MedImmune's Greenleaf on Biopharmaceutical Innovation and Biobetters

Now is not an easy time to lead a pharmaceutical company. The patent cliff is fast approaching, pipeline challenges remain, capital markets are tight, and the blockbuster model is fast on its way out. Meanwhile, regulations on sales and marketing continue to tighten.

Yet MedImmune President Peter Greenleaf, named to the post in February, is not daunted by these challenges. On the contrary, he is confident that the industry, and his company, can handle them. “In the next 10 years, we will see important breakthroughs in the biotech space,” he says.

Not Backing Off From Internal R&D

Continued investment in in-house research and development is one of the keys to get there, he believes. His company has nearly tripled the number of R&D projects in its pipeline compared to the roughly 40 projects in development before its 2007 acquisition by AstraZeneca.

Volume alone is no panacea, of course. Achieving higher success rates in product development requires taking more innovative approaches early, Greenleaf believes, including developing diagnostic approaches alongside clinical development. “Instead of taking a shotgun approach, if we start looking at predictive markers early and get just that patient population into clinical trials, we can have much greater success,” he says.

Like many others in the industry, Greenleaf also stresses that early-stage development needs to factor in health economics—“the value equation”— to ensure not only that drugs can get approved, but that they will be reimbursed. “We have to identify the right targets and ensure early on that there’s interest from external partners—including the government, who is becoming an increasingly large payor,” he says.

Healthcare Reform and Biobetters

Greenleaf agrees with Wall Street’s assessment that the US healthcare reform bill is good for the pharmaceutical industry, primarily as a result of increased patient access to treatments, in spite of the greater price pressures that can be expected. “The increased competition will require increased innovation,” he concludes.

Greenleaf also likes the strong intellectual property protections in the biosimilars legislation included in the US healthcare reform bill passed in March. MedImmune does not plan to follow the path of some Big Pharma companies like Novartis or Merck into the biosimilars market. “We don’t see ourselves as a generics manufacturer,” he says. “And that’s consistent with AstraZeneca’s position in small molecules.”

Biobetters, however, are another matter. Greenleaf is among those that believe that by enhancing technology platforms, established products can be improved on. “We are clearly in that [biobetters] space, and will go through the normal BLA process,” he said.

Outsourcing and Insourcing

In an era when Big Pharma is increasing outsourcing, Greenleaf warns of overdoing it. “It’s dangerous to completely outsource biologics manufacturing,” he says.

In fact, MedImmune recently completed the final phase of an expansion of its manufacturing facilities in Frederick, MD. MedImmune has been making capital investments averaging $250 million a year for the past few years. And Greenleaf is not concerned about the possibility of having limited capacity, a problem that many biotech companies have faced as manufacturing productivity has increased.

“As needed, some of our capabilities could be externalized and made available to smaller companies,” he says. “That could shift dollars to clinical development.” Other biotech companies, like Human Genome Sciences, have made such arrangements in the past, but haven’t been common.

H1N1

Greenleaf is also proud of MedImmune’s response to the H1N1 outbreak. “Because we have maintained [within AstraZeneca] our heritage culture as a small, entrepreneurial organization, we were able to respond quickly.” MedImmune was contracted to supply up to 42 million doses of intranasal spray live attenuated influenza vaccine against the pandemic strain.

Nevertheless, Greenleaf sees room for improvement in terms of society’s pandemic preparedness. He notes that his company and others spent a lot of time negotiating contracts, and the first six weeks of his company’s work on H1N1 was carried out without any guarantees of a contract or regulatory approval. The company even ended up filling product before it had an approved label. “We had to attach labels to vials that were already in the freezer,” he said.

“We need to set up a basic structure for how to operate contractually in these situations,” Greenleaf says. Better definition of the regulatory pathway and requirements for clinical development also will help, he says, as would setting up strategic partnerships and joint manufacturing capabilities of some kind. Nevertheless, he feels things went pretty well.

“I give the US government a lot of credit for its handling of the pandemic,” he says. “They were quite agile.”