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The AccessCR Update Keeping Clinical Research Professionals

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The AccessCR Update Keeping Clinical Research Professionals ...

    The AccessCR Update

    Keeping Clinical Research Professionals Informed

     9 Mar 2009

    This Update is FREE to anyone with a professional interest in Clinical Research.

    If you are viewing this information online, please CLICK HERE to register to receive your own

    copy hot off the presses by email.

    Purpose of this update

    This Update is a collation of international articles that AccessCR has identified over the past 2 weeks designed to help those with a professional interest in clinical research stay abreast of the challenges, opportunities, and stories shaping the

    reputation and future directions of the clinical trials industry. While AccessCR provides the occasional editorial comment, we generally leave readers to do their own research and draw their own conclusions about the information presented.

    Please feel free to share this Update, and register to receive it directly (if you haven’t already) on our website.

    Disclaimers: Information presented does not reflect the views and opinions of AccessCR. AccessCR does not have the resources to establish the integrity or bias of authors/media, so subscribers should use their own research if they wish to

    further validate the information provided. AccessCR has no control of the content of websites linked to in this Update. AccessCR has not been paid to include any of the information in this Update, unless clearly indicated as a sponsored link.

    Any editorial comments from AccessCR are made in italics.

    Contents Other Links:

    ? AccessCR MD's Summary

    ? Register to receive this FREE ? Common Abbreviations in use in this Update Update for Clinical Research

    ? Regulatory News (related to clinical research) Professionals Fortnightly

    ? Drugs or Trials Recently Halted, Delayed or Abandoned ? Visit the AccessCR MD's Blog

    ? Trials Just Starting * NEW ? Register for the FREE Quarterly

    AccessCR Clinical Trials ? Public Perceptions, Patient Recruitment and Patient Retention Related Newsletter for the Australasian

    General Public ? General News Articles & Blog posts originating from:

    ? Get Access to Previous ? Generic

    Updates o US

    ? Learn more about AccessCR o UK

    o Rest of Europe ? Find out about AccessCR's o Australia/NZ other Professional Services o China

    o India ? Contact AccessCR

    o Africa ? Join AccessCR on Facebook ? Pharma/Biotech/CRO News and Announcements

    ? Follow AccessCR on Twitter ? Journal Articles

    ? Want to know more about ? Websites to keep an eye on... AccessCR's MD? Visit Janelle's

    ? Training Courses LinkedIn Profile.

    ? Positions Vacant

    ? Coming Events

    ? Time Out: Adding some Work-Life Balance

___________________________________________________________________________________________________________________ ?AccessCR Professional’s Update 9 Mar 2009. Page 1 of 12

    Quick Summary from Janelle Bowden, Managing Director of AccessCR.

Welcome to our new subscribers since the last Update.

Thanks to all those that helped spread the work and contributed to our Burns Research fundraising initiative. We will be

    making a donation of $500 to a research unit in the near future, so will let you know as soon as the recipient is identitied.

The second annual AccessCR Clinical Trials Honour Roll will be launched in our next update, giving all the stakeholders that

    have contributed to clinical trials in Australasia over the past year, (including volunteers, clinical research professionals, sponsors, service providers, funders, ethics committees, etc) an opportunity to get recognised for their

    contribution. Sponsorship opportunities are NOW AVAILABLE. Click here for more details.

As for other news, there is no real earth-shattering news stories this past fortnight to my mind, but here's a few picks to get

    you started...:

    ? The FDA taking regulatory action against a Ranbaxy plant in India for fraud [See under Reg news - US, and General

    News - US].

    ? A sex scandal, with a former AZ executive facing legal action over affairs that are claimed to have possibly influenced

    trial results. [See under General News - US].

    ? There's been a number of stories on the use of technology in recruiting trial volunteers [See under Public perceptions,

    Patient recruitment, etc and Journal Articles].

    ? Roche and Genentech continue their wrangling, and commercial organisations remain under pressure. [See under

    Pharma News].

    I've added a new section this update on trials reportedly just starting. Please let me know what you think, and if this is useful information for you.

I hope you find something interesting below. If you have any jobs, services, training courses, conferences etc you would like

    to make known to the Update's readership, or trials for the community, please contact us to discuss the advertising

    opportunities.

[If you have a problem accessing PharmaTimes articles, register FREE on their website to access them directly. Note:

    AccessCR has no connection to or co-marketing arrangements with PharmaTimes.]

Common Abbreviations in use in this Update

CRO Contract/Clinical Research Organisation

    DTC Direct To Consumer

    EC European Commission

    EDC Electronic Data Capture

    EEA European Economic Area

    EU European Union

    FDA The US Food and Drug Administration

    GCP Good Clinical Practice.

    ICH International Conference on Harmonisation of Technical Requirements for Registration

     of Pharmaceuticals for Human Use

    IRB Institutional Review Board

    Medsafe The New Zealand Medicines and Medical Devices Safety Authority MHRA The UK Medicines and Healthcare products Regulatory Agency NHMRC The Australian National Health and Medical Research Council NHS The UK National Health Service

    OHRP The US Office for Human Research Protections

    PHARMAC The New Zealand Crown entity that manages the NZ Pharmaceutical Schedule RDC Remote Data Capture

    SFDA The drug, food and cosmetics regulatory authority for China TGA The Australian Therapeutic Goods Administration

    WHO The World Health Organisation

     Regulatory News - US, Europe, Australia and beyond

    ? US

     New FDA Documents released:

___________________________________________________________________________________________________________________ ?AccessCR Professional’s Update 9 Mar 2009. Page 2 of 12

    ? DRAFT Guidance for Industry: Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological

    Products Content and Format. This guidance is intended to assist applicants in preparing the Clinical

    Pharmacology section of product labeling to meet the requirements of FDA regulations (21 CFR 201.57) and to

    facilitate communication about this sometimes complicated labeling information. Feb 2009.

    ? An opportunity for public comment on requirements under which the clinical investigation of the safety and

    effectiveness of unapproved new drugs and biological products can be conducted. Specifically: (1) Whether the

    proposed collection of information is necessary for the proper performance of FDA's functions, including whether the

    information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of

    information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility,

    and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on

    respondents, including through the use of automated collection techniques , when appropriate, and other forms of

    information technology. 10 Feb 09.

     The FDA is announcing a public workshop regarding scientific issues in clinical trial design for hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP). 31 Mar 09 and 1 Apr 09, Silver Spring, Maryland.

     The FDA Takes New Regulatory Action Against Ranbaxy’s Paonta Sahib Plant in India. Press release, 25 Feb 09.

     New Interview with Dr. Rachel Behrman, Associate Commissioner for Clinical Programs Director, Office of Critical Path

    Program. FDA.

    ? MHRA / EMEA / EC / EU

     The EMEA have published their 2009 Work programme. 27 Feb 09.

     The EMEA today played host to EFPIA, the voice of the research-based pharmaceutical industry in Europe, for their 14th

    joint annual Information Day. Applied Clinical Trials, 26 Feb 09.

    ? Australia/NZ

     The TGA currently has 13 EU guidelines recommended for adoption, and 1 for non-adoption. Comments due by the 10 Apr 09.

     The TGA have released Draft Guideline for Levels and Kinds of Evidence for Listed Medicines with Indications and Claims

    for Weight Loss. Comments due by 3 Apr 09.

     The TGA have released a Draft Guidance document on the regulation of custom made medical devices. Comments are due by 31 Mar 09.

     Drugs and Trials Halted, Delayed, Failed or Abandoned.

     Takeda Pharmaceutical Co faces a delay in getting alogliptin to market after US regulators said that they need more data to

    evaluate the Japanese drugmaker’s experimental type 2 diabetes drug. PharmaTimes, 6 Mar 09.

     Opko Health have terminated a Phase III clinical trial of Bevasiranib for wet age-related macular degeneration as preliminary results indicated the trial was unlikely to meet its primary end point. South Florida Business Journal, 6 Mar 09.

     Sepracor drug Lunesta fails in anxiety trial. Business Week, 6 Mar 09.

     Pharmos cuts size of Phase IIb clinical trial of Dextofisopam for Irritable Bowel Syndrome mid recruitment. Israel Business News, 5 Mar 09.

     FDA Removes Clinical Hold From Aastrom Phase II IMPACT-DCM Clinical Trial. Compliance Home, 5 Mar 09.

     Catalyst Pharmaceutical Partners is scaling back one of its ongoing clinical trials for the drug CPP-109 (for the treatment of methamphetamine addition) from a Phase II to a proof-of-concept study in order to make cash reserves last a little longer.

    Bizjounrals.com, 3 Mar 09.

     Synta Pharmaceuticals has stopped the Phase III Symmetry trial comparing elesclomol in combination with paclitaxel to

    paclitaxel alone in chemo-naive patients with stage IV metastatic melanoma after an independent data monitoring committee

    identified safety concerns. PharmaTimes, 2 Mar 09.

___________________________________________________________________________________________________________________ ?AccessCR Professional’s Update 9 Mar 2009. Page 3 of 12

     U.S. regulators have declined to approve Genzyme Corp's new Lumizyme treatment for Pompe disease. Reuters, 2 Mar 09.

     Amicus Therapeutics Inc said a clinical hold had been placed on a mid-stage trial of its experimental treatment for a rare

    muscle disorder after two patients experienced serious adverse events and subsequently withdrew from the trial. Reuters, 27

    Feb 09.

     FDA denies approval for Somaxon sleep drug Silenor. Fierce Biotech, 27 Feb 09.

     Basilea Pharmaceutica Ltd. has announced it has halted the EC decision process on Zevtera (ceftobiprole) for the treatment of complicated skin and soft tissue infections pending completion of EMEA GCP inspections. Fox Business 26 Feb 09.

     Pfizer has dropped the development of 2 phase III candidates, esreboxetine for fibromyalgia and PD332334 for generalised anxiety disorder (GAD) after a review of data. In Pharma Technologist, 25 Feb 09.

     MAP Pharmaceuticals Inc experimental treatment (Unit Dose Budesonide) for asthma in children failed a late-stage study. CNN Money, 23 Feb 09.

     Takeda terminates the phase III trial of its investigational compound (TAK-242) for severe sepsis treatment. PharmaTimes, 23 Feb 09.

     Arana Therapeutics Ltd has discontinued clinical development of PMX53 for ocular indications based on insufficient activity. Press release, 19 Feb 09.

Trials Just Starting

(This list is not guaranteed to be exhaustive).

    Phase Treatment Indication Company 1 GTx-758 (an oral luteinizing hormone Men with advanced prostate cancer. Placebo GTx

    inhibitor) controlled, healthy volunteers study

    1 PLX-PAD (placenta-derived stem Treatment of Critical Limb Ischemia (CLI), the Pluristem Therapeutics Inc.

    cells) end stage of peripheral artery disease (PAD) 1 Systemic delivery of AVI-4658 (RNA-Duchenne muscular dystrophy (DMD) AVI BioPharma, Inc.

    based exon skipping drug)

    1 A0001 Mitochondrial diseases Penwest

    1 AE37 (an immunotherapeutic Combination therapy approach for breast and Generex

    vaccine) ovarian cancer patients

    2 Topically applied ESBA105 (a single-Patients with acute anterior uveitis ESBATech AG

    chain antibody fragment directed

    against TNF-alpha)

    2 Nasulin (intranasal insulin) vs placebo Type II Diabetes CPex Pharmaceuticals

    2 oral deforolimus (an mTOR inhibitor) Advanced non-small cell lung cancer Merck/Ariad

    2 TB-402 (long-acting anticoagulant) Prophylaxis of Deep Vein Thrombosis Thrombogenics/BioInvent

    following orthopaedic surgery International

    2 Aerovant (inhaled dry powder) Uncontrolled asthma Aerovance Inc

    2 MORAb-009 (a monoclonal antibody) First-line treatment for patients with Morphotek/Eisai

    plus pemetrexed and cisplatinum mesothelioma

    2 Hookworm infestation Multiple sclerosis University of Nottingham/MS

    Society

    2 XOMA 052 (a monoclonal antibody Rheumatoid arthritis XOMA Ltd.

    targeting IL-1 beta)

    2 SRD174 cream Pruritus associated with atopic dermatitis Serentis

    2 TissueGene-C (TG-C) (localized Severe osteoarthritis of the knee TissueGene, Inc/ Kolon Life

    delivery of allogeneic human cells Science, Inc.

    expressing TGF-beta1 in order to

    induce the regeneration of cartilage)

    ___________________________________________________________________________________________________________________ ?AccessCR Professional’s Update 9 Mar 2009. Page 4 of 12

    2 NXL104 (injectable Hospitalized patients with complicated intra- Novexel

    antibacterial)/ceftazidime abdominal infections

    2 MLN8237 (an oral, selective Aurora A Adult patients with aggressive non-Hodgkin’s Millennium/Takeda

    kinase inhibitor) lymphoma (NHL)

    2 MLN8237 (an oral, selective Aurora A Patients with acute myelogenous leukemia Millennium/Takeda

    kinase inhibitor) (AML) and high-risk myelodysplastic

    syndrome (MDS)

    2/3 arimoclomol (molecular chaperone A subset of patients with the inherited or CytRx Corporation

    regulator) familial form of amyotrophic lateral sclerosis

    (ALS or Lou Gehrig's disease)

    3 116E (Rotavirus vaccine) Severe dehydration and diarrhoea in infants Bharat Biotech

    and young children

    3 Syncria (albiglutide) Type II diabetes GlaxoSmithKline Other Muscle Pattern Recognition (MPR) Assessment of muscle function that can Impact Medical Solutions

    tool assist in the diagnosis and treatment of back

    and neck injuries and illness

    Other Transoral gastroplasty Incision-free procedure for the treatment of UCSF Medical Centre

    obesity

    Other LINX Reflux Management System (a Gastroesophageal reflux disease (GERD) Torax Medical, Inc

    magnetic device)

     Public Perceptions, Patient Recruitment and Patient Retention Related

(See also section Journal Articles)

     Companies turn to web 2.0 to recruit for trials. FierceBiotech, 3 Mar 09.

     Social Networking Sites have a myriad of trial-related uses. eCliniqua, 2 Mar 09.

     Recruitment barriers in a randomized controlled trial from the physicians' perspective - A small postal survey. 7th Space, 2 Mar 09.

     The American Medical Association, the American College of Physicians and others have declared unethical the practice of

    paying doctors "finder's fees" for recruiting patients as clinical research subjects. But only half of IRBs address in writing the

    conflict of interest these kinds of payment incentives pose. American Medical News, 2 Mar 09.

     Pilot projects aim to ease access to clinical data in order to help identify potential trial volunteers. Nature Medicine 15, 226 (1 March 2009) [Full Article only available to Nature subscribers, or with a payment].

     Online Personal Health Records, Clinical Trials and Pharma Search Engine Marketing Pharma Marketing Blog, 26 Feb 09.

     Letters To The Editor Address Recent Editorial Related To Black Parents' Reluctance To Enroll Their Children Into Clinical

    Trials. Medical News Today, 25 Feb 09.

     Study Finds Patients To Be Untapped Resource For Improving Care. Medical News Today 23 Feb 09. [AccessCR: Study finds reminding patients of importance colorectal screening prompted more appointments for screening, than leaving it up to

    doctors alone to inform patients. Is there any reason a similar campaign couldn't be used to improve trial recruitment?]

[AccessCR: With over a thousand visits to the AccessCR Find Trials page each month, and more than 500 now registered on

    our potential trial participant database, could promoting your trials through AccessCR complement your other recruitment

    initiatives, cost effectively?]

Other General News Articles / Blogs:

    ? Generic or World-wide relevance

     CRIX is Operating and Launching FIREBIRD Pilot. (FIREBIRDan acronym for Federal Investigator Registry of Biomedical Information Research Datais an application designed to enable sponsors of clinical trials, the National Cancer Institute

    (NCI), and FDA to manage clinical investigator information required for documentation on Statement of Investigator form

    ___________________________________________________________________________________________________________________ ?AccessCR Professional’s Update 9 Mar 2009. Page 5 of 12

1572, in a fully secure, electronic environment.) Bio-IT World 6 Mar 09.

     Global Scientists Call For Greater Transparency Of Registered Clinical Trials On Endometriosis. Reference to a paper to be publised in Human Reproduction. Medical News Today, 5 Mar 09.

     Pharma Consolidation slos CRO market in short term. Centrewatch Monthly, 5 Mar 09. Also in the same edition: CROs oncology focus grows, and EU CRO's off to a running start in 2009.

     Outsourcing-pharma podcast interview with Frost & Sullivan analyst Barath Shankat giving his opinion on the state of the contract research sector and predictions of how it will develop. 5 Mar 09.

     The Role of Business Intelligence in Clinical Trial Automation. B-eye Network, 3 Mar 09.

     Industry Standard Research has launched a report "The 2009 CRO Quality Benchmarking Study" providing a comprehensive assessment of CRO delivery quality. Marketwatch press release, 2 Mar 09.

     How Open Source EDC Can Make Clinical Trials More Productive Openclinica Blog, 28 Feb 09.

     ICR/EMWA conference on writing clinical trial protocols: Audio wrap-up CRFocus Blog, 26 Feb 09. [AccessCR: Also here you can look at other posts on the same conference.]

     Emerging Markets offer promise and challenge to the pharmaceutical industry: Investor Report. PharmaLive, 26 Feb 09.

     Patient Adherence Programs: Components of Effective Targeting Models. B-eye Network, 26 Feb 09. [AccessCR: This is about compliance in general but might have some relevance to clinical trials.]

     The Press Release Then, Now and Tomorrow. The latest avenue... a Social Media Release. Eye on FDA Blog, 25 Feb 09.

     Pharma staffers feeling insecure and 'overloaded'. FiercePharma, 23 Feb 09.

     Following a successful pilot, the Institute of Clinical Research (ICR) has announced the date of its first Global GCP

    Certification exam as Thursday 23rd April 2009. Medical News Today, 21 Feb 09.

    ? US

     The American Medical Association Foundation has announced the 28 recipients of the 2009 Seed Grant Research Program

    which provides $2,500 grants to medical students, physician residents and fellows to conduct basic science, applied or clinical

    research projects. PRNewswire, 6 Mar 09.

     Obama in a hurry; comprehensive health reform by end of 2009. PharmaTimes, 6 Mar 09.

     Patients can sue drugmakers over label warnings, US Supreme Court rules. PharmaTimes, 5 Mar 09.

     Everybody Loves Sanofi's Giant Human Colon. A marketing stunt with a difference - a 20-foot long, walk-through model of a human colon in NYC’s Times Square. BNet Pharma, 5 Mar 09.

     A profile of Nextrials, the EDC company, and where it is heading in the electronic health records space. Clinpage, 5 Mar 09.

     Obama picks Sebelius and DeParle to head US healthcare. Nature blog, 2 Mar 09.

     Related: Pharma hails Obama’s ―strong‖ choices for health chiefs. PharmaTimes, 4 Mar 09.

     SAS Drug development released an on-demand online version of its software. Clinpage 4 Mar 09.

     Sticker shock may open innovation in pharma. Proposals advocating ―open‖ or ―collaborative‖ innovation in pharma R&D are

    suddenly cropping up throughout the pharma industry in a variety of forums and iterations. In Vivo Blog, 4 Mar 09.

     Is Biopharma A "Buy"? A discussion of the massive selling of biopharma stocks in the wake of President Obama's plans.

    CNBC 27 Feb 09.

     Obama outlines plans for highly radical healthcare reforms, including the introduction of universal healthcare in the USA and

    creation of a workable biogeneric pathway. PharmaTimes, 27 Feb 09.

     How Does a Doc Really Use An Electronic Medical Record? A short video explores the question. WSJ Health Blog, 27 Feb

    09.

     Ignore a form 483? Not wise say FDA. InPharma Technologist, 26 Feb 09.

    ___________________________________________________________________________________________________________________ ?AccessCR Professional’s Update 9 Mar 2009. Page 6 of 12

     Drug Maker (Forest Laboratories) Is Accused of Fraud by the US Justice Department. The NY Times, 25 Feb 09.

     AstraZeneca's Sex-for-Studies Seroquel Scandal: Did Research Chief Bias the Science? Lawsuit claims AZ’s former US medical director for Seroquel and director clincial research in CNS had affairs with a clinical researcher who authored

    publications favorable to Seroquel, and a medical marketer who promoted Seroquel through medical publications and other means, which may have biased the science. BNet Pharma, 25 Feb 09.

     FDA gets funding boost and task list for 09. InPharma Technologist, 24 Feb 09.

     Ranking of 20 Drug Companies' Sales Forces Shows Productivity Flat or Declining. BNet Pharma, 24 Feb 09.

     TGaS Advisors' vice president Gary McWalters believes the drug industry must rethink its approach to regulatory

    compliance and how it works with healthcare professionals. Outsourcing Pharma, 24 Feb 09.

     Venture capital for MedTech "somewhat resilient", with a 18% drop in 2008. Medical Devices Today, 23 Feb 09.

     The Biotech Industry Finally Turns a Profit. BNet Pharma, 23 Feb 09.

    ? UK

     UK worst hit in Europe by pharma industry cutbacks. In total it is estimated that the UK industry has cut 11-15% of jobs across all divisions over the last two years. Pharmafocus, 5 Mar 09.

     Bionic eye gives blind man sight. BBC News, 4 Mar 09.

     As UK Funding Withers, Biotechs Look to Charities to fund research. Bio-World Today, 4 Mar 09.

     Hard to swallow. A look over the use and evidence for new treatments over the ages. Ft.com, 28 Feb 09.

     The British government and the Bill & Melinda Gates Foundation recently awarded more than 90 million British pounds in

    grant money to continue development on microbicides for HIV prevention. Medical News Today, 25 Feb 09.

     Roche has been allowed to rejoin the ranks of the ABPI, after its six-month suspension for bringing discredit on the pharma

    industry. Pharmafocus, 23 Feb 09.

    ? Rest of Europe

     Synexus opens clinical trial site in Bulgaria. PharmaTimes, 25 Feb 09.

     Irish clinical research infrastructure needs more attention. PharmaTimes, 23 Feb 09.

    ? Australia and New Zealand

     Australian Health Ministers’ Conference Joint Communiqué 5th March 2009 including final results for last year’s blitz on

    elective surgery waiting times.

     New magazine targets Australian patients waiting to see their GP. RACGP Press release, 4 Mar 09.

     Web tangles healthcare. Researchers are only beginning to appreciate how information on the web can be used to help inform a patient in ways that augment, rather than replace, actual consultations with doctors, nurses and pharmacists. NZ

    Herald, 4 Mar 09.

     Shaun Holt: Our (NZ) ethics system is now so unwieldy, it's unethical. NZ Herald, 2 Mar 09.

     The Australian Government today announced the appointment of Dr Joe Smith as the new Gene Technology Regulator from

    23 March 2009. Press release, 2 Mar 09.

     Nanotechnology and Social Inclusion report released - Australia. Government press release, 26 Feb 09.

     Funding health research. Barack Obama’s injection of US$10 billion into health and medical research as part of a new stimulus package is a signpost for Australian efforts to stimulate our economy. Research Australia's CEo comments on the

    Australian government exclusion of health and medical research from its stimulus packages. Lab Online, 25 Feb 09.

___________________________________________________________________________________________________________________ ?AccessCR Professional’s Update 9 Mar 2009. Page 7 of 12

     The HoMER consultation ended 20 Feb 09 with 50 submissions reported. For the latest HoMER news, see the February HoMER Newsletter.

     The Australian Government has committed $10 million within Enterprise Connect to support the placement of researchers

    from universities or public research agencies into businesses where it is identified that such a placement would help to

    develop and implement a new idea with commercial potential. Funding of 50 per cent of a researcher's salary, to a maximum

    of $50,000, is available under the Australian Government's new Researchers in Business program.

     For every dollar the federal government spends on skin cancer prevention, it saves more than double the amount in reduced healthcare costs, research shows. Medical Search, 23 Feb 09.

    ? China

     China Biotech in Review: Almost-Deals and Earnings. Seeking Alpha, 8 Mar 09.

     Beijing leads nation in longevity with 80-year average lifespan. China View, 6 Mar 09.

     The People's Republic of China has made several amendments to its patent laws aimed at encouraging innovation and improving international competitiveness which will come into effect on 1 October 2009. Nature Reviews Drug Discovery8, 186-187 (March 2009)

    ? India

     Pfizer, Sanofi vie for Wockhardt biotech. India Economic Times, 6 Mar 09.

     India has announced plans to make the country ―one of the top five global pharmaceutical innovation hubs‖ and create 500,000 new jobs in the sector within the next four years. PharmaTimes, 2 Mar 09.

     The US FDA has stated that a facility owned by India-based Ranbaxy Laboratories ―falsified data and test results in approved

    and pending drug applications‖. PharmaTimes, 26 Feb 09.

     MSD India, Merck & Co’s local subsidiary, plans to recruit an additional 300 staff this year to help it gear up for the launch of new vaccines for rotavirus, hepatitis A and herpes. In Pharma Technologist, 24 Feb 09.

     Law in offing to tighten regulation of clinical trials. The Times of India, 23 Feb 09.

    ? Africa

     Pfizer Close to Settling Trovan Case in Nigeria? Perhaps Not. BNet Pharma, 6 Mar 09.

     Central African countries have formed a network to promote excellence in clinical trials in the region, with ?3m of EU funding being used to improve HIV, malaria and tuberculosis research. Outsourcing Pharma, 26 Feb 09.

Pharma/Biotech/Device/CRO/Generics News or Announcements

     Roche Raises Bid for Genentech to $93 a Share. NY Times, 6 Mar 09.

     Related: Genentech challenges Roche, saying it will debate its financial model ―anywhere, anytime with anyone.In Pharma Technologist, 3 Mar 09; Genentech gives long-term forecast to fend off Roche. CNN Money, 2 Mar 09.

     B-MS signs $385 million atrial fibrillation drug deal in Japan. PharmaTimes, 6 Mar 09.

     Sanofi-Aventis CEO Looks to Cut Research Spending. The budget for early-stage research may be cut in half in favour of partnering with small companies developing drugs. WSJ Health Blog, 6 Mar 09.

     With biotechs under pressure, Bradmer Pharmaceuticals has opted to cut back by cutting 13 jobs--70 percent of its staff--suspending enrollment in a clinical trial and shelving the contract manufacturing of Neuradiab, an experimental therapy for

    brain cancer. Fierce Biotech, 5 Mar 09.

     Vertex Pharmaceuticals is buying Canada’s ViroChem Pharma in a $377 million deal that will further strengthen its position in the field of hepatitis C. PharmaTimes, 5 Mar 09.

     Tigermed, MacroStat forge Chinese CRO alliance. PharmaTimes, 4 Mar 09.

     CEO Baker puts in offer for Life Sciences Research. PharmaTimes, 4 Mar 09.

    ___________________________________________________________________________________________________________________ ?AccessCR Professional’s Update 9 Mar 2009. Page 8 of 12

     Pfizer has signed a deal with India’s Aurobindo Pharma which will see the drugs giant significantly expand its generics operations in the USA and Europe. PharmaTimes, 4 Mar 09.

     Bayer hits earnings target for 2008 amid turbulent economy. PharmaTimes, 3 Mar 09.

     PharmaNet net earnings plummet 56% in Q4. PharmaTimes, 2 Mar 09.

     Xencor and Pfizer Enter into Antibody Technology Licensing Agreement. Centredaily.com, 2 Mar 09.

     Ruth McKernan, Chief Scientific Officer of Pfizer Regenerative Medicine discusses Pfizer's move into stem-cell-based therapies. Nature Reviews Drug Discovery 8, 188 (March 2009)

     Cephalon launches a takeover bid valued at $207 million for Australian biotechnology company Arana Therapeutics. CNBC.com, Reuters, 27 Feb 09.

     Related: ARANA Therapeutics chairman responds to criticism of the $1.40 Cephalon offer. Biotechnology News, 5 Mar 09.

     Omnicare's CRO Division Holds Steady. Clinical Trials Today, 27 Feb 09.

     Elan cuts 14% of workforce as 230 jobs go in Ireland and USA. PharmaTimes, 26 Feb 09.

     Kendle earnings hit by computer programming error that caused problems in one of its client's clinical trials. Outsourcing

    Pharma, 26 Feb 09.

     Icon Clinical's revenues advance by nearly 22 per cent in Q4 2008, but share price slides a little as investors got the jitters over the firm’s cautious predictions for 2009. Outsourcin Pharma, 26 Feb 09.

     Quintiles has been named in TRAINING magazine’s ―Training Top 125‖, the publication’s annual report that ranks

    companies based on their employer-sponsored training and development programs. Listed at number 80, Quintiles is the only

    major CRO in the 2009 rankings. Press release, 26 Mar 09.

     Sanofi-Aventis all but wraps up its 1.8 billion euro acquisition of Czech generics drugmaker Zentiva and sets up a strategic

    alliance with the USA’s Salk Institute for Biological Studies that will focus on regenerative medicine. PharmaTimes, 25 Feb

    09.

     Medtronic Inc. plans to reduce its global workforce in the coming fiscal year, CEO Bill Hawkins said at an employee meeting

    Tuesday. He did not offer specifics. Star Tribune, 24 Feb 09.

     Related: Medtronic to Report Pay to Doctors Who Get $5,000 Annually. WSJ Health Blog, 24 Feb 09.

     Medtronic buys CoreValue + Ventor Technologies spending $1.03 billion. domain-b.com, 24 Feb 09.

     Merck KGaA to buy fertility specialist MediCult for $55 million. PharmaTimes, 24 Feb 09.

     Shire looks at Japanese expansion and deals elsewhere. PharmaTimes, 23 Feb 09.

     CSL sees FY profit up to $1.06bn, says not hurt by crisis. Business Spectator, 18 Feb 09.

    Journal Articles and References

     Times...they are a-changing. An overview of the messages at IIR’s Clinical Trials Congress this year, held in Philadelphia on

    February 10-11. Applied Clinical Trials, 6 Mar 09.

     Clinical Research Employment Trends Toward Independent Working. Applied Clinical Trials, 5 Mar 09.

     Stephen Friend and Eric Schadt reveal their vision for an open-access platform in medical research. Nature 458, 13 (4 Mar 09)

     Global Patient Recruitment. PharmaVoice Mar 09. [It looks like you need to pay for the article, but on the left hand side there

    are links to view the issue/article free, at least temporarily.]

     Clinical trial participation poses ethical, practical issues (for physicians). A discussion of the issues around trial payments.

    Canadian Medical Association Journal, March 3, 2009; 180 (5). doi:10.1503/cmaj.090131.

     Steps and Time to Process Clinical Trials at the Cancer Therapy Evaluation Program. JCO 2 Mar 09. [AccessCR: Looks like ___________________________________________________________________________________________________________________ ?AccessCR Professional’s Update 9 Mar 2009. Page 9 of 12

    an interesting evaluation of the time taken to develop phase III cancer trials. Full article only available to subscribers].

     Meta-analysis of individual patient data versus aggregate data from longitudinal clinical trials. Clinical Trials, Vol. 6, No. 1, 16-27 (2009). [Full article only available to subscribers].

     Recruitment methods employed in the prostate, lung, colorectal, and ovarian cancer screening trial. Concludes: " Direct mail, using rosters of names and addressesfrom profit and not-for-profit (including government) organizations,was the most successful and most often used recruitment method.Other recruitment strategies, such as community outreach anduse of mass media, can be an important adjunct to direct mailin recruiting minority populations." Clinical Trials, Vol. 6, No. 1, 52-59 (2009). [Full article only available to subscribers].

     A centralized informatics infrastructure for the National Institute on Drug Abuse Clinical Trials Network. Concludes: "The identified informatics components provide theinformation and infrastructure needed for our clinical trialnetwork. Post centralization data management operations aremore efficient and less costly, with higher data quality." Clinical Trials, Vol. 6,

    No. 1, 67-75 (2009). [Full article only available to subscribers].

     Confronting challending in intervention research with ethinically diverse older adults: the USC Well Elderly II Trials. Concludes: "The completion of clinical trials involving eldersfrom numerous local sites requires careful oversight and anticipationof threats to the study design that stem from: (a) social situationsthat are particular to specific study sites; and (b) " physical,functional, and social challenges pertaining to the elder population.Clinical Trials Vol 6, No. 1, 90-101 (2009). [Full article only available to subscribers].

     Using portfolio analysis to optimize the riskreturn balance of an R&D portfolio. Nature Reviews Drug Discovery 8, 189-190 (March 2009)

     Market watch: Specialty pharmaceuticals to provide majority of sales by 2012. Nature Reviews Drug Discovery 8, 184(March

    2009).

     GCPj's March 09 Digital Edition [Only available free to subscribers]. The following 2 articles may be of interest: 1. Reading the signs: Placebo response and signal detection: Proven strategies for minimizing placebo effects. 2. Partnering for better performance: What makes for a successful investigator site? Practical solutions for integrating trial conduct with

    patient care.

     PharmaVoice Mar 09. A special edition devoted to issues with going global, such as regulations, language, outsourcing,

    recruitment, technology. [It looks like you need to pay to print/download the articles, but on the left hand side there are links to

    view the issue/article free, at least temporarily.]

     Journal of Clinical Research Best Practices March edition. Articles include: 1. Adverse Event Reporting: Site Preparation; 2.

    Building an Office of Clinical Research and Trials: The UC Irvine Experience. 3. Median Cost per Diabetes Subject by Study

    Phase and Region.

     CRFocus March edition. This edition includes a number of interesting articles related to patient recruitment. 5 Mar 09.

    [Articles may only be available to ICR members].

     An Unbiased Scientific Record Should Be Everyone's Agenda. The PLoS Medicine Editors 24 Feb 2009.

     The challenges faced in the design, conduct and analysis of surgical RCTs. Trials, 2009, 10:9, 6 Feb 09.

     The Elusive Sponsor-Site Relationship. A discussion of several trends in the investigative site landscape that threaten to

    make improvements in sponsorsite collaborative effectiveness even more elusive. Applied Clinical Trials Online, 1 Feb 09.

Interesting or Useful websites recently encountered ....

     HealthMap. A clever, unified and comprehensive view of the current global state of infectious diseases and their effect on

    human and animal health, on a map.

     BioMedReports.com: FDA and Clinical Trial Calendars. [AccessCR: I thought this might be useful for those looking for

    intelligence on what your competitors might be doing. However, it's only available to paid subscribers, and as I haven't

    subscribed, I will leave it to you to evaluate.]

     A new booklet by Australia's BeyondBlue with tips on taking care of health and wellbeing after losing your job or suffering a financial loss. [AccessCR - Given the current environment, I'm leaving this booklet in the update for the foreseeable future, so

    affected individuals know how look after themselves and get the support they need.]

___________________________________________________________________________________________________________________ ?AccessCR Professional’s Update 9 Mar 2009. Page 10 of 12

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