Developing cancer therapies is an incredibly complex, costly, and highly regulated journey. To navigate this challenging terrain, pharmaceutical and biotechnology companies frequently partner with a Contract Research Organization (CRO). CROs are specialized third-party service providers that manage and execute critical phases of the research and development process on behalf of a sponsor. These organizations handle everything from early-stage laboratory testing to the design, management, and regulatory compliance of non-clinical and clinical trials. By outsourcing these highly technical operations to a CRO, innovators can tap into a wealth of knowledge and expertise, dramatically reducing their overhead costs, and bring safe, effective treatments to patients much faster.
During World Cancer Support Month, we raise awareness about prevention, honor survivors, promote local resources for patients and caregivers, and spread hope for everyone impacted by cancer. As a CRO, our primary goal is to partner with pharmaceutical and biotechnology companies to derisk and expedite the development of novel therapies, allowing them to get to patients quicker. The hope is that one day we will be able to eradicate many of the cancers that we are dealing with today.
Support In All Three Phases of Drug Development
Preclinical/Non-clinical
We offer a comprehensive suite of preclinical oncology and immuno-oncology services, leveraging our vast experience with human CDX lines, syngeneic lines, PDX lines, specialty surgical/orthotopic models, and diet-induced obesity models. Our services support robust in vitro screens and in vivo efficacy studies to evaluate novel therapies and clinically relevant combinations. To drive deep translational insights, our testing can be fully integrated with optical and ultrasound imaging, DMPK analytical services, metabolomic and proteomic profiling, flow cytometry, and single or multiplex biomarker evaluations.
Regulatory/IND-enabling
We offer strategic and operational regulatory consulting across pharmacology, toxicology, and CMC regulatory services. This spans program management from lead selection through IND filing. We provide medical writing for pre-IND documentation, protocols, Common Technical Documents - Modules 1-5, Investigator’s Brochures, and Informed Consent Forms. Additionally, we handle full IND compilation, submission, and ongoing maintenance, along with specialized applications such as Orphan Drug, Fast Track, and Special Protocol Assessments.
Clinical Trials
We provide end-to-end clinical trial services, starting with strategic development planning, protocol design, project management, and contracting through site selection, start-up, and monitoring and documentation management. To optimize study outcomes and insights, we integrate biostatistical consulting and analysis, advanced trial data analytics, and specialized flow cytometry testing.
Our Goal to Find a Cure
As a CRO operating at the forefront of oncology, TD2 holds both the privilege and the responsibility to push for breakthroughs in a space still defined by profound unmet needs. Every day, we witness an extraordinary pipeline of promising therapies coming through our doors, and every candidate, regardless of outcome, deepens our collective understanding and moves us closer to a cure. We don't view ourselves as merely a service provider; we are a true partner in the drug development process. By offering an integrated continuum of care, from preclinical in vitro and in vivo studies to regulatory consulting, program management, and full-scale clinical trial support, as well as partnering with Oncologist Dr. Daniel Von Hoff, MD and Dr. Alan Miller, MD, TD2 can offer a seamless translational experience from benchtop to first in patient. Agility, risk mitigation, and cost efficiency are built into everything we do, ensuring that together as a scientific community, we can accelerate the journey toward eradicating cancer.
