The Lean Start-Up: Commercialize or Capsize
Many technology start-ups risk their futures by seriously underestimating the time and effort required to vet external service suppliers. A company's intellectual property advantages are useless if it cannot find the right resources for timely commercialization.
And in this unforgiving market environment, cost effective, rapid commercialization is as essential as a quality concept. Who is better positioned than an experienced, highly successful contract services project manager to facilitate faster commercialization?
An experienced project manager is invaluable in the commercialization process and brings proprietary industry knowledge and well-established relationships throughout the entire supply chain. The project manager recommends capability and capacity options based upon his knowledge of their scientific and engineering competencies, track record, niche technologies, business culture, manufacturing capacity and scalability.
Lean science-based start-ups typically require vetted support services in the following areas:
- preclinical discovery
- scale up
- sourcing of raw materials
- custom synthesis of active molecules
- coordinating pilot or full-scale production activities
- project management
- IND enabling activities in the life sciences sphere, on-time delivery of GMP clinical and commercial supply
VC investment has become incredibly selective. In 2012 only about 80 early stage biotech companies were funded. Leaner and less capital intensive start-ups are more likely to be funded. An illustrative example is a university-incubated start-up that needed to move quickly from the research to scale up stages.
The following two case histories are representative of the challenges that a start-up may face and how an experienced project manager such as Richman Chemical (RCI) can effectively help the start-up to meet these challenges.
Getting an IND Submission Back on the Fast Track
A VC-funded biotech start-up was facing the pressure of a make or break deadline for keeping the firm afloat. The company had submitted an Investigational New Drug (IND) in the women's health market to the FDA, but the IND application was rejected because of insufficient data, inadequate reporting and insufficient cGMP reference standards. Time was critical because the VC firm was threatening to stop funding if the IND application was not approved within six weeks. The VC partner contacted Richman Chemical for help in finding a proficient and comprehensive outsourcing solution.
How did Richman Chemical do it?
We provided all of the services required to successfully resubmit the IND application in six weeks. This included:
- An audit of the technical package submitted to the FDA and identification of problematic data and compliance issues
- Recommendation and management of the implementation of a solution that included the full utilization of USP-grade raw materials
- Identification of all major and minor impurity profiles
- Direction of preparation of clinical trial batches alongside reference standards and validation
- Production of GMP-grade material to serve as a reference standard
- Directed additional tests for the end formulation concurrent with stability testing of the active compound
- Preparation of the drug substance through a complex 12-step synthesis,
- Formulation of the material for optimal efficacy, and
- Packaging the material in the most appropriate format (spray), to assure dosing guidelines would be met
The result was a successful FDA review, a grant of Fast Track status, and additional funding for the biotech start-up.
Consolidation of Raw Material Sourcing Saves Time and Money
The Technology Transfer Office (TTO) of a major East Coast University was working with three start-up biotechs in its chemistry and pharmacology departments. Each of the three was developing a unique product (medical devices and drug product), but all were based on the same chemical platform.
While there was general knowledge amongst the three start-ups that their chemistry was similar, there was no realization that the core preparative chemistry was identical. RCI worked with each of the three to share the sourcing and preparation of the common chemical starting point We developed a plan that allowed each start-up to benefit from the combined chemistry at an efficient scale and time.
Richman Chemical approach saved each start up thousands of dollars in development costs, optimizing their limited equity dollars. One of the companies is now successfully completing first-in-man studies on its medical device, and another is in Phase 1a clinical evaluations.
Richman Chemical was founded in 1987 and pioneered the independent outsourcing model. It is the only company in the market that provides its services throughout many markets including biotech, pharmaceutical and medical devices, specialty chemicals, nanotechnology, food and beverage, and flavor and fragrance.
Christopher Kulp serves as Vice President, Contract Services Business, at Richman Chemical.
Representative services outsourced to Richman Chemical:
- New life science product development and commercialization (cGMP)- Drug Substance (API), Drug Products, Medical Device Excipients
- Personal care and cosmetic ingredient development and production
- Specialty polymer and organic compound development and production in the high-value coatings industry and other chemical markets
- Key ingredient production for formulations utilized by market leaders within the food and beverage industry
- Toll distillation, separation, and on-going solvent recycling