What industry trends, developments or actual outcomes did not shape up as you had expected at the start of 2018?
The negative formation of this question forces a cognitive persistence applied to why these items didn’t materialize, and to thoughts of the upcoming year.
I’ve selected replies to this question from professionals on the Outsourced Pharma Editorial Advisory Board, starting with an insightful list from Darren Dasburg, VP and Head Learning and Development, Global Operations, AstraZeneca.
The Dasburg Dash
For a more in-depth look at technology in our future, and a move to “Biopharma 4.0,” I invite you to read this feature article in the December issue of Life Science Leader magazine, where Dasburg and I explore a wide range of implications and applications.
Prices, Policy And People
1. Rise in commodity prices
Some of the sharp increases were as a result of natural disasters (e.g., Hurricane Harvey) or high demand/few new capacity announcements. However, while prices are fairly high as we ended 2018, my expectation for next year is for this to moderate.
2. Uncertainty in trade negotiations/tariffs
This resulted in more delaying of capital deployment and decision-making than perhaps expected. Some U.S.-based suppliers increased pricing whether or not their supply was based on imported goods, resulting in increased prices for steel drums, higher paper, packaging costs, etc.
3. Low unemployment level - trouble in hiring the right talent
There’s now a situation where the industry is facing unfilled positions, and higher workloads for existing employees, to the point of an arising inability to work on projects that could generate additional revenues/ profits.
Leading Technology Lagging
While there has been a definite uptick in the activities in Big Pharma around creating capability, the actual adoption curve is pretty flat. Long term this presents a real opportunity for low-cost, high-quality drugs; however, most CMOs have been reticent to step into the fray to advertise expertise or equipment capability. This is partially because the cost is significant, and the characterization and regulatory challenges unique.
Pharma and biotech are slowly putting a toe in the water regarding harnessing the potential power that can be derived from Big Data analytics. Most large pharma and biotech have ‘a pet project’ underway, but the integration of this analytics approach has been slow at best.
Despite the FDA’s guidance – which in my opinion was terrible – the industry still looks at KPI’s [key performance indicators] as window dressing rather than core components of business-performance governance. This is a paradigm shift that is slowly evolving. As we see broader adoption of more sophisticated elements of the overall manufacturing and supply chain, the need and value for KPIs to drive business performance via innovative approaches – such as blockchain – will become essential to realize the benefits from these advances.
Unexpected Of The Year
Similar to items above, he’s concerned with what might have progressed to a higher level:
“One topic that has been on my mind throughout the year is the integration of CMO and sponsor operations. At the Outsourced Pharma conferences we have spoken about improving operations by getting more strategic and integrated with our CMOs. I’ve experienced some good results with this concept, but have also had some frustration. I’m curious to know how the industry as a whole is doing to form true partnerships as opposed to transactional relationships.
“Related to this is my curiosity about how serialization is more broadly impacting the integration of supply networks. Some in the industry have proposed that data sharing will force trading partners to become more integrated. I am not seeing this yet, but wonder if others are.”
As Kosewski suggests, we’d like to hear from Outsourced Pharma readers. There’s space below this editorial to add your thoughts. Your “unexpecteds” are vital to helping us understand where we are as a drug development and manufacturing industry today, and what we should focus on as we dive into 2019.
Best wishes for a great start to the New Year.