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COVID-19: A Major Review of How to Protect the Entire Pharma Supply Chain.

I was honored to contribute! Congratulations to Dr Nicola Davies for bringing together a multidisciplinary report entitled COVID-19: A Major Review of How to Protect the Entire Pharma Supply Chain.

This is such an important and timely body of research. I strongly recommend picking up the report but only if you are seeking practical, action oriented advice. Stay safe!

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Heparin, Swine Flu, and the Essential Supply Chain Data

Here we go again.  A recent Bloomberg article once again cited the potential shortage of Heparin, a critical blood-thinning medication.    Attached is the recent article, as well as a case study/excerpt from my book, “Single Point of Failure:  The 10 Essential Laws of Supply Chain Risk Management”.   Once again, the importance of collecting, monitoring and managing critical supply chain data by the products/value you produce comes front and center.  Over the past decade, I’ve worked with more than 50 organizations to design, apply, improve, and deploy activity-based risk management.   Contact me @ gary.lynch@theriskproject.com  if you’d like to learn more.

Latest Article

Deadly Pig Disease Sparks Fear of a Heart Drug Shortage

EXCERPT FROM MY BOOK (currently being revised as 2nd edition)

 

A case study demonstrates how a critical supply chain can be more vulnerable

than anyone thinks. The drug heparin is derived from animal liver cells and

is a vital anticoagulant (formula C12H19NO20S3). It prevents blood clots and is

used to treat acute coronary disease, a trial fibrillation, thrombosis, and pulmonary

embolism; clinical trials for the treatment of arthritis, asthma, cancer, and

even organ transplants are promising. It is also used in bypass and other heart

surgery operations. In other words, it is a vital drug. David Strunce, president

of Scientific Protein Laboratories, Baxter Lab’s main supplier of heparin, says

that the Yuan Intestine and Casing Factory is not in his company’s supply

chain. Scientific Protein can’t trace its supplies in China in as much detail as it

can in the United States. “We’re all dealing with the China collection system,”

Mr. Strunce reported.

China is the world’s largest heparin exporter, shipping more than $100 million

of the substance a year. China’s lack of consistent oversight of its heparin

industry highlights a regulatory gap that’s opening as drug makers increasingly

go shopping globally for ingredients. The raw heparin made by China’s myriad

small producers ends up in the hands of about 50 export companies, which sell

to customers overseas. In the first half of 2008, more than 85 percent of these

heparin exports went to the United States, Austria, France, Italy, and Germany,

according to an industry trade group.

An ideal system for tracing heparin back to the barnyard would involve

tagging individual pigs, then keeping files detailing each animal’s record of vaccination,

feed, and overall health. That record could follow the animal to the

slaughterhouse, providing a paper trail that a drug company or the FDA could

later tap into. Many heparin processors, including Changzhou Scientific Protein

Laboratories (SPL), the plant that supplies Baxter, are registered as chemical or

agricultural-byproducts companies and weren’t checked by health authorities.

Abraxis Pharmaceutical Products, or APP Pharmaceuticals, Baxter’s main rival,

says its Chinese supplier, Shenzhen Hepalink, is able to trace refi ned heparin

back to individual pigs. Shenzhen Hepalink also says it requires suppliers of raw

heparin to follow rules designed to minimize the chances of contamination.

The agency did, at most, 21 inspections of Chinese drug-making facilities

annually in fiscal years 2002 through 2007, according to the U.S. Government

Accountability Office (GAO). That represents a fraction of the 714 Chinese facilities

that, as of the end of fiscal 2007, the GAO says were involved in making

drugs or drug ingredients for the U.S. market. FDA Commissioner Andrew von

Eschenbach has said he would like to station inspectors in China.

Because heparin is derived from living tissue, companies that purify raw

heparin follow a range of steps—filtration, heat treatments, and other processing—

to reduce the risk that it may contain active viruses or bacterial toxins. Since

(continued)

192 Single Point of Failure

mid-2006, China’s pig herds have suffered serious outbreaks of porcine reproductive

and respiratory syndrome, a viral illness commonly known as blue-ear

disease. Sick animals are supposed to be rejected by slaughterhouses, but

enforcement can be lax. Also, infected animals may be slaughtered before

symptoms are recognized.

Some drugmakers say it’s important to be able to trace back to the pigs that

served as raw materials. That way, if patients have adverse reactions to a drug,

the root problem can be discovered and other possibly tainted batches can

be pulled from the market. Many Chinese heparin manufacturers say this is a

very difficult standard to meet in China’s business and agriculture environment.

Wang Shengfu, manager of another raw-heparin maker in China’s Shandong

province, Linyi Meiyuan Seasoning Co., notes that unscrupulous business people

and middlemen can easily “provide buyers with fake records.”14

By 2010, China is expected to produce nearly 25 percent of the world’s

pharmaceutical ingredients, according to a recent study by the investment firm

Credit Suisse. “If you haven’t been in a plant for the last two or three years,

you don’t have any clue what’s going on in those places,” said a congressional

source familiar with investigative work into the FDA by the House Commerce

Committee’s subcommittee. “They could be running monster truck rallies on

the plant floor, and we wouldn’t know about it.”

“The computer infrastructure is outdated, it’s not stable, there is insufficient security and capability,” said Dale Nordenberg, a Science Board member

who specialized in the computer systems. “The FDA is still relying on

an amalgamation of paper-based records and poorly integrated electronic

platforms.” The two main FDA databases cannot agree on how many foreign

companies are subject to FDA inspection. One claims the number is 3,000,

the other 6,800. Compounding the confusion, the FDA uses corporate

names, rather than identification numbers, to track production plants and

registration information. For an agency monitoring the operations of companies

in dozens of countries worldwide, this creates confusion. Indeed,

Scientific Protein’s China operation slipped through the FDA’s inspection

regimen primarily because of confusion over the company’s name. But

Nordenberg is hardly encouraged by the agency’s admission this was at the

root of the FDA’s failure to inspect the plant. “That’s just another heparin

timeline,” he said.15

One expert says as much as 70 percent of China’s crude heparin—for

domestic use and for export—comes from small factories in poor villages. One of

the biggest areas for these workshops is in coastal Jiangsu Province, north

of Shanghai, where entire villages have become heparin production centers.

In a village called Xinwangzhuang, nearly every house along with a narrow

street double as a tiny heparin operation, where teams of four to eight

women wearing aprons and white boots wash, splice, separate, and process pig

Law #6: Managing Production Risk Is a Dirty Job 193

intestines into sausage casings and crude heparin. The floors had large puddles

and drainage channels; the workshops were dilapidated and unheated;

and steam from the production process fogged up the windows and soaked the

walls. There were large ovens to cook ingredients and halls lined with barrels

to store enzymes, resins, intestines, and wastewater. “This is our family-style

the workshop,” said Zhu Jinlan, the owner of one heparin operation, who stopped

sorting pig intestines and invited visitors to a back room, where she lives with

her husband and child. “We’ve been doing this for about ten years.”

Experts say the small, unregulated factories could pose dangers because

they do not have the same controls and rules as large slaughterhouses, which

also produce crude heparin. “If you don’t control the incoming source, it’s very

hard to get rid of the contaminants,” says Liu Jian, a heparin expert at the

The University of North Carolina. Mr. Strunce of SPL says his company never buys

directly from the crude-heparin producers, only through its wholesalers, which

he called “consolidators”—Changzhou Techpool, its Chinese joint venture

partner, and Ruihua. His company, he said, has records documenting all the

transactions. But in Rugao, producers of crude heparin tell a different story.

A sales manager for a major supplier, Nantong Koulong, said he sells directly

to SPL without going through either of the two wholesalers. “We provided crude

heparin to Changzhou SPL,” said the sales manager, Chen Jianjun. Some of

Koulong’s stock comes from the unregulated workshops, he said. The owner

of one such workshop, Ms. Zhu in Xinwangzhuang, said she sold to SPL two

years ago. She also sells to Koulong. “We are really a traditional family-style

plant,” she said. “We have no certificate.”

After an outbreak of blue-ear pig, the disease swept through 25 of China’s 31

provinces and regions in 2008, prices soared and many drug suppliers had to

look to the small workshops. The epidemic said Cui Huifei, a heparin expert at

the Shandong University School of Medicine, “made those biotech companies

inevitably purchase from the family-style plants, for cheaper prices.”16

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Shifting Supply Chains: Are today’s​ risk strategies and programs up for the challenge?

“We cannot direct the wind but we can adjust the sails”  Dolly Parton

Supply chains will shift, will the organizations risk programs and strategies keep pace?

Facing the prospect of a 31% EU tariff, Harley-Davidson must choose between a $2000 per unit or bike increase or dramatically reduce production costs.   Of course, Harley-Davidson is not alone.  The food, drug, agriculture, industrial manufacturing, automotive, mineral and mining, and energy industries all face a similar challenge.    The profitability implications of the global trade wars are being driven by a variety of geopolitical actions such as tariffs, taxes, quotas, banning products, social media propaganda that aim to shift sentiment, and contractual and permitting obstacles (delays).  All these actions impact the supply chain, forcing leaders to seek relief in their supply chains.   For Harley-Davidson, it could result in a shift in manufacturing operations from the U.S. to the EU.

The shift will happen quickly and introduce new processes, technologies, relationships, and players (both internal and external resources).  

Will a “program based” risk strategy keep pace and adapt to cultural, societal and political influences? 

Let’s assume for a moment that the supply has shifted.  Let’s also assume that there are new “local” suppliers or supply networks, transportation and logistics partners, manufacturing facilities (or at least an expansion), regulators and regulatory agencies, warehouses and distribution centers and networks, and on and on.

What is the likelihood that the supply chain related risk programs would be updated in lockstep?  This includes risk programs such as insurance (property, marine & cargo, etc.), supplier risk, supply chain resiliency/continuity, emergency management, safety, security, disaster recovery, crisis and event management, and product recall.  What level of effort and investment will be needed to adapt, adjust or recreate these programs?   How fast can these programs be applied and where on the long list of operational priorities will they rank?   In theory, the operational change and risk management program refresh should occur simultaneously.  In theory! If you are like most organizations, you’ll eventually get there in one to three years.

Why wait?  A change represents an opportunity as well as a risk, correct?  Leading organizations such as Apple, Toyota, Cisco, Biogen, Amgen, JPMorganChase, Amazon, GM, Rockwell Automation, Boeing, and many others rely on a data-centric strategy to support an operational dialogue about performance and risk trade-off decisions.  They rely on historical data and descriptive analytics (the past), augment with real-time market and operational data and predictive (future) and prescriptive (action-oriented leading to  ML/AI opportunity) analytics.

What are some of the ingredients of a Data, Dialogue, and Decision based supply chain risk strategy?

  • consider an investment of time, management priority, resource, and capital to collect the end-to-end product/family related supply chain activity data.  Leverage existing franchise sources of data including the Bill of Materials, ERP systems, sensor data, and numerous functionally maintained spreadsheets that do a darn good job of profiling necessary skills, application software, physical assets (including inventory), warehouse info, critical 3rd parties. Don’t forget to tap into your event, insurance and supplier management SaaS systems. Collect it once and connect to your change management process.
  • aggressively tap into your data scientists (or leverage external resources) to design the data management (architecture, pools, platforms, etc.), data feeds (threat and event categories and vulnerability analysis groups – e.g. switching costs), and algorithms for analysis and dialogue.  This is the first step on your way to applying machine learning and artificial intelligence to managing risk in the supply chain.
  • consider adopting a profitability, value-based strategy for navigating uncertainty and managing risk in your supply chain.   This will require greater knowledge of the industry value chain and your place in it.  It will also require a deeper dive into the financial, information and material flow by product, category, or group level.  This will be important in preparation for the operational effectiveness/performance and risk trade-off dialogue and decision (e.g. should we qualify a second site or supplier, how much safety stock/inventory should we hold and where do we place it, how much insurance coverage do we need, etc.).

Bottom line:   A program approach to risk management is an essential base-level defensive strategy to get the masses to manage risk as dictated by the leadership of the program.   Adopting an aggressive data-driven risk strategy to exploit the opportunity and minimize risk in real-time is needed to compete on risk.

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Apple’s Cobalt Play: A Lesson in Competitive Strategy, Navigating Uncertainty and Securing the Supply Chain

Another Apple Trifecta?   If recent reports of Apple being engaged in discussions with cobalt suppliers are true (and I bet they are) then we are about to witness another  lesson in how to gain competitive advantage as Apple simultaneously executes competitive strategy, uncertainty navigation and supply chain risk management.

Competitive Strategy

CEOs and strategists often define competitive strategy as a point-of-view about the future in which they execute against.  To do so requires focus, unique value and achieving superior returns on capital investment.  One of Michael Porter’s key principles to competitive strategy is that one must thoroughly understand the industry value chain and the value creating and cost generating activities associated with it.   Note:  competitive advantage is achieved at the activity level or in this example, the supply chain resources, technology and processes.

Apple’s leadership has achieved competitive advantage over the past decade by consistently and thoroughly understanding the industry value chain as well as their own product supply chains and related sourcing activities.   As a result, uncertainty surrounding these activities has been greatly reduced thus allowing faster and bolder investment decisions.  The sourcing activity has clearly provided Apple with unique and sustainable value.  Decision making about the future of essential materials, such as Cobalt, are viewed simultaneously through a market and operational lens, then linked to financial performance.

For example, in 2011, Tim Cook revealed that he had entered into long term component supply contracts worth $3.9 billion over the next two years. Apple had locked up 60 percent of the world’s touch panel capacity, creating an industry-wide shortage and making it hard, if not impossible, for competition to release new products or keep the shelves filled. Not the first time, or the last, Apple leveraged its deep insight into the market, strategic suppliers and “timing” opportunities throughout its materials-to-customer supply chain to separate themselves from the competition. They exercised similar prowess with batteries, NAND flash memory, LCDs glass for iPad retina display, memory chips, image sensors, and the special resins that are used to hold chipsets together. Events like these delay competitors from coming to market or keeping inventory on the shelves.  (excerpt From: Gary S. Lynch. “Uncertainty Advantage.” iBooks. https://itunes.apple.com/us/book/uncertainty-advantage/id1196773501?mt=11).

Navigating Uncertainty and Managing Risk in the Supply  Chain

As EVs (Electric Vehicles) and energy storage become more widely adopted the  lithium ion cathode battery demand and use of cobalt will shift from mobile devices to mega-industry equipment for transportation and energy.   Cobalt is an essential material in the production of the lithium ion cathode and Apple’s leadership certainly understands the potential risk.  More importantly, their view is not limited to their primary industry value chain but also competing and adjacent value chain (another Porter principle, competing for profits and understanding the five forces).

Apple once again is aggressively navigating uncertainty, clearing the obstacles ahead as the proceed down the highway.  To do so not only requires a willingness to take risk but also a commitment to gain deep insight into the broader industry value chains, the activities that differentiate their products and the competitiveness for key commodities and capacities.

Now the elephant in the room, do organizations in the healthcare, food and other industries exercise similar rigor?  Are they prepared for a potential large-scale shift in capacity or cost?    Will organizations in these industries be able to compete for supply with the mega-energy and automotive industries?  A shortage of radio-isotopes in 2009 should have been a wakeup call to the industry and strategic planners that a broader view of industry value chains that support their products and services would be needed.   It that case it was the failure of a major producer.  Now these industries are faced with a similar threat because cobalt is used in many products including:  external beam radiotherapy, sterilization of medical supplies and medical waste, and radiation treatment of foods for sterilization (cold pasteurization) – (Wilkinson, V. M; Gould, G (1998). Food irradiation: a reference guide. p. 53. ISBN 978-1-85573-359-6)

 Bottom line:  Apple continues to demonstrate the opportunity to leverage uncertainty for competitive advantage.  To do so requires relentless pursuit of the data and details while simultaneously understanding the competitive landscape both within and outside your industry.