2016 ISPE Biopharmaceutical Manufacturing ConferenceIt is fitting that a city known for its disruptive innovation (think 1960s) would be the gathering place for ISPE’s first US conference on biopharmaceutical manufacturing. Certainly, biopharmaceuticals have disrupted an industry steeped in tradition. Yet that industry is changing and is using ground-breaking strategies to embrace a market that is expected to explode by the end of this decade. Consensus is that both small- and large-molecule players have room to grow in this space, albeit in different ways. And biopharmaceutical’s footprint is such that emerging markets may hold the key for traditional pharma’s ambitions. So, much change and newness all around.

It was no surprise then, to learn that 216 people from 14 countries descended upon the InterContinental Mark Hopkins on 5 December 2016 for ISPE’s three-day Biopharmaceutical Manufacturing Conference. The conference will welcome 39 speakers, from seven countries, to share insights, discoveries and concerns. Two education track sessions, Planning and Managing Capacity Challenges, and Technology Solutions to Meet Capacity Challenges, were designed to provide participants with an understanding of the potential implications of accelerated growth in this sector.

The conference theme—delivering on our promise to patients—is one that ran through the presentations and conversations throughout the first day. Following are some highlights.

A Warm Welcome

John Bournas, CEO and president of ISPE, welcomed delegates, by reminding them that every day, they help implement and put into place operations that put more medicines into the hands of people who need them on an everyday basis. “I feel energized every morning, knowing we at ISPE are contributing in some way to achieving that goal,” he said.

He underscored the international flavor of the conference, and remarked that the knowledge sharing of the sessions also would be international in scope.

John Bournas addresses attendees of 2016 ISPE Biopharmaceutical Manufacturing Conference
CONGRATULATIONS TO THE ORGANIZERS—Bournas congratulated conference co-chairs Andy Skibo, Head of Global Biologics Operations and Global Engineering, MedImmune/AstraZeneca, and Britt Petty, Director of Manufacturing, Biogen, and the organizing committee, which includes Jennifer Cheung, Director, GMP Compliance Audit, Asia Pacific, Roche Singapore Technical Operations; David Clark, Vice President, Global Technical Operations, MedImmune/AstraZeneca; Jennifer Lauria Clark, CPIP, Executive Director, Strategic Development, Commissioning Agents, Inc.; Darren Dasburg, Vice President and Site Head, Boulder Manufacturing Center, MedImmune/AstraZeneca; David Estape, Technology Manager, Life Sciences, M+W Central Europe GmbH; Joseph Famulare, Vice President, Global Compliance and External Collaboration, Pharma Technical Quality, Genentech Inc., A Member of the Roche Group; Juan Hernández Abrams , President, Industrial Services, Fluor Corporation; Antonio Moreira, PhD, Vice Provost, University of Maryland, Baltimore County; and Andre Walker, CPIP, Principal, Andre Walker Consulting.

Bournas went on to present an ISPE “state of the nation.” He began by announcing the impending release of a seminal project collaboration with Pew Charitable Trusts on drug shortages as they relate to sterile injectable products in the American market. “The results of ISPE’s collaboration with Pew contributes to the ongoing discussion on mitigation of shortages.” (Read more on the topic in the January-February 2017 edition of Pharmaceutical Engineering® Magazine). He also highlighted the ISPE Training Institute’s first year, stating that “we’ve had tremendous response from industry, with more than 1,000 people trained during the calendar year.”

Bournas then looked to 2017 and reminded the audience of the upcoming Aseptic Conference, as well as the Europe Annual Meeting in Barcelona. He also announced ISPE’s first Conference on Excellence in Quality Culture and Performance in April, citing the FDA’s recent revision of its Quality Metrics Guidance. “We need to maintain the momentum gained through the Wave 1 and 2 reports,” he said, pointing out that the FDA has put both reports on its website, along with the work The Brookings Institution has submitted on the topic.

He closed with a “rallying cry” for participants to attend the 2017 Biotechnology Conference in Dublin, Ireland, in September 2017, and ISPE’s 2017 Annual Meeting in San Diego next November. “This is your biggest opportunity to network and promote your services.”

My Friend Andy 

Bournas then introduced the day’s keynote speaker, Andy Skibo, an ISPE member for 24 years. He called Skibo a visionary in the manufacturing space and said “I am pleased to no longer have to introduce you as my boss, but rather, as my friend.”

Skibo, former ISPE Board Chair and Chair of the GPMLF (Global Pharmaceutical Manufacturing Leadership Forum), which convenes heads of manufacturing and operations from leading pharmaceutical companies around the world, delivered a presentation on “Significant BioManufacturing Capacity Expansion Drivers, Scale, Consequences”. Delegates gained an understanding of the key changes in the pharmaceutical industry that are driving unprecedented change in the manufacturing environment, and what this means specifically to biologics. They also heard about the risks inherent in planning the USD $20B in investments and the capabilities needed to deliver them.

The GPLMF, he said, is made up of leaders in big pharma and big bio, and informs what is happening within supply chains. He began by telling the story of recent meetings where the conversation inevitably led to a “can we do this?” moment. “With close to $20B in large-scale biologics development, $13B in actual hard development, and much of all of this expansion and development relies upon a narrow group of key suppliers for success.”

He added that current supply chains, focused upon mature products, will have to become segmented supply chains. “While some portion will still be managed for mature products, critically, a significant portion of the supply chain must be focused on agile and flexible response to new pipeline launches and uncertain demand.”

Running the pharmaceutical supply chains are experts from the automotive and apparel industry, among others. And while their skills are being put to good use within the pharmaceutical industry, it isn’t enough to “catch the wave.” Organizations, Skibo said, must shift from managing a mature product line to one that is less so, as the industry shifts to specialty care, with all the complexities and investment demands that entails.

While the answer to “can we do this” is “yes”, Skibo added that proper planning, with focus on the required workforce and delivery methods is imperative for success to occur. And he closed by reminding the audience that “our patients are our drivers.”

From Data to Academia 

The keynote was followed by a General Session, New Paradigms for Manufacturing Capacity, led by Jennifer Laurie Clark.

Laurie Clark introduced Eric Langer, President and Managing Partner, BioPlan Associates, who presented on “Biomanufacturing Global Capacity Trends: New Technologies, Biosimilars, and Innovation,” and then Ruben G. Carbonell, PhD, Director, Biomanufacturing Training and Education Center (BTEC) and the Kenan Institute for Engineering, Frank Hawkins Kenan Distinguished Professor of Chemical Engineering, Technology and Science, North Carolina State University, who delivered “Educating the Workforce for the Future for Biomanufacturing.”

Langer presented a high-level overview of the 2014-2016 results of BioPlan Associates’ annual survey of 222 organizations. He revealed that while there was no standout in the category of most important biopharmaceutical trend, manufacturing production and efficiency is identified as the single most critical trend in bioprocessing, noted most frequently by bioprocessing decision-makers, over the past 3 years. How and when these technologies will be fully commercialized in terms of hiring, and staffing, how to find the right people at the right time for staffing bioprocessing facilities will continue to be a challenge.

Langer next looked at budget shifts since the 2009 recession. New capital equipment saw an 8% increase and the hiring of new staff, 6%, both moving out of a negative budget space.
Outsourced biopharmaceutical manufacturing is growing significantly and steadily, and Langer sees this as a strategic 10-year decision.

He also looked at vendor optimism. Some 30% of vendors indicated they expect to do much better than in the last year. He pointed out this is important because vendors are engines of innovation, with a history of reinvesting in r&d to support new product development. When the participating pharmaceutical companies were asked where they wanted suppliers to invest in new technologies, continuous processing topped the list. 37% of industry said we need to find continuous solutions and 32% said they are actively evaluating or testing a form of continuous bioprocess manufacturing.

Dr. Carbonell presented the results of the BPI/BTEC (BioProcess International/Biomanufacturing Training and Educations Council) survey on challenges and barriers in education and training. He began his presentation by addressing the increased pressures and opportunities biopharmaceuticals have created, and how a new paradigm is required for the future of biopharmaceutical manufacturing. He specifically spoke of the new levels of expertise industry has identified as must haves for new recruits: professional skills, such as management scheduling tools, teamwork, communications, leadership, team organization, financial principles, and big data approaches. These workers of the future are perceived as the most important asset of an organization, and training, an investment.