Interview with Dr. Robert Ruffolo

Yanning Chen

Q: Wyeth strongly encourages its researchers to publish. You yourself have authored nearly 500 publications in the past 30 years. Can you comment on how supporting employee publication benefits the company?

A: It increases the company’s visibility, establishes our image as a place to conduct cutting-edge research, and therefore attracts top talents to join our workforce. It enhances our strategic impact in the industry.

Q: In addition to top research talents, what other factors are important for a company to sharpen its comparative advantages of R&D and to become or remain the industry leader?

A: We all try to recruit the brightest and the most promising, but more importantly we distinguish ourselves by an effective infrastructure and efficient processes. Therefore, the key to success lands largely on strong leadership because it is the leaders who improve or re-design the infrastructure and the processes.

Q: Recently, FDA proposed “pre-competitive sharing of information”, which encourages stronger collaboration between the pharmaceutical companies during drug discovery. In your opinion, to what extent can this suggested information sharing help increase productivity? Do you think it is a realistic suggestion from FDA?

A: More information sharing can surely help reduce duplication of development efforts and better manage similar risks that others have faced in the past. Successful implementation of the recent FDA proposal requires participation from all big players. However, I have not yet seen full collaboration among us. There are several reasons why companies might be reluctant to respond to the proposal. For example, although pre-competitive sharing of information will not necessarily evoke anti-trust issues, its definition is rather vague and therefore can lead us down a risky legal path. In addition, the proposal can involve sharing sensitive information key to the comparative advantages of a company.

On the bright side, big pharmas are all represented on the PhRMA S&R (science and regulatory) committee. We have held constructive discussions over general issues that challenge the entire industry, including the area of pre-competitive research.

Q: What is the bottle-neck for further increasing the success rate of drug discovery and development? How does Wyeth plan to overcome that challenge?

A: Surprisingly the bottle-neck is Phase II. The duration of Phase II has grown longer, stretching from 1.5 years in the past to 2.5 years on average currently. The failure rate of Phase II also has been rising, due partly to low efficacy, partly to poor safety, and the rest to commercial reasons. It is very unfortunate that one-third of the projects terminated in Phase II are due to portfolio fit or inability to recoup the R&D investment. For example, we recently terminated one drug because its development process took so long that the effective patent life became too short to cover the estimated R&D investment. In Wyeth, we are going to take the following measures to reduce the failure rate of Phase II:

1.Oursource some phase II activities to countries like China and India, where there is a large volume of skilled work force and the costs of labor and clinical trials are much lower. In addition, the time zone differences ensure round-the-clock production. Therefore, we can race through phase II at a relatively low cost.

2.Increase communication between marketing and R&D. As a matter of fact, before any development efforts are initiated at Wyeth, R&D always collaborates with the commercial organization to ensure that both medical need and commercial objectives are met.

Q: What risks are involved with outsourcing to China?

A: The key risk is the political and legal environment in China. After all, China and the US embrace very different culture and political systems. In China, insufficient protection of intellectual property is particularly worrisome.

Diversity at workplace (Dr. Robert Ruffolo):

Minorities and foreign nationals account for ~20% of the current work force in R&D at Wyeth. By year 2010, that number may hit 50% of the R&D work force. Wyeth has already taken measures to adjust our environment to the fast demographic changes.

One year diversity program:

The program was designed to provide management training to females and minority employees in R&D who have promising management potential. The initial candidate pool usually includes 60-100 people. They should be nominated by their supervisors, have two 5-star ratings in a row, and possess qualities such as leadership, communication skills, and/or an impressive track record of publications. A review committee will compare all the candidates and narrow the final selection down to about 40 people. Those people will participant in a one-year training program that we have developed at Wyeth, which includes 360 degree evaluations, mentoring, training courses, special projects and many other components aimed to increase their development and movement into the ranks of management. After the trainees complete the program, we monitor their performance, promotions, salary increases and so on in order to measure the results and impact of our diversity training program.

The selection procedure is posted on the company website to maintain transparency and publicity.

We also have an on-going collaboration with UMBC (University of Maryland, Baltimore County) to attract leading minority interns, as well as a formal contract with Wesley, Brown and Bartle (a leading recruitment firm that specializes in placing high performing females and minorities), to recruit a significant number of high potential females and minorities into R&D.