creating a global community of industry, regulatory and ... · industry, regulatory and academic...
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Creating a global community of industry, regulatory and academic
professionals in the field of biopharmaceutical development
What is CASSS?CASSS is an agile, non-profit scientific organization whose strength is in bringing together professionals from industry, academia and regulatory agencies to solve scientific and technical problems in order to advance the development of biopharmaceuticals.
Why attend CASSS meetings?CASSS enables knowledge-sharing, regulatory capacity building and global access by leveraging strategic partnerships, scientific expertise and a diversity of views in all of our activities.
What makes CASSS different?CASSS utilizes its dedicated, volunteer network of experienced scientists to bring together the right people (experienced leaders in the field), the right way (a culture of engagement), at the right time (scientifically relevant content).
What makes CASSS better?
What makes CASSS better?
Practical Applications of Mass Spectrometry
What makes CASSS better?
What makes CASSS better?
What makes CASSS better?
CASSS meetings 2016-2017
Practical Applications of Mass Spectrometry
EUROPE ▪ JAPAN ▪ NORTH AMERICA ▪ SOUTH AMERICA
September 25-28, 2016San Diego, CA USA
January 24-26, 2017 Washington, DC USA
September 27-30, 2016San Diego, CA, USA
May 8-9, 2017Silver Spring, MD USA
14-17 March 2017Brussels, Belgium
April 3-5, 2017Gaithersburg, MD USA
5-6 December 2016Tokyo, Japan
January 23, 2017Washington, DC USA
22-24 May 2017Killarney, Ireland
July 17-19, 2017Gaithersburg, MD USA
Help make CASSS even better• Get involved: Attend meetings, ask
questions, seek out other attendees, engage in discussions.
• Stay involved: Follow up with meeting contacts, provide topic suggestions for upcoming meetings, volunteer your time and effort for future meetings.
• Get others involved: Share meeting outcomes with colleagues. Spread the knowledge.
Welcome to
LATIN AMERICA 2016
5 – 6 September 2016Hyatt Regency HotelMexico City, Mexico
Mission Statement• Provide a venue biotechnology/biological product
discussion that focuses on relevant CMC issues throughout the lifecycle of the product
• Foster collaborative technical and regulatory interactions
• Share information with the regulatory agencies to assist them in merging good scientific and regulatory practices
CMC Strategy Forum History
• The CMC Strategy Forum was launched in 2002 from the well established WCBP Symposium.
• To date, more than 40 Forums have been held in the US (typically 3 per year) resulting in the publication of over 25 peer-reviewed white papers on a wide variety of CMC topics.
• The CMC Forum Europe was launched in 2007 with support from the Biotech Working Party/EMA and quickly became a successful annual event.
CMC Strategy Forum History• The CMC Forum Japan was launched in 2012 with
support from PMDA and JPMA and has been very successful for the past three years. The 5th CMC Forum Japan will be held 5-6 December 2016.
• The inaugural CMC Forum Latin America was launched in August 2014 with support from ANVISA (Brasil), local industry, as well as multiple LATAM regulatory agencies and was very successful. The 4th CMC Forum Latin America (2017) will be held in Mexico City, Mexico, once again, with support from COFEPRIS.
CMC Forum Format• The Forum has two components:
- presentations (frame the discussion)- Workshops where open dialogue and exchange of
ideas among participants is highly encouraged—Typically each workshop will address about 3 specific questions related to a given topic
• The workshop success is dependent on active engagement of the participants
• Questions can be asked in either Spanish or English—simultaneous translation
Latin America Scientific Program Committee• Daniela Cerqueira, ANVISA, Brasil• Rocío Delgado Montero, DIGEMID, Peru• John Dougherty, Eli Lilly and Company, USA• Rivelino Flores, CANIFARMA, Mexico• Fernando Fon, AMIIF, Mexico• Adriana Hernández Trejo, COFEPRIS, Mexico• Carmilia Jiménez Ramirez, Gilead Sciences, USA
Latin America Scientific Program Committee continued• Bernardo Moreira, ANVISA, Brasil• Fabiola Muñoz, ISP, Institute of Public Health, Chile• Ana Padua, Roche International Ltd., Uruguay• Thomas Schreitmüller, representing FIFARMA, Latin
America Federation of the Pharmaceutical Industry• Carlos Solis, Psicofarma, Mexico• Esenbeckia Torres Guzmán, COFEPRIS, Mexico• Jaime Uribe Wiechers, Probiomed S.A. de C.V., Mexico
CMC Strategy Forum Global Steering Committee• Siddharth Advant, Kemwell Biopharma, USA• Daniela Cerqueria, ANVISA, Brasil• John Dougherty, Eli Lilly and Company, USA• Yasuhiro Kishioka, PMDA, Japan• Junichi Koga, Daiichi Sankyo Co., Ltd., Japan • Steven Kozlowski, CDER, FDA, USA• Ingrid Markovic, CBER, FDA, USA• Rohin Mhatre, Biogen, USA• Anthony Mire-Sluis, AstraZeneca, USA
CMC Strategy Forum Global Steering Committee continued• Wassim Nashabeh, F. Hoffmann-La Roche Ltd.,
Switzerland (Chair)• Ilona Reischl, AGES, Austria• Anthony Ridgway, Health Canada, Canada• Nadine Ritter, Global Biotech Experts, LLC, USA• Mark Schenerman, MedImmune, A member of the
AstraZeneca Group, USA• Thomas Schreitmüller, F. Hoffmann-La Roche Ltd.,
Switzerland • Karin Sewerin, BioTech Development AB, Sweden
Strategic Program Partners
• AbbVie, Inc.• Biogen• F. Hoffmann – La Roche Ltd.• MedImmune, A member of
the AstraZeneca Group
Leading Media Partners
• American Laboratory / LabCompare• American Pharmaceutical Review
• BioProcessing Journal• The Analytical Scientist
• The Medicine Maker• The Pathologist
•Technology Networks
Media Partners
• BioProcess International• International Pharmaceutical Quality
Special Thanks to…CASSS Staff:
• Karen A. Bertani, CMP, Director of Meetings (CMC Forum Manager)
• Stephanie L. Flores, CAE, Executive Director• Julie Fowle, Meeting Coordinator• Anna Lingel, Meeting Coordinator• Renee Olson, Senior Program Manager• Catherine Stewart, Director of Finance
Audio-Visual Support:
• Michael JohnstoneMJ Audio-Visual Productions
CMC Strategy ForumLatin America 2016
• Regulatory Convergence: Recent Trends in the Regulations of Biotherapeutic Products in Latin America• Latin American Federation of Pharmaceutical Industry (FIFARMA) – Public Quality Control Testing of Pharmaceutical Products• Latin American Federation of Pharmaceutical Industry (FIFARMA) – Transparency of Regulatory Decision Making
CMC Strategy ForumLatin America 2016
• Lifecycle Management Part One: Control Strategy and Setting Specifications• Lifecycle Management Part Two: Risk Management and Established Conditions
CMC Strategy Forum Latin America 2016
• Attendees pre-registered - 83• Number of regulators pre-registered – 21• Number of academic professionals pre-
registered - 5• Number of companies represented – 38• Number of countries represented – 10
(Argentina, Brasil, Columbia, Denmark, Ecuador, Mexico, Peru, Switzerland, Uruguay, USA)
Survey and Feedback
Your Feedback is Important
We need your help to build our Forums for the future.
CMC Strategy Forum Evaluations will be sent via email on Tuesday, September 6.
Please be sure to complete the survey and hit SUBMIT
Please feel free to answer in Spanish; we can translate
Reminders / AnnouncementsMonday, September 5
12:15 – 13:30 Buffet Lunch in Regency Room F(located on First Floor – same room as the Buffet Breakfast)
18:30 – 20:00 Networking Receptionin Regency Room D1 (same floor)
Reminders / Announcements
Please be courteous and turn off your cell phones during the lectures.
Reminders / Announcements
PLEASE DO NOT take photos or video of lectures unless approved by the presenter.