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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2023 Sponsors Include:

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Company Information

Precision medicine is in our blood, our cells, our genes, and our name. Precision for Medicine (PFM), the full-service global CRO, is purpose-built to accelerate clinical research and development processes to bring life-changing therapeutics to those who need them most. We integrate clinical operations excellence, laboratory expertise, and advanced data sciences to deliver on the promise of personalized therapy; translating research into real-world results and forever reimaging how to get there.

Company Website

To learn more , please visit our website - www.precisionformedicine.com

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You need an Imaging Strategy that’s designed and customized for your oncology clinical trial. RadMD, a Medica Group Company, is your full service imaging core lab solution. Imaging endpoints are often used to support go/no-go decision-making in early phase trials. This is also a critical time to determine the development strategy for later study phases. https://www.rad-md.net/

Company Website

To learn more , please visit our website - www.rad-md.net

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Interested in Learning More About the ‘Canadian’ Opportunity?

Scimega is a niche Canadian oncology CRO acting in Canada for the conduct of global cutting-edge oncology trials sponsored by small to mid-size biotechs.

In the face of an ever-changing clinical trial landscape our robust operations design guarantees sponsors the quickest global site start-up and fastest patient recruitment with assured premium quality data.
Skilled in collaborative vendor teaming, our oncology experts work with your team to devise innovative solutions specific to the unique challenges of your oncology clinical trial.
24 years of unparalleled Canadian oncology experience means our operational KPIs consistently surpass global industry norms.
Explore an Expansion with Us!

Company Website

To learn more , please visit our website - www.scimega.com

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TrialCard Incorporated is a full-service life sciences commercialization partner that provides comprehensive solutions that span the entire biopharmaceutical value chain. In addition to a foundation of fully integrated, digitally enabled patient support services, its broader offerings include everything from late-stage clinical trial management to post-marketing HCP engagement services and proprietary data-as-a-service payer intelligence and insights. Founded in 2000, TrialCard provides commercialization needs for more than 160 life science customers and has connected over 35 million patients with more than $18 billion in branded drug savings to date. The company is headquartered in Morrisville, North Carolina.

Company Website

To learn more , please visit our website - http://corp.trialcard.com/

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Worldwide is changing how the world experiences CROs – in the best possible way. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence, Worldwide Clinical Trials provides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies.

Company Website

To learn more , please visit our website - https://www.worldwide.com

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YPrime’s cloud-based technology streamlines clinical trial data collection and management. Electronic clinical outcome assessments (eCOA) and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone. 

We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. We’re doing more than streamlining your processes. We’re streamlining your research, helping you get to your next milestone faster. 

Company Website

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

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eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. The elluminate® Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. elluminate software and data driven services have been used by more than 100 life sciences companies on over 500 clinical trials to reduce cycle time and improve data quality. For more information, visit www.eclinicalsol.com, or contact us at info@clinicalsol.com.

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To learn more , please visit our website - www.eclinicalsol.com

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DSG, Inc. celebrates over 25 years as a leading global eClinical provider with a fully integrated suite of innovative technology solutions and data management services: Award-winning eCaseLink™ EDC & DSG Designer for Enterprise licensing with CDISC standards; Risk-Based Monitoring, eSource, IWRS Randomization and Clinical Supply, Drug Safety, Patient Profiles, ePRO, CTMS, Site Payment, Protocol Violations, ad-hoc reporting, CDM services, and digital on-demand Clinical Printing services.

Company Website

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

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Philips BioTel Research is an industry leader in medical imaging and cardiovascular safety testing for clinical trials.

Philips BioTel Research offers global operational support for cardiovascular monitoring in all therapeutic areas, and advances imaging services in oncology, cardiovascular, metabolic, musculoskeletal, neurologic, and medical device studies. Their experienced research team comprises key opinion leaders, board-certified cardiologists and radiologists, sub-specialty scientists, and highly trained technicians – who acquire, evaluate, and report high-quality data through an efficient, cloud-based infrastructure. Many biopharmaceutical trial sponsors rely on or scientific leaders to help design and optimize their protocols and statistical analysis plans. We have conducted clinical trials contributing to the market approval of nearly 100 new drugs to date.

Company Website

To learn more , please visit our website - www.gobio.com/clinical-research/

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Signant Health provides solutions that simplify every step of the patient journey to make it easier for people to participate in, and for sites and study teams to run, clinical trials. Signant unites eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies and Endpoint Quality into the industry’s most comprehensive patient-centric suite – an evolution built on more than 20 years of proven clinical research technology. Our intense focus on the patient experience, deep therapeutic area expertise and global operational scale enable hundreds of sponsors and CROs (including all Top 20 pharma) to extend the reach of drug development, expand patient opportunities and improve data quality – helping them bring life-changing therapies to our families and communities around the world.

Company Website

To learn more , please visit our website - www.signanthealth

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Stiris Research is an elite CRO focused on meeting client needs by providing highly experienced Project Management and Monitoring professionals for Phase I-IV clinical trials.  Our strength is seamlessly integrating as an extension of your organization to assemble the perfect team and deliver a highly efficient, cost effective outsourcing solution.

Company Website

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

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Suvoda is a global clinical trial technology company specializing in highly complex, life-sustaining studies in therapeutic areas like oncology, CNS, and rare disease. Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through IRT, eConsent, and eCOA solutions delivered on a single platform.

Company Website

To learn more , please visit our website - www.suvoda.com

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Translational Drug Development (TD2) is a world-class oncology drug development organization specializing in the development of new oncology medicines. TD2 offers fully integrated precision oncology clinical development solutions that combine the highest standards in clinical trials management, disruptive imaging, biomarker strategies, and unparalleled access to real-time patient data.

Company Website

To learn more , please visit our website - www.td2inc.com

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Advarra integrated solutions connects life sciences companies, CROs, research sites, investigators, and academia at the intersection of safety, technology, and collaboration. With the most trusted review solutions, innovative technologies, experienced consultants, and deep-seated connections across the industry, Advarra optimizes research performance, empowers clinical sites, and ensures compliance.  Advarra advances the way clinical trials is conducted to make them safer, smarter, and faster.  

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To learn more , please visit our website - www.advarra.com

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SDC delivers top-tier clinical trial services to pharmaceutical, biologic and device/diagnostic companies.  With strategic scientific consulting and clinical data services (biostatistics, data management/EDC, and IRT/WRS) expertise at our core, our services are scalable via our strategic partnerships to provide full-service clinical trial solutions that are The Right Fit For You.

Company Website

To learn more , please visit our website - https://www.sdcclinical.com/

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Vial is a next-generation CRO that leverages the nationwide Vial site network to ensure faster, higher-quality trial outcomes for sponsors. Additionally, our tech-enabled trial management system, streamlined study startup processes, centralized pre-screening call center, and unparalleled approach to patient recruitment will successfully deliver a superior CRO experience.

Company Website

To learn more , please visit our website - vial.com

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Zanteris offers Clinical Operations, Project Management resourcing, and Consulting services within the Pharmaceutical industry, we use our deep expertise to identify quality solutions that help you execute your clinical study on time. Utilizing our experience of managing clinical trials across a range of medical conditions, we apply a tailored customer experience backed by strong data. Dedicated to optimized studies and risk management, our goal is to support your race in drug development.

Company Website

To learn more , please visit our website - www.zanteris.com

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    Why attend?

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

    Arena International is delighted to announce Clinical Operations in Oncology Trials East will take place in Boston in July 2023! The long-awaited event will offer clinical trial professionals from big and small pharma and biotechs in the oncology space a much-needed opportunity to uncover new technologies and processes to optimize their clinical and outsourcing operations.

    The programme will take a holistic approach to the latest challenges and innovations in oncology operations such as end-user-CMO relationship during COVID-19, the evolvement of virtual trials and DTP in oncology trials along with regulatory updates in clinical trials. The conference will also be the platform for innovative case studies and break out discussions to connect and enhance your knowledge in the oncology space.

    Join us for a two day event filled with case studies, panel discussion and face to face networking opportunities around clinical operations, technology and innovation, and data management.

    Register your interest now to attend the event.

    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

    Testimonials

    See What It's All About

    2023 Agenda

    • 11 Jul 2023
    • 12 Jul 2023
    Expand All

    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

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    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.

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