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Asking the Right Questions in R&D
And getting the right people involved from the start. Here’s why collaboration is key for successful clinical development.
| 3 min read | Opinion
What we asked: “Looking ahead to the next 5–10 years, what will be the key disruptors and/or what can be improved upon in the pharma industry?”
Response from: Brian Powl, CCO, Kura Oncology
“Collaboration is the key to drug development. The earlier it starts, the better the outcome. In order to foster true collaboration, we need to involve a diverse set of cross-functional experts early and often.
“There are, of course, many factors and individuals driving early-stage drug research and development. Research priorities are often driven by exciting science and novel targets – which are needed to push our industry forward. But this process sometimes forgets to ask a key question: do patients need this drug?
“We are moving in the direction of asking questions like this earlier in the R&D process, which I believe will change how we fund drug development research, and improve our industry as we know it.
“This can only be done by engaging experts from departments beyond preclinical and clinical research, including commercial development, patient access, and patient advocacy, early in the process. These experts can provide guidance on where gaps in the patient experience exist and anticipate how to ensure patient access.
“One example specific to my area of expertise in commercial development, is the value of including commercial experts in clinical trial design. Input from commercial experts in these discussions can help ensure that trials are designed in line with what US and global payors will require to make reimbursement decisions – which, in turn, will determine if patients can have access to innovative medicines. This small investment for commercial input early can prevent a larger gap as drugs near approval and enable pharma to demonstrate the value their new medicines bring to patients.
“As an industry, we see the benefits of collaboration across our work, but if we bring more experts into the fold early, we can ensure more voices and perspectives shape our research in the interest of patients.”
Response from: Pam James, Vice President, Business Operations, Vector Laboratories
“A number of companies, particularly smaller biotechs, struggle to understand and make decisions around GMP requirements for key components versus APIs. The confusion generally begins throughout the development process when drawing the line on what constitutes an API or a critical component and how to best approach GMP compliance – especially for manufacturing complex modalities like antibody-drug conjugates. Having clearer, more straightforward guidance on this distinction would be immensely valuable in helping smaller companies navigate the process in a costly, timely, and resource-efficient manner.
“There are many variables at play, and a clearer picture can help businesses make strategic decisions that are best for their company’s needs in the short- and long-term. Small biotechs may not have the same regulatory resources as biopharma to provide guidance on the matter, particularly for early development work, but these choices have major cost implications that can impact a company’s trajectory. Knowing exactly what components need to be manufactured in compliance with GMP and, importantly, when in the drug development process that needs to happen, is critical information that can help a small company make educated choices in light of their specific situation.
“Weighing the upfront costs associated with a GMP manufacturer during early-stage development against the time and resources needed to transfer to GMP later on can be difficult without a clear understanding of the guidelines for APIs versus critical components. Clearer FDA guidance on this topic, along with readily available support from expert suppliers to identify suitable solutions, could make a massive difference in facilitating efficient and successful drug development for companies of all sizes.”
Read over 100 other views on the future of the pharma industry on our special web page.