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Prasad V Saraph
B64-R329
800 Dwight Way
Bayer HealthCare – Biological Products
Berkeley, CA, 94710-2428, USA
In the 21st century, the Biotechnology industry has the • Review the structure of Biotechnology industry
potential to inspire a number of management tools and • Review status of simulation in Biotechnology in-
theories, just as the Automobile industry did in the 20th dustry
century. This paper explores the opportunities for simu- • Explore opportunities for simulation
lation in Biotechnology over the next few years and pro- • Discuss the role for simulation practitioners in the
vides structure for the panel discussion in Biotechnology industry over next few years
and HealthCare track. We detail the structure for Bio-
technology industry, review status and opportunities for 3 INDUSTRY STRUCTURE
simulation and present gap analysis of opportunities and
tools available. The purpose of the panel discussion is to There are three distinct parts of this industry, Drug Discovery
discuss the role for simulation community in Biotechnol- and Development, Operations and Commercial. Once an era
ogy industry over the next few years and identify key ar- of the Big Pharma, small companies and university groups
eas where simulation can add value. now dominate the discovery and research phase. Operations
phase is still the arena for large and established firms –
1 BACKGROUND Pharmaceuticals and Biotech. There is a slow but steady
penetration from Generic manufacturers in this area as well.
Role of Biotechnology industry in 21st century is similar to Commercial phase consists of Marketing, Sales, Distribution,
the role played by Automobile industry in the 20th century Life Cycle Management and in/out-licensing opportunity ex-
(Womack, Jones, Roos, 1991). Automobile industry pro- ploration. Figure 1 illustrates generic industry structure and
moted and developed the science of management (Taylor, roles of these three parts.
1911). simulation tools and theory developed out of rigor
of management science. simulation has been effective in Key Process DD&D OPS Comm
Drug Discovery x
analyzing various operational and strategic issues (quanti- Product Development x x
tative as well as qualitative). Process Development x Drug
Discovery and
Bioanalytics Development x
Subsequent novel industries like Computer and Semi- Formulation & Drug Delivery Systems x
Development
based tools and techniques have become an integral part of Licensing Activities x Operations
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Saraph
Simulation tools have been deployed in Biotech industry By far, this is the largest area of opportunities for simula-
across a large spectrum. There is sophisticated software to tion Tools. The basic advantage of the Operations area is
identify drug candidates, to analyze human genome for de- its similarity with established industries like Process Indus-
cease triggers, to simulate behaviors of drug molecules and tries, which enables application of familiar tools and theo-
human body response and to simulate the manufacturing ries. However, there are key differences that pose a chal-
process mass balance. lenge for simulation practitioners. Some of these
Recently, there have been efforts to utilize simulation differences are as follows:
in analyzing scheduling and operations capacity issues
(Saraph, 2002; Petrides, 2002). However, there is a • Regulatory Environment: Most of the Biotechnol-
marked lack of specialized software to enable industry spe- ogy drugs operate under heavily regulated envi-
cific analysis and optimization. ronment of FDA, EMEA etc.
Biotech industry is recognizing the value of simulation • Cleanliness Requirements: Similar to Semicon-
tools in its pursuit of cost-effective treatment for patients ductor industry, but excursions have far reaching
across the value chain, but the coordinated efforts are far consequences for operations
and few in-betweens. • Quality Test Times: Many of the tests depend on
growth of microbes and as such, take a long time
5 OPPORTUNITIES FOR SIMULATION • Documentation Times: Low product characteriza-
tion creates significant documentation require-
In order to set the stage for discussion on opportunities, we ments for the process and all documents need to
are using the industry structure as a guide. In each of the be checked and reviewed before releasing the
segments, we have tried to put together material that would product to the market.
start the discussion. Though we do not claim the contents • Personnel Skills: Being a new industry, many
to be comprehensive, the intended purpose for the panel processes are not de-skilled enough. Low avail-
discussion is well served. ability of skilled personnel coupled with high de-
mand create many challenges in deployment and
5.1 Drug Discovery and Development Phase hiring/retention of employees.
• Licensing Activities: Various changes to process,
The relatively new status of Biotech industry resulted in
equipment, facilities and products need to be li-
significant activity in Drug Discovery and Development
censed before commercial usage. The outcome of
phase. Various small groups (either in universities or as
licensing applications is variable and can cause
new start-ups) dominate the arena. The tools used also
significant disturbances in operations.
have matured over the past two decades. Information
technology has created new disciplines like Bio Informat- • Documentation Structure: This is a new area for
ics. However, the simulation tools used by this phase are simulation tools, but very critical for Biotech op-
different from the ones used by other established indus- erations. Various types of documents need to be
tries. The focus of simulation in this phase is still on the updated and changed as part of the business. How
specific technologies being evaluated/developed (e.g. Drug best to link these and how to estimate impact of
Molecule Binding, Behavior of Human Body under new individual changes is an intriguing arena.
drugs, Behavior of target cells etc.). The discovery phase
can benefit significantly from simulation tools that address 5.3 Commercial
issues of efficiency and effectiveness of the discovery pro-
cess (e.g. cycle time reduction, improving PTS), but so far The Biotechnology markets can be categorized as mass
the opportunities have not received adequate attention of markets, class markets and niche markets. Mass markets in-
simulation practitioners. clude drugs that treat generic diseases like Diabetes. Class
Development phase relates to the analysis and tests on markets include drugs that treat non-critical conditions like
the discovered drug and leads to Clinical trials. Successful cosmetic enhancements. Niche markets (where most of the
management of development life cycle of drug candidates Biotech drugs exist as of now) cater to small and specific pa-
can create a competitive advantage. In this area, there are a tient populations for very narrow indications.
few efforts directed towards project management, but ap- The commercial phase across all three market segments
plication of simulation tools (especially what-if tools) has has similarities with other industries. Regulated logistics
significant opportunity. simulation tools that would enable (temperature controls, trail of custody), varying requirements
analysis of scale-up issues offer facility/equipment needs, across different regions and markets and new ways to con-
analyze process behaviors over long term are some of the nect with customers (e.g. through PDAs) create unique op-
specific opportunities. portunities to minimize costs and maximize customer service.
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Saraph
Life Cycle Management, though similar in concept with Saraph P., 2002. Capacity Analysis of Multi-product,
other industries, is influenced by patents and long develop- Multi-resource Biotech Facility using Discrete Event
ment and approval cycles. Opportunities to optimize and Simulation, Proceedings of 34th Winter Simulation
simulate the business impact are not fully explored as of now. Conference 2002.
Taylor, F W. 1911. The Principles of Scientific Manage-
6 ROLE FOR SIMULATION PRACTITIONERS ment. W. W. Norton & Co., NY.
US Department of Commerce Technology Administration
The Biotech industry is expecting very healthy growth in (TA/DOC), A Survey of Use of Biotechnology in US
terms of revenues and employment over the next decade Industry, 2003, NY.
(TA/DOC Report, 2003; BIO Facts, 2004). Growing in- Womack J, D. Jones, D. Roos 1991. The Machine that
dustry also brings multitude of opportunities for various Changed the World, HarperCollins, NY.
tools, one of which is simulation.
Simulation practitioners have three key roles to play in
this growth.
7 EXPECTED OUTCOME OF
PANEL DISCUSSION
REFERENCES
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