Drug Information Association (DIA), a US-based non-profit, worldwide association, has unveiled its second annual report. The report offers industry experts’ detailed views on trends they anticipate in the world of medical product development for pharmaceuticals, biotechnology and medical devices in 2014. This year, three trends seem to be striving to take the top place. They include evolution of patient/consumer engagement, regulatory agency support of innovation and learning how to use big data. Here are few of the biggest trends predicted for the year.
Progression of Patient/Client Engagement
The patient/consumer is now recognized as an integral element which could improve patient health and health care outcomes as the industry is trying to progressively increase its understanding of the full potential of patient input.
The design of clinical trials, the endpoints/outcomes, weightage of benefit versus risk, the products to be developed, and those that will stay on the market, will have to wait for patient input. The industry is now looking at ways to absorb patients in dialogue to optimize their input
Application of Big Data
The industry has now understood the potential of what constitutes big data and its application for purposes ranging from innovation and discovery to the assessment of outcomes of treatments. To understand patients in the complex dimensions, traditional analytical methods seem insufficient, owing to the integration of multiple data sets.
A new age analytics approach aimed to understand these big data sets is being developed, which can offer solutions to evidence based questions. Industry specialists will need to improve and build their skill set to work with data and gain maximum output from it.
Regulatory Agency to Back Innovation
Regulatory agencies must support and ensure safety of the new types of products, such as live biotherapies and oligonucleotide therapies in a bid to nurture innovation. Backed by FDASIA provisions and user fee commitments, FDA has been working to accelerate regulatory pathways while collaborating with sponsors through the drug development process.Nanotechnology, biosimilars, regenerative medicine and cellular therapies are few of the areas which need guidance from the regulatory agency, in order to improve innovation in the industry.
Collaboration makes its second successive entry into the top trends for 2014, in line with the DIA thought leaders, after being identified as one of the top trends last year. Provision of high quality care, with better health outcomes for patients, while reducing cost can be accomplished when stakeholders in the health care ecosystem collaborate with each other.There is a need to collaborate with other stake holders; although a small percentage lesser than 20% said they made progress in the area, according to a survey of biopharmaceutical, payer, and provider executives. Biopharma industry needs to position itself as an effective collaborator and must form relationships with diverse stakeholders for innovation.
Personalized Medicine/Tailored Therapies and Companion Diagnostics
Personalized medicine rose to 5th position as one of the most important trends in 2014, compared to 6Th last year. Advances in science have improved understanding of disease states, mechanisms of action of new and existing treatments and reasons for responses to therapies among individuals.
Industry has understood the potential of therapies in smaller appropriately identified patient groups and companies with the co-operation of regulatory agencies that have been optimizing processes for developing companion diagnostics for new and existing therapeutic products.
A field for new companies to compete for development of genetic testing options has been opened by the Supreme Court’s ruling in 2013. The rule states that naturally occurring DNA is not patentable.
The decision will be beneficial, as a number of gene patents are due to expire soon.
Access to precision diagnostics to many patients may be in the offing, as low cost of testing will lead to payer coverage of genetic testing. There are still questions on affordability of precision medicine; while personalized medicine is becoming a reality as benefits and limitations are being identified.
Transparency in Clinical Trial Data
Owing to changes in the last year, a system has been put in place for data sharing; however sharing of clinical trial data continues to be an area of debate in 2014. The EMA received 1,000 comments, when it unveiled plans to release clinical trial data which further delayed the release of final documents until the agency can review the feedback. GSK intends to share clinical data on request to qualified researchers; FDA has also discussed the positive aspects about the release of clinical data.
Implementation of Risk-Based Monitoring in Clinical Trials
Verification of all source documents has been acknowledged as not an effective monitoring approach for clinical trials, according to the FDA.A design for a tailored plan to address patient protection and data integrity risks specific to the study is required. TransCelerate Pharma, a non-profit organization focused on on advancing innovation in research and development, has initiated a project to establish a standard framework however sponsors will need to strategize to allocate their study resources based on risk.
Unmet Medical Needs
Unmet medical needs are a point to focus on in the pursuit of innovation this year. Products duplicating available treatments are not valued any longer; products in developing markets must meet country specific needs while in mature markets there is unmet medical need in diseases like Alzheimer’s, Parkinson’s and certain cancers. Rare diseases will also continue to be a focus of therapeutic development.
Data Standardization and Interoperability
The FDA will need companies to submit standardized, fully electronic data and analysis sets for all submissions by 2018. This has led to adoption of data standards such as CDISC. Combining multiple data sets for big data analysis is enhanced by the application of data standards and the interoperability of data systems does rely on application of data standards for seamless exchange of accurate data.
Companies must work in global markets, mostly in developing markets like China, Pan-Asia, Russia, Eastern Europe, India, Brazil, Argentina, Venezuela & other Latin American countries. As the approach to developing markets is maturing, the challenges of these regions are better understood.
Each country has unique regulatory and health care infrastructures, economics and cultures which must be assessed. In view of expansion, companies conduct early stage analysis and planning to take into account the global factors while creating partnerships to build infrastructure including training of the workforce.
Mobile Health Applications
The FDA has issued its guidance on the types of mobile applications it will regulate; this will facilitate innovation among developers. Many companies are utilizing mobile technologies for patient-reported data, monitoring, and simple communication. It is learnt that context-based applications can collect data about the patient’s environment and prompt reminders or medical team alerts. An enhanced patient-provider relationship needs trust and attention which will result in higher quality care.