managing threats in pharma manufacturing and distribution n.
Skip this Video
Loading SlideShow in 5 Seconds..
Download Presentation


271 Vues Download Presentation
Télécharger la présentation


- - - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript

  1. MANAGING THREATS IN PHARMA MANUFACTURING AND DISTRIBUTION Visual Management Systems, Inc. (otcbb: VMSY) Jason Gonzalez, CEO

  2. Disclaimer SAFE HARBOR STATEMENT Certain statements in this presentation constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements expressed or implied by such forward-looking statements. The forward-looking statements are subject to risks and uncertainties including, without limitation, changes in levels of competition, possible loss of customers, and the company's ability to attract and retain key personnel.

  3. So, “What’s the Problem?” • Getting a drug to market in the US or EU averages over $800 million. • Veterinary and Agro-pharma compounds average over $150 million. • Financiers identify the most valuable asset of Biotech and Pharmaceutical companies as their Intellectual Property (IP) Portfolios. • The Largest Threats to such assets are loose facility controls, employee theft and minimal supply chain management. The largest problems facing pharmaceutical companies are theft of property and information and drug counterfeiting.

  4. What Does This Mean to You? • Diminished values of Intellectual Property Rights • Manufacturers lose revenue. • Employment suffers. • WTO Accession Agreements and Free Trade Agreements Lose Material Effectiveness (forcing more regulations) • In 2007, 2.7 million medicinal products were seized at EU customs borders, a 384% increase over 2006, according to EU statistics released by EFPIA. • Counterfeit drug sales will reach $75 billion globally in 2010* *The Centre for Medicines in the Public Interest

  5. Case Study: Counterfeit Drugs • Counterfeit drugs include products with the correct ingredients as well as others with the wrong ingredients. • Some contain no active ingredients, or contain them in insufficient amounts. Still others have or with fake packaging. • Counterfeiting is a threat to both patented and generic drugs. • Counterfeits also include drugs deliberately or fraudulently mispackaged or mislabeled with respect to identity or source.

  6. Case Study – Counterfeit Drugs:What are the Effects of the Problem? • Counterfeit medicines cause significant injury and death. • Counterfeit medicines contribute to the development of drug resistance; from lower dosage of active pharmaceutical ingredients. • Counterfeit medicines can also cause a loss of trust in the health system by patients and a loss of confidence in brand named Pharmaceutical Products.

  7. Case Study – Counterfeit Drugs :What are the Trends? • 10-20 years ago most counterfeit drugs did not have any active pharmaceutical ingredients (APIs) • Although there are counterfeit APIs, now more and more counterfeit drugs are made with real APIs • In developing markets and emerging countries in Africa, Asia, Eastern Europe, Russia, and Latin America citizens regularly encounter counterfeit drugs • In developed countries, the extent of counterfeit drugs within the drug supply chain is currently small, but the risk is increasing, and internet sales account for the majority of the counterfeit drugs on the market • Most statistics underestimate the problem and potential impact • According to a recent PhRMA study, the five countries with the highest incidence of counterfeiting are China, India, Mexico, Russia, and Brazil.

  8. Primary Threat: Pharmaceutical Theft & “Diversion” • Pharma Theft: -- Theft of the finished dosage form of medicines anywhere in the distribution chain, such as at the site of production, freight forward distribution center, warehouses, pharmacies, or hospitals • Illegal Diversion – When a genuine pharmaceutical product is approved and intended for sale in one country, but is then illegally intercepted and sold in another country. This is often done with false statements or declarations. Sometimes the drugs sold in the other country have not yet been approved by the regulatory authorities.

  9. Primary Threat: Employee Theft Facts • Employees of pharmaceutical drug manufacturers and commercial distributors account for most of the pharmaceuticals diverted through theft. • Individuals also break into pharmacies or clinics to steal pharmaceuticals or commit armed robberies to acquire the drugs. According to the 2002 National Retail Security Survey report, retailers attribute 48 percent of pharmaceutical inventory loss to employee theft.

  10. Theft and Diversion:The Extent of the Problem • Black Market drug sales are considered the most profitable of all current criminal incidence • Internal Theft is the single worst threat in controlled manufacturing, including pharmaceutical and chemical* - estimates exceed $36 billion in losses • The second most prolific crime is barbiturate abuse. As a result, organized crime has moved heavily into narcotics counterfeiting, theft and distribution *US Chamber of Commerce

  11. Industry Trends Impacting the Problems: The Generic Trend • “The shift in generic production away from the developed markets U.S., Europe and Japan adds to the problems of counterfeit drugs and theft” • Why? Regulatory regimes and standards as well as logistics, transportation and distribution oversight practices of pharmacopeias away from the US, EU and Japan are much weaker and susceptible to fraud. • Who are the victims? Legitimate Pharma companies and prescription drug users.

  12. Solutions • Protect the integrity of the supply chain • Cooperate globally to stop counterfeiting of medical compounds • Apply tighter data and facilities security and management to curtail product and IP theft • Partner with regulators, customs and law enforcement to develop and enforce standards

  13. VMSY Visual Management Systems, Inc. OTCBB: VMSY PDG IDS VMS VMSFS A Full-Spectrum Company:Offering Protective Technology • (OTCBB: VMSY) • Visual Management Systems, Inc. • Holding Company Structure Serving as Sole Member of Subsidiary LLCs • PDG • VMS • VMSF • IDS • Flexible Partnership Platform

  14. JV Opportunities: Solutions Development • “Revenue First” Model • Low-risk Technique • Strategic Partner Venue • Exclusivity of Brand Distribution and Specific Technologies • Proven Business Plan Model • Opportunities for Bidirectional Investments • Seeking Joint Venture Development Opportunities

  15. IDS • Intelligent Digital Systems • NY, USA Based Software Development Company • Leading-edge Software Assets • Proprietary Software Integration Applications • Mature Patent Applications in Process • Joint Venture Platform • Stable HYBRID Video and Data Management Platform

  16. VMS Systems Integration • Visual Management Systems, LLC • USA-Based, “VideoCentric” Physical Security Systems Integrator • North American Installation and Support • International Licensing and Design Support Available • Protecting Your Facilities and Intellectual Property

  17. VMSFS • VMS Financial Services, LLC • Captive Lease/Financing Company • Offers Flexible Purchase Options • Applies When Traditional “Bank” Financing is Unavailable • Venue for New Revenue Channels • Value-add Service for Partners and End Users • Protect Facilities with Little Out-of-Pocket Expense

  18. VMS:Growth Through Partnership • Growth in 2008 - 2009 • Continued N. American Expansion • Southeastern Seaboard - Charlotte, NC • Southeastern Regional - Orlando, FL • Southwestern Regional - Austin, TX • Southwest Sunbelt - Phoenix, AZ • Midwest (Great Lakes) - Chicago, IL • Acquisition of Complementary Development Companies • Seeking Overseas Investment • Currency Valuations Favor Euro Investments • Micro/SmallCap Return Potential • Equity and Debt Financing Opportunities • Strategic Investment Opportunities • Participation through Direct Investment and Joint Development Ventures

  19. Technology Solutions:VMii sm • Virtual Manager and Virtual Manager II • Small Commercial Applications • Retail and Food Service • Stable, Tested Platform • Thousands of Units in Service • Ease-of-use Basis • Highly customizable • Economical • Established Commercial Success

  20. Technology Solutions:TechEye® TechEye® • Enterprise Video Management Platform • Allows Industrial Vertical Penetration • Two Pending USPTO Patent Applications with Several Provisional Patent Applications in submission • True Hybrid Capabilities • Accept Video and Data Input from Analog and IP Sources • Extend Useful Life of Installed Infrastructure • Capture Analog Video • 70% of Recorders and 90% of Cameras are Analog • Licensing and Distribution Opportunities

  21. Cooperative Growth • Developmental JVs • New Product Development and Rollouts • Integration Opportunities • Cooperative Marketing • Mixed Use Publicity • Minimizes Competition • Potential Acquisitions • Joint Ventures and Cooperative Development Allow for Managed Growth

  22. Conclusion of Presentation For a copy of this presentation or a corporate profile, please contact: Jason Gonzalez, CEO Visual Management Systems 1000 Industrial Way North Unit C Toms River, NJ 08755 877-323-CCTV

  23. Additional Info: Pharma Counterfeiting • Counterfeit sales are increasing at nearly twice the pace of legitimate pharmaceutical sales -- estimated at 13 percent annually by the Center for Medicine in the Public Interest • Counterfeit drugs are commonly manufactured in countries like China and India • The composition of fraudulent drugs ranges from crude mixtures of glue, chalk and sugar to nearly exact chemical replicas of complex pharmaceuticals

  24. Additional Info: What’s Underway Now? • Supply chain through verification programs, reliance on standards, monographs, tracking and tracing (RFID) technologies, and authentication technologies • Tight controls over physical access to facilities and data centers using biometric access controls coupled with actively monitored video surveillance. • Strict video oversight of any overseas manufacturing, warehousing and transportation facilities. • Establishment of global standards for pharmaceutical ingredients (APIs and excipients) based upon ongoing work of the Pharmacopeia Discussion Group/PDG and cooperative manufacturers and developers

  25. Additional Info: What’s Underway Now? (cont’d) • Radio frequency identification (RFID) tagging of products by manufacturers, wholesalers and retailers is a reliable product tracking and tracing technology • Authentication technologies include measures such as color shifting inks, holograms, fingerprints, taggants, and chemical markers embedded in a drug or its label • Using managed video to actively monitor all points in the manufacturing, warehousing and distribution cycle. • Developing Supply Chain Integrity Programs to help manufacturers expedite distribution cycle (C-TPAT) • Regulating the availability of pharmacy products over the internet.

  26. Credits • According to the FDA 2004 report, “in some countries the counterfeiting of drugs is endemic – with some patients having a better chance of getting a fake medication than a real one” • According to the WTO 2004 Report on Safety of Medicines, “in wealthier countries, new expensive medicines are frequently counterfeited, such as hormones, corticosteroid, cancer drugs, and antiretroviral” • In developing countries, the most frequent medicines counterfeited are drugs to treat life-threatening conditions such as malaria, tuberculosis, and HIV/AIDS” Jeffrey Gren, Director Office of Health and Consumer Goods U.S. Department of Commerce Phone: 202-482-2587 Email: Website:

  27. Drug Counterfeiting Fact Sheet • An estimated 1-2 percent of drugs in North America are fraudulent • Worldwide drug counterfeiting is a $32 billion business • Worldwide drug counterfeiting will be a $75 billion industry by 2010 • According to the Food and Drug Administration, the number of fraudulent prescription drugs intercepted by customs officials nearly doubled between 2004 and 2005 • Counterfeit sales are increasing at nearly twice the pace of legitimate pharmaceutical sales -- estimated at 13 percent annually by the Center for Medicine in the Public Interest • Counterfeit drugs are commonly manufactured in countries like China and India • The composition of fraudulent drugs ranges from crude mixtures of glue, chalk and sugar to nearly exact chemical replicas of complex pharmaceuticals • Changes in packaging, labeling, color, taste, pill shape, and unanticipated side effects are telltale signs of counterfeiting • Many counterfeit drugs are bought via legitimate-looking websites • It’s possible for even drugs purchased at reputable pharmacies to be counterfeit