From The Editor | September 8, 2015

BioPharma Striving For LifeCycle Outsourcing™


By Louis Garguilo, Chief Editor, Outsourced Pharma

BioPharma Striving For LifeCycle Outsourcing™
Panelists guide discussion on an outsourced supply chain. Participants include Ray Kaczmarek, VP Commercial Mfg & Supply Operations (Pacira Pharmaceuticals); Paul Maffuid, VP Pharmaceutical Development and Operations (MabVax Therapeutics); Nils Olsson, VP CMC (Retrophin); Joseph Payne, President and CEO (Arcturus Therapeutics); Philip Roberts, VP Technical Operations (Orexigen); Robin Hooker, Director, Healthcare Marketing (UPS).

I’m usually pretty good at plucking overall themes from the various topics that swirl around international conferences. (Well, at least I think so.) That’s why initially failing to do so for the recent Outsourced Pharma West San Diego (OPW) conference was bothering me.

But having read the headline to this article, you can see I eventually managed my way through. All the discussion and debate, scientific fields and technological edges, and trends and strategies related to biotechnology and pharmaceutical (BioPharma) outsourcing opportunities and challenges, eventually bled together.

I should have known. Here’s the intro to the OPW conference brochure: “… the role of outsourcing throughout a drug’s life cycle – from discovery to commercial – continues to grow to the point where we need to consider expanding our definitions of ‘sponsor’ and ‘service provider.’”

Definitions are expanding precisely because boundaries are blurring among the disciplines and players in the BioPharma outsourcing industry. Let’s start in San Diego.

Currents On The West Coast

First, let’s be clear the OPW panel-audience discussions were focused and outcome-oriented. These were professionals gathered to find solutions, fill particular outsourcing needs, and make an impact on the industry. For example, a panel titled “FDA quality initiative impacts on CRO/CMO relationships” was specific to and may end up with suggestions for the FDA regarding its request for “Quality Metrics Guidance for Industry.”

A specific conference goal was bringing industry professionals to the San Diego biotech cluster to help serve the needs of that community. Mission accomplished. But there are no boundaries in BioPharma anymore: those San Diego biotechs, industry consultants, Big Pharma panelists, and outsourcing service providers, naturally brought with them all the global aspects of all areas of the industry. Regional bio-clusters are wide open to global currents and competition, and can’t ignore the opportunities for relationships around the U.S. and offshore.

Even without a session targeted at China and/or India options and challenges, how these and other offshore locations could – or couldn’t – fit into an outsourcing strategy was raised throughout the two-day conference. Some may have been surprised it was Australia that received a number of mentions: Australia has a growing number of drug discovery and development organizations to partner with. It is an attractive location for clinical trials, and provides a national tax credit on R&D activities performed there. (Outsourced Pharma readers wouldn’t be surprised, though.)

CROs, CMOs, But CRDOs?

Moreover, while the conference aimed its sights on the development and manufacturing (CDMO) side of the outsourcing equation – and had the right people talking to the right people – conversations frequently incorporated contract research organizations (CRO) as well. Not a loss of focus; more a melding of industry. Panelists (including from Big Pharma) and the attendees from start-ups and virtuals inform us that nowadays you need to survey the entire outsourcing landscape to dive wholesale into any part of the outsourcing infrastructure. What’s before, what’s ahead, what’s the business strategy within the entire continuum?

There are a number of reasons for this. The most obvious perhaps is the changing regulatory environment for fast-track approval-paths and smaller target-disease markets. This, and the rise of biologics (and biosimilars) has lead to compressed timelines, innovative partnerships, and more products moving through outsourcing supply chains. Even with small-molecule projects, the stages of discovery and development seem to increasingly intersect at the edges of late discovery-early development.

Next, more companies are basing their business models on a complete outsourcing strategy (for example, Retrophin Inc., and look for an upcoming Outsourced Pharma article on Dauntless Pharmaceuticals). On the service supplier side, CMOs continue to expand service offerings, and at the same time become “technology-platform” providers, reaching as far upstream as possible for that initial customer contact. CROs, on the other hand, are reaching further downstream to keep the customer as long as possible as projects mature. We have seen the rise of CDMOs; maybe next we’ll hear more about CRDOs (contract research and development organizations)? … Well, anyways, I think you get the point.

LifeCycle Outsourcing™ For A New Era

Therefore, even the start-up or virtual biotech largely inexperienced with outsourcing came to the OPW San Diego conference with at least some vision of the entire new-drug discovery and development continuum. BioPharma itself has been reaching and innovating for a fuller service integration as well. It’s a vision that we at Life Science Connect – the producers of OPW – are starting to call LifeCycle Outsourcing™.

This is the ascending of a holistic clarity from the blurring of what in the past were separated parts. The unclear demarcation between: conversations on the costs of outsourcing and venture capital funding of biotechs; measuring the output of your CROs, CDMOs, and other partners; virtual businesses for drug discovery and advanced candidates in fully outsourced models; have all led to a new and growing interrelationship. This is the complete management of your specific outsourcing needs with a fuller understanding of the whole. It reaches down into the nitty-gritty aspects of grabbing onto the best partners in the world, and crafting the best contracts and agreements, up to the ability to show scientific and financial rigor to regulatory authorities and investors.

From the start-up to Big Pharma, when company profitability and strategy – and more than ever existence – is interdependent upon outsourcing throughout the life cycle of new drugs (generics, and biosimilars), then a parallel and holistic view becomes a strategic and managerial necessity. Outsourced Pharma West came through with one heck of a theme after all. My colleagues and I will do our best to continue to provide the information and venues to bring this vision to reality.