What We Do

Asten BioPharma Advisors provides the know-how to enable effective decision making

We evaluate the strengths and weaknesses of candidate therapeutic compounds, as well as the markets in which these compounds will compete.  Our recommendations derive from a complete analysis of relevant information, including: extensive assessment of clinical and preclinical trial data; interviews with key opinion leaders, company executives and scientists; primary literature assessment and analysis of interactions with regulatory authorities.

Services Include:

Opportunity Assessment

At Asten, we offer assistance in assessing the value of biopharmaceuticals products and candidates, enabling you to prioritize licensing/partnering opportunities and internal pipelines. Asten can help you determine the potential commercial value and probability of success of a product or candidate. 

Analyses that we provide, essential to these decisions, include:

·         Current and projected size and value of target markets

·         Unmet needs within the target markets

·         Analysis of the products competing in the target market as well as those in the clinical development pipeline and under regulatory review

·         The revenue potential of the target compound(s) within the competitive landscape, based on projected label and probability of technical/clinical success

·         Assessment of potential for success based on regulatory path/environment

·         Partner/Licensee screens to identify optimal collaborators

·         New indication strategies to maximize the value of existing assets/IP

Product Diligence

We draw upon over two decades of combined experience to vet the risks and merits of specific candidate products before you pull the trigger on a deal or development investment.  

Our deep-dive diligence helps identify potential stumbling blocks before they happen, maximizing the probability of regulatory and clinical success of existing projects and allowing our clients to avoid costly delays or unsound investment decisions.

Areas of analysis include:

·         Relative safety and efficacy profile

·         Novelty and utility of mechanism of action

·         Strength of pharmacology

·         Clinical development strategy

·         FDA filings/communications

·         Impact of projected label on scope of clinical use

·         Potential off-label use

Our unique process provides insights not often found in routine diligence, crucial for the ultimate success of development programs

·         Scrubbing of preclinical program with an eye for good scientific practices historically accepted by the FDA

·         Review of FDA correspondence and triangulation with current clinical development plan

·         Vetting the alignment of the development plan with anticipated product label

·         Review of clinical development plan to maximize the probability of success for the program, not just to achieve the next milestone