ARTICLES BY LOUIS

• 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.

• Who Is Next? Consolidation And Proliferation In The CRO/CMO Market

  4/4/2014

  You can almost hear the questions blowing in on the winds of spring: Who is next? Could it be WuXi PharmaTech looking for a partner in the West or another Chinese provider for consolidation? Or from India, maybe a Jubilant in the hunt? Renewed talk of mergers and acquisitions is in the air.

  Charles River Laboratories (CRL), which nearly wed WuXi a few years ago, and in so doing would have brought East and West outsourcing together in a dramatic fashion, has made it through the ceremony this time and acquired the discovery assets of Belgium-based Galapagos NV, an intriguing U.S.-Europe combination. The specific target assets are BioFocus and Argenta, with both of those being past acquisitions of Galapagos. This one deal is clearly indicative of what the industry – perhaps including pharmaceutical sponsors – has been anticipating.

• A Response From India

  3/28/2014

  A recent article I wrote for Outsourced Pharma on challenges for the Indian outsourcing industry struck a chord with some readers and elicited some high notes. The “music” came from readers in India as well as other countries, and thankfully was upbeat and progressive for the most part.

  Some of the responses reminded this columnist of parts of a book titled “Rivals,” [1] which was published in 2008 by Bill Emmott. Within the book is a discourse on the Indian economy and its relationship (rivalry) with China. More about the book in a moment.

  To sum up the sentiment from readers in India regarding the current topic and article, this one sentence speaks volumes: “India’s low cost is becoming a problem for the whole country.”

   

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  [1] “Rivals”; Bill Emmott, published by Harcourt, Inc. ; 2008

• Communicating R&D Innovations Early And Carefully

  3/5/2014

  You would expect a room full of communications, marketing and public relations professionals to be exuberant in their discussion of how to deliver the company message across platforms and generally boast about their brands. While some of that did take place at the 3^rd Annual Life Science Brand Reputation and Communications Conference in Atlanta (February 20-21), a lot of the discussion focused on FDA regulations and SEC concerns, and the checks and balances applied to patient, media and investor communications by internal legal and investor relations departments.

• The Survey Says Affordability … And More

  2/21/2014

  Life Science is an industry driven by data, with human lives depending on it at any moment of the day. For outsourcing providers hoping to keep on top of sponsor perceptions of CMOs, the data of record is the industry-leading surveyor firm, Nice Insight. Recently they have been helping the industry parse the results of their 2013-2014 Pharmaceutical and Biotechnology Survey.

  The data from this survey is sliced and diced by pharma around the world to help them do some benchmarking (pun intended) of CRO and CMO partners. The Survey serves as a vital aid in helping select the right outsourcing providers, both from a strategic and tactical perspective for individual research programs as well as manufacturing projects. It can also assist with internal versus industry comparisons. For example, it can give insight into questions such as “Why was the experience that I had with a certain CRO different from that of another pharma firm?” And because we work in an industry where  by necessity information is kept confidential, the pharmaceutical sponsors and service providers are often protective of conveying too much information about their relationships (provided they are providing any information at all). The beauty of the survey is that it provides industry-wide data that is available for all of us to peruse and analyze.

• It's A Regional Sale For Contract Research/Manufacturing

  2/3/2014

  During the last few weeks I had the opportunity to speak with three experienced and successful business development professionals in the pharmaceutical contract manufacturing arena. They asked to remain anonymous, so I will simply refer to them as Hu, Himani, and Henry. What I got from these discussions with three individuals from three different countries was contrasting views on outsourcing and the future direction of the contract research and manufacturing industry. You can look at these as different world views, or to put it more accurately, different regional views. 

• 4 Tech Transfer Keys For CMC Success

  Let’s look at two practical activities for tech transfer to CDMOs, and two pieces of just as practical advice for working with those service providers, all four to help you increase your Chemistry, Manufacturing and Control (CMC) effectiveness. 

• Biologics Staying Home, CMOs Destination For Small Molecules

  Jim Miller, President, PharmSource Information Services, Inc., sounds as much like a travel agent as a pharma outsourcing prognosticator at his DCAT Week ’17 market overview on pharmaceutical contract development and manufacturing: Pharma’s billions for biologics are staying home; small molecules continue to hit the road.

• The Future Of CMC Leadership At Radius Health

  New CMC leader — and former colleague — Mike Markey says, “What’s most important to remember about a virtual company is all of our functions work at a desk. None of us actually have hands on; we rely on our CMO partners to get the work done. For me, the external project managers become an integral part of my day-to-day work.”

• Continuous Much More Than Manufacturing

  Bernhardt Trout of the Novartis-MIT Center for Continuous Manufacturing, and Salvatore Mascia of CONTINUUS Pharmaceuticals, Inc., reveal the “true benefits” of this disruptive innovation. It’s not all about enabling new forms of manufacture, but also the discovery and development of novel molecular entities, and all the processes by which we will bring new drugs to patients.