• Biopharmaceutical and biomedical technologies and treatments will be advanced in large part by developing countries. Although only 5% to 7% of biological products now in clinical development will actually make it to the market, they will play an important role as the life sciences industry begins to develop custom solutions for individual patients rather than focusing exclusively on the larger market. But such treatments will require a change in packaging and processing methods, as well as regulatory procedures. Because biological products tend to be unstable, they will add complexity to the production process. Also, unlike many drugs, biological products are somewhat insulated against the threat of generics. That's in part to the newness of bio-based products, and the complexity in substituting similar products for them.
• Pharmaceutical manufacturers need to educate packaging suppliers about their needs and operations, yet it would benefit partnership efforts if manufacturers also visited supplier facilities to understand their capabilities and operations. Think of this in-field information exchange similar to ethnographic research.
• Pressures on pharmaceutical manufacturers continue to build as government agencies and the companies themselves push to reduce costs. Meanwhile, global medical prices continue to decline, consumers demands escalate, R&D and operating costs rise, product lifecycles shorten, and many drug patents expire.
• As globalization continues and companies do business around the world, people will go from switching jobs in the same geographic area or country to moving from one country to another to accept new positions.
• Consolidation and mergers and acquisitions continue around the globe, with generic drug makers are also experiencing this activity. India appears to be a hotbed of such business transactions, led by companies such as Dr. Reddy's and Ranbaxy.
• Although India and China continue to show amazing growth, their countries face major challenges regarding environmental and infrastructure issues.
• Newer technologies merit serious consideration, yet they may not always be the best option. Your company needs to determine if technologies such as RFID and PAT will provide the benefits these technologies tout. Companies sometimes make expensive investments in information technology without fully implementing them and reaping their potential benefits. Enhancing your company's technology will likely require enhancing the training of employees to implement the technology.
That said, the pharmaceutical industry in general is too slow to change and too averse to risk. There are understandable reasons for that, but it must increase its pace while remembering that the safety of the patient is still the top priority.
CONFERENCE PRESENTERS
The bullet-point insights in this story are based on presentations made in Bologna, Italy at the June 12 Congress event, "Research, development and innovation in technology for pharmaceutical processing," held during Pharmintech 2007.
Among the presenters at the all-day Congress were Gert Moelgaard of Novo Nordisk in Denmark, Andrea Chiesi of Italian-based pharmaceutical company Chiesi Farmaceutici Spa, Walter Schiess with Schott Pharmaceutical Systems in Switzerland, PG Shrotriya of the Indian Pharmacopoeia Commission, and Theodore Iliopoulos with Polpharma in Poland.
The Congress was organized by Italy's ISPE (www.ispe.org) affiliate in co-operation with the Parenteral Drug Assn.'s (www.pda.org) Italy Chapter.
