.png)
Developing a new drug is among the most complex and uncertain tasks in the world today. On average, it takes 10-15 years to move a drug from concept to approval. The cost can run into billions of dollars as well. Yet, while this makes for significant investments of time and resources, at the end of the journey, a very small fraction of drug candidates ultimately achieve regulatory approval in the United States (fewer than 10%).
For pharmaceutical and biotech companies, the research and discovery-to-regulatory hurdle is an intimidating challenge. Underlying this process is a big fact that can be easy to overlook: it’s not just about science, it’s about strategy in the form of insights and decisions.
It’s here that advisory expertise presents itself as a discreet but potent accelerator. From influencing a regulatory path to optimally designing a clinical trial, or finding an optimal market access strategy, advisory insights can give years of effort back, reduce wasted spend, and ultimately deliver meaningful therapies to patients sooner.
Why Advisory Support Matters More Than Ever?
Drug development has always been complicated, but what was once an exchange of value between sponsors and their clinical teams is now complicated by many factors:
- Higher regulatory stringency across geographies.
- Competition with multiple organizations focusing on the same therapeutic areas.
- Patient expectations for therapies to be efficacious, accessible, and affordable.
- Point-of-care technology integration - from AI-based drug discovery to digital clinical trials - which poses new opportunities and perspectives but requires new levels of learning.
Most would say that organizations grappling with the intricate science of drug discovery alone have no chance of excelling in all these areas in-house. This creates another reason why advisory support has become an integral part of modern-day drug development.
An advisor can bring their knowledge and perspective; an advisor can often draw wisdom from lessons learned in a thousand projects and countless industries to help an organization make better and faster decisions.
The Hidden Costs of Going Without Advisory Insights
Consider a biotech company with a promising molecule for oncology. The science looks good, but the depth of the oversight surrounding the regulatory submissions for different geographies was underestimated by the company.
And then, it all falls down, a single accident in trial design causes delays that end up taking them several months, necessitating a costly study to redo of the study. By the time the drug was eventually approved, competitors had already launched their cancer drug.
Situations like this are not out of the ordinary or as uncommon as most think. This is an overlooked step in the absence of early strategic counsel that can cost these companies not only millions of dollars, but also have disadvantages with respect to their competition and, more importantly, have patients potentially waiting longer than necessary for new therapies.
Where Advisory Insights Drive the Most Impact?
1. Early Stage Discovery and Development Guidance
In early-stage discovery and development, advisory support assists organizations in prioritizing their pipeline, clarifying drug targets, and developing preclinical experiments in line with long-term clinical objectives.
Resource allocation is often stretched across multiple candidates, however advisors are integral in assisting organisations to identify the assets that are most worthy of the investment.
2. More Successful Clinical Trial Design
Clinical trials are the biggest expense and most time-consuming phase of development. Poor design is also one of the most common reasons for failure.
Advisors can provide support with adaptive trial design, patient recruitment methods, and selection of sites.
For example, real-world data might be used to more accurately identify populations for recruitment, making trials more efficient and meaningful.
3. Navigating Regulatory Pathways
Just like the FDA, EMA, or any other regulatory authority, regulatory requirements will evolve for each agency.
Advisory groups will ensure that the contractor complies with, but is also prepared for, format or structure changes so submissions meet as many of the guideline requirements as possible.
A well-structured regulatory pathway will significantly reduce the time to approval.
4. Risk Mitigation
Drug development is littered with unknowns, and unanticipated safety concerns, obstacles in supply chains, and gaps in funding can jeopardize development at all stages.
Advisors can assist companies by identifying potential risks early on and formulating detrimental contingency plans to minimize the impact if setbacks occur.
5. Commercialization and Market Access
Utilization is only part of the plan. After a drug is approved, the real work is to strategize how to set it up for success in the market!
Advisors provide important information about pricing, payer expectations, competitive positioning, and patient access strategies.
Without these experts, even an approved therapy can struggle in the market.
6. Technology and Digital Transformation.
Drug development today continues to embrace advancements in digital tools such as Artificial Intelligence in drug discovery, cloud-based trial management platforms, and digital biomarkers for patient monitoring.
Advisory experts are available to assist organizations in determining which technologies truly enhance value and how to best incorporate them into practice.
The Role of Expert Partners
While internal R&D teams have unparalleled scientific expertise, external, advisory partners contribute a level of cross-disciplinary perspectives that few organizations can generate internally. They link science to regulation to technology to market context.
Innovation driven firms such as Inobal have emerged as trusted partners for life sciences companies navigating this ecosystem.
They leverage advisory capabilities, combined with a digital solution, to help organizations to de-risk decisions, to adopt modern toolsets, and to rapidly move from discovery to market.
Accordingly, they play more than a consulting role, they act as a strategic partner committed to ensuring that the developed therapies are successful in the laboratory and the market.
Real-World Example: The Difference Advisory Insights Make
Consider two mid-sized biotech companies developing therapies in rare diseases:
Company A organizes itself solely on the expertise they have internally. The team is scientifically sound. However they are struggling with patient recruitment, as well as regulatory questions they did not anticipate. They end up extending their timelines for their clinical trials, causing investors to lose confidence and abandon their projects.
Company B organized an advisory team early on in the process. With patient advocacy groups engaged from the beginning, clinical trial endpoints aligned to regulatory expectations, and digital platforms to help with data collection. Company B ended up with accelerated recruitment, a more robust regulatory submission, and an easier route to approval.
Both companies had science that was sound. However, the difference in outcomes was advisory professionals putting forward relevant insights to support critical decisions.
The Future of Advisory in Drug Development
The drug development process is heading towards smarter, faster, and more patient-oriented development.
Advisory inputs will continue to play an essential part in this process. Some of the trends that will help shape the future of drug development over the next decade.
- Decentralized clinical trials that facilitate new patient engagement.
- AI and machine learning processes that can help predict trial outcomes and optimize drug design.
- Use of real-world evidence helps support quicker regulatory and payer decisions.
- Global collaborations must navigate through various regulatory and cultural contexts.
Advisory support will be the thread that ties together how organizations formulate and implement these innovations in meaningful, strategic, and effective ways.
Wrapping It Up
Drug development has always been difficult, and it will continue to be difficult in the future. The companies that rely on advisory insights as a guide are the companies that transform promising science into actual therapies.
Advisory partners help with the development journey from navigating regulations to commercialization strategies, ensuring that every step is informed, efficient, aligned with patient needs, and implemented with market realities.
If your organization is committed to acting with intentionality and speed, working with a future-focused company that combines life sciences knowledge with digital capabilities like Inobal makes all the difference. Because moving new therapies to market requires more than just speed, it's about strategy.
