ghpResearch, Translation, Commercialisation

www.ghp-magazine.com brought to you by

Innovation Impact Beyond a Billion In conversation with Jeffrey Heenan Jalil, the Global Head of the Healthcare & Life Sciences SBU at Wipro on how they are helping their clients change the lives of millions of people each and every day by enabling them to build breakthrough patient centric business models that drive better health and transform care delivery.

Best Life Sciences Safety & Risk Management Company

Best WBE Life Sciences CRO+ - USA

4 | ghp 2016 International Life Sciences Awards

Best Life Sciences Safety & Risk Management Company

Trends and Opportunities In today’s global economy, traditional business models are being pushed to the breaking point and the challenges are great. With these challenges come significant opportunities and where successful organizations can differentiate themselves from the competition. Organizations are having to find new rev-enues streams and are facing fierce competition from generics and biosimilars. They need to expedite time to market, maximize product longevity, support global distribution models, all while staying on top of the ever growing complex global regulatory environment and internal cost pressures.

To counter these trends, organizations are expanding into new markets and looking to have a mixed portfolio of generic and innovative products. There are oppor-tunities to optimize studies and processes to facilitate proactive insight and derive significant operational efficiencies and quality improvements.

To stay ahead of the game and meet these opportu-nities head on, collaborations and partnerships are critical to an organization’s long term stability and success. This is the key aspect of how Sciformix came to be. We understand our client’s needs and provide solutions that benefit them and enable business transformation.

The SPO Difference: SPOs as Partners of Life Science Organizations Scientific processes or science-based processes can be defined as domain-intensive processes in a scientific area where the achievement of objectives is highly dependent on the subject matter knowledge and experience of the people carrying out the activity. SPOs create value for their clients through their singular industry focus, strong domain competency, exceptional subject matter expertise, and uncompro-mising focus on quality.

SPOs execute processes which are at the highest end of the spectrum with respect to scientific content, while using analytics and processes as enablers. SPOs primarily have exceptional scientific depth by applying science based processes to the entire product lifecy-cle.

SPOs attempt to provide a fit-for-purpose blend of pro-cess excellence, analytical skills for making business decisions and maturity of infrastructure and technol-ogy, thereby providing the benefits of partnering with a BPO (business process organization) and a KPO (knowledge process organization) to the client.

Sciformix Corporation is a leading global Scientific Process Organization (SPO), providing science-based services to biopharmaceutical, generic

pharmaceutical, consumer products, medical devices and other healthcare companies. Our mission is to partner with life science companies to provide

high quality scientific expertise that delivers better quality outcomes and improved efficiencies across the entire product lifecycle with the ultimate objective of improving quality of healthcare for patients worldwide. Key

capabilities and areas of collaboration include safety and risk management, clinical development, post-approval support, medical affairs, regulatory

affairs & operations, scientific writing and technology services.

ghp 2016 International Life Sciences Awards | 5

LI160024

4 | ghp 2016 International Life Sciences Awards ghp 2016 International Life Sciences Awards | 5ghp 2016 International Life Sciences Awards | 5

Global Pharmacovigilance SystemGlobalization of the marketplace and the impact of the latest technologies on healthcare delivery will create significant challenges and opportunities for all stakeholders in the life sciences. Pharmacovigilance (PV) is in transition, with new sources of medical information and methods for its analysis being explored that will transform the current reactive system into one that is proactive. Regulations across the globe are also evolving towards a more proactive approach, but continue to be largely procedur-ally focused. Furthermore, the technical resources required for effective benefit-risk assessment are still at an early development stage.

Greater public awareness of drug safety issues and emerging informatics-based methods for acquiring and analyzing medical information, have sparked global initiatives to transform the current largely reactive safety system into one that is proactive, robust, and more useful clinically. In addition, the emerging importance of patient cen-tricity and increase in publically available safety data are also driving this change.

For organizations to be successful in today’s environment, it is critical that they ensure all safety systems and PV practices employed are firmly tied into a truly global PV framework. Establishing such a framework requires a carefully thought out strategy that takes into consideration the accountabilities and responsibilities of all entities, how they relate to safety directly or indirectly and the harmonization and standardization of processes that may be required.

Establishing a global PV system poses many challenges to organizations of all sizes although they may vary by the type of the organization. For a small company with only a limited number of products, the risk of non-compliance and in-house availability of safety expertise may be a big challenge. For a generics manufacturer, the focus and diligence on product safety and the number of distributors and business partners could be the major challenges. For large companies that have a diverse product mix and vast global reach, ensuring standard global SOPs related to safety and risk management across product categories and regions, and effective oversight of all parties may be the most important challenges.

6 | ghp 2016 International Life Sciences Awards

Best Life Sciences Safety & Risk Management Company

Life Sciences organizations partner with SPOs for such high-end science-based activities to derive value from access to a highly skilled/talented workforce, innovative technologies and optimized processes, resulting in improved quality outcomes, operational efficiencies and cost optimization. In today’s com-petitive environment, life science organizations must identify and focus on their core competencies and outsource non-core activities in order to achieve the ultimate objective of delivering high quality healthcare and healthcare products. Many companies have come to realize that by outsourcing these activities, not only are efficiencies improved and costs optimized, but the total business also improves because the focus of the internal experts shifts to the key growth areas of the organization.

Ensuring Product Safety and Regulatory Compliance in the Ever Growing and Complex Life Science Landscape Emerging market expansion, growing regulatory pres-sures, the ever increasing complexity of managing the product lifecycle, the volumes and sources of various data, coupled with patient and payer pressure to get the safety, efficacy and value of the product right are some of the challenges our clients face. The highly dynamic processes that support these activities must be opti-mized to deliver accelerated timelines during the devel-opment, approval and commercialization of the product. At Sciformix, we create value by employing efficient and mature processes, robust metrics, state-of-the-art technology and scientific expertise to deliver consistent, compliant and high quality results. By providing access to reliable real-time data and comprehensive analyses, we enable our clients to make swift decisions.

The Greatest Barrier and Opportunity to Innovation Lies in Technology Technology has forever transformed the entire healthcare continuum and has ushered in new and revolutionary ways to ensure patient and consumer safety. Technology has also enabled organizations to achieve higher levels of compliance and quality, to derive better insights, and also to increase efficiencies by driving down operational costs. With this said, one of the biggest challenges organizations face is how to effectively integrate the science behind all aspects of the product lifecycle with the technology know-how behind IT. Companies that recognize the impor-tance of an integrated strategy that takes these two elements, along with the changing global regulatory landscape, into consideration will see greater success in managing the lifecycles of their products.

As one of the leading global providers of Safety & Risk Management and Regulatory services, Sciformix is uniquely positioned to combine this rich knowledge with our customized IT solutions. Our integrated drug safety solutions help life science companies build Pharmacovigilance IT reference architecture, deploy signal detection applications and create enterprise portals for safety analytics. Additionally, we also provide solutions for business intelligence, analytics, querying and reporting, validation and regulatory compliance and data migration.

By combining our strength in the drug and regulatory safety space with IT technology solutions and services, we offer companies a cost-effective global model that ensures the highest standards of compliance, quality and agility in reacting to change. Our solutions enable innovation and continuous improvement across the

entire drug product life cycle. This integrated approach to business operations based on a unified platform helps organizations to be more pro-active in their ability to respond to problems and business needs.

Patient Centricity in Pharmacovigilance The importance of Pharmacovigilance (PV) as a science is critical to both effective patient care in clinical practice and public health. Patient-cen-teredness and patient safety have emerged as core elements in today’s interactive and responsive healthcare systems. As patients take more interest in their health and healthcare, they support the maxim of ‘‘Nothing about me, without me’’ and expect caregivers to engage in shared decision making, so that the patients’ voice is always included.

Patients usually report adverse drug reactions (ADRs) to their doctors. However, since only 5% of doctors are estimated to participate in PV, tradi-tional mechanisms may not be efficient in ensuring adequate safety reporting. Data from studies indi-cate that systems which enable direct recording of patient concerns may identify new drug safety signals earlier than professional reporting systems alone. This emphasises that the patients’ role in actively reporting ADRs is key to building a better PV ecosystem.

Patient-centric innovation will be at the heart of the transformation of PV over the next couple of decades and this will likely forever change PV as we know it today. But are we really prepared to implement patient-centric approaches in PV? What steps are required to bring safety to patients, as opposed to bringing patients to safety?

PV organisations that incorporate the patients’ “voice” in PV systems and processes would be better positioned over the long-term to ensure patient safety and add real value back to the patients by enhanc-ing product benefit-risk profiles. Overall, adopting a patient-centric approach and partnering with patients and public for reporting, analysis and communica-tion of safety data seems to be the way forward. Company: Sciformix CorporationWebsite: www.sciformix.com

6 | ghp 2016 International Life Sciences Awards ghp 2016 International Life Sciences Awards | 7ghp 2016 International Life Sciences Awards | 7

Smart Sourcing Strategy: Risk-based Outsourcing Approach and its Evolution Strategic planning, sourcing and implementation of safety and risk management operations are multi-dimensional activities that require consid-eration of a multitude of factors. Compliance, quality and efficiency of safety processes being outsourced is a basic expectation now for more tactical areas of pharmacovigilance (PV) such as call center and case processing due to the maturity of the outsourcing and offshoring environment and processes. This trend helped sponsors to focus their in-house resources on the strategic elements of safety and risk management while leveraging the service provider’s capabilities. Over the past few years companies (large and small) are seeking more strategic partnerships with vendors who have additional specialized capabilities such as safety consulting, medical review, aggregate reporting and signal detection. Furthermore as companies are expanding into new geographies, markets and regions, or consolidating operations due to mergers and acquisitions, specialized capabilities and regulatory knowledge are a critical consideration of a company’s outsourcing strategy and decisions.

An organization’s sourcing strategy would vary based on its product portfolio, stage/phase in the product lifecycle, therapeutic areas, internal capa-bilities, expected case volume, expected complex-ity of cases, geography of product sales and risk management requirements.

By applying our Partner Assessment Framework in the context of each client’s unique outsourcing needs, we help our clients make the right deci-sions and implement the right solutions.

The approach to outsourcing depends on the sponsor organization’s business model, current status and future plans. When it comes to safety, companies are especially risk-averse in their outsourcing decisions and the outcome of a risk-based approach to outsourcing safety services could lead to very different outcomes for different companies. A risk-averse approach for a company which has an in-house PV operations and safety team could mean that they gradually transition activities and/or products to a PV service provider and it may not be critical for the provider to have the scale and all expertise from the start. On the other hand, small companies which don’t have any capability in-house, would look to partner with a provider who has the wherewithal to set-up the entire safety system and operations for them, inclusive of people, process and technology.

Download the Whitepaper: http://www.sciformix.com/smartsourcingstrategy/