Submitted by Devendra Mishra, Executive Director, BSMA
We have witnessed the most apocalyptic crisis since the global influenza pandemic of 1918-1919 which has resulted in over 176,000 human lives lost and 6 million people infected in the USA so far with no end in sight. A war continues to be waged to control and minimize the pandemic. American has always converted crises into an improved New Order and analyzing the trajectory of this pandemic is shedding light on how to emerge from its onerous tentacles. The life cycle of the contagion can be described as consisting of five phases, namely Crisis, Response, Adaptation, Transformation and New Order. There is a sound reason to rewire the supply chain of life sciences with optimism in the face of current adversity.
CRISIS: On February 11, 2020, the World Health Organization announced an official name for the disease that had caused the 2019 novel coronavirus outbreak, first identified in Wuhan China. The new name given of this disease was coronavirus disease 2019, abbreviated as COVID-19. From January 21 through February 23, 2020, public health agencies detected 14 U.S. cases of coronavirus disease, all related to travel from China. New York City’s first confirmed COVID-19 cases stemmed primarily from European and United States sources, according to the first molecular epidemiology study of SARS-CoV-2 from researchers at the Icahn school of Medicine at Mount Sinai. The first nontravel–related U.S. case was confirmed on February 26 in a California resident who had become ill on February 13. Two days later, on February 28, a second nontravel–related case was confirmed in the state of Washington, suggesting that community transmission was occurring by late February.
The crisis brought about loss of human lives as people were infected and doctors at hospitals across the country tried to confront the disease. The first responders were the doctors, nurses, medical staff, many of whom even gave their lives. The essential medical supplies required by the first responders in the cure of the patients proved to be in short supply. Ensuring the safety of the first responders became a matter of grave concern. Sources of the personal property equipment (PPE) and necessary medical supplies were often found in foreign countries. The epidemiological understanding of the Coronavirus was embryonic and similarities with previously known pandemics were virtually non-existent. Medical scientists worked 24X7. A Black Swan had wreaked havoc in human life, paralyzed the supply chain and decimated the economy. It was a crisis filled with despair and uncertainty.
RESPONSE: The CDC policy of social distancing, hand washing, and mask wearing was advanced universally to dampen the spread of the Coronavirus. The state of New York showed extraordinary leadership in organizing the supply chain required for this unprecedented crisis. The Universities of Washington, California (Berkeley) and others data modeled the infection spread, enabling the planning and execution of endeavors to control the pandemic. Collaboration with other states in terms of purchasing of medical supplies proved to be invaluable. Hospital bed capacity was increased. The Federal Production Act was reinstituted to augment medical product needs. Some nearshoring and diversification of suppliers began to see the light of day. Citizens were asked to self-quarantine with a stay at home policy.
ADAPTATION: Professionals utilized digital communication and collaboration tools to work out of their homes with great productivity and students began to take advantage of distance learning services. Pharmacies and grocery stores remained open with guidelines to serve the basic needs of people. Mail order pharmacies flourished. Drastic reduction in consumer demand of certain products and services led to mortality of enterprises. E-commerce replaced traditional retail and delivered many of the goods required. The Digital Economy enterprises, like Google, Facebook, Netflix, Apple were reinvigorated. The home became the center of the universe for entertainment, sports, news and information because digital streaming had become very viable. And information Doctors reached out to their patients through out-bound calls. Life became easier as people gained greater faith in telehealth and telemedicine for time-saving benefits as you did not have to leave your home.
TRANSFORMATION: The proverbial truth that “necessity is the mother of invention” describes the restoration effort for recovery. It appears that not only paradigm shifts are being created, timeline for innovation has been reduced from ten years to three. E-commerce replaced traditional retail and delivered many of the goods required. Streaming of information, entertainment, sports, education and news entities have become the preferred mode of consumption of content. Nearshoring and diversification of suppliers mitigated the hidden risk which had existed all along. FDA is enabling an accelerated development of vaccines and drugs to save lives. Businesses are accelerating deployment of B to B platforms to enable seamless, efficient Interaction. Collaboration among business partners is at all-time high. From shrinking of offices to zoom conferencing, enterprises are becoming lean and more security conscious than before. The Government is being viewed as a helpful partner where regulatory requirements truly enhance healthcare. Auditing for supply chain integrity is not a necessary evil but a profitable endeavor. Blockchain is being explored to build distributed ledgers with the cornerstone of trust. Artificial intelligence is being deployed to better serve the customer. Amazon-like customer service is a sought-after goal for excellence. Overall, a business culture is emerging which augurs well for healthcare.
NEW ORDER: Life Sciences will never be the same as we have known it to be because the price paid for the COVID-19 pandemic has been astronomically high and unbearable. The Trillion $ pharmaceutical industry of the US is beginning to maximize healthcare. An “Antifragile” supply chain is emerging where quantum leaps will be made in terms of Resilience, Agility and Sustainability. More vaccines and drugs being developed with exceptional warp speed. The global supply chain is being rewired where risk optimization is incorporated in the traditional total cost of ownership. Greater impetus for accelerated drug development with streamlined interactions with the FDA. Distance-learning is a desirable augmentation out of the traditional educational system. In the emerging digitally connected world, signals are being transmitted both ways in real time. IOT embedded products and links of the supply chain are designed to provide visibility and accountability. Here are the building blocks of the New Order:
- Supply Chain is Everyone’s Business: The expression “Supply Chain” has been uttered every time COVIC-19 has by medical experts, newscasters, politicians, corporate executives and the common man. Professionals in the healthcare business are exercising their peripheral vision to consider the relevance of the links of the supply chain that precede and follow the task being performed for saving a human life. The functional silos of a business are being viewed in the context of the supply chain which includes suppliers and customers. And decisions are being made with the knowledge that the stakeholders are dependent on each other. A new realization has set in that a flawless execution is required at every step of the supply chain for in many cases life depends on it. The objective of saving a human life from the pandemic is aligning all the stakeholders, however distant they may be from the patient.
- Supply Chain Management – A C-Suite Issue: COVID-19 has raised the subject of supply chain management to the national level as well as to the C-Suites of America’s Corporations. Solutions to most vexing problems lie in the examination of the supply chain of Life Sciences. Every problem has been examined and explained in the context of the supply chain. Historically CPG, Sports Footwear and Retail companies have developed supply chain management to be a matter of competitive edge. Supply chain executives have driven decisions right from the product design stage to manufacturing, distribution and satisfying the consumer. Healthcare is experiencing baptism by fire of supply chain management, from procurement to manufacture and distribution, while dealing with governmental interventions of policies, customs and regulations.
- Re-Configuration of the US Bio-Pharma Supply Chain: The belief in the basic tenet of Globalization will remain unshakable because its rising tide lifts all boats in terms of global innovation, prosperity and human wellbeing. In the past, the design of the global supply chain network of sources of supply, manufacturing, warehousing and distribution had been based on optimization of system-wide cost of manufacturing, distribution, transportation and carrying inventory for a required level of customer service. The unmistakable awakening going forward is that the optimization principle must be modified to recognize the risk of a Black Swan event whose adverse impact of the disruption is colossal, but probability of occurrence is infinitesimal small.
- Accelerated Approval for Drug Development: The inordinately long drug development cycles with high cost and low success rates, under the compliance purview of the Food and Drug Administration, is being challenged. With human lives at stake, the pace of development of a drug or vaccine or diagnostics has gone from slow motion to dizzying speed. Morphing of drug development with commercialization is taking place as Operation Warp Speed is maturing. The Fast Track Act (2014) and Breakthrough Therapy Designation of the FDA are the building blocks of the foundation to reduce the time to test for the coronavirus, from days to minutes. We have witnessed the positive impact of the Fast Track on clinical trials for Cell and Gene Therapy cures and can expect a quantum leap with scientific ingenuity confronting the present crisis.
- Networked Ecosystem of Healthcare: Governor Cuomo’s launch of an online portal to connect hospitals and healthcare facilities across the State of New York will be the model to be emulated by the other States to potentially build a national grid. The plan merges all the hospitals into one operating system with hospitals spread from Buffalo to NYC. Hospitals will be sharing staff, patients, and supplies for the foreseeable future, with Albany overseeing the distribution of resources. Data managed includes demand (patient registrations, treatment, recovery, deaths, etc.), assets (hospital facilities, ICU and regular beds, equipment and tools), inventory of products and supplies (ventilators, masks, swabs, etc.), human resources (doctors, nurses and others), and hospital metadata
- Digitalization of the Lifeline: Supply chains are becoming Intelligent, Responsive and Agile through digital technology. Telemedicine and Telehealth are gaining ground considerably. Internet of things (IoT) is enabling the measurement of the pulse rate in the flow of information between the links of the supply chain. The thermometer manufactured by Kinsa provides an intelligent heat map of potential COVID-19 patients across a million devices that are Internet-enabled. Not to be left behind will be the Apple Watch, Fitbit and other devices to generate signals for the infection for predictive modeling, along with Social Media contact tracing. Amazon.com-like platforms are being built by conglomerates in Life Sciences with solutions from SAP-Ariba, E2Open and others which allow seamless integration and collaboration of systems in real time between the trading partners. Such a platform as a service is growing today to enable continuous flow of information, goods and money between trading partners. Forecasts generated by the customer to feed the supplier and the supplier’s suppliers are driving supply resilience. Consignment Inventory or Vendor Managed Inventory or Supplier Managed Inventory is being resuscitated because safety stock for demand surges requires information sharing in real time and a common platform for doing business.
- Healthcare Enterprise with a Soul: Protecting and rewarding the “First Responders” has finally become the national priority which never existed before the pandemic. We have seen the images of these brave people on television, the Internet, and Online, and read about them daily. Protection has been on top of everyone’s mind and keeping them safe has become a TOP priority.