1st EDITION
Monday April 22, 2013
Chicago • FREE
Clean Harbors: Protecting You and the Environment
Clean Harbors is North America’s leading provider of environmental, energy and industrial services serving more than 250,000 customers including a majority of the Fortune 500. For more than 30 years, Clean Harbors has been helping biotechnology and pharmaceutical professionals manage their environmental services, emergency response and hazardous waste disposal needs. Their programs are custom designed to improve safety, reduce environmental impact and continued on page 8
Translational Models. Transformative Research.
InterVivo Solutions is a drug discovery CRO with a focus on providing high-value in vivo research services designed to help move drug discovery programs forward and improve the probability of clinical success. By leveraging extensive internal expertise as well as deeply collaborative partnerships with industry and academia, InterVivo aims to develop and improve animal models based on emerging science. For sponsors, this means access to robust models, study designs and endpoints often equivalent to those used in the clinic. With flexible capabilities in rodents and canine models, continued on page 40
Better Technologies for On-Site Processing of Bio-Hazardous Medical Waste
Steam is recognized worldwide as an accepted standard for sterilizing bio-hazardous medical waste. More recently, ozone, a powerful oxidant capable of destroying bacteria and viruses, has been introduced and accepted as a technology capable of sterilizing a broader range of biohazardous waste with less energy and greater productivity than other technologies, including steam. Red Bag Solutions (RBS), a continued on page 40
Dustin Shindo: Seasoned Entrepreneur Takes on Multiple Myeloma
Dustin Shindo serves as Chairman and CEO of Pono Pharma, a company focused on the development of targeted therapies for the treatment of cancer and other diseases. A seasoned entrepreneur, Shindo founded successful ventures in the medical device, energy technology, material science, food and beverage, and software industries. Shindo founded Kai Medical and served as Chairman, where he led the company through FDA continued on page 8
Merck—An Innovation Company With a steady focus on innovation and sound science, Merck has worked for more than 150 years to deliver vaccines, medications and consumer and animal health products that improve the lives of millions around the world. Their passion for medicine is evident in the breadth of their product line. Merck offers therapies for the treatment of cardiovascular disease, high blood pressure, elevated cholesterol levels, diabetes, cancer, benign prostatic hypertrophy, asthma and allergies, arthritis, pain, migraine, glaucoma, osteoporosis, women’s health, infectious diseases (antibiotic, antifungal, and antiviral agents) and vaccines to prevent childhood diseases, continued on page 40
Biotech Companies Need Incredible People; Those People Need Benefits—How HR Outsourcing with TriNet Places Focus Back on the Research
From bioengineering human organs to mapping the progression of diseases, many discoveries in the biotech industry often seem like they stem from science fiction. In order to reach such innovations and discoveries, biotech companies must attract and retain some of the most intelligent and educated people in the world. While continued on page 40
Sharp Delivers Reliable Cost-Effective Packing
Who They Are Sharp is a world class provider of health care contract packaging, design and engineering serving the Rx, OTC, nutritional, animal health, and personal care markets. Sharp is recognized for delivering reliable, cost-effective blister packaging, bottling, carded blisters, and pouching. In addition to contract packaging, Sharp has the ability to provide package designs and concepts utilizing the latest state-of-the-art equipment. Their dedicated project management teams serve customers from concept to continued on page 37
1st Edition • Monday, April 22, 2013
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New Jersey’s Celgene: Committed to Improving Patients’ Lives
Headquartered in Summit, N.J., Celgene Corporation is an integrated global biopharmaceutical company that is driven by one mission—to discover and develop life-changing, innovative treatments for cancer and inflammatory diseases. With nearly 30 years of experience in the state of New Jersey, Celgene has established six therapies that
have changed the treatment paradigm for serious cancers, and continues this work through more than 25 ongoing clinical research programs, encompassing more than 300 studies utilizing the company’s therapies. For two years in a row, Celgene has made Forbes’ list of “The World’s Most Innovative Companies” for its discover-
Randox Laboratories— Complete Clinical Diagnostic and Biomarker Solutions
In recognition of the vital role biomarkers play in health care and the development of new medicines, Randox is relentless in their pursuit of industry leading solutions. Founded in 1982, Randox Laboratories has grown into one of the world’s largest and most respected clinical diagnostics manufacturers. While clinical chemistry reagents and instrumentation remains a core focus, Randox has utilized its extensive in-house expertise developed over the years, to branch into
other areas. One of these areas is Biochip Array Technology; an innovative multiplexing method designed to bring greater quality, efficiency and reliability to testing. Multiplex assays are increasingly being viewed as the future of clinical diagnostics. All of this revolutionary development is supported by an in-house Life Sciences manufacturing division, producing the bulk of the required monoclonal and polyclonal antibodies and recombi-
ies, developments and commercialization of therapies, including major products THALOMID, REVLIMID, POMALYST, ABRAXANE, ISTODAX and VIDAZA. For Celgene, it’s important to be located where medical innovation is supported by the state government policies and where the company has access to the resources needed to grow and continue to deliver critical therapies to patients. In New Jersey, state government understands the importance of leading in medical innovation and how the life sciences sector drives the economy, contributing more than $58 billion to the state’s economic continued on page 41
nant proteins. This ensures not only robust reagents for Randox’s own biomarker assays, but is also a separate business division and as such offers off-the-shelf and custom solutions for other diagnostic companies, researchers and pharmaceutical companies on a global scale. Randox recognize the vitally important role which clinical diagnostics and biomarkers play in health care and the development of new medicines, and as a result, are relentless in their pursuit of industry leading solutions. This is continued on page 41
An independent publication not affiliated with any other organization Gary Cox Publisher Steve Cox Senior Associate Publisher Michael Harris National Sales Director Don Bomeisl Richard Mandziak James Martin John McQuaig Bill Morris Andrew Oseman Deborah Yarbrough Associate Publishers Valerie Wilson Art Director Elena Cruz Editor Fernando Barrera Trade Show Coordinator Monique Carter Julie Evans Courtney Ludwig Tiffany Webster Administration BioTech Daily News is published by Source Group LLC ©2013. All rights reserved. Business License #45-4600703
6979 East Broadway Blvd., Suite 109 Tucson, AZ 85710 phone: (520) 722-2000 fax: (520) 722-2014 www.sourceg.net
1st Edition • Monday, April 22, 2013
8
Sphere Fluidics Limited: Single Cell Analysis and Characterization Using Picodroplets
Sphere Fluidics is commercializing a proprietary range of products which can be used to make small pl-nl volume droplets (picodroplets) in which tens of millions of different single cell or molecule tests can be done per biochip. Single cell studies are becoming increasingly important as scientists have found that cell variation is more common than previously thought and contribute to the causation of disease and the generation of novel, valuable biomolecules. The single cell analysis market is now worth almost $800 million and is experiencing rapid growth rates of up to 45 percent per annum. Sphere Fluidics has developed a novel range of biocompatible surfactants (the Pico-Surf series) which stabilize picodroplets for up to several
Q: Please start by telling us a bit about the company, a brief history of Coldstream and an overview of your busi-
PONO PHARMA
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510(k) clearance for a non-contact respiratory rate measurement device. As CEO of Hoku Scientific, Shindo secured customer contracts totaling $2 billion and led the company to a successful IPO on the NASDAQ Global Market in 2005. Q: Please start by telling us a bit about the company, a brief history of Pono Pharma, and an overview of your business today.
A: Pono Pharma is an early stage pharmaceutical development company. Our company is based in Hawaii, but our de-
A Decade of Research Excellence Vince and Associates Clinical Research has been providing clinical research services to the global biopharmaceutical industry for more than a decade. They have assembled an experienced team of clinical research professionals focusing on quality research data while recognizing that speed, responsiveness and accountability are also core needs of their clients.
CLEAN HARBORS
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A Pico-Gen biochip (actual size: 1.5 cm x 1.5 cm)
weeks and do not interfere with cell growth, enzymatic activity or picodroplet continued on page 41
Coldstream Laboratories President and CEO Speaks with BioTech Daily News
Eric W. Smart was appointed President and CEO of Coldstream Laboratories in October of 2012. Prior to his tenure as CEO, he served as Coldstream’s Executive Vice President and led the Business Development, Marketing, and Project Management Teams. Before joining Coldstream, Smart held senior leadership positions at AMRI and Organichem Corporation. Smart holds a Bachelor’s degree in Chemistry from Vanderbilt University and earned his MBA at the University of Maryland. Prior to entering the pharmaceutical industry, Smart served eight years as an officer in the U.S. Navy.
Innovation Profile: Vince & Associates Clinical Research
ness today.
A: Coldstream Laboratories is a full service provider for the development and manufacture of parenteral products and is located in Lexington, Ky. We opened under the auspices of the University of Kentucky’s College of Pharmacy in 1986 as the Center for Pharmaceutical Science & Technology (CPST). In January 2007, the University spun-off the CPST into the private company, Coldstream Laboratories. We are privately held and whollyowned by the University of Kentucky Research Foundation. Coldstream’s manufacturing plant was commissioned in 2007. It was designed continued on page 37
velopment and testing partners are global. Our lead candidate is based on an invention made by the University of Hawaii, University of Munich and University of Zurich. All of which assigned their IP interests to our company. We recently completed new office and lab space to accelerate our growth. Q: Please tell us about the company’s products.
A: Our macrocyclic vinyl ketone based proteasome inhibitor has a unique bonding mechanism compared to other proteasome inhibitors on the market or in clinical trials. What gets us excited is that the compound’s efficacy, toxicity and tar-
cost, and achieve full regulatory compliance to reduce your risk. Clean Harbors understands the key business needs and challenges that pharmaceutical and biotechnology firms face managing their environmental programs. Working with them, you can be assured they share best practices, provide viable options for waste reduction, reuse or reclamation, and find ways to reduce your overall cost of environmental management. Through delivery and performance of a wide range of environmental services as well as employment of industry leading technical and onsite management personnel, Clean Harbors empowers you and your business to focus on what you do best—profitable, safe and efficient operations. Clean Harbors is the only environmental services provider that has the ability to manage 100 percent of your pharmaceutical and hazardous waste, spill cleanups, lab decontamination, and facility maintenance within a companyowned network of more than 300 service centers, more than 50 hazardous waste disposal facilities, and the largest hazardous waste incineration capacity in North America. Clean Harbors has the ability to respond to small emergency needs as well as large spills and releases at pharmaceutical plants, biotechnology laboratories, and research and development facilities. From a small lecture bottle geting profile looks very favorable compared to the currently approved proteasome inhibitors. We are moving quickly through early testing and plan to submit our IND later this year.
Q: What indications do you see your product being applied to? A: The initial indication that we are focused on is multiple myeloma. Multiple myeloma accounts for roughly 1 percent of all cancers and 2 percent of all cancer deaths, and is in need of a proteasome inhibitor that uses a different mechanism and has a better toxicity profile than the proteasome inhibitors that are currently approved.
They have become one of the premier U.S. clinical research sites by utilizing the Physician Research Model of operation where study teams are led by highly continued on page 41
spill or mercury release in a laboratory, to in plant spills or major spills in tank farms or over-the-road, one call to one number—1-800-OIL-TANK (1-800645-8265)—from anywhere across North America connects you to Clean Harbors’ 24/7 network of emergency response service centers. Clean Harbors InSite Services is an environmental services outsourcing program that places select experienced employees at pharmaceutical and biotechnology firms to support you in managing your environmental responsibilities. From the collection and packaging of waste materials, management of satellite accumulation areas, to laboratory support services and complete in-plant cleaning or running your RCRA treatment processes, they provide a comprehensive program to meet your needs. They will also leverage their sophisticated recycling facilities to reduce the volume and cost of your hazardous waste. Clean Harbors, through its SafetyKleen subsidiary, is the largest recycler and re-refiner of used oil in North America, collecting more than 200 million gallons every year. This is a reduction of more than one million metric tons of GHG’s (greenhouse gas) annually, which is equivalent to the annual emissions of 190,000 passenger vehicles. At Clean Harbors their mission is to help protect their customers and the environment. For more information please visit www.cleanharbors.com or stop by Booth #5219. Q: What are you looking to accomplish at Bio?
A: Until now, we have been focused on the early stage development process and haven’t spent much time reaching out to potential partners. However, with the IND and phase I upcoming, finding the right partners is very important to us. Our hope is that we can start meeting potential partners at Bio. Q: How can our readers find out more about your company?
A: For more information, visit www.pono pharma.com, write us at info@ ponopharma.com, or stop by Booth #0310.
Monday, April 22, 2013 • 1st Edition
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Crop Science as Life Science: Success Through Innovation and Change
Bayer CropScience lives success through innovation and change every day. With its highly effective products, pioneering innovations and laser customer focus, they are able to deliver innovations to address unmet customer and market needs—creating benefits for the communities and the environment in which we live here in the United States and worldwide. “That’s why BIO is so important to Bayer CropScience,” said David Nicholson, Head of Research & Development, Bayer CropScience. “Innovation breathes life into our strategy, and here we can share our expertise, knowledge and our strong market position with our peers in both healthcare and agriculture.” Both Bayer CropScience and Health care specialists are searching every day for breakthroughs in complex environments with multi-faceted challenges. However, what brings them together more than ever before, is biotechnology—one of the most important sources of innovation in research today—both in the search for new drugs and in plant breeding. “In Bayer CropScience we have an
integrated R&D network with sustainable crop production solutions,” said Nicholson. “This network is a global Web of nearly 4,500 people working in research and development. Last year our people submitted 204 patent applications and 132 plant variety rights applications, and were involved in 420 collaborations around the world with universities, research institutes and other companies.” Novel traits and agricultural chemical combinations are protecting against abiotic stress (heat, drought, cold, etc.) and increasing crop yields whilst innovative chemistry is leading to better plant health. In 2011 Bayer CropScience launched their proprietary glyphosate herbicide tolerance technology GlyTol in FiberMax cotton seed varieties in the U.S. They also commercialized the industry’s first two combined herbicide tolerant varieties featuring both GlyTol and LibertyLink. In 2012 they launched conventional oilseed rape [sic] seeds in the EU. The company expects to bring more than 15 projects in Seeds to market-readiness for the continued on page 41
Baxter Declares Quarterly Dividend
DEERFIELD, Ill.—The Board of Directors of Baxter International Inc. (NYSE:BAX) declared a quarterly dividend of $0.45 per Baxter common share. The dividend is payable on April 1, 2013 to shareholders of
record as of March 8, 2013. Baxter continues to generate strong cash flow and has returned significant value to shareholders in the form of
SHARP
trolled substances CII-V • In-house package design include 3D renderings, graphic illustrations, CAD/CAM, and sample mock-ups • In-house tooling design and fabrication
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completion utilizing QAD-ERP system to streamline the process to support successful product launches.
Vital Statistics Number of Employees: approximately 600 Key Personnel: George Burke, president and chief executive officer; David Thomson, vice president and chief financial officer; Doug Hill, vice president operations; Jeff Benedict, vice president sales and marketing; Barbara Ost, vice president quality; Rick Seibert, vice president, project management and new business development.
Facilities Sharp Corporation is headquartered in Allentown, Penn., with additional packaging and print shop facilities in Conshohocken, Penn.
Services Offered Capabilities: • Package specialized products, to include: solid-oral dose, specialized drug delivery systems such as transdermal patches, wafers, and extended release formats, liquids, creams, powders and ointments • Biotech kit packaging, including vial labeling and cold storage • FDA compliant cGMP facilities: Con-
COLDSTREAM
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around the use of portable isolator technology to provide a flexible sterile environment for the production of parenteral drug products.
Coldstream has manufactured hundreds of batches of sterile drug products, including production of Phase I through Phase III clinical trial materials, as well as a select group of commercial products. We have approximately 80 employees at our facilities at the Coldstream Research Campus in Lexington, Ky. Q: Please tell us about the company’s services.
A: Coldstream’s services focus on developing and manufacturing sterile injectable products in liquid and lyophilized dosage forms. Our isolator technology provides product containment that allows us to safely handle potent and cytotoxic compounds and offers an ideal solution for the challenges associated
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Recent Developments Today, Sharp is stronger and more responsive than ever. Sharp’s newest facility in Allentown, Penn., is 180,000 square feet containing 30 dedicated suites, supported by a fully automated warehouse. Sharp recently added Biotech and Clinical packaging suites and cold storage capability to their Allentown facility. Sharp has also added to its bottling capacity with four new lines, including in-line cartoning. They continue to provide the comprehensive packaging solutions needed to ensure your success in today’s increasingly competitive market. Sharp management is a blend of experts from both the pharmaceutical and packaging industries, resulting in a highly qualified executive team. Sharp provides in-house services including award-winning package design, tooling fabrication and engineering, and component printing and production. For more information about Sharp, visit www.sharpcorporation.com, call 800892-6197, email info@sharpcorpora tion.com or stop by Booth #2072.
with producing parenteral products that contain highly-potent active pharmaceutical ingredients.
We are a full-service CMO, meaning that alongside our manufacturing capabilities, we also offer development and testing services. Each project is given a cohesive project team led by a dedicated project manager. Our analytical team is responsible for transferring and/or developing and validating analytical methods to support formulation development, release testing, and ICH stability studies. Our formulation development group is responsible for projects ranging from the transfer of an existing process to de novo development of manufacturing processes. Finally, we have a microbiology lab onsite, offering testing for both drug substances and drug products in support of our manufacturing efforts. Q: How can our readers find out more about your company?
A: Please stop by and visit us at BIO Booth #3675 and visit us online at www.coldstreamlabs.com/bio2013.
1st Edition • Monday, April 22, 2013
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INTERVIVO
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cross-species testing is at the heart of InterVivo’s value proposition. Results from a single species provides limited rationale and information for successful transition to the clinic. By offering Proof-of-Concept, Efficacy, Pharmacokinetics and Safety studies across multiple species, InterVivo affords sponsors a higher level of confidence to move forward with a drug. Moreover, InterVivo offers multidomain testing which provides biologi-
MERCK
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human papilloma virus, rotavirus, shingles, and hepatitis A, B and C. Their worldwide product sales in 2012 were $47 billion. Merck’s focus will remain on advancing and augmenting their pipeline, which they believe to be one of the most promising in their industry. Greater scientific discoveries—from their labs and through their collaborations with partners—will allow them to bring new life-changing therapies to patients and a strong financial performance to shareholders. Embracing Partnerships Over the past decade, Merck has estab-
RED BAG SOLUTIONS (continued from page 1)
manufacturing and waste management services company based in Baltimore, offers both steam (SSM) and ozone (OSM) technologies for the on-site processing of medical waste. Both systems complement a broad range of sustainability objectives identified by its worldwide clients. SSM and OSM are designed for safe and cost-effective processing of a broad variety of medical waste, including: • Biological agents and infectious materials • Needles, syringes, and disposable surgical instruments • Sharps containers and needle boxes • Confidential media and proprietary
TRINET
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creating a company dedicated to brain imaging might be complex, few realize that establishing the HR infrastructure required to build a great organization can be a daunting task in itself. In order to be able to focus on their mission-critical research, many biotech companies turn to TriNet. TriNet offers a unique and comprehensive HR solution for small to mediumsized businesses. It allows entrepreneurs and their teams to focus on driving and growing their businesses, instead of spending precious time and resources on workforce administration and containing HR employer-related risks. Companies can reclaim valuable resources by choos-
cal and behavioral signatures of novel compounds useful for distinguishing clinically relevant effects from non-specific effects, and aids in selection of clinical end-points best suited for establishing efficacy. Similarly, InterVivo’s flexibility enables sponsors to establish Pharmacokinetic-Pharmacodynamic relationships and to incorporate safety measures early in the discovery process across multiple preclinical species. This flexible and value-driven approach to in vivo research improves extrapolation to patients and thus can reduce the risk of
clinical failure. InterVivo’s vision is to empower the transition to the clinic and rationalize clinical trial strategy for drug developers. InterVivo’s current focus in rodent model testing includes clinically relevant translational measures such as affective, in addition to traditional reflexive, measures of pain and cognitive tests that can be used in humans. InterVivo also focuses on natural disease models in aging dog populations that complements and augments preclinical data in rodents. Specifically, dogs naturally develop human-like
diseases effectively modeling aspects of Alzheimer’s disease progression, cancer, obesity and osteoarthritis. There is a great opportunity to improve the outcomes of drug discovery research. Providing scientifically valid and clinically relevant solutions for preclinical drug development is a start, but it is essential that we share our collective expertise towards mutual success. They invite you to stop by (the Ontario pavilion) or contact Sal Lemus (sal@intervivo.com) for more information on how you may work together.
lished itself as a key player in executing hundreds of strategic partnerships ranging from academic collaborations to latestage agreements. According to Roger Pomerantz, MD, FACP, Merck’s worldwide head of licensing and acquisitions, “Merck is committed to bringing value to patients by combining small company passion with large company power.” Merck’s commitment to successful collaboration is evident with 57 percent of Merck’s 2012 human health sales attributable to alliance products and patents—including some of their biggest blockbusters. In 2012, Merck executed 61 significant transactions across multiple therapeutic areas and multiple clinical stages—a record number of deals for the company. They also entered into
many smaller licensing deals and research collaborations. These alliances span a range of therapeutic areas, deal types and geographies. Merck welcomes partnerships in a range of therapeutic areas that address unmet needs for patients, as well as technologies that will enhance the productivity of their research laboratories. They are interested in partnerships at all stages of development—from earliest discovery, preclinical through late-stage development, as well as for registered and/or marketed products for regional commercialization partnerships. Merck’s specific partnering interests include the following therapeutic areas: atherosclerosis, cardiovascular disease, diabetes, endocrinology, infectious dis-
eases, neurosciences, ophthalmology, oncology, respiratory, immunology, vaccines and biologics. They look to integrate key product enablers (e.g., biomarkers, diagnostics, devices, drug delivery and information technology) into the development of their products. For Phase III-ready candidates and beyond, Merck is interested in any therapeutic area. They also are seeking regional commercial deals for registered or marketed products. When you partner with Merck, you will have world-class research and development, regulatory, manufacturing, marketing, and sales resources to ensure commercial success for your discovery. To learn more about partnering with Merck, stop by Booth #3048 or visit their website at www.merck.com/licensing.
materials • Blood products and body fluids • Pathogens: bacterial, viral, fungi and other infectious agents • Contaminated animal carcasses and animal bedding and • Some pharmaceuticals
With SSM, waste is macerated and particles are simultaneously surrounded by superheated water and steam until sterilization is achieved. With OSM, waste is made unrecognizable while particles are surrounded by ozone and ozone-infused water until sterilization is achieved. After processing, waste is sterile, safe, reduced in volume up to 90 percent and classified as ordinary municipal trash. Liquids can be discharged into the sanitary sewer and completely accepted
by local regulatory agencies. Solids are converted into a confetti-like by-product that can be recycled or disposed of as ordinary municipal trash. Confidential material such as paper, CD’s, microfilm and other media is completely destroyed and is no longer recognizable or readable. Processing is odor-free with no negative air emissions. In addition, both systems are more environmentally friendly and less costly to operate than other on-site medical waste processing alternatives. Both SSM and OSM are cost-effective, easy to install and safe to operate. Units have a smaller footprint than other on-site medical waste processing technologies requiring less than 250 (76.2) square feet and minimum ceiling height of 9 feet (2.7 meters)
Besides the global use of Red Bag Solutions’ technology by health care clients, Clinical Labs, Pharmaceutical and Bio Technology companies have also found the SSM and OSM on-site systems an appropriate solution for mitigating risk, reducing cost, guaranteeing sterilization and maintaining full control of the destruction process advantageous for their companies. An example of Bio/Pharm related clients with installations are: CEVA Biomune, Genzyme/Sanofi, Shire, USDA, American Red Cross, Medimmune, National Cancer Institute, etc. Red Bag Solutions offers customizable options to support the acquisition and operation 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.
ing a partner like TriNet in the following ways: • Attracting and retaining top talent: Emerging biotech and life sciences companies need to deliver the same enterprise-level benefits to their employees as their established competitors. If you want to hold on to future award winning scientists making sure they have the benefits and support they need is vital. • Focus on core competency: Whether founded by scientists with incredible knowledge of their chosen research domain, or by executives who understand market access and commercialization, biotech companies need to focus on achieving their productivity goals. Building a sustainable and functioning HR in-
frastructure to keep pace with such goals is a distraction at least—a disaster at worst. • Manage HR risk and compliance: At a time when liability risks due to noncompliance have increased significantly and when venture funding has become more expensive and difficult to obtain, companies need to control their costs and minimize their HR risks. Even the smallest mistake can cause ripple effects and have serious consequences. • Scalability: Firms gain an instantly scalable HR infrastructure to help them keep pace with HR requirements when they experience a period of accelerated growth, which can often happen when new discoveries are made. This allows a company to stay flexible and competitive.
• Cloud-based HR Management System: All of TriNet’s services are supported by a cloud-based technology platform. Unlike other HR providers, TriNet’s sophisticated workflow capabilities completely eliminate all paperwork and manual effort. In addition, employees and managers can even access core functions on the go via TriNet’s Mobile App.
The innovations that biotech companies have developed and are developing enrich all our lives. With an HR partner like TriNet, perhaps they can drive more breakthroughs, more discoveries, and more incredible results. For more information, stop by Booth #3256.
Monday, April 22, 2013 • 1st Edition
RANDOX LABORATORIES (continued from page 4)
illustrated by their unrivaled range and quality of products developed, which include: • Multiplex protein/antibody arrays including CNS, cardiac, inflammatory, endocrine and metabolic markers on the patented Biochip Array Technology • Multiplex DNA/RNA arrays including class-leading oncology (KRAS, BRAF,
41 PIK3CA) and infectious disease (respiratory pathogens and STD) arrays on the patented Biochip Array Technology • Life Sciences division offering: - Monoclonal, Polyclonal and Recombinant antibody fragments (ScFv’s) targeted towards cardiac markers and clinically significant protein biomarkers - Human Recombinant Proteins including cytokines, adhesion molecules and tumor markers • Clinical chemistry, offering more than
120 assays including lipids, anti-oxidants, renal, hepatic, comprehensive metabolic profile, cardiac, therapeutic drugs, specific proteins, autoimmune and veterinary parameters • Quality Control – Randox’s quality control sera covers more than 300 parameters and is known to be the most accurate, stable and consistent control material available • Regulatory affairs – Randox is an FDA inspected, ISO 13485 accredited manufacturer, with more than 2000 FDA, SFDA,
CHOOSE NEW JERSEY
SPHERE FLUIDICS
output. Companies with a presence in the state find much of their success through innovative programs and policies, which help to advance New Jersey’s “Innovation Ecosystem.” This ecosystem is collaboration between the private sector, higher education, academic medical centers and government, aimed at fostering medical research and innovation, increasing investment from life sciences companies, encouraging companies to expand in New Jersey and creating an environment that is favorable toward developing medicines and medical devices that
analysis by fluorescence or mass spectrometry. The Company has also launched another novel chemical (Pico-Glide) for surface coating of chips for improved assay performance. This month, the Company released Pico-Break: which enhances recovery of cells and molecules from picodroplets. To complement these novel chemicals, Sphere Fluidics also recently launched a set of around 30 different chips (the Pico-Gen series, see image below) for picodroplet generation. These polymer chips have different dimensions and designs, so a researcher can easily find the optimal chip for
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VINCE & ASSOCIATES (continued from page 8)
experienced Principal Investigators intricately involved in all aspects of the clinical trial process.
The Physician Research Model Their full-time dedicated research physicians oversee all aspects of the clinical trials conducted at Vince and Associates Clinical Research, ensuring that proper medical and technical procedures are completed to the highest degree of quality from subject recruitment to subject discharge.
Populations & Therapeutic Expertise • Abuse Liability • Analog Classroom (ADHD) • Cardiovascular • CNS • Cognitive Testing • Dermatology • Diabetes • Driving Simulator • EEG • Elderly • Healthy Normal Volunteers (HNV)
BAYER CROPSCIENCE (continued from page 37)
broad-acre crops of cotton, wheat, oilseed rape/canola, rice and soybeans between 2011 and 2016. Rounding out the company’s innovative portfolio is the recently added Biologicals business unit. Last year Bayer CropScience acquired U.S.-based biological company Agraquest for its unique technology platform, promising biologi-
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patients need. Richard Bagger, Senior Vice President, Corporate Affairs and Strategic Market Access at Celgene, will be at Choose New Jersey, Inc.’s booth at BIO International to discuss the company’s cutting- edge research and the benefits of being headquartered in New Jersey. For more information, visit www.celgene.com or stop by Booth #0304. • 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 Patient • First-in-Human (FIH) • SAD • MAD • BA/BE • PK/PD • Dose-Ranging and Tolerability • Food Effect • QT/QTc • Drug-Drug Interaction cal pipeline, R&D and manufacturing facilities and its wide range of established green product brands. The company also acquired German Biologics company— Prophyta GmbH, for its products based on well-established biological control agents. Biologics contribute to plant health as a new focus of Bayer CropScience’s R&D strategy. Biologic products protect crops and improve plant health. “Biologics is strategically important for us. It will help strengthen our fruits
Pharmacy Capabilities • Full-time Clinical Research Pharmacist • APHA certified in Immunization Delivery • Trained at PCCA’s Comprehensive Compounding Course • USP 797 certified clean room with Class II Biological Safety Cabinet • Negative pressure, HEPA filtered extemporaneous compounding room equipped with PowderSafe Ductless Balance Enclosure • Comprehensive Pharmacy specific SOPs • Extensive experience in intravenous preparation, including biologics • Extensive experience in extemporaneous compounding • 24/7 monitoring of storage environment • Electronic security access to pharmacy with video monitoring
Recruitment Highlights • More than 2.6 million residents in Kansas City metro area – ethnically diverse population • 56,000-plus research-friendly volunteers in a VERIFIED database • In-house recruitment, advertising and marketing team • Eight member, full-time recruiting staff and vegetable business where we currently have 28 crops and 2500 varieties,” said Nicholson. “We are taking an integrated approach to serving our customers. However, biologics is but one of the exciting new areas, technologies and innovations in our arsenal. Watch this space!” For more information, stop by Booth #2617.
FiberMax, GlyTol, LibertyLink are all registered trademarks of Bayer.
CE and Health Canada registered diagnostic products ensuring we can meet the regulatory requirements of any diagnostic or biomarker development program including 510k, 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 8664 Randox or F: 001-304-728-1890, toll free 8664 Randox1. their specific studies. The Company has already commercialized research instrumentation for picodroplet generation and sorting and plans to launch additional products later this year. A unique offering of Sphere Fluidics is that it provides R&D services where, for example, it will develop a customized workflow and chip for studies of a specific cell type or generation of a new, useful analytical process. In addition, the Company provides Discovery Services, where it uses in-house technology to find and analyze rare, valuable cell or molecular variants for its R&D partners. For more information, stop by Booth #4441. for live calls • Extensive screening histories obtained for effective recruitment • Staff and facilities designed for optimum recruitment and retention of special populations in Phase I
Early Clinical Development Vince and Associates Clinical Research state-of-the-art, 90 bed Clinical Pharmacology Research Unit is the premier research facility, a culmination of years of planning and design by a team of more than 100 clinical researchers led by Dr. Brad Vince, President and Medical Director of Vince & Associates Clinical Research.
The design delivers boutique hotel amenities for the study volunteers and a first class scientific research setting for the biopharmaceutical industry. Bedside 20inch touch screen entertainment systems, in-house theater room and individually themed luxury suites highlight the amenities that study volunteers appreciate. For more information, stop by Booth #2408 or visit www.vinceandassociates .com.
BAXTER INTERNATIONAL, INC. (continued from page 37)
dividends and share repurchases. Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions.