About Starter’s Gate BioQuant Advisory LLC
Clinical drug development is like a horse race.
You hope when your horse is at the starter’s gate that it is a winner, but most are not. Just like when you start in Phase 1. You hope your molecule will reach patients as quickly as possible; they need it. Yet, most are either not safe enough or efficacious enough to reach the finish line. Drug development is about finding a definitive reason to stop development or to continue with a better understanding of how to dose the medication. All of the actions in drug development require good decision making. Good decision making based on clinical data contains uncertainty thus it is based on analysis and probability. Rationally the drug development process consists of a series of studies that have each the best chance of making a clear decision. These studies should be executed and completed as quickly as possible for the patient needs good medicines. Thus, a contradiction, speed is paramount yet so are good decisions which are easier to make with more subjects. Brian Smith has spent the last 30 years helping Eli Lilly, Amgen, and Novartis navigate these contradictions in the sponsor risk portion (Phase 1, Phase 2, and Clinical pharmacology) to help them put together a clinical development plan, consisting of the most efficient and effective design for its clinical trials, which contain the most efficient and effective analyses. His experience is now available to you in order for you to navigate the many pitfalls that exist in the drug development process.
In thirty years, Brian has mentored many quantitative scientists on their career progression.
He believes that there are seven dimensions that a quantitative scientist must continue to improve or understand in order to develop. The most obvious is knowledge of quantitative sciences. There is also knowledge of why your employer is in business, knowledge of disease, knowledge of how a drug works, knowledge of the regulatory landscape, and knowledge of operations. The most important of the seven, however, is learning how to work with others. If you are a quantitative scientist that feels stuck or uncertain, whether about a technical issue or people issue, Brian can help. His years of experience and knowledge can help you understand the best way for you to be as good of a quantitative scientist as you can be.
In his career Brian has written over 30 manuscripts and delivered nearly 50 outside presentations.
Whether it is to a group of quantitative scientists or non-quantitative scientists, Brian looks to keep the audience engaged so that they get the points he is trying to deliver. He can help to train either non-quantitative or quantitative scientists on many issues. Let him help you with your needs.
Triple Crown Services
Quantitative Advisory for Clinical Plan and Study Design
Whether designing a clinical development plan, clinical trial, clinical pharmacology plan or study, Brian’s extensive knowledge and three decades of experience can help you develop a strategy that effectively addresses critical drug development questions.
Brian takes the time to understand your organization and molecule to tailor solutions that best fit your needs. He has experience in cardiovascular, metabolism, respiratory, ophthalmology, autoimmune, neuroscience, and infectious diseases; with additional expertise in oncology and musculoskeletal programs. His ability to learn quickly allows him to contribute value across a wide range of therapeutic areas.
Consulting Services Offered
✔ Strategic quantitative planning for early and clinical pharmacology development ✔ Clinical trial and clinical pharmacology study design
✔ Regulatory strategy and submissions (FDA, EMA)
✔ Interpretation for decision-making
Rates
💰 $300 per hour – Standard consulting rate
💰 $10,000 for a 40-hour block over 1 month – Discounted rate for long-term engagements
DMC Services
Although once rare, data monitoring committees have become more frequent in the early development space. Brian has served as the DMC statistician as an employee at Novartis and will do the same for you.
Rates
💰 $300 per hour – Standard consulting rate
Mentorship for Quantitative Scientists
Are you looking to accelerate your career as a quantitative scientist? With 30 years of industry experience, I offer a structured mentorship program designed to provide personalized guidance, industry insights, and strategic career development.
Who is this for
✔ Early-career professionals (<5 years of experience) looking to build foundational industry knowledge, improve technical skills, and navigate career growth.
✔ Mid-to-senior-level professionals (5+ years of experience) aiming for leadership roles, advanced problem-solving, and strategic decision-making in drug development.
Program Structure
6-month mentorship program (one session per month, 60 minutes each)
One-on-one virtual mentorship tailored to your specific needs
Personalized career and technical guidance based on real-world experience
Actionable strategies to enhance your impact in the pharmaceutical industry
Pricing
💰 $900 – For professionals with less than 5 years of industry experience ($150 per session)
💰 $1,500 – For professionals with 5+ years of industry experience ($250 per session)
Topics Covered
✅ Navigating the pharmaceutical industry as a statistician or clinical pharmacologist
✅ Best practices for designing and analyzing clinical trials
✅ Understanding regulatory expectations (FDA, EMA)
✅ Career progression, consulting, and leadership development
How to Get Started
1️⃣ Apply for mentorship – Send an inquiry to discuss your goals and determine fit.
2️⃣ Schedule your sessions – Flexible scheduling to fit your availability.
3️⃣ Gain insights and grow – Work with an experienced mentor to refine your skills and strategy.
Quantitative Training and Presentations
Brian is an experienced speaker who has delivered over 50 presentations at scientific conferences over the past 30 years. Whether speaking to a group of quantitative or non-quantitative scientists, Brian ensures his audience remains engaged and takes away key insights. He has been introduced as “the funniest statistician I have known” and has even been known to sing a bit if it helps demonstrate a point. His style is always engaging, sometimes controversial, but always thought-provoking.
Brian’s expertise allows him to effortlessly navigate complex mathematical explanations while also crafting relatable analogies for non-quantitative audiences. He is equally skilled at training both technical experts and non-technical professionals on a wide range of statistical and data-driven topics.
Speaking Engagement Fees
💰 New Talk (customized for your event)
1-hour keynote: $5,000
Half-day session (3–4 hours): $7,500+
Full-day workshop (6–8 hours): $10,000+
💰 Previously Given Talk (Minimal Customization)
1-hour keynote: $3,500–$4,500
💰 Previously Given Talk (No Changes, Just Delivery)
1-hour keynote: $3,000
Pricing may vary based on travel requirements and event size.
Past Talks and Courses - General Audience
Building Blocks of Biostatistics
A Primer on Clinical Trial Design
Sample Size Estimates in Clinical Trials
Bayesian Statistics
How Statistical Science Benefits Clinical Pharmacology
Adaptive Trial Designs
Dose Ranging Phase 2 Studies
Multiplicity in Clinical Trials
Issues in Trial Design of Pediatric Studies
Why Controlling for Covariates is Critical for Observational Research (with an explanation of propensity scoring)
Past Talks and Courses - Quantitative Audience
Clinical Trial Design
Decision Rules and Probability
Estimation and Endpoints
Impact of Choice of Endpoints
Bioequivalence Criteria Applied to Dose Proportionality
Exploratory Analysis
Nominal and Ordinal Data Analysis
Statistical Analysis of ECG Data
The Most Important Skills of a Quantitative Scientist
Three Ideas for More Quantitative Approach to Model Selection
Using Pilot Study Information to Help Size a Definitive Trial
About
Starter’s Gate
Thirty years: thirty years of quantitative drug development, thirty years of quantitative mentorship, thirty years of research and training. With that experience comes expertise and wisdom in the quantitative space. Whether you are a company that needs expertise and wisdom as you develop a molecule, a quantitative profession that needs expertise and wisdom as you develop your career, or you are a pharmaceutical leader that needs expertise and wisdom to develop your people, Starter’s Gate BioQuant Advisory can provide you with your needs.
