A Guide to Time Lag and Time Lag Shortening Strategies in Oncology-Based Drug Development – Biotech Blog (blog)

Transformation of a new scientific idea into a new oncology-based drug requires atremendous amount of time, effort and investment. The initial, but critical first step in thisprocess is transferring basic oncology research into a clinical application known as atranslational or bench to bedside study. As a postdoctoral fellow who performsprostate cancer research related bench work, I have been asking how long my project might take to reach a patient as a cure rather than just becoming another scientific publication! I realize that for a cancer patient who has been waiting for a new drug treatment to survive, the time length that is required for drug development could actually cost the patient their life. From this point of view, the time length between bench work and a follow-on translational study (also called time lag) is critically important. Clearly the biggest problem is to ask and determine how it could be possible to decrease the time lag and allow potential benefits of a bench work to reach patients more quickly.During my Advanced Studies in Technology Transfer program at the Foundation for Advanced Education in the Sciences (FAES) Graduate School at NIH, I worked to uncover answers for these questions as my Capstone Project.

The calculated time lag typically of 10 years for new oncology treatmentBefore proposing solutions to shorten time lag in oncology drug development, I wanted to better define the time lag between bench work and translational study. For this purpose, I used the Pharmaprojects database (produced by Citeline/Informa PLC), to follow the global clinical drug development from bench to patient and to calculate the time lag for the three most common cancer types: breast, lung and prostate cancer. 97 drugs were examined for time lag calculation for either breast, lung or prostate cancer. The time length between patent priority date and regulatory approval date was calculated for each drug. The average time required to launch a cancer drug was determined to be 11 years, 10 years and 10 years, respectively for breast, lung and prostate cancer.

What are the reasons for time lag?To be able to uncover the reasons for a 10 year long time lag in cancer drug development, the key opinion leaders, including principal investigators, scientists, researchers from the National Cancer Institute (NCI), the National Center for Advancing Translational Sciences (NCATS), Yale University, Massachusetts Institute of Technology (MIT), Queens University School of Medicine, Dentistry and Biomedical Science, Belfast (U.K), and Regeneron Pharmaceuticals were interviewed, to formulate suggestions for helping new drugs reach from bench to bed side more quickly.

During these interviews, the following questions were discussed:

Scientific and Non-Scientific Reasons for Long Time Lag

For cancer patients, the10-year period to translate a new drug into clinical application is unfortunately more than a life time of delay. After interviews with many researchers, the reasons for a 10 year long time lag could be divided into two categories, scientific and non-scientific reasons. Problems in reproducible data generation, inappropriate use of in vitro/vivo models, and variation in human sample collection are classified as important scientific reasons. On the other hand, poor collaboration among industry and academia, problems in intellectual property (IP) sharing, ineffective public-private partnership due to lack of sharing of research tools are considered as non-scientific reasons.

Future Direction in Oncology-Based Drug Development:Collaboration, Collaboration and Collaboration!

One of the most common recommendations from all researchers whom I interviewed was the importance of collaboration. Most of the researchers think that collaboration should be considered as an inevitable requirement for all scientists to shorten the time lag, because no one can do all by himself/herself. This would encourage the application and use of differing expertise and points of views to support a steadier and more effective overall oncology research program.

Synergy between Academia and Industry

Researchers from both academia and industry also highlighted the importance of academia and industry partnership. Academic researchers have deep scientific knowledge, however they have been facing funding problems to pursue their researchand utilize this basic knowledge. On the other hand, pharmaceutical companies generally have funding and applied skills, but they are often dependent on academiaand small biotech companies for fundamental knowledge and novel discoveries. It isreally a relay race against time for scientists from both academia and companies needto complete together in order to benefit oncology patient care. Therefore establishing astronger and living connections between academia and pharmaceutical companies cancreate a shortcut and synergy to make to the journey from bench side to bedsidequicker than ever before.

Repurposing of FDA Approved Drugs for Oncology Applications

For one of the interviews for this article, a principal investigator from a major universitysaid that the time lag in bringing his research to market is only 2-3 years, because hislaboratory studies FDA-approved drugs for different indications. Using FDA-approved drugs for other indications, or repurposing the drug, would dramatically reduce time lagand overall cost. The most exciting part of successfully repurposing drugs, of course, is that development of a drug into a new treatment for a patients benefit will be quicker.

About the AuthorBerna Uygur is Postdoctoral Intramural Research Training Award Fellow at NICHDwhere she has been researching the role of cell fusion mediated cancer stem cell regeneration and drugresistancein prostate cancer microenvironment and she has been also researching extracellularvesiclesmediated communication between prostate cancer cells. Prior to joining theNICHD,Berna received her PhD in Biochemistry and Molecular Biology from UniversityofMaine, USA, where she studied Regulatory Role of Slug Transcriptional Factor inProstateCancer. She received her Master of Science degree in Applied MedicalScience from Universityof Southern Maine, USA, where she studied Toxicology ofSilver Nanoparticles in DifferentOrigins of Human Cells. She received both her firstMaster of Science degree and Bachelor Science degree in Textile ChemistryEngineering from Ege University, Turkey. Berna isinterested in translational scienceand technology transfer in biomedical research. Sheadvanced her interest intechnology transfer by completing the Advanced Studies inTechnology Transferprogram at the Foundation for Advanced Education in the Sciences (FAES) GraduateSchool at NIH. She has been pursuing her interest in translational science byattendingNIH-Duke University Clinical Research Training Program at NIH.

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A Guide to Time Lag and Time Lag Shortening Strategies in Oncology-Based Drug Development - Biotech Blog (blog)