With the emergence of basket trials in the early-phase oncology setting, clinical research teams are…
In my last post we looked at the need for a visionary drug development plan. Today’s post will outline the third most important asset in a successful drug development plan: Strategic Advisors and a Strong Leadership Team.
[Tweet “Prerequisite #3 for successful #oncology-drug-development: Strategic Advisors & Strong Leadership. http://bit.ly/YxtlWx #oncologyscimega.com”]Accurate, rigorous science and a robust longitudinal development plan are the two main assets to strive for in theory, but in practice they can be hard to attain on your own. Fortunately, there is a solution. If you’re investing time, money and resources to develop a compound, test it and then get it approved with quality data, you need to have a strong leadership team who can pull in complimentary experts and strategic partners to help get it all done on-time and within budget. These experts may include a toxicology expert for safety, a clinician to select the best administration method and a GMP specialist to guide you through the manufacturing process.
These strategic partnerships will bring different expertise to the multifaceted challenges you will face during the drug development process. These can include among other things:
1) Refining the technology itself;
2) Overseeing the regulatory requirements and ensuring quality assurance;
3) Managing pharmacovigilance;
4) Facilitating operations during clinical trials and accelerating the overall trial process;
5) Developing personalized software;
6) Elaborating and launching the business and commercialization process;
7) Developing patents and providing legal advice; and
8) Promoting collaboration with Key Opinion Leaders in the industry.
In the business of oncology drug development, expert advice will be found amongst medical oncologists and consultant groups such as Clinical Research Organizations (CRO).
The medical oncology community is key to helping drug developers uncover the real-world needs of patients and are, therefore, essential throughout the drug development process. But, strong and trustworthy alliances with medical oncologists is not always a given for biotechnology companies. However a knowledgeable CRO may be leveraged to promote collaboration between both groups.
A CRO that specializes in oncology will deliver an added advantage as it already maintains strong relationships with oncologists, which will facilitate the collaboration between sponsors and potential investigators or other clinical oncology experts. A CRO will, however, be much more than a mediator for developers. Depending on their expertise, CROs will offer specific services in various activities from early to late stage product development. The expertise of both the medical oncologist and the CRO will combine to help transpose preclinical models into the reality of the clinical world and in doing so will optimize translational studies.
A CRO will also work closely with the developer’s scientific team in early stage phases to reevaluate the objectives of the trial and the protocol design according to the industry’s requirement and taking into account trials that are currently active. A consultant’s experience and knowledge in clinical oncology research as well as the contacts he or she has developed will help shorten timelines throughout the trial. They will also help select the most qualified research team to collaborate with on-site for a particular trial. This facilitates patient enrollment and improves the quality and integrity of the data.
When selecting a partner you want someone that will give you options to choose from and who will act as an extension of your team by taking ownership of their projects and collaborating with you to achieve the best outcomes rather than managing to maximize their own profits. To use a sports analogy, you want to work with partners who “play for the jersey, not the money.”
Beyond the scope of clinical trials, there exists a variety of other qualified experts that can help promote a drug on the market and facilitate the creation of strategic alliances with bigger groups or pharmaceutical companies. It is important to note that the choice of the right partner, no matter what stage you are at in drug development, will limit your risk and greatly improve your chances of success. Furthermore, with the right team and partners in place, early termination of a trial for reasons other than patient safety, does not necessarily imply the end of the product. Strategic partnerships and strong leadership can often turn around a situation that was once considered a failure.
Knowledge, rigor, leadership, good judgment, open-mindedness, patient-centricity and of course strategic alliances are all critical components in achieving small victories towards enhancing patient outcomes.
Do you have any advice you’d like to share from your clinical development experiences? Please share your thoughts and best practices. We’d love to hear from you.