Innovations in the Biotech Supply Chain Management

Foster City, CA, October 29, 2015:  The 2015 Bio Supply Management Alliance Conference met in Foster City, CA at the Crowne Plaza Hotel. The 240+ members in attendance heard a broad spectrum of speakers address the major issues confronting supply chain executives in the biopharma industry, namely genomics-data-driven incubation, improved processes in the end-to-end supply chain of this highly regulated industry, and SCM innovations and technologies driving dramatic changes.  The collaboration between BSMA and the Council of Supply Chain Management Professionals (CSCMP) produced a town-hall-like environment at the extraordinary summit of professionals.

Voicing the Innovation in SCM spirit of the event, Amanda Cashin, PhD, Director of the Accelerator Program at Illumina, presented the Plenary Keynote titled “Genomics Innovations: Shaping the Future of Medicine.” Illumina  supports  an innovative funding program for genomics startups. She noted. “The cost of sequencing has declined faster than Moore’s Law. It cost $3 billion to sequence the first genome. With today’s advanced technology, the cost has come down to$1,000 and takes one day vs. 3 years for the original sequencing. As a result, sequencing is now accessible, rapid, and the promise of Genomics innovations is still early in the game.” The early promise for the biopharma includes precision medicine, such as  drug discovery, and tailored therapeutics – matching the right drug for the right patients.

As anyone associated with supply chain management can attest, the process is filled with uncertainty on many fronts. David Volk, Director of Supply Chain for Hoffmann La Roche-Genentech spoke about some of the uncertainties of dealing with the industry’s regulatory process. His keynote titled, “Accelerated Product Launch with FDA: Integrating Clinical and Commercial Supply Chains,” used a case study on Gazyva, a treatment for leukemia. He identified the biggest general challenge as uncertainties in clinical trials regarding supply needs due to serving multiple sites while the company is running 500 trials per year. Gazyva received breakthrough therapy designation from the FDA based on a strong safety and efficacy review during clinical trials. As a result, the FDA requested that Genentech accelerate the launch of Gazyva by six weeks and asked if clinical supply could be used for the launch. The launch team applied agile have solutions to resolve many ambiguities during the launch phase. This required collaboration both internally and with the regulatory agency (FDA in this case) which was key to the successful early launch.

Andrea Goddard, VP & Head of Global Quality, presented ““Biologics Drug Substance Quality Management: Integrating the Global Supply Chain”.  She pointed out that, unlike the Volkswagen’s scandal of compromised diesel emissions testing, quality in the corporate culture must be ingrained with every employee. For a biopharma company, that means, “Think first of the individual patient.” She addressed the challenges of demand uncertainty, especially at the clinical level; suppliers making small, unreported process changes; storage and transport (accidents, cooling failures, customs issues, etc.); and, disaster recovery (understanding all potential risks and mitigations). She also noted that FDA guidance for industry including CGMPs is a risk-based approach.

Carl Finamore, Director, Healthcare Industry Advisory at PwC, highlighted “Balancing Cost, Service, and Risk to Achieve Operational Effectiveness”. The PwC “Operational Effectiveness Index” (OEI) is a way to measure biopharma operational performance. The OEI uses 13 metrics which are represented in a 3-D performance pyramid graph. The three parameters focus on minimizing total lifecycle costs; minimizing operational risk; and maintaining high service levels to meet patient needs. He concluded that the OEI tool can be sued to manage or measure all facets of the biopharma industry including CMOs, a company’s internal network and overall industry performance.

“Industry 360° – Advancing the Efficacy and Integrity of the Global Supply Chain”, was a panel moderated by Wayne McDonnell, Partner, Life Sciences Advisory, PwC. Kevin Pegels, Vice President, Global Supply Chain, Biotech Division of Bayer  Healthcare, identified his #1 challenge as growth. “Our biotech division will grow 15-20% this year. As a result, we’re broadening our global network and getting into topics like network allocation and process standardization across sites. This includes product data change management, master data, cold chain management and inventory.” He identified his #2 challenge as implementing best practices for postponement. Posed as a question, he asked, “How do we postpone packaging of some of our smaller products for highly volatile markets and move them into a regional facility and still remain compliant? We also looking at components like syringes that we can label closer to where we package and be more agile and flexible as well.” Andrea Goddard, VP & Head of Global Quality Biologics Substance, Genentech also posed her biggest challenge as a question: “How do we adjust and adapt to build more agility into our substances?” Paul Seaback, Head of Global Supply Chain USA at Gilead Sciences, noted that he’s quite passionate within the company about how to integrate and collaborate both internally and externally. As he realistically noted, “We can’t always tackle all of these topics simultaneously. We have to tackle them on some sort of priority basis. What’s important to understand is how we’re doing it now and how we can use data to adjust to the changing needs of the market.” The final panelist, George O’Sullivan, Sr. Director of Supply Chain & Strategic Sourcing, Kite Pharma, cited the challenges posed by the personalized treatment solution.  Perhaps exemplifying innovation the most, he explained Kite’s circular supply chain, ”A cancer patient undergoes a 4-hour process to harvest a supply of white blood cells. These are shipped via an orientation agnostic dewar to Kite’s facility. In effect, the cells are retrained over the next two weeks in Kite’s facility to attack the cancer. The retrained cells are then shipped back to the medical facility to reinject into the patient, an example of the patient-to treatment-back to patient circular supply chain.”

Rick Blasgen, President and CEO, Council of Supply Chain Management Professionals (CSCMP) delivered the keynote address titled, “Meeting Challenges in Today’s Global Supply Chains: A Personal Road Map.” He noted the many similarities between supply chains across other industries and biopharma supply chains. He noted that innovation is happening very rapidly and said, “Supply Chain as a profession crosses all boundaries. If we find life on Mars, we’ll be the Intergalactic Council of Supply Chain Professionals, first on the scene to deliver goods and services,” which drew a chuckle from the audience.

Immediately following his address, Blasgen moderated a panel titled, “Bio-Tech Meets Hi-Tech: Driving Innovation”. Panelist, David Ginsberg, VP, Supply Chain, Sonic Manufacturing (an Electronic Manufacturing Service), said, “We bring a million parts per week into our building so our supply chains can become complex. We didn’t like what we saw as models for the EMS industry. So we focused on data quality and exception management. We’re now at a stage in our evolution where we can drop in customer demand on the front end and the parts will show up in the dock with no human intervention and move across the [manufacturing] floor with no management sign-offs. When it works, it’s flawless. We currently run about two-thirds of our material through the system and are working to get the rest into it.” Mark Buck, Global Supply Chain and Procurement Leader, Bio-Rad Laboratories said, “We have lots of risks. When I came to Bio-Rad from Selectron and Apple, I thought I knew supply chain. But the biopharma industry has lots of risks. When I came to Bio-Rad, I had to learn cold, semi-cold and hot supply chains all in one place at the same time, just so one of our customers can be happy. He’s a scientist and didn’t understand supply chain at all. There’s a lot of compliance and risk that are very unique for this industry.” Jim Latimer, Director, Purchasing, Medivation, echoed Buck’s point about the uniqueness of the industry. “The biopharma supply chain has unique characteristics and challenges. As an industry, we have some unique risks not associated with other supply chains.” Finally, Tim Jordan, Director, Siemens Healthcare added, “The biggest issue I have is the collaboration the different silos inside the company. It’s hard to get them to understand the impact of a decision they made last year on that design when it has a 15 or 20 year product lifecycle.”

Reflecting on the overall Plenary Session, Kevin Pegels, the Vice President of Global Supply Chain USA at Bayer Healthcare (Biotech), summed it up really well, when he remarked, “This year’s conference was the best BSMA event that I have attended. The morning presentations were very engaging and thought provoking. The CSCMP linkage was a great idea.  The afternoon tracks provided good detail for those that desired to go deep on certain topics.  The overall attendance set a record.” Echoing his sentiments was Lawrence Feirman, Director of Client Solutions at UTi. Who remarked, “I thought the conference was one of the best I have EVER been to! The conference was well organized, the speakers and their material were relevant, researched, and of importance to me, and many others with whom I spoke. There was an air off excitement, especially from the opening presentation by Ms. Cashin. Seeing former co-workers, clients, and a number of targeted clients, was money and time, well spent!”.

The Plenary Sessions were followed by major parallel tracks of Clinical Supply Chain, Young Professionals Career Development and Global Distribution Network Integrity with focus on temperature-controlled distribution. BSMA Awards for Excellence in Supply Chain Management were given to Genentech and Fisher Clinical Services.