Clinical Operations in Oncology Trials East Coast 2023

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

11 - 12

July

2023
  • Boston, MA, United States
  • Complimentary
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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

Session reserved for YPrime

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

Technology spotlight: eClinical Solutions

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

2:30 PM

Session available for event sponsor

3 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

3:30 PM

Afternoon refreshments and networking

4 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

4:30 PM

Session available for event sponsor

8 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

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

Session reserved for Worldwide Clinical Trials

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

Session reserved for Scimega

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

Session reserved for Precision for Medicine

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

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

2:30 PM

Session reserved for RadMD

2:30 PM

Session reserved for RadMD

3 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

3:30 PM

Afternoon refreshments and networking

4 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

4:30 PM

Session available for event sponsor

5 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

5:30 PM

Chairperson’s closing remarks

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: Assessing the possibilities of using cell therapies to attack solid tumours

Debora Barton, Chief Medical Officer, TScan Therapeutics

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

Session available for event sponsor

12:15 PM

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

12:45 PM

Lunch, networking and prize draw!

1:45 PM

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

Speakers

2:15 PM

Session available for event sponsor

2:45 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

3:15 PM

Chairperson’s closing remarks

Speakers

2023 Speakers

Select a speaker to learn more

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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, 3:00 PM

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Michelle Joseph
Associate Director, Data Management

Session Details:

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

2023-07-11, 3:00 PM

Session Details:

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

2023-07-11, 4:00 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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Sashka Dimitrievska
Senior Director, Global Therapeutic Area Head Oncology Clinical Insights

Session Details:

Study design: best practice for increasing your chances of success

2023-07-11, 2:15 PM

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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

Session Details:

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

2023-07-11, 3:00 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, 5:00 PM

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Fatima Scipione
Senior Vice President, Strategic Alliances and External Affairs

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, Penrose TherapeuTx

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, 1:45 PM

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Tatiana Kolesnikova
Director, Oncology and Hematology

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, 2:45 PM

Session Details:

Chairperson’s closing remarks

2023-07-12, 3:15 PM

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Humphrey Gardner
Chief Medical Officer
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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, 4:00 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, 5:00 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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Kate Findlen
Senior Director, Clinical Operations

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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Galyna Ganieva
MBA, Clinical Study Lead, Development Operations and Portfolio Management

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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George Naumov
Chief Operating Officer
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Giovanni Abadessa
Vice President, Head, Oncology Early Development

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

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, 12:15 PM

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ALICE DRUMHELLER
Vice President Of Clinical Operations, Sensei Bio

Alice Drumheller has over twenty years’ experience in the clinical operations area with the focus on executing clinical trials. Prior to joining the Sensei Bio, Alice was Senior Director of Clinical Operations at MacroGenics where she executed the company’s clinical strategy. Previous 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 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.

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Jim Palma
Executive Director

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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Anni Li
Clinical Programs Director

Session Details:

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

2023-07-11, 5:00 PM

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Sara Musalli-Lee
Associate Director, Clinical Operations

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
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Abigail S Dirks
Research Data Analyst

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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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

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Contact Us

SPONSORSHIP ENQUIRIES

Conor Taylor

Sponsorship Sales Manager

+44 (0) 20 7936 6870

SPEAKING OPPORTUNITIES

Douglas Webber

Programme Director

+44 (0) 20 7866 9411

MARKETING ENQUIRIES

Moona Popal

Marketing Manager

+44 (0) 20 7936 6656

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:

 

Douglas Webber

Programme Director


+44 (0) 20 7866 9411