There’s more to Wyoming than this.
In Part Two of this series, Dr. Lindemann highlights some of the life science companies which are already operating in Wyoming.
The concept of a state or region leveraging its strengths is critical if it wishes to grow and develop its own life science cluster. And Wyoming appears to be leveraging its strengths in biocomputing, bioinformatics, and other areas highlighted by Dr. Lindemann.
Life Science Industry Niches for Wyoming
The typical life science company requires long time frames for product development and large amounts of capital before becoming profitable. For example, pharmaceutical development of a new therapeutic drug, from start to finish, requires an average of 13 years and between $1.8 billion to $5 billion dollars or more.
FDA approval of therapeutic molecules has very low rates of success that have not dramatically changed since the 1970’s.
Many experts are predicting dramatic changes to the life science industry; changes driven by the new structure of healthcare, loss of revenue due to expiration of patents, the increasing expense of developing and launching new drugs or devices, expense of research and development and lack of efficiency as well as concerns about the integrity and transparency of product development.
One trend on the upswing is the outsourcing of product research, development and manufacturing.
Companies whose business models are to perform research and develop on contract and perform outsourced life science work belong to one of the groups known as Contract Research Organizations (CROs) or Contract Manufacturing Organizations (CMOs).
These companies offer a range of services from general to specialized covering, all steps and stages of therapeutic drug, medical device, and life science product development.
Outsourced development and manufacturing manages costs and timelines as well as compensating for limited or non-existing resources, expertise, and skills of the client company.
Large life science companies of the future may more closely resemble the virtual start-up life science companies of today, devolving into virtual or near virtual minimalistic companies; a significant change from the brick and mortar all-inclusive large vertically integrated companies currently in existence.
Coupling the expectation of virtual life science companies continuing to grow in number due to the unwinding of the large mega pharmaceutical companies with the expectation of fledgling virtual life science companies remaining as a business model indicates an expanding market and need for CROs and CMOs.
Contracting CROs and CMOs, on a company-to-company basis, offer a spectrum of specialties from the general to the specialized. Competing in such an ecosystem requires, on the general end, attention to price sensitivity, location and customer service while specialization draws heavily on the value that the CRO or CMO brings to the product development process.
Value based on specialization is dependent on recruiting and developing staff with a unique set of skills or the development of patent protected processes that provide services to produce products “faster, better, cheaper.” Specialization allows the company freedom to be at a distance from a client. After all, the product offered is the fabled better mousetrap.
Wyoming Bioscience Niches
Currently, Wyoming is home to several bio-services companies: Astec LLC, Glycobac LLC, Detente Genetics LLC, PlanktOMICS algae bioservices LLC, and Biodelivery LLC as well as an early-stage drug development company, FPR Pharma LLC.
Additional bio-services companies can be germinated in Wyoming, along with bio-repositories, niche drug discovery companies, agriculture biotechnology, bio-computing and bioinformatics.
Ryan Mulholland (CEO, Ptolemy Data Systems, Sheridan, Wyoming) provides a visionary and thoughtful rationale for placement of secure data warehouses and data processing in Wyoming.
This rationale is equally valid for placing bio-repositories and data storage facilities for life science companies, in Wyoming.
Like computer data, life sciences have rare and critical assets that if lost or inactive could mean the demise of a project or company. Often these assets are cell culture lines, yeast strains, bacterial cultures, algae strains, genetic clone libraries (genomic, cDNA, or synthetic), stem cells, germ cells, blood samples, tissue samples, or critical and rare material testing reagents.
Further, sample storage from research and development as well as clinical trials is increasing in importance. The need to store and split the samples for analysis and possible re-testing is a critical point for many of the new drugs under development by pharmaceutical companies.
Bio-repository processing of samples requires the steps of ingestion (labeling and documentation), tracking, splitting and storage. Split samples are stored at separate locations within the bio-repository to ensure sample integrity as well as reduce the risk of accidental loss.
In general, the facility will need stable and redundant power, emergency power, sample tracking and facility monitoring systems, backup Internet access and security (physical, sample and Internet).
In addition, secure Internet access to allow the client to monitor and inventory samples as well as select samples for testing, retesting or for shipment to a researcher would be of significant advantage.
Early stage drug discovery
Before the development of combinatorial chemistry in the 1970s, the vast majority of therapeutic and medically beneficial medicines came from natural sources with a medicinal ethno-botanical history. Examples are aspirin from the bark of the White Birch Tree, Digoxin from Fox Glove and more recently Taxol from the bark of the Yew tree.
The vast world of Nature contains many plants that needs must be investigated for the potential of containing chemicals and compounds that may prove to be commercially profitable.
Early stage drug discovery can be a lucrative niche that a company located in Wyoming can exploit. One possible niche is leveraging the medical ethno-botanical history and experiences of the regional Native Americas to identify compounds and chemicals with an eye toward creating products with health and therapeutic benefits.
This endeavor would require a corporate structure that utilizes the input of the Native Americans as well as their skill and expertise to extract, identify, and develop those chemicals, compounds and biological products.
The basic business model of the company would be to extract, identify, test, and develop to the point of “proof-of-concept” followed by licensing the products and patents to companies for commercialization. Revenue would flow into the company through patent royalties and sale of the compounds for manufacturing of the licensed products.
With the existence of secure data warehouses in Wyoming and the increasing standing of University of Wyoming in computer sciences as well as the existence of a programmer’s guild in Sheridan, an additional niche for exploitation by a Wyoming-based company would be the bioscience fields of Biocomputing and Bioinformatics.
These companies perform analysis of chemicals and compounds to project toxicity, and activity as well as the effects of modifications to the chemicals and compounds. Further, computer analysis of DNA, RNA, and proteins, as well as the “OMICs” fields, whole cell modeling and life science big data are areas ripe for the development of programs and methods.
All of these activities require large amounts of data storage, computing power and programmers.
Biocomputing and Bioinformatics include Digital Pathology, a field of application that digitally scans pathology slides and stores the images.
With many of the scanning systems, the digital image can be analyzed using algorithms to provide numeric results with statistical parameters. In addition, reconstructed digital images displayed in a three-dimensional format, provide a process to explore virtual pathological samples.
Digital Pathology is a valuable tool for researching the toxicology of candidate drugs. Further, as a healthcare device, Digital Pathology systems are beginning to gain a footing in the US healthcare market.
Currently, digital pathology is common in Europe, with the country of Hungary has a Pathology Net linking all of the pathology departments allowing exchange, review and storage of the images, reports and information.
Wyoming Biocomputing and Bioinformatics companies will have the benefits of reduced operating expenses, stability, security and access to the world through high-speed Internet.
Biotechnology applied to agriculture has already generated many unique products. The expectation is that the continued and increased application of the biosciences to agricultural problems will provide novel resolutions to many of the problems facing production, drought and disease resistance.
In the realm of Agricultural Biotechnology, Wyoming could leverage its’ existing strengths in cattle and horses as well as venture into the development and production of novel feeds.
The generation of energy using bioscience techniques and applications has a significant potential in Wyoming.
The State already has companies working toward increasing the output of methane gas from old coal bed methane wells by manipulating the community and ecosystem of bacteria that breaks down the coal to generate methane gas.
Additionally, across the state, many resources exist from which to generate alternative fuels such as biogas, methanol, ethanol, and biofuels. These resources include cellulose sources, manure, and plant lipids.
Energy Biotechnology offers the potential to generate electricity on-site and sold to the grid for distribution or consumed locally as an alternative source of energy for offices and manufacturing companies.
Wyoming has the building blocks to create a viable life science industry and the life science industry is trending toward increased use of CROs and CMOs.
All we need to do, as a statewide community, is work together to face this challenge and embrace this important trend to cement our prosperous future.