Molecule to Market: What Biotech Leaders Need Most at Each Phase of Drug Development

Most biotech companies share a similar ambition throughout drug development: to move a great idea from concept to clinic, and ultimately, to patients. But reaching that point takes more than science. It requires sound judgment, timing, collaboration, and experience at every stage.

Early on, you’re focused on research and discovery. Later in the process, you’re managing scale, compliance, and the ongoing complexity of clinical trials. There are multitudes of success and failure points along the way.

It’s been found that 30% of discoveries fail in Phase II, and over 58% of discoveries fail in Phase III.¹ How can you best look ahead to boost your success—and foresee what obstacles you may encounter?

Research & Development

In the earliest stages, pure motivation drives your team. You’re on the brink of something new—chasing signals, narrowing targets, and validating your approach. It can feel as if you’re in your zone of genius, however the work isn’t simply scientific—it’s extremely strategic, too.

What is the most efficient path to meaningful data? How do you balance innovation with what’s feasible under today’s regulatory expectations? And which points are strong enough to back an IND submission?

How do biotech companies benefit from partnerships?

This is where experience helps immensely. You don’t need directions or process advice. You need a collaborator who knows when to push for another assay, when to lock the design, and when to decide if you’ve hit go or no-go criteria and need to find another path forward.

Process Development

As your discovery takes shape, your focus shifts to how to develop it—safely, reliably, reproducibly, and at a scale that makes sense for the next phase. It’s a time when technical rigor meets practical decision-making.

During process development, bench work is taxing, and it can be easy to miss recognizing future obstacles or details. We’ve seen teams stall because a promising molecule wasn’t built for manufacturability early enough. We’ve also seen others accelerate because they made process design part of their development thinking from the start.

How do process development services help with scalability and optimize drug development?

By working with a collaborator to review your research, budget, and overall plans, you’re enabling an outside perspective that’s led by experience. You’ll be enabled to catch inefficiencies before they become a problem, future-proof your decisions, and plan for scale.

Process development isn’t just about getting ready for GMP. It’s about protecting the integrity of your molecule and your timeline.

Pre-Clinical

It’s exciting to see your data begin to take shape during pre-clinical research. It’s where proof of concept meets reality—and risk. You’re running toxicology studies, evaluating PK/PD, and monitoring for pieces that can make or break an Investigational New Drug (IND) submission.

What’s the secret behind a successful IND process and submission?

During the weeks leading up to IND submission, you should be able to feel confident: confidence in your data package, your comparability story, and your ability to defend it.

What matters is not simply executing the appropriate studies, it’s knowing how to interpret the results in the context of your next regulatory conversation. It’s understanding how the data could translate into human risk, and bridging the data to real life through a rigorous approval process.

Clinical Phases I–III

Once you’re in clinical trials, the stakes—and the spend—rise sharply. Every decision now carries downstream consequences, and you need to keep a close eye on funding and budget.

In Phase I, it’s about proving safety and learning about the effects of your drug. Phase II is about showing you can make a difference—enough to justify the next investment. By Phase III, it’s about execution at scale: operational precision, global coordination, and the ability to adapt when things inevitably change.

How can you benefit from a clinical trial management system?

For you, the pressure isn’t simply the scientific results. It’s financial, operational, and reputational. You’re managing investors, timelines, and, ultimately, human risk. We understand the constant tension between moving fast and getting it right.

A clinical trial management system or team can help with the operations of the trial—sourcing suppliers, identifying patients, and ensuring your design is carried out.

Commercialization

If you’re here, you’ve already beaten extraordinary odds. Now your journey truly unfolds.

Commercialization is where you transform from a development organization into a product company. It’s about consistency, reliability, and trust from regulators, payers, and, ultimately, patients in need of your discovery.

It’s also where long-term partnerships really matter. You’re building a sustainable business and starting to develop your brand in the market.

Every launch brings its own learning curve. The challenge isn’t just to deliver a new drug. It’s to maintain quality and supply under the scrutiny that comes with success.

Developing a new therapy or drug ready to go to market is as much a business strategy as it is about scientific research. When you have a partner who understands both, you’re able to move forward with more confidence and a higher chance of success.