Who They AreSharp is a world class provider of health care contract pack-aging, design and engineering serving the Rx, OTC, nutri-tional, animal health, and personal care markets. Sharp isrecognized for delivering reliable, cost-effective blisterpackaging, bottling, carded blisters, and pouching. In ad-dition to contract packaging, Sharp has the ability to pro-

vide package designs andconcepts utilizing the lateststate-of-the-art equipment.Their dedicated projectmanagement teams servecustomers from concept to

continued on page 37

Sharp Delivers ReliableCost-Effective Packing

Monday

April 22, 2013

1st EDITIONChicago • FREE

continued on page 8

Clean Harbors is North America’s leading provider of en-vironmental, energy and industrial services serving morethan 250,000 customers including a majority of the For-tune 500.

For more than 30 years, Clean Harbors has beenhelping biotechnology and pharmaceutical professionals

manage their environmentalservices, emergency responseand hazardous waste disposalneeds.

Their programs are customdesigned to improve safety, re-duce environmental impact and

continued on page 8

Clean Harbors: ProtectingYou and the Environment

Dustin Shindo serves as Chairman and CEO of PonoPharma, a company focused on the development of tar-geted therapies for the treatment of cancer and other dis-eases. A seasoned entrepreneur, Shindo founded

successful ventures in the med-ical device, energy technology,material science, food and bev-erage, and software industries.Shindo founded Kai Medical andserved as Chairman, where heled the company through FDA

Dustin Shindo: SeasonedEntrepreneur Takeson Multiple Myeloma

InterVivo Solutions is a drug discovery CRO with a focuson providing high-value in vivo research services de-signed to help move drug discovery programs forwardand improve the probability of clinical success.

By leveraging extensive internal expertise as well asdeeply collaborative partnerships with industry and aca-demia, InterVivo aims to develop and improve animalmodels based on emerging science. For sponsors, thismeans access to robust models, study designs and end-points often equivalent to those used in the clinic.

With flexible ca-pabilities in rodentsand canine models,

continued on page 40

Translational Models.Transformative Research. With a steady focus on innovation and sound science,

Merck has worked for more than 150 years to deliver vac-cines, medications and consumer and animal health prod-ucts that improve the lives of millions around the world.

Their passion for medicine is evident in the breadth oftheir product line. Merck offers therapies for the treatmentof cardiovascular disease, high blood pressure, elevatedcholesterol levels, diabetes, cancer, benign prostatic hyper-trophy, asthma and allergies, arthritis, pain, migraine, glau-coma, osteoporosis, women’s health, infectious diseases

(antibiotic, antifungal,and antiviral agents)and vaccines to preventchildhood diseases,

continued on page 40

Merck—An Innovation Company

Steam is recognized worldwide as an accepted standardfor sterilizing bio-hazardous medical waste. More re-cently, ozone, a powerful oxidant capable of destroyingbacteria and viruses, has been introduced and accepted as

a technology capable of steriliz-ing a broader range of bio-hazardous waste with less en-ergy and greater productivitythan other technologies, includ-ing steam.

Red Bag Solutions (RBS), a

continued on page 40

Better Technologies forOn-Site Processing ofBio-Hazardous Medical Waste

From bioengineering human organs to mapping the pro-gression of diseases, many discoveries in the biotech indus-try often seem like they stem from science fiction. In orderto reach such innovations and discoveries, biotech compa-

nies must attract and re-tain some of the mostintelligent and educatedpeople in the world. While

continued on page 40

Biotech Companies NeedIncredible People; Those PeopleNeed Benefits—How HROutsourcing with TriNet PlacesFocus Back on the Research

http://www.bayercropscience.com

http://www.aptalispharmaceuticaltechnologies.com

ies, developments and commercializationof therapies, including major productsTHALOMID, REVLIMID, POMALYST,ABRAXANE, ISTODAX and VIDAZA. For Celgene, it’s important to be lo-

cated where medical innovation is sup-ported by the state government policiesand where the company has access to theresources needed to grow and continue todeliver critical therapies to patients. InNew Jersey, state government understandsthe importance of leading in medical in-novation and how the life sciences sectordrives the economy, contributing morethan $58 billion to the state’s economic

In recognition of the vital role biomarkersplay in health care and the developmentof new medicines, Randox is relentless intheir pursuit of industry leading solutions. Founded in 1982, Randox Labora-

tories has grown into one of the world’slargest and most respected clinical diag-nostics manufacturers. While clinicalchemistry reagents and instrumentationremains a core focus, Randox has uti-lized its extensive in-house expertise de-veloped over the years, to branch into

other areas. One of these areas isBiochip Array Technology; an innova-tive multiplexing method designed tobring greater quality, efficiency and re-liability to testing. Multiplex assays areincreasingly being viewed as the futureof clinical diagnostics. All of this revolutionary develop-

ment is supported by an in-house LifeSciences manufacturing division, produc-ing the bulk of the required monoclonaland polyclonal antibodies and recombi-

4 1st Edition • Monday, April 22, 2013

An independent publication not affiliated with any other organization

BioTech Daily News is published by Source Group LLC ©2013.

All rights reserved.Business License #45-4600703

6979 East Broadway Blvd., Suite 109Tucson, AZ 85710

phone: (520) 722-2000fax: (520) 722-2014www.sourceg.net

nant proteins. Thisensures not onlyrobust reagents forRandox’s own bio-marker assays, butis also a separatebusiness divisionand as such offersoff-the-shelf and

custom solutions for other diagnosticcompanies, researchers and pharmaceu-tical companies on a global scale. Randox recognize the vitally im-

portant role which clinical diagnosticsand biomarkers play in health care andthe development of new medicines, andas a result, are relentless in their pursuitof industry leading solutions. This is

Randox Laboratories—Complete Clinical Diagnosticand Biomarker Solutions

continued on page 41

continued on page 41

Headquartered in Summit,N.J., Celgene Corporation isan integrated global biophar-maceutical company that isdriven by one mission—todiscover and develop life-changing, inno-vative treatments for cancer and inflam-matory diseases. With nearly 30 years ofexperience in the state of New Jersey,Celgene has established six therapies that

have changed the treatmentparadigm for serious cancers,and continues this workthrough more than 25 ongo-ing clinical research pro-grams, encompassing morethan 300 studies utilizing the

company’s therapies. For two years in a row, Celgene has

made Forbes’ list of “The World’s MostInnovative Companies” for its discover-

New Jersey’s Celgene: Committed to Improving Patients’ Lives

Gary CoxPublisher

Steve CoxSenior Associate Publisher

Michael HarrisNational Sales Director

Don BomeislRichard Mandziak

James MartinJohn McQuaig

Bill MorrisAndrew Oseman

Deborah YarbroughAssociate Publishers

Valerie WilsonArt Director

Elena CruzEditor

Fernando BarreraTrade Show Coordinator

Monique CarterJulie Evans

Courtney LudwigTiffany WebsterAdministration

http://www.btlaw.com

http://www.protecsinc.com

http://www.tembua.com/BioMedical

8 1st Edition • Monday, April 22, 2013

510(k) clearance for a non-contact respi-ratory rate measurement device. As CEOof Hoku Scientific, Shindo secured cus-tomer contracts totaling $2 billion andled the company to a successful IPO onthe NASDAQ Global Market in 2005.

Q: Please start by telling us a bit aboutthe company, a brief history of PonoPharma, and an overview of your busi-ness today.

A: Pono Pharma is an early stage phar-maceutical development company. Ourcompany is based in Hawaii, but our de-

velopment and testing partners are global.Our lead candidate is based on an inven-tion made by the University of Hawaii,University of Munich and University ofZurich. All of which assigned their IP in-terests to our company. We recentlycompleted new office and lab space to ac-celerate our growth.

Q: Please tell us about the company’sproducts.

A: Our macrocyclic vinyl ketone basedproteasome inhibitor has a unique bond-ing mechanism compared to other protea-some inhibitors on the market or inclinical trials. What gets us excited is thatthe compound’s efficacy, toxicity and tar-

geting profile looks very favorable com-pared to the currently approved protea-some inhibitors. We are moving quicklythrough early testing and plan to submitour IND later this year.

Q: What indications do you see yourproduct being applied to?

A: The initial indication that we are fo-cused on is multiple myeloma. Multiplemyeloma accounts for roughly 1 percentof all cancers and 2 percent of all cancerdeaths, and is in need of a proteasome in-hibitor that uses a different mechanismand has a better toxicity profile than theproteasome inhibitors that are currentlyapproved.

PONO PHARMA(continued from page 1)

Q: What are you looking to accomplishat Bio?

A: Until now, we have been focused onthe early stage development process andhaven’t spent much time reaching out topotential partners. However, with theIND and phase I upcoming, finding theright partners is very important to us. Ourhope is that we can start meeting potentialpartners at Bio.

Q: How can our readers find out moreabout your company?

A: For more information, visit www.ponopharma.com, write us at info@ponopharma.com, or stop by Booth #0310.

Sphere Fluidics is commercializing aproprietary range of products which canbe used to make small pl-nl volumedroplets (picodroplets) in which tens ofmillions of different single cell or mole-cule tests can be done per biochip. Sin-gle cell studies are becomingincreasingly important as scientists havefound that cell variation is more commonthan previously thought and contributeto the causation of disease and the gen-eration of novel, valuable biomolecules.

The single cell analysis market isnow worth almost $800 million and is ex-periencing rapid growth rates of up to 45percent per annum. Sphere Fluidics hasdeveloped a novel range of biocompatiblesurfactants (the Pico-Surf series) whichstabilize picodroplets for up to several

weeks and do not interfere with cellgrowth, enzymatic activity or picodroplet

Sphere Fluidics Limited:Single Cell Analysis andCharacterization Using Picodroplets A Decade of Research Excellence

Vince and Associates Clinical Researchhas been providing clinical research serv-ices to the global biopharmaceutical in-dustry for more than a decade. They haveassembled an experienced team of clini-cal research professionals focusing onquality research data while recognizingthat speed, responsiveness and accounta-bility are also core needs of their clients.

They have become one of the premierU.S. clinical research sites by utilizingthe Physician Research Model of opera-tion where study teams are led by highly

Innovation Profile: Vince &Associates Clinical Research

Eric W. Smart was appointedPresident and CEO of Cold-stream Laboratories in Octo-ber of 2012. Prior to histenure as CEO, he served asColdstream’s Executive VicePresident and led the BusinessDevelopment, Marketing, andProject Management Teams.Before joining Coldstream,Smart held senior leadership positions atAMRI and Organichem Corporation.Smart holds a Bachelor’s degree inChemistry from Vanderbilt Universityand earned his MBA at the University ofMaryland. Prior to entering the phar-maceutical industry, Smart served eightyears as an officer in the U.S. Navy.

Q: Please start by telling us a bit aboutthe company, a brief history of Cold-stream and an overview of your busi-

ness today.

A: Coldstream Laborato-ries is a full serviceprovider for the develop-ment and manufacture ofparenteral products and islocated in Lexington, Ky.We opened under the aus-pices of the University of

Kentucky’s College of Pharmacy in 1986as the Center for Pharmaceutical Science& Technology (CPST). In January 2007,the University spun-off the CPST into theprivate company, Coldstream Laborato-ries. We are privately held and wholly-owned by the University of KentuckyResearch Foundation.

Coldstream’s manufacturing plant wascommissioned in 2007. It was designed

continued on page 41

continued on page 41

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cost, and achieve full regulatory compli-ance to reduce your risk. Clean Harborsunderstands the key business needs andchallenges that pharmaceutical andbiotechnology firms face managing theirenvironmental programs. Working withthem, you can be assured they share bestpractices, provide viable options forwaste reduction, reuse or reclamation,and find ways to reduce your overall costof environmental management.

Through delivery and performanceof a wide range of environmental serv-ices as well as employment of industryleading technical and onsite manage-ment personnel, Clean Harbors empow-ers you and your business to focus onwhat you do best—profitable, safe andefficient operations.

Clean Harbors is the only environ-mental services provider that has the abil-ity to manage 100 percent of yourpharmaceutical and hazardous waste,spill cleanups, lab decontamination, andfacility maintenance within a company-owned network of more than 300 servicecenters, more than 50 hazardous wastedisposal facilities, and the largest haz-ardous waste incineration capacity inNorth America.

Clean Harbors has the ability to re-spond to small emergency needs as wellas large spills and releases at pharma-ceutical plants, biotechnology laborato-ries, and research and developmentfacilities. From a small lecture bottle

CLEAN HARBORS(continued from page 1)

spill or mercury release in a laboratory,to in plant spills or major spills in tankfarms or over-the-road, one call to onenumber—1-800-OIL-TANK (1-800-645-8265)—from anywhere acrossNorth America connects you to CleanHarbors’ 24/7 network of emergency re-sponse service centers.

Clean Harbors InSite Services isan environmental services outsourcingprogram that places select experiencedemployees at pharmaceutical andbiotechnology firms to support you inmanaging your environmental respon-sibilities. From the collection andpackaging of waste materials, manage-ment of satellite accumulation areas, tolaboratory support services and com-plete in-plant cleaning or running yourRCRA treatment processes, they pro-vide a comprehensive program to meetyour needs.

They will also leverage their sophis-ticated recycling facilities to reduce thevolume and cost of your hazardouswaste. Clean Harbors, through its Safety-Kleen subsidiary, is the largest recyclerand re-refiner of used oil in North Amer-ica, collecting more than 200 million gal-lons every year. This is a reduction ofmore than one million metric tons ofGHG’s (greenhouse gas) annually, whichis equivalent to the annual emissions of190,000 passenger vehicles.

At Clean Harbors their mission is tohelp protect their customers and the en-vironment. For more information pleasevisit www.cleanharbors.com or stop byBooth #5219.

A Pico-Gen biochip(actual size: 1.5 cm x 1.5 cm)

Coldstream LaboratoriesPresident and CEO Speakswith BioTech Daily News

http://www.nceast.org

http://www.carolinashealthcare.org

http://www.btec.ncsu.edu

http://www.amriglobal.com

http://www.cleanharbors.com/biotech

http://www.eternityhealthcare.com

http://www.cordenpharma.com

http://www.njbrilliance.com

http://www.redbag.com

http://www.ponocorp.com

http://www.southtexasblood.org

http://www.medicaldistrict.org

http://www.skgf.com

http://www.pharmapprove.com

http://www.redcross.org

http://www.wakeforestinnovations.com

http://www.altheatech.com

http://www.intervivo.com

http://www.vinceandassociates.com

http://www.biovectra.com

http://www.spendmd.com

http://www.randox.com

http://www.therapurebio.com

http://www.dtz.com

http://www.spherefluidics.com

http://www.loeb.com

http://www.genomequebec.com

37Monday, April 22, 2013 • 1st Edition

completion utilizing QAD-ERP system tostreamline the process to support success-ful product launches.

Vital StatisticsNumber of Employees: approximately600Key Personnel: George Burke, presidentand chief executive officer; David Thom-son, vice president and chief financial of-ficer; Doug Hill, vice presidentoperations; Jeff Benedict, vice presidentsales and marketing; Barbara Ost, vicepresident quality; Rick Seibert, vice pres-ident, project management and new busi-ness development.

FacilitiesSharp Corporation is headquartered inAllentown, Penn., with additional pack-aging and print shop facilities in Con-shohocken, Penn.

Services OfferedCapabilities:• Package specialized products, to in-clude: solid-oral dose, specialized drugdelivery systems such as transdermalpatches, wafers, and extended release for-mats, liquids, creams, powders and oint-ments• Biotech kit packaging, including vial la-beling and cold storage• FDA compliant cGMP facilities: Con-

SHARP(continued from page 1)

trolled substances CII-V• In-house package design include 3Drenderings, graphicillustrations, CAD/CAM, and samplemock-ups• In-house tooling design and fabrication

Recent DevelopmentsToday, Sharp is stronger and more re-sponsive than ever. Sharp’s newest fa-cility in Allentown, Penn., is 180,000square feet containing 30 dedicatedsuites, supported by a fully automatedwarehouse. Sharp recently addedBiotech and Clinical packaging suitesand cold storage capability to their Al-lentown facility. Sharp has also addedto its bottling capacity with four newlines, including in-line cartoning. Theycontinue to provide the comprehensivepackaging solutions needed to ensureyour success in today’s increasinglycompetitive market.

Sharp management is a blend ofexperts from both the pharmaceuticaland packaging industries, resulting ina highly qualified executive team.Sharp provides in-house services including award-winning package de-sign, tooling fabrication and engineer-ing, and component printing andproduction.

For more information about Sharp, visitwww.sharpcorporation.com, call 800-892-6197, email info@sharpcorporation.com or stop by Booth #2072.

DEERFIELD, Ill.—The Board of Directorsof Baxter International Inc. (NYSE:BAX)declared a quarterly dividend of $0.45 perBaxter common share. The dividend ispayable on April 1, 2013 to shareholders of

record as of March 8, 2013.Baxter continues to generate strong

cash flow and has returned significantvalue to shareholders in the form of

Baxter Declares Quarterly Dividend

continued on page 41

continued on page 41

Bayer CropScience lives suc-cess through innovation andchange every day. With itshighly effective products, pio-neering innovations and lasercustomer focus, they are ableto deliver innovations to ad-dress unmet customer andmarket needs—creating bene-fits for the communities andthe environment in which welive here in the United Statesand worldwide.

“That’s why BIO is so important toBayer CropScience,” said David Nichol-son, Head of Research & Development,Bayer CropScience. “Innovation breatheslife into our strategy, and here we canshare our expertise, knowledge and ourstrong market position with our peers inboth healthcare and agriculture.”

Both Bayer CropScience and Healthcare specialists are searching every dayfor breakthroughs in complex environ-ments with multi-faceted challenges.However, what brings them together morethan ever before, is biotechnology—oneof the most important sources of innova-tion in research today—both in the searchfor new drugs and in plant breeding.

“In Bayer CropScience we have an

integrated R&D network withsustainable crop production so-lutions,” said Nicholson. “Thisnetwork is a global Web ofnearly 4,500 people working inresearch and development.Last year our people submitted204 patent applications and132 plant variety rights appli-cations, and were involved in420 collaborations around theworld with universities, re-

search institutes and other companies.”Novel traits and agricultural chem-

ical combinations are protecting againstabiotic stress (heat, drought, cold, etc.)and increasing crop yields whilst inno-vative chemistry is leading to betterplant health.

In 2011 Bayer CropScience launchedtheir proprietary glyphosate herbicide tol-erance technology GlyTol in FiberMaxcotton seed varieties in the U.S. They alsocommercialized the industry’s first twocombined herbicide tolerant varieties fea-turing both GlyTol and LibertyLink. In2012 they launched conventional oilseedrape [sic] seeds in the EU. The companyexpects to bring more than 15 projects inSeeds to market-readiness for the

Crop Science as Life Science: SuccessThrough Innovation and Change

around the use of portable isolator tech-nology to provide a flexible sterile envi-ronment for the production of parenteraldrug products.

Coldstream has manufactured hundredsof batches of sterile drug products, in-cluding production of Phase I throughPhase III clinical trial materials, as wellas a select group of commercial products.We have approximately 80 employees atour facilities at the Coldstream ResearchCampus in Lexington, Ky.

Q: Please tell us about the company’sservices.

A: Coldstream’s services focus on devel-oping and manufacturing sterile in-jectable products in liquid andlyophilized dosage forms. Our isolatortechnology provides product containmentthat allows us to safely handle potent andcytotoxic compounds and offers an idealsolution for the challenges associated

with producing parenteral products thatcontain highly-potent active pharmaceu-tical ingredients.

We are a full-service CMO, meaning thatalongside our manufacturing capabilities,we also offer development and testingservices. Each project is given a cohesiveproject team led by a dedicated projectmanager. Our analytical team is responsi-ble for transferring and/or developing andvalidating analytical methods to supportformulation development, release testing,and ICH stability studies. Our formulationdevelopment group is responsible for proj-ects ranging from the transfer of an exist-ing process to de novo development ofmanufacturing processes. Finally, we havea microbiology lab onsite, offering testingfor both drug substances and drug productsin support of our manufacturing efforts.

Q: How can our readers find out moreabout your company?

A: Please stop by and visit us at BIOBooth #3675 and visit us online atwww.coldstreamlabs.com/bio2013.

COLDSTREAM(continued from page 8)

http://www.hdp.com

http://www.italtrade.com/usa

40 1st Edition • Monday, April 22, 2013

creating a company dedicated to brain im-aging might be complex, few realize thatestablishing the HR infrastructure requiredto build a great organization can be adaunting task in itself. In order to be ableto focus on their mission-critical research,many biotech companies turn to TriNet.

TriNet offers a unique and compre-hensive HR solution for small to medium-sized businesses. It allows entrepreneursand their teams to focus on driving andgrowing their businesses, instead ofspending precious time and resources onworkforce administration and containingHR employer-related risks. Companiescan reclaim valuable resources by choos-

ing a partner like TriNet in the followingways:• Attracting and retaining top talent:Emerging biotech and life sciencescompanies need to deliver the same en-terprise-level benefits to their employ-ees as their established competitors. Ifyou want to hold on to future awardwinning scientists making sure theyhave the benefits and support they needis vital. • Focus on core competency: Whetherfounded by scientists with incredibleknowledge of their chosen research do-main, or by executives who understandmarket access and commercialization,biotech companies need to focus onachieving their productivity goals. Build-ing a sustainable and functioning HR in-

frastructure to keep pace with such goalsis a distraction at least—a disaster atworst. • Manage HR risk and compliance: Ata time when liability risks due to non-compliance have increased significantlyand when venture funding has becomemore expensive and difficult to obtain,companies need to control their costsand minimize their HR risks. Even thesmallest mistake can cause ripple effectsand have serious consequences. • Scalability: Firms gain an instantlyscalable HR infrastructure to help themkeep pace with HR requirements whenthey experience a period of acceleratedgrowth, which can often happen whennew discoveries are made. This allows acompany to stay flexible and competitive.

TRINET(continued from page 1)

• Cloud-based HR Management Sys-tem: All of TriNet’s services are sup-ported by a cloud-based technologyplatform. Unlike other HR providers,TriNet’s sophisticated workflow capa-bilities completely eliminate all paper-work and manual effort. In addition,employees and managers can even ac-cess core functions on the go viaTriNet’s Mobile App.

The innovations that biotech companieshave developed and are developing en-rich all our lives. With an HR partner likeTriNet, perhaps they can drive morebreakthroughs, more discoveries, andmore incredible results.

For more information, stop byBooth #3256.

cross-species testing is at the heart of In-terVivo’s value proposition. Results froma single species provides limited rationaleand information for successful transitionto the clinic. By offering Proof-of-Con-cept, Efficacy, Pharmacokinetics andSafety studies across multiple species, In-terVivo affords sponsors a higher level ofconfidence to move forward with a drug.

Moreover, InterVivo offers multi-domain testing which provides biologi-

cal and behavioral signatures of novelcompounds useful for distinguishingclinically relevant effects from non-spe-cific effects, and aids in selection ofclinical end-points best suited for estab-lishing efficacy. Similarly, InterVivo’sflexibility enables sponsors to establishPharmacokinetic-Pharmacodynamic re-lationships and to incorporate safetymeasures early in the discovery processacross multiple preclinical species. Thisflexible and value-driven approach to invivo research improves extrapolation topatients and thus can reduce the risk of

clinical failure.InterVivo’s vision is to empower the

transition to the clinic and rationalizeclinical trial strategy for drug developers.InterVivo’s current focus in rodent modeltesting includes clinically relevant trans-lational measures such as affective, in ad-dition to traditional reflexive, measuresof pain and cognitive tests that can beused in humans. InterVivo also focuseson natural disease models in aging dogpopulations that complements and aug-ments preclinical data in rodents. Specif-ically, dogs naturally develop human-like

INTERVIVO(continued from page 1)

diseases effectively modeling aspects ofAlzheimer’s disease progression, cancer,obesity and osteoarthritis.

There is a great opportunity to im-prove the outcomes of drug discovery re-search. Providing scientifically valid andclinically relevant solutions for preclinicaldrug development is a start, but it is es-sential that we share our collective expert-ise towards mutual success. They inviteyou to stop by (the Ontario pavilion) orcontact Sal Lemus (sal@intervivo.com)for more information on how you maywork together.

human papilloma virus, rotavirus, shin-gles, and hepatitis A, B and C. Theirworldwide product sales in 2012 were$47 billion.

Merck’s focus will remain on advanc-ing and augmenting their pipeline, whichthey believe to be one of the most promis-ing in their industry. Greater scientific dis-coveries—from their labs and throughtheir collaborations with partners—willallow them to bring new life-changingtherapies to patients and a strong financialperformance to shareholders.

Embracing PartnershipsOver the past decade, Merck has estab-

lished itself as a key player in executinghundreds of strategic partnerships rang-ing from academic collaborations to late-stage agreements. According to RogerPomerantz, MD, FACP, Merck’s world-wide head of licensing and acquisitions,“Merck is committed to bringing value topatients by combining small companypassion with large company power.”

Merck’s commitment to successfulcollaboration is evident with 57 percentof Merck’s 2012 human health sales at-tributable to alliance products andpatents—including some of their biggestblockbusters. In 2012, Merck executed61 significant transactions across multi-ple therapeutic areas and multiple clini-cal stages—a record number of deals forthe company. They also entered into

many smaller licensing deals and re-search collaborations. These alliancesspan a range of therapeutic areas, dealtypes and geographies.

Merck welcomes partnerships in arange of therapeutic areas that addressunmet needs for patients, as well as tech-nologies that will enhance the productiv-ity of their research laboratories. They areinterested in partnerships at all stages ofdevelopment—from earliest discovery,preclinical through late-stage develop-ment, as well as for registered and/ormarketed products for regional commer-cialization partnerships.

Merck’s specific partnering interestsinclude the following therapeutic areas:atherosclerosis, cardiovascular disease,diabetes, endocrinology, infectious dis-

MERCK(continued from page 1)

eases, neurosciences, ophthalmology, on-cology, respiratory, immunology, vaccinesand biologics. They look to integrate keyproduct enablers (e.g., biomarkers, diag-nostics, devices, drug delivery and infor-mation technology) into the developmentof their products. For Phase III-ready can-didates and beyond, Merck is interested inany therapeutic area. They also are seek-ing regional commercial deals for regis-tered or marketed products.

When you partner with Merck, youwill have world-class research and devel-opment, regulatory, manufacturing, mar-keting, and sales resources to ensurecommercial success for your discovery.

To learn more about partnering withMerck, stop by Booth #3048 or visit theirwebsite at www.merck.com/licensing.

manufacturing and waste managementservices company based in Baltimore, of-fers both steam (SSM) and ozone (OSM)technologies for the on-site processing ofmedical waste. Both systems comple-ment a broad range of sustainability ob-jectives identified by its worldwideclients.

SSM and OSM are designed for safeand cost-effective processing of a broadvariety of medical waste, including:• Biological agents and infectious mate-rials• Needles, syringes, and disposable sur-gical instruments• Sharps containers and needle boxes• Confidential media and proprietary

materials• Blood products and body fluids• Pathogens: bacterial, viral, fungi andother infectious agents• Contaminated animal carcasses and an-imal bedding and• Some pharmaceuticals

With SSM, waste is macerated and parti-cles are simultaneously surrounded bysuperheated water and steam until steril-ization is achieved. With OSM, waste ismade unrecognizable while particles aresurrounded by ozone and ozone-infusedwater until sterilization is achieved.

After processing, waste is sterile,safe, reduced in volume up to 90 percentand classified as ordinary municipaltrash. Liquids can be discharged into thesanitary sewer and completely accepted

RED BAG SOLUTIONS(continued from page 1)

by local regulatory agencies. Solids areconverted into a confetti-like by-productthat can be recycled or disposed of as or-dinary municipal trash. Confidential ma-terial such as paper, CD’s, microfilm andother media is completely destroyed andis no longer recognizable or readable.

Processing is odor-free with nonegative air emissions. In addition, bothsystems are more environmentallyfriendly and less costly to operate thanother on-site medical waste processingalternatives.

Both SSM and OSM are cost-effec-tive, easy to install and safe to operate.Units have a smaller footprint than otheron-site medical waste processing tech-nologies requiring less than 250 (76.2)square feet and minimum ceiling heightof 9 feet (2.7 meters)

Besides the global use of Red BagSolutions’ technology by health careclients, Clinical Labs, Pharmaceutical andBio Technology companies have alsofound the SSM and OSM on-site systemsan appropriate solution for mitigatingrisk, reducing cost, guaranteeing steriliza-tion and maintaining full control of thedestruction process advantageous for theircompanies. An example of Bio/Pharm re-lated clients with installations are: CEVABiomune, Genzyme/Sanofi, Shire,USDA, American Red Cross, Medim-mune, National Cancer Institute, etc.

Red Bag Solutions offers customiz-able options to support the acquisition andoperation of SSM and OSM equipment.For more information visit Booth #3860,www.redbag.com or contact Bill Norton,Red Bag Solutions at 443-524-0013.

output. Companies with a presence in the

state find much of their success throughinnovative programs and policies, whichhelp to advance New Jersey’s “Innova-tion Ecosystem.” This ecosystem is col-laboration between the private sector,higher education, academic medical cen-ters and government, aimed at fosteringmedical research and innovation, in-creasing investment from life sciencescompanies, encouraging companies toexpand in New Jersey and creating an en-vironment that is favorable toward devel-oping medicines and medical devices that

patients need.Richard Bagger, Senior Vice Presi-

dent, Corporate Affairs and StrategicMarket Access at Celgene, will be atChoose New Jersey, Inc.’s booth at BIOInternational to discuss the company’scutting- edge research and the benefits ofbeing headquartered in New Jersey.

For more information, visitwww.celgene.com or stop by Booth#0304.

CHOOSE NEW JERSEY(continued from page 4)

41Monday, April 22, 2013 • 1st Edition

experienced Principal Investigators intri-cately involved in all aspects of the clin-ical trial process.

The Physician Research ModelTheir full-time dedicated research physi-cians oversee all aspects of the clinicaltrials conducted at Vince and AssociatesClinical Research, ensuring that propermedical and technical procedures arecompleted to the highest degree of qual-ity from subject recruitment to subjectdischarge.

Populations & Therapeutic Expertise• Abuse Liability• Analog Classroom (ADHD)• Cardiovascular• CNS• Cognitive Testing• Dermatology• Diabetes• Driving Simulator• EEG• Elderly• Healthy Normal Volunteers (HNV)

• Hepatitis• Methadone/Buprenorphine• Medical Device• Metabolic/Obesity• Ophthalmology• Pain and Inflammation• Pediatric• Psychiatry• Post-Menopausal Women• Pulmonary• Sleep Disorders• Substance Abuse and Addiction• Women’s Health• Vaccines• Others upon request

Early Development Trails• Proof-of-Concept (POC)• Adaptive Design Studies: HNV and Pa-tient• First-in-Human (FIH)• SAD• MAD• BA/BE• PK/PD• Dose-Ranging and Tolerability• Food Effect• QT/QTc• Drug-Drug Interaction

VINCE & ASSOCIATES(continued from page 8)

illustrated by their unrivaled range andquality of products developed, whichinclude:• Multiplex protein/antibody arrays in-cluding CNS, cardiac, inflammatory, en-docrine and metabolic markers on thepatented Biochip Array Technology• Multiplex DNA/RNA arrays includingclass-leading oncology (KRAS, BRAF,

PIK3CA) and infectious disease (respira-tory pathogens and STD) arrays on thepatented Biochip Array Technology• Life Sciences division offering:- Monoclonal, Polyclonal and Recombi-nant antibody fragments (ScFv’s) targetedtowards cardiac markers and clinicallysignificant protein biomarkers- Human Recombinant Proteins includ-ing cytokines, adhesion molecules andtumor markers• Clinical chemistry, offering more than

120 assays including lipids, anti-oxidants,renal, hepatic, comprehensive metabolicprofile, cardiac, therapeutic drugs, spe-cific proteins, autoimmune and veterinaryparameters• Quality Control – Randox’s quality con-trol sera covers more than 300 parametersand is known to be the most accurate, stableand consistent control material available• Regulatory affairs – Randox is an FDAinspected, ISO 13485 accredited manufac-turer, with more than 2000 FDA, SFDA,

CE and Health Canada registered diagnos-tic products ensuring we can meet the reg-ulatory requirements of any diagnostic orbiomarker development program including510k, PMA or CE marked IVD submission

For more information, visit www.randox.com, www.randox-lifesciences.com www.randoxpharmaservices.com,or call 001-304-728-2890 toll free 8664Randox or F: 001-304-728-1890, toll free8664 Randox1.

RANDOX LABORATORIES(continued from page 4)

dividends and share repurchases. Baxter International Inc., through

its subsidiaries, develops, manufac-tures and markets products that saveand sustain the lives of people with he-mophilia, immune disorders, infectiousdiseases, kidney disease, trauma, and other chronic and acute medical conditions.

BAXTER INTERNATIONAL, INC.(continued from page 37)

broad-acre crops of cotton, wheat, oilseedrape/canola, rice and soybeans between2011 and 2016.

Rounding out the company’s innova-tive portfolio is the recently added Bio-logicals business unit. Last year BayerCropScience acquired U.S.-based biolog-ical company Agraquest for its uniquetechnology platform, promising biologi-

cal pipeline, R&D and manufacturing fa-cilities and its wide range of establishedgreen product brands. The company alsoacquired German Biologics company—Prophyta GmbH, for its products based onwell-established biological control agents.

Biologics contribute to plant healthas a new focus of Bayer CropScience’sR&D strategy. Biologic products protectcrops and improve plant health.

“Biologics is strategically importantfor us. It will help strengthen our fruits

BAYER CROPSCIENCE(continued from page 37)

and vegetable business where we cur-rently have 28 crops and 2500 varieties,”said Nicholson. “We are taking an inte-grated approach to serving our customers.However, biologics is but one of the ex-citing new areas, technologies and inno-vations in our arsenal. Watch this space!”

For more information, stop by Booth#2617.

FiberMax, GlyTol, LibertyLink are allregistered trademarks of Bayer.

analysis by fluorescence or mass spec-trometry. The Company has also launchedanother novel chemical (Pico-Glide) forsurface coating of chips for improvedassay performance. This month, the Com-pany released Pico-Break: which en-hances recovery of cells and moleculesfrom picodroplets. To complement thesenovel chemicals, Sphere Fluidics also re-cently launched a set of around 30 differ-ent chips (the Pico-Gen series, see imagebelow) for picodroplet generation.

These polymer chips have differentdimensions and designs, so a researchercan easily find the optimal chip for

SPHERE FLUIDICS(continued from page 8)

their specific studies. The Company hasalready commercialized research in-strumentation for picodroplet genera-tion and sorting and plans to launchadditional products later this year. Aunique offering of Sphere Fluidics isthat it provides R&D services where,for example, it will develop a cus-tomized workflow and chip for studiesof a specific cell type or generation ofa new, useful analytical process. In ad-dition, the Company provides Discov-ery Services, where it uses in-housetechnology to find and analyze rare,valuable cell or molecular variants forits R&D partners.

For more information, stop by Booth#4441.

Pharmacy Capabilities• Full-time Clinical Research Pharmacist• APHA certified in Immunization Delivery• Trained at PCCA’s ComprehensiveCompounding Course• USP 797 certified clean room with ClassII Biological Safety Cabinet• Negative pressure, HEPA filtered extem-poraneous compounding room equippedwith PowderSafe Ductless Balance En-closure• Comprehensive Pharmacy specific SOPs• Extensive experience in intravenouspreparation, including biologics• Extensive experience in extemporane-ous compounding• 24/7 monitoring of storage environment• Electronic security access to pharmacywith video monitoring

Recruitment Highlights• More than 2.6 million residents inKansas City metro area – ethnically di-verse population• 56,000-plus research-friendly volunteersin a VERIFIED database• In-house recruitment, advertising andmarketing team• Eight member, full-time recruiting staff

for live calls• Extensive screening histories obtainedfor effective recruitment• Staff and facilities designed for optimumrecruitment and retention of special pop-ulations in Phase I

Early Clinical DevelopmentVince and Associates Clinical Researchstate-of-the-art, 90 bed Clinical Phar-macology Research Unit is the premierresearch facility, a culmination of yearsof planning and design by a team ofmore than 100 clinical researchers ledby Dr. Brad Vince, President and Med-ical Director of Vince & AssociatesClinical Research.

The design delivers boutique hotel ameni-ties for the study volunteers and a firstclass scientific research setting for thebiopharmaceutical industry. Bedside 20-inch touch screen entertainment systems,in-house theater room and individuallythemed luxury suites highlight the ameni-ties that study volunteers appreciate.

For more information, stop by Booth#2408 or visit www.vinceandassociates.com.

http://www.cmcbiologics.com

http://www.medtrack.com

http://www.merck.com/licensing