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Read These Best Practices and Industry News Articles on our DIA Website

MODEL FOR TRANSFORMING A PHARMACEUTICAL MEDICAL INFORMATION ORGANIZATION TO MEET THE NEEDS OF THE EMERGING HEALTHCARE LANDSCAPE

by David J. Jones, MBA Partner, TKG Healthcare Consulting

Tiziana M. Fox, PharmD Senior Director, Medical Information, Janssen Scientific Affairs, LLC

goals for better outcomes and increased quality of care, new and different types of medical information regarding drugs will be required within a compliant framework for pharmaceutical companies. To meet this growing demand, Medical Information organizations (MI) in pharmaceutical companies will need to transform themselves to align with the changing needs of customers and stakeholders.

Transforming the MI organization requires commitment to a systematic approach that involves redefining strategic direction and creating a strategic transformation plan. The MI organization needs to align around the strategic transformation plan, define a future-state model, and implement the required changes in capabilities, culture, structure and process to enable the model. Once it has completed the transformation, the MI organization will be in a position to develop strategies and plans that address the needs of customers and stakeholders in the emerging healthcare landscape.

The US healthcare system began a transformation around 2008 that was accelerated by the Affordable Care Act in 2010. Many segments of the healthcare system are well underway in moving to value-

ERICK GAUSSENS

MICHAEL GABRIEL

DAVID J. JONES

JENNIFER GOLDSMITH

CHITRA LELE

TIZIANA M. FOX

New This Month!

This article is the first in a series compiled by the DIA Medical Communications and Scientific Writing Community on the critical role of medical information dissemination as the healthcare landscape shifts. Additional articles on this topic will appear in our November peer-reviewed scientific journal Therapeutic Innovation & Regulatory Science and can be accessed starting November 1 at http://tirs.sagepub.com

Medical information is playing an increasingly important role as the healthcare system transforms to a value-based model. As health systems, government, payers and other stakeholders advance their

GLOBAL FORUM | ADVISEV

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gfgfprocesses and systems. That priority in turn has led to major investment in better regulatory information management (RIM), and as of the first quarter of 2014, 42% of surveyed companies were shown to have in place a global authoritative source for regulatory information. That figure is expected to rise to 88% by the end of 2015. But achieving a global authoritative source of information goes beyond implementing new solutions and processes. It requires (1) careful management of the capacity, technical, process and data challenges that arise, (2) interactive and ongoing discussions with the affiliate companies, (3) development of a more strategic role for the affiliates, (4) communication about changes well in advance, and (5) management of concerns before they escalate.

IDMP CREATES BOTH OPPORTUNITIES & CHALLENGES IN MANAGING COMPANY-WIDE DATA

by Erick Gaussens Chief Scientific Officer, ProductLife Group

Just as pharmaceutical companies are in the process of preparing to meet one set of requirements for regulatory data — the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) — the conversation is starting to turn to the next, far more comprehensive requirement: The Identification of Medicinal Products (IDMP), a set of International Organization for Standardization (ISO) standards for universal identification of drugs.

Recent discussions have demonstrated that regulators are committed to the July 1, 2016, European Union legislative deadline for implementation of

documents is both time consuming and costly, impacting on content review and approval lifecycles, and impeding product-to-market delivery. To quantify the issue, the OPDP received approximately 85,000 FDA 2253 submissions in 2014 – up from 80,000 in 2011 – and the figure is consistently rising.

As such, the FDA has been planning to implement electronic submissions for a number of years. Currently, the OPDP only accepts hard-copy submissions. These must be accompanied by a completed FDA 2253 and a copy of the product’s current professional labelling or package insert (PI). Additionally, all submissions must adhere with Common Technical Document (CTD) standards, an internationally agreed upon submission framework recognized in Europe, Japan and the US for the preparation of applications regarding new drugs.

CHANGING REGULATORY & COMMERCIAL CLIMATE PUTS AFFILIATE MODEL UNDER SPOTLIGHT

by Erick Gaussens Chief Scientific Officer, ProductLife Group

The way global pharmaceutical companies work with their regional regulatory affiliates is undergoing comprehensive change amid the need to improve how regulatory information is managed across the enterprise.

Both regulatory and commercial pressures are encouraging companies to develop a global authoritative model to manage their regulatory information. Indeed, a Gens and Associates survey of 37 of the top 60 biopharmaceutical companies shows the top business priority for 2014 is to globalize key

based approaches in order to achieve quality metrics, optimize outcomes and minimize overall costs. Among other goals, value-based approaches seek to better target specific patient populations as well as to provide the most cost-effective treatment. Several strategies are being employed to achieve these targets such as the development of clinical pathways to reduce variation in clinical practice, decision support techniques at point of care, and engaging patients to give them greater accountability for their own healthcare decisions and behaviors. Common and central to these strategies is the availability of scientifically sound, reliable, tailored and current medical information to inform and equip practitioners with knowledge for medical decision making, as well as information needed to help healthcare professionals help patients make decisions.

PREPARING TO SUBMIT FDA 2253 FORMS THROUGH THE ESG

by Michael Gabriel Industry Solutions Director, Zinc Ahead

Under US FDA regulations, all advertisement and promotional labelling for commercial drugs must be submitted to the Office of Prescription Drug Promotion (OPDP) for review at the time of initial publication or dissemination. The OPDP, under FDA guidance, subjects all promotional material to a strict review process against a criterion of compliance and regulatory standards. Each submission is required to be accompanied by a completed transmittal form, known as FDA 2253.

It is well documented within the industry that traditional posting and delivery of hard copy FDA 2253

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ENSURING OPERATIONAL EXCELLENCE IN DRUG SAFETY

by Chitra Lele, PhD Chief Scientific Officer, Sciformix Corporation

With drug safety evolving into a key priority area for the biopharmaceutical industry, the emphasis on quality and compliance has increased substantially. As regulatory oversight of company safety activities for approved pharmaceutical products becomes more holistic than simply assuring adequate and compliant procedures that meet legal obligations, the system is being transformed into one that is more proactive, robust and more clinically useful.

Regulations are increasingly targeted towards strengthening companies’ pharmacovigilance or product vigilance (PV) systems and defining clear roles and responsibilities across both the regulatory agencies and the industry. With evolving regulations and increasing complexity and volumes, many companies now outsource safety operations to specialized providers who can deliver effective and cost-optimized solutions that are scalable and assure compliance and quality.

The International Conference on Harmonisation (ICH), European Medicines Agency (EMA) and US Food and Drug Administration (US FDA) have communicated their expectations with respect to quality management systems (QMS) for PV as guidance for implementation of efficient PV systems.

eTMFs deliver deep operational efficiencies and high TMF quality. Additionally, those using advanced eTMF technologies reported experiencing greater inspection readiness, visibility and standard operating procedure (SOP) compliance as well as cost savings compared to those using local file systems or simple cloud file shares.

As regulatory and competitive pressures quickly mount, more life sciences companies are on the cusp of evolving from what have been largely manual TMF processes and simple file shares or paper towards new, advanced eTMF technologies to enable paperless trials. In fact, one in 10 respondents (13%) are already leveraging purpose-built eTMF applications that include process-driven workflows and capabilities for managing trial documents and data electronically. Further, the number of TMF owners actively building or evaluating eTMF applications to support efficient collaboration throughout a clinical trial study is up from 17% in 2010 to 33.6% today, according to a 2014 DIA TMF Reference Model survey.

This growing digital movement suggests that historical barriers to going paperless are diminishing. In the 2014 Veeva Paperless TMF Survey, only one major barrier emerged among a majority of TMF owners–concern over being able to grant secure access (62%). Cost, the next-ranking barrier, was cited by a minority of respondents, who noted concerns with the costs of technology (38%) and implementation (33%), while less than one-third indicated concern over regulatory requirements for wet signatures (28%).

IDMP, and with less than two years to meet the requirement, the pressure is on companies to become able to control and manage their regulatory data. It’s not a simple task, because it requires a significant time commitment to determine where and how data will be sourced, as well as having in place the processes and technology needed to support data collection and active archiving.

The IDMP places several impositions (1) on the industry, because it requires the harmonization of a vast amount of regulatory and corporate information across countries in regulatory profiles of prescription drugs, generic drugs, over-the-counter drugs, medical devices, and the like, and (2) on affiliates. Companies are also required to maintain information for all aspects of a product — including the product’s active pharmaceutical ingredient, formulation and excipients — and to ensure that the information is consistent at all manufacturing plants and within the supply chain.

TOMORROW’S TRIALS: PERCEIVED BARRIERS TO GOING PAPERLESS CRUMBLE IN THE CLOUD

by Jennifer Goldsmith Vice President, Veeva Vault, Veeva Systems

The recently published Veeva 2014 Paperless TMF Survey: An Industry Benchmark examined the current state of electronic Trial Master File (eTMF) adoption as well as the benefits, drivers and barriers to implementing electronic processes. This in-depth study of more than 250 TMF owners showed that

Read these complete articles online under “Health Care News” at http://www.diahome.org/News-and-Publications/Newsroom/Industry-News.aspx