Reducing time off front end design

In spite of the global economic slowdown and depressed market sentiment, the pharmaceutical industry displayed higher valuations. Eric Unrau, Project Director of International Operations, CRB Consulting Engineers discusses these trends and his company's value add to life science companies with Usha Sharma

What is the scale of CRB Engineers' on going activities?

We are a full service architecture and engineering firm established in early 1984 in the US. We are a privately held company that mainly focuses on the life science industry which includes pharmaceuticals and biotechs including vaccines, laboratories, etc. We have also done a number of vivarium and other advanced technology projects. Our work includes projects in the US and Puerto Rico, as well as Europe and Asia.

What really attracted CRB Engineers to enter the pharma/ biopharma consultancy services niche?

There has been continuous growth in the life science industry. CRB began serving this industry by providing mechanical and electrical design services and realised there was a lack of expertise in process and scale-up design capabilities in the consulting industry. CRB hired several nationally and internationally recognised process engineers who had operating company experience and understood the requirements for regulated facilities. With this additional capability we focused on growing and serving this industry.

How big is the pharma consultancy services market?

Biotech and pharma is our main focus and we are continuously evolving to meet the demands of this market. Last year the global pharma consultancy services market may have been worth around $3 billion in revenues. However, globally there has been a significant slowdown and a number of major projects have been halted in the past year. The unpredictable economic climate has altered investment plans in almost all countries. However, at this time we do see some stabilisation of the markets. Non-disclosure agreements (NDA's) continue, although at a lower level than before. Pharma applications may be down globally, but biotech seems to be on a slight rise. When one looks at India specifically, India does continue its rapid growth in comparison to other areas. From what we have seen, the Indian market is growing at approximately 10-15 percent a year. For 2009-10 we predict sustainable growth in the industry here.

What are the key benefits a firm like CRB offers Indian pharma or biotechnology companies?

CRB provides design services, pre-construction, construction and commissioning services to our clients in this industry. These services provide value to our clients in the increasingly challenging regulatory environment that exists today. CRB has been executing projects for more than 20 years in the areas regulated by the US FDA, EU, Japanese and other regulatory bodies. Our abilities to assist our clients in understanding these requirements, the changes, the trends in process, qualification and facility design are critical to our clients' success. As an example, CRB's knowledge base has been utilised in assisting to write and review ISPE baseline guides for the industry - key knowledge documents that provide guidance.

From a design perspective, utilising a risk based approach to designing our clients' processes and facilities reduces our clients' overall risk. Current trends in the industry demand better, faster, cheaper. Through understanding these challenges and drivers, CRB's design solutions provide the best facility at the best cost for our clients - the best overall value. CRB does this by working very closely with our clients and our client design team. Within the Indian market, this translates to CRB supporting the facility programming and front end design of the facility and process, and utilising or partnering with local consulting expertise and the client team to execute the projects.

How would consultation at the early conceptualisation stage help pharma companies?

CRB engages with our clients and assists them in understanding the project drivers, risks, investment requirements, scope and challenges, schedule, regulatory issues or challenges, product requirements, process design, facility and site requirements. Understanding these requirements at the early stages of the project, and designing to the right scope and budget for our clients is a huge key to make our clients successful, and thereby CRB successful. Our clients need to understand where and how to spend their money on a project, and the front end programming and design process identifies the critical aspects and risks of a project and the investment. You want to know what is important and critical, and what is not, and the costs associated with those. Utilising CRB's global expertise, along with a local partner is a key to make our client's projects successful.

How does your company work according to the regulatory requirements, keeping in mind the client's budget as well?

Our resources are very knowledgeable, many of whom have years of pharma or biotech operating company experience. That knowledge and know-how provides high level results very efficiently. Because our focus is in the pharma and bio markets, we maintain a strength and current knowledge of trends and practices in the market. We consider our resources to be thought-leaders in the industry providing those ideas and concepts to our clients. Consulting can be quick and efficient when starting from that knowledge base. We also utilise front-end project programming workshops and tools that quickly identify key design requirements to jump-start projects much more quickly than traditional approaches. CRB has helped our clients significantly reduce time off the front end design, getting it done more effectively and for better value.

What kind of business alliances or partnerships do you have? What is your relationship with Spectrum Pharmatech?

CRB currently has an existing global alliance with the PM Group out of Ireland. This alliance has proved successful for both CRB and PM Group executing projects around the world, mainly in Ireland and Europe. This alliance is not exclusive as we have also worked with local firms in different regions of the world. The PM Group has recently opened an operation in Singapore and we have jointly performed work in Asia, including India, in biotech. That relationship continues to grow and be successful for our clients.

As CRB grows, we continue to evaluate ways to move our business forward in serving our clients directly and utilising our partners, which includes working with local firms. The execution approach of using localised partners allows the facility design to be done in the most efficient and economical manner. With regard to Spectrum Pharmatech, we are currently working on an opportunistic, ie. project by project, basis in India as it is a new relationship and one that can help CRB and Spectrum grow our capabilities in India. Our focus is on satisfying our clients with high quality, high value services. CRB and Spectrum do currently have project work we are executing together.

Till now how many pharma projects you have completed?

We have worked for leading multinational firms such as Shire, Novartis, Pfizer, Wyeth, Merck, sanofi, Genzyme, GSK, Amgen and many others. We have done projects in many countries across Europe as well as work in Western Asia, India, China and Singapore. India is forecasted to continue its foreign investment opportunities in to the country, and as such should see strong growth in the coming years. CRB is positioning ourselves for these opportunities and are continuously improving how we can best serve our clients, both multinational and Indian based, here in India.

What is the employee strength of CRB? Are you planning to increase your workforce?

CRB has more than 350 employees. We have 10 offices across the US including Puerto Rico. We are aggressively planning our growth outside the US in terms of partnerships and manpower. In India, CRB is looking at several local markets, including Mumbai and Bangalore, but at this moment nothing is finalised.

Currently, which are your most promising markets?

For us, the US is the biggest market and represents 80 percent of our business, leaving 20 percent of our revenue coming from ex-US clients/projects. These projects are executed with our partners in Europe, South America, Middle East and Asia. For Asia specifically, we are currently working on projects in India, Singapore and other Asian countries. Overall, CRB is targeting 10-15 percent growth in the current fiscal year.

u.sharma@expressindia.com