Emerson Exchange 365

A Q&A with Saroj Patnaik, Director, Life Sciences Industry Solutions, Emerson Process Management

The Emerson Exchange Life Sciences Industry Forum will be held on Wednesday, April 2, from 10:45 a.m. to 12:15 p.m.

Go here for more information on Emerson's Life Sciences

What are the major issues and trends facing the life sciences industry?

• The overall population is aging, including in the developing world. About one-quarter of the world's population is over 65 years old. This will increase demand for more affordable medicines.
• Also driving demand is an increase in health-conscious consumers, who will demand better drugs for longer, healthier lives. These consumers will also want outcome-based treatments-drugs that treat diseases, not just symptoms.
• Drug company research and development will shift toward personalized medicines-drugs that work best for particular populations, based on their genetics and other factors-instead of pursuing "blockbuster," one-size-fits-all drugs.
• The U.S. Food and Drug Administration's Quality by Design (QbD) and Process Analytical Technology (PAT) guidance enables inline quality checks versus checking quality after the fact, or at the end of the batch.
• These trends demand manufacturers produce more high quality drugs faster and at lower cost.

What are the biggest challenges/barriers facing the life sciences industry?

• The aging population will affect industry in another way: Skilled workers will become rarer as experienced Baby Boomers increasingly retire. The United Nations suggests the percentage of prime working age adults will drop over the next two generations, despite overall increases in the world population. This skill shortfall will be particularly severe in developing nations, where high-skill workers are already in short supply.
• Quality-related regulations will continue to evolve, challenging the industry to maintain efficiency in the face of stiff competition.
• Downward pressure on prices will increase, partly due to the acceleration of off-shore manufacturing.

What are the biggest opportunities facing the life sciences industry?

• Drug makers generate an enormous amount of data that is not currently exploited to its full potential. Analytics in the data may speed up the discovery of new molecules through better understanding of disease pathologies. The analytics can also improve production of high-quality medicines through better understanding of manufacturing processes.
• It's possible to further reduce time-to-market through better information transfer among the industry's various silos, especially R&D and manufacturing.
• QbD, PAT, and continued process verification (CPV) offer great flexibility that can reduce discarded batches.

What can Emerson do to help its life sciences customers?

• Emerson is committed to helping drug manufacturers lay the groundwork for the "factory of the future."
• Batch Analytics is part of the big data opportunity -- it predicts product quality by gaining insights from past good batches and applying that to the running batch.
• Emerson has the expertise and technology to help drug makers face today's challenges and future ones.

What is your take on the long-term outlook for the life sciences industry?

• Personalized medicine will involve more personalized preventive diagnostics. Based on hereditary DNA make-up and disease profiles, a fetus will be diagnosed in the womb. In other words, the fetus can be treated before birth.
• Drug companies will develop biotech strategies to make faster-acting vaccines-using faster production methods. One World Health Organization (WHO) research project is developing a mobile vaccine factory that works like a cement truck preparing its mixture en route to the construction site. The objective is to reach remote villages, understand a disease's genetic profile, produce vaccines for that village, vaccinate, and move on to the next village.
• It means we have to innovate into micro batching and, as a result, data management will rise exponentially.