Headquartered in Dublin, Ireland, HiTech Health enables pharmaceutical, biotechnology, and medical device companies to bring new medical products to market. HiTech Health is focused on helping companies move as efficiently as possible while maintaining the highest quality standards and instilling complete confidence in the commercial supply chain. HiTech Health supports a range of companies in developing, launching, and supplying their products in the EU and U.S.
We recently spoke with Brian Harrison, founder of HiTech Health Limited, about how the company is adjusting to the new norm, and how HiTech is working to assure supply chain integrity in the face of a pandemic.
How have you seen the supply chain industry change during this crisis?
There are significant challenges for companies in managing their supply chain at this time. In the pre-COVID world, companies could place orders and expect materials to arrive when due, but now everything is different. During this crisis, we are helping companies manage their supply chain on a daily basis by assisting them in keeping in communication with suppliers and shipping companies, assessing the impact of shipping lane changes (e.g. total flight disruption of >80% in Europe in May 2020), managing paperwork including importation documentation — all of these activities have to be done within a very highly-regulated environment, requiring significant know-how and expertise.
How can companies deal with supply chain disruption during this time?
Start by thoroughly understanding your supply chain. We recommend a detailed risk/business continuity assessment to ensure that all risks are understood. With that knowledge base, companies can then develop mitigation plans to ensure product supply. Operational experience in supply chain management is key to understand these issues fully.
What does the future look like for the industry?
I think the future is bright for the industry. There is a huge focus at present to solve the COVID-19 crisis with developments in diagnostics, anti-viral medicines, and vaccines. This brings an emphasis but also an opportunity for the industry to demonstrate leadership in solving this crisis.
Going forward, I expect that companies will focus on business continuity. In this environment, key considerations will include the location of the manufacturing, total costs, dual-sourcing options, and looking at internal manufacturing versus the use of contract manufacturing.
While there are impacts to ‘business as usual’ because of COVID-19, most biopharmaceutical companies have adapted effectively to working remotely, and this way of working will likely be embedded as an effective way for companies to work in the future.
What does product development look like right now?
Simply put, these are challenging times for new product development. The major regulatory agencies such as the FDA and EMA have prioritized COVID-19 product development activities. In cases where clinical trials have been fully enrolled, there is likely minimal impact on the product development plans and timelines as many activities can be carried out remotely. However, products that are not COVID-19 related and that are in development and need access to patients for clinical trials are severely impacted.
What advice do you have for companies to get through this time?
It’s now more critical than ever for companies to focus on their people, partners, and customers. Leadership and teamwork are always essential for business success, but now these solid relationships are essential. Since many people must work remotely, it is crucial to find ways to celebrate success, build team spirit, and continue to build and strengthen all relationships.
How has HiTech Health been directly involved with helping in relation to the COVID 19 pandemic?
An example of this was with a HiTech Health client who received approval for its hospital surgical product by the FDA in Q1 2020 just as uncertainty and disruption hit global supply chains. Working in partnership with its client and using its network, HiTech Health provided the following support and key activities:
- Quality oversight of manufacturing of the new product at multiple CMO’s in different countries
- Certified all batches of product for further processing to commercial supply through our Qualified Person (QP).
- Managed shipments of the bulk drug substance to the drug product manufacturer and on to the US for secondary packaging
- Designed, implemented and executed shipping validation protocols to verify the robustness of the selected transportation methods and routes
- Ensured all importation documentation was successfully completed by our Responsible Person (RP).
Another example of solid partnership and networking is when COVID-19 first began to have an impact in Ireland, as elsewhere in the world, there was a significant shortage of hand sanitizer available in the country. We knew that many distilleries were trying to navigate often confusing national legislation and regulatory requirements to understand if they could help by manufacturing and supplying sanitizers.
Keen to play our part, we reached out to a local distillery to offer our expertise to help as switching to make alcohol for sanitizers instead of whiskey, which required critical changes in the manufacturing process. The distillery gained approval for the manufacture of sanitizer and is now supplying to charities and medical staff and facilities working on the ‘front line’ of the COVID outbreak.
HiTech Health has also participated in Irish government agency feedback aiding supports to be put in place that will help other companies to be maintained and function while also ensuring products can be supplied to patients.
HiTech Health client list includes Horizon Therapeutics, Jazz Pharmaceuticals, IPSEN, and Takeda, to name a few. For more information about HiTech Health, please visit www.hitech-health.com