A Firsthand Account Of Hiring A CMO

By Dr. Neil Ross

Using contract filling organizations for parenteral products is a common practice in the pharmaceutical industry, since doing so develops a product process, produces clinical batches for trials, and validates and implements a production process. Using these organizations also helps to speed product to market, avoid investment in a parenteral pilot or production facility, and ease registration timelines due to already-established facility registrations.

The needs for our company — a small start-up veterinary/biotech — in using a contract facility were:

• help speed product to market
• ensure regulatory compliance of the production process
• ease regulatory issues regarding product development
• provide pilot batch production for clinical trials under cGCP conditions
• work long-term to validate our process and eliminate technology-transfer requirements.

We were looking for a company capable of providing pilot-scale production, which then could be scaled up (by the same company) on similar equipment to speed CMC (chemistry, manufacturing, and controls) registration on the product for validation batches. Since we are a small company, the product would not move from the partner’s production site due to economic reasons for technology transfer.

The process began by defining the company’s needs in an RFP packet which included:

• the confidentiality agreement
• the RFP document
• specifications, methods, and MSDS (material safety data sheet) on the product
• special needs of the product.

We first wanted to review potential partners with our industry contacts and gain new leads from those contacts, as well. This gave us insight into the companies’ capabilities. We also conducted a thorough Internet and trade journal search. Our initial broad list was then reviewed for capabilities based on our product needs and narrowed to a primary list of potential partners.

The next step in the process was to discuss the project with each company and gauge their interest. It was interesting to note that not all companies showed interest in our project ­— some didn’t have the equipment capabilities, while other weren’t interested due to the fact that our product was veterinary-focused.

The remaining companies then received the CDA (confidential disclosure agreement) from us for review. In most cases this was very efficiently handled, but in a few, it was a very long process, sometimes taking up to two months to get a signature after several drafts.

The RFP was then submitted to each company on the final list along with a paper quality audit form to fill out for the quote process. As expected, there were numerous technical conference calls to define in more detail each company’s particular needs, and it was again interesting that not all the questions were the same.

We then collected the bids over an eight-month period. Some companies responded in three weeks, and others missed their deadline by up to three months due to continued requests for more information.

We collated the results and found a highly unusual spread of quotes — the low was 25% of the highest number we received from various companies. Of the 13 quotes received, only 4 seemed close to one another.

Another interesting point was that we requested the quote be broken down into the various elements — testing, filling, testing validation, process transfer, etc. Only four companies followed our requirement while the others lumped many costs together or just gave a total cost with little breakdown.

We then began the selection process as follows:

• review and compare paper quality audit forms
• review economics by segment to see where emphasis is placed on costs
• review/confirm earlier assessments by our external contacts of potential partners
• verify which companies require capital investment vs. noncapital investment for the product
• confirm  all questions and technical expertise on interviews of RFP
• review value vs. cost per vial.

The list was then narrowed down to the final four candidates. They are now being audited by our QA and operations personnel. At the same time, the negotiation for the long-term production will be carried out to verify which of the four candidates is the best for a long-term partnership on the product.

Dr. Neil Ross is VP of operations at Nuovo Biologics. He has had an extensive career in the pharmaceutical industry spanning 35 years. He graduated from the University of Missouri with degrees in biological research and pharmacy.