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

Mike Hennessy, Sr.

In the past 16 months, the public gained some insight into the complexities of drug development. The rapid development and emergency approval of the Pfizer/BioNTech and Moderna COVID-19 messenger RNA (mRNA) vaccines should not, however, give the impression that these tasks were easy. These innovations were built on years of research, with setbacks and successes.

The development of new drug modalities, such as mRNA vaccines, push researchers to develop bespoke technologies, methods, and processes to meet scientific, safety, regulatory, characterization, and manufacturing requirements for innovative treatments.

The cover story for this issue examines how researchers developing emerging biotherapies must address unique challenges associated with cell therapies, intranasal vaccine delivery, and virus-like particles, as well as the cold-chain limitations of mRNA vaccines. The solutions to these innovation hurdles will have implications for the success of future new biotherapeutic modalities and can set the stage for future life-saving treatments.

Some innovations are happening at the particle level, as formulators look for ways to engineer APIs to improve solubility, permeability, and release profiles to better target drug delivery using milling, spray drying, and other processes. The emergence of potent biologic drugs creates the need for risk assessments for operator exposure and manufacturing containment requirements. Learn how these challenges are being addressed in the Development articles in this issue.

As the pandemic-related headlines fade, the routine of bio/pharma development and manufacturing continues, with efficacy, safety, and quality at the forefront.

The potential for cross contamination is a major concern in multi-use drug manufacturing facilities; cleaning and cleaning validation are frequent targets of regulatory inspections. This issue looks at best practices for cleaning continuous manufacturing systems as well as recommended cleaning validation strategies.

In addition, the editors report on ways drug compounding facilities are turning to robotic technology to reduce the risk of human error, streamline operations, and improve good manufacturing practices.

Emerging technologies and improving basic operations will continue to be bio/pharma industry themes and will be the ongoing focus of coverage in 

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

When referring to this article, please cite it as M. Hennessy, “” 

Articles

Technology advances foster new therapies.

From the Chairman: Technology Advances Foster New Therapies

Editor's Note: This article was originally published online at PharmTech.com on Jan 6, 2021.

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 now much uncertainty we were living under.

Nine months later, 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 US 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 past 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 

The United States has two vaccines approved for emergency use, one from 

, and the AstraZeneca/Oxford vaccine has been approved for 

 undergoing clinical trials at the moment, including 20 in Phase III 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, 

 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 

Centers for Disease Control and Prevention

 (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.

 told us that the holidays slowed the rollout considerably. Nancy Messonnier, MD, a physician with the National Center for Immunization and Respiratory Diseases at the CDC, 

 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 an imagine instead where we will be nine months from now.

Mike Hennessy Sr is the founder and chairman of 

When referring to this article, please cite it as M. Hennessy, Sr., "How Pharmaceutical Innovation is Saving the World," 

Viewpoint: Mike Hennessy, Sr., founder and chairman of MJH Life Sciences, commends the leadership of the pharmaceutical industry in combatting the COVID-19 pandemic.