Regulatory business process services: A strategic enabler

Transcription

1 Regulatory business process services: A strategic enabler

2 Achieving cost containment and regulatory savvy through partnership Life sciences companies are under enormous cost and resource pressure. According to 2014 estimates from the Tufts Center for the Study of Drug Development, it costs $2.6 billion to bring a new drug to market, a massive increase over the 2003 Tufts estimate of $802 million.1 To rein in expenses, companies have looked at various measures from portfolio management and narrowing the therapeutic focus to seeking to outsource and partner with contract research organizations (CROs) and business process services (BPS) providers. Companies must also innovate to grow in a rapidly changing regulatory environment, where every stakeholder in the health ecosystem is becoming more tightly entwined. Part of this innovation requires embracing digital technology and the disruptions that come with it new ways of thinking, innovating, collaborating and engaging with partners, affiliates and health authorities. While the CRO model is widely accepted across the life sciences industry with around 55% of clinical trials being outsourced 2 there is still room to partner more extensively beyond clinical execution. When working with a BPS partner, some companies see estimated savings of between 20% and 30% across regulatory submissions, product registrations, regulatory operations and affairs, and regulatory consulting and legal representation through more efficient and cost-effective use of compliant technology and proficient personnel. BPS spans strategic consulting, business process development, technology expertise and document analysis right down to the preparation of regulatory documents. Working with a BPS vendor gives companies access to validated systems, better marketplace insights, robust regulatory capabilities, well-defined business process know-how and around-the-clock support. 1 Cost to Develop and Win Marketing Approval for a New Drug Is $2.6 Billion, Tufts Center for the Study of Drug Development, November 18, 2014 Plus, BPS providers bring an industry-wide, big-picture perspective that gives companies the knowledge and capabilities to strengthen their core competencies and even tap into new business opportunities while remaining compliant. When life sciences companies enter into a synergistic BPS partnership, they can gain CRO Buying Trends, Nice Insight CRO, buying-trends.aspx 2

3 Agile workload management Case study Cloud solution, BPS partnership support expansion Challenge: A midsize pharmaceutical company with a focus on pioneering pain management had undergone a cycle of significant corporate cost reduction, taking its regulatory department from a team of 18 people to just five. This process took place during a period of increased regulatory submission demand, and the loss of expertise made it difficult for the regulatory team to meet that demand. The company needed an environment that could support internal needs, as well as vendor and partner access to information and documents. From a BPS point of view, having a partner that could flex to support significant increases in submission demand was a priority. Solution: The company selected a robust document management system with the ability to manage Electronic Common Technical Document (ectd) submissions in a flexible way through a cloud-based solution, which allowed both its staff and its BPS partner to publish and perform quality control. By selecting a BPS partner with follow-the-sun capabilities, the company was able to take advantage of both onshore and offshore capacity to support submission activity peaks and troughs and effectively manage its workload. Benefits: Today, the company is expanding its business and growing into new and related therapeutic areas, all while meeting growth in submission demand without adding internal resources. more than the simple management of submission documents. The partnership can facilitate development and growth. It can draw on best practices, drive a flexible and scalable resource model, reduce overall corporate costs and harmonize processes and operations. Here are three scenarios in which BPS can help life sciences companies meet their regulatory transformational needs. Agile workload management Life sciences leaders must walk a delicate but critical balance between build-andgrow and run-and-maintain. Each of these drivers presents the business with difficult problems regarding the scalability and flexibility of systems and processes. The global nature of the life sciences industry means that companies will likely have products in regions where the primary focus is on life-cycle maintenance and where the challenge is to ensure that systems and data centers are properly resourced to meet those needs. In all markets, the considerable cost of product commercialization and the high rate of product failure during clinical trials place a premium on flexibility and process improvement. Life sciences companies must also effectively manage times of constraint and ensure that their businesses do not falter when research and development (R&D) challenges arise. BPS lets companies manage multiple regulatory activities. It helps them improve process management by engaging SMEs to increase R&D efficiency through better oversight across the product life cycle. Regulatory departments are particularly subject to the peaks and troughs of global submissions, which can mean having staff members who are underutilized at some periods and overtaxed at other times. BPS helps to fill those gaps as required and supports a move toward lean staffing. 3

4 Optimize utilization Case study BPS partnership enables scalability, innovation Challenge: A small oncology-focused life sciences company had a single Investigational New Drug (IND) and was preparing its first electronic submission to the U.S. Food and Drug Administration (FDA) in The company had a very small regulatory group with no publishers in house to support the work, no tools to leverage an electronic submission, and lack of expertise to manage the process properly and efficiently. The company needed an experienced partner to help it through the process. Solution: An early priority was to stay ahead of FDA developments and move away from paper and toward electronic submissions. Over the years, the company has built a closeknit relationship with its BPS partner, gaining access to high-performance tools of the trade, domain expertise and submission publishing best practices. Further, having a partner with onshore, offshore and nearshore resources allows for 24-hour support when required. Benefits: Through the partnership, the company has gained a flexible and scalable model for all its submission needs. At any given moment, there may be submission activity, and no matter what the volume is, the company knows it can rely on its BPS partner to perform the work and deliver high-quality submissions in a timely manner. This new business strategy of building lasting relationships allows the client to focus on several other value-add and core competency activities. Maximize efficiency and optimize utilization From the largest business to the smallest, life sciences companies are looking to cut costs yet achieve more. Companies are growing at a rapid rate, changing direction, or trying to integrate new businesses or products all with fewer resources. Meanwhile, in an increasingly complex digital world, data is coming from multiple sources across numerous platforms. Turning that data into knowledge that can help the business gain a competitive advantage or improve how it responds to regulations has to be balanced against the imperative to drive down overhead. BPS supports companies regardless of size, growth or changes at whatever stage they may be in, and it lets them respond to regulatory submission requirements without having to add permanent staff. Small, innovative companies with little regulatory expertise can focus on getting a product through the R&D phase and subsequently through approval while remaining lean to attract potential buyers or partners. Many larger companies have been diversifying their business by reinventing themselves and focusing on core competencies. Working with a trusted BPS partner provides a combination of high-performance solutions, subject matter expertise and best-practices methodologies. Companies increasingly recognize the value of BPS. While it helps these companies react to an issue new guidance, cost, lack of know-how, lack of time they are taking a strategic approach to BPS to enable operational efficiency. In a merger-and-acquisition (M&A) or business-diversification situation, a lot of tasks need to happen quickly, and few companies are in a position to manage this turnaround themselves. Following major business changes, companies need a partner that can continue with the day-to-day activities involved in getting submissions out the door while the companies concentrate on aligning systems, processes and other internal strategies. It is important that a BPS partner have the flexibility to work in any type of environment and the compatibility to leverage a wide range of software. 4

5 Maximize efficiency Case study Centralizing, using BPS partner labor boosts abilities Challenge: A large pharma company had gone through a major diversification, separating its business to enable it to clearly focus on core competencies. The overall company had been working with a BPS partner, and following the structural changes, the business continued that partnership but with a view to harmonizing and centralizing the global submission process. Solution: U.S., EU and Singaporean submission processes were brought under one roof, managed by the client but leveraging BPS expertise from the long-term service provider. The company had to handle more work with fewer resources and needed to know that its partner could provide the quality and flexibility required. Benefits: Through its relationship with its BPS partner, the company has gained 10 dedicated and experienced staff members trained on internal systems and processes, high-quality support of the submission process, the ability to rely on the partner as an extension of its team, and a strong team for highpeak scenarios. Success in a BPS marriage Like any relationship, outsourcing requires commitment from both the client and vendor, as well as a willingness to work through difficulties. What is needed from each party in order for the relationship to thrive and bring benefits to both? Preparation. BPS can and does provide life sciences companies with highly skilled experts, while at the same time removing costs from the company. But, to outsource to a third party, you should provide your BPS vendor with the types of tools that allow it to manage your needs job aids, work lists and records, and standard operating procedures. Clear Governance. Instrumental to a successful outsourcing relationship are governance and communication. Your BPS vendor doesn t know what you are thinking; it doesn t know the internal workings of your company or function (or at least not until the relationship has matured); and it can t fix your problems unless you document what those are. Undoubtedly, a good BPS vendor can manage your business process reengineering for you, but it would need to be contracted to do so, and you would still need to communicate your requirements. Transparency. Communication is crucial at all times. When both parties are communicating, there is transparency, and when you have mutual trust and respect, you are well on the way to becoming a family. In the best BPS relationships, your vendor builds up its client contacts to make sure they feel secure by helping them succeed. Indeed, in a real BPS family situation, your vendor makes you look like a hero. 5

6 Operationalize business change Case study 1 Managing submissions in-house support as needed Challenge: For more than 10 years, a small biotech company with a focus on rare diseases has worked with an outsourcing partner to handle full submission management to the U.S. Food and Drug Administration and the European Medicines Agency. The company had a small regulatory group with no publishing capabilities in house, without the resources to deploy its own tools and without the expertise to manage Electronic Common Technical Document (ectd) submissions. Solution: In the past few years, the company wanted to explore options to bring some publishing in house and sought help to manage this change through a Software as a Service (SaaS) platform and ongoing support from its BPS partner as needed. After several successful submissions and two approved biologic license applications, the company has more flexibility to move toward a model in which work is performed predominantly in house in the SaaS environment while leveraging its BPS partner where needed. Benefits: After a long and successful journey, the biotech company has grown and moved away from a throw it over the fence relationship to a partnership with its BPS provider. From a position where the company didn t have a regulatory operations group, defined business processes or overall know-how, it has grown its expertise and capabilities thanks to the guidance, mentorship and experience gained through a longterm partnership. As a result, the company has matured and achieved business change to the point where it can now take ownership of its publishing work while continuing to work with its BPS partner and leverage expertise as needed. Operationalize business change Change is the one constant. Whether it s a new product, a new region, downsizing, in-licensing, an acquisition, diversifying the business or responding to new compliance requirements, life sciences leaders are continually required to demonstrate their ability to manage change. For example, when a new tool or process is introduced, the challenge is not only to ensure that it is deployed efficiently with across-the-board user understanding and adoption, but also to assess how it interacts with other tools and processes already in place. Solutions and tools may be owned by various functional groups throughout an organization, yet there is a need to ensure greater harmonization across the enterprise, good communication flow and governance around processes. BPS aligns the technology and processes required to increase efficiency with good business processes and the ability to leverage smart people to create a productive environment for change. A significant change in direction at a business can have a huge impact on how critical but noncore processes, such as regulatory submissions, are managed. Companies need to determine what is required to support business change and how best to respond to a changing and increasingly patient-centric healthcare marketplace. BPS: A flexible and strategic approach Combining flexible and progressive regulatory technology solutions and processes with a strategic BPS approach will help companies drive change that benefits regulatory and commercial needs in an increasingly complex healthcare ecosystem. BPS also provides opportunities for life sciences companies to develop new types of collaboration and partnership that will enable them to respond to a rapidly changing and converging business environment. 6

7 Operationalize business change Case study 2 BPS partnership enables cost reduction, focus on the business Challenge: After streamlining the business and renewing its focus on core competencies, a large pharma company adopted a significant strategic business change: It outsourced all documentlevel formatting and publishing activities. The move was driven by a corporate initiative to reduce cost and to move critical but nonstrategic activities such as publishing out of the business. The company also recognized the BPS partnership as an opportunity to increase productivity and efficiency and respond to growing demands during the submission process. Solution: The company now has dedicated resources from its BPS partner in the United States and in China to meet its regulatory needs. The relationship has been hugely successful for the company and has exceeded goals. Authors/contributors DXC Technology life sciences business process services (BPS) Joe Salamon Joe Salamon leads the DXC Life Sciences BPS group, holding responsibility for the Regulatory Operations, CDISC/Biometrics and Regulatory Consulting practices. He has 25+ years sales and operational experience in advisory services, outsourcing and IT in the Life Sciences and Consumer industries and has worked in 28 countries. He possesses a deep grasp of the business processes and supporting technology spanning phases I IV clinical development, pharmacovigilance, health economics (HEOR), market access and regulatory affairs. Leslie P. Wan As the global head of Regulatory Engagement Management (REM) for DXC Life Sciences BPS, Leslie Wan leads a team in bridging the resources gap for DXC clients. The REM team facilitates movement of complex submission components to a successful endpoint. Leslie has worked in the pharmaceutical industry for 10 years. She began her career in 2006 as a project manager at Image Solutions Inc. (ISI), which was acquired by DXC in Leslie holds a bachelor of science degree in Biochemistry and a master s degree in Toxicology. Benefits: To date, the BPS partner has handled 120,000 documents, or 58 million pages, while the pharma company can concentrate on what it does best: research and development, and supporting products on the market. Learn more at BPS. About DXC DXC Technology (NYSE: DXC) is the world s leading independent, end-to-end IT services company, helping clients harness the power of innovation to thrive on change. Created by the merger of CSC and the Enterprise Services business of Hewlett Packard Enterprise, DXC Technology serves nearly 6,000 private and public sector clients across 70 countries. The company s technology independence, global talent and extensive partner alliance combine to deliver powerful next-generation IT services and solutions. DXC Technology is recognized among the best corporate citizens globally. For more information, visit DXC Technology Company. All rights reserved. CSC-247_MD_9724a-17