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How Development and Validation Are Changing for the Life Sciences Industry

16 June, 2020
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As COVID-19 continues to spread across the globe, life science companies are doing everything possible to facilitate the manufacture of critical medical supplies and the development of an effective vaccine. More than 40 vaccine candidates are now being developed concurrently. The fastest vaccine on record took four years from project launch to full approval for human use, but efforts targeted at the novel coronavirus are attempting to develop one within 18 months. This is one relevant example of how many organizations within the life sciences industry are attempting to expedite every possible aspect of the development and validation processes.

 

The Current Situation

The National Institutes of Health (NIH) recently announced that they were launching a partnership with the Food and Drug Administration (FDA) and 16 private companies, including some of the cornerstone corporations in the pharmaceutical industry. This is bolstered by international partnerships between some pharmaceutical companies. The FDA has targeted eight specific areas:

  • Issuing diagnostic emergency use authorization to allow unapproved medical products or unapproved uses of medical products when doctors believe it is necessary.
  • Providing regulatory relief specifically targeted at expediting testing methods and supplies.
  • Postponing all foreign inspections for a limited time, allowing medical supplies sourced from offshore manufacturers to be delivered as quickly as they can be received and processed.
  • Cracking down on companies selling fraudulent products to increase trust in the quality of the supplies that are available.
  • Increasing access to respirators for healthcare personnel.
  • Issuing new policies to increase the number and availability of diagnostic tests.
  • Closely monitoring the supply chain to rapidly pivot if COVID-19 outbreaks impact any link in medical product logistics.
  • Authorizing the emergency use of personal respiratory protective devices during the pandemic.

All of these efforts tie into two primary categories: development and validation. The partnerships that have been created, combined with a relaxed regulatory atmosphere, have had a demonstrably positive effect on the production of desperately needed medical supplies, such as ventilators. Cosmetics companies are manufacturing hand sanitizer. Apparel companies have retooled factories to focus on medical gowns and masks instead of jeans. Automotive corporations are creating ventilator components by the thousands.

These mechanisms should also substantially speed the completion and approval of a safe vaccine. However, this is only half the battle. Once it’s complete, the struggle will center primarily on supply chain logistics as nations determine how best to deliver and administer the vaccination.

 

The Unanswered Questions

When the vaccine becomes available, hundreds of millions — if not billions — of doses will be needed, creating a demand that’s all but unprecedented. To a large degree, medical companies that will form the backbone of the delivery system are playing a waiting game. Until a vaccine nears human trials, many variables are unknown. What is the shelf life? What size needles and vials are required? Will cold storage be necessary? The answer to this last question alone could fundamentally change the entire nature of the supply chain.

Other issues include geographic and geopolitical issues. Will administration be targeted in specific, densely populated urban areas as a testbed (making logistics much easier), and how will that compare to delivering the vaccine in remote, hard-to-reach areas?

There are also geopolitical dilemmas. At least 69 countries have banned or restricted the export of medical devices, medicines and protective equipment. Whether these bans are lifted, remain in place or are even tightened will substantially impact the capacity to manufacture, deliver and administer substantial numbers of vaccinations. No one is sure how FDA approval in the United States will translate to China’s NMPA or any other national drug administration authority. These components will have a significant issue on how the supply chain reacts.

 

What Happens Next

However, there are things that medical supply companies can be doing now to prepare for the eventual tsunami of demand. First, they can streamline their processes. The more efficiently companies do business now, the more effectively they can expand when the need arrives. Using machine learning and artificial intelligence can be tremendously beneficial to the supply chain across the board.

Second, companies can begin developing relationships with alternate suppliers. Because of the continually evolving nature of both medical and export policies around the world, suppliers have no idea whether their supply chains in six months will bear any resemblance to how they’re structured now. This is another area where AI and machine learning can be heavily leveraged: the tools exist to track all aspects of the supply chain in real time, facilitating rapid transitions as various links are affected.

These are challenging times, but the core principles of supply chain realities remain unaffected. Investing in modernizing supply chains now will reap rewards in both the short- and long-term.

Tami Schultz

Tami Schultz is the Vice President of Business Development at Dynamic Computer Corporation, where she leads the sales and account management functions with her expertise in developing and executing strategy. As a service outsourcing veteran, Tami has a proven track record in leading complex national and global service programs that leverage technology to enable business objectives while growing market share. She is also a member of Michigan Women in Technology and the Supply Chain Leaders in Action – Women in Action Committee.

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