Maxiom Group Specialized Workshops

Flawless Execution: Deploying Lean Tools to Drive Performance and Support Growth

Application of Lean concepts has become key to operational performance at a world-class level. It has emerged as a critical approach to improving the competitiveness of business operations. Recently, Lean has garnered much more attention in pharmaceutical and other life science companies due to more stringent compliance requirements and margin pressure brought on by a combination of generic products, managed care pricing, and thin pipelines.

In this workshop we discuss why Lean tools are important in the life sciences industry and how executives can use these tools to help make their companies more efficient and more profitable. Topics include:

• Defining Lean tools and concepts
• Considerations for applying Lean in life sciences
• Linking issues with the right Lean tools and methods
• Case examples for deploying these tools including:
  • workplace organization and productivity improvements
  • batch tracking and disposition process improvements
• Lessons learned regarding Lean implementation

Creating the Lean Office: Simplifying Work and Eliminating Waste is Not Just for Manufacturing

Companies are now finding that Lean tools and methodologies are no longer just for manufacturing. They are just as successfully applied to "back office" areas, where Lean has not traditionally been used. G&A Departments, such as Purchasing, Finance & Accounting, HR, R&D, and IT are achieving real cost savings from applying Lean Office concepts.

In this workshop we describe how to identify the need for Lean in the back office of life science companies, including consideration of compliance and regulatory issues. We then discuss 'Lean Office' tools that can be used to streamline and eliminate waste, such as: 5S, Visual Controls, Standardized Work, Leveling and Office Layout/Teams. Finally, case studies are presented to illustrate how some of these concepts have been applied in real situations.

Business Process Design for Life Sciences: Unique Challenges, Unique Solutions

Life science companies face a unique set of challenges in supporting the growth and operations of their business. Some face the need to quickly build capabilities and scale the organization to establish commercial operations. Others seek to improve efficiency, standardize operations and reduce costs to improve margins and better meet regulatory scrutiny. In either case, designing effective business processes across multiple functional groups is essential for aligning the organization.

In this case-focused workshop, we discuss the distinctive challenges and characteristics of designing business processes in the life sciences industry. Using real examples to illustrate a spectrum of client situations and objectives, we will present insights on:

• Adopting a business process orientation to viewing and managing the business
• Finding the right balance of science, business and innovation in business process design
• Establishing scalable business processes in preparation for commercial launch
• Streamlining and enhancing business processes in a compliance-driven environment
• Ensuring that new business processes are implemented and sustained over time

New Insights: The Art and Science of Achieving Product Launch Success

Commercial product launch is the key event in the success of a product and a life science company. A successful launch has long term effects on market acceptance and the ability of the company to prosper and help patients. A "lackluster" launch can have long term impact, well beyond reduced sales and decreased market penetration. It can also negatively affect corporate reputation, future in-licensing opportunities and stock price.

In this workshop, we discuss important insights into the "art and science" of launch excellence. And how, whether it is a company's first product, or a re-evaluation of the launch process, the right combination of the science of rigorous processes integrated with the art of understanding the changing customer marketplace, can provide an effective strategy to achieve market leadership. Specifically, we discuss redefining product launch success including:

• Current status of launch practices in the marketplace
• The difference in sales and market penetration with varying prelaunch and launch activities
• Identification of critical areas in market leadership that define success
• Review of a new model/roadmap for launch planning

Charting a Course for Commercial Launch: Ensuring a Successful Journey

The launch of a new commercial product can be a daunting challenge for most life science companies. The organization must make the transition from an R&D-driven company to one that must blend technical and business excellence. There is often no clear trail to follow, many obstacles to confront and plenty of opportunities to get lost along the way.

In this interactive workshop we explore strategies for successfully planning and executing a commercial launch along with practical next steps that can be taken including:

• How to develop an overall vision, objectives and organization for commercial launch
• How to establish an integrated launch planning and project management approach
• How to develop an enterprise and functional launch roadmap
• What are the likely obstacles and risks
• How to conduct a commercial launch readiness assessment?
• How to stay on course, including making corrections and managing commercial launch risks

Mastering the Virtual Supply Chain: Visibility, Control and Performance

Many pharmaceutical, biotechnology and medical device companies operate as 'virtual manufacturers', outsourcing one or more steps in their supply chain, such as API or drug substance manufacturing, drug product production, fill/finish, or packaging. Although these companies outsource, as license holders many still retain responsibility and ownership for the product through all stages of supply, and as a result must closely track the product and manage their outsourced vendors. Otherwise, they may risk regulatory compliance and penalties, loss of product and contractual liability.

In this workshop we discuss the challenges of managing a virtual supply chain and how to overcome them through a combination of organization, business processes and information solutions. We focus on:

• Increasing Visibility: how to gain more timely insight to crucial information regarding your virtual supply chain as well as how to see into operations of key suppliers and contract manufacturers, areas that you do not own
• Taking Control: how to proactively manage your supply chain and supplier base to anticipate changes and mitigate risk
• Improving Performance: how to leverage the strength of your suppliers to lower costs and improve yields

Clinical Trial Supply Chain Management: Strategies and Tactics for Improving Performance and Cost

Clinical trials continue to represent the longest and most costly aspect of launching a new drug or device. Challenges have increased due to global regulatory requirements, information technologies, study complexity, and internal demands for speed. Efficient and cost effective management of the clinical trial supply chain is critical for meeting study timing and budget goals.

To thrive in this increasingly complex environment, life sciences companies need to understand the challenges and implement processes to improve performance. In this workshop we will focus on strategies and tactics to implementing cost effective clinical trial supply chains.

We will review key areas where supply chain organizations can have a direct impact on both cost and overall trial efficiency. This includes making better and/or different decisions and working more proactively and as a partner with the clinical organization.

A life sciences company case example highlighting how some of these strategies were deployed to reduce the cost and improve the effectiveness of clinical materials supply will be presented.

Leveraging ERP to Drive Business Excellence:
How Emerging Companies are Taking Advantage of Embedded Best Practices

Small and mid-size life science companies face a unique set of challenges in supporting the growth and operation of their businesses including:

• The need to rapidly scale your business in support of commercial launch
• Maintaining financial and business control across a traditionally research focused organization
• Responding to the potential of quickly changing business models including an IPO, partnering, acquisition and/or in-licensing

In this workshop we will discuss how life science companies are leveraging Enterprise Resource Planning (ERP) solutions early in their life cycle to:

• Establish scalable and compliant business capabilities in preparation for commercial launch
• Adopt life sciences industry best practices
• Enforce compliance through embedded business processes in the software
• Drive change throughout the whole organization

Tools and methodologies that lead to successful ERP implementation will also be presented along with a case study to demonstrate the decision making process and success of an ERP solution at an emerging biopharma company.

ERP in Life Sciences: Defining Benefits - Debunking Myths

Life science companies face significant challenges as they evolve through their growth cycle. The ever growing complexity of their business and the industry requires continuous development of systems that can help organize and streamline processes and manage business information.

Enterprise Resource Planning (ERP) systems are the backbone of most commercial companies. ERP systems incorporate finance, human resources, manufacturing, inventory, and distribution into a single, integrated software program that runs off a common database so departments can more easily share information and make better decisions. This integrated approach has tremendous payback including:

• Eliminating duplicate data and duplicate data entry
• Supporting cross-functional business processes - the way work actually gets done
• Utilizing common information to make decisions - one source of the truth
• Developing better controls and enhanced compliance
• Developing a better command of the business and business performance

Despite these benefits, adoption of ERP systems by emerging life science companies has often been controversial. Although some argue that an ERP system is unnecessary, unaffordable, or that there is too much risk in implementing these systems, nothing could be further from the truth.

In this workshop, Maxiom Group will cover:

• The business conditions under which a system is implemented and the types of software available.
• How to get started in developing an enterprise systems plan which will identify and prioritize requirements as well as the process for choosing an appropriate system.
• A biopharmaceutical company case study discussing the ERP decision making process and the results of the implementation.

Maxiom Group will dispel the various myths of ERP systems and demonstrate how companies can incorporate a system that will evolve as their business needs warrant.