Editors' Desk

  1. Is The Virtual Biotech Model In Jeopardy? 3/10/2016

    It appeared we were coasting uninterrupted to a global outsourcing industry fully able to support a wide variety of virtual business models and strategies. But conversations with executives at established biotechs reveal an unfolding reality.

  2. At Biogen, Three Keys To Outsourcing 3/2/2016

    Thomas Holmes, senior director for Global External Manufacturing, Biogen, says: (a) cost is not the strategic driver in CMO selection; (b) “dual sourcing” is revenue independent; and (c) the time from drug approval to market launch is all of 48 to 72 hours. 

  3. Insiders' Guide To Winning In The Drug Delivery Device Market — Part 4: Vertical Integration 2/23/2016

    The tenets of vertical integration can drive a complete combination product development strategy, as well as establish the internal core competencies needed to consistently execute that strategy. I recently sat down with Anand Subramony, VP of drug delivery and device development at Medimmune (the global biologics arm of AstraZeneca). We discussed his thoughts on trends in the drug delivery device market and how the business philosophies of vertical integration can play a role.

  4. Biopharma Climbs The Serialization Mountain 2/11/2016

    The data associated with drug-product serialization will be Everest-like; accessing it may pose every bit the security risk. The difference is millions of people may be trying to access the summit … every day. What’s clear today is that a national program for drug serialization looms large on the horizon, and rises, if you will, high into the data clouds.

  5. Insiders' Guide To Winning In the Drug Delivery Device Market — Part 3: Quality Systems 2/9/2016

    I recently sat down with Christopher Eustace of Hospira, who has over 27 years of quality experience in both the pharmaceutical and medical device industries, to discuss how a combined QS program is necessary for life science companies striving to capture their piece of the delivery device market.

  6. 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. 

  7. 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.

  8. Insiders' Guide To Winning In the Drug Delivery Device Market — Part 2: Regulatory Compliance 1/26/2016

    I recently sat down with David Amor, managing partner at MEDgineering, Inc., to discuss the challenges associated with bringing drug delivery devices to market, as well as emerging therapeutic areas and technologies. David’s background is in mechanical and biomedical engineering, with expertise in regulatory systems and compliance. 

  9. 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. 

  10. 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.