From The Editor | December 17, 2015

Pharmaceutical Outsourcing: What Are You Thinking?

louis-g-photo-edited

By Louis Garguilo, Chief Editor, Outsourced Pharma

Pharmaceutical Outsourcing: What Are You Thinking?

Consider how humans interpret important and extended conversations. The cognitive process includes a gradual identification of recurring topics and points, as well as a fair amount of heuristics. There are also the less significant asides that upon further introspection grow larger in meaning. What are these themes and undertones from this year’s conversations that will continue into the New Year? I’ve captured some interpretations below.

I hope you have some time to spend with this final editorial of 2015. Thank you for reading, responding, and contributing throughout the year. Best wishes for 2016.

Who Are We?

Louis Garguilo
More pharmaceutical work than ever before is performed at outsourcing service providers and external partners. It’s important for sponsors to know these scientists, engineers, managers, and executive leaders working on their behalf. In 2015 we (again) dealt with “knowledge transfer” from pharma to providers. Just a few months back we looked at recruiting into the service provider industry, where there is a growing responsibility to obtain, train and maintain the best workers:

Are There Enough Biomanufacturing Workers In The U.S.?

Who Wants To Work At A CMO Anyways?

On the discovery side, we learned how pharma is effectively reaching out to (global) academia:

GSK’s Discovery Fast Track Contract Starts With Super-Moon Eclipse

Can Bayer Innovate the Incubator For Japan?

A comparison we should continue to make throughout 2016: Will biopharma outsourcing obtain more of the productivity and profitability that enhanced project management has provided other industries (e.g., aerospace, automobile, information technology, and semiconductors)? Enhanced project management is a meme to watch for:

Pfizer Says Science First In Alliance Management

Breaking Down Silos In The Field of Pharma

What Have We Become?

New business models abound. Today, they drive the way we develop and manufacture drugs, generics and biosimilars. We used to have “biotech,” but now we speak in terms of “virtuals,” “start-ups,” and “private equity,” analogous to their use within the Internet industries. Increasingly, we have companies with models like this:

New-Era Drug Rx: C-Corp Per Compound And Large Dose Of Outsourcing

An All-Outsourcing Model For Orphan Drugs

We’ve had to adapt to changing regulatory environments, shifting societal attitudes and perceptions, and the mutable politics of healthcare in general:

Can This Outsourcing Model Save Health Care?

Biosimilars Part 2: It’s All About Dollars Now

Of course the billion-dollar question remains: What should new drugs cost, and how can value be better assigned to a doctrine of price fairness? At Outsourced Pharma, we took a direct look at some leading indicators:

Measure Lives Gilead Returns, And The Returns It Provides

Will Pfizer-Allergan Inversion Lower Drug Costs?

Where Are We Going?

The geographic answer to this question is, “Everywhere.” Drug markets, drug companies, and pharmaceutical outsourcing leave no corner of the world uncovered.

But that doesn’t mean we’re all reading from the same map. We have questions regarding a global system where higher pricing of drugs in the U.S. subsidizes lower pricing in other parts of the world. Borders come lined with stark demarcations when it comes to regulations:

Harmonized Post-Approval Changes: A Vaccine For Global Drug Shortages

However, our most immediate concern – and concern is the correct word – is an industry bifurcated into East vs. West:

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

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

Sponsors, providers, regulators and consultants now gather to discuss all these moving parts, opportunities and challenges, at Outsourced Pharma Conferences. I’m proud to say we’ve taken a leading role in the search for best practices and new paradigms to more effectively shape our advancing outsourcing industry:

BioPharma Striving For LifeCycle Outsourcing™

In 2016, Can Outsourcing Relationships Survive The Biopharma Life Cycle?

A Final Word: Leadership

At the beginning of the year I took a somewhat iconoclastic look at leadership:

Naked Leadership: Stripped To Results In BioPharma

Misjudging Leadership In the BioPharma Industry

Why this off-kilter viewpoint? To deal with all the above successfully, we’ll need enlightened stewardship, and thus should think long and hard about what that might best look like. Paraphrased from the recent article Black Swans In Pharmaceutical Outsourcing:

We’ve reached an interesting point where the service provider industry needs to make a decision: Are we going to lead? Are we going to take the reins, or let leadership fall back to big pharma? The pendulum could swing back, and pharma could say our partners are not taking a leadership position in this ... Will service providers become a leading force in the pharmaceutical industry?

The subject of leadership, though, wasn’t dealt with exclusively from an attitude of inquiry. Here’s a direct example of leadership in action:

Leadership At “The Best CMO In The World”

And finally, in this end-of-the-year spirit, if asked to give out a “Leader of the Year Award” for our broader industry (yes, I realize nobody is actually asking), I’d select Pfizer CEO Ian Read.

I’d select him foremost for his sheer determination – in the face of mounting societal and governmental skepticism regarding pricing, business practices and the like – to pursue global advantage for his company. Certainly not the first decision of its kind, and equally certain not a direction we can all agree on, but by orchestrating a “reverse-merger inversion” with Allergan in the U.K., this Pharma leader’s actions reverberate deeply within and echo widely without the biopharma industry. And by extension, this is the most important theme of these times for readers of Outsourced Pharma:

The business of drug discovery, development, manufacturing and marketing is now second to none in global consciousness and importance, and the significance of outsourcing within that heightened position grows in equal measure.