~~ Getting Patients a Drug That Works

October 25, 2017

David Marash

MENG, Keck Graduate Institute

Supply chain integrity is a fundamental component of effective patient treatment. The 10th annual Biosupply Management Alliance Conference highlighted many challenges and solutions in this space.

Thermal and vibrational shocks were singled out as major sources of deviation and product loss. Biologic therapeutics can undergo irreversible changes that reduce or eliminate their effectiveness if they are exposed to temperatures outside an acceptable range. Per CargoSense’s presentation, temperature deviations within the supply chain inflict $35 billion of losses on the pharmaceutical industry each year. Excessive physical stresses from handling and movement can similarly impact product integrity in transit. According to UPS’s presentation, drug product can be subjected to over 100,000 shocks from tarmac vibrations in a single shipment and these shocks are the greatest source of product loss in the pharmaceutical supply chain.

Corporations with representatives present at BSMA ranging from FedEx and UPS to Bayer and Fisher have entire departments dedicated to counteracting these potential setbacks. They are constructed to collectively manage the entire scope of the pharmaceutical supply chain and ensure that the best possible processes are implemented with considerations towards cold-chain management, security and manifest integrity, and other factors.

            In an alternative approach to the problem, third-party vendors provide innovative technology that mitigates the transportation issues that current supply chain managers and transportation service providers can’t account for with improved processes. These companies are providing solutions that mitigate problems inherently associated with transportation processes, such as Envirotainer’s specialized containers that actively control internal temperature as a counter to the currently inevitable variability of temperature in transit.

Continued innovation in processes and technology will lower costs for the pharmaceutical industry and improve patient outcomes by providing a more robust supply of medication. Looking forward, outside-the-box solutions that eliminate rather than mitigate the major sources of deviation could have massive impact on supply chain efficiency and integrity.

HAPPY BIRTHDAY BSMA!

Oct 18, 2017

Devendra Mishra

Co-Founder and Executive Director, Bio Supply Management Alliance

 

When the Bio Supply Management Alliance (BSMA) was born a decade ago right here in the Bay Area, the goals were lofty: create a worldwide community of operations and supply chain management leaders and professionals in the biotech, biopharma, and biomedical device industries. Since then, I’ve been overwhelmed by the growth and success of the global industry, and in particular, the role that California and Silicon Valley have played in its success.

Not surprising then that I didn’t have to look far to find keynote speakers for our 10th annual conference in Foster City. Supply Chain executives from Kite Pharma, Illumina and Roche shared case studies that reinforce California’s leading-edge in employing new technologies that are rapidly advancing how life-saving products are being produced and delivered.

Tim Moore of Kite Pharma has a particularly tough job as his company develops personalized cancer immunology for patients across the globe. Cell therapy is fundamentally different than biopharma products, so each patient represents another “batch”; therefore production takes place in a lab environment vs. a manufacturing site. This on-demand capacity, with little raw inventory storage, necessitates a stable stream of dependable suppliers that can respond to a made-to-order operation. Kite uses an integrated model for delivery, equivalent to Amazon, including a dashboard interface.

Kaoru Nishino of Roche talked more about developing new strategies to address shrinking lead time. Nishino referenced the “inconvenient truth” that supply chains have a long way to go in becoming more collaborative and efficient. Despite the scientific orientation of the industry, people are set in their ways and are threatened by new technology. Silicon Valley tech trends can close the gap. For example, the sharing economy can help with spare capacity such as unused resources or shared insights. However, Nishino warned that technology isn’t a complete panacea, and software alone doesn’t change an industry. Additionally, firms that are destined for organizational efficiency might need to make way for a more collaborative platform.

Kevin Pegels of Illumina described a “customer-centric supply chain transformation.” Illumina’s rapid growth has forced it to develop a fast-paced, collaborative culture, something that has more recently been realized in the supply chain context. Illumina created a goal for 2020 that called for 100 percent availability of life-changing products through innovative supply chain solutions. Like Kite, the company has an end-to-end focus and is also looking at efficiencies such as packaging transformation and bulk options. The result of this transformation: fewer backorders, better customer ratings, along with cost savings that have helped this unit become a value-add for the company.

The conference also included panels, including “The Resurgence of Manufacturing in Biomedical and Bio-pharma” moderated by City of Fremont’s Director of Economic Development, Kelly Kline, that focused on the importance of agility and responsiveness to product and process changes. Among the panelists were Mike Prindiville with Intuitive Surgical, Mike Zuerlein with Illumina, and Gregory Theyel with the Biomedical Manufacturing Network.

This panel explored key factors that give the Bay Area a competitive edge in being chosen as a prime location for manufacturing companies. For example, there are close to 800 manufacturing companies including biomedical and biopharma companies in Fremont alone! The Bay Area’s popularity as a manufacturing hotbed stems from favorable factors such as speed and agility for getting products to market, access to supply chain components making coordination easier, and high-quality delivery in a strictly regulated environment.

The engaging conversation also focused on talent, employment, and the acute workforce gap in the manufacturing sector — for example, with 1.2 million job openings, there are only 200,000 graduates able to fill those jobs. Keck Graduate Institute students in attendance enjoyed the interactive discussion and walked away with great tips from panelists. For example, more employers agree that soft skills and the ability to solve problems are highly coveted traits in job seekers over technical skills alone.

We ended the day with many discussions about the challenges and opportunities of biotechnology innovation in the Bay Area. The event also allowed for plenty of networking opportunities — and judging by the excitement level and impromptu break-out discussions during networking, not only was the event a success, but BSMA has also achieved the lofty goals that we set 10 years ago.

BSMA Conference Report

October 17, 2017

Nancy Matti

Master of Engineering, Biopharmaceutical Processing 2018
Keck Graduate Institute
Claremont, CA

As a graduate student studying various process developments and manufacturing platforms, I never looked into what happens to my drug product afterwards. I naively assumed shipping the product to the pharmacies and hospitals around the world was the easiest step. The BSMA conference was beneficial in that it gave me a snapshot of what supply chain is, current problems plaguing the industry and stakeholders involved.

The keynote speakers and panelists that were chosen for the conference were phenomenal. It was a pleasure to hear from Kite Pharma, Roche, and Illumina about creating savvy strategies for supply chain for individualized therapies that are real-time and competitive. Moreover, it was enlightening to include a section on how the current administration’s tax and trade policies are affecting supply chain. The conference took a turn for me at this point and merged the supply chain world with our current reality. The interdisciplinary panelists provided a new twist to supply chain and the conference took into account the factors that are currently affecting supply chain in the US and particularly in California. Overall, it was a brilliant blend of the business, strategy, finance, manufacturing and technology.

The most interesting statistic I learned is the pharmaceutical industry loses $35 billion every year due to deviations during transport. Having an industry-wide shared perspective on product stability is pivotal in advancing the industry forward. In particular, Rich Kilmer’s talk on blockchain was insightful in showing how companies can use distributed ledger technologies to share information on the product, while also maintaining integrity. It is a disruptive technology that can now bring together the manufacturer, distributer, and pharmacy, in which each can validate the data independently so there is a distributed consensus among all major stakeholders. As a future manufacturer, I now know this is one method I can implement to assist in passing information along to aid in preventing product loss.

Attending this conference allowed me to understand the capacity of supply chain, and it gave me homework to research further. In addition, I networked with individuals from various companies that can assist in guiding my thought process as I apply supply chain to my master’s design project this year. Ensuring patients receive the life-saving medications they need on time without damaging the viability of the product is of the utmost importance. The BSMA conference provided a new piece to the puzzle of how to ultimately put the patient first. I would certainly consider attending more conferences hosted by the BSMA committee.

 

 

Swetha Prabhakaran
10/17/2017

As biopharmaceutical process engineers-in-training at KGI, most of us are only exposed to the R&D, process development, quality and regulatory features of the industry. I’m sure that the other BSMA conference attendees in my cohort would agree that the experience has really opened our eyes to the supply chain aspect of the biotech industry. The supply chain was something we took for granted and therefore overlooked, but clearly it is one of the most important aspects of the industry. Simply put, the supply chain is the bridge to the people that the industry serves. Here are some of the key take-aways that stood out to me during the conference:

Tim Moore’s keynote address about CAR-T therapies’ made-to-order and direct path to patients represents innovative technologies in both therapeutics and supply chain. CAR-T therapy is impressive in its own right, however there is much to be credited to the electronic monitoring that Kite uses to make communication with hospitals and patients easier. Kite’s risky venture into the startup software company that initially only had a fledgling idea definitely payed off. Because the ease of communication in their supply chain system allows them to bring treatments to patients quickly and effectively, it enables Kite’s growth capacity for over 4,000 treatments per year.

Kaoru Nishino’s presentation on how current technology trends can be used to improve current supply chain practices was also very relevant. He mentioned how social networking and social media can provide real-time feeds of different data, and how sharing economies have emerged in order to make up for and optimize spare capacities and underused resources. He also indicated that machine learning and AI are emerging as useful tools for sifting through big data and user patterns in order to implement a more autonomous supply chain.

Kevin Pegels mentioned how in the initial stages of Illumina, because it was such a fast-growing company, the demand limited the supply chain. In fact, during that time, the supply chain was not even considered an asset. However, after changing their mindset and focusing on understanding customer requirements in order to handle orders differently, they realized that cost savings are actually driven by the supply chain. I can imagine that this is probably the case for most other companies as well.

From the “Industry 360 – Taking a Quantum Leap in Rewiring the Biotech Supply Chain” panel with Kevin Pegels, Horacio Enriquez, and Laurent Foetisch, we found out that the problem with big data isn’t that it is big: it’s the lack of access that makes it an issue. If this data was more accessible or presented better, then it would allow for better decision making. And without this basic need fulfilled, the fancier tools such as the internet of things and machine learning is unhelpful.

From the same panel, we were able to take a look into the future, with distributive manufacturing. The intent behind distributive manufacturing is that manufacturing sites will be focused and dispersed in areas to better serve more populations. This concept seems to be a good idea for remote or underserved locations, and there will probably be a trend towards this Amazon-like distributive model in the future. However, there was a caveat mentioned: the biotech industry is a risk-adverse industry. There are too many challenges facing the established infrastructure regarding distributive models for it to be implemented any time soon. But even though it is not viable in the short term, increasing demand or need will probably drive its emergence in the future.

Many other discussions, lectures, and panels were held during this conference, and I was happy to experience it all. The BSMA conference was a fantastic crash course in the world of biosupply chain management and technology, especially for a bioprocessing student such as myself. I am fortunate to have learned more about the bridge between the innovations that we will soon be making and the patients that those innovations will help serve.

Addressing Global Risk and Opportunities

Response to regulatory uncertainties and rapid innovation in the global supply chains for temperature-controlled medicines were highlighted at the 8th Annual Conference of the Bio Supply Management Alliance (BSMA). Although much attention was naturally placed on large molecule biotech drugs, several speakers made the point that every product has prescribed temperature ranges, even tablets shipped at “ambient temperatures”.   A veteran of the cold chain industry, Douglas Wettergren of Envirotainer remarked,  “This was our seventh year attending the BSMA fall event and this was by far the largest one in terms of delegate attendance.  It is nice to see the interest grow as this is my most valued and favorite industry show of the season.  BSMA sets the bar as the best opportunity to network with executive level decision makers in the Biotech industry.” (more…)

Innovations to Meet Regulatory Requirements, Reduce Costs, and Improve Efficiency

Calabasas, November 12, 2015. The 2015 Bio Supply Management Alliance (BSMA) Conference met in Foster City, CA at the Crowne Plaza Hotel. Executives from over 40 biopharma companies addressed challenges and exchanged solutions for Clinical Supply Chain Management which poses one of the biggest challenges for supply chain managers in the biopharma industry. The fundamental takeaway for the clinical supply professionals was that growth in the number of trials, increased compliance and the global scope of trials, are spurring companies to automate outdated paper-based or spreadsheet based clinical supply chain processes. Based on detailed global surveys of clinical sites, vendors and sponsors have a great deal of improvement to help their sites be more successful. Presenters cited compliance issues – frequent production, protocol, formulation or labeling changes; multiple clinical sites; and, end-to-end clinical supply chain issues stretching all the way to the patient; as the biggest challenges (more…)

Foster City, CA, November 3, 2015:  When the 2015 Bio Supply Management Alliance Conference met in Foster City, CA on October 15th this year, every supply chain professional in attendance was in agreement about one thing. The way that we think about and approach the career path of young professionals in biotech hoping to move up the supply chain management ladder is fundamentally flawed. (more…)

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. (more…)

The biopharmaceutical sector is rapidly evolving – can your supply chain keep up?  

By Prashant Yadav, Director of Healthcare Research at the William Davidson Institute, and faculty member of the Ross School of Business at the University of Michigan, USA ~ published in “The Medicine Maker” June 26th, 2015

The biopharmaceutical industry is undergoing a striking transition. In developed markets, one-size-fits-all medicine is being replaced with higher-efficacy treatments for targeted populations. In emerging markets, a burgeoning middle class and larger public investments in healthcare infrastructure are resulting in rapid growth of the pharmaceutical sector. In some developed and emerging markets, reimbursement lists favor domestically produced pharmaceuticals, making local manufacturing a requisite for market entry. Smaller target markets for each molecule; volatility in regulatory and political environment in emerging markets; and stronger payer influence in developed markets are resulting in more frequent changes in commercial decisions. All of these trends are stepping up pressure for speed, flexibility and reliability in the pharmaceutical supply chain. (more…)

In industries such as high-tech electronics and consumer products, the demand-driven supply chain has been a disruptive innovation yielding significantly greater benefits compared with the historical supply driven strategy. In contrast, the biotech industry appears under-served in this regard where a transformation is underway in the industry from being innovators and marketers to becoming a bottom-line focused business. (more…)