Biotech execs: FDA can be good, or “horrifying”

From Reuters Health:

By Lisa Richwine

BOSTON, Feb 24 (Reuters) - Biotechnology companies trying to get new drugs to the market have had experiences with U.S. regulators that range from productive to “horrifying” as they craft early development plans, senior executives told Reuters this week. Interactions can vary vastly between Food and Drug Administration divisions that review products and provide guidance to companies long before they seek approval to sell a drug, company officials said. “We have some very good experiences and we have had some horrifying experiences, where you wonder, ‘Where did that come from?’” Genzyme Chief Executive Henri Termeer said at the Reuters Biotechnology Summit in Boston.

NVI experiments with PAT for vaccines

One of the more intriguing presentations from last week’s IFPAC show in Arlington, Va. was that by Mathieu Streefland, PAT project leader for the Netherlands Vaccine Institute. Streefland and colleagues are complementing traditional vaccine-monitoring techniques–which tend to be very low-tech and low-cost, and can be up to 50 years old, Streefland noted–with the latest genomic and proteomic methods. NVI is also using NIR to fingerprint the batch-cultivation process for the institute’s whooping cough vaccine.

The team is in the midst of establishing allowable process variation, and is working with Siemens Pharma Group and Applikon Biotechnology on more advanced means of process control.

A one-on-one interview with Streefland is available at PharmaManufacturing.com.

–PWT

Microanalytics meet microfluidics in Rome

A noteworthy event: The Center for Process Analytical Chemistry, or CPAC, will hold its first-ever satellite conference in Rome next month (March 20-22). The meeting will bring together experts in the fields of microanalytics and microfluidics–something Center director Mel Koch believes is a first of its kind.

Koch was promoting the event this week at the annual IFPAC forum in Arlington, Va., and said that response has been surprisingly good from the pharmaceutical and other industries. At IFPAC, Koch also presided over discussions on the New Sensor Sampling Initiative, or NeSSI, an effort to modularize and miniaturize analytical instrumentation.

More on the Rome gathering and NeSSI can be found on CPAC’s home page.

– PWT

GSK enlists sales staff to win over hearts and minds

Michael Pucci, GlaxoSmithKline’s vice president for external advocacy, is asking the company’s sales team to lead a campaign to shore up the industry’s image.

The sales force “is out speaking to Rotarians, Elks, Lions Club members, senior-citizen groups, weekly newspapers, schools and every community group they can think of. And Mr. Pucci said GSK has enough sales reps to cover every county in every state in the country,” Ad Age writes.

“Reputation matters,” Pucci said. “In this industry, it’s so important. We have to tell that story of how we’re investing for the future.”

Will it fall on deaf ears?

– PWT

Layoffs at J&J, P&G focus on R&D

At J&J’s R&D facility in Raritan, N.J., 300 scientists and support workers will be laid off, according to the Associated Press, and early research efforts will be carried out at Spring House, Pa.  Proctor & Gamble is laying off 300 scientists at its facility in Mason, Ohio, by the summer.

Strong Medicine and Pharma’s Pact with Society: Perspectives from India

A new article by Mitul Desai in the Georgetown Journal of International Affairs (warning: article had appeared on Black Enterprise web site but LINK is no longer active)discusses India’s reaction to the new patent regime, and what it can teach the global pharmaceutical industry.  He argues that the industry must:

• understand global resentment towards intellectual property laws
• examine the history of pharmaceutical companies and patent laws in India to understand how they shaped public opinion
• acknowledge the importance of public relations strategies and a global outlook.

WHO calls for creation of anticounterfeiting task force; Drug counterfeiters convicted after a 3-year FDA probe

Last week brought anticounterfeiting news both on the macro and the micro scale. First, at a three-day conference in Rome, the World Health Organization called for the creation of an anti drug counterfeiting task force.

“People don’t die from carrying a fake handbag or wearing a fake T-shirt. They can die from taking a counterfeit medicine,” said Howard Zucker, Assistant Director General for Health Technology and Pharmaceuticals at WHO. “International police action against the factories and distribution networks should be as uncompromising as that applied to the pursuit of narcotic smuggling.”  Read more about it.

Meanwhile, on the “micro” scale, in Florida, two members of a drug counterfeiting ring were convicted of conspiring to relabel and distribute fake Lipitor and other drugs. The Florida-based “cog” in this $13-million operation faces five years in prison and a $250,000 fine.  Read the AP news wire report here.

GPhA responds to FDA: User fees okay in exchange for more favorable treatment

The Generic Pharmaceutical Association (GPhA) issued a quick response to FDA’s suggestion that it pay user fees to help support the Office of Generic Drugs (OGD), whose resources have been increasingly taxed in recent years. Fine, GPha says, as long as the Agency would support legislation to bring generic drug products to market faster.

“Providing a minimal amount of additional funding for the Office of Generic Drugs (OGD) will provide a tremendous return on investment, resulting in long-lasting dividends to all health care purchasers and health care programs, GPhA said. What follows is the rest of the organization’s statement:

“A modest investment in OGD — such as $15 million — would help to make
more affordable medicines available to consumers and public and private
health care purchasers, who would save billions of dollars,” said GPhA
President and CEO Kathleen Jaeger. “Those savings also would enable the

Dr. Reddy’s buys Betapharm; Could your next job be with an Indian firm?

India’s Dr. Reddy’s has bought Betapharm for over $570 million (cash). Ranbaxy had also bid for the company, as we’d learned earlier this week.

Dr. Reddy’s Laboratories, Ltd., India’s third largest drug company, manufacturers both generic and branded drugs, as well as APIs and diagnostics, and is clearly becoming a force to reckon with in the global pharmaceutical industry. For more insights, read this brief profile of the company’s founder, Dr. Anji Reddy.

As his and other Indian companies diversify and globalize, there is a good chance that your next job may be with an Indian company—and not necessarily in Mumbai but in the U.S., Canada, South America, or wherever you live.

In the U.S., Ranbaxy is looking for a few good people, mainly in New Jersey; Dr. Reddy’s has two openings. For those of you with engineering and IT backgrounds, Tata Consultancy Services, a company that appears to be bridging the gap between process plant automation and IT consulting, is expanding rapidly, and also in hiring mode.

-AMS

FDA challenges GPhA and broaches subject of user fees; Biosimilars approval unlikely until 2009

Today, Scott Gottlieb, FDA’s Deputy Commissioner for Medical and Scientific Affairs, spoke before the Generic Pharmaceutical Association, responding to the association’s criticism of the Agency’s generic drug approval process and funding for the Office of Generic Drugs (OGD). 

He challenged generic drug makers to examine the “root causes” for failed applications, singling out the need for better communication with their API suppliers outside the U.S., to ensure the quality of Drug Master Files. He also brought up the issue of user fees for generic drugs.

Among the points he made:

• OGD’s budget has doubled since 2001, staffing has increased and will rise again this year
• Since 1996, the average time for approval has dropped 40% to 16 months
• Sponsors should use the dissolution data posted on the Internet in their applications.
• Complete applications result in multiple review cycles. Last year, 93% of generic applications were rejected during the first cycle, and 59% during the second cycle.

Mr. Gottlieb also emphasized the need for better science, which would establish generic equivalence, not only for biologics, but also for inhaled medicines and liposomal drugs.

Biogenerics would be a multi-billion-dollar market, but FDA approval has been in limbo for some time, prompting Sandoz to sue FDA last year over its refusal to approve the human growth hormone follow on, Omnitrope. The EU has already approved the compound.

A guidance document may be issued sometime this year, Angelo De Palma writes in an upcoming article in March’s issue of Pharmaceutical Manufacturing magazine, but full approval is probably at least three years away. 

Although the science of protein diagnostics is improving, Dr. De Palma writes, follow-on biologics manufacturers in the U.S. may have to prepare themselves for the prospect of clinical trials.  Although most project a market in the $5-to-$10-billion range, one financial analyst expects the biosimilars market to reach $50 billion.

-AMS