Phastar recently welcomed Billy Amzal as Head of Strategic Consulting. A statistician, public health scientist, and entrepreneur, Billy brings more than 25 years of experience across the biotech and pharmaceutical industries, health agencies, and consulting.
His expertise lies in innovative, regulatory-grade statistical methodologies including adaptive trial designs, model-based meta-analysis, Bayesian approaches, and predictive modeling using real-world data (RWD). We spoke with Billy about the opportunities ahead for clinical trial design, the rise of AI, and how biotech companies can rethink their development strategies for maximum success.
Q1: What are the biggest opportunities in strategic consulting today?
There is growing demand for early and smart evidence planning. That means designing development strategies where statistical rigor meets practical relevance, anticipating what regulators, payers, and patients will need years before submission.
The most value is delivered when we help clients navigate uncertainty, for example in the case of rare diseases with limited precedent, new mechanisms of action with uncertain comparators, or complex global submissions. Strategic consulting helps bridge the gap between clinical ambition and regulatory reality, especially when integrated with strong biometrics execution.
Q2: How do you see AI and novel methods transforming clinical development?
AI has advanced rapidly and is being adopted faster than many previous innovative methodologies. While there is still a journey ahead before we reach fully regulatory-grade AI, the progress is impressive.
There are three main areas where AI is already making an impact:
Automation: Tasks like quality control, documentation, site selection, breach detection, literature review, and safety reporting can all benefit from AI-driven tools.
Exploration: Machine learning is being used to uncover patterns in disease progression, drug response, and patient subgroups.
Prediction: This is the most promising area, though still underused. AI can support projections from short to long-term outcomes, simulate patient journeys, and extrapolate across populations. To be reliable, these methods require high-quality input data and robust validation.
Q3: What are the top three trends the industry should watch for regulatory and HTA success?
Earlier and better integrated use of RWD
The quality and accessibility of RWD has improved significantly. RWD can now support regulatory-grade use cases such as optimizing endpoints and target populations, long-term benefit-risk modeling, or using external control arms. But drug developers must start early, building both access and strategic capabilities to generate the right evidence.
Ensuring generalizability and transportability of trial results
Regulatory agencies are recognizing that trial results do not always translate across geographies or subgroups. There is growing guidance and use of tools like Bayesian borrowing to adjust or supplement trial data for different regions.
Novel data augmentation and simulation methods
Whether through Bayesian models, synthetic patients, or simulation, new methodologies are helping to complement trial data. The intersection of unmet needs, regulatory acceptability, and technological capability is expanding quickly, creating an important opportunity for the industry to modernize trial strategies.
Q4: What’s one piece of advice would you give to emerging biotechs?
Don’t be afraid to innovate or think differently. Following standard development pathways may feel safe, but they can be suboptimal, especially for biotechs working on first-in-class compounds or orphan indications.
Being thoughtful about trial design, endpoints, and evidence strategy early on can make all the difference. Innovation with the right scientific foundation is more likely to succeed than simply copying precedent.
Q5: Why is Phastar well positioned to help address these challenges?
Phastar combines deep statistical and data science expertise with the flexibility and responsiveness that biotech and pharma companies need. We offer clients both strategic guidance and hands-on implementation, which is a rare combination.
We also have a strong foundation in regulatory-grade innovation — not just promising concepts, but validated, accepted methodologies. That’s what sponsors need today: partners who can challenge assumptions while staying grounded in what will work in practice.
At Phastar, our strategic consulting team brings deep scientific expertise and real-world experience to help sponsors navigate complex development challenges with confidence.
