For those few of you (and you're very erudite I'm sure) who have actually read a substantial majority of my posts on this blog, you may ask yourself what's the process of selecting topics. It doesn't seem like there is a theme going here. As many blogging books advise, write about something you know and the narrower the better to build a community following. Seems like good advice. I tried that but ran out of subject matter quickly.
As a result, after making probably a dozen posts on raw material characterization (see Jan 1st, 5th, and 10th to get ball rolling) topics, I found I was going to be out of fodder until the next phase of this program was completed and data starting coming in (soon, soon).
That left me with a decision. Should I blog less frequently and wait for the data? I was worried about losing writing momentum, plus I had never blogged so I felt that I needed to learn some things (etiquette, software, etc.) and test others (written content, pictures/video, voice). I opted to endeavor to persevere.
So I decided to post on other topic areas within my business & the industry. By forcing myself to read (first) and then write daily, I really help myself stay abreast of industry topics and trends. What I post -- usually relates to me in the following manner: industry trend (R&D restructuring), competitors to my business, big customer for me or one that I wish was a bigger customer for me, science directly related to products/services that I sell, emerging geographic markets - mainly BRIC, and legal decisions that I feel will have a significant impact on the market environment and competitive landscape.
Given my employer, this opens up quite a spectrum of competitors, technologies, markets, products and services (these alone encompass raw materials for use in biopharm/pharm production, CMO services like vaccine manufacturing and manufacture of ADCs, analytical services, cell engineering, etc). Thus, the smorgasbord feel - perhaps - to my postings. By following this path, there is almost always something newsworthy related to the topics above.
So I've been doing this 3.5 months, so what might I observe?
Clearly the industry has reached a stage of maturity where restructuring is necessary. We're effectively seeing a coalescense of the pharma and biotechnology industry. This means that many biotechs will go away or be absorbed into larger companies. It means the pharma guys will bring techniques like lean (to take out cost) and better risk management practices to biotech groups. It is needed to compete as the generics and biosimilars emerge as strong competition during this period. It means companies will reduce their internal R&D - we've all seen the layoffs. It means new R&D outsourcing models - with both private and public sectors and parnerships - even amongst peers see Asia Cancer Research Group. It means companies need to come up with a strategy to address emergine markets and to compete with generics/biosimilars. If you can't beat 'em join 'em - companies like Sanofi-Aventis, AZ, Pfizer and Cephalon all have made moves on generic producers. On the flip side, Teva has made moves in the oncology area for more novel compounds to diversify is world leading generics portfolio.
Markets are moving East (doh!). You could knock me over with a sledge hammer, pile-driver and Sherman tank! Hopefully, we've all heard of the BRIC countries - China and India in particular are especially prominent in the pharma arena. They represent triple threat - customers, service providers and competitors!
With regard to competitors, I note the emergence of CRAMs in India and China - particularly the former - and the pharma companies in India who are opening CRAM divisions too. From a company perspective - I notice that Lonza has continued to shift resources East and has opened facilities for both small and large molecules in India, China and Singapore. Again this is all consistent with the market data that the East is growing much more rapidly than the developed countries in the West and represent best targets for incremental sales growth. Also it is difficult to ignore when a new competitor like Merck KGaA enters the supplier space in a more agressive way through its acquisition of Millipore. Clearly, Merck is serious about further diversifying from its drug business and is trying to build a portfolio of strength with its chemicals and the filters/reagents that the Millipore portfolio will add - all the better to service a bigger chunk of the biopharm production flow. And remember, Merck's CEO remains adamant that this acquisition was worth every single penny.
Otherwise, from a technology point of view, I plan to spend more time writing about the zinc finger nuclease technology exclusively licensed by SAFC, and its use to create very novel platform production CHO cell lines (or other cell types) for use in the biopharm industry. This will enable more control over the efficacy of a drug (e.g. MAbs glycosylation) and may pay particular dividends in the manufacture of non-MAb proteins.
I also plan to follow closely any impact the Judge Sweet gene patent ruling will have on the evolution of the industry - both legal and development climate. I imagine the latter will take a few years to be fully evident as we wait for further appeals and perhaps other cases to hit the courts.
And, believe it or not, I expect to start a new series of posts based on raw material characterization - entitled "The Raw Material Detectives".
Posted by Bruce Lehr April 19th 2010.