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Legal IQ spoke to Ligia Gata, IP Manager at Bioingenium, to discover the IP challenges faced by the Pharmaceutical industry in 2015. In this interview, Ligia provides insight on the importance of IP for R&D centers and SMEs, the key elements to consider for effectively preserving intellectual property, cutting costs using IP and she responds to the claim 'do patent rights stand in the way of getting treatment to those who need it?'
Peggy Chaudhry is one of the leading experts on pharmaceutical anti-counterfeiting and gray markets. An economist, Professor of International Business at Villanova, and author of “Protecting Your Intellectual Property Rights,” Peggy is at the forefront of this costly and dangerous problem.
Counterfeit and substandard medicines have serious human health and economic costs the magnitude of the counterfeit and substandard drug problem has gained significant public attention due to a number of high profile incidents and greater media focus. According to the Centers for Disease Control and Prevention (CDC), an estimated 10% – 30% of medicines sold in developing countries are counterfeit.
What’s the most invaluable tool you’ll need to detect counterfeit pharmaceuticals at a crime scene? Spectrometers, of course.
Analytical technologies – especially portable spectrometers – play a large role in detecting counterfeit products. One of the top spectrometer experts is Ravi Kalyanaraman, an Associate Director at Bristol Myers Squibb.
Jason Blumenauer is the Director of Global Security at Cardinal Health and an expert in supply chain security. In this interview, he discusses the role of carrier management; how he sources and selects the right carriers, assessing opportunities for theft, tips for proactively protecting against theft and, finally, appropriately responding to thefts when they occur.
Dr. Peggy E. Chaudry, of Villanova School of Business at Villanova University, discusses the top five harmful commodities seized, the pharmaceutical crime incidents, illegal internet pharmacies and the proposed new sentencing guidelines to handle them in this past presentation.
Bruce L. Gundy is responsible for directing investigations involving crimes against AmerisourceBergen Corporation. In this past presentation, he discusses curbing diversion and counterfeits entering the supply chain, the five phases of investigation and lessons learned in the investigations.
Near-Infrared (NIR) and Raman spectral techniques, which are complimentary in nature, have been used widely to detect counterfeit drugs. Both techniques are rapid, onintrusive and nondestructive that can be used for the analysis of many classes of pharmaceutical dosage forms.This whitepaper is co-authored by speaker Ravi Kalyanaraman of Bristol-Myers Squibb.
Marjorie Clifton is executive director of the Center for Safe Internet Pharmacies and has over 16 years of communications, advocacy and public policy experience. She regularly appears on CNN, CNBC, Fox, and national radio.
One of the effective ways to authenticate a pharmaceutical product is by using Raman spectroscopy to obtain a unique spectral ‘fingerprint’ of the authentic drug product itself that can be used to evaluate a suspect sample by spectral comparison to determine if it is indeed a counterfeit. This whitepaper is co-authored by speaker Ravi Kalyanaraman of Bristol-Myers Squibb.
Eugene Hackett, Director, Corporate Security, Bristol-Myers Squibb Company, discusses the improvements in the penal law, the private/public partnership and best practices for combating counterfeits with a focus on Columbia in this past presentation.
Steve Stein, Technical Accounts Manager at KODAK and John J. DiPalo, Chief Operating Officer at Acsis, discuss a century of regulatory change from products to packaging to pedigree in this past presentation.
Technological advancements in Micro-Electromechanical Systems
(MEMS) for NIR, and in the telecommunication laser industry for Raman, along with advances in optical and detector components miniaturization for both, have led to drastic reductions in size of these spectrometers which have made them portable. This whitepaper is co-authored by speaker Ravi Kalyanaraman of Bristol-Myers Squibb.
4 Great Visualizations: Counterfeit Pharmaceuticals. We scoured the web to find the best infographics.
Counterfeit and diverted pharmaceuticals are major problems that put consumer health and company reputations at risk in the global market. As part of an effort to overhaul track and trace rules and increase the accuracy of supply chain information, the U.S. Food and Drug Administration (FDA) is implementing widespread changes for the pharmaceutical industry.
The continuous growth of the global counterfeiting industry is a major cause for concern. Fueled by the proliferation of internet use and social media platforms, the magnitude of global physical counterfeiting is estimated to have increased considerably since the beginning of this century. The US Chamber’s Measuring the Magnitude of Global Counterfeiting study seeks to provide a deep-dive analysis of trade-related physical counterfeiting on a comparative level and provide a breakdown of the share of the global rate of physical counterfeiting. Report courtesy of the U.S. Chamber of Commerce.
How can the patient be sure the medication he/she is going to take is exactly what the doctor ordered? Every year, substandard, spurious, falsely-labeled, falsified and counterfeit drugs work their way into the market and eventually into the homes and hands of patients treating everything from routine illnesses to chronic conditions.
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Serialization/aggregation regulations are being implemented or are already in place, in many countries around the world.Contract development and manufacturing organizations (CDMOs) have their own unique set of challenges to meeting serialization requirements. Servier CDMO began tackling this problem early on, to not only be in compliance, but to be positioned to leverage serialization/aggregation technology and data for greater success.
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Estimates suggest that the global counterfeit drug market sits somewhere between US$75 and $200 billion and represents 10–50 percent of all drugs sold in some low-income countries. This articles looks at the past, present, and future of counterfeiting drug screening.
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This article demonstrates that Drop Coat Deposition (DCD) technique for the biologics drug product sample, coupled with confocal Raman spectroscopy can be effectively used to fingerprint protein based biologics pharmaceuticals. These spectral fingerprints can be used routinely to screen and detect biologics counterfeits.
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As Internet activity grows, the availability of medication online has also increased. Consumers may be tricked into buying what they think is real only to pay the ultimate price when they take counterfeit medication. So, how can the pharmaceutical industry tackle this problem and keep consumers safe from harm?