Sales and Marketing (100 years out)
No need for a prediction. See 30 years out.
Production (30 years out)
The catch phrases of the past 20 years will become a reality: Manufacturing Execution (MES), Electronic Batch Records (EBR),
and Process Analytical Technology (PAT) become commonplace in the industry. QbD is adequately described by a validated MES
where production is continuously improved via PAT, resulting in an EBR so that Quality by Design fades away as it is absorbed
by the other three disciplines. Technology workers will be beside the chemical engineers in creating the production process.
S88 evolves and becomes a standard language by which production processes are described.
Production (100 years out)
Pharmaceutical production will become much more automated, of course, but it will also become much more customized. Think
of it like automobiles. Cars on the lot come in different models, colors, and come equipped with different accessories. You
can pick one off the lot that best meets your needs. For a little more money, and a little more time, you can choose among
available options and have the car built for you. And for a lot more money and time, you can have a car pretty much customized.
Pharmaceuticals will be the same way. Emergency room patients will have to pick a medicine off the shelf. Those patients with
not so acute conditions may order a medicine with certain common adaptations for their race, family history, or geographic
location. Elective procedure patients might order a customized pharmaceutical. The factory will be equally efficient at making
a large batch of off-the-shelf product or a single prescription quantity of a special order. This will be possible through
the use of automated controls with supply chain optimization databases.
Infrastructure (30 years out)
The role of IT will be enhanced to become a bigger part of the "product." Information that is typically simply printed on
the product package will be encoded on RFID chips on the packaging, and that information will be available for at-home or
in-clinic computing. For example, the home computer will automatically scan the label of a bottle put in the bathroom medicine
cabinet. It will know what the medicine is, for whom it has been prescribed, and how often they are to take it. The computer
will know the other medicines the patient has in the cabinet and whether there exist contraindications, and if so, it will
automatically alert the head of the household. People will value pharmaceutical products that have complete pedigree information
on the label. IT departments will be relied upon to make sure the data are accurate. The typical in-house IT department will
be quite small. Most IT work will be farmed out to service providers located around the world. Hosted applications will be
Infrastructure (100 years out)
Information throughout the society will be ubiquitous, like electricity is now. Every person will have a wireless personal
digital assistant. When in the office, the PDA will activate the equipment needed to perform useful work. When one is at home,
the PDA will activate household appliances. When one is in the car, it will monitor the engine as well as the music player
and phone. And when one is at the physician's office or in the pharmacy, the PDA will be able to provide historical data on
blood pressure, heart rate, medicine consumption, and will download these data to the physician or pharmacist upon demand.
Each person will have their medical history on their PDA, available to the physician at the user's discretion.
Software engineers will be managing this infrastructure by issuing voice commands to software design servers that will configure
needed functionality. Development at the pharmaceutical company will involve hardly any traditional programming skill at all-only
a deep understanding of data and process models. A combined process and data language will emerge, similar to the SQL language
we have for relational databases. Engineers will support the hardware and communications infrastructure with much the same
discipline as current-day electrical engineers support the power grid.
Fortunately for us, even a hundred years out, we will still not see the likes of Gort, Robbie, R Daneel Olivaw, HAL, or Skynet.
Thank goodness! Not only that, with the advances in medical science, we might just be there not to see them.
Herschel Kenney, senior director, manufacturing and quality systems, Purdue Pharma