Destiny Biopharm Consulting 

Doug Williamson MD

Thirty years of CNS Clinical Development Strategy experience, from First in Human to Loss of Exclusivity

SERVICES

Development Strategies

I can help you design a development strategy which systematically de-risks your asset at each stage while providing a steady stream of potential value inflection opportunities.

Opportunity Assessments

I can help you assess market potential and identify development challenges for your portfolio, acquisition or partnership decisions.

Regulatory Pathways

Whether you need to demonstrate proof of concept as efficiently as possible, optimize registration study plans or expand and protect your market with phase IV data, I have the study design experience you need.

Trial Designs

Regulators are almost always willing to embrace innovation if it improves outcomes for patients. within an acceptable risk/benefit framework. Let me help you explore possibilities.

Experience spanning large and mid-size pharma, CRO, and biotech

Proven strategies at every stage of development

Target Engagement to Proof of Concept

Success at Proof of Concept has been shown* to be greatly improved if target engagement and consequent pharmacodynamic response has been validated. And Proof of Concept experiments which are focused on signal detection or validation, with a high threshold for success, yield more dependable results which enhance subsequent phase III success.

Launch is just the beginning of the product lifecycle

Your product’s lifecycle should evolve guided by a pro-active “evidence strategy” serving as the roadmap for the generation of new indications and line extensions, real world evidence, exploratory data and a steady stream of new publications which refresh and enhance its “scientific brand”.

*Morgan et al (2012); Can the flow of medicines be improved? Drug Discovery Today, 17(9-10), 419-424

Registration shouldn’t mean exploration

Phase III is often too late to be learning the fundamental efficacy, safety and dosing characteristics of your potential product. Registration studies should be largely confirmatory in nature, adding commercial, payer and real world characteristics to the story while also providing the key data required for marketing authorization. At the same time, innovative design can save time, reduce placebo response and enhance probability of success.

TESTIMONIALS

“Doug has broad and deep Pharma RD knowledge, spanning from early development to medical affairs. He has a very solid strategic and tactical view on what it takes to bring a drug forward throughout development to end of life cycle management. He has over the years obtained great experience into first in human studies, robust proof of concept studies, larger phase 3 trial as well as post marketing studies. He is astute in identifying what is the best pathway forward, with a keen eye to what brings most value and has the most feasible development plan in a portfolio of assets.”

— Johan L.

“Doug is one of the most thoughtful, connected, and motivating leaders I have seen in the pharmaceutical industry. He is both visionary and pragmatic, experienced and innovative. Confident, yet open to advice and counsel.”

— Shani H.

“Doug has a unique mix of strong R&D technical competencies, good understanding of the business, and excellent leadership.”

— Peter A.

“Doug understands what it takes to lead international teams through the drug development process. He is fluent in all phases of development and can strategically design solutions which are influential at an industry level.”

— Lori F

Free initial consultation