BS in Public and Community Health from Southern Connecticut State University in New Haven, CT.

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2023-07-12, 9:00 AM

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Jim Palma
Executive Director, TargetCancer Foundation

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

Session Details:

OPENING KEYNOTE PRESENTATION: Patient experience in oncology trials: where are pharma and biotech companies falling short?

2023-07-11, 9:00 AM

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Sara Musalli-Lee
Associate Director, Clinical Operations, Tessa Therapeutics

Session Details:

PANEL DISCUSSION: Navigating the perfect storm as a small biotech company: what you need to know to succeed

2023-07-11, 10:00 AM

Session Details:

PANEL DISCUSSION: Looking beyond the USA, which regions offer the best opportunities for early phase oncology trials?

2023-07-11, 12:30 PM

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Debora Barton
Chief Medical Officer, TScan Therapeutics

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2023-07-12, 9:00 AM

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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:

A SITE PERSPECTIVE: How can sponsors support sites in order to minimize workload and enhance performance?

2023-07-11, 11:30 AM

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Dawn Kaminski
Vice President, BD Operations, eClinical Solutions

Dawn has over 20 years of experience in the pharmaceutical industry. She have worked within every level of clinical data management, from Data Coordinator to Senior Director where she participated in or had oversight for more than 250 clinical trials.

During her time in the industry, she has provided consultation to organizations on clinical trial conduct, best practices in Data Management and data capture as well as developed standardized libraries and templates to support the adoption of CDISC standards. She is an active member of SCDM as a GCDMP SME, course designer and webinar presenter as well as Co-Chair of the annual conference (2018-2021) and serves on the SCDM Board of Trustees. Dawn is involved as a member of the CDISC-CDASH core team, Diabetes sub-team, CDASH CFAST Expanded Leadership Team and former Co-Chair of the CRF Library project.

Dawn currently holds the position of Vice President, BD Operations, where she supports business development as a Clinical Subject Matter Expert for both software and data services as well as overseeing the Proposals and Solution Consulting departments.

Session Details:

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

2023-07-11, 1:00 PM

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Julie Martin
Chief Executive Officer, Scimega

Julie Martin - CEO & co-Owner joined Scimega 9 years ago. Having worked for 2 other CROs before, 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 & business acumen. She equates that success with setting a clear vision for the organization’s continued sense of purpose. Her leadership & 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.

Session Details:

Getting hard feasibility data: how to do it

2023-07-11, 10:30 AM

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Tom Gottschalk
Senior Director, Business Development, TrialCard

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

Session Details:

Innovative processes to better address today’s oncology trial dynamics

2023-07-11, 4:45 PM

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Sarah Anderson
Executive Director, Oncology Strategy Lead Worldwide Clinical Trials

Sarah R. Anderson is an Executive Director, Oncology Strategy Lead at Worldwide Clinical Trials.  Ms. Anderson has dedicated the past 17 years to building and advancing innovative oncology clinical trial concepts through development execution. Her passion is leading therapeutic strategy development along with a strategic thoughtfulness on advancing clinical trial options to patients in a local community setting.

Session Details:

Diversifying Your Site and Patient Population in the Local Community Setting

2023-07-11, 9:30 AM

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

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

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

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

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

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

Session Details:

Imaging considerations for early phase oncology trials

2023-07-11, 2:45 PM

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Ashley Finan
Senior Director, Portfolio Management, YPrime

Ashley Finan is Senior Director, Portfolio Management at YPrime with over 15 years of clinical trial experience. In this leadership role, she is responsible for implementing operational excellence within portfolio management and ensuring quality and consistency across the project management teams. Ashley is an eCOA subject matter expert whose work will soon be published in The Journal of the Society for Clinical Data Management, a peer-reviewed industry journal. Ashley has held varying operational roles across multiple modalities including project management, contracts specialist, and medical writing.

Session Details:

eCOA data collection solutions for the unique needs of oncology studies

2023-07-11, 12:00 PM

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Anand Merchant
Clinical Information Science Associate Director, Information Practice, Late Oncology

Anand Merchant is the Associate Director, Clinical Information Sciences, supporting Late Oncology studies at AstraZeneca. He has over two decades of experience spanning areas of cancer and clinical research, bioinformatics, and scientific project management. His work with multidisciplinary teams has yielded impactful collaborative projects in both academia and government environments. He leverages all his learnings to improve the patient journey by helping design innovative clinical trials that are adaptive to the emergent challenges of our times. In his current role, some of the key responsibilities are to implement novel approaches and create interactive visualizations that systematically harness evidence from the vast array of literature and database resources. These evidence-based analytics provide scientific intelligence that support critical design assumptions, evaluation of technical aspects, assessment of benefit-risk profiles, and maximizes opportunities to ensure enrollment of a diverse and inclusive patient population relevant to the study.

 

Anand Merchant holds a medical degree, a Masters in Biomedical Informatics from the University of Medicine and Dentistry of New Jersey (now a part of Rutgers University), and a Doctoral degree in Biomedical Sciences from the University of Connecticut Health Center.

Session Details:

Study design: best practice for increasing your chances of success

2023-07-11, 2:45 PM

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Ruth Subach
Vice President, Clinical Development and Operations
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Mundayat Jyoti Reddy
Executive Masters in Emergency & Disaster Management, Medical Science Liaison
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Maria de Assis
Senior Director, Clinical Operations, OriCell Therapeutics

Session Details:

PANEL DISCUSSION: Looking beyond the USA, which regions offer the best opportunities for early phase oncology trials?

2023-07-11, 12:30 PM

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Bob Bauer
Director, Operational Strategy

Bob Bauer is Executive Director of Operational Strategy at Precision for Medicine.   He is a  a 22-year clinical operations professional with 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 clinical trials that have incorporated decentralized elements, including remote data capture, electronic informed consent (eConsent), electronic clinical outcome assessments (eCOA), home health services, telehealth solutions, meta-sites, and cutting-edge wearable and mobile health technologies.

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Loan Vuong
Senior Clinical Trial Manager, Pyxis Oncology
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Sarah R Anderson
Executive Director, Oncology Strategy Lead, Worldwide Clinical Trials

Sarah R. Anderson is an Executive Director, Oncology Strategy Lead at Worldwide Clinical Trials.  Ms. Anderson has dedicated the past 17 years to building and advancing innovative oncology clinical trial concepts through development execution. Her passion is leading therapeutic strategy development along with a strategic thoughtfulness on advancing clinical trial options to patients in a local community setting.

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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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