Mike Hennessy Sr., Chairman and Founder of MJH Life Sciences

With the worst of the Covid-19 pandemic behind us in the US, as more Americans get vaccinated, mask and social-distancing measures are lifted and the public settles back into relatively normal life and work routines—contrasted with the devastation still unfolding in India as it deals with Covid’s second surge—there may not be a better time than the present to explore the theme of supply chain disruption in the pharma industry. 

. If not to learn about the hard but valuable lessons manufacturers and their suppliers gained while navigating the pandemic, and 

new strategies in digitalization and risk monitoring

 employed as a result, then to hear insights on how the global community can best 

 in areas such as drug serialization and track and trace.

And, as we examine this month as well, advances in those fields and the larger pharma distribution picture will go only as far as compliance to and understanding of changes in supply chain regulations. Take, for example, the Drug Supply Chain Security Act (DSCSA), originally passed in 2013. As we report 

 in news on recent FDA-issued guidances, the agency has delayed enforcements of several new DSCSA mandates until 2023. One of those is the requirement of pharma products to be serialized and labeled to support an interoperable, electronic system for identifying and tracing medicines throughout their journey in the US. 

This kind of standardized system, the thought is, will enable better data sharing and thus improve supply chain efficiencies and patient safety. As our coverage illustrates, the industry is making progress in achieving full DSCSA implementation—on the 

The takeaway message is clear: the need for transparency and visibility across the supply chain is critical. That’s what these regulations are trying to ensure. And that’s the focus of optimization pursuits on the industry side. The end goal is the same—getting medicines safely to patients uninterrupted. Thank you for reading.

— Mike Hennessy Sr. is the founder and chairman of MJH Life Sciences.

Articles

Taking stock of lessons learned during pandemic—and opportunities to grow stronger

Building a better supply chain

In March 2020, the United States was in the early stages of the Covid-19 pandemic. We shut the entire country down and ground the economy to a halt in an effort to slow the spread of the virus. Think back to March, and how much uncertainty we were living under.

Nine months later, the FDA approved two Covid-19 vaccines under emergency authorization. Before New Year’s Day, millions of Americans had received the vaccine, including front-line physicians and health care providers and nursing home patients, our most vulnerable citizens.

Nine months. Take a moment to let that sink in.

The mainstream media has crafted a narrative around the Covid-19 pandemic that’s almost entirely negative. For the purpose of ratings, they have described the U.S. response to the pandemic as blundering from one mistake to the next. This narrative is false.

There is another way—a more accurate and underappreciated way—to tell the story of the last nine months. It is a story of heroism, innovation, and precise science, performed under unbelievable pressure.

Let’s not mince words: The United States and the world needs to appreciate the role of the pharmaceutical industry—the researchers, physicians and business leaders—who are rescuing the world from Covid-19. It’s the medical breakthrough of our lifetime.

Instead of dwelling on why many in the media are ignoring this, let’s review some facts.

Since the discovery of Covid-19, here is what scientists have accomplished: They identified a novel virus, unlocked and sequenced its genetic code, created new therapies to save lives, and developed multiple safe and effective vaccines using messenger RNA technology, a technology hopefully applicable to future vaccine development. Margaret Liu, MD, a member of the MJH Life Sciences Covid Coalition, called it a breakthrough for mRNA vaccines.

The United States has two vaccines approved for emergency use, one from Pfizer/BioNTech and another from Moderna, and the AstraZeneca/Oxford vaccine has been approved for emergency use in the UK. In addition, there are 64 vaccines undergoing clinical trials at the moment, including 20 in phase 3 trials. In the United States and around the world, the pharmaceutical industry has answered the call and invested heavily in this effort.

This was the fastest vaccine development program in history, and it’s not even close. David Pride, MD, a microbiologist at the University of California San Diego, estimates that vaccines typically take 10 to 15 years to develop. Until the Covid-19 pandemic, the fastest development timeline was four years, for the mumps vaccine.

Many government systems moved quickly to lessen the burden of onerous regulations and provide funding so that vaccines could be developed quickly but with still rigorous standards. Perhaps it should be a lesson to all of us that regulation/innovation can be calibrated more effectively during “normal” times as industry races to develop new therapies for our world’s other pandemics—cancer, diabetes, heart diseases and more.

The next step of the process—distribution of the vaccine—will be as challenging as the development phase, if not more so. But again, the pharmaceutical industry is rising to the occasion. Factories around the world are working in overdrive to produce hundreds of millions of vaccine doses.

Already, less than a month after the Pfizer vaccine was approved, more than 15.4 million doses of vaccine have been distributed across the country, and more than 4.6 million people have received their first dose, according to CDC data. Many patients are already receiving their second dose.

While 15.4 million doses are impressive, some expected 20 million doses. But even that is moving the goal line a bit, as six months ago many observers didn’t think we’d get a vaccine until 2021.

Members of our Covid Coalition told us that the holidays slowed the rollout considerably. Nancy Messonnier, M.D., a physician with the National Center for Immunization and Respiratory Diseases at the CDC, expects a rapid jump in administered vaccines during these first few days of 2021.

Every day, more people will be vaccinated. After health care workers and our most vulnerable citizens, other frontline workers will be next. Teachers will be vaccinated so our children can return to school. And soon, all Americans will be able to go to their doctor or walk into a CVS or Walgreens and receive the vaccine.

Remember, we did all this in nine months, with the help, dedication and expertise of our pharmaceutical industry heroes. Next time you turn on the TV and see negativity, turn it off and imagine instead where we will be nine months from now.

Mike Hennessy Sr. is the founder and chairman of MJH Life Sciences.

The Covid-19 vaccine, and the speed at which it was developed, is the medical breakthrough of our lifetimes