2016 has officially arrived.
Big changes are afoot in the biopharma industry. Yet, many of the trends we saw in 2015—large-scale M&A activity, payer pushback against drug prices, and a focus on category leadership and big-data analytics—will continue to unfold.
BioPharma Dive tapped into the expertise of top thought leaders in the industry to get their takes on what comes next in pricing, M&As, drug development, transparency, and much more.
Dr. Rachele Berria, Vice President and Head of Diabetes Medical Unit, Sanofi
"As we await a cure for diabetes, we will witness additional strides in artificial pancreas-related discoveries. People living with type 1 and type 2 diabetes will become more proactive in ways to achieve better control of their condition and well-being, and 2016 will be the year of combination treatments for diabetes. We will move away from a step-wise, 'time-to-failure' approach.
Healthcare providers will have many complementary mechanisms of actions to count on for both oral and injectable formulations. This will become reality as many pieces of diabetes management, including data analytics, medication regimens, HbA1c levels, CGM measurements and patient-reported information become readily available. The result will be cost-effective outcomes and solutions for patients, providers and payers."
Dr. Bert Liang, Chair of Biosimilars Council & CEO of Pfenex
"In 2016, we will see a greater degree of consolidation, with small molecule generics companies considering biosimilar investment as a growth engine that drives innovation, lowers costs and increases access. This will become particularly apparent as the statutes of industry regulations are made clearer in the courts."
Michael A. Griffith, Executive Vice President at inVentiv Health and President, Commercial Division
"Transparency in pricing will reach beyond the pharmaceutical company narrative and drug WAC. Look for the examination of the entire supply chain for more efficient models. Just as the retail industry was disrupted by consumer access to price comparisons and online shopping, drug purchasing by the ‘patient payer’ is overdue for a disruption."
Brian Overstreet, CEO, Advera Health Analytics
"In 2016 we will see data and technology-driven systems drive healthcare the same way data drives the financial markets. It will become the rule and not the exception for health organizations to mandate the use of big data because otherwise it would be negligent to ignore data that reveals potentially life-saving information.
In 2016 the industry will start routinely adopting technology platforms that give them broad insight into the total financial implications of taking one medication over another. Hospitals and health networks will be able to improve drug decision-making by incorporating a thorough analysis of the most current post-approval drug side effect data through the systematic use of advanced data analytics with regard to adverse drug events.
The benefits will be realized in a reduction in adverse event costs, such as hospital readmissions or other serious consequences, as well as improved outcomes among patients."
Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development, Novocure
"We look forward to the emergence of new combinations of existing and new treatment modalities in the treatment of cancer. In 2016 we should start to see the impact tumor treating fields have alone and in combination with chemotherapies, immunotherapies and targeted agents on the lives of cancer patients worldwide."
Kevin Robert Frost, CEO, amfAR, The Foundation for AIDS Research
"I think we’ll see some exciting advances in several areas of HIV cure research, such as latency reversing agents and gene therapy."
Dr. Barry Mennen, Washington, D.C.-based physician
"I believe this will be the year that genomic-based personalized medicine will impact certain of the common genetically complex diseases such as type 2 diabetes, hypertension, atherosclerosis, COPD, asthma and coronary artery disease.
Up until now, genomically-informed therapeutics has been essentially limited to certain cancers and genetic diseases such as cystic fibrosis and muscular dystrophy; however, this could be the breakout year where specific combinations of mutations in the more common conditions mentioned above will direct pharmacotherapy.
This will necessitate genomic testing in the offices of family practitioners, pediatricians and internists and tailored therapy that will offer greater efficacy and fewer adverse events."
Dr. Hugo Stephenson, Executive Chairman, DrugDev
"As part of the interest in supporting sites, increased focus on improving payments processes will shape the coming year for the biopharma industry. Until now, 'near enough' has been 'good enough' when it comes to payments (e.g. 90-day pay cycles, little transparency into what those payments are for) even though untimely and unreliable payments can significantly decrease site satisfaction with clinical research.
We are seeing more and more CROs and sponsors interested in improving the way they process payments in an effort to improve site relationships. This makes it easier for sites to do business and that will have long-lasting benefits throughout the industry.
There also will be an increased focus on the patient experience. We expect to see greater recognition that the patient is central to the clinical trials process. This change has already begun, and is being championed by groups such as CISCRP.
In the short-term, this will mean delivery of tools that enable sites to provide clinical trial patients with a better experience because of participating in their studies. These tools will enable better sharing of information with patients (e.g. lay summaries, their own data, study results), and will explore ways of making it easier for data to be collected with a reduced burden on the daily lives of clinical trial patients."
Ashish Singh, Partner and Head of Bain’s Global Healthcare practice
"Bain has demonstrated how biopharma leaders have created the most shareholder value by focusing on a few, sustainable leadership positions in Product Categories (distinct from Therapeutic Areas). Examples are Gilead in HIV and HCV, Roche in oncology or Novo Nordisk in diabetes.
This focused strategy of Category Leadership has been proven to provide superior returns on investment in R&D and commercial. M&A and asset swaps (e.g between Novartis and GSK) are critical to building category leadership positions. Therefore, expect the M&A wave to continue, especially as strong category leadership positions might prove to be the one successful strategy for pharma to counter the increasing global reimbursement pressure."
Ruchin Kansal, Executive Director of Business Innovation at Boehringer Ingelheim
"The industry’s increasing focus on patient centricity is transforming the way companies think and approach the market. This is being driven by patients taking a more active role in managing their health and healthcare.
Technology is providing new ways to interact with patients. In 2016, we’ll continue to see companies engage with patients in meaningful ways ranging from trials to care. A key part of this will be a focus on enhancing the patient experience through digital health tools and solutions that help us better understand diseases, track treatments, improve outcomes and therefore provide more value to patients."
Dr. Michael Kiebish, Vice President of Systems Medicine at Berg
"There will be an increased focus on combination therapies between immuno-oncology and targeting metabolism in cancer. We are looking for improved utilization of molecular profiling for patient stratification in clinical trials and for pharmaceuticals currently on the market to engage the future of outcome based reimbursement pharmacoeconomic models.
In addition, we are also looking for increased utilization of mobile health devices in patient stratification and real-time health monitoring during pharmaceutical development, as well as a greater focus on drug development in the neurodegeneration space."