Project Management Approach to Successful Outsourcing: Richman Chemical Case Studies

1
Project Management Approach to Successful
OutsourcingRichman Chemical Case Studies

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

2
Introduction

• RCI is a premier company in outsourcing
• Many years of process and project management
  experience
• Problem-solving focus
• Knowledgeable, flexible
• Able to identify optimal manufacturing locations
  for your specific needs

3
Introduction (continued)

• Expertise working with numerous categories of
  customers
• Virtual Technology - Medical Device
• Pharmaceutical - Nutritional
• Specialty Chemical - Electronic
• Ability to assist with a wide range of
  outsourcing requirements (both large and small
  scale)
• Custom/Toll Manufacturing - Sourcing
• All compliance types - Logistics

4
Call the Sourcing Experts at RCI!

• Customer A Contract Manufacturer
• Requirement Needed scale-up of a hard-to-find
  pharmaceutical intermediate
• Original supplier was unable to produce the
  intermediate beyond RD quantities

5
Call the Sourcing Experts at RCI! (continued)

• Solution RCI was able to locate a European
  vendor through their extensive international
  network
• Result The project was a success!
• RCI procured the material, arranged importation,
  and facilitated customs clearance

6
A Business in Jeopardy!

• Customer A desperate company
• Requirement In need of raw material
• Regular international vendor unable to satisfy
  immediate / unexpected requirement due to time
  considerations inherent with importation

7
A Business in Jeopardy! (continued)

• Solution RCI identified contacted domestic
  manufacturer
• Material was procured and delivered on time
• Result A grateful customer who was able to
  maintain a positive relationship with THEIR
  client!

8
Expert Sourcing Opportunities

• Customer Diagnostic Company
• RCI customer back for more quality sourcing
  opportunities
• Requirement Product cost and inventory reduction
  initiative for several products supplied by other
  vendors

9
Expert Sourcing Opportunities (continued)

• Solution RCI was able to
• Import quality bulk material at reduced cost
• Arrange custom packaging per customers release
  quantity
• Provide warehousing
• Ensure timely releases at the customers request
• Result Materials were
• Sourced - Housed
• Packaged - Delivered in a timely,
  cost-effective manner

10
Virtual Manufacturing Company Needs Complete
Package

• Customer A virtual company
• Requirement Customer needed
• Raw materials sourced
• Manufacturing
• Storage
• Logistics

11
Virtual Company Needs Expert Outsourcing!
(continued)

• Solution RCI set up all required aspects of the
  project
• Sourcing of raw materials from outside the U.S.
• Drying and packaging of intermediate
• Transporting intermediate to secondary processing
  facility for agglomeration
• Complete logistics management
• Storage and periodic release of final product
• Result Virtual company was able to produce
  product in a timely, cost effective way!
• One-stop shopping made project manageable

12
One Man Cannot Do It Alone!

• Customer Medical doctor/independent researcher
  in need of full staff
• Doctor developing new drug candidate
• Requirement Customer in need of
• Small scale custom synthesis
• Process development
• Development of protocol
• Scale-up

13
One Man Cannot Do It Alone! (continued)

• Solution RCI was able to
• Provide all requirements utilizing a qualified
  custom synthesis laboratory within our
  manufacturing partner network
• Contract a larger facility for production
• Result The one-man team now had the resources
  and capabilities of a fully-staffed lab all
  within the budget of an independent researcher
  who had an idea which is now an important drug
  candidate

14
EMERGENCY! Need a Novel Chemical Excipient-
STAT! 

• Customer Medical device company targeting
  expansion into new market
• Requirement Needed a crucial (and hard-to-make!)
  excipient for clinical trial work
• Novel organic compound formulated with the actual
  medical device to provide the desired properties.
• BIG problem the company had NO expertise in the
  synthesis of complex organic compounds.

15
EMERGENCY! Need a Novel Chemical Excipient-
STAT! (continued)

• Solution RCI was able to
• Optimize the synthetic process
• Scale it up to the appropriate manufacturing size
  
• Develop an FDA-approved, cGMP manufacturing
  protocol for successfully making the critical
  material
• All within a span of approximately 18 months.
• Result Satisfied customer and long term supply
  agreement

16
High Energy in Low Supply

• Customer Major military contractor
• Develops high performance propulsion materials
  for proprietary applications
• Requirement Needed highly explosive starting
  material for sensitive formulation
• Ultra volatility of the substance necessitated
  the skills of highly trained chemists

17
High Energy in Low Supply (continued)

• Solution RCI maintained a close relationship
  with a custom manufacturing site having a strong
  background in highly energetic chemistry
• Result The job was done
• Quickly - At a low cost
• Safely - Efficiently

18
A Problem Needed Solv-ing

• Customer Large chemical company who used a
  highly purified solvent for in-house testing
  protocols
• Requirement Needed large quantities of purified
  solvent IMMEDIATELY
• Current supplier cancelled deliveries and
  discontinued process
• No technology was provided

19
A Problem Needed Solv-ing(continued)

• Solution RCI was able to
• Identify a new purification process that worked
• Set-up regular manufacturing at a local facility
• Contribute in developing an alternate process
• Coordinate shipments for the year
• Establish a long term supply agreement
• Result The chemical company was able to continue
  the supply of purified solvent to its customers
  at the right price

20
Biotech Firm turns Virtual

• Customer Start-up Biotech company
• Re-invented itself as a virtual firm
• Has no laboratory, pilot, or manufacturing
  facilities
• Requirement New virtual company needed cGMP
  facility for scale-up of crucial intermediate

21
Biotech Firm turns Virtual(continued)

• Solution RCI provided
• Management for the production of the intermediate
  at a cost-effective cGMP facility
• FDA-related advice concerning intermediate
  production
• Result
• Successful production
• On time delivery
• Ready-to-use cGMP facility at their disposal for
  future clinical trial and commercial requirements.

22
Special Thanks toAndrea PlackeProject
Management AssistantSummer 2004
Intern(University of Delaware)