FDASmart  Inc. (US)   Presents:

“Pharmaceutical AntiCounterfeiting in Emerging Regions:
Who’s Winning the Battle”

Full Day Event Overview:

On March 4th,  2011 – FDASmart Inc (NY,USA) will host  a one-day forum on “Pharmaceutical Anti-Counterfeiting in Emerging Regions: Who’s Winning the Battle”.

The World Health Organization (WHO) estimates that counterfeit drugs make up about 25%   of the global medicine market  in developing countries.  The US based Center for Medicines in the Public Interest (CMPI) projects that by 2010, $ 75 billion US dollars worth of counterfeit drugs will be sold annually.

This unique one-day forum  brings together international and local Indian stakeholders from the pharmaceutical industry, government and leading pharma associations in India to address the number one problem : the war against drug counterfeits !
On March 4th in Mumbai, we will present the latest developments on the rapidly growing ,global drug counterfeiting scenario in emerging regions, discuss   the root causes that drive counterfeiting in underdeveloped  regions, then present  a thesis that a multi-level &  multi-stakeholder,  simultaneous joint effort  is mandatory in order to successfully combat  anti-counterfeiting .
Recently, the Foreign Trade Ministry of India made an announcement: that  Exporter of Pharmaceutical products will build track and trace capability for their exported medicines using barcode technology with  GS 1 global standards  by July 2011 to protect and ensure that India’s global generic industry continue with its reputation as the “pharmacy to the world”.
Several things come to mind:
- A realistic target date?  California has extended its e-pedigree deadlines to 2015  for a reason. Find out why.

-Does India have the serialization, authentication technologies to make this happen or do we partner with global technology providers to achieve this goal ?

Joseph Ringwood - COO- Systech International (NJ, US) and one of our key guest speakers  had this to say regarding the Foreign Trade Ministry Serialization announcement:
“We serve the global serialization market. This emerging regulation from India is different than that being implemented in Turkey and actually resembles California legislation.  A key point to be made is that the track and trace requirements do not specify infrastructure or the need to capture data and maintain it in any type of database for queries. This type of serialization is useless unless the product can at the very least be authenticated.”
-Who will police that Indian drug exporters observe this mandate and abide with the legal requirements?
COME attend the Anti-Counterfeiting Forum on March 4th and discover answers to these strategic questions and more !
Speakers from the US and India  will discuss  multiple level  of  anti-counterfeiting initiatives  that start  from packaging  level all way to consumers (PoD -Point of Distribution)

 One of our US experts will be discussing efforts in the African continent (Nigeria) by  the  national regulatory agency NAFDAC (National Agency for Food & Drug Administration & Control ) including a consumer driven, innovative first of a kind mobile phone authentication system.

The one-day  forum will feature several case studies on successful implementation of state of the art authentication, serialization and other technologies in the war against counterfeiting.

Roger Bate, from the American Enterprise Institute (AEI), says  “a lack of coordinated and dedicated effort is hindering anti-counterfeiting efforts. “

On a basic level, the lack of a universally accepted definition of what a counterfeit is underpins many problems.  Fundamentally, any fake drug  is illegal but lately Big Pharma seems to be equating “FAKE Drugs” synonymous to violating IPP – Intellectual Property Protection.  The recent detention of Indian generics in European ports, coupled to the drafting of legislation in Kenya and Uganda, has given countries reason to believe Western anti-counterfeiting efforts are at least partly motivated by desire to strengthen IPP.

Result? Emerging regions that are increasingly relevant to the global pharmaceutical industry like China and India take on a DEFENSIVE position, starting a  blame game that involved WHO (World Health Organization) and stifling international cooperation among ALL stake-holders.

Why Attend:

Fake drug sales are expected to grow at 13% yearly till 2010, a rate significantly higher than the estimated 7.5% annual growth for genuine pharmaceutical commerce. The alarming trend of counterfeiting drugs is growing and though most occur in developing regions, counterfeiting ultimately takes its toll on the global pharmaceutical industry thus affecting  stakeholders everywhere but most specially consumers who bear the most dire of all consequences possibly leading up to life threatening situations or death.

Counterfeiters have become technology savvy with the Internet as well as  with overcoming anti-authenticating modalities.  Greatly encouraged  with their recent successes &  ability to get away with their  crimes, they see no end in sight  to their assault.   A new, intelligent  and multi-phased,  simultaneously executed  plan of counter attack is  the only hop   if we are to win the drug counterfeit ‘wars’. This webinar explores some of the anti-counterfeiting  options used  by experts overseas which include the Director General  of NAFDAC  who have implemented these solutions successfully.

Who Should Attend:
Various stakeholders involved in combating counterfeit medicines and those who want to learn the latest developments from emerging regions including:

●  Pharmaceutical manufacturers  those involved with global drug quality, brand protection, supply chain,               conveyance  security
●  Pharmaceutical distributors & associations
●  Drug packaging, labeling companies
●  Drug regulatory agencies, customs &  police
●  Pharmaceutical  Patients and safe medicines advocates
●  Anti-counterfeiting product and service providers                
●  Inter-governmental  agencies (IGOs) involved with healthcare and IPR protection (Intellectual Property          Rights)
●  Non-Govemental Agencies (NGOs) involved with healthcare specially developing regions
●  Anti-Counterfeiting consulting service providers- IP, legal, investigators, etc

Key take-aways you will LEARN !
» Understand  the obvious plus  sometimes subtle  root causes of anti-counterfeiting specially in less economically developed countries
» Understand  why key differences in counterfeiting between Western life style drugs from  life-saving medicines in short supply in emerging countries like Africa and India and China require different approaches
» Learn how continuous deterioration of economic conditions plus lack of public awareness  makes  even cheaper generic drugs susceptible to counterfeiting, e.g. Indian generics re-labeled “Made in China” for sale in Nigeria
» Comprehend how counterfeiting is enhanced by the lack of compliance to regulations that prohibit the selling of drugs out of pharmacies and authorized outlets and what emerging nations are doing today to rid of this supply chain break-down
» Learn how NAFDAC is using a multi-level approach to detect and seize counterfeits while simultaneously educating the population on how to distinguish good medicines  from bad.

On March 4th –come listen, inter-act and meet peers to discuss the global drug counterfeit menace and learn how you can assist in the war against them !
Speaker # 1:

Mr. Alden Zecha – CFO/Strategist –Sproxil Inc

Alden Zecha serves as CFO / Strategist  at  Sproxil, creator of the first mobile phone based authentication system for emerging regions.
Sproxil and its CEO Ashifii Gogo was recently acknowledged by President Bill Clinton during the recent Clinton Global Initiative, September  21-23, New York City.

President Clinton’s congratulatory video on Sproxil is available at: http://sproxil.com/cgi2010.php

Alden Zecha- CFO /Strategist of Sproxil will feature the Sproxil consumer based anti-counterfeiting solution that is in pilot stage with NAFDAC – National Pharmaceutical Regulatory Agency  in Nigeria and being considered for use in Haiti and other emerging regions.  He will provide more details on why their system worked with stats proven on the ground during the NAFDAC pilot program.

Other new initiatives underway with yet other pharmaceutical emerging regions will also be discussed.
Speaker # 2:

Mr.Praful Naik

Chief Scientific Officer

Praful Naik has a doctorate degree in Pharmaceutics from the Institute of Technology, Banaras Hindu University, India. He has over 18 years of industrial experience and has held positions of diverse responsibilities in the Pharmaceutical industry. He is currently the Chief Scientific Officer and Executive Director on the board of Bilcare Limited, a publicly listed company headquartered in India. Bilcare is an international, integrated products, processes and technologies provider to the global pharmaceutical and other industrial segments which includes its path-breaking nonClonableID™ Security Technology.

Praful is responsible for the global scientific affairs initiatives and provides support to all strategic business initiatives, worldwide. He has over 10 research paper publications and has extensively lectured at national and international conferences and global forums. Praful has to his credit 5 Indian patents, 1 USA and 4 International patents and has over 100 patent applications in various stages of grant. Member of several associations, organizations and academic institutions, he also sits on the expert committee of the Indian Pharmacopoeia Commission, is the member of the CII’s National Committee of IP Owners, represents the Indian Pharmaceutical Organizations IDMA and OPPI on WHO-IMPACT and was the member of “National Working group on Scientific and Technological Measures to counter spurious and sub-standard drugs and diagnostic centres” constituted by the Principal Scientific Adviser to Government of India. Praful was conferred with the “Distinguished Service to the Pharmacy Profession” by Association of Pharmaceutical Teachers of India in 2008, the “Outstanding Performance Award” by the Institute of Pharmaceutical Education & Research in 2009, was awarded the Certificate of Innovation for the nonClonable security technology at Innovations 2010 by the IIT Bombay Alumni Association and was invited to speak at the prestigious Science and Technology Forum 2010 at Kyoto, Japan on Security in the Age of ICT.
Speaker # 3:

Mr. Joseph Ringwood

Chief Operating Officer – Systech International

Mr. Joseph Ringwood is the Chief Operating Officer- Systech International.

Mr. Ringwood is responsible for directing Systech's strategies for growth both domestically and internationally and to grow customer, business and technology partner relationships.. Mr. Ringwood has architected successful teams leading to outstanding performance in diverse industries including: packaging machinery, business process outsourcing, and professional office solutions.

With more than 25 years of sales, marketing, and general management experience in business-to-business environments, Mr. Ringwood plays a key role in Systech's business operations. Mr. Ringwood is tasked with expanding Systech's market position as a provider of Packaging Execution Systems to the world's leading pharmaceutical companies including Pfizer with its Viagra product packaging

Joe will speak on :
“Establishing a State of Readiness - Mass Serialization as a Business Strategy”

Ringwood will take an in-depth look at the global serialization landscape. He will offer a strategic view of what manufacturers should consider when selecting a serialization approach.

Additionally, he will include real-world examples from industry thought leaders AstraZeneca and LifeScan to illustrate the business benefits of implementing a configurable and flexible serialization solution.

During his talk, attendees will learn about the following:

• Global pharmaceutical serialization snapshot
• Best practices to implement a global serialization approach
• Examples of how leading pharmaceutical manufacturers,
   AstraZeneca and LifeScan, leveraged a configurable and
   expandable solution to address serialization
• Lessons learned in mitigating risk in deploying serialization
Speaker # 4 :
Mr. Jean-Michel Cambie

Director Vision Strategic Initiatives
Mr Cambie is responsible for directing the Vision Strategic Initiatives and Strategic Business Development for Cognex International, especially in the Pharmaceuticals market, where reliable data collection and grading is key to ensure optimal traceability implementation. Mr Cambie has 20 years Sales and Marketing experience in industrial automation and vision, and an extensive international experience at a large variety of hi-tech companies in Europe, the Middle-East and Asia, with proven track record at accounts development and retention.
Speaker # 5 :  
Dr. Milind Antani

Head-Life Sciences Practice – Nishith Desai & Associates – International law firm with offices in Mumbai-Bangalore-Singapore and Silicon Valley, VA
Dr. Antani will discuss first of all what the legal definition of counterfeits are in India and how that differs from the IMPACT (WHO) or Western regions.  Unless we all can agree to just what a counterfeit drug is, seizures of Indian generic drugs bound for Brazil in route in Amsterdam is bound to be repeated elsewhere.

Dr. Antani will then feature various legal arsenals at your disposal as pharma manufacturer, exporter or consumer to combat counterfeits.
Speaker # 6 :  
Mr. Rajeev Tembe

Head Business Development
ACG Associated Capsules Pvt. Ltd.
Mr. Rajeev Tembe presently heads Business Development at the ACG’s ‘Innovative Cell at the company. The unti’s objective includes Identifying, developing & marketing products for the niche market. He is in charge of business development for Products with USP, products with anti-counterfeit features, products tailor made for custome specific customer requirements.  

He is involved with special Anti –Counterfeit printing technology for printing on capsules , cold shrink capsules & few other products currently under development. Special product for one of the leading pharmaceutical company has been developed.Trace & Track- Anti-Counterfeit Technology. He has expertise with with packaging films, like Desiccant Formpack, PVC, PVC/PVDC, Aclar, Cold Form Blister foil, alu foils, Metered dose inhalation, DPI (Direct Powder inhalation)He is also conversant with pharmaceutical machineries, like capsule filling, blister packing & Fluid bed equipment.
Speaker # 7 :
Mr. Ram Banarse

Asst Commissioner- FDA
• Mr. Ram Banarse worked in Pharmaceutical industry in various capacities for ten years. He. He has gained experience in development of Non sterile dosage Formulation and setting of new Oral Liquid, Capsule and tablet manufacturing section as per norm provided under WHO guideline on quality management of pharmaceutical preparation.

He joined Food and Drug Administration Maharashtra in 1990. His quest for acquiring knowledge prompted him to obtain a degree in Law and also Post Graduate degree M.Sc. in Clinical Research He has used his industrial experience for up gradation of compliance of good manufacturing practices by the pharmaceutical industry through statutory inspection.

• While working in Intelligence Branch of F.D.A., he has interdicted various inter State rackets of spurious drugs. He has been awarded for his contribution of exploring inter state racket of spurious drugs by State of Maharashtra. Many have been arrested from his constant vigilance.

• He has been associated with many organizations like Pharmaceuticals Chemist Association, Founder member of All India Drugs Control Officer Confederation beside this he is actively associated with IPA and He is a life member of IPA.
Speaker # 8 :
Mr. Daryll Mascarenhas

General Manager ( Supply Chain )
GlaxoSmithKline Pharmaceuticals Ltd.
Mr. Daryll Mascarenhas is currently General Manager, Commercial Supply Chain at GlaxoSmithKline Pharmaceuticals Ltd. (GSK), a Big Pharma company and one of India’s oldest Pharmaceutical setups. His current span of control includes; Demand Replenishment, Logistics, 3rd party Warehousing and Sales Administration covering over 4000 customers spread across the length and breadth of India, churning $ 400 million in revenue every year. Daryll joined GSK in 1995 and has a rich and varied functional experience covering Market Research, Field Sales, Brand Management and the Supply

He holds an MBA in Marketing from the Institute for Technology & Management, Mumbai and a dual Supply Chain specialization from APICS (USA). He is a regular speaker at Supply Chain forums, where his forte is covering emerging trends and strategies for the Pharma sector.  
Speaker # 9 :
Mr. Zubin Jimmy Dubash

Vice President & National Head
TTSL VAS Services
Mr. Zubin Jimmy Dubash is Currently Vice President & National Head of New Products Innovations at Tata Docomo, Tata Photon, Tata Indicom & Virgin brands. Responsibile for strategy and innovation for all the brands of Tata Teleservices.

A JBIMS alumni, He has industry working experience of 16 years with companies such as - Network Institute - a Microsoft Solution Provider, Vodafone (India), British Gas Broadband & Tata Teleservices Ltd. Have spent the last 13 years in the rapidly-growing telecom & broadband sectors in India, managing various functions including Roaming, Business Development, Product Management and Mobile VAS. Since 2000, have been closely associated with Mobile VAS in India, and have been a part of pioneering breakthroughs with operators like Hutch (Now Vodafone) & currently Tata Teleservices Ltd (TTSL).
Speaker # 10 :
Mr. Shashank Pore

Head-Brand Communications & VAS
TTSL CSR (Corporate Social Responsibility)
Shashank Pore is Head- VAS & Marketing Communication for Tata Indicom / Photon & walky at Tata Teleservices. Previously-he served as Assistant Vice President for Marketing also at Tata Teleservices – Maharashtra. He was Assistant General Manager at Idea Cellular Ltd and Brand Manager at Gillette

For more information contact Ram Balani at 516-515-9642 or email at rbalani@fdasmart.com