Oncology and Hematology Expertise
The search for answers can’t wait
Oncology and hematology studies dominate the clinical trial landscape, but the path to regulatory approval is complex and uncertain. And for the millions of patients each year facing a cancer diagnosis, the search for answers can’t wait.
While advancements in oncology and hematology clinical research bring hope to patients, they can present challenges to drug developers, including:
- Complexity of innovative trial designs and master protocols
- Enrollment barriers that hinder diversity and inclusion goals
- Intense competition for qualified sites and patients
- Higher data volume and collection requirements compared to other therapeutic areas
- Rapidly changing standards of care and clinical strategies
- Regulatory and payor requirements that necessitate long-term follow-up
To navigate these complexities, you need a nuanced clinical development strategy and the partnership of an experienced contract research organization (CRO) with patient-centric technologies and end-to-end solutions that span all phases of development.
With experience in more than 700 hematology and oncology clinical trials, the PPD™ clinical research business of Thermo Fisher Scientific has expertise across the full range of cancer therapies — from immuno-oncology and targeted therapies to novel and emerging therapies, including cell and gene therapies.
Learn more about managing complex clinical trials
Accelerating hematology and oncology clinical research with proven experience
For more than 30 years, drug developers have partnered with us to develop and commercialize their hematology and oncology treatments. Success in hematology and oncology clinical research requires partners with a deep understanding of the disease and an unrelenting dedication to developing the solutions patients need. In the past five years alone, we have supported 34 oncology drug approvals in the U.S. — including three first-in-class products — and 25 EMEA approvals.
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Advance your clinical research with a full spectrum of end-to-end oncology solutions
We provide support in all phases of oncology development — from early drug discovery support and clinical development to market access and commercial strategy — with innovative technologies and solutions. Our dedicated teams are equipped with the knowledge, experience, and solutions to reduce patient burden and make trial participation viable for patients while achieving optimal doses, accelerating timelines and maximizing cost savings.
With a full spectrum of end-to-end solutions, we enable drug developers of all sizes to:
- Leverage adaptive trial designs that take advantage of innovative approaches in data collection and statistical assessments
- Flex midstream by altering control arms or expanding the number of arms in response to early findings
- Enrich the patient population using biomarker-driven randomization to target subjects most likely to respond
- Select an appropriate country mix based on the phase of clinical development, patient population, competition, regional and national standards of care, regulatory environment and protocol complexities
By partnering with us, you gain access to the latest oncology technologies, world-class laboratories, contract development and manufacturing organization (CDMO) services, and peri- and post-approval services.
Explore our end-to-end oncology capabilities
Next-generation sequencing
The search for answers requires transformative technology that advances. Oncomine™ Solutions — the latest technology for fast-profiling and next-generation sequencing of key biomarkers and comprehensive genomic profiling — provides molecular insights to inform the most critical decisions with speed and accuracy.
Learn more about Oncomine solutionsComprehensive oncology and hematology laboratory services
Across every phase, PPD™ Laboratory services deliver the quality data needed for fast, accurate decision-making. Our hematology/oncology portfolio spans:
- Antibody-drug conjugates (ADCs)
- Biologics
- Biomarkers
- Cell and gene therapies
- Companion diagnostics
- Small molecules
Our collaboration with NeoGenomics expands oncology testing for clinical trials in areas such as genetic testing, pathology testing and interpretation services.
PPD Laboratory services enabled the development of 24 of the top 25 best-selling oncology drugs of 2020.
Get to know our therapeutic leaders in oncology and hematology and hear how they can help move your program forward
Meet the complex demands of innovative oncology drug development with specialized capabilities
The application of innovative trial designs — such as adaptive designs and master protocols — can have a big impact in the early phases of drug development when decisions have far-reaching consequences.
Adaptive designs can transform your study by leveraging accumulating data to answer multiple questions and inform decisions in a flexible process. The ability to modify your trial as it progresses allows for accelerated timelines, reduced costs and improved quality and efficiency of decision-making.
With adaptive trial design, potential issues are revealed earlier, enabling faster “go, no-go” decision-making and more confidence in outcomes.
We are considered experts in innovative adaptive trial designs and master protocols with more than 40 in oncology. Our proven experience designing and operationalizing adaptive and other innovative trial designs, through our Adaptive Design and Master Protocol Working Group, enables you to unlock better information, faster.
Oncology imperatives podcast
Leverage proven expertise in cell and gene therapy oncology clinical trials
When it comes to cell and gene therapy (CGT) clinical trials, you need to put your trust in expertise and experience. The PPD clinical research team of Thermo Fisher Scientific has spent decades on the development and management of CGT trials, including 160 immuno-oncology studies and 137 cell and gene therapy trials across tumor types and therapies.
Over the years, we’ve supported more than 33,000 patients, and we offer comprehensive laboratory support for cell and gene therapies, including CAR-T therapies.
Facilitating adoptive cell therapy oncology trials
Adoptive cell therapies are one of the largest classes of novel immunotherapies. While interest among drug developers continues to grow, the adoptive cell therapy development ecosystem is complex and requires continual learning and process refinement. As technology advances and impactful therapies are developed, drug developers will need an experienced CRO to support trials and manage logistics.
Read more about the current challenges in adoptive cell therapy clinical development from both the site and CRO perspective.
Immuno-Oncology Center of Excellence
Immuno-oncology therapies present an area of opportunity in hematology and oncology drug development. New immunotherapies, which are demonstrating improved median overall survival and an acceptable toxicity profile, offer evidence for optimism.
With the PPD™ Immuno-Oncology Center of Excellence, we enable drug developers to pursue their therapies with confidence, providing a knowledge base on the competitive environment, efficient adaptive designs, and the dynamic regulatory landscape that surrounds these rapidly evolving immunotherapies.
Our experience spans more than a decade and includes more than 160 trials on:
- Adoptive cell therapies
- Cancer vaccines
- Checkpoint inhibitors
- Cytokines
- Immune modulators
- Monoclonal antibodies
More than 33,000 patients have participated in these trials at more than 5,000 sites worldwide. And our experience with cell and gene therapy trials continues to grow, with a background in more than 30 CGT studies. Our Cell and Gene Institute offers cross-functional expertise that spans diverse technologies and delivery mechanisms, including cell, gene, gene-modified cell and advanced tissue technologies.
It also offers cross-functional expertise with oncology and hematology physicians conversant in CAR-T therapies with investigators and key opinion leaders at the top of their field.
Navigate the nuances of complex oncology trials
Between the logistical and operational considerations and the challenges of enrolling representative patient populations into studies, cell therapy clinical trials are complex. By identifying key obstacles, drug developers can unlock strategies to overcome them – and increase patient access while designing safer trials.
The current trends in oncology research
Making tomorrow’s medicines
Rare disease and pediatric expertise
With regulations like the RACE for Children Act, drug developers have expanded their pipelines to focus more intentionally on therapies for rare and pediatric cancers. Hematology and oncology clinical trials are complex, and these challenges increase with a pediatric population.
Our experts guide you through the careful planning and consideration needed for rare and pediatric oncology clinical trials. With experience across all phases, indications and therapeutic areas — including more than 500 clinical studies — the cross-functional team at our Rare Disease and Pediatrics Center of Excellence delivers innovative, patient-centric solutions to skillfully address the most complex challenges of these trials.
Explore how to advance pediatric hematology-oncology drug development Learn more about the Rare Disease and Pediatric Center of Excellence
Patient- and site-centric solutions
Gain access to differentiated patient- and site-centric solutions that support both the patient and clinician to improve identification, diversity and inclusion in clinical trials.
With our proven trial optimization methodology, you experience on-time delivery, high-level site enrollment and performance through:
- Development consulting and early engagement to limit amendments and reduce costs
- Data-driven analysis to optimize the trial and mitigate risk
- Investigator feasibility and site selection recommendations
- Continuous feasibility and optimization feedback loop for time and cost savings
Our just-in-time methodology for oncology recruitment allows you to jump-start enrollment with:
- Access to diverse populations
- An augmented approach with ongoing risk mitigation and a performance-based price model
- A network of more than 300 sites and more than 1,000 oncologists, hematologists and urologists
- A record of zero non-enrolling sites in the just-in-time community
- Patients exposed to more trial options, while allowing sites to focus on studies for which they have patients
- An opportunity to accelerate overall study performance
Learn more about our patient- and site-centric solutions Learn more about how we can increase patient diversity in oncology clinical trials
Training sites for oncology trials with SiteCoach
For health care practitioners who want to improve their trial site’s capabilities to either become a new clinical trial site or enhance their clinical trial capabilities, we offer SiteCoach training in key areas such as foundational training and patient diversity.
The advanced clinical research training program offers robust education, coaching and support, enabling community sites to become qualified to manage complex trials.
SiteCoach includes:
- Comprehensive training and tools at each stage of the clinical trial process
- Optimally timed training before, during and after the study to ensure continuity of support
- Virtual, in-person or hybrid training approach to meet your specific needs delivered as one full course of four modules or one abridged course of two modules
- A user-friendly online interface that includes a learner community portal with resources and tools
For sites interested in reducing barriers to patient trial participation, we offer the DCT (decentralized clinical trial) Network Certification training program.
Watch this video to learn more about SiteCoach training capabilities.
