Project Management Approach to Successful Outsourcing: Richman Chemical Case Studies

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

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

Richman Chemical Inc. www.richmanchemical.com

ACS 2004 Philadelphia, PA

Introduction
(continued)

• Expertise working with numerous categories of customers
– Virtual Technology – Pharmaceutical – Specialty Chemical - Medical Device - Nutritional - Electronic

• Ability to assist with a wide range of outsourcing requirements (both large and small scale)
– Custom/Toll Manufacturing – All compliance types
Richman Chemical Inc. www.richmanchemical.com

- Sourcing - Logistics
ACS 2004 Philadelphia, PA

Call the Sourcing Experts at RCI!

• Customer: A Contract Manufacturer
• Requirement: Needed scale-up of a hardto-find pharmaceutical intermediate
– Original supplier was unable to produce the intermediate beyond R&D quantities

Richman Chemical Inc. www.richmanchemical.com

ACS 2004 Philadelphia, PA

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

Richman Chemical Inc. www.richmanchemical.com

ACS 2004 Philadelphia, PA

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

Richman Chemical Inc. www.richmanchemical.com

ACS 2004 Philadelphia, PA

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!

Richman Chemical Inc. www.richmanchemical.com

ACS 2004 Philadelphia, PA

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

Richman Chemical Inc. www.richmanchemical.com

ACS 2004 Philadelphia, PA

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 – Packaged
Richman Chemical Inc. www.richmanchemical.com

- Housed - Delivered in a timely, cost-effective manner
ACS 2004 Philadelphia, PA

Virtual Manufacturing Company Needs Complete Package
• Customer: A virtual company
• Requirement: Customer needed:
– – – – Raw materials sourced Manufacturing Storage Logistics

Richman Chemical Inc. www.richmanchemical.com

ACS 2004 Philadelphia, PA

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
ACS 2004 Philadelphia, PA

Richman Chemical Inc. www.richmanchemical.com

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
ACS 2004 Philadelphia, PA

Richman Chemical Inc. www.richmanchemical.com

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
Richman Chemical Inc. www.richmanchemical.com ACS 2004 Philadelphia, PA

EMERGENCY! Need a Novel Chemical Excipient- STAT!
• Customer: Medical device company targeting expansion into new market • Requirement: Needed a crucial (and hardto-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.

Richman Chemical Inc. www.richmanchemical.com

ACS 2004 Philadelphia, PA

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
Richman Chemical Inc. www.richmanchemical.com ACS 2004 Philadelphia, PA

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

Richman Chemical Inc. www.richmanchemical.com

ACS 2004 Philadelphia, PA

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

Richman Chemical Inc. www.richmanchemical.com

ACS 2004 Philadelphia, PA

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

Richman Chemical Inc. www.richmanchemical.com

ACS 2004 Philadelphia, PA

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
Richman Chemical Inc. www.richmanchemical.com ACS 2004 Philadelphia, PA

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

Richman Chemical Inc. www.richmanchemical.com

ACS 2004 Philadelphia, PA

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.

Richman Chemical Inc. www.richmanchemical.com

ACS 2004 Philadelphia, PA

Special Thanks to:
Andrea Placke
Project Management Assistant Summer 2004 Intern (University of Delaware)

Richman Chemical Inc. www.richmanchemical.com

ACS 2004 Philadelphia, PA