At last year’s BIO CEO & Investor Conference, BIO and BioMedTracker presented data showing that drugs in development for oncology indications had the lowest overall clinical trial success rate of all therapeutic areas in development since 2004. We have updated these numbers to include clinical trials through December 2011. Although overall success rates did improve slightly, oncology remained in last place.

The chart below illustrates why oncology’s overall success rate is so low relative to other therapeutic areas. The overall Phase I to FDA approval (2004-2011) for oncology was 6.7% vs. all other therapeutic areas combined yielding 12.1%. This 2x delta is driven primarily by the big drop in Phase III success for oncology trials:

For this year’s BIO CEO & Investor Conference, we hosted an oncology panel topic to ask “Why?”: Why do oncology Phase IIIs have the lowest success rate? Is there a trend or defining characteristic in trial design for trials that are successful vs those that are not? Are there characteristics of Phase II trials that are predictive of Phase III success? Where is trial design headed and will this enable a reverse course?

The panel, moderated by Michael King, Jr. of Rodman & Renshaw, hosted an experienced line up of oncologists from both industry and academia:

• Mohammad Azab, MD, M Sc, MBA, CMO, Astex
• Michael M. Morrissey, PhD, President & CEO, Exelixis
• Robert F. Ozols, MD, PhD, SVP, Fox Chase Cancer Center
• Konstantin H. Dragnev, MD, Hematologist/Oncologist, Dartmouth-Hitchcock Medical Center

Why is oncology so much more difficult?

Dr. Azab kicked off the discussion by pointing out that there is an endpoint issue in oncology. The gold standard is the overall survival endpoint, but it is rare to get solid data for survival in Phase II. Typically Phase IIs are run for progression-free survival (PFS) or response rates (overall, complete, and partial response rates). This is very different from infectious disease or lipid lowering drugs, where the Phase endpoint is well defined and translated into the Phase III design. For example, unlike endpoints used in oncology, HepC and HIV have highly quantifiable markers such as viral load that provide direct, predictive value for Phase III. In oncology, the Phase II can be set up differently from the Phase III as the Phase II is often run to gain just initial evidence to justify more rigorous, quantitative investigation.

The real change needed to improve the success in oncology is to run better Phase II trials, according to Dr. Azab. And this does not necessarily mean randomized or double-blind, but it means running trials with clear, robust criteria for success.

Is it a design issue?

BioMedTracker’s Michael Hay presented data from our recent BIO/BioMedTracker analysis of Phase II cancer trial design components.  A subset of the data is presented below, and shows Phase II trial characteristics for trials that made it to Phase III. These 97 Phase II trials were divided into those that were successful in Phase III vs those suspended after reporting Phase III results. In terms of numbers, 46 were advanced from Phase III (went on to NDA/BLA submission with the FDA), and 51 were suspended after Phase III results.

For major trial parameters such as randomized/non-randomized, open-label/double-blind, and single/multi-arm, the difference between successful and unsuccessful programs was not statistically significant. In other words, more complex randomized, double blind, and multi-arm trials do not stand out as more likely to translate into a successful Phase III and eventual approval. Looking at the numbers, it seems single arm, open-label trials in Phase II are just as good at driving success in Phase III. The panelists, as noted below, gave hints as to why this may be the case.

Single-arm, open-label Phase II trials in recent approvals

Recent news drove the discussion on this topic. Pfizer’s (PFE) Xalkori was approved for lung cancer in 2011 based on two single arm, open-label Phase II trials with 255 patients total. Response rates were high (~60%), durable, and the patient population was enriched via biomarker. Curis’ (CRIS) Erivedge was recently approved in a 104 patient single arm, open-label Phase II trial based on response rate primary endpoints (see Genentech/Roche PII release here).

Roche’s (RHHBY) Zelboraf , approved for melanoma in 2011, had a biomarker and solid response rates in a 132 patient single arm, open-label Phase II, and was approved after a 675 patient Phase III trial.  Pfizer’s (PFE) Inlyta was approved last month for RCC with a 723 patient randomized, open-label trial after conducting a 62 patient single arm, open-label Phase II. Incyte’s (INCY) Jakafi was approved for myelofibrosis after two randomized, double-blind Phase III trials in 525 patients after a 153 patient open-label PI/II study.

Dr. Dragnev, who specializes in lung cancer, explains that we are moving from non-mechanism based therapies to refined mechanism based therapies. Thus biomarkers will be more predictive, and we will see more trials that are small and focused. However, getting the right biomarker is a challenge. Sometimes we get it right (Xalkori), and sometimes not (early EGFR work), so we need to spend more time in Phase I validating the biomarkers.

The real answer: Biomarkers

Although the number one recipe for success in the future may be biomarkers, Dr. Azab noted that Avastin is a good example of not being able to find a biomarker, but developing a great drug. However, the industry is realizing that successful drugs without some form of companion diagnostic will be the exception in the future.

Dr. Azab expanded on what is meant by “biomarker”: It does not only mean finding the readout that correlates with clinical activity. Biomarkers can also tell you when the targeted pathway is being hit, even in the absence of clinical activity. The latter, when used early on, can help drive plans for progressing compounds designed for a specific biological hypothesis. As Chief Medical Officer at Astex (ASTX), Dr. Azab is searching for biomarkers in every ongoing Phase I trial as he believes biomarkers must be identified early on in order to drive the Phase II studies.

Dr. Ozols brought up that Herceptin would not have been approved in breast cancer, had Genentech not had the Her2 diagnostic. He added to Dr. Dragnev’s point that we need predictive Phase I trials. In the past, we focused on toxicity, PK/PD, and dosing, but now with all the antibodies in the clinic, we often do not need to worry about dose toxicity as most biologics have low side effects in cancer. The focus must be on identifying activity early on.

One key obstacle with both types of biomarkers, is obtaining the biopsy sample, and obtaining it in sufficient quantity and quality for analysis. A further complication for biomarkers is the complexity of the disease itself. Most indications can be broken down into a mix of many different diseases at the molecular level.  However, there are other non-molecular selection criteria available. When we look back at OSI’s Tarceva, the EGFR mutations were correlated with phenotype such that selection by phenotype alone (female, non-smokers) could enrich the patient population. Secondly, the rash that developed in responding patients was also indicative of clinical activity.

At Exelixis (EXEL), bone scans are used to correlate PFS and other clinical benefit endpoints for cabozantinib. CEO Michael Morissey said he would be reluctant to bring any drug forward if it did not have some diagnostic/biomarker associated with it. Dr. Azab agreed, but added that the readout must actually provide evidence of hitting the intended target or pathway.

The grey area: endpoints

One issue brought up by the panel is the disagreement and inconsistency at the agency level on survival endpoints, surrogate endpoints, and single arm studies. One example is accepting PFS vs. overall survival. In the case of Avastin in ovarian cancer, there was solid PFS, but FDA wanted overall survival. However, it seems the EMEA will accept PFS. Dr. Ozols added that many oncologists feel that PFS is a clinically valid endpoint for approval, but that there is some debate over the degree of PFS required. For example, most everyone would agree that a 12 month difference is meaningful, but we enter into grey areas near two months. So the debate remains in the actual interpretation of how many months represents clinical benefit.

Just last week, we saw the ODAC vote 12:1 against Amgen’s (AMGN) Xgeva. Even though Xgeva is the first drug to significantly increase bone metastasis-free survival in castration-resistant prostate cancer, the four months was less than what FDA wanted, which was six months. When Dacogen was reviewed for AML today, the vote was 10:3 against, and median survival was seven months with p=0.11. So, some would view the FDA as being “hard-line” in the grey zone. Of course, there are exceptions, as illustrated by Xalkori being approved on response rates.

Dr. Ozols pointed to the recent termination of the PARP inhibitors for ovarian cancer. AstraZeneca’s Olaparib  program was suspended due to a lack of clarity around how PFS outcomes in the Phase II study would translate into overall survival benefit in a larger Phase III. Although the Phase II study had high PFS scores, and many docs found the study to be a success, there was no certainty on how to select patients to definitively meet significant overall survival endpoints.  This case also emphasizes that there is a need to select beyond hereditary mutations (like BRCA) and into post-hereditary mutations that arise over time. Perhaps these biomarkers are harder to identify due to the heterogeneity of the cancers found in any given population under study (in this case, finding markers for homologous repair deficiency which correlates with clinical response).

Another example is Bipar’s iniparib, a PARP inhibitor studied in breast cancer in Phase II and III. The Phase II was a success in that the 123 patient randomized trial demonstrated statistical significance for survival and high response rates. However, the 519 patient randomized Phase III did not meet its primary endpoint (overall survival). Although some of this may be attributed to design variables that were modified, it shows that simply using randomized trials and looking for survival is not the answer to all the failures we are seeing. What can happen in the control arm is that, for various reasons, the control (chemo only) group has a very poor response (low survival) and this boosts the statistics for the active arm.

Dr. Dragnev pointed out that Gemcitabine was approved without survival endpoints, but rather on patient reported outcomes. It took 14 years before the next approval without survival, and only a couple of drugs in the last 30 years were approved with patient reported outcomes. Dr. Ozols adds that for the Quality of Life (QoL) endpoint, reviewers essentially glaze over this as it is not as scientific to be used as a surrogate. Dr. Azab argued that patient reported responses have proven difficult in terms of data collection completeness and consistency.

Another issue with the FDA panel process, according to Dr. Ozols (who was an ODAC member in the 1990s) is that there can be panels where there is not an expert on the particular indication under review.  As our understanding of cancer deepens, the complexities surrounding each indication grow. At the same time, drug products are becoming more specialized in down regulating tissue specific pathways. All of this may require more specialists to evaluate therapies in niche sub indications. Dr. Ozols adds that the ODAC has become more conservative over time.

Why aren’t there more adaptive trials in oncology today?

Synta (SNTA), Infinity (INFY), and Sunesis (SNSS) were mentioned as having taken an adaptive design approach to their ongoing trials. Exelixis (EXEL) CEO Michael Morissey added that some cabozantinib trials were run in such a manner as to select patients based on active histological factors allowing for recruitment in an iterative fashion.  One of the issues with adaptive trials is that it is not as easy to register the trial with FDA. Other issues arise with statistical evaluation and logistics, which become top issues when registering a trial with FDA.

Regarding the statistical evaluation, and the PFS vs overall survival discussion earlier, Dr. Azab throws in the quote of the conference: “The joke among statisticians is that statisticians are the people that think Columbus did not discover America, because at the initial trial design his endpoint was to discover India!” Adaptive trials suffer from the same kind of criticism. A sponsor might set up a trial heading after one endpoint or patient group, but may find a better group or surrogate endpoint along the way. This creates a complicated set of data to interpret from a statistical viewpoint.

This week President Obama issued a Presidential Memorandum that challenges the federal government to substantially increase purchases of biobased products over the next two years, driving new job growth and innovation.

The United States Department of Agriculture (USDA) already designates 64 categories of biobased products for federal procurement and this memorandum asks Agriculture Secretary Tom Vilsack to increase the number of both designated categories of and individual biobased products eligible for preferred purchasing by 50 percent within one year.

BIO applauded the president’s directive to strengthen and expand the USDA BioPreferred program. “Biobased products meet consumer demand for items that are affordable and healthier for the environment,” said BIO President & CEO Jim Greenwood. “The United States is well positioned to use its leadership in biotechnology, agricultural productivity and manufacturing innovation to build a biobased economy.”

The memorandum includes provisions to establish a web-based registration system for biobased products, increase reporting of biobased product purchases and implement solutions to increase the visibility of biobased products and the BioPreferred program.

The biobased product industry already employs more than 50,000 people in the United States and will continue to create tens of thousands of jobs across the country in the coming years. The memorandum also asks Vilsak to prepare a report on job creation and the economic impact associated with the biobased product industry.

This directive was one part of three significant actions announced by the president based on recommendations from the White House Rural Council. The other initiatives include promoting regional rural job creation efforts and developing a rural healthcare workforce.

“My Administration is committed to using every tool available to promote economic growth and create good jobs in rural America,” said President Obama. “Today’s announcements reflect our continued focus on expanding opportunity for rural Americans and all Americans, including supporting new and innovative businesses, and improving rural health care and education.”

The president’s announcement came right on the heels of Sen. Debbie Stabenow’s (D-Mich.) new “Grow it Here, Make it Here” initiative to advance the emerging bio-based manufacturing industry. It encourages strengthening the USDA Biopreferred program and spurring commercialization of new agricultural innovations to help create new jobs in the United States. The new “Grow I Here, Make it Here” initiatives would increase access to capital for bio-based manufacturers and improve marketing of bio-based products as well.

BIO supports the President’s directive and Stabenow’s proposed legislation. “Expanding biobased production can also reduce our reliance on foreign oil and generate new jobs in manufacturing, agricultural production and forestry,” said Brent Erickson, executive vice president of BIO’s Industrial & Environmental Section. “Policies that provide technology neutral support to biobased products and renewable chemicals, such as the BioPreferred program, can help the industry continue its progress.”

The USPTO held a hearing on February 16 to collect testimony from interested parties to discuss factors affecting the availability of confirmatory, or second opinion, genetic testing.  However, the hearing quickly devolved into testimonies addressing so called ‘gene patents’ and genetic testing more broadly.

Dr. Hans Sauer testified on behalf of BIO and first raised the question whether there is in fact patient demand for an ‘independent second opinion genetic test.’  While doctors would likely agree that patients sometimes ask for a second opinion on a doctor’s treatment recommendations, how many patients desire a genetic test (or any other test) to be run again without any indication that there was something wrong with the initial test?  Insurance companies likely would not cover a confirmatory test, further limiting the desirability of seeking such confirmation as the patient would have to pay the full cost of a repeat genetic test out of pocket.  More generally, it must also be asked whether just offering a re-test really translates into a true patient benefit. A repeat test does not necessarily provide peace of mind. It can create doubts in the patient’s mind about the reliability of the doctor’s treatment recommendation. It can prolong uncertainty, give rise to unrealistic hopes, cause significant unnecessary out-of-pocket cost, and create indecision where treatment decisions are urgently needed. These potential negatives must be considered too.

On the broader question of access to genetic tests in the first instance, Dr. Sauer highlighted that available data indicates that a patent premium for genetic tests does not seem to exist.  One study compares similar genetic tests with one test based on exclusively licensed ‘gene patents’ and the other nonexclusively licensed finding no “obvious price premium attributable to exclusive patent rights.”

Finally, Dr. Sauer showed a map of Medicaid coverage by State of a particular type of genetic test for breast cancer, highlighting the differences in coverage.  As Dr. Sauer points out,

“If a poor patient in Nevada doesn’t have access to an advanced molecular diagnostic test, and right across the border in California a similar patient has access to the same test, there’s obviously something wrong with that, but how can that be a patent problem? How can it be a patent problem in Nevada and not a patent problem in California? That’s not how we understand patents to operate – inescapably, there’s something else at work here. “

Dr. Jill Biden and U.S. Labor Secretary Hilda Solis will embark on a five-state “Community College to Career” bus tour to highlight innovative industry partnerships this week. The tour will begin on February 22 with a visit at Columbus State Community College before continuing to DG Medical.

Dr. Jill Biden, wife of Vice President Joe Biden

At DG Medical, Dr. Biden and Secretary Solis will join BioOhio and Sinclair Community College officials to see first-hand the impact of a U.S. Department of Labor grant-funded biomedical training program led by BioOhio.

Launched in 2010, the three-year Ohio Bioworkforce Training Partnership aims to deliver training to 660 displaced or underemployed workers in declining industries for careers in Ohio’s growing bioscience industry. In addition, 40 incumbent workers will receive more advanced training to move into higher level jobs. Several DG Medical employees have completed training at Sinclair Community College, one of the program’s six college partners.

Secretary of Labor Hilda L. Solis, 25th United States Secretary of Labor

Last week, President Obama announced a new $8 billion Community College to Career Fund co-administered by the Department of Labor and Department of Education to forge new partnerships between community colleges and businesses to train two million workers with skills that will lead directly to jobs.

Dr. Biden, a community college instructor for 18 years, and Secretary Solis, who began her career in public service as a community college trustee, will highlight the unique role community colleges can play in creating a flexible, highly-skilled 21st-century workforce to help businesses meet the specific emerging needs in their regions.

Special thanks to my friends at BioOhio for the heads-up and press release on this public awareness initative.

Last week, I wrote about the systemic failure of public schools to prepare kids for science and math focused jobs. These aren’t just theoretical jobs of tomorrow, they are well-paid positions that American employers literally can’t fill fast enough.

Despite this nation’s poor international ranking in both math and science educational achievement, tech focused jobs in the U.S. have grown at three times the normal pace through this past decade. This trend is expected to amplify through the foreseeable future.

Generation STEM: What Girls Say about Science, Technology, Engineering, and Math

Looking specifically at the people who hold these science and tech jobs, the gender gap is unmistakable. Men outnumber women three-to-one. Interestingly, a nationwide survey of 1,000 teen girls from the Girl Scout Research Institute shows that a lack of interest in science isn’t the problem.

There is a long-standing biased perception that girls don’t perform as well in math and science as boys. However, the American Association of University Women has shown that high school girls and boys perform equally well in math and science.

If this is the case, why aren’t girls prioritizing STEM (Science, Technology, Engineering, and Math) fields when thinking about their future careers? I suspect this is another example of how public school systems, and universities for that matter, are not adequately preparing students for the requirements of today’s workplace.

Here are some interesting findings from a recently released report, entitled Generation STEM: What Girls Say About Science, Technology, Engineering and Math:

• Overall, a majority of girls find STEM fields interesting: 74 percent of teen girls are interested in the fields of STEM and in STEM subjects.
• Girls are interested in the process of learning, asking questions, and problem solving: 88 percent of girls like to understand how things work; 85 percent like puzzles and solving problems; and 83 percent like doing hands-on science projects.
• Girls interested in STEM are high achievers who have supportive adult networks and are exposed to STEM fields.
• Although interest in STEM is high, few girls consider it their number-one career choice, given competing opportunities and interests: 81 percent of girls are interested in pursuing STEM careers, but only 13 percent say it is their first choice.

Realizing that entrepreneurship is a key ingredient in economic development, states and localities continue to support programs that assist bioscience businesses and capitalize on the regional presence of universities and/or federal laboratories.

With this fact in mind, Peter M. Pellerito, a senior policy consultant at BIO, and I recently collaborated on a report that investigates what specific steps have been taken across the United States as a means of attracting bioscience companies and expanding job opportunities.

The three areas we looked at were:

• State Legislative Strategies
• Supporting Bioscience Industry with Venture Capital and Discovery Funds
• Incubators and Economic Development Centers

This report was the third and final installment of a series on workforce development strategies.

Read the other reports here (part 1) and here (part 2).

A co-founder of Greenpeace speaks in favor of one of the things the organization has most vehemently opposed over the years. Dr. Patrick Moore was the keynote speaker at this week’s Manitoba Special Crops Symposium in Winnipeg.

Moore served for nine years as President of Greenpeace Canada, and seven years as a Director of Greenpeace International. As the leader of many campaigns Dr. Moore was a driving force shaping policy and direction while Greenpeace became the world’s largest environmental activist organization. You could say since that time his perspective on sustainability and environmental responsibility has changed somewhat.

He was asked about genetically modified crops, something he describes as one of the most important scientific advancements society has made. That’s why he is particularly concerned about Greenpeace’s success in blocking the introduction of Golden Rice, a GM crop.

“Other GM rice varieties are able to eliminate micronutrient deficiency in the rice eating countries, which afflicts hundreds of million people, and actually causes between a quarter and half a million children to go blind and die young each year because of vitamin A deficiency because there is no beta carotene in rice,” says Moore. “We can put beta carotene in rice through genetic modification, but Greenpeace has blocked this.”

Moore says this is a crime against humanity because they are preventing the curing of people who are dying by the hundreds of thousands a year due to vitamin A deficiency.

He says another example of the positives genetically modified crops provide is they’ve allowed agriculture to do things it couldn’t do otherwise, for example growing soybeans that produce omega-3 fatty acids. He says this will be a boon for the aquaculture industry, vastly increasing its feedstock.

“One of the limitations on aquaculture is that fish and shellfish need omega-3 fats, and the best place to get them is from fishmeal, but fishmeal is a limited supply,” says Moore. “But if we can grow soybeans and other terrestrial crops that have the foods necessary for fish production, we can vastly increase aquaculture.”

Patrick Moore is the author of Confessions of a Greenpeace Dropout: The Making of a Sensible Environmentalist.

American business leaders rue the lack of home-grown skilled workers. This is a problem governors and legislators have been acknowledging for years. However, a recent report from The Thomas B. Fordham Institute indicates that many states continue to ignore the need for strong science curriculums as a means of producing workers for an increasingly high-tech economy.

This quote says it all:

“American science performance is lagging as the economy becomes increasingly high tech, but our current science standards are doing little to solve the problem. Reviewers evaluated science standards for every state for this report and their findings were deeply troubling: The majority of states earned Ds or Fs for their standards in this crucial subject, with only six jurisdictions receiving As.”

Here’s another quote from the report that cuts right to the chase:

“The results of this rigorous analysis paint a fresh—but still bleak—picture. A majority of the states’ standards remain mediocre to awful. In fact, the average grade across all states is—once again—a thoroughly undistinguished C. (In fact, it’s a low C.) In twenty-seven jurisdictions, the science standards earn a D or below.”

If you have an hour and a half to kill it would be worthwhile to watch this presentation of the report’s findings:

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BIO recently submitted its Special 301 Submission highlighting intellectual property (IP) challenges around the world.  In particular, BIO informed the United States Trade Representative (USTR) of the persistent problems biotech companies face with issues including counterfeiting, large backlogs and patent office inefficiency, differing judicial standards for enforcement, compulsory licensing, inadequate data protection, lack of patentability of biotech inventions, overbearing genetic resources access and benefit regimes, technology transfer issues and a great need for international harmonization of patent standards and procedures.

During the Special 301 Submission process, USTR collects comments from the public which includes a variety of stakeholders such as the Semiconductor, Video Game, Agricultural, Pharmaceutical,  Apparel, Manufacturing and other major exporting U.S. industries.  Associations that focus on IP issues across industries also weigh in including the International Anti-Counterfeiting Coalition, the U.S. Chamber of Commerce, and the International Intellectual Property Alliance USTR will release its final report based on public feedback and its own investigations by embassy officials around the world “on or around April 30, 2012.”

As we celebrate Black History Month, we should take time to recognize the contributions made by George Washington Carver and understand their relevance to today’s development of the bioeconomy. Carver was one of the founding fathers of the “chemurgy” movement, the branch of applied chemistry that derives industrial products from agricultural raw materials and the predecessor of modern industrial biotechnology.

Carver, born into slavery in Missouri in 1861, left home at about 10 years old to pursue an education. From an early age, Carver pursued an interest in plants and ended up earning a bachelor’s degree in agricultural science and a graduate degree from Iowa State University. Carver spent most of his career teaching and researching at the Tuskegee Normal and Industrial Institute in Alabama, devoting his time to teaching sustainable farming, which for him included developing new uses of agricultural products that could boost farm profits.

To encourage and aid farmers in adopting sustainable practices, Carver and his students developed more than 300 industrial uses for peanuts, sweet potatoes and other crops that could be grown in rotation with cotton and corn. Carver helped educate Southern farmers on the need to conserve soil productivity through crop rotation. Carver’s inventions included everything from plastics, glue, soaps and paints to dyes for cloth and leather, medicines and cosmetic ingredients made from peanuts, sweet potatoes, or other crops and agricultural residues.

Industrial biotechnology developed in ways that Carver might never have imagined, but it remains true to the goal of a sustainable bio-economy that includes production of useful everyday products. Continuing his legacy, industrial biotechnology companies today are developing new methods to use renewable agricultural resources to manufacture fuels, plastics, chemicals, pharmaceuticals and food ingredients.

In 2008, BIO created the George Washington Carver Award given annually at the World Congress on Industrial Biotechnology and Bioprocessing. It is given to innovators in academia, the private sector or government whose work has tapped industrial biotechnology to develop sustainable biobased processes or products. A scholarship, given in the name of the recipient, accompanies the award.

BIO presented the first annual George Washington Carver Award to Dr. Patrick Gruber, CEO, Gevo, Inc., celebrating his accomplishments in creating and commercializing a new plastic made from annually renewable resources. In 2009, BIO awarded DuPont Chairman of the Board Charles O. Holliday, Jr., recognizing his commitment to industrial biotechnology as a tool for sustainable business growth. In 2010, the award went to Dr. Greg Stephanopoulos of MIT who is currently Bayer Professor of Chemical Engineering at MIT. His work now focuses on engineering a microbe for cost-effective production of oil and biodiesel. Last year’s award was given to Feike Sijbesma of Royal DSM NV for leading his company’s efforts to promote bio-based products over those relying on fossil-fuel resources.

The 2012 Carver Award winner will be announced at the 9th Annual World Congress on Industrial Biotechnology and Bioprocessing in Orlando, Fla., April 29 – May 2 at the Gaylord Palms Resort & Convention Center.