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by Daniel R. Matlis

I recently wrote a whitepaper discussing how Biological product manufacturers seek to achieve two seemingly contradictory objectives:

1. Implement tight controls over every step in the manufacturing processes to increase product yield and quality. 
2. Provide for a flexible manufacturing process allowing for maximum equipment reconfiguration and utilization lowering capital investments.

In the paper we examine technologies which can enable the transformation required to simultaneously achieve the objectives thereby reducing process variability and costs, while increasing product yields and quality.

The folks at Camstar, the white-paper’s underwriter, have asked me to participate in a 3 part webinar series based on the research findings.

The webinars will address key business regulatory and technology challenges facing the Biotechnology industry, as well as provide practical and proven approaches firms can use to address them.

The topics to be covered in the series include:

Making Life-Science from Life – The State of the Biotech Industry

This webinar will focus on the current state of the industry and provide framework for tools and techniques Bio-Technology and Bio-Diagnostics products manufacturers can take advantage of to address challenges and opportunities.

Pursuing the Golden Batch (From Data to Truth)

This session will discuss a variety of tools and techniques which can be used to identify key parameters responsible for making a Golden Batch, and the means of translating the analysis into repeatable and controllable processes.

The Future is Now –Manufacturing Personalized Medicines Today

Manufacturing approaches in Biotech are as varied as the products being manufactured. They range from outsourcing and factory-less manufacturing, to dedicated equipment and flexible manufacturing for quick facility reconfiguration. This webinar will cover need for a flexible, configurable and adaptable manufacturing system of record.

If you would like to attend one of these Webinars on the entire series please click here to register.

By Daniel R. Matlis

This weeks CIO magazine has an interesting article entitled “Tilting at Silos: Fostering Teamwork Between Insulated Groups”  http://www.cio.com/article/118350?source=nlt_cioinsider
The author makes a good analogy between Don Quixote’s attack on windmills and the need for the Tech industry to tear down organizational silos.

In Life-Sciences, Windmills are armor plated and surrounded by motes.  Most Life-Science manufacturers are organized in well defined and delineated functional areas, each with specific roles and responsibilities.  Each of these functional areas have traditionally operated as silos or stove pipes, having their own well defined, independent and often unaligned goals, objectives and incentives.

For example, R&D might be incentivized on the number of new inventions or patents filed, regardless of how many of those make it to market successfully. On the other hand, sales people may be compensated on the number of units sold, regardless of how many are returned due to defects. This level of independence has lead to the “catapult effect”, where deliverables are thrown over the wall to the next functional area to deal with.

Today, as products become more complex, regulatory requirements more stringent and prices more disputed, medical device organizations must examine the entire product lifecycle and develop a unified, focused and interdependent approach to enable the creation of synergy and shared goals across the entire organization. This approach enables the development of products and processes which reduce variability and meet critical quality requirements with the least amount of time, resources and costs expended.

Technology is often viewed as the panacea to interconnecting silos and tilting windmills. Although technology is available today to enable this level of integration, technology can only enable change, not drive it. Tilting armor plated windmills requires cultural and organizational changes supported by mature technology.

By Daniel R. Matlis 

The Lifetime warranty is why so many people buy Craftsman Tools. It doesn’t matter if you inherited that wrench from your grandfather, as long as it says Craftsman on it, Sears provide you with a replacement if it brakes.
There is a business reason for this; Sears bets that the high quality of their tools will minimize warranty costs. 

But who would give a money back guarantee on Drugs?

According to Reuters, Janssen-Cilag, a division of Johnson and Johnson, has proposed such a guarantee to the National Health Service (NHS) in England for Velcade, a drug used to treat myeloma, a type of blood cancer.

According to published reports, patients on Velcade showing a full or partial response to the drug after a maximum of four cycles of treatment would be kept on it, with the treatment funded by the NHS.  However, patients showing minimal or no response would be taken off Velcade - and the costs would be refunded by Janssen-Cilag.  

Is this a sign of things to come? 

I think so.

This approach could enable a new health care paradigm, where all involved have the proverbial “skin in the game”. Patients get access to drugs that are nearly certain to be effective. Health care payers can “afford” to make new, and let’s face it expensive, treatments available to patients since they are provided a degree of confidence of treatment effectiveness, and limited downside though a refund.

As we move to personalized medicine, Pharmaceutical companies will be able to offer, with a high degree of confidence, the right treatment, to the right patient, at the right time.

With this confidence, manufacturers could move to a money back guarantee model, since, much like sears, the incidence of refunds would be minimal.