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a biotech strategy and development consultancy
  • 15 Years of Experience as a Biotech CEO
  • 37 Years of Experience in the Pharma/Biotech Industry
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Biotech Strategy Consulting for CEOs & Companies

Partner with Evexia Research LLC, a biotech strategy consulting firm that focuses on biotech companies' needs for strategy and new product development advice. Typical clients are C-suite personnel at biotech start-ups grappling with fundraising issues or new product development. Evexia provides real-world advice based on 15 years of experience as a biotech CEO and 37 years in pharma/biotech.
During our time in the industry, we have been involved with several new product launches, two successful NDAs, and a number of early-phase projects moving from research into preclinical development and later into human stage. Evexia personnel have been involved in ADHD, antiarrhythmics, anticoagulation, depression, obesity, pain, and substance use disorders.
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Contact us now if you’re a first-time CEO learning the process of leading biotech product development, or a venture capitalist seeking counsel for your portfolio companies. And to learn more about our experience in the field, download the following resume:
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EVEXIA RESEARCH INC FREQUENTLY ASKED QUESTIONS

If you are a biotech CEO or other C-suite member or an investor interested in biotech, you may have questions on the topics below. You may have other questions as well. Note, these topics are not exhaustive but are typical matters I have encountered over 15 years as a biotech CEO and over 35 years in pharma/biotech. I can be available to consult with you on these and other topics.
New Product Development Questions
How to determine the indication for your product candidate?
It depends on the pharmacology and the potential disorder. Use a validated animal model to test the hypothesis. I can provide guidance on selection of preclinical CROs
Is Orphan Designation a possibility? How to prepare an Orphan dossier
When to incorporate market research? When can questions be answered by secondary market research vs. primary market research?
Market research may be used to validate a product forecast or evaluate a product profile. One can also use market research to evaluate potential product positioning. Assessments here are critical for the forecasts, e.g, pricing, estimated market share, launch curve, etc. Secondary research can be a cost-effective way to monitor/evaluate a potential market. Use primary market research to validate your key product candidate assumptions
How to create a financial model to assess the potential value of a development program
There are numerous ways to do this, either internally or with use of an outside advisory firm. For an example, see the following paper and accompanying Excel model from Nature Biotechnology: Stewart, J., Allison, P. & Johnson, R. Putting a price on biotechnology. Nat Biotechnol 19, 813–817 (2001). https://doi.org/10.1038/nbt0901-813. The model is complex but I have worked with the model for years so can provide guidance
Intellectual Property
What are steps after the initial Invention Disclosure Form (IDF)
Using your IDF, your patent attorney will file a provisional patent application which defines your earliest filing date. This will be followed by a Patent Cooperation Treaty (PCT) filing for overseas territories. Later your filing will mature into a series of full prosecutions by country
Form (What countries to include in the dossier? What should be your criteria in the selection?)
One generally considers the US, western Europe, Japan, and China as major markets. Additional potential territories are Brazil and India because these are large countries but also because each have strong generics industries. In order to fight generics you should have a valid patent in place in the territory
Clinical Questions
Optimizing your clinical program
A first step should be to meet with FDA in a pre-Investigational New Drug Application (IND) meeting. See FDA.gov. In the event FDA will not grant a meeting, there are experienced regulatory consultants in lieu of the pre-IND meeting. I can offer direction on advisors
How to work with your principal investigator (PIHow to work with your principal investigator (PI) and Key Opinion Leaders (KOLs)and Key Opinion Leaders (KOLs)
You will have a PI who will work with you and your Chief Medical Officer (CMO) to develop a protocol for use with sites, regulators and Institutional Review Boards (IRBs). Later the PI may work with you and KOLs to prepare manuscripts for publication. Your PI and KOLs can be important advocates for your product(s) so a good relationship is important
Should you use normal subjects, or can you go directly to patients, i.e., a phase 1/2a trial?
Generally, FDA will require normal healthy subjects for your phase 1 study, however, FDA may allow you to utilize patients in the target indication for initial safety studies. This especially applies to rare diseases or programs in disorders that could receive accelerated review. This is an excellent point to raise in a pre-IND meeting
Preclinical Questions
How to determine how much toxicology to initiate human studies?
The pre-IND meeting with FDA is the best source. If you are envisioning chronic use you should plan on 6- and 12-month rat and dog toxicology studies as well as 24-month rat carcinogenicity studies. This is only a fraction of what is required. Note: preclinical toxicology requires detailed advice from an expert. I can provide direction to good advisors
How to select a preclinical CRO?
In vivo pharmacology/toxicology studies are conducted by dedicated preclinical CROs. I have experience with Porsolt, PsychoGenics, and Charles River Labs (among others)
Chemistry, Manufacturing, and Control (CMC) Questions
How to select the contract development and manufacturing organization (CDMO)?
It is known that biotech companies tend to underestimate the complexity of CMC. Depending on the technology, e.g., large molecule vs. small molecule and development stage, there are many potential CDMOs. I can direct you to expert advisors
Business Development Questions
What is your goal, IPO vs. M & A?
Exiting via an initial public offering (IPO) or merger and acquisition (M & A) are the typical exits sought by biotechs. If the IPO market is not optimal then M & A is often the typical exit today. There are countless considerations when considering M & A: global vs. M & A, retention of US rights and licensing rest of world (ROW), etc. This is another area where dedicated expert advice is needed. I could make introductions
How to prepare for pharma due diligence
Develop a secure file sharing system. Citrix ShareFile is an example system. A successful file sharing system requires a great deal of forethought and outside guidance can be helpful
When is the historical optimum time to exit?
With phase 2 data, ideally upon completion of the End of Phase 2 (EOP2) meeting.