Coffee in our new library

6. december 2015 at 18:06 | Veronika Valdova, ARETE-ZOE
Enjoy your cup of coffee and feel free to browse through selection of the most interesting materials produced for various projects in the last couple of years.

Library router:

Course Global Pharma Primer: The material included in these five modules serves many interests by facilitating understanding of construct, dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately determine access, availability, and effectiveness of pharmaceutical products. We introduce and describe the highly specialized and often disconnected components of pharmaceutical research, drug development and manufacturing, marketing, regulatory policies and practices, and use case studies to qualify the relative effectiveness of safeguards to prevent harm. Additionally, how have pressures to reduce health care costs or increase safety actually affected both aspects of public concern within a global context because transnational interests influence national circumstances.

Survival guide to stem cell research and therapies: the course provides comprehensive guidance to publicly available resource materials, libraries and registries for people who are interested in understanding currently available treatment options involving human stem cells.

Big data in drug safety: The paper makes a case for change in the way data on safety of medicines is collected, structured, analyzed, visualized, and shared; moving away from the system of active reporting of individual case reports into national and international databases, toward collection and analysis of anonymous structured summary data from health care providers, in order to allow analysis of total numbers of treated patients and treatment outcomes; including adverse drug reactions and off-label drug use, to provide meaningful, population-based, statistically valid, bias-free, real-time information on safety and efficacy of products on the market without endangering patients' privacy. Such approach would significantly reduce privacy concerns and add value for stakeholders who are interested in timely and accurate information on benefit:risk profile of medicinal products.

Risk analysis primer: A variety of representative drug cases that have led to regulatory revisions will be template across the develop model to illustrate where signal detection could have been noticed that would have reduced patient casualty by providing an improvement in understanding to physicians prescribing medicines as an entry point for multidiscipline inclusion in process optimization and hazard reduction. Can drug development timelines be compressed while increasing regulatory confidence that public health interests and protections also advance?

Risk management plan (RMP) for opioid therapy: Prescription opioids cause more deaths than all illicit drugs combined. Law enforcement focus is on strict control of Rx and preventing diversion. This RMP focuses on frequent control of therapeutic range (TR). Frequent TR checking is possible if there is high capacity equipment with high sensitivity and specificity. Minimization of sample preparation time reduces labor time and overall cost.

Book Medicines for Women by Mira Woolrych-Harrison to which I contributed by co-authoring chapter "Political and religious perspectives on managing the risks and benefits of women's medicines," with review of the chapter by Frank Wallace, MD (Avatar Worldlink).

Paper "The human rights responsibilities of multinational pharmaceutical firms in host nation states" published in Journal of the International Relations and Affairs Group in June 2012 analyses the responsibilities of global pharmaceutical industry when conducting research in developing economies.

Article "The dangers of outsourcing personal medical data of PTSD patients" (Monitor SIRS, 2012) analyzes the risks associated with uncontrolled outsourcing of processing of medical data of PTSD patients.

Boyd cycle in clinical research and drug safety: To make any system oriented toward desired outcome, systems approach is necessary to make the feedback mechanism work. Boyd's OODA loop is an elegantly simple grand theory, which contains high quality insight into strategic essentials. OODA loop has extensive domain of applicability, including clinical research and post-market drug surveillance.

Lessons from big industrial accidents and their relevance for the pharma industry, as presented at the 4th World Congress of Clinical Safety, Vienna (2015) organized by International Association of Risk Management in Medicine (IARMM).

Systems Theoretic Accident Model and Processes (STAMP) can be utilized in pharmaceutical industry in multiple different ways to define safe range of operation, impose constraints and enforce them by design and operations.

Course on Good distribution practice and supply chain security is currently under preparation. It will cover introduction into the regulatory environment in the U.S., EU, Japan, China, India and Russia, review case studies and enforcement actions in the area of product tampering and counterfeiting, and explain the impact of globalization and consolidation on supply chain security.

Resource guide relating to the 1080 scare in New Zealand: In November 2014 dairy giant Fonterra and national lobby group Federated Farmers received anonymous threatening to put 1080 poison in infant formula unless the government banned the agricultural pesticide by the end of March. In early March, the New Zealand police held a press conference, in which they appealed to the public for information regarding the threats. Environmental terrorism was widely discussed as the underlying motive. In October 2015, the case took a surprising turn, when local businessman was charged with criminal blackmail.

Current Good Tissue Practice (CGTP) governs the methods used in, and the facilities and controls used for, the manufacture of human cells and tissue based products (HCT/Ps) including all steps in recovery, donor screening, donor testing, processing, storage, labeling, packaging, and distribution. (21 CFR 1271: CGTP).

Application of risk, issue and opportunity management in drug development: the presentation covers establishing an effective risk management process, risk management, relation to other risk management systems, issue management, opportunity management and management of cross-program risks. Special attention is paid to alignment of risk management programs between stakeholders in clinical research, specifically the sponsor, investigator, and IRB/EC.

Book Dark Side of a Mountain is a historical study of the effects of ideology, religion and culture on medical science. Section The Code is dedicated to The Book of Leviticus and its 12th century annotation by Moses Maimonides. The root cause of the 1348 plague was flawed life-science doctrine which could not be challenged due to ideological and religious terror. Section Medical Oaths presents different concepts in medical ethics around the globe. Japanese medical ethics gets special attention, due to unique relationship between martial arts and the art of medicine. Eugenic Trail deals with the topic of pedigree, hereditary entitlement and inbreeding, and search for the causes of societal evils. Eugenics transformed from science to ideology in the mid-19th and early 20th century, but only in Nazi Germany it took on its most malignant form. Whilst the American version was driven by quest for hereditary causes of crime, harlotry, and pauperism, European cousins were pushing a case for the indispensability of noble families out of fear of spread of French troubles (the Revolution of 1848) to surrounding monarchies.

About 90% of all risk management efforts within the industry concentrate on regulatory compliance. Here is an overview of EU regulations in pharmacovigilance.

Diabetes drug Avandia (Rosiglitazone, GSK) was a promising medication and a top-seller until 2007, when its cardiovascular side effects and FDA's role in evaluation of its safety came under intense public scrutiny. Avandia triggered discussion on FDA's role in evaluation of safety of Avandia, and other medicines, and the need for reform in post-market surveillance. STAMP case study utilized research and materials produced during coursework on Life-Cycle Strategic Plan for the same drug.

Reliance of authorities on insider information requires adequate protections offered to whistleblowers, i.e. counseling, financial and legal aid, re-qualification, resettlement and/or a witness protection programs. Risk to whistleblowers is difficult to assess because of unavailability and inaccessibility of relevant data. Little information is available on the outcomes of whistleblower suits in federal/state courts. Obtaining data directly from state courts' systems would require review all tort filings - a prohibitively expensive and time-consuming process.

Area study on Ukraine from June 2015 (resource guide):

Research: Czechoslovakian hospital in North Korea during the Korean War and Activities of Czechoslovakian scientists in the 1950s. Material for this research was collected in 2012 in the Military Historical Archive in Prague and includes wide range of documents mainly from the funds of Ministry of National Defense from the early 1950's.

That's it for now, enjoy your coffee!

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