Virtual Technology Firms and Richman Chemical: Ideal Outsourcing Partners

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Virtual Technology Firms and Richman Chemical
Ideal Outsourcing Partners

• Presented by Christopher Kulp
• Brian Watson
• www.richmanchemical.com

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Background

• Founded in 1987 to address outsourcing
  requirements in the chemical industry
• Expanded outsourcing services to include
  chemical, pharmaceutical, and virtual technology
  companies throughout the world
• Small, medium, and large companies
• Lab-scale to full-scale (milligrams to tons)
• Developed an unparalleled manufacturing network
• Achieved a 45 growth rate over the last 4 years

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Richman Chemicals Services

• Custom/Toll Manufacturing Services
• Process Development
• Contract RD
• Multi-step synthesis (cGMP)
• Organic and inorganic
• Pilot scale-up
• Unit operations
• Blending, distilling, mixing, milling, flaking,
  grinding, recrystallization, high pressure
  reactions, etc.
• Unlimited access to equipment

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Richman Chemicals Services (continued)

• Products
• A Comprehensive offering of raw materials and
  intermediates
• All scales
• Sourcing of hard-to-find raw materials and
  intermediates
• Extensive International network of vendors
• Turnkey Services
• Analytical Testing - Specialized Packaging
• Logistics coordination - Warehousing

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Outsourcing

• What exactly is outsourcing?
• When one company hands over manufacturing
  responsibility to another company for reasons
  including
• Cost Shipping (geographical constraints)
• Timing Compliance requirements
• Is there diminished control for the company doing
  the outsourcing?
• NOT AT ALL
• The outsourcing client gains an expert project
  manager and a more efficient approach the
  result is increased control!
• RCI pre-screens all manufacturing sites and
  requires secrecy agreements to be executed as
  appropriate

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Outsourcing (continued)

• Is outsourcing really necessary?
• ABSOLUTELY
• Many American companies are outsourcing projects
  - including your competitors
• An estimated 42 of all pharmaceutical
  companies will outsource in the year 2004 - a
  1050 increase from the mid 1990s
• Outsourcing can significantly lower costs and
  keep your company competitive in the global
  marketplace
• Lower costs will keep your clients happy
• Source Flavin, John L., et al, Making the
  Transition from a Traditional Model to a
  Technology-based Drug
• Discovery Service Partner, Outsourcing
  for the Future, http//www.contractpharma.com/mar0
  12.htm

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Virtual Technology Outsourcing

• Makes use of strategic partners and data-sharing
  technology (via Internet, electronic documents)
• Each party focuses on core capabilities and
  business areas of expertise
• Ability to focus attention on areas of expertise
• Acquisition of outsourcing department by client
  magnifies its resources at no additional cost
• Development lead times and manufacturing costs
  can decrease significantly Time is money!

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Virtual Technology Outsourcing (continued)

• Time is money
• Increase in competition requires more efficient
  production schedules
• Outsourcing is the answer!
• Development of small scale technologies and the
  need for scale-up work and product manufacturing
  requires the expertise and capabilities of custom
  outsourcing services
• Transform innovative ideas into tangible products
  at lower costs
• Flexibility to form long term relationships or
  join forces for a single project

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Why Not Go To The Manufacturer Directly?

• RCI serves as the Expedia or Priceline of the
  Chemical and Pharmaceutical Industries
• Convenient
• Available capacity located quickly
• Cost effective - regular project opportunities
  result in wholesale pricing from vendor sites
• Multiple options - economy through premium
• By utilizing an extensive proprietary database,
  RCI will find the optimal site for your project!
• Over a thousand potential labs/plants worldwide

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Why Not Go To The Manufacturer Directly?
(continued)

• Working with one of RCIs project managers is
  like having your own Outsourcing Department
• Equivalent to contacting hundreds of vendors
• No additional costs our model realizes cost
  savings by achieving efficiencies inherent in
  finding the best fits
• Leverage to do projects that would typically not
  be considered by vendors on a one off basis
• Personalized, attentive, and flexible service
• Turnkey ability with respect to all project needs

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Establishing More Effective Drug Development How
RCI Can Help

• Drug development is time consuming
• Outsource functions to partners
• Improve efficiency in drug discovery,
  development, clinical batch production, testing,
  commercialization, etc.
• Save and TIME
• Meeting and maintaining FDA compliance
• Increased restrictions and process complications
• More cost effective to outsource at early stages
  of RD
• Assistance with compliance and testing issues
• cGMP guidance provided
• Method Development and Impurity Profiling
  Experience
• Pre-clinical, Toxicology, and Clinical Phase
  Know-How

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Establishing More Effective Drug Development How
RCI Can Help (continued)

• Results
• Optimized lead times
• Reduced costs
• Increased technical capabilities
• Reduced time-to-market
• Quality maintained
• Ability for client to devote more time and effort
  on research efforts, marketing strategies, and
  other core competencies

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Additional Value-added Benefits of Outsourcing

• Ability to scale-up as the company grows
• Custom-built products
• Capacity to develop compounds simultaneously
  rather than one at a time
• Most intermediates or active chemicals can be
  made off-site - saves time!
• Leads to networking!

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Additional Value-added Benefits of Outsourcing
(continued)

• Access to
• Equipment
• Technologies
• Methodologies
• With out the required time, cost, and maintenance
• Hired on specialty services
• RCI supplements companies who do not have the
  staff or time
• Why take up time performing unit operations or
  packaging when your area of expertise is
  synthesis?

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Evolving Virtual Technology Industry

• Three types of companies
• A few global and highly connected companies
• A large number of small specialty companies
• RCI!
• The outsourcing partner who serves the first two
  groups!

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RCI Is Your Ideal Partner!

• Focuses entirely on outsourcing
• Provides experience, knowledge, and flexibility
• Relationship-building
• Access to one-stop shopping
• Identifies suitable manufacturers while the
  customer continues working on core competencies
• Understands the importance of both large and
  small scale projects

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Case Studies

• 1. Doctor developing a new drug candidate
• The doctor was only able to make a few milligrams
  at a time - needed resources of larger lab
• RCI located labs and testing facilities
• A small-scale lab was used to handle process
  development
• RCI managed the transition to a larger facility
• A bioanalytical lab was used to perform testing
• RCI will be ready for large scale production and
  packaging, if necessary

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Case Studies (continued)

• 2. A virtual company
• Needed synthesis of chemical compound
• RCI provided all services required by the
  customer
• Sourcing of raw materials Particle size
  alterations
• Spray drying Transportation
• One-stop shopping made the project more
  manageable for this virtual company

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Case Studies (continued)

• 3. Start-up biotech firm turns virtual
• cGMP facility was needed for scale-up of an
  intermediate
• RCI assisted this company when it was strictly a
  biotech company, so when this company turned
  virtual they turned to RCI
• RCI successfully produced
• On time delivery
• A ready-to-use cGMP facility at their disposal

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Summary

• Outsourcing is a necessary alternative to
  traditional manufacturing
• More efficient concept-to-market
• One-stop shopping
• RCI is your ideal partner!
• The Expedia of the chemical and pharmaceutical
  industry
• Extensive knowledge and understanding
• Working with 1 project manager from RCI is
  equivalent to enlisting an entire outsourcing
  team
• Ultimately your company will be extremely
  competitive in the global marketplace!

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If a problem can be specified then it can be
contracted out. This leaves the foundations
bright scientists able to concentrate on the more
intractable and potentially more interesting
problems that cannot yet be specified- Sir
James Black
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Special Thanks toAndrea PlackeProject
Management AssistantSummer 2004
Intern(University of Delaware)