Les Edwards and Austin McDonald have created the Isogen Science Center, a faster, better and cheaper way for pharmaceutical firms to bring novel life-enhancing and life-saving drugs to market. Entrepreneurs and techies are synonymous with innovation and that’s exactly what Les and Austin accomplished by taking a new approach to existing technology.
They identified a niche in pharmaceutical outsourcing, the small to medium-scale manufacturing of injectable drugs for clinical trial and early commercial sales.
Their unique synergy honed on twenty years of experience in pharmaceutical manufacturing allowed them to see an unsatisfied requirement to solve the process, facility and capacity problems commonly associated with the highly-niched, low volume clinical and early-stage commercial, global sterile filling market.
The parenteral dose contract manufacturing sector is about a $2 Billion segment of the overall $40 Billion pharmaceutical industry outsourcing market.
Historically, these processes required the typical Pharma firm to make an investment of over $100 million and about 4 years on average to develop the sterile manufacturing capability prior to receiving regulatory approval. Utilizing their collective experience combined with their soul brothers, the Isogen team deployed advanced technologies, built the facility and began delivering product to customers in just one year. The Isogen Science Center was built at a fraction of the time and cost that a pharmaceutical company would expend to build a similar facility.
In addition, the Center meets global manufacturing standards.
Basically, the Isogen solution enables customers to plan clinical and market launches of single or multiple therapeutics at the same time while dramatically reducing the costs and risks inherently associated with in-house and outsourced alternatives. It eliminates Biopharma’s having to spend millions of dollars over years to build additional clinical and commercial sterile filling capacity thus reducing sterile manufacturing capital costs in a era of growing financial pressures and the competitive need to reduce time-to-market for new drugs.
Isogen also provides engineering and analytical services and has chemistry, microbiology and material sciences laboratories incorporated into the Science Center. The Center can handle most classes of therapeutics, including potent cytotoxic monoclonal antibodies, vaccines or any products that require special handling.
The Evolution of the Innovation
Les and Austin really epitomize Bobby Kennedy’s famous motto “think of things that never were and ask – why not”?
In the 1990’s both had successful consulting businesses and had the gained the reputation as luminaries, and even competed with each other for certain projects. Out of mutual respect in 1992 they collaborated on building the first isolator based syringe filling line, which is still used today!
In 1994 Les founded Advanced Barrier Concepts with two soul brothers, and in 1996 Austin started GL Engineering with one of his soul brothers. In 2007, after working on numerous cutting-edge pharmaceutical manufacturing projects, they joined forces to create the concept for the Isogen Science Center to improve upon existing processes based upon over 100 projects that they had worked on for major Pharma firms around the world.
Based upon their reputation, contacts and years of experience in the industry Les and Austin easily raised $3 Million from personal investors, themselves and colleagues. This allowed them to firm up their strategic plans and to hire key staff to implement their plan.
They also met with local economic development agencies from surrounding States and decided that Delaware offered the best location for Isogen. The Delaware authority also provided another $1.5 Million in debt and as a result of their efforts the Wilmington Trust Bank also provided $7.5 Million.
In April of 2009 Isogen officially opened for business and in July completed its media fills and began delivering product to customers, an unprecedented accomplishment in these economic times.
The Value Proposition
As a result of their years of experience and contacts in the industry Les and Austin were able to easily “spread the word” on Isogen’s unique selling proposition: GMP Filling – The way it should be“. Their value proposition was simple and cost effective – a filling facility that would have everything a large-scale manufacturing facility has, but sized to meet the budgets and unique need for smaller batch clinical trials.
This was a truly classic niche market opportunity – a significant unmet customer requirement with virtually no competition. A first movers advantage if there ever was one.
They knew that their message would resonate with Pharmaceutical firms, both large and small, allowing them to get novel and orphan life-saving and life enhancing drugs to market faster. Effective marketing has already created a demand for Les and Austin to speak at industry events, generated sales, and the demand for customer visits and audits from companies of all sizes.
In addition to consulting revenue Isogen is pursuing over 120 opportunities with large, medium and small pharmaceutical companies. Projected revenue for 2009 is $4.9 Million, the first year of operations. Based upon the initial reaction from the market and continued marketing activities, Isogen is positioned to be the best specialty manufacturing service provider in its market niche.
The goal for the brand is to be the market leader in aseptic contract manufacturing.
Why did Les and Austin create Isogen? In their words “loyalty to one another and the faith that the hard work done and excellence achieved will result in life-saving medicines and drug-therapies getting to market faster, safer, and better”.
In Isogen we have yet another great example of an answer to Bobby Kennedy’s query to “think of things that never were and ask – why not”? Les and Austin assembled a team to make this happen and in the process has created an atmosphere of trust and communications between vendors, clients and employees where people can do the best work of their careers.
If you are an entrepreneur or techie struggling to make your idea a commercial success let’s start a dialogue.
Bob Donnelly, is CEO of VAAS Americas, the U.S. unit of the Chennai, India based maker and distributor of industrial valves. A coach, educator, and advisor to founders/CEOs of growing firms, he is a serial entrepreneur, having started, grown and sold several technology based businesses. Earlier in his career he held senior management positions with IBM, Pfizer, and Exxon.
He has developed an online MBA program in Entrepreneurship for Rushmore University with managers from global firms enrolled in the program. Since 1998 he has served as a venture mentor at New York University’s Stern School of Business Berkeley Center for Entrepreneurial Studies, where he advises start-ups on business plan development, marketing strategy, and presentation skills.
He writes the online Entrepreneurial CEO column for Chief Executive.