12th Annual Pharma Anti-Counterfeiting & Serialization 2023
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WHY SHOULD YOU ATTEND?
Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference.
Speakers
JASON BEEVER
US Dept of Homeland Security
JASON BEEVER
US Dept of Homeland Security
JASON BEEVER, Supervisory Special Agent, US Department of Homeland Security
Mr. Jason Beever is the acting Section Chief at the National Intellectual Property Rights Coordination Center, located in Arlington, VA. In this capacity, he leads a team of Special Agent Program Managers and Analysts dedicated tosupporting andinvestigating Intellectual Property Crimes and other violations of federal law.
Mr. Beever started his Law Enforcement career in 1996, and as a Special Agent with HSI he has worked numerous investigations ranging from human trafficking and human smuggling to child exploitation, financial fraud, and Intellectual Property Rights violations.He has had the privilege of working in offices around the nation and has worked as a Senior HSI Representative in an overseas capacity in a U.S. Embassy.
Mr. Beever is a 2018 World Customs Organization Certificate of Merit recipient, and a 2017 Director’s Award recipient for Law Enforcement Excellence.
RAVI K
Bristol-Myers Squibb
RAVI K
Bristol-Myers Squibb
RAVI KALYANARAMAN, Scientific Director – Forensics and Innovative Technologies (FIT), Bristol-Myers Squibb
Ravi Kalyanaraman, PhD is the Director of the Forensics and Innovative Technologies (FIT) group within Global Quality Analytical Science and Technology at Bristol‑Myers Squibb (BMS) Company. He received his PhD from the University of Idaho in 1995 and did his post-doctoral work at the University of Puerto Rico. He has been with BMS since 2002 and his work has focused on leading and developing new and novel analytical techniques to detect pharmaceutical counterfeits, and to support particulate and foreign matter characterization in the manufacturing process (bio, pharma, and cell therapy).
His interests are mainly in using vibrational spectroscopic techniques, such as Raman, mid- and near-infrared (NIR) and hyperspectral imaging for pharmaceutical counterfeit detection. His group extensively uses microscopy (IR, Raman and SEM) and energy dispersive spectroscopy (EDS) for elemental analysis for particulate and foreign matter investigations. He leads a team in global quality organization that is involved in the analysis of products received from patient complaints and from corporate security groups.
NELIO DRUMOND
Takeda
NELIO DRUMOND
Takeda
NELIO DRUMOND, Associate Director – Global Manufacturing Sciences, Takeda
Nélio Drumond is a PharmD by training with a PhD in Patient Centric Drug Product Design. He shares several years of experience in the Pharmaceutical Industry, providing scientific and strategic leadership to drug product development programs during clinical stages, including their scalability and validation for commercial use.
Nélio spent the last 2 years in Germany overseeing Takeda’s external supply portfolio and has recently moved to the US to support the launch and commercialization of new drug therapies. Dr. Drumond is a strong advocate for patient centric drug product design and is regularly invited to speak at various international conferences.
SEBASTIEN M
Ferring Pharmaceuticals
SEBASTIEN M
Ferring Pharmaceuticals
SEBASTIEN MAUEL, Head of Serialization & Product Security, Ferring Pharmaceuticals
MICHAEL K
BeiGene
MICHAEL K
BeiGene
MICHAEL KEENAN, Director, Global Brand Protection, BeiGene
Mike Keenan is a pharmaceutical and consumer products industry professional of more than 25 years, having held positions of increasing responsibility at Pfizer, AstraZeneca, Mondelez International, Allergan and most recently, BeiGene. In his latest role as Director, Global Brand Protection, Mike has developed global, cross-functional programs to protect BeiGene’s cancer medicine portfolio. Mike is a recognized industry expert in brand/supply chain security and is also an experienced practitioner in workplace investigations, executive protection and other corporate security disciplines.
Before entering the private sector, Mike served as a Court Officer in the New York State Office of Court Administration for seven years. He holds a bachelor’s degree in English from St. Joseph’s University and resides in Lincroft, New Jersey with his wife Christine and his two children, Sam and Michael.
AYSE BAKER
Corcept Therapeutics
AYSE BAKER
Corcept Therapeutics
Ayse Baker has over 25 years’ experience in pharmaceutical industry with focus on building and leading regulatory affairs teams worldwide. Ayse held increasing regulatory roles in both large and small pharmaceutical companies. Her expertise includes leading scientific and regulatory strategies for registration of small molecule and biologic drug products in therapeutic areas: oncology, neurology, hematology, diagnostic imaging, diabetes and inhalation products. Ayse started her career in pharmaceutical industry at Abbott Laboratories as a research scientist.
Ayse received a PhD in Chemistry from University of Illinois at Chicago. MBA from Lake Forest Graduate School of Management. She completed her post- doctoral fellowship at Loyola University Stritch School Medicine in Department of Hematology and Oncology. She was awarded Outstanding Young Investigator Award of Biochemistry / Biophysics for elucidating mechanism of action for light activated drugs in treatment of cancer. Ayse is active and a frequent speaker in national and international trade organizations and prestigious academic institutions. She was recognized for her contributions to the Regulatory Affairs profession by the trade organization and became a Fellow of the Regulatory Affairs Professional Society (RAPS) in 2016 and currently serves on the RAPS Board of Directors.
VIGNESH N
Aurobindo Pharma
VIGNESH N
Aurobindo Pharma
VIGNESH NAGARAJAN, Associate Director – Distribution Operations, Aurobindo Pharma
YURICEL T A
Roche
YURICEL T A
Roche
YURICEL TAMAYO ALVAREZ, Regulatory Affairs Specialist, Roche
“Graduate of Chemical Degree in the Easternt University of Santiago de Cuba, Cuba and currently in an ongoing masterated program in the University of Nebrija, Spain; Yuricel Tamayo Alvarez, who prefers to be named just Yuri, is a passionate human being who has worked for more of 18 years in the cosmetic, nutraceutic and drugs industry; the last 11 years dedicated entirely to the pharmaceutical industry in diverse management position related to I+D, Manufacture, Quality Control and Quality Assurance, Regulatory Affairs and Regulatory Policy. Between 2013 to 2015, Yuri was the Technical Director of Reference Laboratory of the National Agency for Regulation, Control and Sanitary Surveillance of Ecuador, the competent drugs authority of Ecuador; this position allowed him to collaborate actively in the construction of local regulation.
[ The patient as focus as mainly beneficiary of his work is an premise for Yuri, always committed with any project to allow us bring major benefits to the patients, to the environmental care which is the ruth of him turned in pioneer in the understanding of the e-labeling and in generation of influence to adopted it in Ecuador.”]
MARIA A R
Novartis
MARIA A R
Novartis
MARIA ANTONIETA ROMAN, Head Regional Regulatory Policy, Emerging Markets LATAM, Novartis
DOUGLAS LIPTAK
Sanofi
DOUGLAS LIPTAK
Sanofi
DOUGLAS LIPTAK, Sr. Mgr, Product Security & Information Protection NA Security, Sanofi
Douglas Liptak is the Senior Manager of Investigations for Sanofi, a pharmaceutical manufacturer, as part of their Global Product Security (GPS) group, since 2000. He received a dual major degree in Criminal Justice/Political Science from Kutztown University of PA and an MBA from Webster University, St. Louis MO in 2003. Prior to joining Sanofi, Douglas was the Regional Security Manager/Investigator at Merck & Co., Inc. for 7 years in Whitehouse Station NJ, and prior to that he was the Director of Safety & Security for the Hunterdon Healthcare System in Flemington NJ for two years.
His current responsibilities include oversight of investigations related to product issues within North America, which include, but are not limited to, counterfeiting, diversion, cargo theft, financial fraud, internal theft, intellectual property, product infringement, and other items related to the compromise of Sanofi medicines.Douglas has led investigationsinto the largest animal health counterfeiting operation within North America, as well as the first trade secret theft prosecution of pharmaceuticals involving online websites.
Douglas has received certification as a business management leader from Georgetown University in 2015, as well as a Brand Protection Professional from Michigan State University, as a member of their Center for Anticounterfeiting and Product Protection program (A-CAPP) in June 2021.He has received certification for the completion of OSINT investigations – Level 1-6 – from Infraguard, Los Angeles office, and sits as a member of the Anti-Counterfeiting Task Force for the National Association of Manufacturers (NAM.) Additionally, he serves as a Board member for the NCFTA’s Partner Advisory Committee (PAC) as the pharmaceutical industry representative.
COLLINS AGORO
Evolve Traceability
COLLINS AGORO
Evolve Traceability
COLLINS AGORO, Founder and Director, Evolve Traceability
Mr. Collins Agoro is the founder and director of Evolve Traceability Africa, a start up involved with offering consulting services on topics surrounding implementation of GS1 standards, Traceability, Supply chain security, Capacity building, Digital health, in Low Middle Income Countries. He has previously worked with notable companies namely Roche, USAID and B.Braun.
Collins has been working in the counterfeit and traceability space for the last 8 years and has gained considerable experience working in Europe, Middle East, Africa and currently the United States. His key assignments have been Supporting African governments in the GS1 standards and Traceability implementation initiatives and as a Project Manager for the European Union Falsified Medicine Directive Implementation. Additionally, Collins has been involved in the support group for the US DSCSA implementation, alongside participating in various Technical Working Groups on Policy and Governance development around GS1 standards implementation and traceability.
He is a seasoned speaker in various forums around supply chain security and patient safety and derives passion from growing up in Africa and understanding explicitly the danger of counterfeit and falsified medicine in the public health system. Collins holds a Bachelor of Engineering degree in Industrial Systems Engineering and a Master’s degree in project planning and management focusing on the impact of global health standards implementation in public health supply chain systems.
RICK MAZUR
Eastman Kodak Company
RICK MAZUR
Eastman Kodak Company
RICK MAZUR, WW Director of Market Development, Packaging; Inkjet, EASTMAN KODAK COMPANY
Rick Mazur is currently the worldwide Director of Market Development for Packaging for Eastman Kodak’s Digital Print Solutions business. Rick has over 25 years of experience in marketing, sales and business development, with International Paper and Kodak Polychrome Graphics, before joining Kodak. In his current role, Rick is focused on helping brandsand packaging converters employ digital technology to drive sustainable growth.
He is currentlyleading Kodak’s launch ofinkjet packaging solutionswith a focus on the folding carton, personal care and flexible packaging segments that are seeing growth in ecommerce, security, track and trace, food packaging and personal care market sectors.
SEAN MURPHY
AmerisourceBergen
SEAN MURPHY
AmerisourceBergen
SEAN MURPHY, Manager – Manufacturer Operations, AmerisourceBergen
Sean Murphy has been with AmerisourceBergen since 2014 and has over 10 years of experience in supply chain logistics and legal compliance. He is currently a manager of the Manufacturer Operations & Data Services team. He has been involved in the internal DSCSA project since 2018 working to ensure that AmerisourceBergen & their external trading partners are ready to meet industry traceability standards. Prior to his current role, Sean Murphy worked as an analyst driving supply chain optimization for the Replenishment Operations team.
GARY POND
Colorcon
GARY POND
Colorcon
GARY POND, Global Program Lead – Authentication, Colorcon
Gary has over 25 years of Life Science expertise and 8 years in healthcare technology. He has held sales & marketing leadership positions at Sanofi, Merck & Co. and Abraxis Bioscience. Immediately prior to joining Colorcon, he led the Brand & Marketing Center of Excellence at IQVIA.
Gary currently leads the commercialization efforts for authentication solutions at Colorcon. Colorcon is a world leader in the development and supply of film coating system,specialty excipients and functional packaging and offers innovative digital on-dose technologies and detection services for the authentication of medications.
JOSE C S
Catalent Pharma
JOSE C S
Catalent Pharma
JOSE CAMARA SANTIAGO, Validation Engineer, Catalent Pharma
José has more than 20 years of experience in the Pharmaceutical, Medical Devices and Biotechnology industry. His expertise has been focused on Computerized System Validation (CSV) Projects in compliance with FDA 21 CFR Part 11, CFR 820, GAMP 5 and ISO 13485 standards. Possess strong background in CSV projects to support QC Analytical Laboratories and manufacturing operations according to SDLC Methodology. Experience with diverse Quality Systems Management. For example, CAPA & Investigation, Change Control, JDE, Maximo, etc. Strong exposure to work in the FDA, ICH, DEA, ISPE and PDA regulated environment oriented to the high level of quality standards. Experience in Process Excellence and Lean tools. Professional experience supporting and leading projects for new technology/equipment, aseptic rooms, process improvement, technology transfer, etc. Expertise working with Logical Controls based in Manufacturing Equipment controlled with PLC (Ladder), and HMI. Experience in Line Level Serialization Technology Projects. Expertise with the new implementation of the Optel TrackSafe Serialization System in Packaging Portable Lines and HERMA High Speed Bottle Line Level Serialization. Experience leading Engineering Projects.
José holds the following certifications: Certified Quality Auditor, Certified Quality Engineer, and Six Sigma Green Belt per ASQ.
Native of Puerto Rico, José holds a Bachelor of Science (BS) with a major degree in Chemistry and a minor degree in Mathematics from the Interamerican University of Puerto Rico, Metropolitan Campus.
GEOFFREY P
PBWT
GEOFFREY P
PBWT
GEOFFREY POTTER, Partner, Patterson Belknap Webb & Tyler
Geoffrey Potter is a Partner and Chair of the firm’s Anti-Counterfeiting Practice and Brand Protection team. A highly-experienced trial lawyer, Mr. Potter litigates counterfeiting and product diversion cases on behalf of major corporations in multiple industries worldwide. These cases primarily involve counterfeit products with the potential to cause serious injury or death, including counterfeit medical devices, pharmaceuticals, nutritional supplements, beverages and other consumer, industrial and electronic products.
Mr. Potter also litigates to recover for fraudulent insurance claims, false pharmacy adjudications and fraudulently obtained discounts and rebates, and has successfully recovered tens of millions of dollars on behalf of pharmaceutical companies. In addition to this work, Mr. Potter also litigates cases for and against financial institutions and investment funds, as well as cases concerning accountant liability, defamation, consumer and shareholder class actions, unfair competition, copyright, breach of contract and fraud. He has also conducted numerous securities and employment arbitrations and internal investigations involving Foreign Corrupt Practices Act violations, accounting improprieties and employee malfeasance.
In the anti-counterfeiting arena, he has successfully sued and executed seizure orders globally against hundreds of individuals and businesses that have manufactured and distributed counterfeits. This has resulted in the seizure and destruction of millions of counterfeits and the collection of millions of dollars in settlements and judgments. Repeatedly, Mr. Potter’s efforts have resulted in counterfeiters being incarcerated.
Outside of litigation, Mr. Potter counsels clients on integrated risk reduction solutions and best practices for avoiding counterfeiting problems. He advises on proactive methods to secure products and packaging against counterfeiters and on the development of programs to guard and monitor distribution channels.
Chambers USA named Mr. Potter a Leading Practitioner for Intellectual Property Litigation known for his work in “high-stakes brand protection disputes.” The guide calls him a “noted authority on anti-counterfeiting issues” and clients described him as “one of the most brilliant, innovative, creative attorneys I have had the pleasure of working with,” as well as “one of the smartest, most strategic thinking, aggressive lawyers… in IP.” He is also praised for being “able to think outside the box” and for being “a lawyer who genuinely looks out for his client’s best interests.” He is also listed as a “Litigation Star” for New York by Euromoney Institutional Investor PLC’s Benchmark Litigation. Cited as an authority on anti-counterfeiting in more than a hundred articles, his recent quotes have been published in The New York Times, Wall Street Journal, International Herald Tribune, Forbes, Bloomberg and Financial Times. He is also a frequent speaker and teacher at anti-counterfeiting conferences.
Admissions:
• U.S. Supreme Court
• U.S. Court of Appeals, Second Circuit; Third Circuit; Seventh Circuit; Ninth Circuit; Federal Circuit
• U.S. District Court, Southern, Eastern and Northern Districts of New York
• U.S. Court of International Trade
• New York
• Colorado
• District of Columbia
• U.S. District Court, Eastern District of Michigan
Professional Activities:
• MEMBERSHIPS: New York State Bar Association; American Bar Association, Member, Intellectual Property Division; New York Civil Rights Coalition, Corporate Counsel and Member, Board of Advisors; EcoHealth Alliance, Board of Directors
• HONORS: Recognized as a Leading Practitioner for Intellectual Property by Chambers USA; Listed in World Trademark Review 1000 – The World’s Leading Trademark Professionals.
Education
• New York University School of Law (J.D., 1988)
• Cornell University (B.A., 1984)
TIMOTHY W
PBWT
TIMOTHY W
PBWT
TIMOTHY WATERS, Litigation Partner, Patterson Belknap Webb & Tyler
Timothy Waters is a Partner in the firm’s Litigation department and a member of the firm’s Anti-Counterfeiting Practice and Brand Protection team. Mr. Waters represents manufacturers and brand owners in complex litigations against the producers and distributors of counterfeits and illegally diverted products. Mr. Waters’ practice focuses on counterfeit products that have the potential to cause serious injury or death. He has investigated, litigated against and successfully shut down multinational counterfeiting networks on behalf of clients including major pharmaceutical companies, medical device manufacturers, and tech firms.
Exercising trademark owners’ rights under federal law, Mr. Waters has successfully obtained and executed dozens of ex parte civil seizure orders at counterfeiters’ offices and warehouses, seizing their electronic and paper records, and removing from their shelves hundreds of millions of dollars’ worth of counterfeit medical and consumer products. Mr. Waters has obtained eight-figure judgments against those counterfeit manufacturers and distributors, and obtained permanent injunctive relief prohibiting the companies and their principals from ever again buying or selling his clients’ products. Mr. Waters also successfully litigates against gray-market distributors and others who illegally divert his clients’ products, obtaining similar monetary and injunctive relief.
In addition to anti-counterfeiting and brand-protection litigations, Mr. Waters represents large corporations in trademark and copyright actions, consumer fraud lawsuits, and breach-of-contract and indemnity disputes.
Outside of litigation, Mr. Waters counsels manufacturers and markholders on brand-protection strategies, including combatting and deterring counterfeiting, unlawful diversion, and fraudulent billing and reimbursement practices.
Representative Matters
• Representing a major pharmaceutical company in a litigation against domestic and international companies and individuals manufacturing, distributing, and laundering the illicit proceeds of counterfeit HIV medication.
• Representing a major pharmaceutical company in lawsuits against gray-market distributors selling ex-U.S. products to U.S. pharmacies and retailers, including products repackaged into counterfeit U.S. packaging.
• Successfully represented a major medical device manufacturer in a series of litigations identifying, suing, and shutting down an international network that was manufacturing and selling to U.S. hospitals defective and bacterially contaminated counterfeits of surgical devices.
Admissions
• U.S. Court of Appeals, Second Circuit; Third Circuit
• U.S. District Court, Southern and Eastern Districts of New York
• New York
Education
• Harvard Law School (J.D., magna cum laude, 2008)
– Executive Editor, Harvard Law Review
• University of California, Berkeley (B.A., with highest distinction, 2003)
MARK KARHOFF
Ten Count Consulting
MARK KARHOFF
Ten Count Consulting
MARK KARHOFF, Principal Consultant, SCM, Life Sciences, Serialization, Ten Count Consulting
Mark Karhoff is a supply chain consultant and founder of Ten Count Consulting, LLC. Mark has 30 years of experience in program management, process improvement and supply chain solutions. Ten Count assists clients on system implementations and process to comply with DSCSA (Drug Supply Chain Security Act). He has served as a client representative with industry groups such as PDG (Partnership for DSCSA Governance), HDA, NABP, GS1, PDSA and FDA workgroups to establish standards and build alignment meet the unfolding US Law. He is currently serving as a DSCSA consultant for NABP in their efforts to align state regulators and trading partners on DSCSA tools.He lives with his family in Chicago and believes in advancing corporate social responsibility through partnerships with not for profits.
You can reach him at mark.karhoff@tencountconsulting.com or connect with him on LinkedIn.
KARLA L. PALMER
Hyman Phelps & McNamara
KARLA L. PALMER
Hyman Phelps & McNamara
KARLA L. PALMER, Director, FDA & DEA Investigations, Hyman Phelps & McNamara
Karla Palmer is a Director at Hyman, Phelps & McNamara, PC, in Washington, DC, which is a boutique law firm specializing in FDA and DEA law. She has a strong litigation background. Karla represents clients on a range of legal, regulatory, investigation and enforcement issues.
She has addressed industry audiences across the country on FDA and DEA compliance, including all aspects of the passage and implementation of the 2013 DQSA including both compounding and supply chain issues, its guidance documents, and implementing regulations.
ERIC MARSHALL
Leavitt Partners
ERIC MARSHALL
Leavitt Partners
ERIC MARSHALL, Principal, Leavitt Partners
Eric Marshall is a principal in the Washington, D.C. office of Leavitt Partners and the Executive Director of the Partnership for DSCSA Governance (PDG), a public-private partnership between industry and FDA that is committed to implementing supply chain security protections in the U.S. At Leavitt Partners, Eric advises complex health care coalitions on health policy and provides consulting services to drug and device companies. A regulatory lawyer by training, Eric is an industry specialist in the areas of drug, device, and diagnostics regulation. A portion of Eric’s practice is focused on domestic and international supply chain security, an area in which he is a recognized thought leader.
A seasoned facilitator and consensus-builder, Eric leads Leavitt Partners’ robust alliance practice, helping the firm and clients build, convene, manage, and advise numerous industry collaboratives committed to advancing sound health policy initiatives. Prior to joining Leavitt Partners, Eric practiced law, counseling health care and life science clients on regulatory, compliance, and transactional matters.
Eric graduated Order of the Coif from the University of Minnesota Law School and has a bachelor’s degree in economics and finance from the University of Northern Iowa.
Sample Attendees
Conference Schedule
Meet and to network with your conference colleagues.
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12th Annual Pharma Anti-Counterfeiting & Serialization 2023 – Day 1
06th September
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12th Annual Pharma Anti-Counterfeiting & Serialization 2023 – Day 2
07th September
08:30 – Coffee and registration
09:30 – Morning Chair’s opening remarks
MARK KARHOFF, Principal Consultant, SCM, Life Sciences, Serialization, Ten Count Consulting
STOP COUNTERFEIT DRUGS
09:40 – “Advance Analytical Technologies to Screen Counterfeit Drugs”
RAVI KALYANARAMAN, Scientific Director – Forensics and Innovative Technologies (FIT), Bristol-Myers Squibb
10:20 – Regulatory and Industry perspective on counterfeit medicines
AYSE BAKER, VP of Corporate Regulatory Affairs, Corcept Therapeutics
11:00 – Morning Coffee & Networking
CHALLENGES & OPPORTUNITIES
11:30 – Keynote Panel Discussion: Fight against pharma counterfeiting must go deeper – How to fight this plague?
• Are we ready for the (DSCSA)Drug Supply Chain Security Act?
• Waging war against counterfeit medicines
• As a company, where should you start to handle the situation better?
• Way into the future? How to prepare for it? What should be done?
• Utilize social media to educate the consumer to identify counterfeit drugs
• How to avoid counterfeits and make your supply chain and products more secure?
• Tracking and taking down illicit sellers: what tools do you need?
• A guide to surviving tough counterfeit economic conditions
• Lessons to learn from RoW
Moderator
MARK KARHOFF, Principal Consultant, SCM, Life Sciences, Serialization, Ten Count Consulting
Panellists
RAVI KALYANARAMAN, Scientific Director – Forensics and Innovative Technologies (FIT), Bristol-Myers Squibb
DOUGLAS LIPTAK, Sr. Mgr, Product Security & Information Protection NA Security, Sanofi
COLLINS AGORO, Founder and Director, Evolve Traceability
12:20 – Promoting Patient Safety and Security through Innovative On-Dose Coating Technologies
• Impact of Serialization on Patient Safety
• Industry Drivers for On-Dose Authentication Consideration
• Regulatory Perspective of On-Dose Microparticles in Film Coatings
• Advantages/Disadvantages of Commercially Available On-Dose Coating Technologies
GARY POND, Global Program Lead – Authentication, Colorcon
12:40 – Networking luncheon / Exhibition Visit
13:40 – How to proceed further in fight to stop counterfeit drugs? Fight to stop fakes
• Harmonizing Supply Chain policy framework across various jurisdictions globally.
• Advocacy and Awareness (Lobby groups) programs on the importance of supply chain security
• Adopting standard Digital solution/Tools for the fight against counterfeit
• Enhancing collaboration between key players in the Global supply chain ecosystem i.e MAH Donors Governments Wholesalers Importers.
COLLINS AGORO, Founder and Director, Evolve Traceability
14:20 – Introduction to Homeland Security Investigations and the IPR center and How we combat counterfeit in pharmaceuticals
JASON BEEVER, Supervisory Special Agent, US Department of Homeland Security
15:00 – Afternoon coffee & Networking
SERIALIZATION, TRACK & TRACE
15:30 – Keynote Panel Discussion with the experts – Serialization, Track & Trace – Improve efficiency and safety in the pharmaceutical supply chain
• Current state of security vulnerability in serialization in the pharma and biotech industries
• Where are we lacking in global standards and transparency?
• Best practices that organisations should implement for regulatory compliance for serialization
• Combating falsified medicines with modern technologies – The way forward
• Gaining value from Serialization: Efficient internal operations
• Securing your supply chain
• Practical approach to implementing a serialization solution – Challenges and Solutions
Moderator
MARK KARHOFF, Principal Consultant, SCM, Life Sciences, Serialization, Ten Count Consulting
Panellists
VIGNESH NAGARAJAN, Associate Director – Distribution Operations, Aurobindo Pharma
SEBASTIEN MAUEL, Head of Serialization & Product Security, Ferring Pharmaceuticals
SEAN MURPHY, Manager – Manufacturer Operations, AmerisourceBergen
16:20 – “Regulatory Update: FDA Delays Enforcement of Certain DSCSA Provisions-What’s Next?
”
KARLA L. PALMER, Director, FDA & DEA Investigations, Hyman Phelps & McNamara
16:50 – Chairperson’s Closing Remarks and end of conference day 01
17:00 – 18:00 – Networking Drinks Session
08:30 – Coffee and registration
09:30 – Morning Chair’s opening remarks
MARK KARHOFF, Principal Consultant, SCM, Life Sciences, Serialization, Ten Count Consulting
MARKET ANALYSIS & CURRENT OVERVIEW
09:40 – Considering Patient Factors during Pharma Packaging Design & Engineering
• Packaging design selection during drug product development focus mostly on shelf-life and market requirements.
• Considerations should be given to incorporate the physical needs of target patient populations into the final packaging design.
• Patient populations with specific health conditions and disease patterns may struggle to handle particular packaging designs and access medication.
• The subject of Patient Centric Drug Product Design will be key to ensuring adequate patient packaging usability.
NELIO DRUMOND, Associate Director – Global Manufacturing Sciences, Takeda
10:20 – Keynote discussion: Learn how to hunt down and stop pharmaceutical counterfeiters
• Case study on a criminal ring that sold more than $250 million worth of counterfeit antiviral medication to US pharmacies nationwide
• Best practices for creating and updating your brand protection programs
• Identifying and navigating today’s counterfeiting markets and related legal challenges facing the pharmaceutical industry
GEOFFREY POTTER, Partner, Patterson Belknap Webb & Tyler
TIMOTHY WATERS, Litigation Partner, Patterson Belknap Webb & Tyler
11:20 – Morning Coffee & Networking
11:50 – Building a Pharmaceutical Anti-Counterfeiting Program
• Defining pharmaceutical brand security incidents – counterfeiting, diversion and theft, other
• Current industry risk profile
• Importance of fostering internal partnerships for anti-counterfeiting/brand protection (working group, executive steering committee)
• Importance of defining roles in your anti-counterfeiting program
• Corporate Security, QA, Legal/IP, Supply Chain, Regulatory Affairs, Corporate Communications, other
• Importance of building investigative policy and procedure regarding pharmaceutical product integrity investigations and related actions.
MICHAEL KEENAN, Director, Global Brand Protection, BeiGene
12:30 – From Production to Protection: Harnessing High-Performance Inkjet Print in Pharma Packaging
• Explore how inkjet printing safeguards product authenticity across production and supply chain. Learn about security, readability, accuracy, and more.
• Boost pharma production integrity: Discover automation tools and compliance benefits (including DSCSA) of inkjet print technologies.
• Elevate pharma security: Uncover inkjet print’s role, compliance tools, and tech insights for smart investment choices.
RICK MAZUR, WW Director of Market Development, Packaging; Inkjet, EASTMAN KODAK COMPANY
13:00 – Networking luncheon / Exhibition Visit
14:00 – Systech UniTrace Overview
• Serialization – Governance Standards for Customers
• Serialization – Warehouse Management System (WMS)
• Serialization – Report Connectors
• Serialization – Batch Rework
JOSE CAMARA SANTIAGO, Validation Engineer, Catalent Pharma
REGULATORY
14:30 – Opportunities in regulatory systems against counterfeits.
• Regulatory systems must establish clear regulations that prevent manufacturing and commercialization of counterfeit drugs
• Regulatory agencies in most of the world have limited resources and surveillance is compromised by these limitations
• Anticounterfeit regulations should be considered as essential pillars for mature regulatory systems
MARIA ANTONIETA ROMAN, Head Regional Regulatory Policy, Emerging Markets LATAM, Novartis
15:00 – Panel Discussion: Regulatory Perspective – Recent updates and Global developments
• How best can you work with agencies to support your anti-counterfeiting strategy and maintain visibility?
• Recent evolving regulatory frameworks towards counterfeit drugs
• Regulatory perspective on counterfeit medicines – what is the global answer to this global plague?
• Most recent track and trace regulations
• Comparing the DSCSA and the EU/FMD
• Online counterfeits – working together with the regulators to overcome this issue
• What have we learnt from the Covid times and where should we be heading?
Moderator
MARK KARHOFF, Principal Consultant, SCM, Life Sciences, Serialization, Ten Count Consulting
Panellists
AYSE BAKER, VP of Corporate Regulatory Affairs, Corcept Therapeutics
YURICEL TAMAYO ALVAREZ, Regulatory Affairs Specialist, Roche
KARLA L. PALMER, Director, FDA & DEA Investigations, Hyman Phelps & McNamara
ERIC MARSHALL, Principal, Leavitt Partners
15:50 – Chairperson’s Closing Remarks
16:00 – Afternoon Coffee & End of 12th Annual Pharma Anti-Counterfeiting & Serialization 2023
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Sponsors & Partners
We wouldn’t be able to host our conferences without help from these amazing companies.
A huge thanks to all our sponsors and partners!
Colorcon
Colorcon
Colorcon is a world leader in developing, supplying, and supporting formulated film coating systems, modified release technologies, and functional excipients for the pharmaceutical industry. Our purpose is to improve health and wellness through convenience, compliance, and safety. Our best-in-class products and technologies are complemented by our extensive application data and value-added services to support all phases of solid oral dose design, development, and manufacture.
Our focus on market issues and technology development has earned Colorcon an international reputation as a pharmaceutical supplier of choice. That reputation is based on superior product quality, unparalleled technical support, extensive regulatory assistance, and reliable supply from multiple locations. Colorcon has 11 manufacturing facilities, including 7 film coating plants, 25 technical service laboratories globally and more than 1400 employees exclusively dedicated to its customer base.
Colorcon provides innovative digital on-dose technologies and detection services to verify medications. Colorcon’s on-dose authentication system, SoteriaRx®, provides a level of authenticity, transparency, and brand protection not previously available to the Pharma industry. SoteriaRx delivers a digital security layer to safeguard patients and uphold brand integrity.
Visit our website: www.colorcon.com
Eastman Kodak Company
Eastman Kodak Company
• Kodak (NYSE:KODK) is a leading global manufacturer focused on commercial print and advanced materials & chemicals.
• With 31,000 patents earned over 130 years of R&D, we believe in the power of technology and science to enhance what the world sees and creates.
• Our innovative, award-winning products, combined with our customer-first approach, make us the partner of choice for commercial printers worldwide.
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Ten Count Consulting
Ten Count Consulting
TCC is a supply chain consulting firm located in Chicago with clients across the US and in all sectors including manufacturers, distributors and dispensers. We help clients:
– Understand and achieve DSCSA and other compliance
– Wisely leverage and implement innovative technologies
– Increase measurable value and reduce operating costs through digital transformation
Visit our website: www.tencountconsulting.com
Virtue Insight
CONCEPTUALISED BY
Virtue Insight
CONCEPTUALISED BY
Virtue Insight equips business professionals around the world with the latest indepth industry knowledge and provides networking opportunities in the telecom, infrastructure and pharmaceutical industry. Our aim is to provide a platform to share knowledge and insights and provide our event attendees to network effectively and deliver maximum ROI by make new business alliances. We strive to produce high quality conferences which include the latest topics which are delivered by world class leaders of the industry.
Our motto is to offer our customers the expertise and connections for a profitable business. Our events encompass an optimum chance to gain maximum value in terms of networking and an opportunity to sponsor and exhibit to attract new business alliances.
Clocate
SUPPORTED BY
Clocate
SUPPORTED BY
Event Brite
SUPPORTED BY
Event Brite
SUPPORTED BY
Testimonials
A huge thanks to all our sponsors, attendees and partners!
Great Storyline with the speakers. Everything was very relevant and interesting. Well organised “},{“name”:”Food And Drugs Authority, Ghana”,”designation”:”Head, Market Surveillance Unit”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”_id”:”3b8df8f”,”quote”:”
Very interactive and gave platform for information sharing, Very Interative
“},{“name”:”Element Six “,”designation”:”Business Development Manager”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”_id”:”34ab65e”,”quote”:”
Good subject knowledge from all the presenters. Good meeting room environment and refreshments
“},{“name”:”Bayer Consumer Care AG”,”designation”:”Head Global Packaging Management”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”_id”:”eb31001″,”quote”:”
Well organised. Mainly good speakers, good lunch and good venue
“},{“name”:”horus security”,”designation”:”Horus Security Consultancy”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”quote”:”
An interesting conference, informative on both a personal and professional basis
“,”_id”:”8ca6872″},{“name”:”Selcia ltd”,”designation”:”Business Development Director”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”quote”:”
Very Informative - good range of topics covering regulatory, data protection and supplies of services. Excellent discussion and networking opportunities
“,”_id”:”a127a82″},{“name”:”Novartis International”,”designation”:”Product Security Analyst”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”quote”:”
u201cVery interesting insights, all topics covered were relevant and useful to anti-counterfeiting efforts in pharma.u201d
“,”_id”:”0583018″},{“name”:”QPQuandary”,”designation”:”CEO”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”quote”:”
u201cThe eclectic mix of speakers and delegates provided an excellent opportunity to build on existing knowledge and gain wider knowledge of the subject of pharmaceutical anti-counterfeiting.u201d
“,”_id”:”ca8a9eb”},{“name”:”AstraZeneca Plc”,”designation”:”Regional Investigations Director EMEA, Global Security”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”quote”:”
u201cThe day was well attended by a wide range of industry representatives and resulted in informative and helpful discussion.u201d
“,”_id”:”d9d5bce”},{“name”:”Food And Drugs Authority, Ghana”,”designation”:”Regulatory Officer ( Safe Disposal of Regulated Products)”,”photo”:{“url”:”https://usa-canada.virtueinsight.com/wp-content/uploads/2022/03/no-sepk.png”,”id”:6161,”size”:””,”alt”:””,”source”:”library”},”quote”:”
Good platform to learn about what others are doing about the menace SSFFC medical products, Very Insightful program. Given me more exposure to the global efforts at fighting fake medicines
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Great Storyline with the speakers. Everything was very relevant and interesting. Well organised
WCO IPM Manager
Very interactive and gave platform for information sharing, Very Interative
Food And Drugs Authority, Ghana Head, Market Surveillance Unit
Good subject knowledge from all the presenters. Good meeting room environment and refreshments
Element Six Business Development Manager
Well organised. Mainly good speakers, good lunch and good venue
Bayer Consumer Care AG Head Global Packaging Management
An interesting conference, informative on both a personal and professional basis
horus security Horus Security Consultancy
Very Informative – good range of topics covering regulatory, data protection and supplies of services. Excellent discussion and networking opportunities
Selcia ltd Business Development Director
“Very interesting insights, all topics covered were relevant and useful to anti-counterfeiting efforts in pharma.”
Novartis International Product Security Analyst
“The eclectic mix of speakers and delegates provided an excellent opportunity to build on existing knowledge and gain wider knowledge of the subject of pharmaceutical anti-counterfeiting.”
QPQuandary CEO
“The day was well attended by a wide range of industry representatives and resulted in informative and helpful discussion.”
AstraZeneca Plc Regional Investigations Director EMEA, Global Security
Good platform to learn about what others are doing about the menace SSFFC medical products, Very Insightful program. Given me more exposure to the global efforts at fighting fake medicines
Food And Drugs Authority, Ghana Regulatory Officer ( Safe Disposal of Regulated Products)
Venue Details
Venue:
Hilton Garden Inn O’Hare
Address: 2930 S. River Road Des Plaines, IL 60018
Phone: (847) 296-8900 | Direct Line: (847) 636-5391 | Fax: (847) 954-2384
Visit Our Website: ohare.hgi.com
Get Involved
Speaking Opportunities
Fen Castro
fen@virtueinsight.co.in
+91 44 42108101
Sponsor / Exhibit / Delegate Bookings
Piyush Patel
piyush@virtueinsightevents.com
+44 20 3509 3779
