After almost nine years of working at Pharm Exec magazine, it’s time for me to move on. I have a new career opportunity in global health, but I couldn’t leave without telling you that I’ll miss you.

Pharm Exec was my first writing and editing gig and, when I joined, I knew next to nothing about pharma. So it’s been fun to grow up thinking and analyzing the industry each day, entirely focused on this small niche that has such a big impact.

Some fond memories:
• Thinking back to when life was easy, before the PhRMA code, OIG’s focus on pharma, and a reluctant FDA
• Interviewing Fred Hassan, Jeff Kindler, John Lechleiter, Matthew Emmens, Margie McGlynn, and so many other pharma CEOs, talking about their vision for healthcare
• Watching the rise of biotech and walking into Genentech in 2006 wearing a full-out suit, only to find that the executives were wearing ripped jeans and sneakers
• Reporting on the AIDS crisis in Africa and watching the industry respond to it
• Realizing how everything changed after Vioxx
• Meeting people with true insight
• Becoming active in HBA, an organization that has offered so many positive opportunities to improve my network and career.

Pharm Exec has grown and developed over the years under Editor in Chief Patrick Clinton, Publisher Jay Berfas, and the rest of the staff. I’m proud to have been a part of this team and the work they do to inspire the industry. I also have to say thank you to the people out there (you know who you are) who have done so much to encourage me along the way. I feel like the tortoise on top of the fence—there’s no way it could have got there without a lift. So for the great contacts, sources, story ideas, background information, or simply giving in a well written second draft—hank you.

Still, you won’t miss me too much. You can always find me on LinkedIn, at i.HUG, the charity I co-founded which has a school and clinic in Kabalagala, Uganda, and also as the newest member of the Pharm Exec Advisory Board.

See? I told you that you wouldn’t be able to get rid of me. Don’t forget to stay in touch and let’s keep trading big ideas.

But now that the bubble has burst, pharma can expect what Russell predicted a decade ago: a more competitive industry, with greater focus on pharmacoeconomic data, ROI, and less tolerance for me-too drugs. “The economic miracle is over—there will be a struggle to survive in this industry,” he says.

Russell, a speaker at the Reuters healthcare conference today, breakfasted with Pharm Exec at the W Hotel, and offered a preview before tomorrow’s main event, the business update for its Human Genetic Therapies (HGT) business. The meeting will take place in HGT’s new Lexington, MA, headquarters, and with more than 1,000 employees (up from 300 in 2005), it will also provide a visual reminder of how this business is a growth engine for Shire.

Over the last three years, this specialty pharma company has grown and diversified both its product portfolio and geographic reach. A few years back, Adderall XR accounted for the lion’s share of Shire’s sales. But recently announced Q3 earnings show that the company has succeeded in bringing along its newest drugs—and for the first time, new product sales exceeded those of Adderall XR (and not a moment too soon, as generic Adderall arrives on the market in just six months). With almost two dozen potential launches planned for 2008-2015, Russell says the company is in “the best shape it’s ever been.” He attributes this to strong IP (even for its next-stage ADHD drug Vyvanse), a heavy focus on orphan drugs, and Shire’s litany of productive deals including Jerini.

On Tuesday, Russell will address HGT and outline Shire’s seven-year plan. (“Five years was too short, 10 too long,” says Russell.) It includes expansion into China and  a reorganization along patient lines; drugs for diseases that serve more than 50,000 patients will fall under specialty pharma head Mike Cola; smaller drugs will fit within Shire HGT, presided over by Sylvie Grégoire. Russell says this paradigm best capitalizes on the different commercialization models, enabling smaller orphan drugs to fully leverage the “advocacy-based selling model.”

But it’s not all roses for Shire. In the short-term, the company will experience a dip in sales in 2009, and possibly 2010, as it fully transitions away from Adderall XR. Perhaps a bigger issue is the biogenerics bill that’s shaping up among legislators. Russell plans to visit Washington, DC, several times over the next few months to conduct what he characterizes as much-needed education on the interaction between intellectual property and biosimilars. Right now, small molecules have 20 years of patent life, but biologics only have seven. “Without 12 or 14 years of exclusivity, it just might not warrant the investment,” says Russell. “You see the reaction when I tell people that—their eyes light up and you can tell they are beginning to understand.”

Coats is referring to the pressure that cash-strapped biotechs are feeling to sell out and says he gets no less than five calls a day from small companies desperate for suitors. “The VC guys are saying you better get another revenue stream or control the costs, because the money is just not coming in,” he says.

It’s an interesting vantage point for Eisai, which unlike some Big Pharma competitors doesn’t have to go through the massive reorganization and downsizing.

Part of that has to do with the more careful business planning on behalf of the Japanese companies, according to Elizabeth Evans, a senior specialty sales rep with Eisai. “The culture is different,” she said. “It’s the worst thing to fire someone, so they think very much about the long-term before making the hire.”

Coats notes that 21 percent of the company’s revenue now comes from specialty drugs—with more promising therapeutics on the way out of its new MGI Pharma acquisition. But Eisai has just 1,000 specialty reps. “Because we haven’t taken on the infrastructure, we don’t have to go through the pain that a lot of the other companies have,” he said.

Rather, the pharma company of the future will be built through partnerships instead of a lot of heavy M&A. “M&A and all the work you have to do on integration is a big distraction,” said Coats. “Look at Merck. There was a lot of pressure to do a merger. But they held the line until there were drugs coming out of the pipeline.”

Coats also notes that Jeff Kindler has made some right moves in this direction for Pfizer; he’s willing to take the hit now by holding out on a lot of the M&A that will just build up infrastructure and make the patent cliff steeper for as long as possible. Instead, the company is seeding projects throughout the rest of the industry that will bring it revenue streams in the future.

Reporting to you from Chicago at the Sixth Annual Healthcare Businesswomen’s Association leadership conference, where the story—set in this city of the new US President—is all about change.

The Pharm Exec crew arrived in a surprisingly tranquil Windy City—the only explanation that it was the calm after the storm of Tuesday’s election. Certainly, many HBA members had been up all night watching the election, with a dozen members who took to the streets and joined the rally for Barack Obama at Grant Park.

“It was like being at Woodstock,” said Nancy Larsen, President of PROmedica Communications, who was part of a group that attended the rally. “Even though we were standing shoulder-to-shoulder in this massive crowd, it felt serene to be with all these people—it gave me goose bumps.”

“It’s not watching history—it’s actually being a part of it,” said Eve Dryer, Principal and President of Vox Medica Public Relations.

Yet even with the election front-and-center in the nation’s consciousness, executives here seem more focused on pharma’s patent cliff crisis and the latest round of layoffs, instead of major healthcare reform.

“We get the sense that there is some pent-up demand for talent,” said one attendee. “We think people might begin hiring after the election—we’ll be able to tell by year end if that is happening. People may begin hiring because we don’t get the sense that Obama will get to healthcare first.”

The focus of the conference is leadership development, and many conversations and presentations were peppered with concern over how tough times will affect careers in pharma, particularly for those who have been traditionally underrepresented.

“Many of the banks were at the forefront of setting up on-ramping and off-ramping career tracks for women—they had to—and really paved the way for other industries,” said Meryl Zausner, CFO of Novartis. “But now, those efforts will be hampered.”

Still, it seems that many companies are trying their best with programs to bring up women and other minority groups. Novartis CEO Ludwig Hanston accepted the HBA’s 2nd Annual ACE Award on behalf of the company for  its Empowering Women Impacting Novartis and Women in Leadership program.

Meanwhile, Johnson & Johnson (the 2007 ACE Award winner) had a chance to take the stage to talk about how it is seeking to expand its workplace program for women, all 60,000, with new efforts to focus on its European affiliates, sales force in Japan, and even to its group in Cape Town, South Africa while Adrian Sax, who heads business development for King Pharmaceuticals, spoke about the grassroots efforts for inclusion happening at smaller companies.

But consider this. The first ideas for GPP were formed a decade ago, and now the time is right for GPP2: the new, revised Good Publication Practice.

Why now? Pharma publication practice is a hot potato. Purported cases of publication-related ‘misconduct’ or alleged misdemeanors reflected in high profile clinical publications come to light, it seems, every month. More often than not big pharma is the target, like this in the Wall Street Journal, like this in Annals of Internal Medicine.

And then FDAAA turned up the heat. Results posting in 12 months means pharma supported clinical trials will be out there in the public domain quick, and posted in some detail on clinicaltrials.gov.

Clinical publications had better keep up. A peer reviewed analysis of clinical trial data published in a journal and out there when the same data is posted on clinicaltrials.gov means that interpretation is no longer just anyone’s (or everyone’s?) business. And, yes, clinical publications had better shape up too: it’s not good news when stories hit the press about undisclosed conflicts of interest in clinical papers, or suppression of less than favorable data.

GPP2 will deliver best practice guidance for the post-FDAAA era (the ‘post-posting’ era?). It will capture the evolution in best publication practice seen over the last decade, drawing on newest guidance (new Declaration of Helsinki, new ICMJE, and more). As always, GPP will encourage responsible and ethical publication practice. It will help those involved in the publication and communication of clinical information funded by companies to keep up with the rapidly changing environment.

Working with support from the International Society for Medical Publication Professionals, the GPP2 Steering Committee will open its Global Consultation on the first draft of the new guidelines late in 2008. You can expect GPP2 to offer advice about preparing for and executing GPP for clinical trial papers as well as, for example, for special cases like abstracts and presentations, post hoc analysis, meta-analysis, and reviews. Get in touch with Chris Graf to get involved.

Disclosures: Chris Graf is co-chair, ISMPP Standards & Best Practices Committee. He is Associate Editorial Director at Wiley-Blackwell. He is Publisher of International Journal of Clinical Practice. He owns no stocks or shares.

And for the rest of us? Well, at least there’s the Healthcare Businesswoman’s Association (HBA) and its annual Leadership Conference. The event is being held next week in Chicago (and if it’s the hometown of the President, we expect it to be all the more exciting). With more than 600 attendees already registered, it will be the largest meeting of its kind. One-third of these women are vice presidents and above, so for the ladder climbers in the industry, this is the place to be.

Pharm Exec will be doing on-site blogging—so stay tuned for regular updates. In particular, we’re looking forward to the panel of “Hard Lessons, Sweet Successes,” moderated by Charlotte Sibley, HBA’s 2008 Woman of the Year. Charlotte shocked the luncheon crowd in May when she revealed her own story of the ups and downs of working in the pharmaceutical industry. (To read her story, click here) This time, she puts tough questions to an esteemed panel including Dierdre Connelly, President, Lilly USA; Len Kanavy, Vice President, Commercial Operations of Genentech; Renee Tannenbaum, Global Head, Commercial Operations, Novartis AG; Eisai’s President Lonnel Coats; and Ginger Graham, Two Trees Consulting, former CEO Amylin.

“Language is very important, and you have to understand how it affects perception,” says Maria Hardin, vice president of patient services for NORD (National Organization for Rare Diseases). “You have to think of the 30 million patients with rare diseases as a whole. We don’t want to salami slice it any more than we already have.”

Hardin presented today at CBI’s Pre-Approval Access conference, here at the Hilton Baltimore, and said she is concerned that classifying some drugs as “ultra-orphan” and others just “orphan” will artificially divide services and access to life-saving drugs. “We refuse to use that word,” she says.

Instead, says Hardin, the word “ultra-orphan” has been put into play by pharma companies that specialize in treating rare diseases. But sources say that this sub-classification has at least one utilitarian purpose.

“How do you explain to a regulatory agency that your trial only has 30 patients in it–and half of those are on placebo control?” asks Mark DeRosch, senior director of regulatory affairs for Vertex Pharmaceuticals. DeRosch plays a part in the development of the company’s promising cystic fibrosis candidate, VX-770.

Based on an eight country, decade-long analysis, Dr. Andree Bates, president of Eularis, reports that named patient programs have a positive effect on revenue.How positive? By observing how 33 drugs performed in cash markets a year after commercial launch, Eularis deemed there was a 1.362 times higher odds of spending $1 on a drug that participated in these pre-launch programs compared with one that did not. (For those of us who are “statistically challenged,” Bates put it another way: Let’s say a pharma company was about to launch a drug and expected a 5 percent market share. If that same company launched the drug, but had run a pre-approval access program, they can expect that market share to be 6.7 percent.)

Across the board, there has been little to no research done on the ROI of named patient programs, probably because the driver of such programs is patient need. Not to mention, the whole idea of named patient programs and financial benefit seems just sticky. Although companies are allowed to charge for drugs that are available pre-launch, many companies elect to charge an artificially low price or not at all – a decision, says Tim Tustin, Shire’s managing director, export, they may regret later on.

“Companies can be accused of seeding the market – of not charging patients until the drug is available commercially, and then having to charge a price,” he says. “Governments can then look at price, and it might not be what they expected.”

The British-born Tustin also remarked on the EU-US divide when it comes to pre-approval access programs. “I now understand the questions my US colleagues ask,” he says. “The US and UK systems for these drugs are diametrically opposed.”

More information on pre-approval access programs can be found here.

Photo by MTSOFAN

UBS publicized an anticipated attendance of 3,000 investors which may be difficult to produce with attention easily diverted by the market swings and lack of appetite to invest. Attendance Monday was sparse in the morning with an increase peaking with a standing- room-only attendance at the 2:00 pm Pfizer presentation. The audience listened intently looking for some favorable news from this industry giant. Ian Read, President of Pfizer’s Worldwide Pharmaceutical Operations, gave a reassuring talk that Pfizer was doing its best to remain strong and produce the future revenues worldwide that stockholders depend upon. But then when the Dow indicator reached a 370 point loss and the price of oil at $120 per barrel (the largest one-day price increase in history) appeared on the MS NBC financial news screen in the major hall outside the presentation rooms, the attendance returned to low morning levels.

It wasn’t surprising that expectations were low as attendees went through the motions of listening in on some private and public companies talks that appealed to them or from whom they wanted to hear reassurance on their pre-existing investments. There wasn’t any of the excitement that marked meetings in previous years. In fact, the high drama of the day was the Hoffman La Roche, Ltd presentation in the morning. Curiosity about the implementation plans for Roche’s buyout of the remaining 40% of Genentech and Roche’s access to sufficient funds dominated the questions in the packed Roche breakout session. The audience seemed sadly resigned to the outcome anticipated by the Roche speakers Dr. Jean-Jacques Garaud, Chief Medical Officer & Head of Global Drug Development, and Dr. Karl Mahler, Head of Investor Relations. Genentech presents at the conference on Wednesday.

This week’s four-day conference includes over 300 companies in biotechnology, genomics and discovery tool, medical technology and pharmaceutical fields. It has been one the largest annual life science investment meetings on the East Coast rivaling that of JP Morgan’s (former “H&Q’s” January meeting in San Francisco.

Clinton spoke to the crowd about how the organization has applied what it has learned from pooling patients to drive down prices for HIV therapies to the issue of malaria, where it has secured a series of deals at “every level of the production chain” to lower the price and ensure new supply of the world’s most effective anti-malarial agents. The Foundation’s work to reconfigure the market, says Clinton, is important to expanding access, but ensures that there is still enough profit margin to keep manufacturers from taking their investment elsewhere. (Although Clinton did note that he thought deep tax benefits for companies engaged in R&D for neglected diseases was the way forward.)

At the heart of these deals are price ceilings on the price of artemisinin, a crop grown in China, India, and East Africa, which is the key ingredient in new combination-based therapies that have become the WHO-approved gold standard to treat uncomplicated malaria, particularly in Africa where drug resistance to chloroquine has become such a problem. The volatility of the artemisinin crop (Clinton held up the plant to emphasize his point) has resulted in a 700 percent swing in price over the last six years. It is expected that these new compacts will lower the price of ACTs by 30 percent, and encourage even more companies to enter the area because they can better predict supply of artemisinin and demand by patients.

There are several ACT formulations, but Novartis’ Co-Artem (artemether-lumerfantrine) is the hundred-pound gorilla in the area, given that it supplies 85 percent of the global public sector market for ACTs, according to WHO’s Andrea Bosman, MD. Novartis has been attempting to stabilize the price of Co-Artem by taking deep losses when the artemisinin crop is in short supply.

“We never made any money on Co-Artem—we’ve only lost money,” explained Dan Vasella, CEO of Novartis, who was at the press conference in a show of solidarity with several other API and generic manufacturers that are also part of Clinton’s New Deal for malaria. “I only hope that these prices are sustainable,” he added, his excitement no doubt tempered by Novartis’ real experience of stock-outs, shortages, and other on-the-ground knowledge gained from its years supplying the African market with Co-Artem.

This announcement comes on the heels of the Senate’s authorization of a $48 billion package for AIDS, TB, and malaria, which, says Clinton, will allow the foundation’s efforts to go even further, as they will be used as part of a holistic package of malaria prevention and control