Title: Developing and Sustaining an Operational Excellence culture: A Contract Service Provider's Approach to Maximising Organisational Engagement


Description: It is now widely accepted that many Operational Excellence (OE) programmes have failed or are failing due to lack of a true cultural change. Learn how you can drive your organisation beyond just concentrating on the low hanging fruit, towards achieving greater dividends and sustained success. Since its initial implementation in 2009, the OE cultural-change at Alkermes has focussed on a number of key initiatives including: Reorganisation into value streams - helping to move from a functional silo system to a culture of supporting requirements; Creation of a burning platform - based on the business challenges faced by the organisation  and the implementation of strong communication processes across the organisation to exact change.
 
Dr Kevin Brady holds a PhD in Pharmacology and has worked extensively in the Pharmaceutical Industry in Ireland. Kevin has held roles of increasing responsibility in both Pfizer and Genzyme in manufacturing operations. He has developed and implemented Operational Excellence initiatives in these companies and is a certified Green Belt. At Alkermes, Kevin heads up Operational Excellence at the Athlone Ireland site where he has helped in the establishment of a strong Op Ex culture. His work involves partnership with Large and Mid size and Virtual Pharma companies to optimise their processes during development or Tech Transfer using Lean Six Sigma Methodologies as well as overseeing the commercial manufacture of new and existing oral solid dosage products from the Irish site.

Among the challenges the industry faces what do you consider as some of the most pressing?

Due to the high volume of patent expirations and site closures in recent years, it is now considered a sound strategic move, from big pharma to smaller players, to increasingly rely on outsourcing service providers to fulfil specific tasks, solve problems, and improve efficiency and productivity.
While engaging in an outsourcing solution may make good commercial sense to the pharma company seeking efficiencies in their business, it is essential that one chooses wisely when seeking a partner to scale-up and manufacture one’s prized product. There are many examples of CMOs that have ran foul of regulatory agencies in the U.S. and Europe – with  plant shutdowns, product recalls and warning letters in relation to client-based products.  Having product produced at the right price, at the right time, is of no merit if the product is deemed defective on grounds of quality.  In selecting an outsourcing partner, it is critical for the sponsor company to spend time examining a service provider’s quality and compliance systems.  This should be undertaken through examination of the provider’s quality record with regulatory agencies and also through site visits to ensure the integrity of key quality systems throughout the company. Checks and balances need to be agreed between both parties and a culture of transparency and trust should be developed so that when issues do arise, they can be dealt with in an open and collaborative approach.  Through this collaborative-partnership approach, quality product can be consistently produced thus preventing some of the quality-related nightmares we have witnessed in the industry in recent years that have been so damaging to a company’s reputation and the products produced and sold. 
 

Besides quality, what other elements are essential in successful partnership arrangements?

Three elements we at Alkermes Contract Pharma Services consider  essential to fostering and maintaining long-term relationships are: experience, expertise and enthusiasm. Alkermes Contract Pharma Services has been in the pharmaceutical development, scale-up  manufacturing business for over 40 years and successfully manufacture products for a bluechip client list including seven of the top ten pharma companies in the world. While experience and expertise are basic elements to offer a company seeking contract pharma services, having enthusiasm to go the extra mile, to bring the project over the line is, we believe essential for long term project success

How do you celebrate success with your contract pharmaceutical partners?

Typically this can take the form of reduced cycle times measured using metrics such as On Time In full (OTIF) and Right First Time (RFT). Where price reductions have been achieved due, for example, to process improvements, these savings can be passed on to our partners. Ultimately we are providing our Partners with what they want, which is the highest quality product with shortest lead time possible and lowest cost.

Is it fair to say that your OE culture has impressed your partners in the pharmaceutical industry?

We deal with small and large pharmaceutical companies and some have more experience with OE than others. Most if not all of our partners have been very impressed with our OE programme and are interested in learning more about it. Indeed, nowadays, there is often an expectation to propose and provide continuous improvement to our customers and we have positioned OE as the vehicle to provide these improvements.