Gil Roth03.01.07
Ask the Board: What Makes A Good CMO?
The relationship between manufacturing partners is a dynamic. It is unlikely that the nature and scope of the relationship is well defined at the time that the legal and quality agreements are executed. So, while we attempt to craft agreements that are all-encompassing, experience suggests that flexibility and cooperation between the parties makes or breaks the relationship. Changes in specifications, forecasts, and regulatory strategies are almost certain. A good manufacturing partner is one that understands the factors that drive these changes, and can react accordingly. Partners either succeed or fail together.
--Paul D'Angio, Celgene
Building up a spirit of actual partnership is the most important thing. Without trust you can forget the technical side, as one party will always be blaming the other for the inevitable problems that turn up in projects (and there is no escape from these!). If you get along with whom you are working you can also be honest about any shortcomings and resolve them. That's why alliance management has become such a big issue. Companies that are good at this tend to have good relationships with outside suppliers and this reputation gets around.
--Faiz Kermani, Pharmbiosys
I think there are four main characteristics that are most important in a truly good manufacturing partner. First, it all starts with open and honest communication with agreement on expectations between the customer and manufacturer. This is most often where I see relationships break down and can be avoided with open communication. Second, maintaining a consistent high level of quality and compliance. Third, is flexibility in being able to handle shifts in customer demand, especially important with newly launched products and in situations where you are the sole supplier. Lastly, is sharing best practices in order to improve yields, delivery or cost of goods. Establishing and regularly communicating Key Performance Indicators for these key characteristics will ensure that the relationship continues to grow and prosper for both the customer and manufacturer.
--Terry Novak, DSM Pharmaceuticals, Inc. / DSM Biologics
The best characteristic of a good manufacturing partner should be "quality production delivered on schedule." A true partner takes the responsibility for producing quality product, because the viability of his/her customer in the marketplace assures his/her longevity. Supplying that quality product to market in time is as critical for assuring repeat business.
--Dilip Parikh, DPharma Group
I have only one characteristic and that is Trust. When a product owner places their product in a provider's plant, there is 100% trust that the provider will do the right thing every hour every day. Every employee at the provider has to do the right thing all the time. All of the other aspects of the relationship are important - the classical Quality, Service, and Value – but they are subsets of the Trust equation. If there is no Trust there is no relationship as the product owner always has to be on the lookout, always wondering if things are OK. Did the operator follow the making instructions at 3:00 a.m.? Did the batch not meet specs because of an anomaly, or because the operator took a shortcut? If there's trust, the thought shouldn't arise. This manifests itself when problems arise, as they inevitably will. Being able to sit across the desk from the provider knowing they can be trusted and what they are doing to correct a problem is the right thing -- it's like the TV commercial -- it's priceless.
--Bob Calabro, OSG Norwich Pharmaceuticals
A good manufacturing partner meets FDA/EMEA requirements while consistently striving to anticipate future requirements and making the investments for current requirements in a timely manner. The Business Development and Project Management of the CMO work as a team with well defined roles/responsibilities.
The good CMO recognizes that timely delivery and accountability is more important than the lowest price. At the same time, a good CMO regularly demonstrates its "value" through providing efficient and thorough services which meet, if not exceeds the requirements of the clients.
Upon commercialization of the product, the good CMO works with its clients on regulatory/analytical issues, raw materials, components and actual final product delivery. Additionally the CMO challenges its clients to provide accurate forecasts and financial rewards for superior efforts.
At the end of the day, the good CMO must remain profitable in order to continue being the good manufacturing partner.
--name withheld by request
A good manufacturing partner is one that has:
Credibility: Credibility with local as well as the U.S. regulatory agencies with regards to manufacturing for big Pharma companies for a sustained period of time.
Capability: Capabilities to manufacture varieties of Intermediates/APIs/Dosage forms (drug products). This is not necessarily a ‘One-Stop Shop.'
Capacities: Having ‘flexible' available capacities to manufacture at short notice, and additionally, to handle high-volume capacities for the manufacture of a large volume product.
Cost efficiencies: These are critical because there is usually rationalization in big Pharma companies to reduce the current number of manufacturing sites to derive substantial cost advantages.
--name withheld by request
XenoBiotic Laboratories (XBL) looks for the same characteristics in its strategic partners as those expected of any reliable contract organization: 1) quality, 2) reliability, 3) responsiveness, and 4) reasonable cost for service. Strategic manufacturing of specialized dosage formulations, or synthesis of radiolabeled test articles, or reference chemicals, can often be coordinated to provide smoother transitions for specialized protocols dealing with bioanalysis, mass balance, and metabolism studies. As most outsourcing groups quickly learn, cost as a value item, while an important consideration, can be misleading if the quality, responsivenss and reliability are not deliverable as required. Wise selection of a compatible strategic partner will usually pay dividends in long term savings of time, and may deliver tangible cost savings by eliminating the need for corrective work at a later date.
--Neil Lewis, XenoBiotic Laboratories
The most important characteristic of a CMO is the ability to make good choices when evaluating potential partners and their projects. A CMO really needs to make sure they can support the project with both physical and human resources. For both parties benefit it is important to periodically review the scope of the project as well as to discuss change to scope as soon as possible. Many of the following characteristics have been written about in articles but here are my top ones (not necessarily in order) when evaluating CMOs:
• Experienced, responsive management
• Staff level experience
• Financial solvency
• Regulatory track record
• Technical resources (Engineering, analytical development, etc.)
• Quality Systems/staffing
• Location
• Costs
--Jack Regan, Anesiva
The characteristics of a good partner are consistent across technologies and processes. The most important attributes are technical competence, systems compatibility and sufficiently high quality project management capable of pulling together a team that can deliver the project on time.
The supplier needs to demonstrate that it has the capacity to deliver the material in a timely way, well trained personnel, and quality systems that meet your company's expectations. It is important to have the right technology in place to perform any needed testing, and that, if at all possible, parallel testing systems exist at both the sponsor and manufacturing sites. The partner also needs to be able to meet expectations around other deliverables such as interim and final reports. Finally, where the project stands at any given time should not be a mystery. Project management and communication systems need to be in place that assure progress, or lack thereof, is communicated promptly. A good partner should provide this information in a proactive way, giving the sponsor a sense of confidence that the partner is on top of the work and dealing with issues as they arise rather than waiting for the sponsor to spot an issue and ask for a resolution.
--name withheld by request
Good manufacturing partners will provide each other with accurate forecasts, can look for (and receive) collaborative licensing, development and supply services. A good manufacturing partner will treat each others products and services as if they were its own.
--name withheld by request
A good manufacturing partner is one who:
(1) provides sufficiently developed technology for transfer to the contractor;
(2) is forthcoming with their expectations with regard to all the project's requirements;
(3) communicates all the available project information to the contractor prior to initiation;
(4) provides sufficient information to allow the contractor to accurately estimate the project cost; and
(5) understands that a mutually beneficial relationship, i.e. a fair profit for everyone, depends upon items 1-4.
--Philip G. Trager, Consumer Product Testing Co.
From our new study Biopharmaceutical Contract Manufacturing 2007: Quality, Capacities and Emerging Technologies, our survey of pharmaceutical and biotechnology manufacturing directors noted that a good manufacturing partner is someone who has a strong reputation, offers good customer service and is flexible to a potentially changing environment. In addition, throughout our survey, the directors expressed the need for the contract manufacturing partner to be able to openly communicate with the client about issues and work with the client in solving problems as they arise. In addition, while price is always an important criteria in selection a contract manufacturing partner, none of the directors rated it as a top criteria.
--William Downey, High Tech Business Decisions