former head of german cro imform sentenced for ... - scimega€¦ · what is scimega’s...

Volume 10, Issue 34 Copyright © 2006 by CenterWatch. All rights reserved.

Peter U. Witte, former president andchief executive officer of IMFORM, acontract research organization

(CRO) based in Darmstadt, Germany, wassentenced this month to four years in jailin Munich District Court for fraud, corrup-tion, and aiding and abetting the betrayalof confidence.

Witte confessed that for years he haddefrauded his principal client, Japan-basedpharmaceutical company Sankyo, with billsfor several million euros for services suppos-edly performed during a drug study, accord-ing to a published report in SüddeutscheZeitung. As the principal mitigating factor,

besides the confession, the court consideredthe fact that Witte repaid almost all of thedamages. An authorized representative forSankyo collected bribes for giving preferenceto the accused, according to a publishedreport.

CWWeekly has been investigating whatled up to Witte’s sentencing for severalmonths.

According to a senior IMFORM manager,a for-cause financial audit was requestedduring the first half of 2005 by the Munichoffice of Japan-based Sankyo to investigatebilling practices on the part of IMFORM for

Former Head of German CRO IMFORM Sentenced forFraud, Corruption

Community Research, an investiga-tive site based in Cincinnati, Ohio,has expanded its phase I research

capabilities by 60 beds in relocating to alarger facility. The center maintained 26 phase I beds prior to the expansion.

The new location is connected toCincinnati Children’s Hospital, providing thesite with easy access to its dedicated centrallaboratory services.

J.D. Cornett, the center’s director of busi-ness development, has seen a big increasein the phase I market and expanded thecenter’s capacity to address that growth.“There is certainly a great need for quality

phase I sites out there, and we feel like wenow have the capacity to meet the marketneed.”

Despite the favorable market, Cornettwas concerned about growing the businesstoo quickly. He added that CommunityResearch aims to develop preferred relation-ships instead of taking on trials in sheer volume. “There are a lot of phase I researchmills out there. When you make that envi-ronment you can lose a lot of the intimacyboth in dealing with the client and with the patients,” said Cornett.

The site also moved its main offices from

Community Research Expands Phase I Capabilities

A CenterWatch Publication

August 21, 2006

page 3

Breaking News and Market Intelligence for the Clinical Trials Industry

Covalent Group returns toprofitability in Q2…2

A coalition of minority-based health-care organizations supportslandmark clinical trial…2

Company Profile. . . 4An interview with Denise DeakinpresidentScimega Research

Drug & Device Pipeline News. . . 5CenterWatch has identified 16 drugs anddevices that have entered new trial phasethis week.

Trial Results. . . 6CenterWatch reports on results for 10 drugs. Visit www.centerwatch.com forreal-time updates on drugs in clinical trials.

Biotech Review. . . 8Biotech briefs from Bioworld Today.

page 3

Copyright © 2006 CenterWatch. Duplication of this publication is prohibited. CWW1034

CWWeekly August 21, 2006 2 of 8

Industry BriefsCenterWatch Information Services

The CenterWatch MonthlyA monthly newsletter featuring in-depth stories on the clinical trials industry and grant opportunities.Annual subscription is $425.

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CROs

Covalent Group returned to profitabili-ty in its second quarter as net revenueexcluding reimbursement revenuejumped 55% to $3.6 million. The com-pany reported net income of $670,000,or $0.05 per share, an improvement of$1.2 million, or $0.09 per share, com-pared with a net loss of $483,000, or$0.04 per share, for the comparableprior year period. Kenneth Borow, M.D.,president and chief executive officer,said, ”We are very pleased with theCompany’s return to profitability in thesecond quarter of 2006. We continue tomake significant strides in all aspects ofour operations. Our reported net rev-enues of $3.6 million exceeded the pre-viously announced guidance of $3.0-$3.4 million that we provided in June2006. This figure represents our highestnet revenue since the second quarter of2004. The main catalyst for our growthhas been a robust new businesspipeline in conjunction with startup ofpreviously delayed programs.” Borowreported its backlog of signed contractsis now $32 million, up nearly 40% from$22.7 million on Dec. 31, 2005.

Patient Recruitment

A coalition of minority-based healthcareorganizations, including the National

Medical Association (NMA), theAlliance of Minority MedicalAssociations, Howard University andthe National Minority Health MonthFoundation (NMHMF)) announced theirsupport for a landmark clinical trial tobe conducted in patients of combinedAfrican and European lineage who self-identify as blacks. The support of thistrial is part of a larger, concerted effortto accelerate minority enrollment inclinical trials. “Progress to date inenrolling minorities in clinical trials hasbeen relatively slow and uneven,” saidAlbert Morris, MD, NMA’s president.“One of our organizational goals is toencourage greater representation ofminorities in new drug clinical trialswhose aim is to address major unmetmedical needs in society as a whole.”The Leukotrienes in Coronary ArteryDisease (LTCAD) study is a multi-centerphase III clinical trial initiated bydeCODE genetics to examine the safetyand efficacy of DG031, a developmentalcompound for the prevention of heartattack. Recent research suggests thatthe risk for heart attack among individ-uals of combined African and Europeanancestry who carry a variant of thegene encoding leukotriene A4 hydrolase(LTA4H) is two-and-a-half times greaterthan average.

http://www.datalabs.com



Features (continued from page 1)

a large project outsourced by Sankyo andcontracted to IMFORM. Witte had beenresponsible for billing Sankyo. Employees atIMFORM cooperated with KPMG auditors todetermine what had been going on, accord-ing to a senior IMFORM manager.

“It turned out that he had been over-billing Sankyo on this particular project, tothe tune of about 2.2 million euros. We thendiscovered from the auditors that there wasa supplementary contract that he had withSankyo on a private basis for another 5.2million euros, of which he had furtherinvoiced 1.9 million euros. We looked ateach other saying, ’This is clearly grossfraud,’” a senior IMFORM manager toldCWWeekly.

KPMG auditors completed their write-upin June 2005. According to a senior

IMFORM manager, when Witte was con-fronted with the findings, he tried to justifythe billing on the private contract by sayinghe had worked 2,000 hours on the project,which would have meant that he had barelyslept. Witte also claimed that another 1.7million euros were payments made to hisCentral Eastern European network, which heclaimed was secret, and he couldn’t possiblytell the auditors who they were. “It was alltotal rubbish. That was the point when thereal investigation started,” a senior IMFORMmanager said.

In November 2005, German policearrested Witte. “Witte was taken from theoffices here in full view of the whole compa-ny,” a senior IMFORM manager said. Wittewas considered a flight risk and held untiljust before Christmas 2005, according to asenior IMFORM manager.

What led to suspicion of fraudulent prac-

tices at IMFORM was a change in billingpractices at Sankyo. Until early last year, theSankyo team was based in Düsseldorf,Germany, and only reported direct to Japan.Their money came straight from Japan andnothing was ever audited, according to asenior IMFORM manager. But in early 2005,that group was moved to Munich and cameunder the control of the German managingdirectors and one of them who had a legalbackground “smelled a rat,” according to asenior IMFORM manager. Sankyo proceededwith the prosecution in September, 2005. Ittook another few months to build the caseand for German authorities to issue arrest warrants.

IMFORM’s business and assets were soldto Premier Research at the end of 2005 forapproximately 7 million euros, with anupfront payment of 2 million euros.

IMFORM

Austria Belgium Bulgaria Canada Croatia Czech Republic Denmark Estonia Finland France Germany Hungary Italy Israel Latvia Lithuania Netherlands

Norway Poland Portugal Romania Russia Serbia Slovak Republic Slovenia Spain Sweden Switzerland Ukraine United Kingdom United States

providing phase I-IV CRO services in over 30 countries

it downtown location within Christ Hospitalinto the new larger facility adjacent toCincinnati Children’s Hospital. In addition toits phase I unit, the center has three clinicalfacilities in the greater Cincinnati and north-ern Kentucky areas. As a result of the expan-sion, Community Research now employs atotal of about 50 personnel. “We’veexpanded our staff accordingly, we have adozen or so physicians with PI [primary

investigator] and sub-investigator status andwe have a site director as well as a numberof staff in technical and coordinating,”added Cornett.

Cornett noted that since CommunityResearch is not tied to any academic med-ical center or hospital, it can use centralinstitutional review boards (IRBs). “We’revery timely and efficient. Being a free-stand-ing entity in the private sector has a lot ofbenefits. When you have to use local IRBs,the time delay alone can cost customers a

lot of money,” added Cornett.Community Research was founded by

physicians David Mayleben and BruceCorser in 1995 as a sleep research centerand now conducts phase I through IV stud-ies in a number of therapeutic areas. Thecenter works closely with its sister company,Sleep Management Institute (SMI), a centerfor sleep disorder testing and treatment alsofounded by Corser.

Community Research

http://www.premier-research.com

What is Scimega’s background?Andrée Marceau and I co-founded and co-ownScimega. We both have nursing backgroundsand we met when we were working at a glob-al pharmaceutical company that was lateracquired. We had many oncology projectswhen we were working there. We were bothCRAs then, which gave us the opportunity tobe out in the field and meet investigators andstudy coordinators. What we realized was thatsites felt a lot of frustration with CRAs. Theywould say, ’CRAs come to our sites and they’renot very well versed in oncology and it’s a bur-den for us because we already have a lot ofwork to do and we feel like we have to trainmonitors that come to us. They think if theyknow about rheumatology or cardiology thatthey can monitor oncology trials, but that’s notthe case.’ They weren’t specifically talkingabout the CRAs that came from our companybut they were talking about a general malaise.At that time, both my partner and I hadacquired quite a bit of experience working inthe pharmaceutical industry, so we knew a lotabout monitoring and project managementand were very interested in starting our owncompany. We knew we wanted to specialize inoncology because we saw an unmet need inthe industry.

What differentiates Scimega from otherCROs?The fact that we’re an oncology CRO differenti-

ates us. Our employees are immersed 100% inunderstanding oncology clinical trials. That’s allwe do here. We don’t make any exceptions.We’re constantly providing solutions to ourclients in terms of what their specific needs arein oncology. Because of a significant increasein the volume of oncology drug development,there’s been a tremendous desire on the partof CROs to re-define themselves as companieswith an expertise in this therapeutic area. Weare ahead of other companies by nine years.Scimega is the real thing.

What changes in the industry have youobserved?In 1998, the need for an oncology-specificCRO was met with skepticism on the part ofdrug developers. But, today many biopharma-ceutical companies have worked with a multi-therapeutic CRO on monitoring an oncologyclinical trial, so they’ve had the experience ofdata coming back to them needing a lot ofcleaning, not to mention various problems atthe sites. You can’t take a CRA with experiencein other therapeutic areas, put them in anoncology setting and expect optimal perform-ance immediately. Today, an oncology-specificCRO is not nearly as hard a sell as it used tobe because companies see the benefits. Youreally do need to have monitors and projectmanagers who understand all the criticalissues surrounding doing clinical trials inoncology.

What are the advantages to being anoncology CRO in Canada?I’d say the excellent oncology clinical researchenvironment. Traditionally, only 3% to 5% ofadult patients participate in oncology clinicaltrials. Add to this the increasing complexity andsheer number of these trials and it makes foran environment that’s highly competitive.Canada is an excellent market, and it goes waybeyond the exchange rate and other hard costsavings. Even though we’re a much smallercountry than the U.S., Canada does very wellin terms of recruitment and retention, duelargely to its universal healthcare system andto its privileged patient-caregiver relationships.To treat patients and see them through thewhole process, often in one institution, allowsfor good follow-up—an issue that is vital incancer trials. Canadian patients are also realbelievers in the benefits of clinical research. Inaddition, Scimega’s CRAs have privileged rela-tionships with the 90 active sites we workwith. So, if you combine what Canada offerstogether with the strengths that Scimega candeliver, the result is a true synergy that repre-sents real added value for U.S.-based companies.


Profile: Oncology Contract Research Organization


Scimega Research, Montreal, Quebec

An interview with Denise Deakin, president

Year founded: 1998Offices: 3Employees: 17Active Projects: 18Telephone: (450) 629-2200, ext. 25Email: [email protected] site: www.scimega.com

http://www.averioninc.com


Drug & Device Pipeline News


Company Drug/Device Therapeutic Area Status Sponsor Info

Athersys ATHX- 105 obesity IND accepted by the MHRA, (216) 431-9900phase I trials planned in the UK www.athersys.com

Alantos ALS 2-0426 type 2 diabetes Phase I trials initiated enrolling (617) 577-001150 subjects www.alantos.com

deCODE DG051 myocardial infarction Phase I trials initiated +354 570 1900www.decode.com

Nastech PYY(3-36) obesity Phase I trials initiated enrolling (425) 908-360012 subjects www.nastech.com

Depomed gastroesophageal gastroesophageal Phase IIa trials planned (650) 462-5900reflux disease reflux disease www.depomedinc.comcompound compound

Amarillo oral interferon idiopathic Phase II trials planned enrolling (806) 376-1741pulmonary fibrosis 60 subjects www.amarbio.com

Shionogi/ S-364735 HIV Phase II trials planned +81 06-6202-2161GlaxoSmithKline www.shionogi.co.jp

ViroPharma/ HCV-796 hepatitis C Phase II trials planned (610) 458-7300Wyeth www.viropharma.com

Hana Marqibo acute lymphoblastic Phase II trials initiated enrolling (650) 588-6404leukemia 44 subjects www.hanabiosciences.com

Genzyme Synvisc osteoarthritis Label expansion filed for (617) 252-7500EU approval www.genzyme.com

Novartis Galvus type 2 diabetes MAA submitted for +41 61 324 11 11EU approval www.novartis.com

Neurochem Kiacta AA amyloidosis FDA approvable letter (450) 680-4500www.neurochem.com

Tibotec Prezista HIV Approved in Canada (609) 730-7500www.tibotec.be

Centocor Remicade psoriatic arthritis FDA approved for new indication (610) 651-6000www.centocor.com

Proctor & Gamble Actonel male osteoporosis FDA approved for new indication (513) 983-1100 www.pg.com

Sanofi Aventis Plavix myocardial infarction FDA approved for new indication +33 1 53 77 40 00www.sanofi-aventis.com

http://www.clinicaltrialmedia.com


Trial Results


Immunology/Infectious Disease

Advancis Pharmaceutical reported positive results from a phase III trial ofAmoxicillin, for the treatment of pharyngi-tis/tonsillitis due to Group A streptococcalinfections. This double-blind, double-dummy,randomized, parallel-group, 50-center non-inferiority trial enrolled 620 subjects whoreceived a 775 mg Amoxicillin PULSYStablet, once a day, for 10 days or 250 mg ofpenicillin, four times a day, for 10 days. Thetrial met the primary endpoint of statisticalnon- inferiority with 85% of the PULSYSgroup achieving bacterial eradication versus83.4% of the penicillin group. Secondaryendpoints met statistical non-inferiority aswell in clinical cure rates at the test-of-curevisit and bacterial eradication rates at thelate post-therapy visit. Based on theseresults, Advancis expected to file a NDA foronce daily Amoxicillin by late 2006 or early2007.

VaxGen reported positive results from aphase I trial of rPA102, the company’santhrax vaccine candidate. This randomized,double-blinded, controlled, multicenter trialenrolled subjects who received rPA102, invarying doses, four weeks apart. It wasdesigned to demonstrate a clear relationshipbetween the rPA102 dose administered andthe subsequent immune response. Safetydata were positive with no serious adverseevents or toxicities reported. Efficacy data

were also positive with higher antibodytiters seen in subjects who received threeinjections of the vaccination versus thosewho received two injections. Based on theseresults, Vaxgen planned further developmentof this drug.

Enzo Biochem issued positive long termresults from a phase I trial, initiated inJanuary 2001, of HGTV43 for the treatmentof HIV. This trial enrolled five subjects whosestem cells were collected, treated withHGTV43 ex vivo, then re-infused. Long-term safety data were positive with treat-ment well tolerated and no adverse eventsreported. Efficacy data collected demonstrat-ed that the engineered stem cells were ableto survive long term in vivo and to produceCD4+ cell progeny containing functioningantisense genes. At 12 months post-treat-ment antisense RNA was present in all fivesubjects. At 48 months, four subjects wereavailable and three out of the four had anti-sense RNA present and at month 60 it waspresent in one out of the three subjects. Inall the subjects tested, anti-HIV-1 antisenseRNA was found in the CD34+ bone marrowcells. Enzo is further investigating HGTV43in phase I/II trials at this time..

Tibotec Pharmaceuticals reported posi-tive results from a phase IIb trial ofTMC125 for the treatment of HIV. Thisdose-finding, randomized, partially blindedstudy enrolled 199 adult HIV-1 infected sub-jects who had received prior treatment.

Subjects were randomized to receive 400mg or 800 mg bid of TMC125 (n=159) witha background regimen or best availablecontrol regimen (n=40). Safety and tolera-bility data results demonstrated that themost commonly reported adverse eventswere diarrhea (22%), pyrexia (20%) andrash (20%) for the TMC125 treated groupcompared with 15%, 10% and 8%, respec-tively, for the active control group. Seriousadverse events were reported by 27% ofthe TMC125 group and 18% of the controlgroup. Efficacy data revealed that meanchange from baseline in viral load at week48 for the TMC125 400 mg and 800 mgbid and active control groups was -0.88, -1.01 and -0.14 log10 copies/ml, respective-ly. In the subjects with NNRTI resistance,those receiving TMC125 400mg or 800mgbid in combination with an optimized back-ground regimen the viral load productionwas significantly greater than in the activecontrol at 48 weeks, p=0.018 andp=0.002, respectively. Tibotec is conductingphase III trials of TMC125 at this time.

Transport Pharmaceuticals issued posi-tive results from a phase IIb trial of device-enhanced acyclovir for the treatment of herpes labialis. This multi-center, random-ized, double-blind, placebo-controlled, clinic-initiated, proof-of-concept trial enrolled 200non-immunocompromised subjects, aged18-75 years, with histories of recurrent coldsore outbreaks (three or more annually).

page 7

http://www.bioanalytical.com

CWWeekly Augus 21, 2006 7 of 8

Trial Results (continued from page 6)

Safety and tolerability profiles were positivewith reported adverse events similar toplacebo. Efficacy data demonstrated thatthe median time to healing for the treat-ment group was 113 hours versus 148hours for the placebo group (p= 0.02). Thesub-group of participants who were treatedat the first visible onset of infection dis-played a time to healing of 71 hours versus120 hours for the placebo group (p= 0.03).Transport plans to conduct additional phaseII trials in the next year.

Neurology

Schering AG/Berlex Laboratoriesissued positive results from a phase IIIstudy of Betaseron for the treatment ofmultiple sclerosis. This international,multi-center, double-blind, randomizedtrial, dubbed BENEFIT, enrolled 487subjects who presented with a singleclinical episode suggestive of MS. At theonset of this episode subjects receivedsubcutaneous injections of Betaseron(250 mcg), or placebo, every other dayfor up to 24 months. Data revealed thatsubjects in the Betaseron treatmentgroup had a 50% reduced risk of devel-oping clinically definite MS comparedwith the placebo group. Additionally,subjects in the treated group were twotimes better protected against develop-ing MS, as defined by the McDonalddiagnostic criteria, than those in theplacebo group. An sBLA, requesting an

expanded label for Betaseron, is cur-rently under review by the FDA.

Obstetrics/Gynecology

Ferring Pharmaceuticals reported posi-tive results from two phase I trials ofActyve transdermal patch, which deliv-ers a peptide through pulses, for the treat-ment of infertility. The first trial enrolled 45healthy women who received the peptide atvarious dose levels using the Actyve patch,subcutaneous injections or intravenousinjections, delivered in multiple daily dosesfor up to 21 days during the 28-day cycle.Plasma concentrations of the subjects indi-cated Actyve as a potential way to deliverthe peptide. The second study enrolled 50healthy women who received the peptide invarious doses via the Actyve patch or subcu-taneous delivery, for the same treatmentcycle. Plasma profiles indicated that thosereceiving the peptide via the patch achievedpotentially therapeutic levels and providedsharper profiles than the subcutaneousdelivery. No unexpected adverse eventsoccurred in either trial. Ferring planned tocommence phase II trials in the near term.

Oncology

Pharmexa issued negative results from aphase II trial of PX104.1, in combinationwith QS-21, for the treatment of breastcancer. This trial planned to enroll 40 sub-

jects who were to receive four initial immu-nizations of PX 104.1 (1.25mg), formulatedwith Alhydrogel adjuvant and mixed withQS-21 adjuvant, for six weeks, followed bybooster immunizations every four weeks, forup to 26 weeks. Preliminary results from thefirst 10 vaccinated subjects demonstratedthat this formulation failed to meet thetrial’s primary endpoint of objective tumorresponse. The vaccine did not slow downtumor growth and cancer progressed in all10 subjects. Based on these results the trialwas stopped. Pharmexa intended to analyzefurther data for possible expansion into adifferent patient population.

Raven Biotechnologies, reported positivepreliminary results from a phase I trial ofRAV12 for the treatment of adenocarcino-mas. Data has been evaluated from threetreatment cohorts of 21 subjects whoreceived RAV12, intravenously, in weeklyescalating doses of 0.3 mg/kg to 1.5 mg/kg,for over four weeks. Safety and tolerabilityoutcomes established a maximum tolerateddose with associated side effects of infu-sion-associated abdominal discomfort andliver function test abnormalities. Abdominaldiscomfort and liver function test abnormali-ties were transient at lower dose levels.Preliminary efficacy data revealed that treat-ment with RAV12 led to one subject achiev-ing partial remission and three subjects withstable disease. In two subjects time to dis-ease progression surpassed four months.The phase I trial was ongoing at this time.


http://www.clinicalfinancialservices.com


Biotech Review

Shares of Durham, N.C.-based Icagenplunged 73.6% Aug. 4 following news thatan independent Data Monitoring Committeerecommended the company stop treatinghalf the patients in a phase III trial of ICA-17043 for sickle cell disease. Falling $3.12,the stock (NASDAQ:ICGN) ended the day at$1.12 – setting a new 52-week low for acompany that priced at $8 its initial publicoffering of five million shares only 18months ago. The DMC found no specificsafety issues with the trial in its interimanalyses, but suggested that the companycontinue enrolling only those patients receiv-ing concurrent hydroxyurea, an antineoplas-tic drug used in hematological malignancies.For patients not on hydroxyurea about 50%of those enrolled so far the DMC recom-mended the drug be discontinued and thatpatients proceed to the end of the followupperiod. The trial, called ASSERT (A StratifiedSickle Event Randomized Trial), began inFebruary 2005, only a few weeks afterIcagen conducted its $40 million IPO.

PDL BioPharma, of Fremont, Calif., is antic-ipating further discussions with the FDA fol-lowing a phase III miss of its vasoactive pep-tide, terlipressin, in patients with Type I hepa-torenal syndrome. Though the top-line resultsindicated a positive trend, they failed toshow statistical significance in kidney func-tion and survival against Type I HRS, a poten-tially fatal complication arising from

advanced liver disease. The data will be further analyzed, and PDL and partner,Orphan Therapeutics LLC, of Lebanon, N.J.,expect subsequent discussions with the FDAbefore deciding on a course of action. Thecompany inherited U.S. and Canadian rightsto terlipressin as part of its 2005 acquisitionof Edison, N.J.-based ESP Pharma The trial,conducted by Orphan, randomized 112patients with Type I HRS to receive terli-pressin or placebo every six hours until eithera reversal of HRS was noted or the end ofthe 14-day treatment period. As of June 30,PDL had cash, cash equivalents and mar-ketable securities totaling $414.3 million.

A Conforma Therapeutics spinout, barelythree months old, closed a $27.5 millionSeries A financing to cover phase II trials ofits only product, Calsed, to treat small-celllung cancer. The San Diego-based company–Cabrellis Pharmaceuticals–emergedfollowing the $250 million May acquisitionof Conforma by Biogen Idec, ofCambridge, Mass.

BioCryst Pharmaceuticals., ofBirmingham, Ala., is set to begin a pivotaltrial of its lead cancer compound, Fodosine(forodesine hydrochloride), by the end of thisyear after agreeing to a special protocolassessment from the FDA. The study willevaluate two formulations of the drug simul-taneously, an intravenous version for early,

acute treatment followed by maintenancetherapy with an oral form of an equivalentdose. Fodosine, a transition-state analogueinhibitor that targets the purine nucleosidephosphorylase (PNP) enzyme, will be testedin about 100 patients who have failed twoor more previous induction therapies foracute lymphoblastic T-cell leukemia/lym-phoma. The multicenter, open-label, nonran-domized, repeat-dose study is designed todetermine the rate of complete remissionachieved with that regimen of Fodosine asthe primary endpoint.

In its first venture financing round, NanoBiosecured $30 million in private equity to sup-port ongoing development of its nanoemul-sion-based therapies for infectious diseases.The company has received the first of three$10 million tranches from Washington-basedprivate equity fund management companyPerseus, and expects to receive the remain-ing funds for completing certain clinical mile-stones.

Copyright © 2006 CenterWatch. Duplication of this publication is prohibited.

From BioWorld TodayThe stories included in Biotech Review havebeen provided to Thomson CenterWatch with full permission from Thomson BioWorld,the publisher of BioWorld Today. Copyright © 2006 Thomson BioWorld.

Thomson BioWorld is located at 3525Piedmont Road, Building 6, Suite 400,Atlanta, GA 30305 U.S.A. Please call (800)688-2421 or (404) 262-5476 for more information. Or visit www.bioworld.com

http://www.centralabs.com

T H O M S O N C E N T E R W A T C H

What’s new in this edition?

■ About 150 new slides with hundreds more updated from the 2005 edition

■ 2005 Year in Review

■ Drug Pipeline activity and updates on a dozentherapeutic areas (Breast

Cancer, GERD, Parkinson’sDisease, Prostate Cancer, Type 1 Diabetes, etc.)

■ Index of charts, tables and companies mentioned

The State of the Clinical Trials Industry is back with a 2006 edition filled with 400 pages of detailed insight into the trends and history impacting the clinical researchindustry. It contains 440+ up-to-date charts and graphs, 2005 Year in Review and important articles relating to each chapter topic.

State of the Clinical Trials Industry 2006 includes data on:

■ World-wide sales (pharmaceutical, medical device and biotech)

■ Overall R&D spending and cycle times

■ U.S. and world-wide clinical research spending

■ Causes and costs associated with delays

■ Trial success based on company size NEW

■ CRO market size, growth, costs and performance

■ Site perceptions of sponsors and CROs

■ Regulatory Submissions and Approvals NEW

The State of the Clinical Trials Industry

2006 is an ideal resource for learning about and tracking the clinical researchindustry, creating dynamic data-driven presentations, and preparing businessplans and marketing strategies.

To order your copy for only $499, call (800) 765-9647 and ask for code 59424 or complete the order form on the backof this flyer and and fax it back to us at(617) 856-5901.

To view the table of contents and a few sample pages, visit the ProfessionalBookstore at www.centerwatch.com.

State of the Clinical Trials Industry 2006

former head of german cro imform sentenced for ... - scimega€¦ · what is scimega’s...

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