Introduction

For much of the past two decades, pharmaceutical innovation has been framed around the molecule. Discovery has led the narrative. Delivery has followed. That distinction is beginning to blur.

After nearly four decades in pharmaceutical development across multiple leading organizations, Rosaleen McLaughlin, Chief of the Scientific Advisory Board at InstaPill,  has seen this shift firsthand. Her view is measured, but clear.

“The drug molecule itself obviously brings about the therapeutic effect,” she says. “But the formulation is really critical in influencing the delivery and the effectiveness of that therapeutic.” 

It reflects how products succeed or fail beyond controlled environments.

1. Where translation, not discovery, becomes the constraint

In early development, formulation is often positioned as a downstream function. The assumption is that once the molecule is established, delivery can be optimized around it.

In practice, this separation rarely holds.

Formulation can influence how a drug is absorbed, how consistently it performs, and whether it can be manufactured at scale. It also shapes whether patients will use it as intended.

McLaughlin points to a recurring issue. “Quite often people develop very complex solutions that aren’t then translatable,” she says. “You’ve got to keep the end goal in mind and not let it become an academic exercise.” 

That end goal extends beyond clinical efficacy. It includes manufacturability, scalability, and real-world usability.

2. A shift from convenience to consequence

Oral drug delivery provides a useful example of how this thinking is evolving. Orally disintegrating tablets have traditionally been positioned as a convenience format. That characterization is becoming insufficient.

“The great thing about the ODT platform is that it’s not just about convenience,” McLaughlin notes. “It can drive patient compliance.” 

Compliance is often treated as a secondary outcome. In reality, it has a direct impact on clinical effectiveness and healthcare utilization. In certain therapeutic areas, the implications are more immediate.

“In antipsychotics, patients are known to ‘cheek’ their medication,” she explains. “They hold it in the mouth and remove it afterward. With an ODT, that’s not possible.” 

The intervention is formulation-led, and the impact is behavioral.

3. From support function to performance driver

The role of delivery is also expanding in how therapies are performed.

“With particular ODT platforms, sublingual and buccal delivery is achievable,” McLaughlin says. “That can improve bioavailability, acoid first pass metabolism and also give a faster onset of action compared to the gastrointestinal route.” 

This moves formulation beyond enabling access to the drug. In certain cases, it enhances the therapeutic outcome itself. As a result, delivery platforms are increasingly being evaluated not only for usability but also for their ability to influence pharmacokinetics and clinical response.

4. Scalability as the defining filter

Across McLaughlin’s experience, one principle remains consistent. “Scalability is the key.” 

Scientific validity alone is insufficient. The formulation and process must translate across development stages and into commercial manufacturing. This requires a detailed understanding of both the product and the process, along with clarity on their respective constraints. It also requires that a formulation strategy be established early.

“You need a really good understanding of the biopharmaceutical profile you want to achieve, and a mechanistic understanding of what you want to achieve  before you even start.”

As delivery systems become more sophisticated, expectations from CDMOs have shifted accordingly.

“I think very high on people’s list is quality and regulatory compliance,” McLaughlin says. “And then the proven ability to consistently deliver on time, and provide value for money.” 

What follows is execution. The ability to consistently deliver a well-characterized product through a robust and reproducible process. Manufacturing models are also evolving, particularly through automation and digital integration.

“Automation can drive GMP compliance, process efficiency, and quality by eliminating human error,” McLaughlin notes. 

Digitization enables greater visibility and control across production, from electronic batch records to real-time process monitoring. Artificial intelligence remains in an early stage of adoption, but its trajectory is clear.

“We’re only at the start of how AI can help,” she says. “But it will allow quicker and more informed, data-driven decisions.” 

5. Keeping pace with changing therapeutics

The nature of drug development itself is shifting, particularly with the growth of biologics and more complex molecular structures.

“The landscape of therapeutic molecules is changing all the time,” McLaughlin observes. “The challenge is how drug delivery evolves to meet that.” 

This includes expanding the scope of oral delivery systems and exploring their applicability across a wider range of therapeutic categories.

In Summary

The industry continues to invest heavily in discovery. That will not change. What is changing is where value is created. It is no longer sufficient to develop a molecule that works. It must be delivered in a way that is reliable, scalable, and aligned with how patients actually use it.

In that context, formulation is not a downstream activity. It is where much of the outcome is decided.

Key Takeaways

● Pharma innovation is expanding beyond discovery. The molecule defines potential, but delivery determines how consistently that potential is realized in real-world settings.

● Formulation is central to outcomes, not a downstream step. It directly influences absorption, patient use, manufacturability, and scalability. 

● Patient behavior is a critical but under-addressed variable. Non-adherence, swallowing difficulty, and misuse continue to impact therapeutic effectiveness. 

● Drug delivery platforms are evolving into performance drivers. Approaches such as ODTs, like those provided by InstaPill,  are moving beyond convenience to influence bioavailability and onset of action. 

● Scalability remains the defining filter for success. Strong science alone is insufficient; products must translate reliably across development, manufacturing, and patient use.