Product launches see pharma and biotech companies handing over drugs with incredible value, both commercially and to the health of patients globally, to contract packaging partners. Many of the virtual and small biotech companies simply lack the infrastructure necessary to handle packaging and large pharma companies tend to outsource as contract service providers offer experience and significant surge capacity for short or extended periods of time.
One of the primary goals for every drug launch is expediency. From the moment a drug receives regulatory approval, the countdown begins to get products packed and shipped to ensure that patients receive much needed therapies as soon as possible.
Talk early and clearly and collaborate
In every product launch, it is vital that both parties collaboratively establish and agree on parameters and expectations – scales, timings and special requirements all need to be discussed in detail. Sharp’s approach is to establish a cross-functional team with varied expertise for an initial project launch. It’s important that objectives are communicated as early as possible which allows the teams to establish a work plan with milestones that will ensure agreed objectives and deadlines are met. To this end, getting visibility of a launch as early as possible is vital.
In an ideal scenario, planning would begin 12-18 months prior to the expected approval. However, where there are existing relationships between brand owners and contract partners, where similar products are already being packed and qualification of equipment, validations and audits have already been conducted, it is possible to shorten launch timescale by months. The success of such rapid launches often hinges on gaining the full support of the customer, including their executive sponsorship, to ensure the product and all necessary launch information will be available to the agreed schedule. Many of Sharp’s pharma clients treat our sites and our employees as an extension of their own business. Sharp’s regulatory, quality and engineering project leads work very closely with clients, and where possible, our client’s external teams will align directly with their Sharp project leads ensuring we can move at a fast pace. This kind of responsive collaboration is key to the success of rapid launches.
The broader trend towards outsourcing to contract manufacturers (CMOs) and other vendors creates a greater need for early alignment and ensuring all stakeholders involved as early as possible is important. Most brand owners will determine the components being utilized in a launch with their own specific qualified vendors – others may rely on their contract packaging partners for input on componentry. Irrespective of who is involved and why, all parties need to be engaged and expectations clearly communicated and understood to ensure a smooth launch.
4 mistakes to avoid
There are essential steps that need to be taken to facilitate a smoother, rapid launch and even manufacturers with experience in outsourcing can make mistakes. Four of the most common ones to avoid are:
1. Overlooking the availability of test material to utilize the qualification of a line
A vital part of clarifying and communicating expectations is discussing how a line will be validated. A common challenge at Sharp has been accessing placebo product and the components for qualification activities of a launch in lieu of expensive drug product.
2. Not understanding internal requirements
Brand owners sometimes make last minute specification changes without understanding their own internal requirements. For example, final agency approval of components often requires specification updates – this can create delays if unplanned for.
3. Not fully leveraging the experience of your contract partner
Trust the experience and expertise of your contract partner to ensure you are focused on the more critical factors of your launch. Customers will often focus on things that they perceive as high priority that in truth are par-for-the-course. An example Sharp often sees is customers focusing heavily on preparing for pre-approval inspections which occur sporadically and often only happening on unique products being handled for the first time. In reality, clients should be able to trust their contract partners to give them the insight and updates on approval as well as leverage their expertise and use them as a guide through the launch.
4. Obfuscating long-term plans
Being as transparent as possible with respect to demand scenarios which could impact capacity demands post launch will help every link in a respective supply chain plan more effectively. As the majority of launches now tend to extend beyond the initial approval timeframe, collaborative discussions on various forecast models allows both manufacturers and packaging & distribution partners to put plans in place.
Shifting market dynamics
There are two major trends that will continue to affect the speed of launches over the coming years.
Firstly, the growth in the biopharma space and the subsequent weighting of drug development pipelines towards large molecules continues to challenge contract packagers in their flexibility and responsiveness. However, the concurrence of this trend with the push by regulatory agencies to approve treatments for rare indications across all therapeutic categories over the last 12-15 months is exacerbating the effects. Therapies in the oncology, central nervous system (CNS) and diabetes space are all getting pushed through in a rapid fashion and this means that every new innovative drug in these spaces has become a critical, rapid launch.
Some organisations don’t have the capability or the capacity to get their launch volume packed and shipped and need a reliable partner to manage that initial demand. For drug products with rare indications, it often makes sense to use a contract partner for the long term to support ongoing production because most manufacturers don’t have the capabilities to manage smaller scale, high-value, high touch-point products with complex packaging requirements.
The second trend – and this will be a short-term, yet very intense challenge – is the pressure of getting a COVID-19 vaccine to market quickly. This will almost certainly happen within the next 12-36 months and will prove extremely taxing to all participants in the sterile-fill manufacturing space. The domino effect will be that capacity in clinical and commercial packaging businesses will soon be taken up with all the potential COVID-19 projects in the pipeline.
To help them navigate through these scenarios, brand owners need to have strong relationships in place with reliable contract packaging partners built on trust and constant communication.
What to look for in a partner
Trust is essential. It’s a very significant decision for a company to hand over their product to be packaged at a contractor site. Without trust, there is no meaningful partnership.
In most cases, trust is built on the contractor’s experience with a wide range of products over a long period is vital. Every launch is different, but the more challenges a company has faced and overcome, the better positioned it is to deliver against expectations. An excellent track record and a history of regulatory compliance speak to that experience.
The recent COVID-19 pandemic also highlighted a number of frailties across the pharma supply chain. Every business should have robust continuity response plans in place to manage disruptions caused by pandemics, earthquakes, volcanic eruptions, protests and so on. These plans should be made clear during the early planning phases. Contract partners are also often part of the solution, offering redundancies to manage changes in demand.
Partner with Sharp
With over 65 years in business, we have the experience and expertise to design and engineer a packaging solution that meets your new product launch needs. We collaborate with you to deliver expert, flexible and tailored services that meet the most stringent quality demands – Sharp, part of UDG Healthcare, is your trusted pharmaceutical and biopharma packaging partner.