Comments on: The Pharma 2.0 Trend For 2010

By: Markus Roemer

Markus Roemer — Sat, 03 Jul 2010 07:16:11 +0000

I can’t agree more. Pharma 2.0 means Quality Management 2.0, IT Validation 2.0 and innovations through every business and production process. Companies which have started this year with such approaches can now cut down costs at about 30 %, in parellel strengthend their compliance level. If it is a pharma-ready MS Sharepoint platform used as DMS, electronic Validation Tools or integrated QM solutions – all of them help to reduce costs and cover the hot topics of audits and regulatory requirements. Some suppliers also support and deliver iPhone Apps, Google office, open source software and so on -how far can we go? As long as it helps to delivery traceabilitiy, compliance and even reducing costs I really like all the different solutions.

By: Jason Dunklee

Jason Dunklee — Tue, 22 Dec 2009 16:21:39 +0000

This article hits some key points as do the comments by Gabe Gurman regarding “leaner, globalised entity whose increased scale is achieved ‘virtually’ rather than through accretion”. I would like to qualify this by suggesting this trend is definitely applicable to mature companies and potentially the established & growing companies – but less so to emerging companies launching their 1st or 2nd product.

In our consulting practice we tend to group companies into buckets as described above and treat them as experiencing different trends and having different needs. For example, a mature organization see global implementation of a large, integrated, internally supported quality management IT system (QMS) as a way to achieve virtualized global efficiencies, while an emerging company may opt for a hosted, on-demand, web-based QMS to achieve global collaboration.

Finally, as we look at hot topics for the coming year, let’s not forget the chronic themes of potential compliance issues (e.g. FDA observations), patent expirations and improving operational performance (e.g. production yield).

By: Jim Sabogal

Jim Sabogal — Tue, 08 Dec 2009 04:35:48 +0000

I can agree with your article and the basic premise that the industry will remain ’status quo.’ I see this as an opportunity for IT to step up and be the enabler of “process innovation.” I believe IT will provide the next steps for the industry to reach the Pharma 2.0 business model. This will be achieved by ‘integration’ of new SaaS applications between silos of information. IT service providers that can ‘connect’ these applications while cutting costs will be the norm for next year.

By: Gabe Gurman

Gabe Gurman — Tue, 01 Dec 2009 20:34:43 +0000

In general, the findings outlined here are in line with what we’ve been seeing in the industry, especially the idea that in 2010 we’ll see more sharing and collaboration between siloed departments in global organizations. More than ever before we’re hearing from our customers that IT systems need to extend across the global enterprise, as companies grow their operations to more disparate locations around the world. M&A activities in the Pharma domain are a contributing factor to this as well. I think this globalization will continue to be an overall positive development for the industry, but if companies aren’t careful, it can also severely impact quality and compliance. That’s why in 2010 I also expect to see an uptick in the industry in issues regarding quality and compliance with differing global regulations, as well as increased sophistication in the ways that companies manage their disparate suppliers and implement global quality processes across the enterprise.

-Gabe Gurman, VP research & development, Sparta Systems

By: Formulation Development

Formulation Development — Mon, 30 Nov 2009 17:47:37 +0000

Very interesting post. The pharma industry may remain somewhat “status quo” for 2010, but it’s good to see that even with slow growth, that cutting costs and reducing time-to-market will remain a priority. I also agree that as this industry continues to grow, IT and technology solutions will also be crucial within the pharma industry.