FDASmart

A Full Day Seminar with Networking on Pharmaceutical Anticounterfeiting in Emerging Regions - Edison, New Jersey – April13th-2011


"Winning the War Against Pharmaceutical Counterfeits in Emerging Regions: How To Stay One Step Ahead !"

Anticounterfeting

Venue: 
Pines Manor, Edison, New Jersey
Address :
2085 Route 27 (Lincoln Highway) Edison, NJ 08817
Date:   
April 13th-2011    8:30am – 5:30pm
Price:  
One Price - $ 459 - Includes ALL !
Fee includes seminar conference materials, continental breakfast, coffee breaks, Asian lunch (sushi served) plus Networking with our world-class speakers and your peers from big Pharma, innovative anticounterfeiting solution providers, pharma KOLs, international pharma Media/journalist, etc
Early Bird One Price of $ 459 Includes All !

Click here to Register

Full Day Event Overview:

What do the following have in common?

- A Senior Scientist – Manager  from Bristol Myers Squibb

- A  former Eli Lilly quality expert turned analyst/reporter on international pharmaceutical quality matters

- A   consumer-based mobile authentication vendor assisting in the war against counterfeits in Nigeria  (NAFDAC)

- A world class serialization solutions  provider with five of the top ten big pharma as its customers,

- A legal US FDA expert  based in Washington, DC  who specializes wit IPP (Intellectual Property Practice)

- An NIR expert  who introduced NIR spectroscopy to pharmaceutical applications

They’re ALL COMING to FDASmart’s April 13th full day seminar –forum on anticounterfeiting to shed light on  just how to stay ahead of pharmaceutical counterfeiters today and in the future!

Make no mistake about it –  THERE’s a WAR GOING ON   but this one does not involve guns nor bullets but WHAT WE ALL HAVE in our medicine cabinets, i.e. pharmaceutical drugs !

With counterfeiters becoming smarter & more sophisticated than ever before,  staying ahead of them can become challenging !

Pharmaceutical drugs are  a big problem causing death in some cases and getting bigger each day specially in emerging regions like Africa, China, India and others.

According to the Center for Medicine in the Public Interest, counterfeit drug sales are expected to reach $75 billion globally by 2010 – skyrocketing by 90% from the 2005 level. Reported counterfeit incidents in recent past involved 112 countries and 639 branded, generic, and over-the-counter (OTC) drugs, according to the Pharmaceutical Security Institute -- and most instances go unreported because “you don’t know what you don’t know.”

Today’s pharmaceutical counterfeiters use sophisticated technologies and techniques to counter whatever protective measures we have in place including RFID, barcodes, taggants and other finger printing schemes, even recent mobile authentication systems.

It takes constant vigilance and monitoring but more IMPORTANTLY  innovative solutions including new generations of science including nano chemistry, unique finger printing with NIR,  new  RFID encryptions and even mobile authentication systems to name a few, working together to stay on TOP of COUNTERFEITERS !

Come April 13th at Pines Manor, Edison, New Jersey-  FDASmart has assembled a world class group of  solution experts that include big pharma solutions,  NIR science including portable scanners, packaging serialization, innovative authentication system using mobile SMS  by consumers at point of sale, legal and media tools to fight the scourge of counterfeit drugs in developing regions of the world like China and India.

Come meet your peers and network while learning what’s happening with the  anti counterfeiting battle front where pharmaceutical manufacturers, regulatory agencies, government, the supply chain and now even consumers themselves do their PARTS so that all together WE WIN THIS WAR !
 

FEATURED SPEAKERS:
 
On April 13th –come listen, inter-act and meet peers to discuss the global drug counterfeit menace and learn the latest technologies and solutions to combat counterfeit drugs in emerging regions where it has reached crises proportions.
 
Session 1: Detecting Fake Drugs Using Portable Spectrometers”
   
9:45am – 10:30am : Mr. Ravi Kalyanaraman - Senior Scientist-Manager
Bristol Myers Squibb (BMS)
 

Description: 

Pharmaceutical industry and federal agencies are finding ways to counteract the increasing threats caused by pharmaceutical counterfeiting. 

Several technologies are currently available to detect a counterfeit drug. This talk will feature how these portable spectrometers can be used in the field for counterfeit drug detection.

Anticounterfeiting techniques include covert and overt features added to the packaging material and also on the drug product itself. One  effective way is to develop unique spectral fingerprints for the drug product and test the suspect product against these fingerprints to identify counterfeits and also to authenticate legitimate ones.

Near-Infrared (NIR) and Raman spectral techniques, which are complimentary in nature, have been used to fingerprint drug products for this purpose. In the past few years portable versions of these spectrometers have paved the way to detect counterfeit drugs in the field.

Speaker Background :
Mr. Ravi Kalyanaraman is a Senior Scientist at Bristol-Myers Squibb Company in Global Analytical Technology group with Technical Operations.

His recent work with Bristol-Myers Squibb has been focused on developing new and novel techniques to detect pharmaceutical counterfeits. His interests are mainly in using vibrational spectroscopic techniques, such as portable Raman and Near-Infrared (NIR) for pharmaceutical counterfeit detection and for product authentication in the field.

He is also a co-lead of an analytical team that is involved in the analysis of products received from complaints and from corporate security groups
He received his Ph.D. from the University of Idaho in 1996 and has been with Bristol-Myers Squibb since 2002.
 
Session 2: “Key Factors to Implementing a Successful Consumer-Based Anti-Counterfeiting Solution”
   
10:30am – 11:15 am : Mr. Alden Zecha - CFO/Strategist – Sproxil  

Description: 

Mr. Alden Zecha will feature the Sproxil consumer-based anti-counterfeiting solution that is in nationwide use in Nigeria in cooperation with NAFDAC (National Agency for Food and Drug Administration and Control) the National Pharmaceutical Regulatory Agency and providing protection for numerous products including those from GSK and Merck Serono. Coverage of Sproxil’s patented Mobile Product Authentication™ (MPA) solution is also being expanded throughout several additional emerging regions in Africa and India.

He will provide details on how and why their system has delivered significant benefits for consumers, brand owners, and government agencies including statistics regarding substantial sales increases for products using MPA. New initiatives underway with additional pharmaceutical brands and regions will also be discussed.

Speaker Background :
Mr. Alden Zecha serves as CFO and Strategist of Sproxil, a U.S.-based company that provides world-class brand protection in emerging markets through software and services that work anywhere there are mobile phones. Responsible for the overall strategy, finance and administration of the company, Zecha brings to the role more than 20 years of broad-range executive expertise in operations, strategy and finance, and vast experience from work in more than 20 countries. 

Prior to joining Sproxil, Zecha co-founded and served as CFO of ultra-luxury travel company PrivatSea and as CFO of Rethos, a sustainability and corporate social responsibility social media website. He also co-founded an OTC drug distribution company and worked with the Japanese MHW (FDA equivalent) on regulatory compliance issues for Procter & Gamble. Zecha previously worked with consulting firms, Monitor Group and BearingPoint, and served as international economic development specialist for the State of Hawaii.
 
11:15 am – 11:45am :   Coffee Break (30 minutes )
   
Session 3: “Establishing a State of Readiness - Mass Serialization as a Business Strategy”
   
11:45am – 12:30pm : Mr. David M. DeJean - Vice President, Business Development -
Systech International™ 

Description: 

Mr. DeJean will take an in-depth look at both local and 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:

  • Local and Global serialization landscape and the impact on solution considerations
  • 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 Background :
Mr. DeJean is responsible for developing the strategy and business plans for building, supporting, and managing the international network of partners for Systech International™. Our partner programs include Marketing Partners, Value Added Reseller, Select Solution Providers and our Strategic Original Equipment Manufacturers enabled to deploy the Systech Serialization Platform globally. 

Systech developed a  line of monitoring and control solution that includes automated procedural management, analytics and reporting of information for pharmaceutical products packaging. With the addition of serialization and ERP integration, Systech has evolved their offering into a complete Packaging Execution System (PES).

With over 25 years of experience, Mr. DeJean has held various Engineering Management, Product Marketing and Sales Management positions within Systech.  Mr. Dejean is tasked with expanding Systech's partner network as providers of Packaging Execution Systems to the world's leading pharmaceutical companies.
 
12:30 pm – 1:30 pm: Lunch (60 minutes )
   
Session 4: “ GDP (Good Distribution Practice) Initiatives Driving Toward a More Secure Global Drug Supply Chain”
   
1:30 pm – 2:15 pm : Mr. Jerry Chapman - CIO - IPQ (International Pharmaceutical Quality)  

Description: 

The drive to control counterfeiting is part of a larger effort on both the national and international level to better secure drug supply chains by strengthening GDPs.  This presentation will focus on these GDP initiatives both in emerging and global markets, their relevance in the anti-counterfeiting efforts, and the goal of achieving  their global harmonization

Speaker Background :
Mr. Jerry Chapman serves as Chief Information Officer and Senior Editor at International Pharmaceutical Quality (IPQ).
He has 31 years working experience at Eli Lilly and Company including responsibilities  in technical and leadership positions in product development, manufacturing, quality positions at the plant and manufacturing site levels, corporate quality, and quality systems
At Lilly-Jerry Chapman was involved with:

-QA for biosynthetic API manufacturing operations.
- He Co-led FDA and EMEA inspection preparation and participated in execution
-As part of Corporate QA- he  designed and implemented comprehensive GMP Intelligence process, a process to identify pertinent GMP regulations, inspection findings, trends, and best practices, then analyze, communicate, manage, and archive that knowledge
-He created,  designed and implemented  CGMP training programs, and delivered training sessions

Jerry Chapman is a  Member  of PDA, ISPE and  Founder and chair of the MWDG GMP Intelligence Subgroup,  2004 – 2010.
Jerry Chapman has a Bachelors degree in chemistry and microbiology from Purdue University, MBA from Butler University Indianapolis.

 
Session 5: "IPR and More Legal Arsenals to Combat Pharmaceutical Counterfeit Drugs"
   
2:15 pm – 3:00 pm : Mr. Terry Gaffney - Intellectual Property Practice Manager
Eckert Seamans, Cherin and Mellott, LLC.
 

Description: 

Terry Gaffney will discuss  the legal definition of counterfeits  and how that differs from the IMPACT (WHO) or Western regions.  He will highlight how various geographies including the US and emerging regions leverage legal vigilance and ultimately use legal courts to take action against counterfeiters.

He will discuss various legal arsenals at anyone’s disposal to counter counterfeit pharmaceutical drugs in the US and present some first-hand experiences with a pharmaceutical company in South Africa.

Speaker Background :
Mr. Terry Gaffney is a intellectual property practice member  based in Washington DC at the full –service law firm, Eckert Seamans, Cherin and Mellott, LLC.

Terry’s medical background, combined with his extensive experience advising pharmaceutical and medical device companies gives Eckert Seamans  additional depth in the health care and life science sectors, a continued focus for the firm.
 Terry Gaffney practices in the area of intellectual property law with a heavy emphasis on life sciences matters. He has over 20 years' experience leading efforts for clients with matters before the U.S. Food and Drug Administration, the U.S. Federal Trade Commission, Congress and other government agencies with regulatory control over the pharmaceutical, biologics, medical device and dietary supplement industries.

Mr. Gaffney’s practice includes advising pharmaceutical, biotechnology, medical device and dietary supplement companies on matters involving a wide range of issues related to the development, manufacture, reimbursement, and sale of pharmaceutical, biologic, medical device, and dietary supplement products. He also has extensive first chair trial experience involving complex scientific and medical issues and his litigation practice includes ANDA Paragraph IV Certification.

Prior to entering the practice of law, Mr. Gaffney worked for SmithKline Beecham, P.L.L.C. and on the critical care nursing staff at a large teaching hospital.

Mr. Gaffney earned his J.D. from the Cleveland State University, Cleveland-Marshall College of Law and his undergraduate degree from John Carroll University.
 
3:00pm– 3:30pm : Coffee Break (30 minutes )
   
Session 6: “Stating One Step Ahead of Counterfeit Drugs: Anytime/Anywhere Tools to the Rescue”
   
3:30pm – 4:15pm : Mr. Emil W. Ciurczak - President - Doramaxx Consulting  

Description: 

Estimates of counterfeit drugs  are as high as possibly 25% in India with over 50% reported in some areas of Africa.  China, due to its size and history of not recognizing western patents is almost a separate problem.

Many approaches are being tried, among them RFID (radio frequency ID). Numerous companies are attempting to use lab-based analytical methods, while more are using portable (or hand-held) near-infrared and Raman spectrometers for on-the-spot checks.

 Chasing counterfeit drugs is a complex undertaking anywhere, Even when a single company makes a single dosage level, it may be made at numerous sites. This gives a slightly different “spectral fingerprint” for each location, making a spectral database large and unwieldy to create. Sending samples to a laboratory is time-consuming and means that shipments need to be quarantined for long periods of time, possibly denying needed medicines to ill patients.

The logistics of identifying so many proprietary and generic dosage forms, liquids, pastes, capsules, and tablets, with any single technique are very complex, expensive, and time-consuming. With a large number of hardware and software options, very few of which are compatible, the problem seems insoluble. In addition, there are so many conflicting laws and jurisdictions that a simple solution seems far away.

This talk will outline some of the successes and failures to date and will discuss some upcoming methodologies that may be able to bridge these legal and technical gaps.

Speaker Background :
Mr. Emil W. Ciurczak has been in the pharmaceutical industry since 1970 (Ciba-Geigy, Sandoz, Berlex, Merck, and Purdue Pharma), performing method development on all types of analytical equipment.

In 1983, he introduced NIR spectroscopy to pharmaceutical applications. He also consulted for Technicon (Bran & Leubbe), NIRSystems (FOSS), CDI Pharma, Infrared Fiber Systems, Brimrose, and Buchi.

Since 2005, Emil has been Contributing Editor for Pharmaceutical Manufacturing magazine (and for Spectroscopy; 1987-2007).He has written and edited several texts and chapters: “Handbook of NIR Analysis” (1st, 2nd, and 3rd editions), “Pharmaceutical and Medical Applications of NIRS” (2nd edition in progress), “Molecular Spectroscopy Workbench”.  Emil sits on several magazine editorial boards, is active in SAS, is a founder of the Council for NIRS, and was the 2002 chair for IDRC (Chambersburg Conference).

Emil is a consultant in the field of NIR (lab and process applications) and holds patents for NIR-based devices and software. He consults with various pharmaceutical companies, instrument manufacturers, and the FDA. He was a member of the PAT sub-committee (Validation) for the FDA and member of the PAT Expert Committee for the USP. He was the 2004 recipient of the EAS Achievements in NIR Award.

Emil W. Ciurczak has advanced degrees in Chemistry from Rutgers and Seton Hall Universities and he has been teaching (college adjunct) since 1979 including Stevens Tech, College of St. Elizabeth, Hood College, and Mount St. Mary’s College  as well as short courses (in NIR and PAT/QbD) for the ACS, CfPA (US and Europe), SPIE, ASSA, and other organizations.
 
PANEL DISCUSSION:
4:15-pm – 5:00pm : Moderated by Jerry Chapman - IPQ
– all our day speakers will participate as Panel Members.
We wish to invite the audience to participate during the Panel Discussion.
   
Panel Discussion:  This  panel will focus on how various stake holders in the pharmaceutical supply chain need to collaborate and continually deploy the next innovative anticounterfeiting measure or solution to stay one step ahead of  counterfeiters in emerging regions.

All aspects will be looked at –i.e. from pharmaceutical manufacturer to distribution, regulatory agencies  and ultimately consumers themselves.
   
5:00pm – 5:30pm: POST Event Networking  

 
Click here to Register
 

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