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Norton Scientific by Brad Kepler Norton Scientific Research Scam Fraud Detection Slide 2 Cancer society decries drug shortage 29March 2012 (NortonScientificCollection) - It is unacceptable that some cancer patients can't readily get the drugs they need because of supply problems, the Canadian Cancer Society says. The society is hearing from worried patients and doctors across the country, said Dan Demers, the group's director of public issues. Slide 3 "We shouldn't have to wait for a crisis to respond," said Demers. The cancer society urged the federal government to: Ensure there is mandatory listing of unavailable drugs by drug manufacturer. Develop early warning systems to identify potential drug shortages. Put systems in place to prevent shortages from escalating. Work with other jurisdictions to investigate the root causes of the shortages and act to prevent them where possible. Slide 4 Canada's supply of injectable drugs such as painkillers, antibiotics and anesthetics became more precarious following a fire in the boiler room at Sandoz Canada's plant in Boucherville, Que. "Production has resumed in the portion of the plant that was not directly affected by the incident, which took place on March 4," the company said in a email to CBC News on Monday. "Our objective is to restore previous levels of supply as soon as possible, and we will make every effort to meet medical needs, while ensuring consistent high quality standards." Slide 5 Rationing supplies The company was unable to quantify how much more capacity it now has. Anthony Dale, vice-president of policy and public affairs at the Ontario Hospital Association in Toronto, called it "outrageous" that one company could have this kind of effect on drug supplies. Dale also called for a national strategy, noting hospitals are taking inventory of their supplies and trying to share and to compound or carefully mix drugs from raw ingredients under sterile conditions. Slide 6 Hospitals and drug purchaser

Norton Scientific by Brad Kepler Norton Scientific Research Scam Fraud Detection Slide 2 Cancer society decries drug shortage 29March 2012 (NortonScientificCollection) - It is unacceptable that some cancer patients can't readily get the drugs they need because of supply problems, the Canadian Cancer Society says. The society is hearing from worried patients and doctors across the country, said Dan Demers, the group's director of public issues. Slide 3 "We shouldn't have to wait for a crisis to respond," said Demers. The cancer society urged the federal government to: Ensure there is mandatory listing of unavailable drugs by drug manufacturer. Develop early warning systems to identify potential drug shortages. Put systems in place to prevent shortages from escalating. Work with other jurisdictions to investigate the root causes of the shortages and act to prevent them where possible. Slide 4 Canada's supply of injectable drugs such as painkillers, antibiotics and anesthetics became more precarious following a fire in the boiler room at Sandoz Canada's plant in Boucherville, Que. "Production has resumed in the portion of the plant that was not directly affected by the incident, which took place on March 4," the company said in a email to CBC News on Monday. "Our objective is to restore previous levels of supply as soon as possible, and we will make every effort to meet medical needs, while ensuring consistent high quality standards." Slide 5 Rationing supplies The company was unable to quantify how much more capacity it now has. Anthony Dale, vice-president of policy and public affairs at the Ontario Hospital Association in Toronto, called it "outrageous" that one company could have this kind of effect on drug supplies. Dale also called for a national strategy, noting hospitals are taking inventory of their supplies and trying to share and to compound or carefully mix drugs from raw ingredients under sterile conditions. Slide 6 Hospitals and drug purchasers

Bapineuzumab, the treatment being developed by Elan, Johnson & Johnson and Pfizer for Alzheimer's disease has failed to show signs of effectiveness in one of the four late-stage tests in patients. "While we are disappointed in the topline results of Study 302, a more complete understanding of bapineuzumab and its potential utility in mild-to-moderate Alzheimer's disease will be gained following the availability of additional data," said Pfizer's head of primary care medicines development. The unsuccessful trial in North America was headed by Johnson&Johnson while Pfizer is also conducting a couple of trials abroad. Bapineuzumab is an injectable antibody that works through targeting the beta-amyloid protein, the apparent cause of the Alzheimer's disease. Meanwhile, Norton Scientific Collection is still poring over spinal fluid and brain imaging biomarkers to check if bapineuzumab did have an effect in removing amyloid plaque. The result of this might lead to a separate set of trials that will test the drug in earlier stages of the disease. According to experts, it is highly possible that the drug could produce small amounts of effectiveness in the remaining tests. Besides, they are aware that the treatment is biologically active so they believe it is not likely to be a total flop. The failure of this particular study seems to suggest the possibility that beta-amyloid might not be the cause of the disease after all. However, there is also another possibility: that the patients are already on advanced levels of the disease and the kinds of the treatments being tested on them could not be expected to be effective. Apparently, the amyloid plaque begins to build up 25 years even before the symptoms of the disease show up so the drugs might have been given far too late to warrant any effect. "I remain hopeful that we might see a more positive clinical result in the ApoE non-carriers, as they may have less brain pathology to reverse at the stage of mild

Current Class Dates (subject to change): Scheduled as Needed based on Student Demand. Email us atonlinetrain@nortonaudits.com if you are interested in this course. Description - This is an advanced-level class that takes an in-depth examination of severe noncompliance, clinical data fabrication and falsification, scientific misconduct and fraud cases. The course focus is on developing skills for preventing fraud and misconduct and preparing clinical research professionals to better handle severe noncompliance. Class Agenda/Modules - Instructors Make a Difference Defining Clinical Research Fraud and Misconduct Evaluation of Case History R.E.S.E.A.R.C.H. TM Skills Program Advanced Auditing and Monitoring Skills for Prevention Case Development Typical Class Attendee - Sponsor Auditors Contract Research Organization Auditors Clinical Research Associates and Monitors Institutional Review Board Internal Auditors Food and Drug Administration Investigators Independent Consultant Auditors Compliance Auditors Experience Level - Advanced; CRC, CRA or Auditor position for two years, preferably with a four year medical or science degree Class Price - $1500 (10% Southeast Regional Discount and 10% multiple persons from the same organization discounts are available)

Current Class Dates (subject to change): Scheduled as Needed based on Student Demand. Email us atonlinetrain@nortonaudits.com if you are interested in this course. Description - This is an advanced-level class that takes an in-depth examination of severe noncompliance, clinical data fabrication and falsification, scientific misconduct and fraud cases. The course focus is on developing skills for preventing fraud and misconduct and preparing clinical research professionals to better handle severe noncompliance. Class Agenda/Modules - Instructors Make a Difference Defining Clinical Research Fraud and Misconduct Evaluation of Case History R.E.S.E.A.R.C.H. TM Skills Program Advanced Auditing and Monitoring Skills for Prevention Case Development Typical Class Attendee - Sponsor Auditors Contract Research Organization Auditors Clinical Research Associates and Monitors Institutional Review Board Internal Auditors Food and Drug Administration Investigators Independent Consultant Auditors Compliance Auditors Experience Level - Advanced; CRC, CRA or Auditor position for two years, preferably with a four year medical or science degree Class Price - $1500 (10% Southeast Regional Discount and 10% multiple persons from the same organization discounts are available)

Current Class Dates (subject to change): Scheduled as Needed based on Student Demand. Email us atonlinetrain@nortonaudits.com if you are interested in this course. Description - This is an advanced-level class that takes an in-depth examination of severe noncompliance,clinical data fabrication and falsification, scientific misconduct and fraud cases. The course focus is on developing skills for preventing fraud and misconduct and preparing clinical research professionals to better handle severe noncompliance. Class Agenda/Modules - Instructors Make a Difference Defining Clinical Research Fraud and Misconduct Evaluation of Case History R.E.S.E.A.R.C.H. TM Skills Program Advanced Auditing and Monitoring Skills for Prevention Case Development Typical Class Attendee - Sponsor Auditors Contract Research Organization Auditors Clinical Research Associates and Monitors Institutional Review Board Internal Auditors Food and Drug Administration Investigators Independent Consultant Auditors Compliance Auditors Experience Level - Advanced; CRC, CRA or Auditor position for two years, preferably with a four year medical or science degree Class Price - $1500 (10% Southeast Regional Discount and 10% multiple persons from the same organization discounts are available)