Translational medicine uses our understanding of the target biology/ expression in disease states and integrates it with our knowledge of drug pharmacology. It is critical to understand these complex interactions early on in development to improve the probability of success in later stages of drug development.

“REVEAL THE MEDICINE WITHIN THE MOLECULE”
Smarter, insightful drug development is the key to fuelling an efficient R & D program, bringing with it the following advantages:

Thoughtful, data driven decision making to progress portfolio Leaner, efficient and data rich R & D programs Best chance of benefit for participating patients Minimisation of overall R & D spend by reducing or eliminating redundancies Maximisation of output from each experiment or study.

We are currently in a very challenging but exciting period in oncology drug development. In recent years there has been steady development in the understanding of molecular and cellular process in tumor biology seeding and cancer progression. Cancer drug development is very risky with many inherent uncertainties, translational knowledge gaps and inefficiencies alongside the highest attrition rates across different therapeutic areas. Yet it requires huge investment in terms of huge capital expenditure.

Currently < 5% of new oncology molecules in phase I make it to approval. Between 1990 and 2005, 1631 molecules were studied in phase II yet only 7 were approved for use in lung cancer. [1] It is important to note that most failures in oncology drug development occur in later stages of development i.e. phase II and III. This is painful in terms of capital loss and effects the industry’s innovative capabilities to advance medical research for the benefit of patients. In order for us to fight cancer, we must challenge traditional clinical development paradigms and invest time and effort in better understanding the biology of the target. It is also crucial to define what success means for the program at the earliest stages in the development process. We should aim to raise standards in early exploratory capabilities and generate data that’s informative and drives further development. Drug development is a high risk venture and marginal / modest clinical benefit will result in failure.

WHAT CAN WE DO SMARTLY TO ACHIEVE SUCCESS ?

…….We can help………
We at EERA Clinical have a team of physicians with extensive experience in exploratory & clinical oncology drug development, in both small molecules and biologics. The team at EERA Clinical will apply their vast experience and recent innovative study designs to leverage success in clinical development programs. EERA Clinical’s knowledge of a therapy area will assist clients in designing a fit for purpose clinical development plan including choice of indication, comparator etc. In order to be successful you need the right skills, expertise, flexibility and adaptability.

We have it all, in-house. Across the value chain, our group can assist you with the following activities:

Early data review and gap analysis Assessment of new biological targets, mechanisms and their viability. Review and creation of target product profiles Support through pre-clinical experiments to first in man and beyond Establish clear milestones and GO / NO GO criteria in development plans. Strategies to optimize data value – smart risks Benefit / Risk analysis as continuum Clinical Development Plan and Protocol Development Assess the competitive landscape – Competitive intelligence Due Diligence in Pharma Partnering Biosimilar development strategy

“WE CAN HELP YOU & THE DRUG SUCCEED”
Our experts can work very closely with your product development team to help you make decisions to balance out risk, money and time.