Virtual Management of a Pre-Clinical start-up Therapeutics Company

Issue B4D Approach Client Benefit
Company with some preclinical data needed to raise money and take a patented product, licensed in from another small therapeutics company through to the stage when it could be successfully out licensed. B4D wrote a business plan containing a unique strategic element in the clinical development plan. This element provided the early proof-of –concept VC’s find attractive. Key to this was the B4D insight that a certain surrogate endpoint in healthy volunteers could be used to prove the concept for a different indication in the target patient population. The company raised approx. $10 million through nondilutive and VC finding and advanced the lead compound from the preclinical stage to clinical proof-of-concept. B4D managed the company for 4 years.
 

Drug Development Team for Preclinical Oncology Company

Issue B4D Approach Client Benefit
Company with two employees needed “gap-filling” virtual drug development team to assist in developing and implementing a preclinical proof-of concept plan for their lead candidate. B4D used its combined expertise to pull together the preclinical and clinical and regulatory strategy up to Phase II. The work included managing the early research and development conducted at various CROs including API manufacturers, formulation companies and preclinical oncology CROs. B4D also assisted in contract negotiations, due diligence preparatory work and preparing time and cost estimates and target product profiles. Company has closed ongoing financing and has collaborations in place with manufacturing and formulation companies capable of supplying clinical grade material. Several viable novel formulations with potential to progress into the clinic are being studied at preclinical CROs with specific expertise in oncology. Leading clinical oncology experts have expressed interested in the clinical development plan and target product profile.
 

Regulatory Advice for a Start-up Device Company

Issue B4D Approach Client Benefit
Canadian company needed to understand US regulations and how best to proceed with testing. B4D explained device classification and predicate selection as well as animal/bench testing needed for 510(k) approval. B4D then reviewed the client’s data and advised on next steps. Company concluded negotiations with a US based company to acquire the asset. The acquiring company has now completed the studies B4D recommended which are needed to gain approval in the US.
 

Due Diligence on a Potential Product for Investment for a VC

Issue B4D Approach Client Benefit
A VC company with little experience in the pharma/biotech area had a Term Sheet with a researcher to invest in a promising therapeutic. The VC engaged B4D to assist with due diligence and the development and implementation of the clinical development plan. Following a review of the available data, the B4D team mapped out an orderly due diligence program beginning with an IP review. Project was terminated following the IP review upon recommendations made by B4D to VC client. This saved the client millions of dollars as the project was deemed not commercially viable based on the IP situation.