While continuous manufacturing technologies have been a topic kicking around for years now, this year it seemed everyone—regulators, academics, and industrial scientists—were certain that continuous processing would start to become a reality. Yesterday, I attended a meeting hosted by the New Jersey chapter of the International Society of Pharmaceutical Engineers (ISPE) where once again, continuous processing was the topic. Bernhardt Trout, director of the Novartis-MIT Center for Continuous Manufacturing, presented the results from the Center’s ongoing academic work developing the equipment and chemistry that will someday enable end-to-end continuous manufacture of small-molecule solid dosage forms in a paradigm Trout called “ultra-lean, ultra-QbD manufacturing.” Alton Johnson, vice president for Global Manufacturing Services, Marketed Products at Pfizer followed with a presentation describing Pfizer’s ongoing initiatives to implement continuous manufacture for several unit operations.

If the attendance and the Q&A session are any indication, continuous processing is indeed a topic to watch. So much so in fact that Pharmaceutical Technology will be hosting an afternoon of panel discussions and interviews on the topic as part of its Signature Series program at Interphex. We will kick off the presentations on Tuesday, March 29, at 1:30 pm on the Main Stage in the Exhibit Hall, where I will be moderating a panel in which FDA’s Moheb Nasr joins Fernando Muzzio from Rutgers and Alex Cheuh of Pfizer to explore the challenges and benefits of continuous processing as seen by regulators, academics, and industry professionals.

Following the panel presentation, we will continue to explore the topic in one-on-one interviews with James Evans, associate director for the Novartis-MIT Center for Continuous Manufacturing, who will discuss the prospects for developing a start-to-finish manufacturing line for small-molecule pharmaceuticals. Next, in my interview with  Invetech’s Vice President for Business Development, Bob Speziale, I’ll explore the prospects for developing a continuous processing line for the large-scale manufacture of therapeutic stem cells. I hope you’ll join us for these presentations.

1:30-2:30: Panel Discussion: Challenges for Continuous Processing

Panelists: Moheb Nasr, Director, Office of new Drug Quality Assessment, CDER, FDA; Alex Cheuh, Director/Team Leader of the Technology, Science and Operations Group, Pfizer Global Supply Division, Pfizer Inc.; Fernando Muzzio, Professor Chemical Engineering, Rutgers University and President, Mixing Consultants, Inc.; Moderator is Michelle Hoffman, Editorial Director, Pharmaceutical Technology

2:30-3:30: Interviews

The Future for a Fully Integrated Platform with James Evans, Associate Director Novartis-MIT Center for Continuous Manufacturing.

Automating Stem-Cell Manufacturing with Bob Speziale, Vice President Business Development, Invetech.

Indeed, while many other trade shows are enlarging their content focus—expanding session selections to include, for example, biotechnology and/or nanotechnology, and provide floor space on exhibition halls for equipment geared towards those industry sectors, PharmIntech remains staunchly focused on pharmaceutical packaging. The event, Corbella explained, “is highly exclusive, a niche event…targeted to the needs of the relevant business community.”

So important is the event and the industry to Italy’s economy, that a press conference kicking off the event featured Pier Luigi Bersani, Chairman of Italy’s Democratic Party and leader of the opposition to the Berlusconi government. In his speech, Bersani, a former Italian Minister of Economic Development, focused on Europe’s current economic woes. “If we are to have a single currency,” said Bersani, “we need a coordinated economic policy. You cannot have a single currency and then have 15 different economic policies.” Europe, said Bersani, needed imagine the economic landscape of 2015 and institute “policies to cope with technological challenges. We need to promote a new industrial policy.” Such policies, said Bersani, include “networking of small enterprises. It is no longer about territorial vicinities.” Bersani also called for a “permanent system of tax relief for research embedded within the Italian tax system.”

Examples of international consortium building were in evidence on the show floor at Pharmintech, where German equipment suppliers—long seen as competitive to the Italian industry—formed a large contingent of exhibitors. The attendee roster was also very international and included delegations from regions as far flung as China and South America. All in all, an impressive showing—and another reason to be passionate—in case the food, the wine, the architecture aren’t enough—about Bologna.

I received notices from the three major pharmaceutical trade organizations, PhRMA, BIO, and GPhA, each one serving up its perspective on the Act. But I’ve also heard from more remote voices from rooms that I don’t usually hear from.

The Americans for Prosperity (AFP) sent me a number of very urgent messages. “Nightmare Becomes Reality: Congress Ignores American People, Passes Washington Takeover of Health Care,” screams one in 36-point type. In the organization’s statement, Phil Kerpen, AFP’s vice president for policy says, “This legislation will demolish the doctor–patient relationship.”

“This reckless law will put a federal bureaucrat between patients and doctors, while giving Washington unimaginable power in deciding the insurance coverage, diagnostic tests, and treatment of individuals.” In addition, “The real cost of this bill is likely to be $2.5 trillion…. Tax increases and massive cuts in government services at the federal, state, and local levels will most certainly occur.” Finally, says the statement, “this bill was also an assault on our democracy.”

Tijana Ignjatovic, strategic healthcare analyst at Datamonitor, wrote to let me know that “Cost strain on private and public payers in the long run will drive market down.” According to Tijana “…imposed discounts and rebates, in addition to raised industry fees will lead to a market dip.” And while Tijana believes that these “negative effects will be offset as revenues begin to rise,” after 2015, she also predicts “greater government participation in provision of healthcare.”

The truth is neither President Obama, nor the AFP, nor the Congress, nor Tijana Ignjatovic knows exactly how this legislation will play out or its long- or short-term consequences. What we do know is that the wealthiest country on Earth cannot provide adequate healthcare coverage for about 10% of its citizens. Among the rest who are covered, only the very wealthiest few don’t worry that a personal health emergency of large enough proportions could wipe them out financially in spite of their coverage. Businesses claim that insurance premiums are a drain on their bottom lines, and many say that without the burden of providing health insurance to their employees, they’d be able to boost salaries. The truth is the current system is broken and needs to be fixed.

Interestingly, the AFP laments that the House legislation still leaves 22 million Americans uninsured. But if the AFP and organizations like it are truly concerned about those Americans, why don’t they propose an acceptable alternative to the current bill, rather than spend their time and resources lambasting the bill on the table? The same goes for all of the Republicans who voted against the bill. Unless they are prepared to defend the system as it is, merely getting in the way of some solution—albeit an imperfect solution—is not good enough. There is still time for opposition voices to join those in favor of reform to craft a bill that addresses the problem and doesn’t just add to the general din of dissention and dissatisfaction.

*With apologies to Truman Capote.

Dividing patients into subpopulations is hardly a novel concept. It’s been a long time since anyone lumped together all cancer patients, or diabetes patients, or patients with cardiovascular disease. I’d even say that some sort of personalized medicine is built into many drug discovery programs these days, as drug companies have come to grips with the notion that the days of the one-pill-fits-all blockbusters are mostly behind them. At the same time I am not prepared to believe that Dr. Collins is conflating the notion of personalized medicine (also called “targeted therapeutics,” with treatment targeted to specific subpopulations of patients) with “individualized” medicine, where each patient receives medication tailored for their unique genome and none other (with the possible exception of autologous cell donation). So again, I must wonder whether Dr. Collins isn’t setting up a false dichotomy. I see no reason for comparative effectiveness to be pitted against personalized medicine. Rather, I can foresee a comparative effectiveness approach that amends the Utilitarian notion of “the greatest good for the greatest number,” to the “greatest good for the greatest number for whom it will do the greatest good.”

But last night belonged to the Pharmaceutical Industry.

The Prix Galien USA celebrates innovation in American pharmaceutical sciences, and last night in the Whale Room of New York’s Museum of Natural History, the industry celebrated its best. Public television host Charlie Rose mc’d the proceedings, which included a speech by Elie Wiesel, winner of the 1986 Nobel Peace Prize and member of the Prix Galien USA committee. Wiesel lauded the audience for their humanitarian mission in improving the people’s health and lives.

Gerald Weissmann, committee chair of Prix Galien USA, and research professor at NYU School of Medicine, remarked on the important partnership between industry and academia. “The 2009 Prix Galien USA winners represent what is possible when basic scientific research translates to drug development and discovery,” he said.

The two winners of the Prix Galien USA Pro Bono Humanum Award shared their own hopes for the possibilities of pharmaceutical science. Awardee Barry Bloom, the Joan L. and Julius H. Jacobson professor of public health at the Harvard School of Public Health made an impassioned plea for funds for a tumor genome screening project, as a first step towards personalized, rational cancer care.

Awardee Jeffrey Sachs, director of The Earth Institute, Quetelet Professor of Sustainable Development, and professor of health policy and management at Columbia University spoke of the need to provide basic interventions to address the health needs of people in the developing world.

The winners for pharmaceutical innovation are as follows:

Best Pharmaceutical Product:
Novartis Oncology, for Gleevec, a highly specific, rationally-designed drug to fight chronic myeloid leukemia and gastrointestinal stromal tumor.

Best Biotechnology Product:
Two companies, Amgen for Nplate and GlaxoSmithKline for PROMACXT shared this award. The award-winning drugs both treat thrombocytopenic purpura by increasing blood platelets without causing unwanted effects in the immune system.

Best Medical Technology:
Veridex for CellSearch CTC Test, a device that isolates and identifies cancer cells circulating in whole blood of patients with metastatic breast, colorectal, or prostate cancer.

In a season where the US healthcare agenda and the pharmaceutical industry are undergoing intense national scrutiny, it’s nice to stop and take pause, and celebrate the very best of our scientific and medical achievements.

Congratulations to all of the innovators.

Visit Prix Galien’s website for more information.

Evidence for that may be at hand already. Genzyme announced earlier this week that that it believes FDA will approve a new manufacturing facility in Framingham, MA, for its drug Myozyme, a biotherapeutic for a rare neurological disorder called Pompe disease. Approval to manufacture the drug in the new facility had been delayed over a year. The reason? Ostensibly, FDA felt the bioprocessing in the new facility would differ sufficiently from that of the existing facility as to produce a drug different from the one manufactured in the existing plant. In essence, the drug produced in the new facility would be treated as a separate entity. And to underscore this fact, Myozyme manufactured in the Framingham facility will be sold under the name Lumizyme.

If FDA is treating identical formulations manufactured with presumably identical processes in different plants operated by the same company as different drugs, then one has to agree with Gottlieb that differing formulations, manufactured by different companies using different processes will indeed face a long an arduous regulatory road—one that just might stretch out for, say 12 or so years. 

Late last week, while discussing spending priorities, McCain vice-presidential nominee, Sarah Palin, derided the government for spending money on “fruit fly research in France. I kid you not,” said Governor Palin. (To see the comment in its context, please see the video on YouTube.)

I don’t know whether this means that the McCain/Palin ticket is not aware that fruit fly research has given modern science the underpinnings for all the genetic research of the past 40 or so years (including the specific research project to which she alludes, which was conducted not in France, but at the University of North Carolina, and which in fact is uncovering important insights into the genetics of autism), or whether they do know and still don’t think it’s worthy of government funding.

In either event, I seriously question the wisdom of placing our science policy in the hands of such people.

Posted by Michelle Hoffman for Hallie Forcinio, Packaging Forum Editor, Pharmaceutical Technology