Dear Readers,

Since the beginning of the 21st century, pharma M&A activity has exploded. In addition to mergers and acquisitions, outsourcing of research and manufacturing has become common place. Whether or not this will translate into a more viable industry, however, has yet to be determined. Many of the mergers and acquisitions were predicated on increased efficiency in the discovery and development of new drugs and therapies as the lack of new products is a major threat to many branded pharmaceuticals companies.

The industry has focused on closing the innovation gap for more than two decades. No one solution can bridge the R&D productivity gap. The future of pharma innovation demands a holistic approach that addresses every R&D dimension—strategy, organization, funding, technology and expertise.

For this inaugural edition of CHEManager International Pharma & Biotech we asked R&D experts of chemical & pharmaceutical companies to share their opinions on success factors and challenges in research and the role of IT tools and human ingenuity. More than twenty opinion leaders ranging from CEOs to heads of research and process development have responded to our questions. Their statements deliver first-hand insight into their innovation strategy and provide an outlook on the future of pharmaceutical research.

Biosimilars On The Upswing

The market for biopharmaceutical products is expected to boom over the next two decades. Industry estimates that 30% to 40% of all pharmaceutical products in the next 10 to 15 years will be produced with biotechnological processes. With many research-based products already in the pipeline, the first batch of biosimilars is fast approaching registration, an important milestone in the process.

But Biopharmaceuticals face enhanced regulatory requirements for traceability along the process development life cycle, and a push for new technology, solutions for process optimization, and transparency in process development.

Opportunities in Drug Manufacturing

On the pharma manufacturing side, there is a tendency away from big-volume products to small-volume products in general. According to Dr. Thomas Zimmer, VP European Operations of the International Society for Pharmaceutical Engineering (ISPE) we will see more modular concepts allowing a shorter change over time and a higher agility of a factory. This is of special importance for biopharmaceutical products and underlines the need for excellent engineering. As the importance of high-potency APIs is increasing, CDMOs and CMOs boost investments in dedicated high-potency manufacturing lines.

The Art of the Alliance

Just two decades ago, many scientists worked silently and isolated in their “silos.” Cooperation with companies and institutions was more the exception than the rule. This has changed completely. Alliances between big pharma and scientists, hospitals and biotech firms are common practice in the health-care business. About half of today’s top-selling drugs are the result of such partnerships. In order to be effective, every alliance needs professional management. Dr. Magid Abou-Gharbia, author of our feature article, is a living example of a scientist who has been a facilitator and accelerator of collaboration in pharma research.

Staying Ahead In Outsourcing

Outsourcing of research, development and/or manufacturing activities continues to be an important topic for pharmaceutical companies of all sizes as it enhances the overall performance of companies by enabling them to focus their resources on core activities. Accordingly, the contract research, development and manufacturing industry continues to grow, driven by an expanding array of customer requirements presenting new challenges for outsourcing partners and CMOs.

Contract research and contract manufacturing organizations (CROs/CMOs) today are an integral part of the pharmaceutical industry. CROs and CMOs, however, do not only benefit from growth opportunities but they also face some new challenges.

Regulations Dominate Pharmaceutical Logistics

Together with rising outsourcing by manufacturers, the importance of logistics service providers along the health-care supply chain further grows. There has also been a strong increase in the complexity of pharmaceutical logistics. The complexity continues to increase, as evidenced by requirements for tracking cooling chains and serial numbers. Tamper-proofed packaging represents a good solution to improve the safety of pharmaceutical products and to fight the booming trade in counterfeit medicines.

Dr. Michael Reubold and Dr. Ralf Kempf

Editors, CHEManager

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