ARTICLES BY LOUIS

• Fibrotech Knows Translational Research Methodology, Shire and Pharma Industry Agree

  7/8/2014

  Australia-based biotech with anti-fibrosis program designs the best path to clinical success. By Louis Garguilo, Executive Editor, Outsourced Pharma

• Fireworks At BIO 2014 San Diego

  7/1/2014

  Aboard USS Midway, San Diego Bay – The late evening sky west of the ship’s deck lights up with fireworks feting the assembled attendees and honorary of the Biotechnology Industry Organization’s 21^st annual international conference and exhibition. Bright lights rise meteorically and explode in an array of color and excitement, illustrating visually the enthusiasm and energy of the biotechnology industry gathered on board, and by extension around the world.

• Pharma Might Learn About M&A Integration From The CMO World

  6/9/2014

  The urge to merge in the pharmaceutical industry has been strong in 2014. However, the ability to get a deal done and successfully integrate those that transpire is far from guaranteed. This might ring true particularly with the kind of high-profile deals we are seeing recently. Pharma might benefit from some insight into one such deal from the provider side of the business.

  This spring Jim Mullen became CEO of DPx Holdings B.V., formed in a $2.65 billion transaction combining JLL Partners’ assets Patheon and Banner Life Sciences, with Royal DSM’s Pharmaceuticals Products business. Mullen previously held the title of CEO of Patheon. This was a large deal in the service provider sector. In a recent interview with Outsourced Pharma, Mullen walked us through some of the key elements that allowed the deal to transpire.

• The Genes Of The Industry From BIO 2000 – 2014

  6/9/2014

  The first Biotechnology Industry Organization (BIO) annual conference and exhibition I attended was in 2000 in Boston. Early registrants had to be accompanied through cordoned walkways by Boston police mounted on large horses. There were crowds of people, some quite angry, waving creative signs and yelling about staying out of their genes and stopping the altering of their food.

  I am not one to be overly squeamish, but I remember thinking it was fifty-fifty: Either a protester would get me or I would be trampled by one of the horses. I was working in economic development for the state of New York as a Senior Director of Industry Development, and had just been handed the biotech industry cluster. Now I thought I knew why. Maybe I should have asked a few more questions.

• Just When You Thought It Safe….Another Pfizer-AZ Preview

  5/15/2014

  Please consider giving us a bit of credit here at Outsourced Pharma. We reported, like everyone else, the news of Pfizer going after AstraZeneca. What we did not do was inundate you with a whole bunch of conjecture and speculation on the potential deal.

  A lot of attention is of course expected and needed when the biggest pharma in the world goes after an international firm that also makes a lot of news. The media coverage has indeed been informative, well thought out, and thought provoking. It has also reached levels of opining on opinions of the opinions quoted by other sources. Discussed has been whatThere has been discussion of what  this deal might mean for the independent companies, respectively; their separate and combined pipelines and therapeutic areas of prowess; the portents for the entire pharma industry; the impact on patients and drug prices; employees and lay-offs; the economic development, tax policies, and the national pride of the U.S. and U.K. governments; and the newcombined corporate entity that then might be split up again. And all this is happening before we know if the merger is even going to occur.

• What Beer Can Teach Us About Outsourcing

  5/6/2014

  I’m not a biologist or chemist, but apply these disciplines to beer and my interest is immediately piqued. Mix in a discussion of outsourcing – contract brewing, if you will – and we add a dose of professional relevance as well. Yes, this article is related to the pharma industry, so stay with me here if the beer reference didn't wet your thirst.

  First, though, an anecdote about the beer. It starts years ago when the production of my favorite brew was outsourced abroad to serve international markets. The taste never matched up to the original, as confirmed by aficionados of this brand around the world. I was recently reminded of this situation while reading a review in the Wall Street Journal of the new book The Craft Beer Revolution by Steve Hindy. For one thing, it appears outsourcing in the microbrew industry – the biotechs of beer – is being questioned. Would a microbrew from, for example, Brooklyn Brewery, be less than honest with its customers if they outsourced production far from the five boroughs?

• CPhI Report: For Manufacturing “Process” Or “Quality,” It's Statistical Control

  4/24/2014

  According to a new report entitled CPhI Pharma Insights, pharma needs to drive manufacturing forward, and advancements should come from within companies, not from the outside push of regulatory bodies. Advancements coming from within will lead to lower costs and improved quality. When the advancements are pushed from the outside, they can keep prices high and hurt efficiencies.

  The report, based on a cross-section of industry participants in a survey on manufacturing, is a succinct read and analysis of the current state and future needs in this segment of the pharmaceutical industry. What with recent and very publicized quality-related challenges in manufacturing – both at outsourced plants and internal facilities – it would have been surprising if quality hadn’t come out in the survey as the top focus for pharma. Indeed, “improving product quality” was ranked number one.

• Is Long-Term Unemployment An Issue For Pharma?

  4/24/2014

  As we slipped into the booth at the local diner, it occurred to me that the last time I had spoken to Glen was at this same venue. “Yeah, that was two years ago,” he said with a tinge of nostalgia. Two years ago? Time had flown by for me but I know it was not the case for him. Glen still had not found a new full-time position.

  A Ph.D. scientist (organic chemistry) with solid people skills and senior management experience, I was surprised when he got down-sized. I was just as sure he would end up in a good place in the long-run. Unfortunately, the long-run never came. After pursuing “more than 100 legitimate job leads and conversations throughout the pharmaceutical industry,” Glen is still looking for a new job. And just like that, I found myself sitting face-to-face with the long-term unemployment epidemic that is afflicting many individuals in the U.S., as well as scientists and pharmaceutical employees from around the world.

• The Language Of Our Industry

  4/21/2014

  True character and the quality of our thoughts are revealed in the way we talk about ourselves and the events in which we participate. We may purposely affect certain patterns of language, but the real thing is sooner or later uncovered.

   

  Or something like that. We also know we have to walk the talk, as the more succinct saying puts it. Considering specifically the language of the contract drug discovery, development and manufacturing industry, in a recent outsourcing survey conducted by contractpharma.com, 75% of respondents said that they would use the word “partnership” to describe their relationship with their contract service providers. That has to be good news for both pharma sponsors and the CROs/CMOs around the world, and points to an improvement in level of service delivered by the latter.

• Sun Pharma, Ranbaxy and the Deming Management Method

  4/8/2014

  Where the Japanese have failed, the Indians will succeed? Sun Pharmaceutical Industries Ltd has not only agreed to step in and purchase Ranbaxy Laboratories Ltd, symbolically they have stepped up to the plate for the entire Indian manufacturing industry. It is in some regards an audacious move: The Japanese, known for high quality manufacturing standards, could not bring Ranbaxy through its challenges. It may not have been a strike out for Daiichi Sankyo, but they have taken a walk. Now an Indian manufacturer is in the batter’s box for team India.

  Sun Pharma is not downplaying the objective here. “ We are not looking at synergies of manufacturing; the focus is to achieve compliance" at Ranbaxy, said Dilip Shanghvi, managing director of Sun Pharma. Competitors or otherwise, shouldn’t all India wish them well? The rest of the world – and the FDA – is surely watching carefully.