Symptoms For Arthritis

Knol Utility for Medical, Market & Healthcare Research

The Knol Platform potential for patient generated data, biomarkers, medical, market and healthcare research is discussed. Such research and survey can benefit the pharmaceutical, biotechnology, diagnostic, medical device and equipment companies. Patient input, electronic diary and assessments are routinly obtained through cell phones and internet. Patient input with approved and marketed drugs with high safety margin for new indications and long term follow up can be managed on the web. Similarly data about use of OTC and generics, biomarkers, genome, topical self application and some vaccines can be shifted to knol. Patients and healthcare providers organize into online communities, use telemonitoring, obtain drugs and funds to test new hypothesis in healthcare. The UK Swine Flu Web site has established diagnosis and prescription by internet.

Krishan Maggon

Krishan Maggon Knols

Under Creative Commons Attribution 3.0 License

Copied from office.microsoft.com Clip Art and Image Library

Introduction

During the past 30 years, medical, marketing and healthcare research have become more complex. The advent and increasing use and spread of internet and cell phones has provided new means of obtaining patient own input into the data base as listed in the Box.

The web and knol platform offer new opportunity in management and creation of patient generated data, market research, drug combo, drug switch and treatment survey and instant feedback.

Following types of survey can be carried out

MedWatch Global Survey on Medication Taken, Patient Preferences, Cost factor, Copayments, Compliance, adverse events reporting, brand selection, ease of use,

Market study, Online study, discontinuation etc

Only outlines and selected possibilities are discussed for business reasons.

Drug Administration, Satisfaction, Costs Survey :

Oral, injection (iv, sc, im), topical, inhalation, spray, suppositoire

Commercial data

Sponsor Obligations/Duties

DeCode Genetics in Iceland has done several gene hunting studies by collecting biological samples from the country with more than 10000 patients with a disease through patient help groups. The 23and Me company owned by wife of Sergey Brin (Google founder) has started a gene hunt study in 10, 000 parkinson Disease patients in the USA. The patients will organise into an online community and will be helped by Parkinson Institute and clinical center and Michael J Fox Foundation for Parkinson's Research. Patients will fill an online form, give informed consent and their own assessment of the disease, symptoms and lifestyles and send a biological (saliva) sample for DNA analysis. Patients in the study will pay $25 for full genomic analysis instead of normal $400 price. About 1.5 million patients suffer from Alzheimer's Disease in the USA. By comparing the DNA of patients with normal controls across the human genome, genetic variations involved in the disease can be discovered. The data might be of poor quality as only patients report and score their disease and symptoms which can be adressed by providing a learning video and slide show.

Owned by wife of Sergey Brin, one of Google founder

https://www.23andme.com/

Parkinson Disease genetic search through patient based initiative

Google Co-Founder Backs Vast Parkinson's Study

http://www.nytimes.com/2009/03/12/business/12gene.html?pagewanted=print

www.xoutb.info/

Sensors and sensitivity. http://www.economist.com/science/tq/displaystory.cfm?story_id=13725679

http://instedd.org/

Global map of disease like WHO and CDC/NIH can be supplemented by using computers and cellphones as sensors for collection of healthcare related data, finding and remote monitoring of patients, tackle disease outbreaks. Similarly healthcare facilities can be mapped and disease specialists can be identified through Biomedical Citation Index and from editorial board members of Medical Journals and advisors to WHO, FDA, NIH and healthcare charities.

Knol provides healthcare companies with an alternative low cost data and new mode of action of their drugs. Results of these studies may expand on- and off-label usage, reach new patient populations, generate data for publication and establish new relationships with opinion leaders. These trials can become critical pieces of product development strategy.

Some commercial data has been deleted to protect copyright

Table 1. Global Burden of Disease WHO Data (updated June 2009) Millions of world's patients are sick, suffering and dying while waiting for safe, affordable & effective drugs and healthcare delivery from the Industry, Research Establishment, NGO, Health Charities, Foundations, WHO and Governments. These global citizens are tired of excuses from the healthcare establishment, international and national rulers. Help poor patients by faster approval of new drugs, low cost manufacture and distribution of affordable drugs. Disease Incidence/yr millions Deaths/yr million Type and associated Diseases Infections 3000 Malaria, Tuberculosis, AIDS Neglected Diseases 1200 Hepatitis, Leishmania, Filariasis, dengue, STD, Leprosy, Viral, bacterial and fungal infections, Drug resistance Cardiovascular 300 17.5 Hypertension, lipid disorders, obesity Rheumatic heart, CHF Diabetes 246 1.1 Obesity, Hypertension, Lipid disorders Retinopathy, Foot Ulcers, Lactic acidosis, Nephropathy, Neuropathy Cancer 100 7.5 Prostate, Breast, Lung, Colon Respiratory 300 Asthma 210 COPD 4 Tobacco, Pollution Neurological 80 Epilepsy, Parkinson's disease, Depression Alzheimer's Disease, Schizophrenia Infant Mortality 112 underweight 9 Malnutrition, poor sanitation Maternal Health 0.5 during childbirth 2.7 million new cases AIDS 40 2.9 Malaria 500 0.8 Tuberculosis 2000 (9 million new cases 2007) 1.6 Drug Resistant TB, HIV-TB co-infection

Table 2 Clinical Trial Approval Timelines in the USA and Europe (in months) Approval FDA/EMEA IRB/ERC Bioethics Genetic/BIMO Review RISK Benefit etc IND/CTC 6 1-3 3-6 1-3 Phase I 3 1-2 Clinical Phase II-III Drugs 3-6 1-3 1-3 Biologics 6-12 3 6 2 NDA/PLA/BLA/MA New Drugs 6-24 Biologics 9-24 Orphan Drugs, Drugs for rare and neglected disease, Life saving drugs get priority and faster review and approvals Patient Generated Healthcare Survey, Medical and Market Research Global Health & Public Private Partnerships (PPP) United States Cancer Statistics http://apps.nccd.cdc.gov/uscs/ http://www.cdc.gov/nchs/ Heart Diseases and Stroke Maps http://apps.nccd.cdc.gov/giscvh3/ http://www.cdc.gov/DHDSP/library/aian_atlas/maps_aian_women.htm http://www.cancer.gov/cancertopics/understandingcancer/cancer/Slide25 Under Creative Commons Attribution 3.0 License Copied from office.microsoft.com Clip Art and Image Library Prescription Drugs j0403584.jpg Procedure WHO/CDC/NIH Global Map to find and locate patients Google Malaria Search to find patients and interested parties Google Scholar Malaria search to find and locate experts Local PC and Mobile/Cell phone network management system to connect patients, sponsors and experts Develop cell phone forms, patient diary, disease assessment, webcam, video to exchange data Google Analytics to analyse data and provide rapid feedback. Set up controls and check ups to improve quality Patient Initiated Clinical TrialsPatient Initiated Clinical Trials Untitled Presentation docs embed Principle Investigator Co investigators Protocol inputs Timelines Patient recruitment Ethical approval CRFs Biological samples Books and Monographs Biotechnology and Pharmaceutical Indu...Biotechnology and Pharmaceutical Indu... Blockbuster Drugs and R&DBlockbuster Drugs and R Paradigm Medical Market Research The UK official Swine Flu web site has pioneered the diagnosis of Swine Flu and electronic prescription delivered through a medically validated algorithm and under oversight by medically qualified staff Swine Flu [Influenza A (H1N1)v] Pandemic Review Informed Consent in Second Life A virtual hospital (ongoing project and study in UK) may receive 20 volunteers with learning disabilities and provided a virtual tour of the hospital, visits by virtual nurse and doctors, check up, lab tests, diagnostic and the treatment options. It is way to test subject ability to understand and give informed consent. If initial results are encouraging, a full scale study will be started to validate this approach. Informed consent and virtual worlds: The avatar will see you now A way of helping the mentally impaired to give informed medical consent http://www.economist.com/sciencetechnology/ June 25th 2009 The French Redcross has started the use of Facebook and Twitter to contact potential blood donors during the summer vacation period to increase blood supplies and donation NCI Funded Web Trials in Telehealth and Telemedicine NCI funded $100 million for 430 studies in 2008. http://fundedresearch.cancer.gov/search/get?sic=Telehealth&fy=PUB2008 Telemedicine NCI provided $15 million for 92 studies in 2008. http://fundedresearch.cancer.gov/search/get?sic=Telemedicine&fy=PUB2008

Acknowledgements

Thanks are due to Mr. Jean-Antoine de Mandato (PDP, Geneva) for providing office facilities and administrative support.

Global Market Research and Top Ten Drug Reports

Overview

• Global Pharmaceutical Market Review & World Top Ten/Twenty Drugs 2008
• Global Biotechnology Market Review & World Top Ten Biotech Drugs 2008
• Top Selling Human Medicinal Brands of 2007
• Pharmaceutical and Biotechnology Industry Overview 2007
• Top Selling Human Medicinal Brand and Global Pharmaceutical Market 2008

Pharmaceutical and Biotechnology Industry Overview 2008

Pharmaceutical

• Global Arthritis Market Review 2008 (World Top Ten RA Drugs)
• Global Angiotensin II Receptor Antagonist Market Review 2008
• Global Antiviral/Antibiotics Market Review 2008 (World Top Ten Antimicrobial Agents)
• Global Cancer Market Review 2008 (World Top Ten Cancer Drugs)
• Global CNS Market Review 2008 (World Top Ten CNS Drugs)
• Global Cardiovascular Market Review 2008 (World Top Ten CV Drugs)
• Global Diabetes Market Review 2008 & World Top Ten Diabetes drugs
• Global Respiratory Market Review & World Top Ten Respiratory Drugs 2008

Biotechnology, Biologics

• Global Biotechnology Market Review & World Top Ten Biotech Drugs 2008
• Global Vaccine Market Review 2008 (World Top Ten Vaccines)
• Global Monoclonal Antibodies Market Review 2008 (World Top Ten MoAbs)
• Global Biologic Market Review & Top Ten Biologics 2008
• Billion Dollar Generics & Global Generic Market Review 2008
• Billion dollar biologic medicines of 2008
• Billion dollar biologic medicines of 2007
• Pharmaceutical and Biotechnology Industry Overview 2007

Market Research

M&A Review: Pharmaceutical & Biotechnology Industry

Market Research Reports Review (Data Discrepancies)
Book

Global Market Research Reports (Pharmaceutical & Biotechnology Industry) 2008

• Pharmaceutical, Biotechnology, Diagnostic, Medical Device Industry
• Knol Internal Medicine Textbook
• Collaborative Books

Healthcare Costs, Quality

• Health Fraud Knols
• High Priced Prescription Drugs
• Quality Assurance Health Group Knol Authors
• Increased Healthcare Costs- What can be done?

Biotechnology to Nanotechnology?

• Public Private Partnerships (PPP) Healthcare

Publications and Writing

• Publishing in knol vs Biomedical Journals
• Knols Citation
• Super Knols
• Knol Writing Tips
• Knol Site Metrics

Journals

• Journal of Therapeutic Biotechnology (JTB)

http://clinicaltrials.gov/

http://www.centerwatch.com/

http://www.uhhospitals.org/PatientsVisitors/ClinicalTrialsListing/tabid/1104/Default.aspx

http://www.clinicaltrialssearch.org/medical_research_laboratories_international_clinical_trials.html

A Randomized Trial of Therapies for Type 2 Diabetes and Coronary Artery Disease

The BARI 2D Study Group

Published at www.nejm.org June 7, 2009 (10.1056/NEJMoa0805796)

http://content.nejm.org/cgi/content/full/NEJMoa0805796

Oldfield V, Dhillon S, Plosker GL. (2009) Tocilizumab: a review of its use in the management of rheumatoid arthritis. Drugs. 69(5): 609-32.

doi: 10.2165/00003495-200969050-00007.

GMP Guidelines

http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GoodManufacturingPracticeGMPGuidelinesInspectionChecklist/default.htm

GLP Guidelines

http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm135197.htm

IRB

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046745.htm

Informed Consent

http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm

European Medicine Agency

http://www.emea.europa.eu/

ICH

http://www.ich.org/cache/compo/276-254-1.html

1. Maggon KK. Aspects of clinical pharmacology and bioavailability of Azapropazone in

   "Azapropazone - 20 Years of Clinical Use", Edited by KD Rainsford, Kluwer academic

   publishers, Lancaster, U.K., 1989.

2. Christen Y, Waeber B, Nussberger J, Porchet M, Borland M, Lee R, Maggon KK,

   Shum LY, Timmermans P. and Brunner HR. Oral administration of DuP 753, a specific

   angiotensin II antagonist to normal volunteers. Circulation 83:1333-1342, 1991.

3. Maggon KK, and Lam GN. Interaction of Cimetidine with Nsaids. XIIth European

   Congress of Rheumatology, Budapest, July 1991.

4. Maggon KK, Slee AM, Demos CH, Development of antifungal agents by

   the pharmaceutical industry. Drugs of Today 27:317-330, 1991.

5. KKMaggon and SMaggon. WHO GLP Guidelines. Ist Draft. 1991.WHO, Geneva

6. Maggon KK, Mechkovski AP. Total Quality Management in the Pharmaceutical Industry.

   Drug News and Perspectives 5:261-270, 1992.

7. Maggon KK, Mechkovski AP, Krylov UF. Total Complex Quality Management for drugs in

   the area of research, development and initial manufacturing .

   (In Russian). Himiko-Farmaceutical Zurnal ( Moscow) no 4, 4-10, 1993.

8. Maggon KK, Brandt, D. Standard operating procedures and the conduct of clinical trials.

   Appl.Clin. Trials 3, 46-49, 1994.

9. Maggon KK. Immunosuppressive gold rush and drug development. Drug News and Perspectives

   7, 389-401, 1994.

10. Maggon KK. Medical uses of sulfur hexafluoride. Drugs of the Future 19, 1101-1107, 1994.

11. Maggon KK. Linking research strategies to market opportunities in development of

    cardiovascular drugs. Drug News and Perspectives 8, 560-571, 1995.

12. KKMaggon and SMaggon. Discovery and development of losartan, an orally active angiotensin II receptor antagonists. Abstracts International Symposium of Trends in Life Sciences. Jawaharlal Nehru University, New Delhi, India. Dec. 17-19, 1997

13. MaggonKK. New Drug Development for Alzheimer's Disease. Abstracts International Symposium of Trends in Life Sciences. Jawaharlal Nehru University, New Delhi, India. Dec. 17-19, 1997

14. KKMaggon. Ayurveda. Abstract of Symposium on Medicine and Ethics, Davos, February 4-5, 1998

15. Maggon K. Risk Benefit Assessment of Glitazones. Express Pharma Pulse. Mumbai. September 12, 2002.
    

16. Maggon K. Ups and down in drug development. Express Pharma Pulse. Mumbai. October 3, 2002. Express Healthcare Management Mumbai, October 16, 2002. http://www.expresshealthcaremgmt.com/20021031/edit2.shtml

17. Maggon K. Activated Protein C in treating sepsis. Express Pharma Pulse, Mumbai

    February 27, 2003, Express Healthcare Management Mumbai, March 1, 2003

18. Maggon K. Risk benefit assessment of APC. Express Pharma Pulse, Mumbai . March 6, 2003. Express Healthcare Management Mumbai, April 1, 2003

19. Maggon K. New Drug Discovery and Development in India. Drug News and Perspectives. Prous Science, Barcelona. 16(Supplement) .March 2003, 1-19.

20. Maggon K. New Drug Discovery and Development in India. Drug News
    and Perspectives. 16(Supplement), 1-19, March 2003.

21. Maggon K. A passage to India. Good Clinical Practice Journal, 10, 29-32,
    2003. PJB Publications, UK.

22. Maggon K. The ten billion dollar molecule. Pharmaceutical Executive. 2003; 23: 60-68.

    http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=75665

23. Maggon K. The future of the research based pharmaceutical industry. Editorial Express Pharma Pulse. January 29, 2004.

    http://www.expresspharmapulse.com/20040129/oped01.shtml

24. Maggon K. Rise of biologicals. Editorial Express Pharma Pulse. February 5, 2004. http://www.expresspharmapulse.com/20040205/editorial02.shtml

25. Maggon K. Clinical studies with new drugs: My Indian Experiences. Express Pharma Pulse. March 4, 2004.

    http://www.expresspharmapulse.com/20040304/editorial02.shtml Express Health Care Management March 15-30, 2004. http://www.expresshealthcaremgmt.com/20040331/oped01.shtml

26. Maggon K. Role of Contract Research Organizations in new drug development. Express Pharma Pulse. March 25, 2004. http://www.expresspharmapulse.com/20040325/editorial02.shtml

27. Maggon K. Marketing of medicines in India. Essential Drugs, WHO. April 15, 2004. http://www.essentialdrugs.org/edrug/archive/200404/msg00038.php

    bmj.bmjjournals.com/cgi/eletters/328/7443/778

28. Maggon K and Barik S. New Drugs and treatment for respiratory syncytial
    

    virus. Reviews in Molecular Virology 14, 149-168, 2004.
    

29. Maggon K. Setting new standards about drug safety. .Express Pharma Pulse 22 May 2004. http://www.expresspharmapulse.com/20030522/edit2.shtml

30. Maggon K. Toxicology Testing in India for medicinal products. Express Pharma Pulse. Pharma Reseach Special Issue, July 29, 2004, Mumbai, India. http://www.expresspharmapulse.com/20040729/pharmaresearch05.shtml

31. Maggon K. Site and Investigator Selection for global Phase II-III trials in India. Controlled Clinical Trials.25, 366-377, 2004.
    

32. Maggon K. Regulatory reforms and GCP Clinical Trials with New Drugs in India. Clinical Trials. 1/5, 1-7, 2004.

33. Maggon K. Supply of study drug. Can. Med. Assoc. J. 2006.