FEATURE ARTICLES

The Rocky Journey To Refocusing BioMarin
The Rocky Journey To Refocusing BioMarin

Recognized today as one of the world’s most-innovative companies, BioMarin was a far cry from that 12 years ago when Jean-Jacques Bienaimé took over.

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ALSO IN THIS MONTH'S ISSUE

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WEB-EXCLUSIVE EDITORIAL

  • Biosimilars In Hospital Settings: What You Need To Know
    Biosimilars In Hospital Settings: What You Need To Know

    A few months ago, Biosimilar Development published an interview with Dave Picard, VP of biosimilars and injectables for AmerisourceBergen, who shared his predictions on how biosimilars will fit into hospital distribution models. Based on the popularity of that article, we decided to reach out to another leading U.S. drug wholesaler for their perspective on the topic. In this Q&A, Chadi Nabhan, M.D., VP and chief medical officer of Specialty Solutions at Cardinal Health, discusses biosimilar uptake at the hospital level — and how biosimilar companies should be planning their distribution strategies.

  • Beyond The FDA Guidance:  Practical Considerations For Quality Agreements
    Beyond The FDA Guidance: Practical Considerations For Quality Agreements

    Much has been written in recent months about the FDA’s final guidance for industry, Contract Manufacturing Arrangement for Drugs:  Quality Agreements, issued in November 2016.  Recently, a thorough assessment of the guidance requirements and gaps was published on this website. (See FDA's New Quality Agreement Guidance — What It Says (And What It Fails To Say) and Examining FDA's New Quality Agreement Guidance.)

  • Building A Productive Relationship With FDA: Beyond The Science
    Building A Productive Relationship With FDA: Beyond The Science

    Whether your relationship with the FDA starts with pre-IND feedback or simply with an IND submission itself, these early interactions will likely form the basis for a long (and hopefully happy) marriage.  After all, this liaison could very well last beyond submission and initial approval of a marketing application to include additional trials relevant to the drug’s development and labeling.  As there is no manual available for building an effective and collegial relationship with the FDA, this article offers helpful tips to assist sponsors in establishing and maintaining this critical union.

  • What Would Steve Jobs Tell The Pharma/Biotech Industry?
    What Would Steve Jobs Tell The Pharma/Biotech Industry?

    Whether you’re a fan of Steve Jobs and his products or not, two things are undeniable: He was very successful and very different. Now you can relax; this short article will not provide a blow-by-blow account of the man and his methods. “What would Steve Jobs tell the pharma/biotech industry?” is just a metaphor to encourage our industry to radically change — not by reinventing the wheel, but by copying the success of others.

  • Engaging A Life Science Consultant: Common Pitfalls & Best Practices
    Engaging A Life Science Consultant: Common Pitfalls & Best Practices

    This article summarizes insights gleaned from interviews with multiple consultants, each of whom has at least 25 years’ experience in the life sciences space — and from conversations with the life science companies who hire such consultants to ensure that their systems meet the product quality attribute/specification requirements mandated by their respective regulators.

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BEYOND THE PRINTED PAGE

  • 6 Industry Icons Weigh In On Internal Rate Of Return For Biopharma R&D

    In the July 2017, Life Science Leader magazine we will be publishing the article — Balancing Biopharma’s Bright Future Against Its Tarnished Image — 6 Retired CEOs Share Insights For Today’s Industry Leaders. The story features six former CEOs: Mike Bonney (Cubist); Hank McKinnell, Ph.D., (Pfizer); Francois Nader, M.D., (NPS Pharmaceuticals); David Pyott (Allergan); Stephen Sherwin, M.D., (Cell Genesys); and Henri Termeer (Genzyme).

  • CSL Limited CEO Shares Insights Beyond Just How To Grow Revenue

    Being the head of any Big Pharma is bound to test an executive’s work-life balance. But when that Big Pharma is headquartered in Australia, and the company prides itself on being a “global operation,” maintaining any kind of work-life balance is a formidable task. “I’m not the poster child for how to strive for work-life balance,” admits Paul Perreault, CEO and managing director of CSL.

  • 9 Questions With Takeda Oncology’s Chief Counsel And Head Of Patient Advocacy

    In 2002 Liz Lewis joined Takeda where she is currently chief counsel and head of patient advocacy at Takeda Oncology. Lewis sat down with me to share how she helped enhance Takeda Oncology’s patient advocacy organization.

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LIFE SCIENCE TRAINING INSTITUTE COURSES

Making Training Stick: Ensuring Your GMP & Task Training Is Effective June 22, 2017
1pm-2:30pm EDT, Online Training
How To Establish The Number of Runs Required For Process Validation June 28, 2017
1:00 - 2:00 PM EDT, Online Training
CRO Oversight Post ICH GCP E6 (R2) Addendum July 10, 2017
11:00am- 12:00pm EDT, Online Training
Monitoring Plan Development: Post ICH GCP E6 (R2) Addendum August 25, 2017
11:00am- 12:00pm EDT, Online Training
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MAY 2017 DIGITAL EDITION

2017 CMO AWARDS SPECIAL EDITION

BLOGS

  • Biopharmaceutical Industry CEO Of The Year — An Update
    Biopharmaceutical Industry CEO Of The Year — An Update

    On April 25, 2017, I posted a blog asking the question, Who Is The Biopharmaceutical CEO Of The Year. In the blog, I included a link to a short survey. Our goal was twofold: see if there was enough interest in continuing to pursue such an award, and generate an initial list of names that would be in contention. Thus far, 10 names have been submitted via dozens of submissions, but it’s too early for us to make any decisions or conclusions based on such a small amount of data.  

  • Biopharma Innovation — Value At Any Price?
    Biopharma Innovation — Value At Any Price?

    In March I attended The Conference Forum’s R&D Leadership Summit. One of the panels that provided a great deal of insight involved executives discussing how to assess and create value for patients, payors, regulators, and society. This event employs the Chatham House Rule, which means “Neither the identity nor the affiliation of the speaker(s), nor that of any other participant, may be revealed.” Despite not being able to reveal that info, I still think the ideas that were shared will prove valuable.

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