Here, in 2018, the biotech industry is in the early stages of what has been called a Renaissance in healthcare. Breakthroughs in science are making truly personalized medicine a reality, and new approaches that harness the immune system to fight serious diseases are being developed regularly. Major breakthroughs are occurring on the business side, too. Here’s a look at three trends on prominent display at BIO-Europe Spring 2018 that will remain strong throughout the next several years.
Digital Health Growth
Digital health has transformed from an oddity needing explanation into a vital and expected component of the biotech industry. Transparency Market Research predicts it will grow at 13.4% per year between now and 2025 to become a USD 535.6 billion market. While healthcare providers see obvious advantages from technologies that enable remote monitoring and telemedicine, drug developers stand to benefit too. “We’re promoting real-world evidence collection. Drug developers can have a lot of patient data coming back about safety and efficacy and outcomes,” says Megan Coder, executive director, Digital Therapeutics Alliance. “Another strategy is to integrate a digital therapeutic into patient protocols for clinical trials to minimize the need for higher drug dosages.” Coder notes the difference between digital health apps used for general patient monitoring and telemedicine, and digital therapeutics that are specifically focused on the treatment of medical conditions. "Digital therapeutics are clinically-validated solutions used in drug development and medical care to improve visibility into complex treatment processes and simplify pathways to create better outcomes. They undergo rigorous clinical testing through randomized clinical trials and real-world pilots to demonstrate their safety and efficacy," Coder points out. "When used in clinical trials and patient care, they can improve the overall quality, cohesion, outcomes, and value of healthcare delivery." Their value is based on enabling in-depth insights into the treatment process for providers as well as for patients. “If digital solutions are used in clinical trials, they are likely to be used by patients following a drug’s post-market approval,” she says.
China Biotech Industry Emerges
The CFDA took significant steps in 2017 to harmonize its regulatory environment with those of the West. Among the most notable: speeding regulatory approval and allowing data generated outside of China to support certain drugs. More specifically, the CFDA offers tacit approvals of INDs within 60 days, priority review for novel oncology drugs, and conditional approval based upon data generated outside of China for orphan drugs and those meeting urgent clinical needs. It also now treats cell and gene therapies as drugs and redefined the term “novel drug” to mean novel globally—not just in China, according to Greg Scott, speaking at Biotech Showcase™ in January, 2018. These changes are an important step in transforming “Manufactured in China” to “Developed in China,” and the investment community is taking notice. The number of partnering deals in China more than doubled from USD 3.9 billion in 2016 to USD 8.3 billion in 2017. The greatest percentage (49%) of partnerships are in oncology, with infectious diseases in second place with 12% of the partnering deals. Overall life sciences investments grew 97% from 2016 to USD 39.8 billion, and venture capital funding grew 122% to USD 11.7 billion. Those figures, coupled with a growing middle class and continued government support, will continue to make China a trending biotech ecosystem. As Jonathan J. Wang, Senior Managing Director of healthcare fund manager OrbiMed Asia, notes, “China’s biotech industry is transforming from that of a ‘copier,’ which depended on such old, inexpensive generic products as interferon, growth hormone, and EPO, to a young innovator that is creating proprietary ‘me-too’ and ‘me-better’ products. With that change, the industry is expanding its target market from mostly China to the world. With a large and growing market that is ranked #2 in the world and relatively less expensive resources, China is entering the global stage as a strong competitor and potential partner.” To learn more about the state of China, join us in the workshop, "New opportunities in China, from drug development to commercialization."
The Power of Patient Advocates
The role of patient advocates in drug development has grown from pure advocacy to something broader. Rather than serving primarily as a gatekeeper to patients, advocacy groups increasingly are bringing together payers, key opinion leaders, policy makers, caregivers, and patients to shape drug development and drug policy. Working with advocacy groups early can have a big return on investment. Early involvement allows these groups to share insights and expertise can result in more robust programs and relationships that can be tapped throughout the drug development space. It also allows them to help define rare conditions, identify the most effective diagnostic tools, and standardize treatment by sharing information with a wider group of stakeholders. Patient advocates also are becoming active in the regulatory side of development, helping show that a new approach is needed and, sometimes, helping clear regulatory hurdles through their relationships with lawmakers and regulators. Drug developers, therefore, are wise to forge strong relationships with patient advocates early, and to manage those relationships throughout a project’s development...even when that means going back to the drawing board. “Early investment in patient advocacy groups creates the opportunity to be a part of the broader stakeholder conversation early. There is little to no risk in supporting the growth of these organizations. Significant potential upsides exist including enhanced patient access for clinical trials, stronger connections to the prescriber community and development of strong patient advocates to support the regulatory process,” noted Chris Von Seggern, MBA, MPH, PhD, Partner at ClearView Healthcare Partners. These three trends—digital health solutions, the growth of China, and alliance management —first appeared a few years ago and have grown rapidly since. Biotechs will do well to consider them in their planning for 2020 and beyond. To learn more, join us in the workshop, "Patient organization expectations: A new kind of alliance management."
Join us in BIO-Europe Spring in Amsterdam from March 12-14, 2018. With a focus on European innovation and global collaboration, BIO-Europe Spring is the premier springtime partnering conference bringing together a “whoʼs who” from biotech, pharma, and finance in the most innovative biopharma clusters in Europe.