Redefining The Sciences Of Drug Safety- Innovative Opportunities For Drug Safety & Risk Management

Print 02 June 2015
Dr. Magalie Emile-Backer / The TRIbune

Industry’s Changing Landscape

The field of Drug Safety has evolved into a dynamic specialty area with growing potential and new outsourcing opportunities for Clinical Research Organizations (CROs).  After decades of public health issues relating to the safety of medicines, the biopharmaceutical industry has undergone volatile changes due to increasing regulatory oversight around product surveillance of marketed products.  The increased surveillance and relatively stringent regulatory climate has been further complicated by the effects of the 2008 financial crisis, which dramatically changed the landscape of the global biopharmaceutical industry. There has also been a lag in Research & Development (R&D) productivity due to the increasing difficulty to discover new drugs and years of focusing on late-stage development.  Today, companies are faced with the need to increase productivity in early stage research in an effort to speed up drug discovery or in-licensing candidates while also increasing  the development of late-stage drug candidates in response to the ever-present pressures of patent expirations. Of note, companies additionally wrestle with the task of balancing compliance with meeting stringent regulatory requirements, particularly when trying to speed up the R&D processwithout exceeding their operational budgets.

Despite these challenges, the sector is recovering with modest growth in forecasted biopharmaceutical R&D expenditures, which means future growth in outsourcing.  Outsourcing services is expected to increase from the current rate of 24-28% to as much as 35% by 2018, and more than 60% in the longer term. In accordance, the CRO market is projected to expand from an estimated $23-25B to over $30B by 2018(Hemavli Bali, Heath Results 2013).  Pharma companies outsource for many reasons, especially to access new capabilities and expertise not readily available in-house. Other reasons to outsource include global reach, increased quality and efficiency, and reduction of internal resource utilization.  According to Bank of America Merrill Lynch, the current market size for late-stage services is about three times that of early-stage and outsourcing can reduce development costs by as much as 20-30%. Altogether, increases in outsourcing R&D services to CROs and other sub-specialty safety firms have created a plethora of opportunities for the CRO industry.  

The NEW Drug Safety- Beyond Case Processing

Innovative surveillance tools and technologies have transformed the field of Drug Safety into a more proactive, dynamic analytical process.  As the field continues to grow, drug safety leaders, regulatory authorities and healthcare providers rely on active surveillance systems to expand knowledge of the medical products we use and regulate.  For example, the U.S. Food and Drug Administration (FDA) has mandatory surveillance systems ( AERs, VAERs, MAUDE and MedWatch) dedicated to furthering the science of medical product safety.  Recently, new pilot programs (such as the FDA Sentinel Project) use federally-held data sources to monitor public health and safety of medicines.  Today, Pharmacovigilance activities are also being employed much earlier  by industry with risk/benefit analysis occuring throughout a product’s development. Safety research professionals have increasing expertise in Drug Safety compared to 20 years ago. This may be due to the growth of sub-specialties of surveillance and risk evaluation of medicines including:

• Pharmacovigilance (PVG): the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
• Risk Management (RM): the systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk.
• Risk Evaluation and Mitigation Strategies (REMS): a strategy used to manage a known or potential serious risk associated with a drug or biological product.
• Signal detection or safety signal (SD): the information that arises from one or multiple sources (including observations or experiments), which suggests a new, potentially causal association, or a new aspect of a known association between an intervention (e.g., administration of a medicine) and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verification [Council for International Organizations of Medical Sciences (CIOMS)].

These specialty areas have grown into a global industry with new and innovative systems and technologies to enhance the safety of medicines around the world.  On July 9, 2012, The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law, which expanded the FDA’s authority and ability to safeguard and advance public health in four key ways: (1) collecting user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biological products; (2) promoting innovation to speed patient access to safe and effective products; (3)increasing stakeholder involvement in FDA processes; and (4) enhancing the safety of the drug supply chain (U.S. Food and Drug Administration website).

Today, opportunities extend beyond basic Pharmacovigilance operation activities such as case processing and medical coding.  Since earlier safety planning has become best practice and is more proactive, company discussions often include development of required pharmacovigilance and risk management plans, innovative safety systems activities in data migration and data mining (i.e. database express set-up and recoding) and a growing interest in better understanding signal detection strategies. Increased safety measures have been taken by regulators and industry researchers to ensure that the benefits outweigh the risks in marketed products, which in turn has lead to the development of new areas associated with the REM-related risk management activities, including the development of regulated medical communications and health literacy of consumer products (i.e., Medication Guides, Package Inserts), qualitative and quantitative analysis and knowledge attitude and behavior surveys (KABs) for healthcare providers and patients. Globally, monitoring of safety, particularly in emerging low-cost markets and developing countries, has also emerged as an important issue due to pharma expansion in these regions after the financial crisis.  Many pharmaceutical companies have moved their operations to these low-cost regions to minimize costly R&D and manufacturing expenses, making global safety even more of a priority due to the increasing use of medicines and growth of clinical trials overseas.

All in all, the growth of Drug Safety presents new opportunities and challenges for the CRO industry.  Many companies, particularly smaller firms, now rely on outsourcing and seek operational support in the management, analysis and interpretation of volumes of safety data for their product portfolios. As a result, CROs must become more competitive by preparing in-house staff and key services to meet the resource needs of a rapidly growing Drug Safety industry.  What are the skills needed to be successful in Drug Safety?  Building a strong safety team to support industry with early safety preparation, regulatory strategy and PVG planning can make or break the analysis of a product making it to market.  As trends in outsourcing continue to rise, many companies, particularly smaller companies, will demonstrate a growing need to partner with CROs that are seasoned and can provide broad areas of safety support. To meet these needs, CROs will have to build capacities to ensure that they have a robust safety team of qualified safety experts and personnel. Key characteristics of a strong safety team include:

1. In-house Expertise- Internal pharmacovigilance teams must be equipped with tools and skill sets to do proper analysis of adverse events including complex quantitative assessments of risk prior to being presented to health authorities.  The ability to perform case processing is just the beginning.  Support is equally needed in areas like: post-marketing commitments, medical writing, and signaling detection.
2. Staff Retention- Reduces interruptions in client projects.
3. SOPs and Processes- established internal standards of quality assurance.
4. Systems & Technology- CROs should be prepared to compete by investing in their own world-class safety database to service the needs of their clients. World-class safety databases reduce costs of data migration. Another advantage is it allows multiple uses for all clients. Companies are seeking to consolidate their safety data so the use of a single safety database rather than multiple databases at different CROs.  Exposure to a various clinical and safety systems (Arisg, Argus, Clintrace, MediData, etc) is also important.
5. Continuing Education & Training- There is a great demand for drug safety technical expertise. However, to date few drug safety certifications and programs are available to develop skills in the growing area. Companies should develop staff training plans using existing expertise, professional development programs, certifications, and lunch and learns. Staffing plan should also include recruitment of skilled and new safety professionals to build internal capacity in pharmacovigilance expertise. 

In conclusion, the days of simply gathering safety data are no longer due to risk analysis regulations and more stringent requirements in protecting human subject research.  Today, it’s more critical to establish a risk/benefit profile, making PVG and risk management plans mandatory for the identification of signals and other safety concerns.  Health authorities require more robust safety data analysis, particularly when reviewing case information, PVG plans, and aggregate report submissions. This growing focus on product safety forces industry leaders in CROs and pharma companies to better understand when and how early to perform proper analysis of adverse events.  Nearly half of the global drug discovery research will be performed by third parties by 2018 (Jim Zhang 2014). This paradigm shift and the strong desire of pharma companies to increase efficiency and improve R&D productivity has positive implications on the drug development outsourcing market.  With the exception of key in-house safety operations, many pharma companies, particularly small and biotech firms, are likely to continue to outsource a large portion of safety work for both developmental and approved products. As new opportunities arise across different sectors of the CRO market, pharma is looking to the CRO industry to fill these gaps in R&D.

TRI is committed to meeting the global needs of industry over the next phase of innovative drug discovery andhas more than 35 years of experience providing support to the drug, biologic and medical devices community.  TRI’s safety team is composed of experts such as MDs, PhDs, PharmDs, Masters, and RNs who have up to 25 years of drug safety experience.

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About the Author

Dr. Magalie Emile-Backer is a drug development scientist with over 10 years of experience in the biotech/pharmaceutical industry with expertise in clinical research, drug safety, pharmacovigilance, and risk management of small and large molecules development.  She also has 4 years experience in the non-profit and public sector as a biomedical researcher for government scientific research and global health initiatives. Magalie holds a doctorate in pharmaceutics and post-doctoral industry training in Pharmaceutical Development.

References

1. Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry April 2015
2. Jim Zhang, Ph.D. (2014), Global Drug Discovery Outsourcing Market Gaining Momentum: Global Sourcing Council
3. Council for International Organizations of Medical Sciences (CIOMS)
4. Q9 Quality Risk Management ICH Guidance 2006
5. FDA.gov http://www.fda.gov/downloads/Safety/FDAsSentinel
6. Hemavli Bali (2013), CROs (Contract Research Organizations) and other outsourced pharmaceutical support services M&A drivers and trends: Results Healthcare

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