San Diego's life science and commercial real estate communities are intertwined more tightly than most probably realize. CREW San Diego recently convened a panel of experts from both disciplines to discuss the important relationship between the two.
Speaking for the life science community were Diane Goostree of BioPharma Catalyst Group, LLC and Hope Spadora representing Life Technologies. Representing the commercial real estate industry and design industries were Greg Bisconti of Cushman and Wakefield, Brett E. Gossett with Alexandria Real Estate Equities and Jim Ferguson of Ferguson Pape Baldwin Architects.
The CREW Corner team chatted in depth with Ferguson about the relationship between the development of life science products and real estate needs.
Q: A life science company's success is based on getting products to market and giving patients better treatment options. What does it take in terms of process, timing, facilities and costs to achieve this?
A: The steps to bring a product to market are: drug discovery research, preclinical studies, Phase 1, 2 and 3 Clinical Trials and FDA's approval of a Biologics License Application (BLA) or New Drug Application (NDA). This entire process frequently takes 10 years or more. Large scale sustained production facility/equipment frequently cost $1 billion or more. These facilities are comprised of a research & development lab, pilot plant and sustained production facility.
Q: The timeline to develop a drug must be carefully correlated with the timeline to develop a facility to produce the drug. What are the challenges?
A: Traditionally the drug development and sustained production facility timeframe have both been about 10 years. The problem is that companies don't typically have the confidence or capital to invest in a large scale sustained production facility that far in advance of the potential to bring a product to market. This challenge is the driver in developing new technologies and means to manufacture in a quicker, more flexible and less expensive way.
Q: At the CREW presentation, there was a discussion of the trend of adapting a facility built for one specific product development so it can accommodate other types of products. Can you give us an example of a project you have worked on with the anticipation of the lab space changing?
A: Traditionally products have most often been manufactured in facilities dedicated to one project. Often the high cost of these facilities is leveraged to develop several drugs on a campaigned basis (only one at any time). We have been involved in a break-through project that combines a major university, a major cancer research organization and large pharmaceutical company. This first of its kind facility will be able to simultaneously product multiple products, using multiple new technologies in a flexible, modular and rearrangeable manufacturing facility. In addition to producing new therapies much faster and with far less expense, this new means of manufacturing is envisioned to produce vaccines to combat bio-terrorism and pandemic influenza vaccines.
Q: What techniques are you using to make facilities more adaptable?
A: Many of our facilities have gone through third and fourth generation users. From these experiences we've honed our new biopharmaceutical building designs to have a robust structure with flexible infrastructure to accommodate a wide range of industry needs over time.
Q: What changes do you foresee in designing and building facilities for life science companies?
A: Facilities for biopharmaceutical companies must respond to the maturity of the company and the drug development stage that the company is in, while at the same time allowing opportunities for the company to at least bridge to the next phase of drug development. In most cases this is to get through at least early phase clinical trials at which time cash flow needs significantly increase, but so does the potential for cash influx from joint ventures, licensing agreements and mergers/acquisitions. From the architect's perspective, the design must enable a company's growth transition with widely flexible facilities that can accommodate a broad range of business scenarios.
Ferguson is president of Ferguson Pape Baldwin Architects. His specialty is design of research and cGMP production facilities for biopharmaceutical and advanced technology companies. A strong advocate for sustainable design, he has been recognized by the U.S. Green Building Council as a LEED Accredited Professional.