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  Career & Employment  
  December 6, 2004
Volume 82, Number 49
pp. 45-50
 



  WORKING UNDER CONTRACT
Pharmaceutical contract firms need diplomatic, cool-headed, and creative chemists
 

  LOUISA WRAY DALTON, C&EN WASHINGTON  
   
 
 

Making a drug is like putting on a play. the cast on stage depends on a whole crew of behind-the-scenes help. In drugmaking, that less visible stage crew largely consists of chemists, other scientists, engineers, and others at companies that provide contract work to pharmaceutical firms.

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FULL SERVE Simons (left) at Exygen Research consults with Kelly Booker on a gas chromatography problem.
PHOTO BY KIM DOOLITTLE
These contract research organizations, often called CROs, don't get their names attached to drugs. Even the bigger ones like Quintiles and MDS Pharma Services are hardly household names. Yet they provide essential services for drug firms, which have become increasingly dependent on CROs over the past 15 years.

"As big as some pharmaceutical companies are, a lot don't have the capabilities to do all of the different screening and services that are required," says Joel Schaefer, director of business development for North America at Cyprotex, Cambridge, Mass. Or the big drug companies may do one task on such an irregular basis that it's more cost-effective for them to outsource it. Small start-up pharmaceutical firms "farm out almost everything," Schaefer says.

CROs vary in size and in the services they provide. Some are like one-stop shopping centers that offer drug discovery help, preclinical animal testing, method formulation, analytical analysis, and logistical and medical help with the clinical trials that each drug undergoes before it gets to market. Other, usually smaller, firms specialize in a technical expertise: scale-up, mass spectrometry, or solid-state chemistry, for example.

CROs developed in the 1970s and '80s and have really become "part of the landscape in the past 15 years or so," notes Christopher-Paul Milne, assistant director of Tufts Center for the Study of Drug Development. They grew even when the pharmaceutical industry was struggling in late 1999 and 2000, Milne says, although they went through a wave of consolidations.

Now, Milne says, there are roughly 1,000 CROs worldwide. Eight to 10 of them--the largest firms--capture about 35% of the business. Small and mid-size CROs divide the rest.

Services offered by CROs naturally adapt to fit the changing needs of pharmaceutical firms. Lately, "CROs have moved somewhat into discovery and into preclinical work," Milne says. "That is where the bottleneck is for drug companies. Newer technologies have provided a lot of promising leads, and we have a lot of early-stage products."

CROs will continue to grow for a number of reasons, says Michael P. Silvon, vice president of corporate planning and development at Bioanalytical Systems, West Lafayette, Ind. One reason is that the pharmaceutical industry is constantly forced to become more efficient because of competition and improving technology. Nimble CROs that incorporate the best technologies often provide more cost-effective service than drug companies themselves can provide. "Pharmaceutical companies realize how much they are paying to do it all in-house," Silvon says. CROs also become expert at specific tasks, so they are familiar with any "bumps" they may encounter throughout the process.

In addition, viable small drug discovery firms are maturing, and they are especially dependent on contracted research. They need to spend the investor dollars they receive as prudently as possible. "It is silly for them to buy a mass spectrometer to do analytical chemistry," Silvon says. Finally, CROs like Bioanalytical Systems "are a variable cost to a pharmaceutical company," he says. "If a project dies, they fire us. That's harder to do in-house."

Because CROs know they can be fired at any time, they do their best to buffer themselves against the fluctuating needs of their clients. They try to maintain stable revenue by keeping a broad base of clients.

THE CLIENTS of M-Scan--a specialty CRO that provides mass spectrometry analysis and testing in West Chester, Pa.--range from small companies that don't own one mass spectrometer to large companies with their own mass spectrometry departments. Those large firms may "hit a snag, and they don't have the time or the resources to solve the problem," says Christopher Ziegenfuss, an associate scientist who has been with M-Scan since he graduated with a bachelor's degree in chemistry seven-and-a-half years ago.

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SOLID ADVICE SSCI's Stahly is proficient in crystallization and solid-state chemistry.
PHOTO BY LASZLO KISS
Ziegenfuss is one of six scientists--all chemists or biochemists--at M-Scan's site in Pennsylvania. M-Scan, which stands for "mass spectrometry consultants and analysts," has two other sites, one in the U.K. and one in Switzerland. M-Scan's scientists do more than consult; they offer mass spectrometry testing and analysis. Yet the work flow is much like a consultant's: erratic. Work often comes in waves. "We have really busy months and slow months, but it is not the same year to year. If you can figure out how to predict it, let us know," Ziegenfuss says.

Still, when the work is there, it needs to be done--and quickly. Because of the nature of a feast-or-famine workload, a CRO can be a high-pressure work environment. "The primary challenges are budgeting and time pressure on projects," says G. Patrick Stahly, chief operating officer at SSCI, West Lafayette, Ind., a CRO that provides help for pharmaceutical firms on solid-state chemistry. "To each client, his or her project is the most important one. We may be juggling 50 projects, but each one of those clients is concerned about their project. You have to be always changing your priorities and trying to meet the expectations of all the different clients. That's a fair amount of pressure to do things right and to do them right the first time."

Part of dealing with the fast pace and tight deadlines at a CRO includes communicating diplomatically with the client. In contract research, the scientists themselves are the customer support. They need to be able to respond intelligently, promptly, and patiently to client concerns, no matter if the client is demanding, confused, or upset. "The number one thing to have is a can-do attitude," say Chad Briscoe, leader of a group that does R&D and new method development for mass spectrometry at MDS Pharma, Lincoln, Neb. When a client comes back with the request that Briscoe's group finish a project sooner or detect a molecule at a lower limit, "we go back to the drawing board, and we figure out a way to make it happen for the client." Briscoe thrives in such an environment, but he acknowledges it is not for everyone.

Pressure at a CRO is usually magnified by the fact that CROs also compete fiercely with one another. "If you get a bunch of CRO people together," Tufts' Milne says, "they'll tell you they spend a lot of energy competing with each other. The wave of consolidations we saw a few years ago shows you what kinds of pressures exist when things go a little bit off."

Pharmaceutical companies also encourage CRO competition. Despite the advantage of picking one CRO that a pharmaceutical firm likes and trusts and always goes to, pharmaceutical companies will deliberately entertain more than one bid on a project to make sure that CROs are pushing each other to offer the most cost-effective and fastest service. Milne says the reason is that the pharmaceutical industry itself is fiercely competitive. "It is a race, very much a race. Any advantage you can get, you're going to take. You want everyone to be in tip-top shape, so you want competition."

In one sense, a CRO's biggest competitors are the drug companies themselves. CROs compete with the in-house resources at big drug firms, and they compete as employers to get the best employees.

"Pay scales generally are a little lower than what you would get at pharmaceutical companies," Silvon says. Yet CROs can attract good employees with the huge variety of interesting science they do. "The chemists coming into our company are exposed to a much broader range of science" than they would see in the same time period at a pharmaceutical firm, he adds.

Stephen Gottschling just defended his chemistry Ph.D. in September at the University of Western Ontario, where he concentrated on organosilicon chemistry. He started at Torcan Chemical, north of Toronto, as a principal chemist in May and says the diversity of chemistry that he has been exposed to since then is impressive. At Torcan, the chemists specialize in scale-up. They take reactions at the milligram and gram level and build them up to the multikilogram scale. So although they are specialists in one sense--scale-up--they deal with an extraordinarily broad range of chemistry.

Gottschling has enjoyed the variety. Plus, he enjoys the challenges of scale-up that he had never really seen in the academic setting. At the large scale, chemical reactions sometimes change, so the reaction control is entirely different. For example, he says, accommodating heat of reaction at the large scale often brings up reaction selectivity and safety challenges that never would have been an issue at the milligram scale.

BECAUSE CHEMISTS at CROs work under tight time and budget restrictions, they usually don't have the freedom to explore intriguing tangents that come up. However, the project goals themselves are often interesting chemical challenges. Clients regularly bring their most intractable problems to CROs.

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MASS SUPPORT Ziegenfuss (left) and Paul Hintz at M-Scan provide expertise in mass spectrometry for drug firms.
PHOTO BY PAUL HINTZ
The investigative analytic group led by Scott Walsh at Chemic Laboratories, Canton, Mass., recently worked on identifying an unknown peak in the spectrum of a product that is already on the market. The client brought the compound to the analytical specialists at Chemic, wanting to know what the unknown analyte was and its origin. Walsh's group had to first choose the best isolation technique. They then isolated the compound and identified it using mass spectrometry. It ended up that the peak came from a flavor ingredient added late in the production process.

"You have to think along the lines of a detective. You have to look a little deeper than what is on the surface," says Chas Simons at Exygen Research, State College, Pa. Exygen is a contract analytical laboratory that will "provide chemical services to almost any chemical industry you can think of," says Simons, who is Exygen's technical lead for the gas chromatography/mass spectrometry group.

Exygen has gradually moved into providing more and more pharmaceutical services. The biological matrices that have come along with that work have provided especially interesting challenges, Simons says. Some of the work that his group does involves characterization of a reaction mixture or validation of a method to pick a certain compound out of blood or plasma. In biological matrices--as opposed to organic solvent reactions--"you have to think about proteins, sugars, and carbohydrates. It takes more and more thought" to first extract and then analyze a target compound, he says.

"Our daily job is to try and solve problems," says Wei Li, group leader of method and validation at Quantitative Technologies, Inc. (QTI), Whitehouse, N.J. Whether her group is trying to separate a polymer that is too large for the pore sizes of conventional columns, or whether they need to analyze a peptide with little or no ultraviolet absorbance, the work provides a variety that is attractive to Li. Also, Li likes the people she works with at QTI. Of the 70 workers employed at QTI, at least 40 are chemists. That proportion is typical for a CRO that provides analytical services. Most such firms must employ a core of chemists, usually with a range of backgrounds.

About 90 chemical engineers; spectroscopists; and physical, organic, and inorganic chemists with a mix of educational backgrounds make up the employee base at SSCI, "basically a company of chemists," Stahly says. SCCI's work on all types of solid-state chemistry requires that diversity, Stahly says, as most CRO work does.

Because CROs need all types of chemists, the firms are worth a look for chemistry graduates, especially those interested in pharmaceutical work. New hires need a good fundamental education in chemistry, Stahly says, an ability to keep several balls in the air (especially under deadline pressure), and excellent communication skills for speaking intelligently and diplomatically to clients.

Chemists at CROs may not be visible to the customers who eventually use the drugs they help create. Yet without their behind-the-scenes help, the production of drugmaking would result in the equivalent of late entrances, unfinished costumes, and inadequate lighting for the performance of the pharmaceutical companies that they serve.

 
     
  Chemical & Engineering News
ISSN 0009-2347
Copyright © 2004
 


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