ARTICLES BY LOUIS

• Drug Serialization Reaching Consumers

  2/8/2016

  Three years into a U.S. initiative for drug “serialization,” companies are: (a) working with the FDA; (b) taking their own steps to traceability; and/or (c) hoping the day of reckoning fades further into the future. But the future is here with serialization reaching into the consumer’s home. 

• Is Marketing Manipulating Your CMO Selection?

  2/2/2016

  A report on biologics API outsourcing provides insights on how marketing and reputation influences BioPharma's selection of CMOs. Both sides need to line up actual CMO performance and capabilities with market perceptions. But sponsors beware: Under a marketing spell, it appears the best strategy to select CMOs is to find those perceived as most expensive.

• More Biotech Mixology For Successful Outsourcing

  1/25/2016

  Last we left off, M. (Ken) Kengatharan, PhD, MBA, serial start-up entrepreneur and scientist – or biotech mixologist – was mixing examples of outsourcing that included falsely inflated balloons and Super Hero deliveries of API. Here Kengatharan draws some final lessons and insights into successful outsourcing. 

• Outsourcing Lessons From A Biotech Mixologist

  1/19/2016

  M. (Ken) Kengatharan is an accomplished mixologist. What he mixes professionally is biotech business models, drug researchers and developers, private and venture capital, entrepreneurs and investors … with a large shot of strategic outsourcing. Through his experiences at the five biotechs he’s put together, we can learn how to improve sponsor and service-provider dynamics.

• Pharmaceutical Outsourcing: What Are You Thinking?

  12/17/2015

  In this final editorial of 2015, we look into the collective mind of the outsourcing industry, and select a leader of the year. The biopharma industry is now second to none in global consciousness and importance, and the significance of outsourcing within that heightened position grows in equal measure. Prepare well for 2016.

• Black Swans In Pharmaceutical Outsourcing

  12/4/2015

  Reading the newest edition of "The Black Swan – The Impact of the Highly Improbable,” while writing a future-looking article, feels, in a word, risky. Nonetheless, here’s an attempt to draw attention to the potential for those rare but highly impactful events – Black Swans – in what currently seems an unstoppable march to more pharmaceutical and biotechnology outsourcing. 

• Will Pfizer-Allergan Inversion Lower Drug Costs?

  11/24/2015

  Remarkably, all the noise swirling around the Pfizer-Allergan deal has knocked off the national stage (at least for the moment) the one specific question that has so occupied health care news throughout 2015: the price of drugs. “Will this move by Pfizer help to lower drug prices?” If so, who’d care so much where Pfizer makes its corporate bed?

• The Global CMO Wars: No More Us Vs. Them (Part 2)

  11/23/2015

  Rudyard Kipling’s early-1900s “border ballad” is often quoted: “OH, East is East, and West is West, and never the twain shall meet.” How long will we carry on our border wars between outsourcing service providers in the East and West? Representatives from pharma, bio and service providers recently worked through this battle in a public forum.

• The Global CMO Wars: No More Us Vs. Them (Part 1)

  11/18/2015

  “So you hire three FTEs to perform some route scouting or further route development, scale up, kilo lab work, or other services. For the year in India it’ll cost you around $150,000. In the U.S., it’ll be around $650,000. That’s a delta of $500,000. How do we consider these numbers? How should we think about this?” 

• FDA Should Make “Quality Metrics” Public

  11/10/2015

  Whether or not you agree with the FDA in its determination to collect “quality data” directly from all drug manufacturers – including CMOs – if the agency moves forward, the real question is this: Should that data, and any rating the agency assigns to individual manufacturing plants for quality standards or “quality culture,” be kept internal at the FDA or made public?