This past April, the Parenteral Drug Association’s Annual Meeting in New Orleans centered on the theme, “Back to the future: Learning from the past in a patient‑centric world.” Through discussions that focused on innovative operational approaches as well as powerful patient-hosted sessions, the show sought to remind manufacturers to keep a patient-focused mindset on the plant floor.
Here are a few snippets of insight from the information-packed sessions:
The burden of rare disease
“It’s 40 years into the Orphan Drug Act and we need to talk about how public health is addressing the needs of the rare disease community,” said Julia Jenkins, executive director, EveryLife Foundation during the opening session.
Jenkins stressed the need to focus on rare disease as a public health crisis, sharing key takeaways from the foundation’s 2019 study which looked at the economic impact of rare disease in the U.S. According to the study, the national economic burden of 379 rare diseases reached nearly $1 trillion in the U.S. in 2019.
With 93% of the 7,000 known rare diseases still lacking an FDA-approved therapy, the solutions must match the unmet need and urgency, said Jenkins, pointing to the need for policy that considers the voice of patients.
“What we can do through public policy is greater than what you can do through a bake sale,” said Jenkins.
Jenkins called for better partnerships between patients, industry and doctors. “It is vital that the drug ecosystem fosters science and innovation, to make sure patients can get the treatments they need to have a better quality of life,” said Jenkins.
The room was packed for operational technology (OT) cybersecurity’s PDA session debut, with the first talk hosted by Siemens, the world’s largest automation and industrial software vendor.
Chuck Tommey, Digital Connectivity executive for Siemens Industry pointed to a historic tension between OT and IT: The groups tend to approach security differently. IT worries about keeping data safe and OT worries about staying productive and keeping people safe, Tommey said.
Aligning expectations can be helped by creating a “cyber culture.” It will take more than just applying technology — success will only come if people and processes on board, explained Tommey. To that end, it’s important to develop and refine an OT cybersecurity roadmap.
“Cybersecurity is a continuous process — if you don’t treat it as such, it will start decaying,” said Tommey.
Fortunately, there is ROI to these strategies beyond just avoiding cyber incidents. Panelists pointed out that manufacturers who hone their cybersecurity strategies benefit from more resilient architecture and more visibility into their processes. Ultimately, manufacturers must consider the bigger picture: Investing in cybersecurity can help promote the development of new treatments and save lives.
Risk is always top of mind for pharma manufacturers. “A single cyber incident can compromise the development and profitability of a drug,” said Vinnie Tarantino, head of Digital Compliance and Protection, GxP-CC, who spoke on cybersecurity risk management.
As plant floors become increasingly digitalized, security risks are also rising. Tommey pointed out that 61% of smart factories have experienced a cybersecurity incident.
“More digital technology in pharma creates more entry points for hackers,” warned Tarantino. During the Q&A session, attendees were concerned with the heavy push to digitalize pharma that is often not balanced with a push for OT cybersecurity.
Mitigating supply chain shortages
In the U.S., 66% of drug shortages are caused by manufacturing issues, noted speakers during the during the Supply Chain Shortages: True Root Causes and Practical Examples panel.
According to Emabelle Ramnarine, who serves as a PDA officer and board director, and recently began a new role as head of Product Management & Development Operations for Boehringer Ingelheim’s U.S. biopharma operations, most efforts to tackle drug shortages from manufacturers or regulators have come only from their respective perspectives. But the problem is too large for one stakeholder to solve alone — managing drug shortages requires holistic multi-stakeholder science and risk-based approaches.
“If we solve in our own lane without considering other stakeholders, we may create unintended problems for other stakeholders,” said Ramnarine.
In order to help solve this problem, more multi-stakeholder discussions were needed. To that end, PDA produced Tech Report 68. First released in 2014, the report describes a risk-based model for the proactive prevention and management of drug shortages due to manufacturing and quality issues. The report gained global recognition for its effort to reduce drug shortages.
According to Ramnarine, who was one of the report’s original authors, PDA is now working on an updated version, which will be available this coming September.