Pharmaceutical and Biomedical Project Management in a Changing Global Environment

Scott D. Babler, Sean Ekins, Scott D. Babler

• Publisher: Wiley
• Year: 2011
• ISBN:
  9781118058213
• Edition: 1
• Topic: Medicine
• Subtopic: Pharmacology

Pharmaceutical and Biomedical Portfolio Management in a Changing Global Environment explores some of the critical forces at work today in the complex endeavour of pharmaceutical and medical product development. Written by experienced professionals, and including real-world approaches and best practice examples, this new title addresses three key areas – small molecules, large molecules, and medical devices - and provides hard-to-find, consolidated information relevant to and needed by pharmaceutical, biotech, and medical device company managers.

Part I: OVERVIEW

CHAPTER 1

PROJECT LEADERSHIP FOR BIOMEDICAL INDUSTRIES

SCOTT D. BABLER

Synergism—Interaction of discrete agencies, agents, or conditions such that the total effect is greater than the sum of the individual parts.¹

“You cannot continuously improve interdependent systems and processes until you progressively perfect interdependent, interpersonal relationships.”

—Stephen Covey

INTRODUCTION—THE CHALLENGE

Medical science has always been on the cutting edge of technology’s promise. The biotechnology revolution of the 1980s created new pharmaceuticals, medical devices, and treatments that are routinely used today. These marvels reduce or eliminate some cancers, successfully treat AIDS infections, provide effective vaccines for many diseases, allow completely non-invasive imaging and diagnoses, and allow surgery with only a small incision. These innovations have changed the face of modern medicine and modern life.

The challenge of making the promise a reality is much larger than the discovery of a medical breakthrough. Converting the discovery to practice, reproducing it, verifying it, producing a prototype or research lot, testing the prototype on animals and then in humans, creating a manufacturing process under high quality conditions, setting up clinical trials, and documenting the processes are only some of the steps required to commercialize a new prod­uct. Developing, gaining approval, launching, and maintaining biomedical products are enormous and complex tasks. Large numbers of researchers, manufacturing, quality, regulatory, marketing, and product support personnel are required to work in tandem to undertake this venture. Supporting these complex products throughout their lifecycles can be equally daunting and challenging.

The cost of developing new pharmaceutical compounds, biological drugs, medical devices, and treatments is very high in terms of research costs, time, personnel, facilities, clinical trials, and exacerbated the low likelihood that the product will prove to be useful. The opportunity to create an important and useful product is tempered by the immense resources required to convert the technologies into an approved product for sale. Success of the process is often not limited by the knowledge and science, but rather by how effectively the thousands of pieces are brought together.

The groups of people required to make such complex products reality come from dozens of different disciplines, company divisions, and organizations beyond the company. Some product development companies are virtual, outsourcing all their work. The large teams and ensuing complicated interactions require processes, organization, and oversight that project management is well prepared to provide.

Change has created new challenges and new opportunities for this highly complex industry. Advancements of new technologies, improvements in quality and design, increasing regulatory scrutiny, and global competition are all raising the bar on what is required to develop and launch new products. Keeping the teams on track to perform the right activities in multiple, parallel paths with clear visibility and effective communication does not happen without significant attention being paid to the processes utilized.

The price of success and the cost of failure have required executives to find the best practice approaches for efficient, effective management of the large resource expenditures needed to enable predictable achievement of company goals. Project management in biomedical companies and organizations has become a norm as one of the most effective management styles for creating value.

GOAL AND SCOPE OF THIS BOOK

This book is concerned with the use of project management methodologies and tools to lead the complex process of designing, making, and supporting biomedical products. It is intended to be practical in its descriptions and analysis of project management work in biomedical companies.

To gather the broadest and most comprehensive view of project management practices in real situations, expert authors from many product areas in the biomedical industry (BMI) were invited to write chapters and case studies on issues that they grapple with on a daily basis. With input from dozens of companies, the approaches, systems, and best practices they share have been tested and are successfully moving this industry forward to solve real world health challenges. These authors will share how project management is being effectively used by BMI experts, illustrate some of the key processes shared by all the companies in this field, and highlight some of the key differences. The common thread will be an analysis of how the complex work is being effectively managed.

The biomedical companies represented by these authors range from very small virtual companies to large international conglomerates, with products in pharmaceuticals, medical devices, biotechnology, and healthcare solutions. Some authors are with consulting firms and one is from a non-profit organization. The resulting approaches, systems, and best practices that they share have been tested and successfully move this industry forward. The expertise of these industry professionals has been validated repeatedly through their successful development of new technologies, product launches, and product support roles. The authors will discuss the complexities and the activities performed to move products forward through their lifecycles. In addition to discussing what must be done, they cover how the work must be managed. Knowing the list of tasks to accomplish is the first step. Fully integrating the cross-functional efforts of the extended project teams and effectively leading to meet the objectives of their organizations is the basis for successful programs.

While there are many books discussing details of project management theory, this book will examine the special challenges faced by those pushing the boundaries of applied medical science and the products which ensue. Realizing that the practice of medicine undergoes continual improvements and the technologies utilized are in continual flux, the approaches for making products to meet contemporary clinical and regulatory demands must also evolve. The very rapid rate of change predicates the need for creating projects that define and meet these new requirements. Opportunities to improve the processes of managing change will be highlighted and discussed. While BMI project management has grown significantly, it is also in flux as organizations seek the best methodologies to manage the ever more costly process of delivering the best in healthcare to patients.

One book can only provide an overview of the many areas where project management operates and benefits BMI companies. The focus of the authors in this volume is devoted to managing the development and support of biomedical products and all associated activities. This book will not cover the service providers of medical care, although these organizations also routinely use project management methodologies to make significant improvements to increase efficiency, safety, and satisfaction of patients and to better manage their organizations.

UNIQUE CHARACTERISTICS OF BIOMEDICAL PRODUCTS

Biomedical products are not necessarily more complicated than other products. A 747 aircraft, computer operated automobile assembler robot, petrochemical refinery, or the space shuttle are all very complex, highly integrated operations and products. Each of them has very significant human health and safety considerations, the highest quality standards, and stringent regulations governing development and commercial use. Each requires thousands of component parts, sophisticated technologies, and complex systems integration to function as intended. Operators of these systems require advanced training to ensure successful operation of each system. Each of these products or operations uses project management to help address the complexities outlined, yet they are still very different from biomedical products.

It is the intention of biomedical products to diagnose, cure, or treat disease, illness, or injury; reduce the impact of chronic conditions; and improve human health. These goals are added to the rigid requirements necessary for the complex examples listed above. Biomedical products are held to a higher regulatory standard for understanding how their use impacts individual people from all genetic backgrounds, age groups, genders, and socio-economic living conditions. Ensuring safety and efficacy in all populations requires multiple clinical trials and the clinical results are submitted to regulatory agencies in all geographies where the product will be introduced. In most cases, the proposed biomedical product must be shown to provide significant advantages over existing products and/or treatments to overcome potential risk tradeoffs and gain regulatory approval.

The additional complexity, detail, and studies that must be coordinated, completed, submitted, and successfully defended have resulted in biomedical companies adopting the methods, tools, and discipline of project management to advance their work. Ensuring that complete planning occurs, assessing and mitigating risk, aligning and managing parallel activity streams, and communicating the impacts of change from one part of a development program to other affected areas are just some of the ways that project management aids these companies. Below are a few of the key forces acting on BMI product teams. Many more will be discussed in the following chapters.

• Complexity: Products require highly technical applications of new science findings and interfaces with the human body (which are only partially understood) in a safe, reproducible, and effective manner. Many BMI products work in combinations, requiring even better understanding of their interactions with multiple organs and tissues, before they can be generally trusted and used.
• Imperfect Knowledge: Current knowledge of the human body does not allow a full understanding of how a specific drug or treatment will interact with the body without extensive clinical trial testing to show the safety, efficacy, and appropriate treatment levels.
• Safety: The product must not cause harm directly or create a higher likelihood of unintended harm with its use.
• Reproducible Patient Benefits: BMI products are used to improve health, cure or mitigate disease, and provide comfort to ill patients. Use of one product precludes other treatments and, therefore, must have a highly reproducible positive benefit over other available options.
• Regulated Products: Due to the criticality to human life, BMI products are highly regulated and monitored. Companies launch their products in as many countries as they can to justify the enormous cost of development. The differences and peculiarities of different regulatory agencies add greater burdens on development teams.
• Highly Changing Environment: BMI products are developed from cutting edge knowledge and technologies. This means that they are developed with information that is constantly changing and being enhanced. One difficulty is that products and product subsystems can suffer from rapid obsolescence. Competitive product pressures drive development and commercialization teams to meet marketing opportunity windows.
• Development Process: The development of BMI products must follow rigid processes to ensure that a high quality, safe, and effective end product is built to meet customer requirements.
• Control of Design and Quality Assurance: Regulatory and quality standards have expanded in recent decades; the current expectation is that quality must be designed into the entire process of creating products. This means that the design must be controlled from the time it leaves the research laboratory until the product is obsolete. A full understand­ing of the key quality attributes of the component parts and final prod­uct is developed, documented, and maintained through product design control, and later by product change control. This highly detailed pro­cess requires cross-functional efforts and results in massive quantities of documentation.
• Documentation Control: The effort expended by BMI companies to maintain accurate, detailed, complete, easily retrievable, and interconnected documentation cannot be overstated. In the view of regulatory agencies, if a process is not well documented, it does not exist. As regulatory standards have been enhanced, large projects to update documentation for legacy (long-term existing) products are common. With acquisitions and divestitures of products, divisions, and whole companies, BMI companies are faced with the challenge of incorporating records from many sources together in a compliant manner.
• Information Technology (IT) Infrastructure: BMI companies are information-intensive depending on design history, specifications, product data, clinical trials, and regulatory submissions. The information must be quickly available anytime, at many locations globally, and in a useful format. In addition, internal and external team members must be able to communicate freely and hold online meetings with distant colleagues. Therefore, a robust IT infrastructure is the lifeblood of BMI companies.
• System Integration: Consider a common hospital test, such as a CT scanner or MRI instrument. Each system has thousands of metal and plastic parts, electronic components, power supplies, data collection computers, data analysis software, data storage, and data communication technology components. Each of these medical devices is a highly integrated system comprised of many subsystems. Creation of these products requires coordinated co-development of many subcomponents by large, cross-functional teams. Efficiently building a system from the parts requires system integration teams to validate performance and verify requirements were achieved.
• Complex Cross-Functional Teams: The product teams in BMI companies are very complex. Not only do they include members from across the company, the inclusion of team members from other companies and organizations is now commonplace. The prevalence of joint ventures, alliances, company collaborations, outsourcing, and consultants is the norm. Businesses that are attempting to maximize their product throughput will work through these more complex relationships to obtain additional intellectual property (IP), patents, proprietary technology, special skills, and knowledge. The need for speed as companies race to launch innovations requires the use of additional help for solving problems and to complete all the work at the right time. Outsourcing work, such as clinical trials, regulatory, project management, and component manufacturing, permits companies to move faster and take on additional opportunities.
• Clinical Trials: Confirmation of the safety and efficacy of the new product must be tested in carefully designed and controlled studies. The trials are highly regulated and require thorough planning and highly effective execution for the product to succeed.
• Risk Management: The complexity of developing BMI products and the safety concerns for patients increases the importance of careful risk planning and management. It is a key factor for success.
• Management: Management of BMI products is a highly cross-functional, integrated process. The methodologies are similar to managing any large development project, and common management systems deployed (i.e., portfolio management and stage gate product processes) utilize some of the best project management processes to plan, execute, and control their products.

The cost of developing a novel pharmaceutical, implantable computerized device, targeted anti-cancer-toxin conjugate, or secure and reliable patient health data storage and retrieval system is very high. The length of time from c...