In recent weeks, there’s been a lot of new discussion around the biotech labeling debate.  On May 10, the International Food Information Council (IFIC) released its latest “Consumer Perceptions of Food Technology” survey, which showed that very few Americans cite biotechnology as an information need on food labels.

Earlier this month, the California Right to Know initiative announced at various rallies held around the state that it had collected the prerequisite number of signatures to get its proposal on the November ballot. The initiative would require biotech foods (also known as Genetically Modified Organisms, or GMOs) and foods containing GMO ingredients to be labeled.

A number of mainstream media outlets reported on the California activity. Andrea Billups’ piece in the Washington Times and Jack Kaskey’s article for Bloomberg nicely sum up why the broader agriculture and food manufacturing community is opposed to the measure:

The California campaign is the best chance for biotech labeling in the United States after the failure of similar bills in 19 states and the rejection of a petition to the Food and Drug Administration last month.

But the California voter initiative is likely to meet fierce resistance from agricultural and business interests, who predict it will prove costly both for growers and consumers. Opponents warn the measure constitutes a “right to sue” initiative that will undercut sales of numerous food items that have been consumed safely for years.

Monsanto opposes labeling modified ingredients because the move risks “misleading consumers into thinking products are not safe when in fact they are,” said Sara Miller, a Monsanto spokeswoman.

The initiative is a “back door” way to hurt the $13.3 billion biotech crop industry, according to Richard Lobb, managing director for the Council for Biotechnology Information. The Washington-based council represents Monsanto and five other biotech-seed developers. “They basically are trying to scare consumers through labeling,” Lobb said in a telephone interview. “The obvious objective is to push biotechnology out of the market altogether.”

Biotech labeling has never been endorsed by the FDA. The agency says crops engineered to tolerate herbicides or produce insecticide pose no greater health risks than conventional foods.

The California Farm Bureau opposes the ballot initiative, along with the California Chamber of Commerce, the California Seed Association, the California Grain and Feed Association, and California Women for Agriculture.

Jamie Johansson, vice president of the California Farm Bureau and an olive farmer from Oroville, Calif., said the initiative puts an enormous burden on growers and packagers, and it prevents any processed food from being labeled as “natural.”

An apple, for example, wouldn’t require a label, but it would if it were ground into apple sauce. The same for almonds: They are fine picked raw, but ground into almond butter, even without any other ingredients, they would not pass the test under provisions of the proposed label law.

Food labels should be reserved for “critically important food safety and nutritional information,” said Brian Kennedy, a spokesman for the Grocery Manufacturers Association, which opposes the California initiative.

The California proposal would mandate a label for foods in which more than 0.5 percent of the product is a genetically modified ingredient. The proposal exempts meat, dairy foods and beer.

The label “would be the equivalent of a skull and crossbones” that would drive away customers and force food producers to stop using engineered ingredients, Joseph Mercola, the labeling initiative’s leading funder with $800,000 in donations, said. Mercola is an osteopath who promotes natural remedies at his clinic in Hoffman Estates, Illinois.

Martina Newell-McGloughlin, director of the University of California Systemwide Biotechnology Research and Education Program, called the labeling proposal “completely blown out of context.”

“To me, the issue with this as a scientist is you are focusing on the labeling of process rather than the labeling of product,” she said. “The issue for safety should be on the product itself if you are going to look at risk-assessment and whether something should be of concern to the consumer.”

“You don’t have a label on sausage telling you how they are made and you probably wouldn’t want one. For biotech products, the issues are an individual’s right to know. If you were going to ask to supply all information made on a processed crop, you’d have a whole encyclopedia attached to everything on your grocery shelf.”

Chris Shaw, a New York-based analyst, said labels identifying genetically modified organisms, or GMOs, won’t change most consumers’ buying decisions. “People who are buying Oreos aren’t going to care if there is GMO soybean oil in there,” Shaw said. “It’s going to be a marginal group of people that will care.”

That’s the consensus of consumers who participated in the IFIC survey.  Seventy-six percent of respondents could not think of any additional information (other than what is already required) that they wish to see on food labels.  Of the 24 percent who wanted more information, only 3 percent (or about five people and less than 1 percent of all surveyed) wanted more information about biotechnology. In addition, 87 percent of Americans say they have not taken any action out of concern about biotechnology.

IFIC President and CEO David Schmidt said the strength of the methodology used in the IFIC survey sets it apart from other surveys looking at food technology issues.

“In the public landscape, we often see polling that tries to provoke or frighten people into giving a certain desired response,” Schmidt said.  “We don’t believe in leading consumers to any conclusion.  We believe our open-ended methodology used at the beginning of our survey provides a more accurate view of concerns on Americans’ minds, and the survey is the most objective and long-term publicly available data set on U.S. consumer attitudes toward food and agricultural biotechnology.”

The survey, formerly the “IFIC Survey of Consumer Attitudinal Trends toward Food Biotechnology,” is part of a series that has been conducted since 1997.

We’re very pleased to announce the Buzz of BIO Winner for the 2012 contest of the BIO International Convention. You voted for your favorites, and it was a tight, interesting race! As such, we’re pleased to introduce you to our winner for the Pipelines of Promise category.

Deuteria Pharmaceuticals, Inc,. who focuses on improving the product profile of approved drugs through ‘chiral switching’, won the Pipelines of Promise category. From Dr. Sheila DeWitt, the company’s president, “As an emerging company with a pioneering approach to therapeutics, Deuteria Pharmaceuticals is pleased to be recognized as a Pipeline of Promise company by the premier conference in the biotechnology industry. This recognition from BIO 2012 provides and strengthens the visibility of Deuteria Pharmaceuticals.” View their website here.

You’ll definitely be seeing these folks around the International Convention. Be sure to look for them in the One-on-One Partnering System, plus, they’ll be giving a presentation in the BIO Business Forum.

Thanks to everyone who participated!

This June, thousands will gather in the biotech hub of Boston!

One of the things the team has been hard at work on, is the online community of myBIO, as those who have attended the Convention in the past will recognize. It’s a very handy, interactive tool that allows you to track companies, communicate with other attendees, and get a bird’s-eye view of all the different events going on. As a registrant, you even have your own profile that can include your photo, your company’s website, and your own social media accounts, like LinkedIn and Twitter feeds.

For those who are completely new to the event, we thought we could dig in to some of the differences between myBIO, and what BIO One-on-One Partnering™ is. Here’s a brief run-down of some topics, the details of which will be discussed further into the post.

Now let’s go into this in more depth.

Number 1:  What’s the difference between a personal event planner, and a meeting scheduler anyway? Essentially, you should use myBIO to plan your day around the events at the BIO Convention, such as the breakout sessions, keynotes, happy hours and so on. Think of it as Google Calendar, with a little Buzz thrown in. myBIO is not the platform that’s used to schedule private meetings with other companies and attendees. After all, the One-on-One Partnering System is all about that: Partnering. So One-on-One Partnering is what you use to send meeting requests to companies you otherwise wouldn’t have access to, and where you can let others know about your products or exciting additions to your pipeline.

Number 2:  How do I know if I have access to myBIO or BIO One-on-One Partnering? Will I know the difference? Yes, you will! If you’re coming to the BIO International Convention, you’re automatically given a myBIO account. It’s just a part of the registration process. In fact, profile details are taken directly from the information you provide during registration, so you don’t need to sign up for it.

One-on-One Partnering on the other hand, because it provides exclusive access to companies, is a separate designation when Registering. If you’re interested in the Business Forum, you must choose either the “Full Convention Access & Partnering” or the “Convention Access & Partnering” Registration Packages. Or if you’re an exhibitor, you would have received information regarding Partnering when registering your booth personnel. Another way to know: if you have it, we’ll send you login info for it, plus details, and step-by-step instructions on how to use Partnering effectively and successfully.

Number 3:  Okay, let’s say I’m signed up for both. Then how do I get to myBIO? And how do I get to One-on-One Partnering? myBIO is always accessible through the main Convention website, at convention.bio.org/mybio

To access BIO One-on-One Partnering, just visit the link in the email that contains your login credentials or go to: oneononepartnering.bio.org/BusinessForum2012. Plus, there are multiple ways to log in from the Convention website that will take you to this page, too.

Everything about Partnering is contained within the One-on-One site. So if you want to send a meeting request, if you want to see your calendar of meetings, when and where — the One-on-One Partnering System is your one-stop shop. You can also add notes to your delegate meeting calendar.

Number 4:  Tell me more about the differences between these two profiles. Think of it this way: the One-on-One Partnering System provides a detailed overview of all the participating companies and who and what they are, while myBIO is more of a look at the individuals within those companies and the events their participating in.

Those who are Partnering at the event will also receive emails from us, reminding you to publish your profile before our deadlines. It’s an easy process, but actually clicking the Publish and Save buttons on the site is important.

This allows your company to be fully visible and searchable in the Partnering System, which also tends to get companies more meetings. And if you’re ever unsure about which profile needs updating, you can always just follow the link we provide you in these emails.

Questions? Comments? Let us know!

By Richard M. Dolinar, M.D., Chairman, Alliance for Safe Biologic Medicines

In today’s budget-constrained world, the goal for health care is not only to save lives but also to save money. On Friday, May 11, the Food and Drug Administration (FDA) will hold a one-day public hearing on important medicines, known as biosimilars, that are under FDA consideration to come to the United States (U.S.) and offer the opportunity to help achieve the second prong of the health care goal: to save money. However, similar to any new medicine approval, patient safety must be paramount.

Biosimilars are attempted copies of innovative biotech medicines that have been available in the U.S. for a number of years. As members of the biotech community know, biologics have revolutionized the treatment of many serious and life threatening diseases in the short history of this industry. Biosimilars offer the hope of bringing life saving biologic drugs from the bench to the bedside in a cost effective manner and serve as another tool in the toolbox of healthcare providers. Unlike traditional pharmaceutical drugs that are made from chemicals and have structures that are well characterized, most biologics are made from living cells, with highly complex structures that are not easily understood, characterized or replicated. As a result, biosimilar medicines differ from generic drugs in that they are “similar to” but not exact copies of the innovator drug they attempt to replicate.

In 2010, the Patient Protection and Affordable Care Act (PPACA) granted the FDA the authority to approve biosimilars. Later that year the agency began consulting with patient groups, physicians and industry to exchange information that would eventually lead to the approval of biosimilars in the U.S. A few months ago the FDA took the first concrete step to create a pathway and issued draft guidance. The public hearing on Friday will allow stakeholders to provide testimony in response to the draft guidance and I am honored to be able to speak on behalf of the Alliance for Safe Biologic Medicines (ASBM).

In addition to my day job seeing patients as a practicing endocrinologist, I serve as the Chairman of ASBM, an organization that is working to raise awareness of biologics and biosimilars, as well as the important steps that should be taken to ensure safe use of these important medicines.   Our organization is composed of diverse healthcare groups—from patients to physicians, medical innovators, and others who have come together to ensure that patient safety is at the forefront of the biosimilars policy discussion.  We were pleased but not surprised to see the FDA lay out a science-based approach in the draft guidance largely building on the foundation laid by the European Medicines Agency (EMA).

The EMA began to establish the first formal regulatory pathway for biosimilars in 2003 and has gathered much data over the past 8 years that can, at a minimum help inform the development of policy in the U.S.  Policy makers should take advantage of this opportunity to learn from their experiences, both positive and negative.

We must also acknowledge that are differences between the EMA and FDA approach most notably in the area of “interchangeability” where the FDA has the authority to designate a biosimilar as interchangeable with its reference product and the EMA does not. This difference is not insignificant for patients in the U.S. because in theory it could lead to biosimilars being automatically substituted for the originator product by the pharmacist without consulting the prescribing physician. In the draft guidance the FDA signaled that it is not ready to prescribe a path to interchangeability at this time, and instead indicated that additional guidance will be necessary to better understand the challenges involved.

Differences aside, there is much to learn from the EMA experience and we believe that it provides a solid blueprint for the FDA to follow. At a minimum, ASBM members believe that the FDA must require biosimilar manufacturers to conduct clinical studies and produce analytical data sufficient to reassure patients and doctors that their products are safe. We also believe that unique nonproprietary names must be assigned to all biologic therapies so that physicians and patients know what caused an adverse event if one occurs.  Finally, as a practicing physician it is imperative that doctors and patients should be able to carefully choose the best course of treatment rather than have legislators and regulators decide for them.

For nearly 18 months, ASBM has been working to educate the public and policymakers about the great promise that biosimilars offer to patients in the U.S. Our message has been relatively simple, making lower cost medicines available to patients should be a priority but their availability must come with the absolute assurance that they are first and foremost safe. Our organization and its members have written Op-Eds, conducted webinars and hosted policy forums to exchange information about the issues and challenges associated with biosimilars. I am proud of the work we have done but ultimately realize as the late great Karen Carpenter sang so many years ago “we’ve only just begun.”

You can find more information at safebiologics.org, find us on Facebook or follow us on Twitter @SAFEbiologics.

In the words of BIO’s Andrew Emmett, Managing Director, Science & Regulatory Affairs, ‘2012 is shaping up to be a momentous year for FDA reform.’ From the reauthorization of the Prescription Drug User Fee Act (PDUFA V) to modernizing and expediting the approval of new drugs and biologics, implementing the new biosimilars pathways and addressing the growing global drug shortage crisis, all eyes are on the current regulatory environment and its role in supporting innovation.

The 2012 BIO International Convention will return to Boston, MA and the Boston Convention and Exhibition Center, June 18-21, 2012 and will feature a breakout session track on regulatory issues.

Attendees can expect the Achieving Regulatory Approval and Compliance educational track to feature leading Food & Drug Administration (FDA) leaders who will share their prospective priorities, senior European medical agency executives discussing international and harmonization issues as well as major biotechnology and pharmaceutical companies exploring best practices and addressing questions.

With drug development a long and costly process, speakers will also address how companies can continue to innovate and attract investor capital.

Highlights include:

FDA Town Hall

Tuesday, June 19, 2:00 p.m. – 3:30 p.m.

Speakers: Karen Midthun, MD, Director, Center for Biologics Evaluation and Research, Food and Drug Administration (FDA) and Janet Woodcock, Center for Drug Evaluation and Research, Food and Drug Administration (FDA)

PDUFA V: Impact on Innovation, Patients, and Modern Medicines – Super Session

Wednesday, June 20, 3:30 p.m. – 5:15 p.m.

Moderator: Steve Usdin, Washington Editor, BioCentury, Co-host, BioCentury This Week

Speakers: Marc Boutin, JD, Executive Vice President and Chief Operating Officer, National Health Council, Peter Greenleaf, President, MedImmune, and Margaret Hamburg, M.D., Commissioner of Food and Drug Administration (FDA)

Analysis and Impact of PDUFA V: What Regulatory Affairs Professionals Need to Know

Tuesday, June 19, 8:30 a.m. – 9:45 a.m.

Moderator:  Janet Jenkins-Showalter, Senior Regulatory Group Director, Genzyme, A Member of the Roche Group

Speakers:  Andrew Emmett, Managing Director, Science and Regulatory Affairs, Biotechnology Industry Organization, Kay Holcombe, Senior Policy Advisor, Genzyme, a Sanofi Company, and Patrick Frey, Director, Office of Planning and Analysis, Center for Drug Evaluation and Research (CDER), Food and Drug Administration

Interchangeable Biosimilars: Distinguishing between Aspiration and Achievement

Thursday, June 21, 8:30 a.m. – 9:45 a.m.

Moderator:  Ramsey Baghdadi, Senior Editor, The RPM Report

Speakers: Erika Lietzan, Special Counsel, Covington & Burling LLP, Joseph Miletich, Senior Vice President, Research and Development, Amgen, Gregory Schimizzi, Co-Founder, Carolina Arthritis, Coalition of State Rheumatology Organizations and Jan Wyatt, Patient Advocate, Arthritis Foundation

Biological Product Pediatric Development in the US: Implementation of PREA and BPCIA

Monday, June 18, 3:45 p.m. – 5:00 p.m.

Moderator: Chin Koerner, Executive Director, Novartis Pharmaceuticals

Speakers: Barbara Buch, MD, Supervisory Medical Officer, Center for Biologics and Evaluation Research, Food and Drug Administration (FDA), Sharon Olmstead, Vice President, Novartis Pharmaceuticals and Karen Weiss, Vice President, Janssen Research and Development

To learn more about the Achieving Regulatory Approval and Compliance educational track and get the most up-to-date program and speaker information, visit http://convention.bio.org/program/.

Patent-Eligible Subject Matter after Mayo v. Prometheus: Exploring the Path Forward is a public round-table event hosted by the Biotechnology Industry Organization and the George Washington University Law School. Guest speakers at the round-table will discuss implementation of the Prometheus decision in patent prosecution practice, in examination guidance in the United States Patent Office, and in patent litigation.  Speakers will also discuss the implications of the decision on personalized medicine and possible ways forward.  Speakers include:

• The Hon. Paul R. Michel
• Richard P. Bress, Latham & Watkins
• Donald R. Dunner, Finnegan
• Raymond T. Chen, USPTO (invited)
• Q. Todd Dickinson, AIPLA (invited)
• Prof. Christopher Holman, UMKC
• Philip S. Johnson, Johnson & Johnson
• Seth P. Waxman, WilmerHale
• Hal Wegner and Andrew S. Baluch, Foley & Lardner
• Paul D. Yasger and Anat Hakim, Abbott Laboratories

Join us on May 16th from 2-5 PM at the Faculty Conference Center, Burns 5th Floor, George Washington University Law School, 716 20th Street NW, Washington, DC 20052.  A reception will follow the program.  For more information and to RSVP please email iplaw@law.gwu.edu with “BIO” in the subject line.

By Stuart Tart, Director of Development, Osteogenesis Imperfecta Foundation

Ten years ago, Greg and wife Leigh brought their new daughter, Mallie, home from the hospital.

Mallie

When she was 9 days old, Mallie was fussy, leading Greg and Leigh to discover that their baby girl had fractured her right tibia and fibula.  The new parents immediately took their daughter to the doctor, who advised them to take Mallie straight to the emergency room. They discovered that Mallie was born with osteogenesis imperfecta, a genetic bone disorder characterized by fragile bones that break easily.

“We were just absolutely frightened,” Leigh remembered.  “I am a nurse, and I don’t remember hearing any of this from nursing school.”

Osteogenesis imperfecta (OI) is a rare heterogeneous disease of connective tissue that affects 8/100,000, or about 30,000 persons in the United States. Although the cardinal manifestation of OI is bone fragility, this rare disease encompasses all body systems. A person is born with this disorder and affected throughout his or her lifetime.  Thus, an infant may be born with multiple fractures, or a child can break his arm and collarbone while putting on a T-shirt. Each fracture is as painful as the first!

Many children and adults with OI have multiple surgeries to try to correct bone deformities and straighten bones so they can live independently. Mallie had her first surgery when she was just 2 ½ years old! Rodding surgery is considered major surgery, and the Holmans knew that it would require their little girl to deal with an overnight stay at the hospital, a hip-spica cast for six weeks, and then months of physical therapy. This surgery was necessary to relieve the bowing in her legs and thus, to prevent osteogenesis imperfecta from stealing Mallie’s ability to walk. To make matters worse, the Holmans learned that Mallie would likely need to repeat the surgery every two to three years, depending on how fast she grows, to replace the rods with longer ones.

Mallie, who turned ten this year, is an excellent student, and she is active in a variety of activities, including swim team, golf, band and orchestra. Although she tries not to allow OI to slow her down so she can still just be a kid, Mallie recently fractured her forearm and reinjured her tibia in her lower leg. Her arm was so severely injured that she needed surgery to place two rods in her bones.  Even though this was her fifth surgery in eight years, it was still an extremely frightening and traumatic experience for her.  After a brief overnight stay in the hospital, Mallie was home and showing off her unbreakable spirit.

The Role of the OI Foundation

The Osteogenesis Imperfecta (OI) Foundation provides information and resources to parents, doctors, educators, and adults with OI; organizes the National Conference on OI for families to gain the medical, research, and coping information they need (to be held in July this year); and advocates for increased funding from the National Institutes of Health, foundations and corporations.

The Foundation also funds groundbreaking research, including the multi-site Longitudinal Study of OI, which is tracking the health of 500 children and adults with OI for 5 years. The goal of the study is to develop a more detailed picture of osteogenesis imperfecta across a lifespan and to improve the level of care.

Build Awareness and Improve Lives!

The OI Foundation is hosting its second annual National OI Awareness Week from May 5-12, 2012. Awareness Week is a week-long event designed to educate communities across the country about osteogenesis imperfecta. National OI Awareness Week is held in conjunction with Wishbone Day on May 6, an international community awareness effort.

Hundreds of volunteers have planned fundraising events, secured proclamations from their city and state officials proclaiming May 5-12 ‘OI Awareness Week’, and are distributing educational materials throughout their communities.

Excitement for this year’s Awareness Week is growing—just last month, the City of Rochester, NY proclaimed May 5-12, 2012 ‘Osteogenesis Imperfecta Awareness Week’!

Awareness efforts like National OI Awareness Week help educate the greater community, leading to additional funding towards research programs and vital information and resources for our caregivers, doctors, nurses, teachers, and the OI community.

For more information or to donate, please visit our website.

Together, we are creating a better future for children and adults living with OI!

By David Saravitz, Alston + Bird

Day 2 of the 2012 BIO Intellectual Property Counsels’ Committee (IPCC) Spring Conference kicked off with a panel on the America Invents Act (AIA).  The panel focused on how practitioners and the U.S. Patent & Trademark Office (USPTO) are dealing with various provisions of this new patent act.

Mr. Ira Finkelstein, Senior Patent Counsel with Baxter Healthcare, led off the session initially discussing the first-inventor-to-file provision of the AIA (§ 3) which becomes effective on March 16, 2013, and the interplay of its one-year grace period for public disclosures by an inventor.  Mr. Finkelstein reminded the audience that in most foreign countries a pre-filing, public disclosure by the first inventor would be disqualifying prior art.  Thus, Mr. Finkelstein concluded that his strategy is: “Don’t rely on the grace period. File early, and file often!”

Mr. Finkelstein also discussed the best mode requirement of 35 U.S.C. § 112, first paragraph.  Mr. Finkelstein pointed out that § 112 still requires an applicant for a patent to disclose the best mode contemplated by the inventors and that he will continue to require his inventors to disclose the best mode in patent applications. According to Mr. Finkelstein, it is likely that this information will need to be in the disclosure anyway, to support claims to narrow, dependent claims.

Dr. Murray Spruill, Leader of the Alston & Bird’s Biotechnology, Chemical and Pharmaceutical Patents Group, took the podium next to discuss “Post-Grant Proceedings.”  Dr. Spruill pointed out that a defendant in an infringement lawsuit older than 1 year after the patent owner files a complaint alleging infringement of a patent needs to decide whether to bring an inter-partes challenge against the patent in USPTO before September 16, 2011 because the defendant would be barred from requesting the new inter partes review proceeding in such a circumstance.  Finally Dr. Spruill reviewed similarities and differences between the new post-grant review and inter partes review proceedings

The third and final speaker was Dr. Remy Yucel, Director, Central Reexamination Unit (CRU), U.S. Patent & Trademark Office.  Dr. Yucel indicated that since the inception of reexamination proceedings at the USPTO the number of reexamination filings per year has generally trended upward.  She indicated that, although there has been a sharp increase in number of reexamination filings per year since 2002, the CRU had reduced the time from filing to the issuance of a reexamination certificate from about 40 months in 2006 to about 22 months in 2011.

Regarding reexamination and the AIA, Dr. Yucel pointed to three key changes that would impact the CRU: the change in the standard for granting an inter partes reexamination (IPR) effective September 16, 2011; the transition from inter partes reexamination to inter partes review at PTAB effective September 16, 2012; and the commencement of supplemental examination on September 16, 2012.  Dr. Yucel indicated that the new, AIA-mandated “reasonable likelihood” standard for instituting an IPR does not require that the requester establish a prima facie case. And, unlike the prior standard of the “substantial new question,” the AIA-mandated standard does not require that a legal question be “new.”

Next, Dr. Yucel turned the focus to Supplement Examination.  Some of the proposed rules that she discussed provide that the request must be filed by owner of the entire right, title, and interest in the patent, that third party participation is prohibited, that the number of items of information is limited to 10 per request, and that an unlimited number of requests may be filed at any time.  Dr. Yucel also discussed proposed rule 610 which indicates that the request must include: a list of each item of information and its publication date; identification of each issue raised by each item of information; explanation for each identified issue; identification of how each item of information is relevant to each aspect of the patent to be examination and how each item of information raises each identified issue; a copy of each item of information; and a summary of each document over 50 pages in length.

Dr. Yucel discussed  the equitable conduct immunization of supplemental examination but later indicated that if Director learns of “material fraud” committed in connection with the patent subject to supplemental exam, the Director has authority to confidentially refer the matter to the Attorney General and may take other action pursuant to § 257(e).  She indicated that the Office regards “material fraud” to be narrower in scope than inequitable conduct as defined in Therasense.  77 Fed. Reg. at 3667.  Before concluding her presentation, Dr. Yucel discussed some additional non-AIA-related changes to streamline the reexamination practice before yielding the podium to permit the audience to ask her and her fellow panelists some questions.

Throughout BIO’s 9th annual World Congress on Industrial Biotechnology and Bioprocessing various audiences were discussed including businesses, manufacturers, investors and government. The final plenary session took a look at customers. Melody Bomgardner of Chemical Engineering News moderated the panel, “What’s Driving Demand for Biotech Products: A Customer’s Perspective” that included executives from The Coca Cola Company, Goodyear Tire, United Airlines and Estee Lauder.

Goodyear Tire is working with Genecor to produce high quality synthetic rubber largely from renewable raw materials that would replace the seven gallons of crude oil required to produce a single passenger tire. They hope to have the tires on the commercial market in the next year, and David Benko, Goodyear’s Director, Materials Research & Development, said that while performance is still the top criteria for consumers, that the environmentally-friendly factor comes right after that as a huge selling point.

Robert Sturtz, Director of Strategic Sourcing for United Airlines, shared some staggering statistics on the airline industry’s fuel use related to cost. The industry uses 17.5 billion gallons of fuel in a given year and just a one-cent increase per gallon in the price of fuel can drive their costs up by $175 million. Speaking in terms of barrels of oil, a $1 increase per barrel increases costs by $420 million per year. While not all of these costs are passed on to the consumer, customers could certainly benefit just as the airlines could from a decreased dependence on the volatile petroleum market.

Scott Vitters, Coca Cola’s General Manager of their PlantBottle Packaging Platform talked about their PlantBottle technology, which is a packaging approach that replaces up to 30 percent of the PET in bottles with plant-based materials. The goal is to eventually create a bottle from 100 percent plant materials, and Coca Cola plans to replace its entire line of plastic bottles with PlantBottles by 2020.

Drivers behind this decision for Coca Cola are cost, trust and product differentiation. They hope to achieve a cost advantage by lessening their dependence on volatile fluctuations in petroleum prices, enhance customer trust with increased environmental performances and set themselves apart from other brands with this technology.

Vitters said they’ve had a terrific reception from customers so far including customers like Walmart and McDonalds where they’ve seen the conversation shift away from cost back to quality. End-use consumers have responded very positively as well. Heinz ketchup, who has partnered with them in using this packaging, placed a QR code on their bottles for more information on PlantBottle technology that received more than a million hits in its first month. He said that it’s important to create awareness of what they’re doing to really connect with consumers and differentiate their brand.

By Eric Langer, Managing Partner, BioPlan Associates, Inc.

Two-thirds Spending more for Improved Productivity

Almost two-thirds (64.2 percent) of biomanufacturers will increase their budgets for new technologies to improve efficiencies and costs for downstream production this year. Data from our newly released 9th Annual Report and Survey of Biopharmaceutical Manufacturers, include responses from 302 global biomanufacturers, and an additional 185 vendors to the industry. We find that budget increases this year are not just incremental changes: almost 1 in 10 will be making large increases (of 20 percent or more) in these areas, while a further 1 in 5 plan an increase of 10-20 percent.

Budget increases are not limited to technologies that can improve efficiencies and cut costs, though. Biomanufacturers are increasing spending on big ticket items, as well. This year we found that 15 percent of respondents are planning an increase of more than 20 percent in new facility construction. In addition, a clear sign of industry segment growth is that ‘New capital equipment’ is a focus of 12.3 percent, who are planning large increases, with a further 46% planning small to moderate increases. Compared with the past few years, these increases are substantial.

It is also encouraging to see that biomanufacturers are planning to increase their budgets for staffing-related causes. Roughly half of the 302 biomanufacturers surveyed forecast an increase in funding to hire new operations staff and new scientific staff.

Source: 9th Annual Report and Survey, Biopharmaceutical Manufacturing and Capacity, www.BioPlanAsociates.com, April 2012

In a sign that outsourcing growth is slowing, just one-quarter of biotherapeutic developers and CMOs said they would be increasing their funding for outsourced biopharmaceutical manufacturing. This year we also find that biomanufacturers are reserving their largest budget increases for new technologies for downstream (6.4 percent) and upstream production (6.0 percent), much the same as they were last year.

Vendors’ Increasing Budgets for Big Ticket Items

We separately measured 11 areas of budget changes among the 185 global vendors surveyed this year. Industry suppliers are also increasing their budgets in a number of key areas this year, according to our study. And these increases won’t be limited to smaller items, either: nearly half (44 percent) of vendors are planning to up their budgets for new capital equipment, including 6 percent who will be making large increases of 20% or more. This contrasts with just 11 percent planning any decrease in spending in this area, the majority of which are small decreases. Similarly, a third (33.3 percent) of vendors are forecasting greater dollars spent on new facility construction, including 8 percent making large increases.

This is a significant advance from previous years, when the economic downturn forced many suppliers to this industry to retrench and reduce spending. The increased budgets define a systemic optimism among the vendors to this industry that is likely a leading indicator of their expectations for long-term growth of their customers’, the biopharma manufacturers’, budgets.

Other indications are also signaling growth. Nearly half (45 percent) are boosting their marketing budgets, and over half (54.5 percent) will up their sales budgets. This may indicate short-term expectations for more rapid growth.

When shown as cumulative over the past three years, the budget increases (aside from new facilities construction, which has shown sluggish growth the past 3 years) have generally far outpaced the budget slashing that occurred during the economic downturn in 2009.

With budgets up across the board among both biopharma companies, and their vendors, and with increases showing in most all areas over the past 3 years, the industry seems to be on an optimistic trajectory.

References:
1. 9th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production: A Survey of Biotherapeutic Developers and Contract Manufacturing Organizations, BioPlan Associates, www.bioplanassociates.com

About the Author:
Eric S. Langer is president and managing partner at BioPlan Associates, Inc., a biotechnology and life sciences marketing research and publishing firm established in Rockville, MD in 1989. He is editor of numerous studies, including “Biopharmaceutical Technology in China,” “Advances in Large-scale Biopharmaceutical Manufacturing”, and many other industry reports. elanger@bioplanassociates.com 301-921-5979. www.bioplanassociates.com

Survey Methodology: The 2012 Ninth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production in the series of annual evaluations by BioPlan Associates, Inc. yields a composite view and trend analysis from 302 responsible individuals at biopharmaceutical manufacturers and contract manufacturing organizations (CMOs) in 29 countries. The methodology also encompassed an additional 185 direct suppliers of materials, services and equipment to this industry. This year’s survey covers such issues as: new product needs, facility budget changes, current capacity, future capacity constraints, expansions, use of disposables, trends and budgets in disposables, trends in downstream purification, quality management and control, hiring issues, and employment. The quantitative trend analysis provides details and comparisons of production by biotherapeutic developers and CMOs. It also evaluates trends over time, and assesses differences in the world’s major markets in the U.S. and Europe.