Business

China Looks Inward and Outward: Investments in US and EU Biopharmaceutical Companies Are on the Rise

The growth momentum of China’s biopharmaceutical industry continues, with the China Industry Research Institute projecting that the country’s biological therapeutics market could reach 300 billion Chinese yuan (~US$50 billion) in 2019. According to the second edition of our report on advances in Chinese biopharmaceutical technology, this robust growth is boosted by continuing investment into the sector (1). A clear strategic indicator of the country’s intentions in biotherapeutics and biologics has been government investment in bioindustrial hubs, which by next year…

Biologic Labels and Induced Patent Infringement: A Perspective on Evolving US Law

The mechanism for proving patent infringement is changing for developers of both branded and follow-on biologics (either biosimilar or interchangeable). Here we examine how drug labeling can establish infringement, thus affecting follow-on manufacturers accused of inducing others to infringe patents on methods of treating medical conditions. Because precedent is paramount in the US legal system, judges look to small-molecule case history to help them understand alleged infringement by follow-on biologics. The classic approach to induced infringement of generic small-molecule drugs…

Cost of Goods Is Crucial for the Future of Regenerative Medicine: CAR-T Cell Therapy Provides a Case Study in Perspective

In the history of regenerative medicine, 2017 was a critical year. With approvals for Kymriah (tisagenlecleucel) from Novartis AG, Yescarta (axicabtagene ciloleucel) from Kite Pharma (a Gilead company), and Luxturna (voretigene neparvovec-rzyl) from Spark Therapeutics, cell and gene therapies finally made their mark on the regulatory landscape. Then in 2018, those products began both treating patients and bringing in revenues for their sponsor companies. “Patients are being treated, and biotechnology and pharmaceutical companies are being paid for treating them,” said…

Innovation Leadership in Drug Development

A “sea change” in the biotechnology and pharmaceutical industries is leading established players to recruit a new type of drug-development leader. Disruptive innovators such as LG Chem Life Sciences, Google, and Nestlé are challenging established life-science companies to be nimbler, more creative, and more adept at applying new and emerging technologies. To spur creativity and entrepreneurship in research and development, smaller companies and Big Pharma corporations alike are recruiting leaders from different fields both inside and outside the life sciences.…

Competing for Talent: Make Your Biotech Workplace a Powerful Asset

Talent is the lifeblood of pharmaceutical innovation. But there’s more to winning top talent than simply recognizing the value of our “human resources.” It also takes putting that value into action by giving people a workplace that inspires and even delights. Today, forward-looking industry leaders are seeing competitive advantage in rethinking workplace strategy and the role it plays in attracting and retaining talent, according to a 2018 report (1). Once considered to be merely a passive background for discovery, a…

Frameworks and Strategies for Commercialization Success in the Biopharmaceutical Ecosystem

The “biopharmaceutical ecosystem” is a multibillion-dollar industry that encompasses large and small drug companies; ancillary providers of services, technologies, equipment, and infrastructure support; and tertiary groups that provide policy direction, regulatory standards, incubator space, and more. This ecosystem is vast and dynamic, evolving constantly as new ideas take hold to push the industry in new directions and present new opportunities for innovation and commercialization. However, many companies operating within this ecosystem struggle to understand their development and commercialization strategies, and…

China Can Be Ignored No Longer: Long-Term Biopharmaceutical Opportunities Based on Near-Term Demonstrated Growth

China has long served as “the world’s factory,” but many experts in the biopharmaceutical industry have assumed that making consumer electronics, clothing, and toys for a global consumer base does not translate well to making complex biologics on the global stage. However, according to a newly released report, the biopharmaceutical market in China reached a value over US$9 billion in 2018, with the domestic monoclonal antibody (MAb) market there making up a very large percentage of that (1). Much of…

Partnerships in Immunotherapy for the Future of Cancer Treatment

Immunotherapy seeks to harness the power of our human immune system to fight disease. In this rapidly evolving field, collaboration among different stakeholders is essential to bringing new treatments to market. Patient advocacy groups, researchers, hospitals, manufacturers, and government entities all are working together to translate promising new research into life-saving products. Types of immunotherapy include monoclonal antibodies (MAbs) and antibody derivatives, checkpoint inhibitors (immune-modulating proteins), cancer vaccines, T-cell therapies, and cytokines — so the approach involves a range of…

Trends in Real-World Study Design and Postmarketing Commitments in the EU and US: What We Can Learn from Big Data

When a new medicine is approved, there is under a 25% chance that the United States Food and Drug Administration (FDA) or the European Medicines Agency (EMA) will impose, as part of conditional approval, studies conducted to satisfy postmarketing requirements. US regulations governing such studies are found in the 2011 guidance document regarding “Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (1).” EMA regulations are found in the 2017 “Guideline…

Building a Bridge Across the “Valley of Death”: Strategies to Help Support Technology Development

On Thursday 6 September 2018 at the annual BioProcess International Conference in Boston, the first “Technology Round Robin Featuring Six Innovative Bioprocess Technologies” was presented in an interactive session with attendees as active participants, asking questions and engaging in conversation with the six featured entrepreneurs. Detailed below, this session was a culmination of several steps in an overall strategy for some of the companies participating. To fully appreciate the launch of new technologies into the bioprocess arena, you first must…