A private technology company was developing a device for low back pain.
The challenge was to design a study to prove efficacy with this device using a “placebo- controlled” design. Using our extensive experience in developing analgesia products, Danerius, LLC assisted in the design of a study which provided statistically significant evidence of the efficacy of the device. In addition, a presentation was developed to enable the company to raise funds utilizing these data.
Follow up: A registration application has been developed and filed with US Regulatory authorities.
A private, venture- backed company based in New York developing multiple prescription drug products for various metabolic/endocrine disorders.
Danerius, LLC was presented with multiple challenges from prioritizing compounds/indications for development to putting in place an economically responsible, as well as time-sensitive development plan for each project. All challenges were met with approval from the Board of Directors and projects being funded and implemented.
The top two projects achieved statistically significant results in Phase II clinical proof of concept studies in 2009.
A private, family- owned company focused on OTC ophthalmic products.
The challenge was to expand the business into prescription ophthalmic drugs. Given Danerius, LLC’s extensive Rx product development experience, as well as fund- raising capabilities, we were asked to develop a road map to include: develop the product portfolio (from internal and external sources), development plans and timelines, fund- raising possibilities (aka a Business plan) and introductions for fund raising.
All challenges were met. The Danerius, LLC Principal was asked to take a senior leadership role in the newly- formed company.
A publicly-traded biopharmaceutical company which focuses on acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet need. Through strategic alliances primarily with Japanese pharmaceutical companies, the company holds rights to a diversified portfolio of clinical and preclinical product candidates.
The challenge was to revitalize an ongoing pulmonary clinical development program. In a short time, changes for proper dose selection in an acute asthma exacerbation study were accomplished (interacting with key opinion leaders and FDA) and the study was reinitiated and is enrolling. A new COPD program was instituted with the first clinical study about to complete. Business development strategies were also developed and implemented.
A privately-held European company focused on a novel mechanism, topical treatment for several dermatologic conditions.
The Board of Directors requested an on-site audit of the ongoing clinical programs. Within weeks, an action plan was presented to the Board which re-focused the company’s clinical and regulatory strategies. Danerius also suggested revisions to ongoing clinical protocols all designed to accelerate receipt of data to facilitate continued funding of the company. The majority of recommendations were accepted and were implemented with a positive proof-of-concept outcome.