I recently wrote about how top influencers in the fields of biotechnology and biopharmaceuticals are using social and mobile technology to facilitate meaningful conversations that would hopefully lead to collaboration and innovation in these incredibly exciting and fast-changing fields. Advancements with the potential to impact so many of our lives. I went back to some of those social thought leaders for their predictions of what we can expect from biotech and biopharma in the year ahead. The answers were fascinating, with several interesting insights for those looking to invest in these fields.
1. 'Balancing Increased Transparency With Clear Guidelines To Avoid 'Unblinding' Studies
Ben Goldacre, MRCPsych, Research Fellow, London School of Hygiene and Tropical Medicine: "The next big trend for biotech innovation is transparency. The industry is gradually waking up to the reality that it is no longer tenable to routinely withhold the methods and results of clinical trials from doctors, researchers, and patients. The AllTrials.net campaign in the U.K. has been very successful, and is launching in the U.S. in a few months."
The AllTrials initiative pushes for the publication of results from all clinical trials on treatments currently being used, so doctors have all the information available about a treatment to understand its risks and benefits. You wouldn't think we'd need the initiative here in the United States - since 2008, the FDA has required results of all trials be posted within a year of completion of the trial. Unfortunately, an audit published in 2012 showed that most didn't comply.
In an interesting twist, biopharmaceutical companies are also having issues with too much information being shared about clinical trials . . . by the participants on social media. Companies are realizing they need to be more proactive to educate trial participants about the consequences of discussing things like side effects online because they could threaten the integrity of the trial. Suggestions for addressing the issue include setting up private online communities for trial participants, so patients can support each other, but have clear guidelines on what can be discussed to avoid "unblinding" a study.
2. Rightsizing and innovative pricing models
Kiran Mazumdar Shaw, chairman and managing director of Biocon Limited
"Global Trends are moving towards containing healthcare costs and enabling affordable access. Given that the cost of many new drugs is unsustainable for even the wealthiest countries in the world, I foresee new pricing models such as the one introduced by Gilead in the developing world for the Hepatitis C drug, Sovaldi. I predict that this will be adopted by other innovator companies. National formularies are likely to demand 'Pay for Performance' models as in the J&J case for Velcade, the blood cancer drug. Finally, economies of scale will drive the future of drug pricing aimed at providing affordable access to new drugs for larger patient populations."
Gilead Sciences has three pricing tiers for its hepatitis C drug Sovaldi, based on a country's per capita income and hepatitis C prevalence. The result: the drug that has been criticized in the U.S. for its staggering $84,000 treatment price is selling for a shocking 99% discount in India, just $900. Now if we can just get them to do something about that U.S. price tag.
The Johnson & Johnson case is even more intriguing. In order to get the United Kingdom's National Institute for Clinical Excellence to allow Velcade to be used by the National Health Service, Johnson & Johnson had to offer an unprecedented money-back guarantee: for patients who didn't respond to Velcade, J&J refunds the drug's cost to the NHS. It will be interesting to see if Shaw's prediction pans out, and other nations start demanding similar guarantees.
3. Move over mobile health trackers: enter wearable trackers and tattoos
Berci Meskó, MD, PhD. Medical futurist, author of "The Guide to the Future of Medicine: Technology AND The Human Touch" and thought leader on digital health.
"While the year of 2014 was the year of the wearable health trackers, 2015 will be the year of smart clothes. T-shirts and trousers that will be able to measure our health parameters in the most convenient way. Keep an eye on: Hexoskin. And in the coming year, digital tattoos as thin as two micrometers might become available making it the ultimate sensor. With one very thin digital tattoo I could measure whatever I would like to measure. Keep an eye on: Takao Someya"
As someone that loves mobile tech, I always look forward to Berci Meskó's reviews of wearable medical gadgets. I know I'll be following these.
4. Genome editing could correct genetic mutations for future generations
C.S. Prakash, Ph.D., Professor, Tuskegee University
"CRISPR/Cas [a system used for genome editing that corrects errors in the genetic code] will be voted "Word of the Year 2015" and gene editing will go mainstream with the loosening up of regulations for gene silencing and genome editing. I would watch Editas Medicine as they have a patent on CRISPR/Cas technology, the hottest innovation in genomics to date."
"More developing countries will allow genetically modified crops and food, and Europe will wake up and try to catch up with the rest of the world in the use of GMO crops."
The expansion of GM crops has already begun in Europe, with the European Union ruling Tuesday to end the ban on growing genetically modified crops after a push by Britain and Spain. The new rules allow each country to decide for itself whether or not to grow a GM crop once it has been ruled safe by the EU's food safety board. Like here in the U.S., there is very vocal real-world and social opposition in Britain and the rest of Europe to growing genetically modified foods, but it appears they will be moving forward in the U.K. starting in the Spring.
Finally, I also invited Matt Karnes, a thought leader in the highly social medical cannabis market, to weigh in. Here's what he had to say about the future there:
5. Investing in Marijuana, Inc.
"Continued effort on the research and development of new medical marijuana strains will continue to be of interest to biotech investors not only because of the potential revenues that a new product will generate, but more importantly, because a successful innovation will help discredit the current federal government's rationale for classifying marijuana as a Schedule 1 narcotic. Once this occurs, investment in the marijuana industry will intensify. Also, those firms that are able to manufacture products with consistent dosage and potency will be more likely to accelerate the approvals process. Leaders in this category that have begun to show great promise include GW Pharmaceuticals and NEMUS Bioscience."
After a 2014 that saw countless biotechnology and biopharmaceutical product advancements and biotech stocks blowing away the overall market, can 2015 be as exciting? Will our experts' predictions come true? I look forward to watching the developments in the coming year.