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| John Reed, head of Roche's pRED |
John Reed understands what it takes to complete a long-distance run. When he headed up Sanford-Burnham Medical Research Institute in La Jolla, CA, the marathon runner was well known for early starts and fast finishes. And now, as the new head of Roche's Basel-based Pharma Research and Early Development group--better known as pRED--he's in for the run of his life.
When Roche ($RHHBY) brought in Reed to run pRED last spring, the research group was in serious trouble. Big development programs had gone awry, including a failed CETP program, which earned some dyspeptic remarks from analysts. And while gRED--Genentech's side of the R&D equation--loped ahead with some groundbreaking new drugs, Reed was brought in to fix what ailed the struggling group.
This week he was in Manhattan to help cut the ribbon on pRED's gleaming new offices along the East River near 29th and 1st Avenue. And in some respects he was there to also open a new chapter in pRED's story, spelling out in detail his thoughts on a slate of experimental therapies, a clearly defined set of disease focuses and a more ambitious partnering strategy that will form the foundation of a new pRED.
The 250 or so pRED research staffers in Manhattan are all that's left of a once-sprawling organization housed in a Nutley, NJ, complex. It's a major branch of a global organization, with facilities in Switzerland, Germany, Shanghai and London focused on four key arenas: oncology, neurosciences, infectious diseases and cardiovascular/metabolism/ophthalmology.
Reed manages the global group from his office in Basel, a position he earned after gaining an impressive reputation in R&D. Face-to-face he's personable and relaxed, smiling when he says he's pushed back the start of his day, now that he's made the move to Switzerland. His typical 3:30 a.m. starts have been reset to 4:30 a.m., and truth to tell he's running more half-marathons these days than the triathlons he was known for in California.
His commitment to the turnaround at pRED, he says, seated in a conference room overlooking the Hudson River, just takes more of his time.
One of the biggest problems with pRED, says Reed, is that the group was in a state of near-constant turmoil brought on by repeated reorganizations. Every two years, he says, the group's strategy and labs were realigned.
"Having run a lab," he tells FierceBiotech, "I can tell you that it takes 18 months to get set back up."
Now, he says, Roche is committed to keeping the current organization's staff, current addresses as well as its research budget stable for some years. Getting that commitment from Roche--where he now sits on the executive committee--was part of his recruitment package.
The R&D group also had some legacy problems, he concedes, which were apparent as recently as just a few days ago, when the diabetes drug aleglitazar was deemed a Phase III failure following a safety review. But the kind of "one-size-fits-all" drug that aleglitazar represented also illustrated an R&D strategy that has been abandoned. The mantra at pRED today is centered on a familiar corporate theme: personalized meds, preferably ones that are designed for specific, genetically defined patient groups that can be identified through diagnostics.
"We won't be doing trials like that again," he says about aleglitazar. Generalized medicine is out.
"In" these days are new immunotherapies--perhaps the hottest field in drug research today--that can offer a whole new approach to fighting cancer, often through combination approaches that Reed can coordinate with the gRED group.
Reed is enthusiastic about the company's prospects with obinutuzumab/GA101, discovered in pRED's Schlieren, Switzerland, facility. Investigators have been building an impressive body of late-stage data for this cancer therapy, a glycoengineered anti-CD20 antibody that's been hailed as a next-gen Rituxan with clear blockbuster potential. More details on this drug will come out at ASH in December, but it's been picked as a "breakthrough therapy" at the FDA, and Roche has high hopes for an approval soon to treat chronic lymphocytic leukemia. Biogen Idec ($BIIB) is partnered on the therapy with Genentech.
There are also early-stage cancer programs like RG7116, a glyco-engineered monoclonal antibody that inhibits HER3, a logical continuation of the work already done on HER1 and HER2. By engineering the Fc part of the HER3 MAb, RG7116 promises to spur improved cellular cytotoxicity compared to the MAbs in use today.
Then there's RG7155, a monoclonal antibody that targets the colony stimulating factor-1 receptor (CSF-1R), inhibiting the CSF-1 mediated survival of tumor-promoting macrophages while leaving the tumor-killing macrophages to do their work.
One of the big advantages that Roche has is that it can mix and match programs across all three R&D groups at pRED, gRED and Chugai. The combination packages, says Reed, could include a coupling of their PD-L1 drug with other programs.
In the neurosciences field Reed spotlights the schizophrenia drug bitopertin, a glycine transporter-1 inhibitor that's currently in 6 Phase III trials that will read out next year. Bitopertin goes after negative symptoms of schizophrenia, such as problems with social interaction and emotions, relying on a novel mechanism that Decision Resources has estimated can generate more than $1.5 billion in annual sales.
In Alzheimer's, meanwhile, there's a BACE inhibitor program--an area that has proven to be a minefield for R&D--as well as work on the MorphoSys drug gantenerumab, which could pave the way to a BACE-plus-antibody approach to dementia.
Don't look for some major acquisitions to alter the pipeline at pRED. Reed laughed off the rumors that had circulated about a Roche buyout of Alexion ($ALXN) and BioMarin ($BMRN) recently.
"As a member of the executive committee," he told the first person who called him about it, "I think I would have been informed."
Instead, look for more discovery-through-clinical-stage partnerships. Now, about 15% of the 30 or so NMEs at pRED came from partnering, and Reed wants to see the outside-program share grow to about 33%. As part of that effort, for example, they're looking to do more deals with Versant Ventures, which has been gathering programs together through its Inception portfolio, with Roche taking options to buy individual treatments after early testing.
Partnering is going to be particularly active in tumor vaccines, says the R&D chief. Despite some of the setbacks that cancer vaccines have experienced at Merck KGaA and elsewhere, Reed, like others in the field, is optimistic that marrying various therapeutics that can both release the brakes on the immune system while also pressing down on the immune accelerator can transform cancer care in the next decade.
There will also be more deals for antibiotics, a field in which pRED is looking to mount a return with programs that are pathogen-specific, linked to companion diagnostics and focused on hospital-based infections, like a life-threatening case of hospital-acquired pneumonia. And they're more likely to be IV-delivered than oral, with the kind of commercial potential that makes the work worthwhile to a company like Roche.
Just don't look for Reed at any more ribbon-cutting ceremonies: "This will be the last of the moves for some time." Moves, he adds, "are just poison." -- John Carroll, Editor-in-Chief. Follow me on Twitter and LinkedIn.