TGen Drug Development (TD2) is uniquely positioned to ensure that your clinical trial development plan is a commercial success by providing the strategic preclinical and clinical study design for targeted drug development. Whether your needs include study design/protocol writing, site selection and management, patient recruitment, or regulatory support, TD2 can provide the expertise, knowledge and support necessary to advance your compound through the development process. TD2 is an affiliate of the Translational Genomics Research Institute (TGen).

TD2's team of dedicated scientific and medical professionals provide a comprehensive range of clinical services to help clients around the world move a compound from the lab bench to a pivotal trial. TD2 delivers customizable design, oversight and analysis solutions for all phases of clinical development utilizing our De-Risk approach. The heart of De-Risk is the synergy of genomic, informatics, preclinical and clinical innovations, plus the integration of our world class project managers into your team to further accelerate and augment the development of your program.

Clinical Trial Development Plan
The TD2 team will work with you to create a De-Risk clinical trial development plan based on cutting edge science, precision medicine and regulatory approval strategies utilizing innovative combination trial designs. These plans suggest specific preclinical and clinical pathways, protocols and timelines. TD2 implements the program in tune with your individual needs using both in house expertise and outside experts as necessary.

Feasibility studies and investigator selection strategies
TD2 understands that feasibility studies are critical to advancing clinical projects and reducing research time. TD2 will ensure the careful selection and evaluation of investigators and investigational site personnel resulting in successful study completion based on the following criteria:

• Investigator interest
• Estimated patient recruitment
• Current and/or competing trials
• Investigator and site previous experience
• Trial requirements such as imaging, laboratories, and pharmacies and site capabilities
• Quality control processes
• Site personnel workload

Phase I-IIb Study Design
The TD2 team has extensive experience in designing clinical trial protocols that meet the FDA's scientific and regulatory requirements. The experts at TD2 will develop a study design that focuses on adding value at early stages by incorporating the use of biomarkers, circulating tumor cells (CPC's) and imaging, thus giving the highest chance of success early on in your development program.

Drug Development Plan
De-Risking your development plan is the starting point for effective and accelerated oncology drug development, including a plan with an in-depth analysis of not only the costs and market of your product, but the IP, obstacles, approval strategies, nonclinical and clinical programs. In addition to a thorough investigation into your global regulatory plan, investigator IND studies, post marketing studies, prelaunch plan and overall timeline.

Project Management and Trial Coordination
TD2 can assist you in all phases of clinical development from pre-Investigational New Drug (IND) activities through the Phase IIB clinical trial. TD2 will oversee the execution of clinical trials by coordinating the entire process from beginning to end.