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Virtual Drug Development
Nonclinical Cardiovascular Issues

NuCo Development and Fundraising SupportNuCo Development and Fundraising Support
NuCo Development and Fundraising SupportClinical Micro-dosing Program


Client:  Venture-funded Biotechnology Company

The founding management team of a new biotechnology company had spent several years and several million dollars on building out infrastructure, offices, hiring an internal team and executing manufacturing and nonclinical studies at various vendors around the world. Despite the efforts and financial spend, the former team was not able to advance the program beyond the preclinical stage.  The investors hired a new CEO who retained Accellient Partners to evaluate the project, make corrections and redirect the program. 

Accellient Partners and the new management team assembled a cross-functional team of experts with deep strategic and operational expertise to define the gaps and to create a lean nonclinical, regulatory and clinical development plan for the lead compound. The program was redirected from subcutaneous to intravenous infusion and additional manufacturing and nonclinical work was completed at Accellient recommended providers. Importantly, an IND was filed and activated by FDA in only seven months.    

The company changed its route of delivery to one that is more compatible with an acute indication and advanced its program to the clinic in seven months under Accellient’s strategic and operational leadership. In addition, by leveraging Accellient’s comprehensive network of vendors and by focusing studies only on those that were essential to move the client’s program forward, Accellient was able to generate nearly $500K in vendor cost savings for the company.


Client:   Established Biotechnology Company

The toxicology CRO, retained by a biotechnology company, reported that the lead drug candidate caused atrial myocardial toxicity. Epicardial lesions were reported and confirmed as drug-related lesions by the vendor and other consultants. The company put the project  on hold and was at a standstill for many months.

Accellient Partners was recommended for its expertise in cardiovascular toxicology and retained to investigate the problem. Accellient performed an extensive histological review of the lesions and confirmed that they were common auricular epicardial lesions seen in untreated laboratory beagles. Accellient provided appropriate references to resolve  the issue and the CRO reports were revised.

Accellient’s leadership and expertise in cardiovascular disease and cardiovascular pharmacology and toxicology enabled the proper interpretation of the data and the company was able to proceed to an IND submission without further delay. 


Client:  Inventor with a Stranded Repurposing Project

Accellient Partners was contacted by an inventor with a repurposing project. The inventor had developed a sound medical use patent estate, but it was rapidly approaching the end of its protected life. Although the inventor had anecdotal, but nevertheless very convincing evidence that patients with a movement disorder (Tardive Dyskinesia) had substantial benefit from off-label use of an approved medicine, he had been unable to obtain significant financing and new intellectual property. The compound has high solubility and low permeability and was in desperate need of a new formulation to improve bioavailability. 

Accellient reviewed the compelling evidence of activity in Tardive Dyskinesia and worked closely with the inventor to develop business and product development plans. In parallel with those efforts, Accellient identified a new technology to resolve the bioavailability issues and to create new intellectual property. The performance of the new formulation was confirmed in a nonclinical study and Accellient and the inventor worked closely together to redefine this program to raise funds and start a new company.

As a result of Accellient Partners’ expertise and network, Accellient was able identify a new formulation partner, create new intellectual property, form a new company and raise $6M of venture financing to help fund the company through Phase 2 POC. Accellient’s staff is functioning as the COO, CFO and full virtual development partner to launch this new company.  


Client: Top 5 UK Pharmaceutical Company

The company initiated a prodrug program to protect the assets of a top-selling product franchise. Accellient Partners was contacted to evaluate the preclinical data and to develop a traditional IND enabling program to generate phase 1 safety/PK data for a lead candidate. Accellient reviewed the client’s prodrug strategies and data and concluded that PK in animal models was unlikely to be predictive of outcomes in humans and selection of a drug development candidate would be  a challenging task for this project.

Accellient recommended an exploratory IND (micro-dosing) approach to evaluate several candidates in a phase 0 study. We quickly engaged with the project team and defined the assay sensitivity requirement for the phase 0 study through PK modeling. A specific and ultrasensitive LC-MS/MS assay (LLOQ at 3pg/mL) was developed and validated by Accellient. A limited GLP toxicology program was developed and executed and the exploratory IND was filed in 4.5 months. Human PK data was generated 2 months after the exploratory IND filing.

Accellient’s leadership and expertise in bioanalytical and pharmacokinetics has enabled the company to establish a micro-dosing protocol instead of launching a full IND program to evaluate prodrug candidates. In addition, the company was able to monitor the prodrug hydrolysis pathway in humans and validate the working mechanism of metabolism.



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