driving innovation in bio pharma w plm

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Driving Innovation in BioPharma:From Discovery to Delivery with Product Lifecycle Management

Kalypso White Paper by Scott Gibbard, Dr. Horst Groesser and Andrew Hunter

Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management 2

Industry ChallengesThe 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.

Much of this is not recent news. Drug discovery, development and commercialization have always been complex and risky. The vast majority of new product ideas fail. Ideas that do make it out of the labs face an extremely lengthy and expensive journey navigating a highly regulated environment where the rules vary by country. The science is usually complicated and always unpredictable, generating enormous amounts of data and experimental 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:

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 Informatics

Figure 1: Actions taken to

address biopharma business challenges

By 2016, patent exclusivity expiries in one or more developed

markets will impact 13 of the top 20 selling medicines of 2010, including Lipitor®, Plavix®, Advair Diskus®, Crestor® and Nexium®.2

Mergers and acquisitions have made companies bigger and even more complex, carving already siloed functions into specialized sub-functions. Rationalizing differing processes, systems and cultures has proven to be dif�cult.

Scienti�c partnering and collaborations, often operationally complex,

have collided with the culture of monolithic

research organizations not accustomed to

truly sharing their work.

Expansion into emerging markets

has required unfamiliar regulatory environments to be learned and commercial models to be modi�ed or rethought.

Portfolio diversi�cation into new therapeutic

areas or biologics (novel or biosimilars) has required companies to build new

scienti�c capabilities and develop a deep understanding

of new technologies.

3 Driving Innovation in BioPharma: From Discovery to Delivery with Product Lifecycle Management

Manage the Complexity of Innovation

Innovation is More Than Scientific Discovery

Innovation in biopharma is often understood as scientific breakthroughs in basic research and discovery. While the discovery of new molecular entities is the lifeline for biopharma companies, true innovation is not just about the science – it also requires transforming those breakthrough discoveries into marketable products and successfully launching them in highly regulated markets.

In addition to developing new drug products, companies can be innovative in many other ways. Product and service bundling, supply chain restructuring, and information asset management are just a few examples of areas with great innovation potential. While these forms of innovation may not be viewed in the same light as launching a new product after making a high-profile scientific breakthrough, they can accelerate product commercialization, and ensure safe and compliant delivery once the products are on the market. In fact, these other forms of innovation can fuel scientific 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 three fundamental capabilities that biopharma companies need to focus on improving 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.


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:

A management discipline called product lifecycle management (PLM) is an effective approach to improving visibility, traceability and collaboration for a wide range of business processes that create or use product information.

Figure 2: Impact on biopharma

business processes

Process Challenge Impact Solution

Regulatory submissions and product launches

Complex cross-functional coordination, with global product launches adding layers of complexity

Delayed time to revenue; premature launches with increased compliance risk

Improved global collaboration using one longitudinal product data history, created by many functions in multiple formats

Regulatory compliance for marketed products

Coordination of supply chain and regulatory functions working with different, non-integrated systems

Product recalls, or even worse, product withdrawals resulting in loss of revenue and reputation

Improved integration of tools for compliance and change control based on a single source of product information

Handover from R&D to manufacturing and product transfers from one plant to another

Classic “throw over the wall” knowledge transfer often addressed by carving out an organization to manage the transition

Organizational handoffs and no accountability; knowledge loss; difficulty manufacturing at scale

Improved visibility and collaboration between sending and receiving organizations

Portfolio prioritization Often treated as a once-a-year event due to the large effort required to gather data

Delayed kills of failing projects; resource and funding allocations get out of synch with priorities

Improved visibility and collaboration that enables important portfolio decisions to be event-driven throughout the year; timelier re-allocation of funding and resources

Product packaging and labeling

Different packaging (or even branding) and labeling in different markets, complicated by expansion into emerging markets

Delayed launches into new markets; compliance risks with packaging or label changes

Reduced compliance risk through global coordination of packaging and labeling processes


Call to Action: Drive Innovation with Product Lifecycle Management

What is PLM?

Product lifecycle management (PLM) has transformed how products are developed and commercialized in several industries over the last two decades. 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 discipline that integrates the processes, data, people and enterprise information systems comprising a company’s product development, introduction and change control capabilities.

PLM should not be confused with “lifecycle management” (LCM), a phrase often used in biopharma to describe the practice of maximizing a product’s lifetime value by defending/extending market share of approved products through the pursuit of additional indications, new formulations and expansion into new markets. PLM is a broader concept that defines how product information is managed throughout the lifecycle of the product.

Figure 3: PLM adoption

across industries

BioPharma,

Nutraceutical Services

Process, Personal Care,

Household, CPGMedicalDeviceHigh TechIndustrial

Aerospace, Defense,

Automotive

AdoptionLevel

High LowPLMMaturity

Emerging IndustriesGrowth IndustriesEstablished Industries


Innovation in the biopharma industry is not going to get any easier, or any less complex. Given the current challenges companies are facing, it is now time to adopt PLM principles in biopharma in order for companies to succeed at developing and launching new products that deliver desired 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 product

Figure 4: Capabilities within

the PLM platform create an integrated

set of capabilities and Product Record

PLM Platform

Manufacturing & Supply Chain

Suppliers & Sourcing

Packaging & Labeling

Development

ProductPortfolio Data

Quality &Compliance Program

Data

ProductRecord

(Illustrative)

Internal & External

Collaboration

Product Development

Capabilities & Tools

Strategic Capabilities

(Franchise and Therapy Area Strategies, Portfolio Balancing)Collaboration

Portfolio& Pipeline

Management

ProductDiscovery &

Development

Descriptive Product Data

ERP

Transactional Data

Raw Ingredient

Speci�cation

Finished Product

Primary Packed

Drug Product

Drug Substance

Raw Ingredient

ChemicalIntermediate

PharmaceuticalIntermediate

Packaging

PackagingDelivery Device

Excipient

An illustrative logical data model for a

drug product


Figure 5 shows an illustrative example of a basic, logical data model for a drug product.

Yet PLM goes beyond solely providing a version-controlled source of product data for all of the business functions. It incorporates all processes that generate, modify or affect product data along the product lifecycle.

PLM processes capture both structured data and documents. In biopharma, PLM links the “world of science” with the “transactional world” of enterprise resource planning and manufacturing, by transforming and enhancing scientific and experimental drug information into descriptive drug product master data. PLM puts a company’s most valuable innovation asset – product data, from concept through commercialization to end-of-life – at the center of their innovation efforts.

The product data that forms the backbone of PLM represents all types of data collected during the entire product lifecycle – including early concept ideas, market research, business cases, clinical trial results, description of key processes, phase gate reviews, clinical strategies, and launch plans. Any data that describes the product and its properties can be an element of the Product Record.

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.

PLM Platform

Manufacturing & Supply Chain

Suppliers & Sourcing

Packaging & Labeling

Development

ProductPortfolio Data

Quality &Compliance Program

Data

ProductRecord

(Illustrative)

Internal & External

Collaboration

Product Development

Capabilities & Tools

Strategic Capabilities

(Franchise and Therapy Area Strategies, Portfolio Balancing)Collaboration

Portfolio& Pipeline

Management

ProductDiscovery &

Development

Descriptive Product Data

ERP

Transactional Data

Raw Ingredient

Speci�cation

Finished Product

Primary Packed

Drug Product

Drug Substance

Raw Ingredient

ChemicalIntermediate

PharmaceuticalIntermediate

Packaging

PackagingDelivery Device

Excipient

An illustrative logical data model for a

drug product

Figure 5: Drug product example

It is now time to adopt PLM principles in biopharma in order for companies to succeed at developing and launching new products that deliver desired in-market results.


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:

The takeaway for biopharma companies: several industries share similar complexity characteristics, and have successfully implemented PLM solutions to address these challenges while reinvigorating their product innovation efforts.

Figure 6: Comparison of complexity across industries


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.


Summary: PLM Can Drive Innovation in BioPharmaGrowing 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.


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.

[email protected]

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.

[email protected]

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.

[email protected]

Contributors: Laurens Broekhof, Senior Manager [email protected]

Sunny Sun, Senior Consultant [email protected]

Products Ideas Innovation

About Kalypso

Kalypso is the world’s premier innovation consulting firm, helping clients improve performance by delivering on the promise of innovation. Kalypso offers clients full service capabilities including Business 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 more information, visit http://kalypso.com. Follow @KalypsoLP on Twitter and on Facebook at http://facebook.com/KalypsoLP.

driving innovation in bio pharma w plm

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