Project Management Approach to Successful Outsourcing: Richman Chemical Case Studies

1. Project Management Approach to Successful Outsourcing:Richman 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 R&D 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 customer’s release quantity • Provide warehousing • Ensure timely releases at the customer’s 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 to:Andrea PlackeProject Management AssistantSummer 2004 Intern(University of Delaware)