The patent cliff is beginning to reduce Big Pharma’s sales figures as generic versions of branded drugs enter the market. Although FDA has remarked that pharmaceutical innovation is beginning to increase, not all companies are going to be able to market enough new drugs to make up for lost sales. So how will these vulnerable companies maintain their profits? Read more »

As Congress returns from summer recess, and national campaigns begin, job creation is undoubtedly the theme for the near term. Debates over the role of government in stimulating economic growth through fiscal and regulatory policy are inviting opinions from all sides of the political spectrum. Despite all the contention that is and will continue to ensue, there is generally one agreed-upon precept: innovation is a valuable tool to create and sustain economic growth. But how does the quest for innovation square with government regulation? That debate is taking shape not only broadly but in the nascent field of synthetic biology, where scientific, public-health, and business interests are converging. Read more »

During this cost-conscious time, many patients and other healthcare payors are opting for generic versions of branded pharmaceuticals. Biopharmaceuticals have claimed a place in the spotlight, but the US currently has no regulatory pathway for biosimilars. That could change after FDA releases its final guidance on follow-on biologics later this year. Read more »

Some drugmakers have blamed what they see as a slow and overly cautious FDA for the industry’s weak pipelines. Last week, I cited drug-approval figures to show that the agency was not standing in the way of innovation. A closer look at the figures contradicts another part of the critics’ argument—the industry’s pipelines may not be so weak after all. Read more »

The ICH Q11 guideline on the development and manufacture of drug substances may be one of the most  awaited regulatory guidelines in recent harmonization history. The concept for this guideline was developed in May 2008, and at the end of last month, June 2011, FDA published the Step-2 consensus document as draft guidance for industry comment. In general, the document aims to provide guidance on how industry can develop process and drug-substance (that is, chemical and biological entities) understanding. This guidance is important because of its focus on APIs—perhaps the most important component of any drug product—and because it addresses biopharmaceutical manufacturing, an area that is growing like wildfire in terms of R&D but has been somewhat stifled when it comes to global regulatory guidance. The document is also of great interest to industry because of its attention to “understanding”—a key concept of quality by design. Understanding of a drug-product’s materials and their functionality and characteristics is becoming more important and, in fact, is critical for any quality- or risk-based approach to bio/pharmaceutical manufacturing today. These types of approaches, promise the authorities, are meant to provide regulatory flexibility for manufacturers. Read more »

Facility rationalizations, outsourcing, and staff reductions can provide only so much of a cushion to pharmaceutical and biopharmaceutical manufacturers about to drop off the patent cliff. The ideal way to remain profitable is to discover and develop innovative new drugs, but this task has proven increasingly difficult for drugmakers over the past few years. Jonathan Leff, a managing director at venture-capital firm Warburg Pincus, says that FDA is partly to blame. Read more »

It’s not hard to find employees at large- or small-molecule drug companies who have gripes about FDA. On and off the record, people have complained that the agency’s review process is slow and that its decisions can be erratic. Perhaps hoping to make a positive contribution to this discussion, the Biotechnology Industry Organization (BIO) made several proposals last week for improving FDA’s operations. Read more »

In my first blog post on the 4th PDA Europe Workshop on Monoclonal Antibodies, I touched upon some of the issues discussed around the QbD paradigm, the assessment of critical quality attributes and what this actually means to industry and regulators alike. There was plenty of discussion and debate, with one or two people questioning whether a QbD approach was even practicable. Read more »

At this week’s Partnering for Global  Health Forum, sponsored by BIO and BioVentures for Global Health, in Washington, DC, a unique panel of government leaders from emerging markets discussed what it takes to do business in their countries. Among the panelists were: Argentina’s Lino Barañao, Minister of Science, Technology and Innovative Production; India’s T. Madham Mohan, the Ministry of Science and Technology Biotechnology Department Advisor; South Africa’s Bongi Gumede, Senior General Manager, Technology Innovation and Marketing, Technology Innovation Agency; and Brazil’s Julio Ramundo, Managing Director, Venture Capital, Environmental and Capital Markets Division, Brazilian Development Bank. Also on the panel to provide analysis and perspective was industry expert Steven Burrill, CEO of Burrill & Company. Read more »

NIH Director Francis S. Collins gave the keynote speech at today’s Partnering for Global Health forum in Washington, DC, sponsored by BIO and BioVentures for Global Health. He spoke about why global health is a priority for the organization, and for the United States. For starters, Collins pointed out that recent scientific advances such as RNAi, small molecule screening, and genomics of pathogens, are allowing researchers and drug developers to fight infectious diseases. As a result, the pharma and healthcare sectors are able to look beyond the Big 3 diseases (HIV/AIDS, TB, and malaria) and pay more attention to neglected diseases such as dengue, as well as chronic noncommunicable diseases (e.g., hypertension, diabetes, cancers), which are growing in both developed and developing nations. Another reason that global health advocates are setting higher goals–and achieving more—than they have in the past has a lot to do the enthusiasm and global perspective of the younger generation, noted Collins. “We can tap into that energy,” he said. Read more »