Pharma's Prescription: How the Right Technology Can Save the Pharmaceutical Business
By Kamal Biswas
()
About this ebook
The pharmaceutical industry needs a shot in the arm – and not a moment too soon. The executive suite is mired in a bygone era, a time when extensive, well-funded pharmaceutical R&D produced blockbuster drugs, kept everything in-house and reaped the financial rewards. But that way of working needs to change. Executives now need to know what the technologists in their companies are doing in order to survive the next decade. Written for those new to industry, as well as for experienced professionals or specialists looking to expand their knowledge, this book is a must-read for business executives and information technologists alike.
Pharma’s Prescription bridges the knowledge gap between current business practices and the most valuable technologies today. This book is filled with practical, real-life examples from industry and is a straightforward guide for all pharmaceutical and information technology executives who need to improve their businesses.
- Focuses on practical solutions that are easily incorporated in your day-to-day work
- Integrates business operations and information technology
- Highlights the industry's top turn-around stories
- Discusses pharmaceutical industry trends, growth opportunities, innovation drivers, regulatory complexities, and emerging market operations
Kamal Biswas
Kamal Biswas is a Partner and Leader of the Global Life Sciences Consulting Practice at Infosys. He has nearly two decades of hands-on experience in the pharmaceutical industry. Kamal worked for 10 years in pharmaceutical technical R&D, manufacturing plant design, manufacturing operations and new product launches. Kamal moved into management consulting to drive forward industry growth and margin preservation, accelerate innovation and improve compliance. He has worked with many pharmaceutical majors including Ciba Geigy, Novartis, Pfizer, GSK, Aventis, J&J and BMS, either as an employee or as a consultant. Kamal has also developed several technology driven solutions that have helped pharmaceutical companies transform business functions to enhance business values for the company and customers. He has worked in Europe, Asia and the Americas and currently lives with his family in the US. He has a Masters in Engineering, went to business school for International Marketing, is a certified ISO9000 Quality Auditor, and member of the board in several industry forums. Kamal is a strategist and evangelist of pharmaceutical business transformation through non-traditional methods and frequently speaks at industry councils.
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Pharma's Prescription - Kamal Biswas
councils.
Introduction
When Stephanie was born in Monaco in 2012 she was born with a 90-year life expectancy; once this level of life expectancy becomes a reality all over the world the pharmaceutical industry will have kept its promise. With the advancement in technology this could be a viable reality and could improve even more in the near future. Human life expectancy has more than doubled in the last century and we are now moving towards tripling it soon. Access to clean drinking water made the initial impact, but the advent of pharmaceutical products has extended it considerably more.
When Linda first finds a lump in her left breast at the age of 39, she is very worried. She is first comforted and placated by her physician for several reasons—firstly, it looks noncancerous and secondly science and technology have advanced enough to find a cure with a higher success rate. The doctor’s first prediction is incorrect and Linda’s lump proves to be cancerous, but the prognosis is still good. With the advancement of genetic engineering and technology today, scientists have identified several gene subtypes, each with a unique genetic fingerprint to diagnose breast cancer with a survival rate of over 90%. This was less than 50% two decades ago.
In Liberia or Sierra Leone over 40% of people have been a victim of counterfeit drugs. Counterfeit medicine—a deliberately mislabeled drug with respect to identity or source―is a huge problem in sub-Saharan Africa and it needs to be stopped. Sproxil, the social enterprise to empower consumers, uses cell phones to text a code on any medication they have, to see if it’s counterfeit. With only 4% of households in Africa having internet connectivity, a cell phone-based solution is trying to crack down on counterfeit medicine issues. This and other similar mobile technology solutions can easily combat the USD 600 billion counterfeit industry [1a].
Today, half of the world’s population lives on less than two dollars a day and a billion on less than one dollar a day. The advancement of healthcare and technology has to be far more affordable than it is today. So, the task isn’t just to find innovative ways to treat but also at an affordable cost.
Christina’s appeal on a website says it all. Her 35-year-old husband and father of their two children is suffering from Primary Sclerosing Cholangitis (PSC), a chronic liver disease, and the only recovery option is to do a liver transplant. He has been on the waiting list for over a year and has almost lost hope in finding a donor before he breathes his last. A liver recipient currently waits between seven months and four years and almost one out of four of them die before a donor is found.
Christina doesn’t yet know how she will raise money for the transplant. A liver transplant can typically cost up to half-a-million US dollars. This is not affordable for this single earner family of four. But Christina’s situation will change soon with the help of a 3D liver printing solution. Organovo has printed functional human liver tissue—yes, liver tissue which will produce a fully functional liver as 3D printing matures further [1b]. This will eliminate the long waiting list and make transplants affordable to all. Technology will make this miracle work.
The pharmaceutical industry has brought significant changes to our lives in two waves: firstly by inventing medicines that cure disease and secondly by inventing newer and more efficient techniques with higher success. Technology plays a colossal role in improving healthcare in society today.
However, things are not as shiny as they look. The majority of the world’s population does not have access to medicines. Although individuals as well as most governments see health as a priority and access to health as a right, 80% of the world’s population have no or very little access to medicine. Business and technology combined have a huge task to accomplish—make medicine accessible to most of the world’s population. The pharmaceutical business is central in making this happen throughout the world’s healthcare ecosystem, along with providers and payers and with the help of innovative technologies. The industry has done a terrific job in improving medicines—they have very successfully brought in several new medicines and there are brilliant people around to make pharmaceutical science more meaningful to society. On the other hand, technology is constantly changing with newer and better solutions to serve human health. Although both business and technology teams have done extremely well in their own fields, there’s a great opportunity to combine the two for a much better result. This can happen through focusing more on the interface between business and Information Technology (IT). Business needs better understanding of IT possibilities to improve business outcomes and IT needs to understand business functions and challenges better to apply newer technologies more meaningfully. This book entirely focuses on this interface.
In mid-2000, I led a team to build an IT solution for analyzing existing product mechanism of action and predicting the possibilities of repurposing them for other disease conditions at one of the top five global pharmaceutical companies in the US. On one occasion, when an R&D scientist was explaining the business process, he used the term GxP
and an analyst in my team asked him, What is GxP?
The scientist paused for several seconds before carrying on. He saw this as a very silly question as he expected anyone who works in this area to be well versed with the foundational industry regulations, e.g. Good x Practice (GxP). It was, however, a valid question from the analyst as this was her first project in a pharmaceutical company. Though both of them were correct in their thinking, and even if we believe that no question is entirely wrong or irrelevant as it always removes ambiguity from the mind of the inquirer, it doesn’t always offer value to everyone. This reminded me of the story of the middle school student who had to find X
in a triangle. The student had circled the X
and written Here it is
. This story makes everyone laugh, but the student was logical―he found the X
in the diagram as if he was playing a treasure hunt game and wasn’t sitting for the math exam. The examiner did of course expect a different level of maturity for better acceptance. These stories reflect the need for stronger basic knowledge in the area of work for higher success. The IT team needs to know the fundamental elements of pharmaceutics and business should have a basic understanding of technology for harmonious teamwork.
Today, everyone in the business needs to be a team player. Individual excellence needs to be expanded to form part of the goals of the larger team to make a business successful. An effective team can be created only if one understands what others want from you or how your output can offer and add value to others. Knowing what others do and using your deliverables is not easy. When I worked as a process design engineer in a pharmaceutical R&D laboratory, I always wondered how a lab-scale process is converted to mass-scale production. This question took me to the product scale-up lab, then to manufacturing plant design work and finally to the shop-floor production operations. I couldn’t stop there; my next question was How is the product I manufacture sold in the market
and that led me to the product launch team. My desire to always understand the next step of what I do led me to work across various functions. When I moved to the manufacturing shop floor operation from the scale-up team, I wondered if my earlier job would not have been more meaningful if I had known more about the production operation. Knowing the customer is the best way to improve your own work. This brought me to the realization that every executive, manager, supervisor or technician in the ecosystem should build on this desire to understand how their services are used by their customers.
However, moving between job functions is easier said than done. Hence, I wanted to write this book to provide a quick overview of all the business areas without actually having to work in those areas. This book will allow the entire community to quickly understand various functions in the pharmaceutical value chain well enough to make their own work more meaningful. A wider view of the industry will help readers become aware of their internal and external customers and it will make their daily work more customer-centric.
As the pharmaceutical industry goes through a series of challenges including declining topline growth, a dried product pipeline, increasing regulatory demands and changing customer needs, the role of technology increases remarkably. Every company is being challenged by shareholders to justify high R&D investments while earnings per share are shrinking every year. The industry response includes restructuring of business organizations to make them nimble, increasing the focus on customers, identifying non-core work to be executed through external partners and using innovative technologies to make operations more simple, efficient and productive.
Pharma’s Prescription is meant to prepare stakeholders of the pharmaceutical business and technology interface to take on the journey of technology-driven business improvements together. When I moved into the IT consulting world, I found it difficult to have meaningful business conversations with people who had limited business knowledge in spite of having vast technical knowledge. This knowledge gap prevents pharmaceutical and technology companies from effectively applying the right technologies which will improve business operations. Technology companies fail to proactively identify more complex industry problems due to lack of business knowledge, and pharmaceutical business stakeholders are unable to secure the technological benefits due to a limited understanding of available IT solutions. This book will help business executives, IT executives, analysts and programmers to understand the pharmaceutical business process across the entire value chain as well as IT solutions that can improve business outcomes. These business and IT leaders will significantly enhance their preparedness for and understanding of technology innovations, the potential impact on the pharmaceutical industry and within their business function. Readers will be able to use the knowledge to discuss strategic and operational initiatives, both with their business and IT