Enablement Examples - Helping our Clients Reach their Goals

Any technology, regardless of its scientific innovation, is never realized until it can reach the market through licensure for sale. Holders of these valuable assets, whether large multinational companies, investors, biotech start-ups or inventors, encounter challenges to their development plan in various areas. Using its breadth of disciplines, Benchmark is able to assist our clients in addressing these challenges be they basic science, clinical science, regulatory, process development, manufacturing, or a myriad of other points at which development stalls.

Within the confidentiality afforded all clients, a sampling of the numerous accomplishments of Benchmark's enablement expertise include:

Opening a unique entrée into a $ 15 billion market with the world's first plant-derived vaccine license

Brought to Benchmark by Fortune 100 Company: Technology & IP for Vaccines made from Plant Transgenes.

Advantages: No animal origin components, breakdown of import export barriers-access to global markets, improved expression and stability of antigens (better vaccines)
Potential Market: Veterinary Vaccines- $3 billion, Human Vaccine market -$ 12 billion
Problem: Demonstration that technology would work and could be licensed by a regulatory body
Solution: Benchmark modified the technology to fit current regulatory.
Result: 3 new patents; Benchmark designed, constructed and currently operates on behalf of the client the world's first manufacturing establishment license for production of the world's first plant-derived vaccine license.

Unlocking and accelerating the development of technology and its value

Brought to Benchmark by an Australian public biotech company: Novel Vector Vaccine delivery platform

Advantages: Removes need of vaccine industry to rely on use of eggs to produce vaccine
Potential Markets: World Avian Influenza Market $3.7 billion and $3 billion veterinary vaccine.
Problem: Failed to have acceptable AIV challenge performed despite over 4 years and significant expense. Needed successful efficacy trial to support concept to potential licensees and for regulatory approval of the platform.
Solution: Benchmark has one of North America's only private Biosafety Level Three (BSL-3) facilities capable of conducting tests with Avian Influenza. Benchmark was able to successfully complete efficacy trial and present data within 10 months.
Result: Client has submitted its product and platform for regulatory approval. Accelerated and broadened licensing opportunities for the Client.

Finding the valuation path in the regulatory maze

Brought to Benchmark by start up Biotech- Novel technology to orally deliver bioactive compounds (vaccines, probiotics, immunostimulants, antibiotics and other bioactive agents)

Advantages: Oral delivery broadens the market size for all market segments. Reduces labor costs, targeted delivery, mass immunization (pandemic). Potential market $ 900 million
Problem: No existing guidelines for regulatory approval of an oral delivery platform. Company lacked expertise to design and manage facility. Company lost time and money trying to hire and manage the project internally.
Solution: Benchmark designed a program to demonstrate the features of the technology in a controlled environment while setting new standards for approval. The USDA approved the concept. Benchmark designed and built the facility on its campus that also includes vaccine production.
Result: Within 18 months of accepting the project the company obtained USDA approval of its facility and first commercial product.

Giving to a niche market player the competitive advantage to secure and expand a market

Multinational Nutrition Company wanted to enter the biologics market but lacked the expertise to test and license the technology.

Market potential: $250 million
Problem: Company lacked expertise and faced experienced competition in the field
Solution:Benchmark completed the development of the product and presented the regulatory filing on behalf of the client.
Result: Product was approved and has entered the market. Features developed by Benchmark afford this new product cost of goods and shelf life benefits over competitive products, The client broadened its product portfolio expanded its commercial success and obtained 3 new patents.

Lowering the clinical trial cost and increasing the claims footprint

Publicly traded biotech brought probiotic technology to Benchmark.

Market size: $ 2 billion
Problem: Company wanted to make medical claims differentiating it from its competition and lacked differentiating test capability for selection of the probiotic.
Solution: Benchmark led the effort to obtain on behalf of the client the first ever Investigative New Drug (IND) file in the space. Benchmark utilized its testing capabilities to identify the desired Probiotic then created a pilot scale manufacturing space for clinical trial material within our facility at substantial time and cost savings to the client.
Result: Company has entered Phase I clinical trials utilizing product produced under its direction in the pilot plant.

Assessing and differentiating available technologies presented for licensure and development

Multinational top-5 pharmaceutical company brought competing technologies to Benchmark.

Market size: $ 3.5 billion
Problem: Company sought to discern which technology among competing entities to pursue licensure and development.
Solution: Benchmark led the effort to conduct differentiating studies to determine which asset held the best opportunity for successful development and commercialization. Studies were conducted to provide clear answers in a timely fashion and without undue expense. Allowing the client to make an objective decision based upon definitive data.
Result: Company has gained data necessary to make informed decisions and advance desired assets into further development.