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DR. SCHMIDT-BADER: "CONTINUOUS PROCESSES ARE THE FUTURE OF PRODUCTION"

The cost pressure in health care, rising demands of patients and rising costs in the development of new drugs influence the pharma production. Dr. Torsten Schmidt-Bader answers questions in regard to future challenges for the pharmaceutical industry and trends in production.

What challenges will the pharmaceutical industry face in the future?

Schmidt-Bader: In addition to increasing costs arising out of stricter official standards with regard to the safety and effectiveness of new drugs, companies will have to reckon with declining margins in an increasingly competitive market environment as a result of generic drugs. The pressure on prices is already being increased during the pricing process as a result of the introduction of pharmacoeconomic methods and by further restrictions on the reimbursement side as a result of direct market interventions (discount contracts, price reductions after market approval). At the same time, new targets have to be identified and innovative drugs developed, approved and successfully launched at increasingly shorter intervals.

How do companies react to that?

Schmidt-Bader: Today, global companies primarily respond with rapidly effective measures, such as reducing costs in operational departments and the outsourcing of cost-intensive processes to low-wage countries. In the medium term, this can be effectively supported by optimizing corporate structures with the aid of excellence programmes, the introduction of quality by design or organizational development. All in all, companies are showing a great deal of interest in strategic partnerships in order to shorten development times.

Which direction will pharmaceutical production have to take to meet these requirements?

Schmidt-Bader: Not only from the perspective of the shareholder (corporate earnings), but also with regard to treatment costs in the healthcare sector (drug costs), pharmaceutical production must become more economical, more flexible and more focused on quality in the future. Topics such as increases in OEE and upgrading existing processes with regard to performance, process reliability and yield are on the agenda.

Which trends are already emerging?

Schmidt-Bader: Future trends in the production field are likely to include continuous processes for the production of high-volume products, on the one hand, and the flexible production of small batches and special drug formulations within the framework of patient-specific therapies, on the other. In the process, greater importance will be attached to the documentation of safe production processes by quality assurance systems. In tomorrow’s pharmaceutical production systems, improved availability of data will be essential during and after the production process for the purposes of approval, analysis and traceability. The necessary data architectures are likely to entail a significant development of IT infrastructure – in terms of both size and organization.

Dr. Torsten Schmidt-Bader is the founder and CEO of moveproTEC Compliance & Innovation Advisory, a consulting company that is specialized of the evaluation of processes and quality systems in the life sciences and process industries. He is certified as a food chemist and holder of a doctorate in pharmacy and an expert in the areas of GMP compliance, process control and regulation.

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