From The Editor | April 17, 2017

Biotechs And Pharma Crystal Clear On Awards: CMOs Must Take All

Source: Outsourced Pharma
Louis Garguilo

By Louis Garguilo, Chief Editor, Outsourced Pharma
Follow Me On Twitter @Louis_Garguilo

Biotechs And Pharma Crystal Clear On Awards: CMOs Must Take All

While standing mid-stage in midtown Manhattan trying to concentrate on correctly announcing this year’s CMO Leadership Award winners, an errant thought kept intruding: They can't be good at one thing.

Fortunately, that thought didn’t result in any misstated awards or winners. But subsequently pursued, it has led to ideas about why, if biotech and pharma customers rank a CMO as “best of” in one area, they select that same CMO in so many other areas as well.

The reveal here is that CMOs have to be placed high on a variety of measurements to measure “best of” on any one individually. Let’s see if we can make sense of this.

Measuring The Many

Quickly, here are some statistics behind the measuring for the 2017 Awards. Eighty-five CMOs were evaluated on 30 performance metrics, based on 339 biotech and pharma company responses to questions reflecting 1,755 service encounters, all resulting in Awards in 6 Core Categories and 8 Individual Attributes (listed below).

Initially striking – and the cause of my onstage thought intrusion – is the fact that if a CMO was an Award winner, with few exceptions they won multiple Awards. In fact, by my count, 22 CMOs were selected as top performers in all 6 Core Categories. Even more, out of those 22 CMOs who were top performers in all 6 Core Categories, 10 were also selected as top performers in all 8 Individual Attributes.

This means those 10 CMOs ran the table on all 14 possible Awards in 2017. (Another 9 CMOs who won all Core Categories were tops in either 6 or 7 Individual Attributes.)

In a sense, these truly exceptional performers aren’t exceptional in one regard: They aren’t necessarily outliers. In fact, we can suggest they form a collective affirmation by the biotech and pharma industry that when it comes to CMOs, “top performance” permeates an organization before it actually arises in any one particular area with consistency.

Sponsors Do Agree on What's Important

As she does each year for Life Science Leader’s CMO Supplement, Kate Hammeke, Vice President, Market Research, at Industry Standard Research (ISR), penned an insightful analysis of the results from this year’s Awards. Here article is titled, Pharma Industry Lacks Consensus On Key Attribute Of A Sponsor-CMO Relationship

Hammeke pursues parsing a different dimension of the data than I am here. She points out that when asked what CMO attribute is most important to a biotech or pharma sponsor in their outsourcing, those sponsor selections are all over the board. She concludes “… this lack of consensus leads to a cloudy decision-making process because no specific criterion dominates the CMO selection decision. Unfortunately … this trend toward greater diversity in selection criteria is going to continue to grow rather than to consolidate around specific metrics.”

Of course Hammeke is accurate and astute in what she’s pointing out to us. I, too, have written about sponsors – from virtuals and biotech start-ups to all shapes and sizes of pharma organizations – and their different needs, and that CMOs today must be flexible to meet those needs. (Here’s one related example.)

However, I’m suggesting the common thread we’ve found running through all that diversity of opinion is that biotechs and pharma of all sizes know exactly what they want: They want it all.

That is to say if a “top performing” CMO in the category of Quality lacks the individual attributes of On-Time Delivery or Right First Time … what’s the point?

And could a CMO even be a top performer in Capabilities but under-achiever in Strength of Science?

Moreover, outsourcing today is just too vital – and at the same time can introduce so much risk – for sponsors to work with a company good at a few parts of the entire equation. Put another way: To get really good at one thing, by necessity you must be good at many things. These categories and attributes identified as important in ensuring a biotech or pharma has the best partner are not unrelated. They are in lock step; part and parcel of the entire activity. The whole is and is not greater than the sum of its parts.

Call It A Culture Of Quality?

Am I going off the deep end on this analysis? I call Hammeke of ISR to ask her thoughts on these musings. (Her first thought was most likely ‘Not him again,’ but she’s too kind to give it voice.) And she puts up with my first line of inquiry: “Is there some unintended but inherent predisposition in our otherwise impeccable surveying and analysis of sponsors responses that leads to the same CMOs winning multiple Awards?”

"I'd say rather you could think of it in terms of the growing emphasis of the culture of quality,” she replies.

Aha. Assuredly, many readers have been having similar thoughts as you’ve been reading this. Today, in many quarters (including originating emanations from the FDA), this type of thinking has been coined as a “Culture of Quality,” an organization-wide commitment to doing everything at a higher level, pursued by biotech and pharma sponsors … and now at their development and supply partners.

Skeptical by nature, and despite the growing books, piles of reports, and oration on this subject, I’d thought “C of Q” an excellent catch phrase adeptly instilled to reinforce an important theme, but wasn’t convinced on the level  of  importance or actual efficacy in practice. That’s been a wrong view on all of this, and the results of these awards make that clear.

But even more than the need for a prevailing cultural change in organizations, with all the opportunities and challenges of drug development and manufacturing in an outsourced model – or an internal model, for that matter – we’ve come to understand we are embedded in a new era, equally born of necessity:

Winners must take all.

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* List of Core Categories

  1. Capabilities
  2. Compatibility
  3. Development
  4. Expertise
  5. Quality
  6. Reliability

List of Individual Attributes:

  1. Accessible Senior Management
  2. Cultural Fit
  3. Innovation
  4. On-Time Delivery
  5. Reputation
  6. Right First Time
  7. State-of-the-Art
  8. Strength of Science