Partnering, networking and making new friends are all top-of-the-agenda for the biopharma industry’s largest U.S. gathering. As you’re preparing to join 16,500+ of your colleagues at the 2013 BIO International Convention in Chicago, we’d like to introduce you to a few standouts featured in the stories below. Also, come meet the BioWorld people, who are pretty interesting, too, at booth 1573. Plus, you can collect BioWorld’s giveaway, which is both practical and sentimental. For 15 years, Publisher Donald R. Johnston has masterminded the creation of our lids. It’s a hotly sought after gift, so come early before we run out.

Avalon’s Lichter: ‘Laid-Back’ Savvy Keeps Deal Flow Strong

When it comes to getting venture capital deals done, the science and the financial terms naturally take center stage, but the personalities of the players need to mesh, too, for the best outcomes.

Women Leaders in Biotech: ‘Walls Are Coming Down’

The glass ceiling is shattered, and barriers to women’s participation in the biotech industry have fallen at every level, including the highest. That is the happy testimony of four leading women in biotech slated to present at BIO 2013, including Rachel King, co-founder of GlycoMimetics Inc.; Leslie Williams, president and CEO of ImmusanT Inc., Jessica Flechtner, vice president of research at Genocea Biosciences Inc.; and Denise Pollard-Knight, managing partner with Phase4 Ventures.

CEOs of Newly Public Biotechs Balance Work and . . . More Work

The initial public offering window may be creaking open for biotech – thanks in part to the new emerging growth company designation included in last year’s JOBS Act – but running a publicly listed small biotech requires as much dedication as ever. Among speakers at BIO 2013 are two CEOs who can attest to that, having helmed their respective companies through the process in the past year – Dave Pritchard of KaloBios Pharmaceuticals Inc. and Lonnie Moulder of Tesaro Inc.

Unconventional Paths Give Young Standouts a Step Up

Among the thousands of interesting people who will be attending the 2013 BIO International Convention in Chicago are young standouts who are already making their mark in biotech, including Josh Sommer, Isaac Kinde, Laura Deming and Andina Mangubat

Navigating Successful Biotechs: CEOs Need to be Visionaries

It takes a special kind of person to be able to help navigate a biotechnology company from its early stages, with all its attendant hopes and dreams into the reality of a truly therapeutic product organization, which generates revenue and builds value for its shareholders. The job description calls for visionaries with business savvy and the ability to keep a positive attitude even when bumps in the road are encountered. BioWorld Today caught up with two such visionaries: Kleanthis Xanthopoulos, president and CEO of Regulus Therapeutics Inc., and Ingmar Hoerr, CEO of CureVac GmbH.

Day One:

One of my kids calls me in the middle of dinner, but I manage to resist the Super Dad habit to answer . . . “I’m in a free zone force field, unreachable to handle family stuff!” She must’ve forgotten that I primed everyone to the fact that I would be busy every minute of every day for four days.

Day Two: Woke up groggy from four hours of sleep, but still with a positive attitude, although unaware that the game plans of my mind and body were heading in different directions. I persisted with the attitude that time is valuable and must be optimized to make the most of the week. However, back-to-back-to-back-to-back sessions left me running on fumes by afternoon. I contemplated taking a nap, but I dared not sleep in my state, for fear of missing my Friday morning flight.

Day Three: I couldn’t find my stylish shoes this morning. Finally I discovered them hiding underneath the armoire in my hotel room where they had tied their shoestrings to the legs in intricate Navy Seal knots. Evidently, they had heard the heat-wave-imminent weather report and had resolved to divorce themselves from the grueling task of resuming our four-day BIO-exodus in the convention center desert. They had a sticky note on the inside that read, “For the love of Hermes’ winged feet, we are Armani – not Dr. Scholls!”

I have to commend my shoes for their insight, as those 96 degrees felt like 96 more pounds added to my frame as I trekked around town to the evening’s round of parties and the gala reception.

Day Four: The convention center looks like a zombie wasteland, with attendees waddling and ambling without apparent purpose or direction, other than to wait for the appropriate time for departure to the airport. The remaining exhibitors – apparently the ones who had drawn the short straws – fingered their smart devices, not even bothering to look up as last-minute foragers pillaged their booths of all bounty, each scooping up pens, bags and tchotchkes by the dozen without the threat of the marketing quid pro quo, or doodad-for-data swap, that had been required to extract as much as a breath mint from their booth strongholds the previous three days.

I was ready to go, with one tired foot already out the door, when I sucked it up and decided to attend that one last Thursday session – the one with the heavy IP topic that was sure to add another few psychological pounds of mental fatigue baggage onto my psyche’s overloaded briefcase. But lo and behold, it turned out to be the zenith of my BIO 2012 experience, with useful information, receptive networking contacts and great story material.

Suggestions for the Brain Trust at BIO

Next year, please consider adding moving sidewalks and chair masseuses.

How about an inaugural BIO convention on the high seas?

Or, for this crowd of ultimate risk takers, consider another meeting site; here’s the phone number for the Las Vegas Convention Center: (702) 892-0711.

What worries me most is the passive acceptance of it all. A few examples to illustrate from BIO 2012:

• During Tuesday’s keynote luncheon, when two former U.S. treasury secretaries droned on about the dangers of our teetering world economy, BIO’s President and CEO, Jim Greenwood said lawmakers are bound for another “mother of all lame ducks” session, and that they will just kick the problem cans down the road beyond the next presidential election. So, we should just accept that more growth time will be wasted as politicians fight for power and bicker ad nauseam? Private business wouldn’t have the luxury of government. Do, or die.
• I was also pretty shocked during that keynote to turn around and see that more than two thirds of the luncheon’s 2,300 attendees has slipped out before the speakers finished. It always happens near the end of talks, but the en masse exit was embarrassing. Are people just numb to economic woes? Bored? One guy near me threw his head back for a nap and snored freely until nudged.
• On Wednesday morning BIO released a survey of Americans and biotech execs about the state of biotech with some unsurprising answers: Everyone remains optimistic about the future of the science, but dismal about regulatory burdens and a weakened economy. Most interesting was that more than half of the execs said they’ve been approached by foreign governments or foreign business development organizations to move operations and jobs overseas. Who can afford to ignore the offer of desperately needed funding support?
• As Greenwood said, we’re at an obvious critical crossroad. We risk losing America’s leadership in biotech innovation. And it’s happening right now.
• Looking back to a 2007 BIO survey, almost two-thirds of industry execs said regulatory burdens were their biggest worry. In 2012, it was virtually the same (55 percent in 2007, compared to 62 percent in 2012). No progress. Nada. In 2007, 9 percent said taxes were a top challenge for the next decade. This year 27 percent rank it as a critical issue.
• Sen. John Kerry (D-Mass.) was a no-show as Wednesday’s keynote luncheon speaker. Greenwood said he had more important obligations in DC. I’m glad he’s staying on the job, but I hope he’s using some of that time to do something for biotech.

I’m not trying to be a buzzkiller at biotech’s biggest party. And I don’t have the answers to the governmental gridlock that’s stifling industry growth and encouraging moves to other countries. Instead, I’m patriotically appealing to all of the 17,000+ attendees to use the power of the democratic process to lean on our lawmakers and not acquiesce to what currently seems like America’s inevitable stumble as the leader in biotech drug development. Naïve? Maybe. Ever hopeful? Absolutely.

But that’s not to say BIO 2012 isn’t a numbers game of the highest order. If you’re one of the more than 17,000 estimated attendees at this year’s conference, you’ll need to have your ducks in a row to navigate in orderly fashion.

The volume of participants associated with BIO is on display around the convention center and practically shouted from the rooftops of Boston. Sixty-five countries represented! Nearly 2,000 exhibitors! More than 150 presenting companies! And 25,000 partnering meetings over four days! That doesn’t even count the 1.7 million square-foot Boston Convention and Exhibition Center, 28 official event hotels, eight shuttle bus routes, dozens of vendors and hundreds of volunteers.

The J.P. Morgan Healthcare Conference may have more panache, but nobody turns out the biotech crowd like BIO.

Still, the numbers that really matter to attendees are the ones they struggle to keep in their heads while dashing between meetings juggling cell phones, laptops, backpacks and the ubiquitous coffee cups. Was that 9 a.m. partnering meeting in cubicle A157 or B175? If you transpose those digits, you could wander aimlessly for hours through the sea of indiscriminate gray cubicles.

The same goes for the massive exhibit hall, lined in no particular order with booths ranging from modest to monstrous. (“These guys really have no money to do a deal?” mused a biotech exec reckoning the cost of one gargantuan display.) Aisles are numbered by the hundreds and marked with massive overhead signs, and fortunately each booth number is posted on the floor – 1357 for those looking for the staff of BioWorld Today.

Then there are the keynote luncheons (two), super sessions (six) and breakouts (125) organized by track (14). But double-check room numbers. If you go searching for 205 when a session is actually scheduled for 250, you’ll find yourself walking in circles and miss half the presentation.

At the end of the day, remember your bus number and boarding station unless you’re willing to cool your aching heels in the taxi queue. Once the last freebies of the day are dispensed in the exhibitor booths and partner pavilions, the line for a taxi can stretch halfway around the exhibit hall.

Even then, the calculations don’t end. There are BIO-sanctioned receptions, invitation-only parties and hospitality rooms galore. At some point you’ll need to tally the people you’ve met, business cards you’ve exchanged and potential deals you’ve arranged. And before you know it, you’ll be planning for the next BIO International, which will take place in Chicago April 22-25, 2013.

Come to think of it, that’s just 10 months away, so start counting.

It started off innocently enough, as I passed by the New York pavilion – “Whadda you lookin’ at? Take a friggin’ ink pen and move on! I’m workin’ here! You’re blocking the aisle – I got customers.”

On to the California booth . . . “Trade your business card for a free sample? It’s the legal medi-juana right here. All you have to do is say the magic word: glaucoma! And chase it with our patented CIRM stem cell martini!”

The China pavilion was easy to spot, as it keeps getting bigger every day – by about an 8 percent growth rate! Its emergence was pushing the Japan pavilion just enough to put their backs against the East wall and the Europe exhibition area into the general vicinity of the toilet. And if the conference exhibition hall doesn’t close precisely on time at noon Thursday, China’s spread could even start shanghaiing the U.S. state pavilions. All this respect without a single company in top 50 biopharma list?

The reimbursement lobbyists, drunk with power, had just taken over Regulatory Row and evicted the FDA from its booth, when I overheard this FDA conversation:

“Let’s set up over there – in the vacant obesity market space. I don’t believe they will be coming this year, since we burst their bottom line bubble.

“Dr. Labyrinthine, would you get together with Dr. N. Terminable and Dr. Persnickety to draw up a guideline to facilitate the pathway to the new location? We may have to petition BIO to extend the conference another few weeks while we meticulously plot the most efficacious course of action.”

People were looking for the Amgen booth, but there was just an empty space on the exhibition floor where it was the day before. No, it wasn’t the bio-rapture – Novartis had just pulled off the most bullish takeover in history, acquiring Amgen in the middle of the convention, and having the Teamsters move Amgen’s booth inside theirs.

Then, exactly 200 years to the June 18 declaration that made the War of 1812 official – all Bio-Hell broke loose as Revolutionary War II was ignited . . . Novartis’ bold move had lit the biopharma fuse. The Big Pharma Immortals had had enough of playing nice and finally turned on one another in a donnybrook the likes that hadn’t been seen in Boston since the 2004 Red Sox-Yankees American League Championship Series.

They flooded BIO’s registration booth with emergency registrations for all their lawyers, black ops fixers, etc., assembling the strike teams to battle outright for supremacy in ruling the new millennium biopharma world. BIO, of course, set a new attendance record that would easily offset the damages to the convention center.

The regulatory overlords tried to stop the madness, but it was only then they finally realized “because I said so” and “I’ll think about it” were no longer effective weapons.

Well, this started the Great Biopharma War of 2012. By the time the large molecule dust had settled, there were only 13 colonies, errr, booths left. Into the broken concrete floor, they staked RXBIG battle flags that bore the rugged symbol monickers of JNJ, PFE, ABT, AZN, LLY, GSK, BMS, RHHBY,  NVS, SNY, MRK, TEVA and TKPHF. Rebels such as Bayer, Novo Nordisk and Boehringer Ingelheim went underground until they could breach the $15 billion-plus large-cap war chest list).

The rebels tried to take the Underground Biopartnering Railroad to seek asylum behind the BRIC Wall, but were met at its perimeter by government forces, armed with compulsory licenses, in litigation formation, under a sign that read “Bring us your tired (personnel), your (cash-)poor (R&D) – but be prepared to leave your IP at the border!”

Meanwhile, the Immortals began negotiations to explore the benefits of merging into one international corporate behemoth, named BioPharMonster Inc., that would hold the health of all humanity hostage.

The Pharma Un-Civil War was a reality, as the seductive forces of biotechnology had done what the competition, regulation and consumer frustration had been unable to do for more than a century: unhinge pharma’s cool.

The floor space (as well as the market space) had been pharma-fied, but there was a small skirmish that was still garnering attention, as several generics makers were mounting a nominal attack on the big pharmas from the rear, with the cry, “Give me biosimilars or give me death!”

In the end, Pfizer, patently fighting off a $10 billion bad mood, still emerged as the revenue victor despite the offensive charge financed by Novartis’ cache of 15 approvals in 2011.

Roche’s booth was afire, but Roche just unshackled Genentech in the clinic by commissioning its biotech enforcer to run amok: “We’ll need to replenish our arsenal and war chest, so, “Genentech, SMASH!”

Wake up, Michael – it was only an allegory! Still, I dread sleeping tonight, lest I suffer a relapse in the forecasted heat wave that starts tomorrow!

No litigation allowed – it’s only a dream, right?

Wear comfortable shoes. Leave the fancy Italian loafers and stilettos at home. You’re going to be doing A LOT of walking. Trust us on this.

To avoid groan-inducing BioClichés, take a refresher course in what NOT to say. Yes, we dusted this one off from last year because people tend to forget and fall back into the same ruts.

Bring your clone. If only you had a doppelganger to rove the exhibit hall and a daytime you to navigate the session and partnering zones of the demanding bi(o)athlon attendee region, you could carouse the party scene as primetime you and cut your foot miles in half! Cloning . . . biotech can do that – can’t it? Because, you probably wouldn’t have any ethical issues with that for this week!

Learn the Bio-centric variation of Rock, Paper, Scissors. Use your non-cell phone hand to play, in order to get through that over-your-head roundtable discussion or while waiting in the free wine line on exhibitor reception night. Makes a great networking icebreaker, too!

- Innovation creates Products (Indomitable Fist)

- Products generate Revenue (Thumbs up)

- Capital buys Innovation (Open handshake)

Pick up your badge early, if possible. It’s also a good idea to familiarize yourself with the convention hall before you’re racing to a last-minute meeting. The Boston Convention & Exhibition Center might seem more compact than the sprawling McCormick Place in Chicago (where many of you recently spent a frantic ASCO weekend), but getting lost in the 1.7 million-square-foot facility will cost you precious time – and add unnecessary foot fatigue.

Use the proper Twitter hashtag. The two most important ones: #BIO2012 and #BioWorld.

Bring a Chowdahrometer, to gauge which local establishment truly makes the best clam chowdah.

Queue up early. If you’re looking forward to the keynote luncheons, make arrangements to get in line early because the lines will snake around the convention center for miles.

Support the pharmaceutical industry. Remember to pack some aspirin, maybe even some Blowfish tablets. The parties at BIO can be legendary, and you don’t want to miss that early morning meeting due to a hangover.

Study up on your Boston English. Here’s a good guide. For instance, don’t worry about those disappearing “Rs.” They usually show up later, i.e. “Open the desk draw for some paper, so I can drawr you a map.” If someone offers you “clam chowdah,” say yes. If they call you a “chowdahead,” that’s not a compliment in Beantown. (Also, you should probably not refer to Boston as “Beantown.” We’ve heard that locals don’t care for that moniker.)

Did we say that you should wear comfortable shoes? We can’t stress this enough.

Support the medical device industry. Pack a shoulder replacement for when the briefcase or bag loaded with a laptop, handouts, etc. gets too heavy.

Make an appointment with a personal masseuse for the end-of-the-day wrap. Go ahead, indulge. You deserve it. And surely you can find some way to write it off.

Bring a universal translator to wade through the financial, legal, regulatory and scientific terminology-speak.

Pack your mental Rolodex, one with automatic face-recognition prompts for all those people you’ve met at previous conferences.

Don’t forget the freakin chargers! For smartphones, laptops, iPad, the razor, the toothbrush and you.

For newbies and seasoned veterans alike, bring dark glasses to hide that dazed look.

Speaking of newbies, this is BioWorld Staff Writer Marie Powers’ very first BIO meeting and says she feels like Gretl from the Sound of Music: “It will be my first party!” Marie’s starter kit includes:

- A re-emphasis on, guess what? Flats only for women, though she deftly adds a package of moleskin.

- Sunglasses and trench coat for the Boston weather extremes.

- Communications gear out the wazoo. (phones, cameras, digital recorder, GPS, netbook, iPad, laptop . . . ) Marie says, “I’ve heard Arianna Huffington works five (!) cell phones. It’s a good thing she doesn’t cover biotech. I’m stickin’ with one.”

- Business cards. Yes Gretl, they still make those paper cards even if recipients will just scan them in and convert/add to their electronic contacts list.

- Tums!

Bring your personal podiatrist. (If you didn’t listen to us about the shoes . . .) This could be covered under preventative care by your carrier until around noon Monday, but once your feet start to shut down in early afternoon protest, it should be claimable under routine care for the rest of the week. Besides, he may accompany and treat you gratis, given his potential for walk-up business!

Ear plugs might help. BIO is a cacophonous event. Next to the feet, ears get the most grueling workout and they also serve as the entry point for most end-of-day headaches. Either you’re making noise or you’re subjected to it: non-stop cell phone chatter, 30,000 shoes clacking, the clamor of 5,000 booth hawkers, the din of flash mob networking and a hysterical Siri vociferously trying to comprehend and resolve 10,000 bio-speak requests.

Don’t forget the calorie counter, as you eat and drink your way through BIO fare. How many crab cakes can you eat in a week?

Pick up a commemorative BioWorld BIO 2012 Boston hat to wear to a Red Sox game Thursday night. Find us at booth #1357 in the exhibit hall.

Remember to look up. C’mon, your emails can wait a nanosecond or two. Make a new friend live and in person. You can trade numbers and emails and start texting later.

Finally, grab a Freedom Trail map. Go ahead, play hooky for an hour or two and trace 250 years of American history.

On Business

“Biotech is all about picking the exception. Granting access to capital to everyone doesn’t strike me as the right idea.”

‑ Bob More, general partner with Frazier Healthcare Ventures, taking an optimistic view on capital constraints. Private biotechs continued to struggle in 2011, raising about as much money as in 2010.

"I think we're going to see a regression to quality."

‑ Jim Healy, general partner at Sofinnova Ventures, on how the venture contraction will mean that only the highest quality companies get funded. Several venture groups pulled out of biotech investing during 2011.

“The take-home message is that it’s easy to build a $25 million company with $100 million cash.”

‑ Tillman Gerngross, CEO of Adimab LLC, on the trend of sliding valuations post-initial public offering. Although a handful of biotechs went public in 2011, the window did not open as wide as some had hoped.

"You can't save your way to success in this business."

‑ Marina Biotech Inc.'s CEO Michael French on the tough financial choices small biotechs must make, such as accepting harsh terms to keep a company moving forward.

“Monday, I was in Chicago, presenting at ASCO. Tuesday, I’m in California, pitching at Goldman (Sachs). And Wednesday, I’m in New York, presenting at Jefferies. How many red-eye medallion miles does it take to get one deal?”

‑ A jet-lagged biopharma CEO, taking a break at the Jefferies 2011 Global Healthcare Conference, and illustrating just how hard biotechs had to work to close financings and partnerships in 2011

On Science

“What happens when the next 10 patients you see require eight different drug combinations based on the mutations in their tumors?”

‑ Outgoing ASCO president George Sledge, on the exponential increases in complexity required to tackle “chaotic” tumors with high mutational load. Personalization of medicine continued to be a theme at ASCO and AACR in 2011.

"You do have to be somewhat of a Talmudic scholar to prescribe this drug."

‑ Lawrence Friedman, member of the FDA Antiviral Drugs Advisory Committee, referring to the regimen for Merck & Co. Inc.'s hepatitis C candidate boceprevir. His comments illustrate the difficulties of putting more personalized treatment regimens into practice.

"The fact that it's inefficient doesn't mean it hasn't made great contributions."

‑ John Mendelsohn, president of the M.D. Anderson Cancer Center, on the National Cancer Institute-sponsored collaborative clinical trials program

“It disturbs me that people are willing to accept this: treating the symptoms and allowing the disease to progress.”

‑ Jerry Colca, president and chief scientific officer at Metabolic Solutions Development Co., on new diabetes drugs

“For every target, almost every company has an inhibitor against it. Medically, as well as economically, we truly need something to get beyond that."

‑ Chiang Li, CEO of Boston Biomedical Inc.

General Wisdom

"A lot of innovation is incremental, not breakthrough."

‑ Glen Giovannetti, global biotechnology leader at Ernst & Young

“I realize it’s absurd to talk about 10Xs or even 5Xs these days.”

‑ Roger Longman, CEO of Real Endpoints LLC

“A combination of good science, good collaborations, good timing and some good luck.”

‑ Mace Rothenberg, Pfizer Inc.’s senior vice president of clinical development and medical affairs in the Oncology Business Unit, on the secrets to the success of lung cancer drug Xalkori (crizotinib)

"You can only set yourself on fire once."

‑ Oleg Nodelman, partner at Biotechnology Value Fund, referring to how pharma stocks tend to jump when they severely cut R&D budgets

"Clearly, there are easier and less insane ways to make a living."

‑ Jim Greenwood, BIO president and CEO, at the BIO 2011 keynote luncheon

I admit it is frustrating to write about companies that are launching yet another Phase III study, because they claim their drug’s “really going to work this time.” And the skyrocketing drug development costs are one reason my fellow Americans and I are paying a fortune every month for health care.

During a Tuesday plenary session, some even asked why biotech can’t operate as efficiently as the technology sector, where seemingly bad ideas are scrapped before they can gain too much financial traction. That doesn’t sound like a bad idea, right? Let’s turn drug development into a factory-like process: advance programs quickly and kill the ones that don’t immediately perform.

In other words, take the go-no go decision out of the hands of the people who invented the drug or the people whose jobs are tied to its success. Create a dispassionate drug development process.

But as BIO’s John Craighead noted, “’dispassionate’ is not a very good word for this industry in general,” and I would have to agree.

Biotech has been built on the backs of scientists working long hours and executives who sometimes seem to champion a drug through the development process by sheer will alone, convincing investors to take a risk on a new – and therefore risky – invention. And more than one biotech has relied on funding from its own founders either to establish the firm or keep it afloat during tough times.

Yes, at the end of the day, the data are what counts. But to get to that data, sometimes there needs to be an extra little push along the way. Because innovation has never been easy.

And this isn’t the technology industry. Biotech isn’t obsessed with making cell phones that can communicate with Mars or a laptop that can fit inside your pocket. Biotech is working on medications that could improve lives or extend lives, possibly even save lives.

So maybe it’s all right to get a little passionate now and then.

Currently there are about 246 drugs in short supply, and that number has risen steadily since 2006. Severe drug shortages are endangering cancer patients, heart attack victims, accident survivors and others. Many people hold the FDA largely responsible for the problem.

FDA’s Rules as a Pebbles in the Innvation Stream
According to a summary report, several drug shortages are the result of “actual or anticipated action by the FDA as part of the Unapproved Drugs Initiative, which is designed to increase enforcement against drugs that lack FDA approval to be marketed in the United States,” those that were available before the Food, Drug, and Cosmetic Act: of 1938 was passed. Manufacturers are balking at “the cost and complexity of completing a New Drug Application (NDA),” as well as “the time for FDA review of Abbreviated New Drug Applications (ANDA) and supplemental applications.” Another major cause cited for the drug shortage was “inability to fully comply with GMP, which results in production stoppages or recalls.” The summary report was prepared by the American Society of Health-System Pharmacists, the American Society of Anesthesiologists, the American Society of Clinical Oncology and the Institute for Safe Medication Practices.

John Goodman at the Health Affairs Blog said “the FDA has been “stepping up its quality enforcement efforts — levying fines and forcing manufacturers to retool their facilities both here and abroad.” The “more rigorous regulatory oversight” has not only slowed production, but also, “the FDA’s ‘zero tolerance’ regime is forcing manufacturers to abide by rules that are rigid, inflexible and unforgiving.”

Economist Michael Mandel also cited rules and regulations as impeding innovation: “No single regulation or regulatory activity is going to deter innovation by itself, just like no single pebble is going to affect a stream. But if you throw in enough small pebbles, you can dam up the stream.”

Biotech Drugs Are a Different Breed (and Breeding Ground)
For biotech drugs, the problem of drug shortages is even more critical, and complex. According to an article in Nature:

Unlike the manufacture of small-molecule drugs, which typically relies purely on large-scale chemical synthesis, biomanufacturing usually involves massive cultures of live cells maintained in rich, contamination-prone media. Anyone who has struggled to keep a 1-litre laboratory cell culture sterile will appreciate the challenge of doing the same for a 10,000-litre reactor. Viruses are stealthy intruders and can lie undetected in a culture for weeks, while the infected cells move down the pipeline to spread the scourge through the manufacturing facility — into those 10,000-litre reactors and through million-dollar chromatography columns This means that viral contamination can shut down drug production for months and cost a company millions of dollars, interrupting drug supplies and leaving patients vulnerable.

At least 17 incidences of viral contamination in biologics have been reported, but many more have gone unreported, according to Nature.

According to the Biotechnology Industry Organization (BIO), the 10,000-liter tanks in sterile manufacturing facilities cannot be built fast enough to keep up with patient demand. In addition, pharmaceutical industry experts believe that since it takes three to five years, and about $450 million, to build a biotech facility, in order for biopharma companies to be prepared to meet the overwhelming patient demand, they would have to make risky investments before receiving FDA approval.

Solutions Sought in Research, Switching to Different Manufacturing ‘Plants’
Researchers at the Massachusetts Institute of Technology, of Cambridge, Mass., are forming a consortium with industry to draw lessons from contamination data that could benefit the industry as a whole, and to publish answers to questions, such as where viral contaminants originate and what the best way to detect and eradicate them is, or how to prevent them altogether. Currently, only six companies have signed up to participate in the pilot phase of the study. Organizers hope that more biotechnology companies will “embrace this rare and valuable opportunity to pool resources without compromising their business interests.”

One solution proposed by BIO is using plants to produce therapeutic proteins. According to a fact sheet:

Traditional methods of producing pharmaceutical materials using microbial fermentation or animal cells are limited by the time and money necessary to build the required manufacturing facilities, and production is limited to manufacturing capacity. It can take a total of five to seven years from laying the first bricks of a traditional biotech facility to extracting pharmaceutical proteins from cultivated cells.

BIO claims that it will “cost significantly less to grow plants with the ability to mass-produce pharmaceutical proteins because plant-based techniques don’t require the same costly capital investments.” In addition, such plant-made production can be expanded more easily if demand for a drug increases. Since “plants are renewable in nature and can produce pharmaceutical proteins within a single growing season, production can be quickly scaled up to meet patient needs.”

Whether drug shortages are caused by the process of producing the drugs, the procedures for approving them or both, it would behoove manufacturers and government officials to engage in dialogue to analyze the problems and attempt to find solutions. Time-consuming, expensive procedures for making biotechnology drugs and lengthy approval procedures are likely to continue, but technology and cooperation can be valuable allies in finding solutions.

By Ilene Schneider, BioWorld Perspectives Contributing Writer

Check out our interview with Nigel Gaymond, the chief executive of the UK’s BioIndustry Association, in which he lays out the state of the UK biotech sector.

We also chatted with Keith A. Katkin, president and CEO of Avanir Pharmaceuticals about his company’s newly approved drug Nuedexta, the first and only FDA-approved treatment for pseudobulbar affect.

BIO’s President and CEO, James C. Greenwood, shared BIO’s legislative goals.

We also posted video of BioWorld’s session, Starting up Biotechs in the New Normal World, featuring a lively discussion about the post-2008 world of venture financing by panelists Stuart Collinson, CEO of Tioga Pharmaceuticals Inc.; Walter Ogier, president and CEO of Acetylon Pharmaceuticals Inc.; Art Pappas, managing partner of Pappas Ventures; and Edward Tenthoff, senior research analyst with Piper Jaffray Ventures.

But that’s just a handful of our video offerings. We stopped dozens of conference attendees in the hallways to get their thoughts on the #BIO2011 experience. Check out the full playlist to relive the misty watercolor conference memories (sorry!).