Perhaps more than any other industry, pharma and biotech have undergone radical change in 2020 as a result of the COVID-19 pandemic. From supply chain security and capacity to clinical trial operations and site auditing – almost every aspect of the sector has been affected.
However, there was a feeling of ‘business as usual’ in some areas as pressures to launch products quickly, deliver more efficient and agile packaging solutions and meet the growing demand for capacities in the biotech sector remained.
Here, some of Sharp’s experts explore how these trends shaped 2020, and predict how they will impact the industry in 2021.
Jeff Benedict, Chief Commercial Officer, Sharp
COVID-19 has driven change on many levels including a broad adoption of work-from-home and demand for virtual support models (such as facility tours and quality audits) from our clients.
The demands that COVID-19 will put on pharma companies that choose to outsource services is going to tax the entire supply chain. It is important now, more than ever, for businesses to collaborate more closely on timing, needs, and market forecasts to prevent interruption to the current supply base. Continued investments in technology and people in order to enhance transparency will be necessary to make this a success.
With more COVID-19 products on the horizon, regulatory agencies and pharma clients will continue to have virtual interactions, as well as modify processes and procedures to continue to speed things through the system. We will continue to see a faster pace with virtual support on audits, site qualifications, line qualifications, line trials and launches.
Dan Stehn, Director of Injectable Packaging, Sharp
Even during what was a uniquely challenging year in 2020, Sharp continued in our role as a vital service provider. We supported the launch of 2-3 new products a month which is a trend that we don’t expect to see changing in 2021 as our customers continue to develop and introduce new products to the marketplace.
COVID-19 will continue to have a significant impact on supply chain. Many pharma companies will need to determine if they will outsource COVID-19 projects or manufacture in-house and outsource end-of-life/generic products. With this disruption combined with lead times for change, challenges acquiring parts and equipment will continue to increase due to COVID-19. That will make mid and long-term planning more critical than ever before and necessary to help de-risk programs.
Pharma companies need to look at the 12-36 month horizon as well as build a 3-5 year plan for both existing and potential programs.
Sascha Sonnenberg, Global Head of Business Development, Sharp Clinical Services
Aside from the pandemic, sponsor companies continue to focus on finding ways to offset the increasing price of Investigational Medicinal Product (IMP) and comparator material. This makes it more important than ever to identify savings and use existing stock more efficiently. One of the areas where efficiencies continue to be made is in packaging. More flexible clinical partners with clearly defined just-in-time (JIT) packaging solutions and processes, like Sharp, will make a real difference here.
As well as offering a more efficient use of products and materials, the demand-led approach that JIT enables is also more compatible with the industry’s focus on patient-centricity – so it will likely become the default operational model in the not-too-distant future.
There are also an increasing number of specialty therapies, including cell and gene therapies, advancing quickly through clinical trials due to the expedited regulatory pathways on offer for such products. In support of this segment, Sharp has established specific capabilities for handling a higher number of smaller batch sizes and related cold-chain requirements.
Hal Lewis, Vice President & General Manager, Specialty & Injectables, Sharp Packaging Solutions
In the Biotech space, we are seeing significant demand for two distinct secondary pack formats.
- ‘Top-loaded’ style offerings, and;
- More traditional tuck cartons.
This is being driven by a number of factors; diverging requirements, the complexity of the primary packaging and kits and how these products need to be presented to the patient or healthcare provider. There may be multiple additional components with the drug in a finished kit. Packaging it in a top-loaded carton allows for inserts and dividers to be added which not only helps protect everything during shipping but also allows for a more logical presentation when the carton is opened by the end user. However, the disadvantage with this approach is a slightly higher cost and a lower overall production run rate when compared with the traditional style tuck carton which also requires less complex and lower cost equipment to run it.
We will likely see both formats continue to be broadly adopted. As therapies become more personalized and complex, and direct to patient approaches become more prominent, more user friendly packs will become increasingly important. Similarly, there will always be a requirement for simpler formats such as vials and injector pens that often do not need the level of final carton complexity and cost that comes with top-loaded packs.
Sharp has ensured it can offer support in both secondary pack formats and it is likely that the industry will look to contract partners that offer this kind of flexibility in the years to come.