Driving Innovation In Bio Pharma W Plm


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This paper explores biopharma industry challenges in product development and innovation, defines PLM for the industry and provides guidance on how to get started on the PLM journey.

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Driving Innovation In Bio Pharma W Plm

  1. 1. Driving Innovationin BioPharma:From Discovery to Delivery withProduct Lifecycle ManagementKalypso White Paperby Scott Gibbard, Dr. Horst Groesser and Andrew Hunter Normal Reversed
  2. 2. Industry Challenges The economic challenges faced by today’s biopharmaceutical industry are well documented. Revenues are contracting due to patent expiries, generics competition and pricing pressure from payers that are demanding clearer demonstration of product value. By 2016, medicines that generated sales of $133 billion in 2010 in the US will have lost patent protection.1 Innovative new products are scarce as R&D budgets chase increasingly difficult scientific problems. For those products that successfully make it through development, the regulatory approval bar is higher than ever. By 2016, patent exclusivity Much of this is not recent news. Drug discovery, development and commercialization have always been expiries in one or more developed complex and risky. The vast majority of new product ideas markets will impact 13 of the fail. Ideas that do make it out of the labs face an extremely lengthy and expensive journey navigating a highly top 20 selling medicines of 2010, regulated environment where the rules vary by country. including Lipitor®, Plavix®, Advair The science is usually complicated and always unpredictable, generating enormous amounts of data and experimental Diskus®, Crestor® and Nexium®.2 results from both failed and successful programs. And yet, many steps taken by companies over the last several years to address these business challenges have only added to the complexity: Figure 1: Mergers and acquisitions Scientific partnering and collaborations, Actions taken to have made companies bigger often operationally complex, address biopharma and even more complex, have collided with the business challenges carving already siloed culture of monolithic functions into specialized research organizations sub-functions. Rationalizing not accustomed to differing processes, systems truly sharing their work. and cultures has proven to be difficult. Expansion into Portfolio diversification emerging markets into new therapeutic has required areas or biologics (novel or unfamiliar regulatory biosimilars) has required environments to be companies to build new learned and commercial scientific capabilities and models to be modified develop a deep understanding or rethought. of new technologies. The biopharma industry’s ability to discover, develop and launch profitable new products has been diminished by the pervasiveness of complexity. In order to drive growth from innovation, companies must manage this complexity within their product development and innovation processes. 1, 2 The Global Use of Medicines: Outlook Through 2016, July 2012, IMS Institute for Healthcare InformaticsDriving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management 2
  3. 3. Manage the Complexity of InnovationInnovation is More Than Scientific DiscoveryInnovation in biopharma is often understood as scientific breakthroughs inbasic research and discovery. While the discovery of new molecular entitiesis the lifeline for biopharma companies, true innovation is not just aboutthe science – it also requires transforming those breakthrough discoveriesinto marketable products and successfully launching them in highlyregulated markets.In addition to developing new drug products, companies can beinnovative in many other ways. Product and service bundling, supply chainrestructuring, and information asset management are just a few examplesof areas with great innovation potential. While these forms of innovationmay not be viewed in the same light as launching a new product aftermaking a high-profile scientific breakthrough, they can accelerate productcommercialization, and ensure safe and compliant delivery once theproducts are on the market. In fact, these other forms of innovation can fuelscientific discovery by allowing quicker answers to “what-if” experiments,ultimately leading to faster advancement of knowledge.When operating in such a complex environment, there are threefundamental capabilities that biopharma companies need to focus onimproving to maintain and enhance their innovation performance: •• Visibility. Scientists with better visibility into one another’s work improve the chances of “connecting the dots.” Better visibility helps management set priorities and ensure resources are allocated in line with those priorities. It can also smooth the transition from research to manufacturing and commercialization. •• Traceability. Better traceability improves the organization’s ability to maintain compliance and address regulatory inquiries. It also enables improved reuse of knowledge assets by allowing product development teams to retrace development decisions made in the past. •• Collaboration. Drug development is a complex, cross-functional endeavor. Increasingly, it involves partnering with researchers from many different organizations. Better collaboration enables a richer understanding of scientific challenges and more innovative product solutions.3 Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management
  4. 4. Improving visibility, traceability and collaboration can have a significant impact on many important biopharma business processes, leading to better product innovation. Figure 2 explores several examples: Process Challenge Impact Solution Regulatory submissions Complex cross-functional Delayed time to revenue; Improved global and product launches coordination, with global premature launches with collaboration using one product launches adding increased compliance risk longitudinal product layers of complexity data history, created by many functions in multiple formats Regulatory compliance Coordination of supply Product recalls, or Improved integration of for marketed products chain and regulatory even worse, product tools for compliance and functions working with withdrawals resulting change control based different, non-integrated in loss of revenue on a single source of systems and reputation product information Handover from R&D Classic “throw over Organizational handoffs Improved visibility and to manufacturing and the wall” knowledge and no accountability; collaboration between product transfers from transfer often addressed knowledge loss; difficulty sending and receiving one plant to another by carving out an manufacturing at scale organizations organization to manage the transition Portfolio prioritization Often treated as a Delayed kills of failing Improved visibility once-a-year event due to projects; resource and and collaboration that the large effort required funding allocations enables important to gather data get out of synch portfolio decisions to be with priorities event-driven throughout the year; timelier re-allocation of funding and resources Product packaging Different packaging Delayed launches into Reduced compliance and labeling (or even branding) and new markets; compliance risk through global labeling in different risks with packaging or coordination of markets, complicated label changes packaging and by expansion into labeling processes emerging markets Figure 2: A management discipline called product lifecycle management (PLM) is an Impact on biopharma effective approach to improving visibility, traceability and collaboration for business processes a wide range of business processes that create or use product information.Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management 4
  5. 5. Call to Action: Drive Innovation withProduct Lifecycle ManagementWhat is PLM?Product lifecycle management (PLM) has transformed how productsare developed and commercialized in several industries over the last twodecades. PLM is the process of managing the entire lifecycle of a product –from its conception, through discovery, development, regulatory approval,to launch, production and end-of-life. It is a technology-enabled disciplinethat integrates the processes, data, people and enterprise informationsystems comprising a company’s product development, introduction andchange control capabilities.Adoption Level PLM High LowMaturity Aerospace, Process, Defense, Medical Personal Care, BioPharma, Automotive Industrial High Tech Device Household, CPG Nutraceutical Services Established Industries Growth Industries Emerging IndustriesPLM should not be confused with “lifecycle management” (LCM), a phrase Figure 3:often used in biopharma to describe the practice of maximizing a product’s PLM adoption across industrieslifetime value by defending/extending market share of approved productsthrough the pursuit of additional indications, new formulations andexpansion into new markets. PLM is a broader concept that defines howproduct information is managed throughout the lifecycle of the product.5 Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management
  6. 6. Portfolio & Pipeline Management De Strategic (Franchise and Therapy Area Capabilities Strategies, Portfolio Balancing) Collaboration S Product Portfolio Data Internal & External Collaboration Manufacturing & Supply Chain Product An Development Product Record lo Discovery & (Illustrative) Packaging m Product Development Development & Labeling dr Capabilities & Tools Suppliers Quality & & Sourcing Compliance Program Data PLM Platform ERP Descriptive Product Data Transactional Data Figure 4: Innovation in the biopharma industry is not going to get any easier, Capabilities within or any less complex. Given the current challenges companies are facing, the PLM platform it is now time to adopt PLM principles in biopharma in order for companies create an integrated to succeed at developing and launching new products that deliver desired set of capabilities and Product Record in-market results. The Product Record At the core of PLM is the Product Record – a single version of the truth for a product and all product-related data. It contains all of the information necessary to design, develop, produce and modify the product. The Product Record is based on a logical product data model that captures comprehensively: a. The physical entities that a product consists of (materials, etc.) b. The informational entities that are associated with a product or its physical entities (regulatory data, supplier information, material specifications, etc.) c. The structural relationships between these entities (product structure) d. Attributes describing the physical and informational entities of the productDriving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management 6
  7. 7. Figure 5 shows an illustrative example of a basic, logical data model for a drug product. Finished Product Packaging Yet PLM goes beyond solely providing a Primary Packed version-controlled source of product data for Delivery Device Packagingnd Therapy Area all of the business functions. It incorporates Drug Product rtfolio Balancing) all processes that generate, modify or affect Specification Excipientuct product data along the product lifecycle. Pharmaceuticalo Data Intermediate Raw Ingredient Manufacturing Drug Substance & Supply PLM processes capture both structured data Chain An illustrative Development documents. In biopharma, PLM links the and Chemical logical data Intermediate Packaging“world of science” with the “transactional model for a & Labeling drug product world” of enterprise resource planning and Raw Ingredienters ing manufacturing, by transforming and enhancing scientific and experimental drug information into descriptive drug product master data. Figure 5: PLM puts a company’s most valuable innovationm ERP asset – product data, from concept through Drug product example commercialization to end-of-life – at the center of their innovation efforts.ata Transactional Data The product data that forms the backbone of PLM represents all types of data collected It is now time to adopt PLM during the entire product lifecycle – including principles in biopharma in early concept ideas, market research, business cases, clinical trial results, description of order for companies to succeed key processes, phase gate reviews, clinical at developing and launching strategies, and launch plans. Any data that describes the product and its properties new products that deliver can be an element of the Product Record. desired in-market results. Can PLM Work in BioPharma? Significant benefits of PLM – such as faster product time to market, and increased productivity in R&D and product/technical operations – have been realized in industries such as aerospace, defense, automotive, high technology, medical devices, food and beverage, and consumer packaged goods. Although the biopharma industry may represent a unique combination of risk, complex science and regulation, its uniqueness does not prohibit it from achieving the same benefits from PLM. 7 Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management
  8. 8. While product development and commercialization in biopharma is certainly distinctive, several significant dimensions of complexity are not entirely exclusive to the industry, as explored in Figure 6: Figure 6: The takeaway for biopharma companies: several industries share similar Comparison of complexity complexity characteristics, and have successfully implemented PLM across industries solutions to address these challenges while reinvigorating their product innovation efforts.Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management 8
  9. 9. Get Started Six Tips for Starting the PLM Journey Like most transformational changes, taking the first step with PLM can be daunting. Fortunately, the nature of implementing PLM lends itself to layering in capabilities as needed. Here are six tips for getting started: 1. Assess your current capabilities. Evaluate the maturity of your current PLM capabilities related to strategy, processes, data management and technical infrastructure. Conduct interviews with a broad cross-section of the organization to ensure accurate and balanced feedback. 2. Align on a vision. The insights gained from the current capabilities assessment will provide the basis of your PLM vision. The vision should crisply articulate your desired future state and support a compelling case for change. The leadership team must align on and believe in this vision, and be prepared to explain and support it. 3. Pick your leader…carefully. Like any major change, it matters who the leader is for your PLM program. The leader should be well respected and connected within your organization. They must be a champion for change, and thus should deeply understand and buy in to the promise of PLM to drive product innovation. The leader should also have excellent communication and influencing skills. 4. Develop a roadmap for a phased approach. Unlike other technology- enabled transformation projects – ERP, for instance – PLM does not need to be implemented with a disruptive “big bang” approach. It can be implemented in phases – an approach that reduces risks, breaks implementation into manageable “chunks” and minimizes organizational impact. It also aids adoption by delivering a steady stream of incremental value as the various capabilities are enabled. 5. Utilize rapid prototyping and iterative design. Use conference room pilots, prototypes and sandbox environments from the very beginning of the project to gather requirements as well as to support organizational awareness. During implementation, “go live” with basic functionalities, and add other functionalities afterwards. Depending on the size and complexity of the organization, a gradual roll-out by franchise, therapeutic area (TA) or region might be the most suitable roll-out strategy. 6. Focus on quick wins. Upfront planning for PLM should be thoughtful and holistic. Most of the benefits will come when product data and processes from multiple business areas are implemented – that’s when cross-functional collaboration and visibility really begin to take hold. That said, select an early adopter area where you expect to demonstrate immediate benefits – such as the Regulatory Operations or Product Labeling group.9 Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management
  10. 10. Summary: PLM Can Drive Innovation in BioPharma Growing complexity is changing the economics of drug development. Many actions taken by the industry to date do not address the central issue of driving innovation to produce more novel medicines to satisfy unmet medical needs. Product innovation has never before been so imperative. In this environment, biopharma executives must assess their innovation capabilities by considering questions such as: •• Are our current methods good enough to overcome the growing complexity in our business? •• How can we free up time to focus on real innovation? •• Do we have a single source of truth for our product information? •• Do we effectively learn as an organization from our product development successes and failures? PLM has transformed product innovation in other highly complex industries over the last two decades, reducing time to market and improving product development productivity as a result. The lessons learned from these industries are relevant, and the biopharma industry must understand how to apply them within their organizations. This includes recognizing that their most valuable information assets – the product data – must be at the center of their innovation efforts, not merely a by-product to be managed by functional silos. Adopting an entire lifecycle perspective to innovation will benefit the measures that matter the most – truly innovative products that generate real health benefits to patients and economic benefits to biopharma companies. PLM processes and technologies can enable this kind of real innovation.Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management 10
  11. 11. About the Authors Scott Gibbard has over 20 years of experience in engineering, product development, strategic planning, performance management and change management in biopharma and other science-driven industries. He holds an MBA from Cornell University, a Master of Applied Science from the University of Toronto Institute for Aerospace Studies (UTIAS) and a Bachelor of Applied Science in Engineering Science from the University of Toronto. scott.gibbard@kalypso.com Dr. Horst Groesser has over 20 years of experience in product lifecycle management (PLM) and supply chain management in the biopharma, medical device, high technology and manufacturing industries. He holds a PhD in Mechanical Engineering and a Diploma in Industrial Engineering from the Technical University of Darmstadt, Germany. horst.groesser@kalypso.com Andrew Hunter has over 25 years of experience in product development, project management and change management in the biopharma industry. He holds a Master of Business Administration from INSEAD, a Master of Science from the University of Warwick and a Bachelor of Science in Mechanical Engineering from Imperial College. andrew.hunter@kalypso.com Contributors: aurens Broekhof, Senior Manager laurens.broekhof@kalypso.com L Sunny Sun, Senior Consultant sunny.sun@kalypso.com11 Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management
  12. 12. About KalypsoKalypso is the world’s premier innovation consulting firm, helping clients improve performanceby delivering on the promise of innovation. Kalypso offers clients full service capabilities includingBusiness and Innovation Strategy, Front End of Innovation, Portfolio and Pipeline Management,Development and New Product Introduction, Value Management, PLM Technology,Leadership and Learning, and Intellectual Property Management. For moreinformation, visit http://kalypso.com. Follow @KalypsoLP on Twitterand on Facebook at http://facebook.com/KalypsoLP.Products Ideas Innovation