As a biopharmaceutical company, you’re in a race to get your products to market as quickly as possible. With the worldwide pharma and biotech R&D forecast expected to grow 2.4% per year to 2022 and the total R&D spend expected to reach $181 billion over the same time period, there’s a lot at stake.1 Along with this fast-paced growth comes increased pressure to be first to market, not only for economic reasons, but also to bring life-saving drugs to patients in need. You’re not alone in facing these issues. Other business leaders are also struggling to overcome these challenges as their companies move through the various phases of drug discovery through to commercialization.
In this brief, we highlight obstacles for bringing drugs to market faster and how some industry leaders are overcoming them.
Challenges in Drug Discovery
Companies that focus on drug discovery are looking for new, relevant drug targets and attempting to determine how best to exploit these targets with safe and effective therapeutics.
In talking with industry colleagues, we were able to identify a number of challenges in this phase of drug discovery:
- Accessing all relevant information to advance drug discovery projects, whether it resides inside or outside the company
- Providing access to all new knowledge in context, among all appropriate researchers, in real time
- Communicating information efficiently across scientific disciplines and geographies
- Modeling disease states preclinically in biochemical and cellular assays that have relevance to the patient population
- Validating disease models to achieve better outcomes and ensuring that early-stage research translates to late-stage human trials
Work in a drug discovery lab is typically years away from reaching the market, so speed is not generally the driver of the lab’s actions. Instead, it’s important to conduct careful, reproducible work. But there are times when a drug target appears to be clinically valid and several companies are working simultaneously to be the first to develop a viable therapeutic. In this case, speed is a concern. According to a lead researcher at a large pharmaceutical company, taking the following actions to balance speed with precision can help overcome challenges:
- Use an external partner to help manage your assets and provide scientific services, so your scientists can get back to research instead of worrying about instrument repair and maintenance.
- Staff up in critical areas so that research on ideas of equal merit can be conducted in parallel rather than sequentially.
- Pay attention to design of experiments (DOE) to be sure all work has maximum impact.
- Prepare drug candidates and key synthetic intermediates in bulk and “at risk” so production of larger quantities, when needed for major experiments, can be done without delay.
- Place related work in the same geographical location to minimize time delays associated with shipping and handling.
- Join efforts with external collaborators who have a required expertise. (Note: this can also slow progress if handled incorrectly.)
Of course, the demand for better treatments to alleviate human suffering is urgent, but not all projects can (or should) be conducted at top speed.
Challenges in Preclinical and Clinical Development
Industry leaders believe that obstacles derailing speed are far more relevant during preclinical and clinical development phases. Activities in these phases focus on whether a drug candidate can be formulated for humans, if it’s proven safe, if it reproduces the lab effects on disease pathways in human patients, and if it can be manufactured consistently.
There are many challenges seen in this phase2:
- The costs associated with preclinical and clinical trials often offset productivity and can delay development.
- While advances in molecular pathogenesis have provided new information about the molecular structure of disease, novel technology and methods must be applied to find new treatments. And that means more time and funding.
- Funding is increasing for new drug development, yet the number of new drug submissions to the FDA has decreased.
- Clinical-trial success rates have dropped over the past few decades; compare a 21.5% success rate (1983-1994) to 16.4% (1996-1999) to 9.6% (2005-2015). Issues with clinical safety and toxicology are a large part of the problem of drug-trial failures. Methods and technologies must continue to advance to improve the transition from discovery to development to clinical trials.
According to the pharmaceutical leaders we surveyed, there are a number of solutions you can consider as you try to overcome these challenges.
Some of these include:3
Process Improvement – All organizations in the biopharmaceutical industry are under tremendous pressure to bring the next blockbuster drug to market fast. By working with a third-party asset management and scientific services partner, you’re one step closer to lab optimization by letting scientists get back to their important research instead of worrying about instrumentation and equipment.
Ensure Regulatory Compliance – To keep your workflow moving smoothly, it’s important to make sure your systems and labs are validated and compliant. Access to consistent, reliable, real-time data that provides insight into your instruments and systems is one way to help make your regulatory process smoother.
Use a Contract Manufacturer – One way to help your company speed time to market is to use a contract manufacturing organization (CMO). By working with a CMO, you have access to their expertise and technologies, helping you get your process up and running quickly.
Integrate Quality – Make sure your own process integrates quality throughout the drug development lifecycle. This allows you to correct any issue that may arise early in the process that can ultimately lead to costly delays.
Advancing a drug product through clinic and into the market quickly is the ultimate goal of most pharma companies. Given the complexity of each development phase, many challenges can present bottlenecks, slowing time to market. Yet there are a number of actions companies can take to help ensure they are able to get their products to market as fast as possible. Keeping a close eye on potential process improvements, properly maintaining instrumentation, having access to useful data, as well as teaming up with a third-party partner are all excellent solutions.
- 12018 Global life sciences outlook l Innovating life sciences in the fourth industrial revolution: Embrace, build, grow. Retrieved from https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/gx-lshc-ls-outlook-2018.pdf
- 2Drug Development: Challenges and Innovations. Retrieved from https://healthlaw.hofstra.edu/resources/infographics/drug-development-challenges-and-innovations/
- 34 Ways to Accelerate New Drug Development. Retrieved from https://blog.etq.com/4-ways-to-accelerate-new-drug-development