a doctor speaking with her patients

Oncology and Hematology

When the stakes couldn’t be higher

Battles in cancer research are hard fought. Every day, thousands of the best and brightest minds work to find better, safer and more effective ways to halt the progression of malignant cells. In 2018 alone, 17 new hematology/oncology drugs accounted for a third of all FDA approvals.    

Your compound is racing to join the fight.

To succeed, you need a partner who knows how to navigate the challenges of oncology trials. From low patient and site enrollment and high toxicity, to complex regimens and intense competition, PPD anticipates and overcomes common challenges while constantly evaluating your trial to rapidly identify and mitigate the unexpected.

In the past five years, PPD has conducted 500+ clinical oncology studies from early phase through post-approval and across nearly every indication, including solid tumors, hematology, hematologic malignancies, cancer-related pain and supportive care.

rendering of a red cell

PPD delivers your oncology/hematology studies by navigating the nuances of complex oncology trials:

  • Leveraging adaptive trial designs that take advantage of innovative approaches in data collection and statistical assessments
  • Flexing midstream by altering control arms or expanding the number of arms in response to early findings
  • Enriching the patient population using biomarker-driven randomization to target subjects most likely to respond
  • Selecting 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

Our solutions scale: whether you are a small biotech or a large, global pharmaceutical organization, we have the team and solution for you.

We continue to build on our vast achievements in oncology and hematology indications.

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Oncology
JAI BALKISSOON
JAI BALKISSOON

“I get great satisfaction from using my past clinical research experience and my current clinical oncology role to help our customers advance their products through the dynamic drug development process. Building PPD’s Immuno-oncology Center of Excellence has enabled us to bring the best operational practices for immuno-oncology drug development to our customers.”

Solving Oncology Trial Challenges:
Patient Recruitment

The numbers tell an all-too-familiar story: too few patients and low-performing sites can jeopardize your oncology trial results.

  • Less than 2% of patients diagnosed with cancer participate in a U.S. clinical trial
  • One in four cancer clinical trials were halted early, with one in 10 stopped for poor accrual
  • A panel of National Cancer Institute and American Society of Clinical Oncology experts identified two of the top barriers to oncology trial enrollment as a lack of trial awareness among patients and physician reluctance to refer patients to a study

OUR SOLUTION: Through our Accelerated Enrollment Solutions (AES) delivery model, we have built a network of 300 dedicated oncology sites and services.

Find out how PPD can help you begin enrolling oncology patients within 14 days – Learn more about our Just In Time Oncology Enrollment

Clinical Development and Real-World Research in China

Our collaboration with Happy Life Tech (HLT) combines their data technology, artificial intelligence and patient access with our global expertise in clinical trials and real-world evidence generation to deliver a comprehensive set of capabilities in China. Benefits to our customers include:

  • The ability to effectively incorporate Chinese patients into global studies. HLT provides access to high-enrolling sites through collaboration with nearly two-thirds of the top 150 hospitals in China across 20+ provinces, covering 100k+ clinical doctors
  • Reduced study timelines and faster access to data study
  • Effective, efficient real-world evidence generation
  • A deep understanding of the changing regulatory landscape
MAXIMIZING THE COMMERCIAL POTENTIAL OF YOUR ASSET

Evaluating the value implications of your compound early and often throughout the drug development process can circumvent potential pitfalls that can stall your drug’s commercial success.

Oncology markets pose multiple unique challenges, such as:

  • Many single arm trials in breakthrough indications make comparative assessments difficult across competitors
  • Lack of trial data for long-term survival outcomes and contamination of survival data by crossover introduce uncertainty in value assessment
  • Diverse, fragmented patient population lead to heterogeneity among study populations and limit generalizability of results
EVIDERA

Evidera, our peri- and post-approval business, accelerates the regulatory and payer approvals through evidence-based solutions that demonstrate the real-world effectiveness, safety and value of your compounds. Evidera’s successes include:

  • Driving reversals of the National Institute for Health and Care Excellence (NICE) decision in multiple oncology indications, including metastatic castration-resistant prostate cancer, multiple myeloma, thyroid cancer and non-Hodgkins lymphoma
  • Partnering with the American Society of Clinical Oncology (ASCO) CancerLinQ to evolve its data and technology into the world’s leading EMR-based oncology data platform

Evidera is helping biopharmaceutical companies evaluate their oncology therapies beyond incremental cost-effective assessments. Our Oncology Value Frameworks Tool identifies product value using existing frameworks, supports pricing and reimbursement value and identifies evidence gaps.

Request a demo of the tool

Evidera’s Experience

400+ immuno-oncology projects across 50+ therapies in support of 13 payer submissions in the past five years alone.

Just in Time Oncology Enrollment

Find out how PPD can help you begin enrolling oncology patients within 14 days.

Learn More
PPD® Laboratories:

A Complete Range of Oncology AND HEMATOLOGY Solutions

Across every phase, customers count on PPD® Laboratories to deliver the quality data needed for fast, accurate decision-making. Our hematology/oncology portfolio spans small molecules, biologics, antibody-drug conjugates (ADCs), biomarkers, cell and gene therapies, and companion diagnostics. And our collaboration with NeoGenomics expands oncology testing for clinical trials in areas such as genetic testing, pathology testing and interpretation services.

Immuno-oncology Center of Excellence

Immuno-oncology has emerged as one of the most promising areas of cancer research, after the 2018 Nobel Prize in medicine was awarded to researchers whose discoveries “brought immunotherapy out from decades of skepticism.”

New immunotherapies are demonstrating improved median overall survival and an acceptable toxicity profile.

PPD has conducted 120+ immuno-oncology trials on monoclonal antibodies, cytokine and 45 checkpoint inhibitors, immune modulators, monoclonal antibodies, cancer vaccines, adoptive cell therapy and cytokines, involving 38,000+ patients at 3,900+ sites worldwide. Our Center of Excellence is a knowledge base for project teams and customers on the competitive environment, efficient adaptive designs and the dynamic regulatory landscape that surrounds these rapidly evolving immunotherapies.

Our experienced leadership bring passion, proactivity and prioritization to your projects

With more than 2,100 hematology and oncology trained staff, PPD provides our customers with dedicated internal resources throughout their studies. Your project team, in turn, receives committed PPD senior management oversight and global therapeutic and operational experts to advance your therapy.

Optimizing Adaptive Trial Design

PPD partners with Berry Consultants, a pioneer in the Bayesian approach to medical statistics, an approach that is radically changing the way research is done throughout the medical industry. Our partnership brings together two pioneers in adaptive design, both committed to pushing the envelope of what modernized design can deliver. While traditional designs contribute to high failure rates and escalating costs because answers to pivotal research questions are obtained only at the end of the trial, adaptive designs leverage accumulating data so early findings can inform trials as they progress. These insights can accelerate timelines, reduce costs, generate more knowledge from a smaller number of patients and improve the overall quality of decision-making to identify the right dose for the right disease in the right patient.

Additional Resources

Learn more about our hematology and oncology capabilities.