Pediatric Center

Sosnowiec, Poland

Pediatric Center

Sosnowiec, Poland

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News Article | May 11, 2017
Site: www.businesswire.com

WILMINGTON, N.C.--(BUSINESS WIRE)--Pharmaceutical Product Development, LLC, (PPD) today announced it recently has added two new leaders in product development, strengthening the global contract research organization’s therapeutic expertise and ability to aid biopharmaceutical clients in delivering life-changing therapies to patients. “PPD’s global team of scientific, medical and strategic experts provides our clients expertise that helps reduce the cost and time associated with bringing medicines to market,” said Rob Dow, senior vice president of medical affairs for PPD. “By joining this team, these leaders deepen our expertise in neuroscience, pediatrics and rare diseases – areas that are very important to PPD and our customers.” Stephen Peroutka, M.D., Ph.D., has joined PPD to serve as vice president of global product development and therapeutic area head for neuroscience. Peroutka has served as an advisor and consultant to several biopharmaceutical companies. He previously served as chief medical officer at Semnur Pharmaceuticals and as chief medical officer and executive vice president of NeurogesX Inc. Earlier, he served as vice president of neurosciences for a large contract research organization (CRO); chief medical officer of Zogenix Inc.; franchise leader for pain conditions at Johnson & Johnson Inc.; founder, CEO and president of Synergia Pharma Inc.; and founder, CEO and president of Spectra Biomedical Inc., a startup focused on identification of genes in migraine, later acquired by GSK. Peroutka served as chief of the neurology service at the Palo Alto Veteran’s Administration Hospital. He earned both a medical and doctoral degree in pharmacology and experimental therapeutics from Johns Hopkins University School of Medicine. Horacio Plotkin, M.D., FAAP, joined PPD as vice president of global product development in the pediatrics and rare diseases therapeutic area and also serves as medical lead for the Rare Disease and Pediatric Center of Excellence. Plotkin most recently served as global clinical development lead at Shire. Previously, he spent three years as chief medical officer of Retrophin, Inc., and held medical director positions at Alexion Pharmaceuticals, Enobia Pharma and Genzyme Corp. He spent 20 years as a practicing pediatrician in the field of pediatric rare diseases. Plotkin serves as adjunct associate professor of pediatrics and orthopedic surgery at the University of Nebraska School of Medicine. He earned his medical degree from the University of Buenos Aires School of Medicine. PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 19,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com. Any statements made in this news release that are not statements of historical fact, including statements about the future performance of personnel, are forward-looking statements that involve a number of risks and uncertainties. These statements often include words such as “anticipate,” “expect,” “suggests,” “plan,” “believe,” “intend,” “estimates,” “targets,” “projects,” “should,” “could,” “would,” “may,” “might,” “will,” “forecast” and other similar expressions. The forward-looking statements contained in this news release are subject to and involve risks, uncertainties and assumptions, and therefore you should not place undue reliance on them. Although PPD believes these forward-looking statements are based on reasonable assumptions at the time they are made, many factors are beyond PPD’s ability to control or predict and could affect the outcome of the subject matter of this news release and our actual financial results, and therefore the outcome and results might differ materially from those expressed in the forward-looking statements. Additional factors that might materially affect the forward-looking statements include, but are not limited to: our ability to recruit, retain and motivate key personnel; the competitive nature of the drug development services industry; changes in trends in the biopharmaceutical industry; rapid technological changes that make our services less competitive or obsolete; the impacts of political, economic and/or regulatory changes on the health care industry; the fact that our backlog may not accurately predict or convert into service revenue; the termination, delay or change in scope of our contracts; industry, customer or therapeutic concentration; the pricing of and cost management of customer contracts; information and communication systems failures; contractual failures; regulatory and ethical standards failures; our ability to attract investigators and enroll patients in clinical trials; violations of laws governing privacy, conduct of clinical trials and/or other pharmaceutical research; competition between existing and potential customers; management of business restructurings and acquisitions; risk relating to the performance of drug development services and our insurance coverages, if any, for such risks; U.S. or international economic, currency, political and other risks; changes in existing or interpretations of tax laws; factors impacting the value of our goodwill and intangible assets; and other factors. PPD assumes no obligation and expressly disclaims any duty to revise or update any forward-looking statements, or make any new forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law. PPD is not responsible for updating the information contained in this news release beyond the published date, or for changes made to this news release by wire services or internet service providers or any other party.


WHIPPANY, N.J.--(BUSINESS WIRE)--Halo Pharma announces the formation of its Pediatric Center of Excellence in support of the development and manufacture of dosage forms tailored for pediatric indications. Halo Pharma has been working closely with pharmaceutical companies to apply its extensive expertise in formulation sciences and its fully integrated manufacturing capabilities across a broad range of scales and dosage forms to overcome the challenges in developing pediatric dosage forms (PDFs) of already approved adult dosage forms. Halo Pharma is proud to be the manufacturer of choice for many of today’s largest pharma companies having been selected to reformulate multiple products across a variety of dosage forms. Companies have come to rely on Halo Pharma as a trusted partner to provide specialized contract development and manufacturing services that meet the regulatory requirements of the U.S., Canada, and Europe, where Halo Pharma is already manufacturing PDFs for commercial sale through its sponsors. Pharmaceutical companies are often asked by the U.S. Food and Drug Administration to conduct clinical trials for pediatric indications of adult dosage forms. The advantages of developing PDFs include the potential for extended patent protection and to obtain expanded indications in pediatric populations. In support of its Pediatric Center of Excellence, Halo Pharma has developed the infrastructure, process trains and equipment needed for efficient, cost-effective, and rapid production of small- to medium-scale cGMP clinical drug products that are used in pediatric clinical studies. Companies that partner with Halo Pharma benefit from close collaboration with our formulation scientists who provide the technical expertise needed to modify adult dosage forms for pediatric use. This may include reformulation to enable a lower strength or making changes to the adult dosage form to improve patient compliance by making the medication easier to take and/or taste better. Halo Pharma has partnered with several pharmaceutical companies already to develop commercially viable PDFs that have received both U.S. and international regulatory approvals. Halo Pharma currently has multiple clinical and commercial PDF programs underway. In nearly all cases, developing a PDF from an adult dosage form requires additional product development work. In many cases, it is necessary to provide the PDF in various strengths matched to different pediatric age/weight brackets. Halo Pharma has the capabilities to manufacture batches of PDFs that typically range in scale from 5 Kg to 1000 Kg, with many requiring multiple processing steps. “Our formulation development and clinical manufacturing capabilities can support a variety of oral solid and liquid dosage forms suitable for pediatric applications, such as granules produced using fluid bed technology and mini-tablets that can be packaged into stick packs, powder in bottles for reconstitution, and our liquid products, which are typically oral solutions and suspensions that can also be time release-based,” says Lee Karras, CEO of Halo Pharma. “We offer our customers over 40 years of commercial drug manufacturing experience and a proven track record of approvals with regulatory agencies around the world," Mr. Karras adds. Halo Pharma can help your company develop, test, and bring to market pediatric dosage forms of your drug products quickly and cost effectively. To learn more about Halo Pharma's new Pediatric Center of Excellence visit www.Halopharma.com/pediatric. Halo Pharmaceutical is a rapidly growing contract development and manufacturing organization (CDMO) that provides scientific and development expertise as well as a wide spectrum of manufacturing services from its locations in Whippany, New Jersey USA and Montreal, Quebec Canada to its international client base. Halo Pharma offers fully integrated capabilities in a variety of dosage forms including tablets, capsules, powders, liquids, creams, sterile and non-sterile ointments and suppositories. The company is registered to work with any of these dosages in the CI-CV DEA designations. Halo Pharmaceutical’s capabilities in the areas of tech transfer, process and product development, production, scale-up/validation and analytical method development allow us to partner with clients from development through commercialization or at any point along the way. For more information please contact services@Halopharma.com.


For additional information or to register for CPhI North America and InformEx 2017, please visit: www.cphinorthamerica.com or www.informex.com. Registration to either event offers full access to both exhibition floors. While more than 630 leading solution providers will populate the exhibition floor, the following are some of the highlights: Aavis Pharmaceuticals Inc. (booth 3210) - Has established a brand new facility and will serve as a CDMO offering end-to-end pharmaceutical development and manufacturing solutions. Capabilities as an integrated service provider and experience with a range of technologies enables ability to serve both innovator and generic companies worldwide. ACIC (booth 2431) - A full-service pharmaceutical company providing API, finished formulations and pharmaceutical machinery. The ACIC service relationship is a very flexible one structuring custom services to meet client needs. Alphora Research Inc. (booth 2138) - Provides API technology development and scale-up services for complex small molecules, including niche APIs, high potency and cytotoxic compounds. Our services cover IND enabling development, phase II & III, and commercial manufacturing of niche APIs. Amcor Flexibles (booth 3105) - Focused on improving sterile fluid delivery with barrier embedded primary containers which remove steps at critical points-of-care, maintain product integrity, and improve product stability. Anguil Environmental Systems (booth 940) - Air pollution control technologies and techniques applied to the pharmaceutical and chemical processing industries for regulatory compliance. Aptar Pharma (booth 3102) – Offering a breakthrough Ophthalmic Squeeze Dispenser, the first and only FDA-reviewed multi-dose delivery system to handle preservative-free eye treatment formulations with metal-free pathways. B&W Tek (booth 3025) - The i-Raman Pro ST is a new portable Raman system that can see through opaque packaging to identify the material inside. Bausch Advanced Technology Group (booth 3114) - Triple Container Filling & Stoppering Machine Type 535 is a flexible modular processing machine featuring three different filling systems: rotary piston pump, peristaltic pump and time pressure on one platform to offer the most flexibility for customers. Baxter BioPharma Solutions (booth 2454) - Baxter's BioPharma Solutions facility in Bloomington, Indiana, was recently recognized as the "Best Contract Manufacturing Organization" at the 2017 Annual Vaccine Industry Excellence (ViE) Awards. Benzo Chem Industries PVT. LTD. (booth 2241) - Manufacturers of pharmaceutical and agro intermediates with four ISO compliant plants. An additional GMP plant will begin operations in August 2017. Bormioli Rocco (booth 3112) - A wide range of Type I Glass, Amber and Flint, produced in a pharma approved environment, following the highest quality standards. Bosch Packaging Technology (booth 3201) - The Solidlab 2 is a multifunctional system capable of granulating, drying and coating with flexible batch sizes from 0.25 to 12 kilograms. BUCHI Corporation (booth 1252) - Introducing the first freeze dryer with unlimited capacity for continuous freeze drying. The Lyovapor L-300 offers two alternately working condensers that automatically clean while freezing down to -105°C. Capricorn Life Sciences (booth 3001) – Out-licensing food supplements, medical devices and pharmaceutical OTC's under brand names or private label. ChemicalInfo (booth 2240) - Directory of World Chemical Producers (DWCP) connects buyers and sellers of chemicals and pharmaceuticals with global producer details including contact and product information. Chemo Dynamics, Inc. (booth 938) - U.S. based CRO/CMO with cGMP facility providing pharmaceutical and biopharmaceutical contract research, custom synthesis, analytical service and small quantity manufacturing. CordenPharma (booth 2160) - Offers development & manufacturing expertise across specialized technology platforms from regulated raw materials through intermediates, APIs, drug product manufacturing & packaging. CurTec  (booth 2231) - Presenting Pharma Grade Packo, screw top jars that have been tested according to European and U.S. Pharmacopoeia and are suitable as primary packaging for pharmaceuticals. DATWYLER (booth 3204) - Offering a unique range of products and services including the most advanced elastomer formulations, coatings, aluminum seals, and processing technologies. EAS Consulting Group, LLC (booth 2551) - Provider of FDA regulatory consulting services, with more than 50 years of experience. Capabilities include performing cGMP audits and mock FDA inspections, quality system implementation and remediation, product development and regulatory strategies, to submissions, filings, registrations, assistance with imports and acting as an U.S. Agent. EMBOCAPS by Suheung (booth 2733) - Introducing a premium empty capsule product line - EMBOCAPS VG ALPHA.  No gelling agents, pH independent disintegration profile, and superior machinability. Erawat Pharma Limited (booth 3126) - An ultra-modern facility brings you hard capsules in easy fitting, sticky free, liquid filling, metallic , preservative and SLS free varieties driven by best standards of quality and consumer satisfaction. FabriChem, Inc. (booth 2121) - D-Galactose from plant origin, L-Tyrosine and L-Leucine from corn protein (vegetable origin) for use in bio pharmaceuticals & cell culture. 1, 2, 6 Hexane triol for moisturizing agent in creams, Guanidine hydrochloride for biopharmaceuticals, Dipicolinic Acid & Alpha Picolinic Acid. FAR Chemical, Inc. (booth 1234) - Manufacturer of fine and specialty chemicals sold to a variety of industries and applications including: pharmaceutical reagents and intermediates, advanced polymers, organometallics, silane & bromine chemistries, and structural composites. Flamma (booth 2344) - Flamma will open its cGMP workshop at Flamma Honkai (Dalian, China) in June providing customers a trusted partner to integrate projects from Italy to China. Also, project managers have been added in Italy and China in order to better serve customers, new capabilities have been added and land has been acquired for company growth and expansion. Fresenius Kabi Product Partnering (booth 2938) - The contract manufacturing platform of Fresenius Kabi offers manufacturing expertise of more than 20 facilities worldwide. A full range of services for both fill and finish of solutions are provided along with emulsions in ampoules, vials, bottles, IV-bags, and pre-filled syringes. Frontida BioPharm, Inc. (booth 2865) - Proprietary AdaptDoseTM encapsulation platform and DuraGran® coated granule technology provides speed, precision, flexibility and cost-savings in the product development through commercialization process. Large U.S., high-capacity facility, with expertise in controlled release granules, fluid bed operations, solvent processing, DEA controlled substances, HPAPI and nanoparticle milling. Fuji Chemical Industries Co., Ltd. (booth 2354) - Sales and marketing of unique specialty excipients, and the contract manufacturing and development of solid dispersion processing with closed spray driers. GBR - Global Business Reports (booth 3261) - Launching the U.S. Pharmaceuticals 2017 book which provides in-depth global analysis and up-to-date insights into all aspects of the oil and gas, pharmaceuticals, chemicals, energy, aerospace and mining industries. Grifols  (booth 3037) - Premixed solutions ready-to-use in PP bag deliver a fixed dose in 50 mL to 1 L ensuring accurate delivery of the drug to the patient. Groupe PARIMA (booth 2807)   - A CDMO specialized in the development and manufacturing of liquids, suspensions, semi-solids and sprays. GSK Contract Manufacturing (booth 3111) - Offering a fully integrated supply chain solution to the pharma/biopharm industry with FDA & EMA approved, multi-product facilities along with providing multiple services for Consumer and OTC markets. Haemopharm Healthcare S.r.l. (booth 3124) - Showing the first needle-free technology that not only enables the use of the syringe without the needle, but also provides a hermetic closure, minimizing contaminations and increasing safety. This patented needle-free technology has been applied to both vials (NIV®) and bags (NIP®). Halo Pharma (booth 3132) - Delivering pediatric products from clinical through commercialization (Microtablets, Stickpacks, Granules for Suspensions, Oral Solutions/Suspensions). Recognized as a Pediatric Center of Excellence. Heraeus (booth 2441) - Specializes in the production of generic pharmaceutical ingredients and is the worldwide leading supplier of Platinum hAPIs. International Process Plants (IPP) (booth 1245) - Used equipment offers the highest value rating possible by offering equipment for < 50% off new with delivery times in days instead of months. I.R.A. Istituto Ricerche Applicate (booth 2257) - Linear and cross linked hyaluronic acid for aesthetic and orthopedic fillers. Kingchem Life Science LLC (booth 1324) – Offers complex chemistry products, processes and capabilities including: Boronic acids, heterocyclic chemistry, halogenations, fluorinated compounds including trifluoromethyl and difluoroderivatives, nucleophilic fluorination, cyogenic chemistry, isocyanates, large Scale HF and KF chemistry. Laurus Labs Limited (booth 1100) - Laurus Generics has combined innovation with efficiency by developing cost effective processes to develop an in-house range of APIs and related intermediates. Laurus Synthesis strives to be recognized as the definitive example of "East Meets West" drug development by combining unparalleled front-end process chemistry expertise in both the U.S. and India with world-class back-end API manufacturing resources. LF of America Corp. (booth 3106) - Contract manufacturing, packaging manufacturing and contract filling of liquid sterile solutions in unit-dose delivery systems. LGC Standards (booth 3241) - LGC Standards is an ISO Guide 34, ISO/IEC 17025 accredited manufacturer offering more than 4,000 pharmaceutical reference standards including: impurities, APIs, excipients and primary standards LGM Pharma (booth 2501) - Provides comprehensive cGMP API sourcing solutions backed by complete technical and regulatory capabilities to a diverse array of U.S. pharmaceutical companies. Macco Organiques, s.r.o. (booth 2554) - cGMP (GMP, Q7 certified), well recognized production and supplier of inorganic and organic mineral salts for the pharmaceutical and biopharmaceutical industry, infant formulas producers, food and beverage manufacturers. ManageArtworks (booth 3235) - Packaging artwork management software that helps life science companies manage the processes, text matter, design and other components of a packaging artwork via an electronic workflow. As a CFR Part 11 compliant system, it offers transparency with effortless tracking, audit trails, alerts and dashboards. Novasep (booth 1456) - Announced that its new €11M antibody-drug conjugate bioconjugation facility is now operational to support our pharmaceutical customers in developing the latest innovative treatments against cancer. Ompi - Stevanato Group (booth 3207) - Developed a new fully passive and fully customizable, integrated needlestick protection - the Ompi EZ-fill® Integrated Safety System (ISS). It provides automatic shield retraction in an elegant and highly customizable way. PCI Synthesis (booth 2128) - Pharmaceutical development CMO based in Newburyport, MA is the largest small molecule drug substance manufacturer in the New England area. PCI is also a commercial manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products for the medical device industry. Polpharma Pharmaceutical Works (booth 2250) - A cGMP-compliant and a FDA-approved European producer of API, providing a wide-range of services including FDF out-licensing and supply and contract manufacturing services. PolyCine GmbH (booth 3223) - Global leader for the packaging of IV solution bags providing: standard films and tubes, peelable films for multi-chamber bags, special films for lipids, gas barrier films, overwrap films, filling & transfer tubes, special modified granules & compounds and hot stamping foil. Polycrystalline (booth 2253) - With the mission of "Crystallization by Design," providing services for the research and development of highly potent API and controlled substances/narcotics. Polycrystalline shares protocols, methods, and raw data customizing activities to meet specifics clients' goals, timeframes and budget. PolyPeptide Group (booth 924) - A world leading GMP peptide (CDMO) with six facilities worldwide in Belgium, France, India, Sweden, San Diego and Torrance. Potasse et Produits Chimiques (booth 1034) - Extensive technical experience for bromination, hydrobromination and related technologies. Brominated compounds are widely used in specialty chemicals, in pharmaceuticals, agrochemicals, polymer additives, and cosmetics products as intermediates. PQE US, Inc. (booth 3130) - Global consulting firm specializing in the life sciences industry. Provides global support in: data integrity assurance, computer system validation, qualification and engineering, quality assurance and compliance and regulatory affairs. Pressure Chemical Co. (booth 1444) - Providing pilot, scale-up, and custom contract manufacturing services in a flexible facility with highly experienced project leaders and operations; enabling clients to: gather process information, reduce startup capital, and bridge the gap beyond current capabilities. Q Laboratories, Inc. (booth 3134) - Provides microbiology, analytical chemistry and research & development laboratory services and helps companies worldwide meet the level of excellence they demand to produce safe, high-quality products. Qosina Corporation (booth 3236) - Purchasing components from Qosina save you both time and money by eliminating tool costs and providing immediate delivery of in-stock solutions. Qualicaps (booth 2913) - Quali-V® capsules are plant-based alternative to gelatin capsules designed to meet the demanding requirements of the pharmaceutical industry. R-Pharm Germany GmbH (booth 3135) - CDMO providing manufacturing, packaging, serialization, formulation, scale-up, product-launch, analytics and stability, as well as high potency API manufacturing. REACHLaw Ltd. (booth 1052) - Offers chemical regulatory compliance helping clients gain market access for their chemical products. Services include: REACH Only Representation, REACH Registrations, REACH Authorisation, REACH Out-Tasking, Advocacy Services, Global Notifications and Consultancy Services. Regis Technologies Inc. (booth 1124) – Utilizing analytical and synthesis expertise, offers a complete structure elucidation package to support IND and NDA filings. Reliance Label Solutions (booth 1013) - GHS, BS 5609 and IMDG certified compliance labeling solutions via the www.theghsstore.com. Rohner Inc. (booth 1151) - This Swiss custom manufacturer will be unveiling their new portfolio of Multi-Customer Products that utilize their core competencies. Roquette (booth 2829) - Features new product offerings that are low endotoxin, multi-compendial grade materials for cell culture and biologic drug formulations. Sabin Metal Corporation (booth 1254) - Provides worldwide customers with logistical support, precious metal financial services, pre-reclaim kilning and safe, accurate and responsible processing, sampling and refining of PM-bearing catalysts. Senn Chemicals AG (booth 2142) - Operates cGMP and ISO certified facilities specializing in the production of peptides and amino acid derivatives. Contract manufacturer that provides the pharmaceutical and cosmetic industry with customized products and individual solutions starting from small scale for R&D, process development, scale-up to commercial production. SK Life Science Inc. (booth 2051) - A global life sciences company known for its presence in custom chemical development, advanced intermediates and active pharmaceutical ingredient (API) manufacturing including a continuous flow process for low temperature and high pressure reaction. Symbiotica Specialty Ingredients SDN. BHD. (booth 2365) - Malaysian manufacturer of steroids with ICH Q7A GMP certification. The site was successfully inspected by the U.S. FDA in 2014 and have filed 8 U.S. DMFs: hydrocortisone valerate, clobetasol propionate, mometasone furoate, betamethasone dipropionate, betamethasone valerate, dexamethasone sodium phosphate, exemestane, halobetasol propionate. Takasago International Corporation (booth 1200) - Possesses Nobel Prize winning technology including commercial experience in continuous flow manufacturing on tonne scale. Facility is FDA Inspected. TCG Lifesciences (booth 943) - Since 2001 TCG Lifesciences, a leading CDMO, offers discovery chemistry and biology services, process development, scale-up, and cGMP manufacturing with >700 highly trained scientists and 3 facilities in Kolkata and Hyderabad. Tergus Pharma (booth 2737) - A full-service topical pharmaceutical research, development, testing and manufacturing company that has been an industry leader for more than 20 years with a state-of-the-art facility in Durham, North Carolina. "Think Topical. Think Tergus." Toronto Research Chemicals (booth 2430) - Extensive product base of 90,000+ bio-chemicals manufactured and used by more than 15,000 researchers and companies in more than 100 countries worldwide. UNIPHARMA, LLC (booth 3043) - Features innovative blow-fill-seal packaging solutions: unit dose, fill seal, liquid stickpacks and conventional filling. Both contract manufacturing and private label products in a FDA compliant, GMP facility. VanDeMark Chemical Inc. (booth 1212) - Provides phosgene chemistry for many markets including pharma, agro, personal care, coatings, sealants & adhesives, plastics, polymers, etc. Ward/Kraft, Inc. (booth 941) - Kansas-based, print manufacturer specializing in the production of forms, labels and plastic products offering GHS and BS5609 section 2 & 3 certified labels. Wego Chemical Group (booth 1027) - Triflic acid and Triflic anhydride have long been used for a number of important reactions in pharmaceutical chemistry and asymmetric synthesis. Now they are more economical than ever thanks to world class production and global distribution. WeylChem (booth 1034) - Offers custom tolling and manufacturing services, as well as advanced intermediate products for the specialty and pharmaceutical markets. To see a full list of exhibitors and the floor plan, click here. Participate in the Epicenter of Pharmaceutical and Specialty Chemical Innovation CPhI North America and InformEx 2017 attendees have access to the sold-out expo floor, featuring more than 630 companies across the complete pharma supply chain, as well as show floor programming, networking events, and much more. With its unique blend of unprecedented global influence and the infrastructure to advance relationships between buyers and sellers, CPhI North America and InformEx will provide a marketplace of solutions and ideas unlike any other. Not yet registered for CPhI North America or InformEx? Free registration ends May 15 - register now! CPhI drives growth and innovation at every step of the global pharmaceutical supply chain, from drug discovery to finished dosage. Through exhibitions, conferences, and online communities, CPhI brings together more than 100,000 pharmaceutical professionals each year to network, identify business opportunities, and expand the global market. CPhI hosts events across Europe, Asia, and now North America, and co-locates with ICSE for contract services; P-MEC for machinery, equipment, and technology; InnoPack for pharmaceutical packaging; and BioPh for biopharma. CPhI provides an online buyer and supplier directory at CPhI-Online.com. UBM Americas, a part of UBM plc, delivers events and marketing services in the fashion technology, licensing, advanced manufacturing, automotive and powersports, healthcare, veterinary, and pharmaceutical industries, among others. Through a range of aligned interactive environments, both physical and digital, UBM Americas increases business effectiveness for customers and audiences through meaningful experiences, knowledge, and connections. The division also includes UBM Brazil's market-leading events in construction, cargo transportation, logistics and international trade, and agricultural production; and UBM Mexico's construction, advanced manufacturing, and hospitality services shows. For more information, visit: www.ubmamericas.com To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/leading-pharmaceutical-and-specialty-chemical-solution-providers-highlight-innovation-at-cphi-north-america-and-informex-2017-300454063.html


News Article | May 29, 2017
Site: www.prnewswire.com

NEW YORK, May 29, 2017 /PRNewswire/ -- This report analyzes the worldwide markets for Contract Research Outsourcing in US$ Million by the following Service Segments: Drug Discovery, Preclinical Research, and Clinical Research. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, and Rest of World. Annual estimates and forecasts are provided for the period 2015 through 2022. Also, a six-year historic analysis is provided for these markets. Read the full report: http://www.reportlinker.com/p04910444/Global-Contract-Research-Outsourcing-Services.html Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 115 companies including many key and niche players such as - Albany Molecular Research, Inc. - Charles River Laboratories International, Inc. - Chiltern International Ltd. - ICON plc Read the full report: http://www.reportlinker.com/p04910444/Global-Contract-Research-Outsourcing-Services.html I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS Study Reliability and Reporting Limitations Disclaimers Data Interpretation & Reporting Level Quantitative Techniques & Analytics Product Definitions and Scope of Study II. EXECUTIVE SUMMARY 1. INDUSTRY OVERVIEW Outsourcing of R&D Projects to Propel CROs Services Market Growth Drivers in a Nutshell Evolving Macro Trends Driving CRO Demand CROs to Significantly Drive Outsourcing Penetration Focus on Efficient, Quality Services to Drive Specialty CROs Market Rise in Investments to Boost Growth Key Therapeutic Areas of Clinical Trial Research Table 1: Global Clinical Trial Services Market by Therapeutic Area: 2016 (includes corresponding Graph/Chart) Primary Factors Influencing CRO Market Pharma and Biotech Companies to Increase Dependence on CROs Outlook Notable Regional Developments Future Model of CRO 2. COMPETITIVE SCENARIO CRO - A Highly Fragmented Market Table 2: Leading Players in the Global Contract Research Outsourcing Market (2016E): Percentage Breakdown of Revenues by Player (includes corresponding Graph/Chart) Table 3: Percentage Breakup of Life Sciences Revenues (2016) of Major Players by Service Type- Preclinical, Phase I, Phase IIA, Phase IIB, Phase III, Phase IV/ Post-Approval, Central Lab and Others Large CROs Seek the Inorganic Growth Route Global CRO Marketspace - A Review of the M&A Activity in the Recent Years Select M&A Activity in the Global CRO Market Noteworthy Contracts of Major CROs CROs Adept with New Technologies to See More Business in Future Streamlining Development of Novel Trial Designs CROs with End-to End Capabilities in Demand Key Opportunities for CROs Technological Superiority - A Definite Advantage Strategies and Tactical Programs for CROs Survival Strategies in Mature CRO Markets Exit from the Industry Expand Scale Capture Niche Segments Strategies to Tap Opportunities in Growing Markets Mobilize Funds Expand Other Services Upgrade Technological and Knowledge Base Form Sub-Contracts or Regional Alliances 3. GROWTH DRIVERS, MARKET TRENDS & ISSUES Increased Spend on R&D Outsourcing Table 4: Global Pharmaceutical R&D Spending (US$ Billion) for the Years 2010 through 2017 (includes corresponding Graph/Chart) Table 5: Percentage Breakdown of Total Number of Compounds in Pipeline by Phase for Pre-Clinical, Phase I, Phase II and Phase III: 2016E (includes corresponding Graph/Chart) Enhancing Site Selection and Patient Enrollment CROs Enter into Alliances to Improve Efficiencies Adoption of Digital Technologies Gains Pace Rising Late-Stage Services Demand and Budget Restraints Drive Market Growth Toxicology Services Gain Notable Attention Pharma Companies Enter into Licensing Agreements with Biotech Companies for New Drug Discovery - A Mutually Beneficial Strategy Pharmaceutical & Biopharmaceutical Trends to Support CRO Penetration Table 6: Global Biopharma % R&D Outsourcing (2014-2020) (includes corresponding Graph/Chart) Table 7: New FDA Drug Approvals (2010-2016): Breakdown of Number of Approvals by Type for New Molecular Entity (NME) and Biologic License Application (BLA) Approvals (includes corresponding Graph/Chart) Focus on Regulatory Oversight and Enhanced Transparency Bodes Well for CROs eClinical Solutions Gain Traction Other Noteworthy Market Trends CROs Monetize Data Service Differentiation - A Sustaining Strategy CROs Tie Up with Diagnostic Companies for Patients Research Networks Move to Cloud Application of Mobile Devices to Collect Real Time Data Gains Ground CROs Provide Exclusive Offers to Lure Big Pharma Challenges Faced by Contract Research Organizations On-shore versus Offshore CRO Business Cutthroat Competition among CROs Management of Clinical Investigation Cost Containment Safety Concerns on Clinical Trials Pipeline Blocks Surging Global Population Offers Increased Growth Opportunities Table 8: Top 25 Countries Worldwide in Terms of Population: 2015 & 2016 (In Million) (includes corresponding Graph/Chart) Aging Population Boosts Opportunities for CRO Table 9: Global Population Statistics for the 65+ Age Group (2015) (includes corresponding Graph/Chart) Table 10: Comparison of Aging Population by Country (1980, 2015 & 2050): Percentage Share of Population Aged Above-65 Years of the Overall Population for Select Countries (includes corresponding Graph/Chart) Increasing Healthcare Expenditure to Spur Demand for Generics Table 11: Healthcare Spending as a Percentage of GDP by Region (2016E) (includes corresponding Graph/Chart) 4. CONTRACT RESEARCH OUTSOURCING - AN INSIGHT Concept Contract Research Organizations (CRO) Contract Research Outsourcing Major CRO Services Ancillary CRO Services Advantages from CRO Drug Discovery Pre-Clinical Studies Clinical Research - Factors Encouraging CRO Services at Various Phases Phase I Phase II Phase III Phase IV 5. RECENT INDUSTRY ACTIVITY WuXi AppTec Takes Over HD Biosciences Laboratory Corporation of America Holdings to Acquire Pharmaceutical Product Development PRA Health Sciences and Takeda Pharmaceutical Inks New Partnership AMRI Enters into Alliance with Bruker Daltonics and HighRes Biosolutions Pharmaceutical Product Development Establishes Rare Disease and Pediatric Center of Excellence Pharmaceutical Product Development to Start Clinical Research Unit in Las Vegas Bracket Acquires CLINapps PAREXEL International to Acquire ExecuPharm Cinven to Takeover BioClinica ICON to Takeover Clinical Research Management Pharmaceutical Product Development Acquires Evidera Velocity Fund Partners Acquires Indipharm Bioclinica Snaps Up Compass Research Charles River Laboratories International Takes Over Agilux Laboratories Charles River Laboratories International Snaps Up Blue Stream Laboratories Charles River Laboratories International Acquires WIL Research Pharmaron Announces the Acquisition of Quotient Bioresearch Amulet Capital Partners Acquires SynteractHCR Holdings IMS Health Merges with Quintiles Almac Clinical Technologies Enters into Partnership with inVentiv Health CSSi LifeSciences Unveils Fully Integrated Medical Device CRO Lovelace Biomedical Commences Operations as Preclinical CRO PAREXEL International Inks Services Agreement with Pfizer BioDuro Commences Operations as a Contract Research and Manufacturing Firm Charles River Laboratories International Forms Partnership with BioMotiv Laboratory Corporation of America Acquires Covance Charles River Laboratories International Snaps Up Oncotest Chiltern Acquires Theorem Clinical Research Charles River Laboratories International Takes Over Celsis International Albany Molecular Research Unveils Integrated Drug Discovery Center 6. FOCUS ON SELECT GLOBAL PLAYERS Albany Molecular Research, Inc. (USA) Charles River Laboratories International, Inc. (USA) Chiltern International Ltd. (UK) ICON plc (Ireland) INC Research, LLC (USA) InVentiv Health, Inc. (USA) Jubilant Biosys Ltd. (India) Laboratory Corporation of America® Holdings (USA) PAREXEL International Corp. (USA) Pharmaceutical Product Development, LLC. (USA) Pharmaron (China) PRA Health Sciences, Inc. (USA) Quintiles IMS Holdings, Inc. (USA) Ricerca Biosciences LLC (USA) Sygnature Discovery Limited (UK) SynteractHCR (USA) WuXi AppTec (China) 7. GLOBAL MARKET PERSPECTIVE Table 12: World Recent Past, Current & Future Analysis for Contract Research Outsourcing by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 13: World Historic Review for Contract Research Outsourcing by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 14: World 14-Year Perspective for Contract Research Outsourcing by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) Table 15: World Recent Past, Current & Future Analysis for Contract Research Outsourcing for Drug Discovery by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 16: World Historic Review for Contract Research Outsourcing for Drug Discovery by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 17: World 14-Year Perspective for Contract Research Outsourcing for Drug Discovery by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) Table 18: World Recent Past, Current & Future Analysis for Contract Research Outsourcing for Preclinical Research by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 19: World Historic Review for Contract Research Outsourcing for Preclinical Research by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 20: World 14-Year Perspective for Contract Research Outsourcing for Preclinical Research by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) Table 21: World Recent Past, Current & Future Analysis for Contract Research Outsourcing for Clinical Research by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 22: World Historic Review for Contract Research Outsourcing for Clinical Research by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 23: World 14-Year Perspective for Contract Research Outsourcing for Clinical Research by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) III. MARKET 1. THE UNITED STATES A.Market Analysis Outlook Drug Developers Rely on CROs to Improve Trial Efficiency and Cost Savings Trial Services Witness Higher Demand Strong Demand for Data Management Services Focus on Innovation and Productivity CROs Focus on Adaptive Clinical Trials Risk-based Monitoring Catches Pace Strategic Corporate Developments Key Players B.Market Analytics Table 24: US Recent Past, Current & Future Analysis for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 25: US Historic Review for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 26: US 14-Year Perspective for Contract Research Outsourcing by Service Type - Percentage Breakdown of Revenues for Drug Discovery, Preclinical Research and Clinical Research Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) 2. CANADA Market Analysis Table 27: Canadian Recent Past, Current & Future Analysis for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 28: Canadian Historic Review for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 29: Canadian 14-Year Perspective for Contract Research Outsourcing by Service Type - Percentage Breakdown of Revenues for Drug Discovery, Preclinical Research and Clinical Research Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) 3. JAPAN A.Market Analysis Strategic Corporate Development B.Market Analytics Table 30: Japanese Recent Past, Current & Future Analysis for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 31: Japanese Historic Review for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 32: Japanese 14-Year Perspective for Contract Research Outsourcing by Service Type - Percentage Breakdown of Revenues for Drug Discovery, Preclinical Research and Clinical Research Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) 4. EUROPE A.Market Analysis Outlook Providers Expand Services in Downstream Drug Development Strategic corporate developments Key Players B.Market Analytics Table 33: European Recent Past, Current & Future Analysis for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 34: European Historic Review for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 35: European 14-Year Perspective for Contract Research Outsourcing by Service Type - Percentage Breakdown of Revenues for Drug Discovery, Preclinical Research and Clinical Research Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) 5. ASIA-PACIFIC A.Market Analysis Outlook Asia-Pacific to Push up Volume Share in CRO Market R&D Outsourcing in Life Sciences on Rise Focus on Select Regional Markets China Market with Strong Growth Potential India Australia Popular Destination for Early Phase Clinical Trials Cost Savings through Tax Incentives Supportive Regulatory Framework Government Focus on Reducing Cost and Time Superior Clinical Trial Quality Strategic Corporate Development Key Players B.Market Analytics Table 36: Asia-Pacific Recent Past, Current & Future Analysis for Contract Research Outsourcing by Geographic Region - China, India and Rest of Asia-Pacific Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 37: Asia-Pacific Historic Review for Contract Research Outsourcing by Geographic Region - China, India and Rest of Asia-Pacific Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 38: Asia-Pacific 14-Year Perspective for Contract Research Outsourcing by Geographic Region - Percentage Breakdown of Revenues for China, India and Rest of Asia-Pacific Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) Table 39: Asia-Pacific Recent Past, Current & Future Analysis for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 40: Asia-Pacific Historic Review for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 41: Asia-Pacific 14-Year Perspective for Contract Research Outsourcing by Service Type - Percentage Breakdown of Revenues for Drug Discovery, Preclinical Research and Clinical Research Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) 6. REST OF WORLD A.Market Analysis Outlook Providers with Specialized Research Techniques to Boost Latin American CRO Market B.Market Analytics Table 42: Rest of World Recent Past, Current & Future Analysis for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 43: Rest of World Historic Review for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 44: Rest of World 14-Year Perspective for Contract Research Outsourcing by Service Type - Percentage Breakdown of Revenues for Drug Discovery, Preclinical Research and Clinical Research Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) IV. COMPETITIVE LANDSCAPE Total Companies Profiled: 115 (including Divisions/Subsidiaries - 120) The United States (47) Canada (5) Japan (1) Europe (27) - France (2) - Germany (6) - The United Kingdom (3) - Spain (1) - Rest of Europe (15) Asia-Pacific (Excluding Japan) (35) Latin America (4) Read the full report: http://www.reportlinker.com/p04910444/Global-Contract-Research-Outsourcing-Services.html About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. http://www.reportlinker.com __________________________ Contact Clare: clare@reportlinker.com US: (339)-368-6001 Intl: +1 339-368-6001 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/global-contract-research-outsourcing---services-300465052.html

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