When I reflect on what I’ve learned in my career in drug development and the multitude of hurdles that need to be overcome to get a drug to market, I’m consistently in awe any make it. A ground-breaking innovation on its own is not enough. You need to fund its development (and a talented team to raise appropriate financing), and another talented team with a myriad of skills to develop it.
Even with the best teams doing the best science, data might not go your way. This is even before any macro trends are considered: portfolio reviews and policy shifts can blindside the development of even the most promising medicines.
For this reason, I celebrate every drug that gets to market. It’s a huge accomplishment; a culmination of years of hard work, determination, innovation and fundamentally exquisite risk management by hundreds of people across multiple disciplines… and let’s face it, a decent dose of luck. But I’m a firm believer you make your own luck.
With this in mind as we move into Q2, how are we—as an industry—navigating these hurdles?
Innovation in action—from the clinic to manufacturing
As a scientist, I’ll start with celebrating innovation, and a groundbreaking product that navigated many obstacles: Phase 3 results announced recently by Revolution Medicines on their RAS(ON) inhibitor, Daraxonrasib, for pancreatic cancer (1). If you’ve not heard about this, it’s an unprecedented breakthrough for one of the toughest forms of cancer to treat. Phase 3 results showed doubled overall survival to over a year in previously treated metastatic pancreatic cancer versus chemotherapy. This will have an incredibly meaningful impact to patients and their families, and has been described by many as “practice changing”–an ambition of mine I expect many of you reading this also share. A huge congratulations to the Revolution team on what will undoubtedly be in the running for drug of the year.
Continuing on innovation, the Eli Lilly manufacturing team used AI to ramp up production of their GLP-1 analogues Zepbound® and Mounjaro® (2). It’s not often innovation in CMC activities is even considered to be mentioned in the press, and whilst the AI angle undoubtedly had a role here, kudos to them as I think it raises the profile of some of the unsung heroes of drug development and highlighted how innovative and impactful pharmaceutical science and engineering can be.
Financing returns while regulatory focuses on flexibility
On biotech financing, it’s pleasing to see improvements versus where we have been, although much of the funding is still going to later stage assets with clinical data. The Nasdaq Biotechnology Index (NBI) is up 62% over the last 12 months and biotech IPOs are at a 53 month high, with year to date IPO financing already exceeding that raised in the whole of 2025. After recent years of ups and downs, deals have again accelerated with over $40 billion in biopharma M&A and more than $80 billion in licensing value secured in Q1 2026 (6-7).
Assets attracting attention share similar characteristics: reducing risk through predictable regulatory pathways and the potential to deliver meaningful data quickly. Little room is left for errors and delays in development, considering pharma companies will face the steepest phase of the current patent cliff over the coming years. More than $170 billion in annual revenue is at risk as major products such as Eliquis® (BMS), Keytruda® (Merck), and Ozempic® (Novo Nordisk) will lose exclusivity (5).
This shift is being reinforced by global regulatory changes. In the US, FDA actions finalized in early 2026 clarified greater flexibility around single pivotal studies supported by pharmacokinetic, mechanistic, and extrapolative evidence, particularly for well characterized compounds (3). Additionally, the reauthorization of the Rare Pediatric Disease Priority Review Voucher program reinforces incentives for sponsors to address unmet needs in younger populations (4).
The UK MHRA has adopted parallel thinking, implementing reforms earlier this year to reintroduce a 14-day initial assessment timeline for Phase I trials (5). This comes after years of extended review timelines, a welcomed milestone that will again make the UK one of the fastest places in the world to conduct early clinical programs.
Reformulations are re-energizing pipelines
Reformulations and line extensions, once viewed as incremental, are now central to sustaining pipelines and accelerating patient impact. This includes strategies such as adapting modified release profiles and dose, adding delivery routes, and earlier consideration for pediatric appropriate formulations to extend the utility of established molecules or broaden patient access across therapeutic areas.
The metabolic field offers a timely illustration: In January, the FDA approved oral Wegovy® (semaglutide 25 mg; Novo Nordisk) for chronic weight management, delivering weight loss efficacy approaching that of injectable GLP 1 therapies, and uptake of the oral form has exceeded expectations (6). Even more recently, the announced retirement of the Rybelsus® brand in favor of marketing the Ozempic® brand exclusively in the U.S. underscores the continued shift of how obesity treatment may be accessed, as oral options expand to patients previously hesitant to use injections (7).
Building drug development for speed and adaptability
Across these examples, it is increasingly evident that drug development must be built for speed and adaptability. Traditional handoffs between formulation development and clinical evaluation, with separate CROs and CDMOs executing these tasks and related vendor management complications that may come as a result, are increasingly mismatched to today’s demands. For many years, Quotient Sciences have discussed the advantages of bringing diverse disciplines together earlier, knowing that the faster we can enable therapies to be understood directly in humans, rather than relying on data from preclinical models, the better.
As such, Translational Pharmaceutics® is purpose-built for this exact moment, supporting faster learning and decision making from emerging clinical data that helps reduce late stage uncertainty while aligning with expectations of regulators. For scientists and clinicians, the integration of services enables decisions that are grounded in data, not assumption. For leaders, integration offers a disciplined way to mitigate risk and prove results that justify further investment.
Ultimately, the ability to rapidly adapt and integrate expertise to drive innovation will determine which therapies reach patients first, and which organizations emerge as leaders in an increasingly competitive landscape.
References
RAS inhibitor daraxonrasib demonstrates initial anti-tumor activity in pancreatic cancer | UT MD Anderson
How Lilly Used AI To Crank Up Production Of Its Popular GLP-1s
FDA actions reshaping drug development in 2026 – Applied Clinical Trials
https://www.appliedclinicaltrialsonline.com/view/fda-actions-reshaping-drug-development-2026
Consolidated Appropriations Act 2026 and FDA reforms – National Law Review
https://natlawreview.com/article/new-fda-drug-reforms-congress-extends-voucher-incentive-clarifies-orphan
Patients to benefit sooner as UK boosts clinical trials attractiveness with faster assessments and agile regulation - GOV.UK
Biotech IPOs stayed at slow pace, but grew larger in the first quarter of 2026 | BioPharma Dive
Q1 2026 Biopharma Licensing and Venture Report – J.P. Morgan
https://www.jpmorgan.com/content/dam/jpmorgan/documents/cb/insights/outlook/jpm-biopharma-deck-q1-2026.pdf
Big Pharma pipeline pressure and patent cliffs – CNBC, January 2026
https://www.cnbc.com/2026/01/07/big-pharma-race-to-snap-up-biotech-assets-as-170-billion-patent-cliff-looms.html
FDA approval and implications of oral Wegovy – Epocrates; CNBC
https://www.epocrates.com/online/article/fda-approves-oral-wegovy-pill-for-weight-loss
https://www.cnbc.com/2026/01/10/2026-is-the-year-of-obesity-pills-from-novo-nordisk-eli-lilly-.html
Novo Nordisk’s Rybelsus officially retired in US as ‘Ozempic pill’ takes branding center stage | Fierce Pharma
The trademarks referenced above are property of their respective owners: Eliquis® is a trademark of Bristol-Meyers Squibb; Keytruda® is a trademark of Merck; Wegovy®, Rybelsus® and Ozempic® are trademarks of Novo Nordisk; Zepbound® and Mounjaro® are trademarks of Eli Lilly and Company.
Translational Pharmaceutics® is a trademark of Quotient Sciences.
