MEETING PROGRAM The Latin American Biopharmaceutical Challenge: Connecting the Dots from Invention to Innovation
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6TH ANNUAL SYMPOSIUM
Clinical & Pharmaceutical Solutions through Analysis
Where Technology and Solutions Meet
Where Together We Progress
The Latin American Biopharmaceutical Challenge:
Connecting the Dots from Invention to Innovation
August 19 - 21, 2019
Espaço Citron
São Paulo
MEETING PROGRAM
Milestone Development Services
CPSA Brasil Pre-Conference 2019
A SCIEX Brasil tem o prazer de convidá-lo para fazer parte do
nosso workshop CPSA Brasil Pre-Conference 2019, que ocorrerá
no dia 19 de agosto de 2019.
O encontro tratará de Fármacos, com foco em Produtos de
Degradação e será uma grande oportunidade para que você
conheça novas maneiras de melhorar sua pesquisa, além de
trocar experiências.
Contamos com a sua presença!
Horário:
das 9h às 13h (welcome coffee a
partir das 8h30)
Local:
Rua Julio González, 132, 14º andar,
Barra Funda, São Paulo, SP
RSVP:
marketing.br@sciex.com
2019
WELCOME
Inspiration. Collaboration.
August 19, 2019
Dear Colleagues:
On behalf of our organizing committee and our sponsors, it is our pleasure to welcome you to the 6th Annual
Brazilian Symposium on Clinical and Pharmaceutical Solutions through Analysis (CPSA BRASIL 2019). Our
meeting and related events will once again feature lively discussions, memorable interactions, and the open
sharing of real-world experiences that focus on the unique challenges facing the pharmaceutical industry –
from bench to bedside.
The goal of CPSA BRASIL is to provide timely, in-depth reviews of innovative technology and emerging practices
through open discussion of industry related issues and needs. Our intent is to feature scientific leaders within
diversified symposia and sponsored events specially designed to be highly interactive where professionals
can openly share their experiences and visions in a collegial setting – where technology and solutions meet…
where together we progress!
We are delighted to feature two outstanding plenary speakers. On Tuesday, Gabriela Barreiro of Eurofarma,
will deliver a plenary lecture on Early Phase Discovery and Development. Our plenary lecture on Wednesday
will feature Thiago Mares Guia of Bionovis who will share his recent work and perspectives for Late Stage
Development Late Phase Drug Development & Clinics: From Pre-Clinical to Clinics. Our goal is that this year’s
program will provide unique perspectives, timely opportunities and continue to inspire discussions during our
annual meeting... and beyond.
Our hope is that you will actively participate, interact, and share ideas during the event. Creativity and
imagination have been key ingredients to making CPSA meetings a memorable experience all over the world.
In this way, a genuine passion for the analytical sciences can lead to personal growth as well as opportunities to
significantly impact the field through participation and leadership.
Special thanks go to the sponsors of this unique event. In particular, we wish to thank CEMSA, GE Healthcare,
New Objective, Prolab, SCIEX, and Waters for giving this meeting life. Muito obrigado! All CPSA sponsors share
the passion and commitment for both innovative technologies and the acceleration of product development.
Enjoy the annual meeting – where technology and solutions meet… where together we progress!
Sincerely,
Mike S. Lee, Ph.D. Carlos Kiffer, Ph.D.
CPSA Founder CPSA BRASIL 2019 Program Chair
2019X ORGANIZING COMMITTEE
PROGRAM CHAIR
Carlos Kiffer
EPM / UNIFESP
COMMITTEE MEMBERS
Douglas Andrade Mark Hayward José Emílio Neto Philip Timmerman
SCIEX ITSP Solutions Icon Clinical Research European Bioanalysis Forum
Gabriel Araújo Lucinda Hittle Regina Olivera Gary Valaskovic
University of São Paulo Merck Universidade Federal de São Carlos New Objective
Pedro Aranha Ivan Jonaitis Kerly Pasqualoto Peter van Amsterdam
Sandoz Agilent Technologies ALCHEMY Abbott
Gabriela Barreiro Rick King Kátia Pastre Oscar Vega
Eurofarma Laboratórios S.A. PharmaCadence Analytical Svcs MAGABI IPEN
Rafael Barrientos Daniel Lebre Adriano Peron Naidong Weng
Eurofarma Laboratórios S.A. CEMSA Laboratories SCIEX Janssen Research & Development
Natália Bellan Ken Lewis Paula Ribiero José Xavier
Sanitary Intelligence OpAns Shimadzu Agilent Technologies
Gisela Bellinello Lídia Lima Renato Ribiero Nathan Yates
Agilent Technologies Federal University of Rio de Janeiro Accutest Research Laboratories University of Pittsburgh
Chad Briscoe Leila Maria Lopes Bezerra Camille Rodrigues da Silva Ismael Zamora
PRA Health Sciences BIDiagnostics Inovatie Molecular Discovery
Jair Calixto Mauricio Magalhães Renato Romano
Sindusfarma EMS U.S. Pharmacopeia
LOGISTICS & MANAGEMENT
Mateus Campos Vanda Magalhães Cristina Ropke
SCIEX Eurofarma Phytobios Communications & Media
Dulce Casarini Thiago Mares Guia Ana Paula Ruenis Carla Marshall-Waggett
Universidade de Federal SP Bionovis ABRACRO New Objective
Marc Chalom Helio Martins Nalini Sadagopan Management & Correspondence
Testo SE SCIEX Agilent Technologies
Mike Lee
Lucas V. Crofi Daniel Maturana Daniel Saidemberg Milestone Development Services
USP NanoTemper Technologies Shimadzu
Tess Doezema Cristina Mendes Gustavo Santos
Arizona State University Instituto Nacional de Propriedade ANVISA
Industrial
Marité Faria Rogerio Sassonia
Amgen Marcelo Moreira Universidade Federal do Tocantins-
ANVISA Araguaína
Saul Fink
Bristol-Myers Squibb Lauro Moretto Ingridy Scachetti
Academia Nacional de Farmácia SCIEX
Jane Finzi
Thermo Fisher Scientific Michael Murgu Priscila Scheinberg
Waters Technologies do Brasil Orygen Biotecnologia
Larissa Fontes
Aché Laboratórios Farmacêuticos Viviane Nascimento Alexandre Scutto
Thermo Fisher Scientific CEMSA
Miller Freitas
Aché Laboratórios Farmacêuticos Shane Needham Suéllen Silva
Alturas Analytics
Apsen Farmacêutica
Roberto Gois
GC-2 Randall Nelson
Leonardo Teixeira
Arizona State University
Instituto de Ciências Farmacêuticas
Caroline Green
Waters Technologies do Brasil
2 Where Technology and Solutions Meet. Where Together We Progress.
SPONSORS
Thank You!
The CPSA annual symposium is made possible by the broad-based support of industry sponsors. The passion for the
analytical sciences and the accelerated discovery and development of pharmaceuticals is shared by each sponsor. As
a result, the event is dedicated to promoting awareness and understanding of the issues and needs associated with
research and development in the hopes of inspiring significant advances in the field.
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August 19 - 21, 2019 3
EXHIBITORS Thank You! Thank you to all of the vendors participating in the CPSA BRASIL 2019 Expo. 4 Where Technology and Solutions Meet. Where Together We Progress.
waters.com O que acontece nos laboratórios torna-se parte de nossas vidas. Desenvolvimento de medicamentos inovadores que nos tornam mais saudáveis. Controle de Qualidade para os alimentos que comemos, as bebidas que bebemos e a água de que dependemos. Soluções para a segurança de plásticos, polímeros e materiais sintéticos que se tornam as roupas que vestimos, os brinquedos com que nossas crianças brincam. Diagnóstico precoce e tratamento de doenças. Padrões elevados para um ambiente mais limpo. Tudo isso começa com a tecnologia analítica da Waters – e a ciência do que é possível. Para descobrir o que é possível em seu mundo, acesse: www.waters.com Pharmaceutical & Life Sciences | Food | Environmental | Clinical | Chemical Materials ©2012 Waters Corporation. Waters and The Science of What’s Possible are trademarks of Waters Corporation.
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Where Technology and Solutions Meet!
Where Technology and Solutions Meet
Where Together We Progress Where East Meets West
Patient Focused Patient Focused
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Mark your calendar!
August 19-21, 2019 October 28-31, 2019 February 4-7, 2020 March 2020 April 2020 May 4-7, 2020
Sao Paulo, Brazil Philadelphia, PA USA London, U.K. Atlanta, GA USA Shanghai, China Boston, MA USA
www.cpsa-brasil.com www.cpsa-usa.com www.cpsa-europe.com www.cpsa-metabolomics.com www.cpsa-shanghai.com www.cpsa-analytics.com
Program Chair Program Chairs Program Chairs Program Chairs Program Chair Program Chairs
Carlos Kiffer Timothy Olah Neil Spooner Abhishek Jha Tianyi Zhang Alla Kloss
EPM / UNIFESP Britol-Myers Squibb Spooner Bioanlytical Elucidata Frontage Sanofi
Solutions Andrew Lee
Neil Spooner Amanda Berg
Spooner Bioanalytical Ismael Zamora IMCS New Objective
Solutions Molecular Discovery
© 2019 Milestone Development Services
All rights reservedPRE-CONFERENCE WORKSHOPS
Monday August 19
NOTE: Workshops are not held at the Espaço Citron. They are each held at unique locations as specified below.
WORKSHOP WORKSHOP
How Innovation Impacts in Personalized Medicine Pharmaceuticals & Degradation
Workshop Leaders: Regina Oliveira, Universidade Sponsored by
Federal de São Carlos-UFSCar; Leila Maria Lopes
Bezerra, BIDiagnostics / CIETEC / USP
Location:
Location: Rua Julio González, 132
Vagão da Inovaçáo, CIETEC/USP 14º andar, Barra Funda, São Paulo, SP
9:00 am - 12:00 pm
SCIEX Brasil is pleased to invite you to be part of the
Drug R&D in a Multi-Omic World: Present and Future CPSA Brazil Pre-Conference 2019 workshop
Workshop Leader: Regina Oliveira, Universidade The meeting will address Pharmaceuticals, focusing on
Federal de São Carlos - UFSCar Degradation and it will be a great opportunity for you
ffThe Age of Proteomics in Clinical Diagnostics learn new ways to improve your search, and exchange
Valdemir Melechco Carvalho, Instituto Fleury experiences.
MONDAY, AUGUST 19
ffO Impacto das Células Tronco no Processo de
Descoberta de Fármacos
Marcos Valadares, Pluricell Biotech
ffTargeter Metabolomics Applications for Cancer and
Cardiovascular Biomarkers Discovery
Amadeu Iglesias, Apex Science
ffHuman Microbiome Impacts on Host Health and the
Role of Omics Platforms
Elisa Haas, Instituto do Coração (INCOR- HCFMUSP)
2:00 pm - 5:00 pm
Drug R&D in a Multi-Omic World: Present and
FutureThe Innovation Era in Medical Diagnostics
Workshop Leader: Leila Lopes Bezzera, BIDiagnostics /
CIETEC / USP
ffInovações em Genômica Pessoal e Medicina
Personalizada
Ricardo di Lazzaro, Genera/Dasa
ffImplantation and Development of Rapid Test for
STEC and ETEC Detection
Letícia Barboza Rocha, Instituto Butantã
ffTestes Rápido: Conceitos Básicos, Aplicações e
Evolução da Technologica
Ana Luísa Rubert Barcelos, Wama Diagnóstica
ffAn Educative Experience Aiming Innovation in
Biomedicine at the University of São Paulo
Luis Carlos Ferreira, ICB/USP
August 19 - 21, 2019 5PROGRAM AGENDA
Tuesday August 20
8:30 AM – 9:30 AM REGISTRATION & CONTINENTAL BREAKFAST
Lobby
9:30 AM – 10:00 AM OPENING REMARKS
Salão Espaço Welcome
Mike Lee, Milestone Development Services
Objectives, Format, and Opening Remarks
Carlos Kiffer, EPM/UNIFESP
10:00 AM – 10:45 AM PLENARY LECTURE
Salão Espaço Early Phase Discovery & Development
Gabriela Barreiro, Eurofarma
11:00 AM – 2:00 PM CPSA BRASIL EXPO
Matisse / Lobby Where Technology and Solutions Meet. Where Together We Progress.
TUESDAY, AUGUST 20
11:15 AM – 12:45 PM SYMPOSIUM SESSION 1
Salão Espaço Clinical Product Development: What Have We Got and What Are the Challenges
Chair: Sônia Dainesi, ReceptaBio
ffDDCM preparation: Challenges When the Drug is Still in Early-phase of
Development
Claudia Cilento, Inovatie
ffNew Designs for RCTs: Adaptative Bayesian Studies, Platform Trials and Enrichment
Alexandre Biasi Cavalcanti, Research Institute, HCor
ffReal World Data: Is This Really Real? Is RWD Applicable in Early-phase of
Development?
Guilherme Julian, IQVIA/RWE
12:45 PM – 2:00 PM SPONSORED LUNCH & ROUNDTABLES
Salão Espaço / Terraco To Be Announced
Sponsored by Nova Analitíca
Chairs: Luiz Bravo, Nova Analitíca; Carlos Kiffer, EPM / UNIFESP
2:00 PM – 3:30 PM JABUTICABA SESSION 1
Salão Espaço Early-Phase and Pre-Clinical Product Development: How Far Have We Matured our
R&D Ecosystem and What Are the Challenges
Chair: Jose Donato, Vita Nova
ffWhen Pre-Clinical Trials Are Not Necessary for Drug Development
Gilberto De Nucci, University of São Paulo
ffADMETox Assessment in Human Organoids Cultivated in Microfluidic Chips
(Organ on a Chip)
ffShining a New Light on Brazilian Biodiversity: Using the New Brazilian Synchrotron
Light Source for Drug Discovery.
Eduardo Pagani, LNBio - Brazilian Biosciences National Laboratory
6 Where Technology and Solutions Meet. Where Together We Progress.PROGRAM AGENDA
Tuesday August 20
2:00 PM – 3:30 PM JABUTICABA SESSION 1 (CONT’D)
ffPharmacometrics: Modelling and Simulation Tools to Facilitate the Integration of
Preclinical and Clinical Development Data
Bruna Gaelzer Silva Torre, Instituto Vitanova
TUESDAY, AUGUST 20
3:30 PM - 5:00 PM JABUTICABA SESSION 2
Salão Espaço Challenges to Transpose from Bench to Business in Biomedical Science
Chairs: Regina Oliveira, Universidade Federal de São Carlos - UFSCar; Leila Lopes Bezerra,
BIDiagnostics
ffBiolinker: Building a Biotech Startup in Brazil
Mona das Neves Oliveira, Biolinker
ffBIDiagnostics Case: Product to Market
Leila Lopes Bezerra, BIDiagnostics
ffOvercoming Challenges in Quantitation of Biopharmaceuticals with Hybrid
Techniques
Regina Oliveira, UFSCar
ffEntrepreneurial Science: From Laboratory to Market
Guilherme Rosso, Emerge Labs
5:00 PM - 6:00 PM VENDOR SESSION
Salão Espaço Chair: Daniel Maturana, NanoTemper
Participating vendors are welcome to share their services, products, and corporate message
within a 5-minute presentation
Wednesday August 21
WEDNESDAY, AUGUST 21
8:30 AM – 9:30 AM REGISTRATION & CONTINENTAL BREAKFAST
Lobby
9:30 AM – 10:15 AM PLENARY LECTURE
Salão Espaço Late Phase Drug Development & Clinics: From Pre-Clinical to Clinics
Thiago Mares Guia, Bionovis
10:30 AM – 12:30 PM SYMPOSIUM SESSION 2
Salão Espaço Early-Phase Product Development: What Are the Technological Challenges and How
Can the Academia-Industry Relationship Improve
Chair: Chair: Rogério Sassonia, Universidade Federal do Tocantins-Araguaín
ffTo Be Announced
Lucas Aquino, IDR Consultoria
ffTo Be Announced
Maíra Simões, Johnson & Johnson
ffTo Be Announced
Peky Noriega, Nanofitotec
August 19 - 21, 2019 7PROGRAM AGENDA
Wednesday August 21
11:00 AM – 2:00 PM CPSA BRASIL EXPO
Where Technology and Solutions Meet. Where Together We Progress.
12:30 PM – 2:00 PM SPONSORED LUNCH & ROUNDTABLE
Salão Espaço / Terraco From Invention to Innovation
Sponsored by New Objective
Chairs: Carlos Kiffer, EPM / UNIFESP
2:00 PM – 3:30 PM JABUTICABA SESSION 3
Salão Espaço Late and Clinical Phase Development:
Progresses and Drawbacks of the Regulated Research
Chair: Gustavo Santos, ANVISA
3:30 PM - 5:00 PM JABUTICABA SESSION 4
WEDNESDAY, AUGUST 21
Salão Espaço What Are the Big Problems Now in the Development or Production of the
Pharmaceutical Industry?
Chair: Daniel Lebre, CEMSA; Daniel Maturana, NanoTemper Technologies
ffBuilding Bioeconomies in the U.S. and Brazil: Confluence, Disjuncture, and
Prospects for International Collaboration
Tess Doezema, Arizona State University
ffAdding Some Intelligence into the Operations of Brazilian Pharma Industry:
Practical Cases
Rafael A. Barrientos
ffForming a Radical Innovation Ecosystem in Brazil through Research Platforms and
Strategic Partnerships
Hatylas Felype Zaneti de Azevedo, Ache Laboratórios Farmacêuticos S/A
3:30 PM - 5:00 PM ANNOUNCEMENTS, AWARDS & CLOSING REMARKS
Salão Espaço Thiago Mares Guia, Bionovis and Mike Lee, Milestone Development Services
ffFounders Awards
Mike Lee, Milestone Development Services
ffProgram Chair Recognition
Mike Lee, Milestone Development Services
ffClosing Remarks
Carlos Kiffer, EPM / UNIFESP
Mike Lee, Milestone Development Services
ffAdjourn
8 Where Technology and Solutions Meet. Where Together We Progress.CPSA Charitable Foundation
Our Mission
Celebrate pharmaceutical research at
the bench, empower the confrontation
of disease at the bedside
Guided by a team who have devoted their lives to advancing science, the CPSA
Charitable Foundation is dedicated to the progress of scientific discoveries from
research to the bedside. We are committed to advancing the public understanding
of biomedical and pharmaceutical research, with the foundational principle that
public knowledge is power. CPSA Charitable Foundation will evangelize and
celebrate our successes in this critical area of research, with an ultimate goal of
focusing additional resources to advance human health.
Find out how you can help
Visit us online at www.cpsacharitablefoundation .orgSOLUTIONS FOR LIFE™
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