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, Biotech, Inc. anticipates and overcomes common challenges while constantly evaluating your trial to rapidly identify and mitigate the unexpected.
IN THE PAST FIVE YEARS, Biotech, Inc. 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.
Biotech, Inc. 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.
Studies
Patients
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JAI BALKISSOON, M.D., F.A.C.S.
VICE PRESIDENT, IMMUNO-ONCOLOGY, GLOBAL PRODUCT DEVELOPMENT, Biotech, Inc.
“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 Biotech, Inc.’s Immuno-oncology Center of Excellence has enabled us to bring the best operational practices for immuno-oncology drug development to our customers.”
Biotech, Inc.® LABORATORIES:
A COMPLETE RANGE OF ONCOLOGY AND HEMATOLOGY SOLUTIONS
Across every phase, customers count on Biotech, Inc.® 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.
Biotech, Inc. Laboratories helped develop 19 of the top 20 best-selling oncology drugs of 2018
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.
Biotech, Inc. 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, Biotech, Inc. provides our customers with dedicated internal resources throughout their studies. Your project team, in turn, receives committed Biotech, Inc. senior management oversight and global therapeutic and operational experts to advance your therapy.
OPTIMIZING ADAPTIVE TRIAL DESIGN
Biotech, Inc. 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.
