I received a call the other day from a sourcing professional at a top five pharmaceutical company looking for recommendations
for manufacturers of clinical supplies. It seems that his current three suppliers aren't answering his phone calls in a timely
manner, and he is getting fed up with the poor service he is receiving. He's also frustrated with the constant turnover in
project managers at his suppliers.
The sourcing professional's problems are a common story these days, as demand for development services has never been greater.
Major biotechnology and pharmaceutical companies are under enormous pressure to advance their pipeline compounds, while funding
for early-stage companies continues to flow. As biotechnology and pharmaceutical companies push to keep studies moving, contractor
resources are being stretched as they try to meet client requirements.
Project managers are the focal point of most customer interactions once a contract has been signed, and their performance
affects both the reality and the perception of how well a study and a relationship are going. Clients depend on project managers
to be their advocates to ensure that their studies get scheduling priority and the necessary resources. They also expect project
managers to keep them informed about progress and problems as they arise. When a project manager has worked a long time with
a particular client, he or she can make studies run more smoothly by knowing the way a client expects work to be done or reports
to be written. The very personal relationship between a project manager and his or her client counterpart is viewed as critical
to study success, and any disruption is seen as putting the project at risk.
Clinical contract research organizations (CROs) have long been aware of the critical role of the project manager in maintaining
client confidence, and have occasionally taken advantage of it during the competitive bidding process by promising to assign
a trusted project manager to a study. Too often, however, the promised project manager was moved to another study shortly
after the contract was signed, creating a sense of distrust and alarm on the part of the client. Many biotechnology and pharmaceutical
companies have taken to insisting on contract language that assures the client that this "bait-and-switch" doesn't happen
Attributes of the current market environment are particularly tough on project managers. The large number of early-stage companies
needing services is especially demanding because managers at those companies often have little hands-on drug development experience
and depend on project managers for guidance on what needs to be done and when. As a result, the project management input for
these clients is often way out of scale to the size and nature of the work that actually has been done.
As for the major pharmaceutical companies, many are using contractors to an unprecedented degree so their sourcing managers
have little direct experience with contractor performance or managing outsourcing relationships. The fact that much of this
work was previously done in-house may mean that the client-side managers are unaware of the cost and time implications of
changes to the scope of work or project schedules. It may take all of the project manager's diplomatic skills to explain to
the client that doubling the order for clinical trial supplies will increase delivery time because suite capacity already
has been committed to other projects.
Clearly, the industry must invest more in its project-management capabilities, but it's not always easy to justify. The benefits
of excellent project management are often intangible and difficult to justify on a cost-benefit basis, so it may be easier
to spend $40,000 on a new high-performance liquid chromatography system than it is to invest that amount in training project
managers (especially given the rate at which project managers seem to be changing companies). Still, companies are getting
the message, and companies such as Bilcare (Phoenixville, PA) are going so far as to have their project managers earn professional certification from organizations
such as the Project Management Institute (Newtown Square, PA).
Company Web sites
A further impetus comes from CRO business models built around integrated solutions that promise to get a biotechnology and
pharmaceutical company's candidates into the clinic faster than if the company were using independent suppliers. The success
of these "one-stop shops" will depend on the effectiveness of their project-management groups in tying the various and geographically
dispersed services into a seamless offering.
Patheon (Toronto, Canada) completed its search for "strategic and financial alternatives" last month with the announcement
that it would receive a cash infusion from a private equity firm. The new investor, JLL Partners (New York, NY), will invest $150 million in Patheon ($138 million after expenses) in exchange for preferred stock, three seats
on the company's board of directors, and voting rights equivalent to 25% of shares outstanding. The investment is subject
to shareholder approval, which is expected at a shareholder meeting scheduled for mid-April. The new funds will be used to
reduce Patheon's long-term debt, which stood at $338 million at the end of January.
With the completion of the investment, Patheon's executives will turn their attention to restructuring the company's operations
to improve profitability and performance. Despite 10 years of rapid, acquisition-driven growth, the company has had problems
achieving sustained profitability and its cash flow has been insufficient to fund ongoing capital improvements. The problems
came to a head in 2005–2006, when its Mova Pharmaceuticals operation in Puerto Rico, acquired at the end of 2004, received
a warning letter from the US Food and Drug Administration and failed to achieve revenue projections. In April 2006, the company's
long-time CEO was dismissed, and the company began a concerted focus on performance improvement while its board evaluated
its strategic and financial options.
The restructuring efforts to date have included plant-level operating improvement campaigns, a program to generate savings
in procurement by leveraging the company's buying power, and ongoing reductions in staffing. The restructuring drive is expected
to pick up steam once the JLL investment is completed and its nominees join the board of directors. JLL Partners is known
for investing in turnaround situations, and JLL is expected to push for more aggressive measures, including possible plant
closings. Rumors to that effect are already circulating on Internet discussion sites.
Evidence from Patheon's first-quarter results indicate that the company is already seeing results from its restructuring efforts
while benefiting from the strong drug-development services environment. Revenues were up almost 9%, driven by a whopping 23%
jump in product development services (formulation, analytical and clinical trial material manufacturing) and 13% growth in
commercial prescription drug manufacturing. A sharp decline in manufacturing of over-the-counter products prevented even stronger
top-line performance. Driven by higher utilization and greater efficiency, operating profit margins rose to 13.5% from 8.9%
The strong first-quarter results suggest that clients are sticking with Patheon despite its recent problems. Some difficult
issues remain to be tackled, but indications are that the company may once again be headed in the right direction.
Jim Miller is president of PharmSource Information Services, Inc., and publisher of Bio/Pharmaceutical Outsourcing Report, tel. 703.383.4903, fax 703.383.4905, firstname.lastname@example.org