Value Creation is the Name of the Game in Bio Partnering
By Marie Powers
BOSTON From the welcoming remarks to the plenary session and workshops, the message to BioPharm America 2012 attendees was loud and clear: Partnering is all about value creation.
"Development is not a solo sport," David Meeker, president and CEO of Sanofi SA unit Genzyme Corp. said in the conference's keynote address. "We all need to be thinking about how to put the pieces together in a way that creates value."
Genzyme could be viewed as the poster child of partnering, with a history that included early deals with academia and small pharma as well as joint ventures and acquisitions until it was acquired by Sanofi last year. After a bit of a rough transition as the operating unit of a big pharma, the company is again on the prowl for partners, Meeker said.
One of the lessons learned from its partnerships and acquisitions on both sides of the table is that "it's not enough to do the deal," Meeker admitted. "It's like marriage. It's easy to get married. The challenge is to stay married."
From academia to small biotech, big pharma to contract research organization, every player in the biotech life cycle either must play a useful role in the development of new compounds or perish, Meeker insisted. And the end goal is not simply to move therapies through approval, but to deliver them into the hands of patients, creating a whole new set of issues. Fundamentally, therapeutic development has always focused on patients, but biotechs face growing resistance from payers if their drugs offer only incremental gains.
"Health care systems are under enormous pressure," Meeker said, suggesting the U.S. may soon follow the path of the UK and Germany, where some approved drugs are not moving to market because they're being denied reasonable reimbursement.
"That is a cold reality of the world we're living in now," Meeker said. "A patient's ability to access a therapy that makes a difference is the end game. That process is moving globally."
Meeker recounted a recent conversation with Reed Tuckson, chief medical officer of UnitedHealth Group, that conveyed a single, sobering message: It's all about cost. Employers are telling insurers they cannot afford to provide every therapy to every employee.
Consequently, regulatory approval won't automatically lead to coverage particularly when a therapy's clinical development program includes placebo-controlled trials rather than comparison drugs.
"We can't be in the position of trying to position something that is not measurably better than what's available today, and at a lesser cost," Meeker said.
Can Pharma Find Value in Immunotherapies?
The topic of value also dominated an opening workshop on immunotherapies that included a mixture of biotech and pharma representatives who politely sparred about the willingness of pharmas to move beyond incremental approaches and embrace potentially game-changing technologies.
"Big pharma doesn't like processes. They like drugs," observed Ronald Pepin, senior vice president and chief business officer of Celldex Therapeutics Inc., in Needham, Mass. "If you're talking about manipulating cells and personalizing medicines, that's not what big pharma does well. They're not comfortable with it, and they don't buy into it."
Randi Isaacs, senior director of oncology translational medicine at Novartis AG, based in Basel, Switzerland, insisted the pharma looks at a broad swath of technology but seeks solutions that will deliver the right drug to the right patient.
"There's been a transition in thinking in drug development," Isaacs said. "We are looking for personalized therapy now. We have a very deep pipeline within translational medicine that comes to us through work with our preclinical folks at the Novartis Institutes for Biomedical Research, but also through our partnering efforts.
"It's like moving the Titanic a little bit," she added. "It's been an evolution, but I think big pharma is ready for this."
Edward Lanphier, president and CEO of Sangamo BioSciences Inc., of Richmond, Calif., argued, however, that Novartis is an anomaly in the big pharma outlook toward immunotherapy. Although pharmas are generally comfortable with antibodies and even allogeneic cell therapies, "you cross a huge chasm if you start talking about autologous cell therapy," he said.
Industry-wide, that conversation is not likely to change until clinical data better demonstrate the value of immunotherapeutics, Isaacs conceded.
"When we evaluate a therapy, I look at three things," she said. "First, is there a plausible mechanism of action? Does the science make sense? Second, is there a selection strategy? We're not dealing with cytotoxics anymore, so do we have a way to select patients, and does some of the preclinical work suggest the target makes a difference?"
Finally, Isaacs looks at the clinical data. In the case of the University of Pennsylvania, the data from just three patients with chronic lymphocytic cancer were sufficiently compelling for Novartis to ink a $20 million deal to develop and commercialize personalized immunotherapy in a variety of cancers using Penn's so-called chimeric antigen receptor (CAR) technologies.
The partners plan to build the Center for Advanced Cellular Therapies on the Penn campus in Philadelphia to focus on the discovery, development and manufacturing of adoptive T-cell immunotherapies through a joint research and development program led by scientists from Penn, Novartis and the Novartis Institutes, with the pharma gaining an exclusive worldwide license to CAR-based therapies developed through the collaboration. (See BioWorld Today, Aug. 12, 2011.)
"The response, and durability of response, really got our attention," Isaacs said. "If other therapeutics or other platforms came with the kind of data that we saw from the Penn deal, big pharma could be more interested."
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