From The Editor | December 27, 2016

Are You The Future of Pharmaceutical Development?


By Louis Garguilo, Chief Editor, Outsourced Pharma

Are You The Future of Pharmaceutical Development?

2016 goes in the record books as a year of mass meditations on innovation in drug development and manufacturing outsourcing. Now ’tis the season for more individual reflection and projection. So yes, I’m talking to you:

“Are you part of this innovative future?”

Maybe you need help answering that. If so, here are some inner deliberations of two industry players – from Pfizer and much smaller drug-developer ADC Therapeutics – made public when they were bushwhacked by this very question during a recent thought-leadership panel discussion.

Big Pharma: More Of The Future Than In The Past

“In a way, we’re a bigger part of the future now than we might have been,” says Bernie Huyghe, Senior Director at Pfizer. “We used to be more reactionary. Now we have actual budgets established specifically for programs designed to think through five- or ten-year plans. Our technology innovation used to be based more on acquiring promising molecules, and trying to fit those into established manufacturing methods. Today we’re taking a much more active role.

“For example, in continuous manufacturing, we’re developing a ‘pod system,’ and the manufacturing units within these portable environments. Moreover, we’re doing it in partnership with a CDMO. More than in the past, we’re taking advantage of other people’s expertise.”

Huyghe continues: “These incremental advances are important and effective. At the same time, we really go after some of the bigger-ticket items as well. We’re not focused exclusively on a five to ten percent increase in productivity; it’s more like fifty to seventy-five percent. For example, we’re literally trying to build a skid where you just put in a master cell-bank file in a fully automated process. I can say that Pfizer and our employees are grasping this vision of taking on a more ambitious role to drive technology.

“So I would say, yes, we are a part of the innovation future.”

What does Huyghe think is the main driver?

“It’s the same pressures everybody is facing. For one, competition is increasing. If it currently takes $2 billion to develop a drug, maybe we can figure out how to cut that down substantially in many cases, and use those funds to invest in more innovation and technology, and provide better returns, and better results for our patients.”           

One shadow in this reflecting mirror of the future hovers over the area of creating workable models for service-provider relationships. During the conference session that elicited Huyghe’s comments, an audience consisting of over one-hundred biotech, pharma, CMO, and other service providers and consultants were asked, “Are there applicable business models for sponsors and providers to drive new technology and innovation?” Sixty-five percent selected this answer: “No, mutually beneficial financial and/or relationship models to drive innovation at CDMOs/CMOs have not been clearly established.” (The remaining 35% selected: “Yes, both sides have, or are reaching, financial, IP-sharing, and other agreements that foster innovation in the external supply chain.”)

Not a bell-ringing endorsement for a future of individuals at partnering companies driving innovation in drug development and manufacturing. Nonetheless, Huyghe remains sanguine heading into 2017.

“I believe leadership philosophy at many Big Pharma has already or is changing,” he says. “There’s a strong push from the top. It’s a push for big change – on the level of Steve Jobs, Elon Musk, and others in other industries – and its more disruptive of the future by design.” And that leadership, we’ve seen, can drive innovation across platforms and partnerships, and down to all the individuals that make up an industry.

A Bigger Future With Smaller Partners

Michael Mulkerrin is Vice President and Head of CMC at ADC Therapeutics. As the company name suggests, Mulkerrin is focused on the development of proprietary antibody-drug conjugates, specifically for the treatment of both solid and hematological cancers.

“Sure,” he says, in response to our query into his future. “As a small company, you have the freedom to innovate more extensively. In our case we’re developing an innovative drug, and working towards antibody-drug coadjutants in an environment where we can also create new manufacturing processes focused on ADCs. Small companies and the individuals within believe strongly in the future of their emerging technologies. And more smaller and virtual companies are going to bring a great deal of innovation to the delivery of better oncology drugs.

“And the way I approach the future is by working with contract manufacturers early, to discuss how to bring these new technologies into a manufacturing process,” explains Mulkerrin. “We look at ways to manufacture materials more efficiently, and at innovative technologies for doing a conjugation, for example. We are even engineering the antibodies in order to gain better therapeutic index and manufacturing efficiencies.”

And, says Mulkerrin, this will then gather the attention of his bigger brethren.

“I think eventually bigger pharma companies will learn of this technology or adopt it. But it’s the smaller companies who will continue to bring those new ideas – and energy – into the development of new drugs throughout the industry.”

What are the clouds that Mulkerrin sees in achieving this successful innovation implementation?

“For one,” he replies, “It’s still difficult to find a contract manufacturer willing to share risk. As an organization, we seek out contract manufacturers willing to embrace new ideas, and incorporate those into their processes.

“Frankly, one of the ways we have engaged in development objectives is to not use large contract manufacturers. Instead, we see success with small CMOs who are like us – building their business upon new ideas and innovations for specific areas of drug development and manufacturing. A model for us is to find new methods to manufacture, and include those in our planning. We then transfer that innovation into contract manufacturers willing to move forward with us, and help us build upon these breakthroughs. These CMOs, too, are a vital part of the pharmaceutical innovation future we are talking about.”

What About Your Future?

Attendees at that conference Huyghe and Mulkerrin participated in were also polled on whether there is “room or opportunity for innovation in your own daily job." Seventy percent responded yes. Now that’s certainly an encouraging result. Can you also answer in the affirmative?

If so, it could very well mean you’re employed at an organization that is a part of the quest for increased innovation in drug development and manufacturing, including at the crucial incremental level, and perhaps the larger disruptive variety as well.

More important is what it says about you personally. Whether executive management, entrepreneur, bench scientist or plant engineer, quality or regulatory professional, project manager, or any other position – your looking for opportunities for innovation during your day-to-day duties places you in a key role in our future. 

If, instead, you currently have to answer this immediate question in the negative, and you are experiencing less of an environment for innovation … there’s still time to do what you can to change your organization, and if necessary alter your personal future in pharmaceutical development and manufacturing.