Elise Brownell This is Me

Education

 Web References

1. 1. R&D Research & Development

   www.rdmag.com/features/0103bio - [Cached]

   Published on: 6/16/2001   Last Visited: 6/16/2001

   Martin Citron and Elise Brownell characterize the spirit , innovation , dedication , and enthusiasm of modern biotechnology.
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   Citron is an associate director at the Thousand Oaks , Calif.-based Amgen Inc. , and Brownell is a global project manager for the Berkeley , Calif.-based biotechnology unit of Bayer Corp.
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   At Bayer Biotech , Elise Brownell is one of three global project managers who orchestrate the activities of dis-covery researchers-like Amgen's Citron-with those at all the other levels in the biotech product pipeline. Brownell is responsible for Bayer Biotech products targeted at diabetes and multiple sclerosis. She coordinates the activities of Bayer staff from research , preclinical development ( in-cluding toxicology , pharmacokinetic , and analytical testing ) , regulatory affairs , quality assurance , process sciences , clinical testing , corporate legal , marketing , and launch personnel.
   
   I have no direct reports , she says. We work with highly innovative and creative new therapeutic principles that come out of research , put them through a rigorous evaluation process , while at the same time figuring out how to actually make the products that might come out of the research..
   
   Brownell is no stranger to the biotech arena she now coordinates. With a PhD in biology from Yale , she has bench experience in expression cloning methods to isolate genes encoding proteins of therapeutic value from immune cells. She has held her current position for leading cross-functional Bayer Biotech teams in the development of novel biotherapeutic drugs since 1996.
   
   Having this technological background is crucial to Brownell's and her projects' success. A project manager must be respected by their scientists when experiments need to be redone , when explanations to in-house experts are required , and when mistakes have to be explained-and they will occur , she says.
   
   Biotech project managers need to have three characteristics , according to Brownell. They must not be one of the inventors , but have a good , solid technical background. They should be proactive and strategic and not be limited to serving only a tracking function. And finally , they must both be an advocate and a negotiator of contracts-both in-house and external.
   
   Just like having a variety of technologies available in the neurodegenerative department at Amgen helps Citron's group run quick experiments without interdepartmental approval , running the development of a new Bayer drug in the same facility where pilot and full production is done is extremely useful according to Brownell. Having all the team members available at one site and establishing those interpersonal relationships is very important , she says.
   
   Bayer Biotech assigns a project manager to its products at a very early stage in the development cycle. We start the discovery process with a clinical process in mind , says Brownell. Modeling a development plan is done at an early stage to anticipate all the requirements that must be met and anticipate problems or bottlenecks that might arise. A biotech development plan is very complex that initially can span 6 or 7 years. The initial plan can include schedules for a variety of toxicology tests , manufacturing formulation , Phase I studies , and Phase II and Phase III clinical programs.
   
   Bayer has accelerated its development of therapeutic compounds over the past 2 years by having its project managers and cross functional teams become more involved with the clinical and marketing aspects of a new product at an earlier stage in the product's development. This has been a really big switch for Bayer Biotech , says Brownell. We now begin with the packaging insert..
   
   Brownell's project coordination overlaps all of the technical areas within Bayer's Biotech organization. Bayer Biotech is organized to provide the core technical competencies that are needed to support its drug discovery and development efforts. A molecular technologies group , for example , focuses on molecular biology including the identification of new genes and proteins. A cell and analytical biology group is responsible for identifying unique biological model systems and establishing assays to investigate the ways newly discovered genes and proteins interact with living cells and receptors.