MEETING PROGRAM - Biopharmaceuticals and Biotechnology for Health: New Trends, Opportunities, Diagnostics and Beyond
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5TH ANNUAL SYMPOSIUM
Clinical & Pharmaceutical Solutions through Analysis
Where Technology and Solutions Meet
Where Together We Progress
Biopharmaceuticals and
Biotechnology for Health:
New Trends, Opportunities,
Diagnostics and Beyond
August 13-15, 2018
Club Transatlântico
São Paulo
MEETING PROGRAM
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2018
WELCOME
Inspiration. Collaboration.
August 14, 2018
Dear Colleagues:
On behalf of our organizing committee and our sponsors, it is our pleasure to welcome you to the 5th Annual
Brazilian Symposium on Clinical and Pharmaceutical Solutions through Analysis (CPSA BRASIL 2018). 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, Denis Golgher, who leads her
own consultancy group covering a wide range of biotechnology aspects in Brazil, will deliver a plenary lecture
on The Future of Human Health: Where Will Biotechnology Take Us. Our plenary lecture on Wednesday will
feature Andrew Simpson of Orygen Biotecnologia who will share his recent work and perspectives for Catching
up with the Biotechnology Frontier in Brazil: Some Ways Forward. 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 both SCIEX and
Thermo Fisher Scientific 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. Thiago Mares Guia, Ph.D.
CPSA Founder CPSA BRASIL 2018 Program Chair
2018 ORGANIZING COMMITTEE
PROGRAM CHAIR
Thiago Mares Guia
Bionovis
COMMITTEE MEMBERS
Douglas Andrade Lucinda Hittle Paula Ribiero LOGISTICS & MANAGEMENT
SCIEX Merck Shimadzu
Communications & Media
Gabriel Araújo Ivan Jonaitis Renato Ribiero
University of São Paulo Agilent Technologies Accutest Research Laboratories Carla Marshall-Waggett
New Objective
Gabriela Barreiro Carlos Kiffer Camille Rodrigues da Silva
Eurofarma Laboratórios S.A. GC-2 / UNIFSEP Inovatie Management & Correspondence
Rafael Barrientos Rick King Renato Romano Mike Lee
Eurofarma Laboratórios S.A. PharmaCadence Analytical Svcs U.S. Pharmacopeia Milestone Development Services
Natália Bellan Daniel Lebre Cristina Ropke
Inteligência Sanitária CEMSA Laboratories Phytobios
Gisela Bellinello Ken Lewis Ana Paula Ruenis
Agilent Technologies OpAns ABRACRO
Chad Briscoe Lídia Lima Nalini Sadagopan
PRA Health Sciences Federal University of Rio de Janeiro Agilent Technologies
Jair Calixto Mauricio Magalhães Daniel Saidemberg
Sindusfarma EMS Shimadzu
Mateus Campos Vanda Magalhães Gustavo Santos
SCIEX Eurofarma ANVISA
Dulce Casarini Helio Martins Priscila Scheinberg
Universidade de Federal SP SCIEX Shimadzu
Marc Chalom Cristina Mendes Suéllen Silva
Testo SE Instituto Nacional de Propriedade Apsen Farmacêutica
Industrial
Lucas V. Crofi Leonardo Teixeira
USP Marcelo Moreira Instituto de Ciências Farmacêuticas
ANVISA
Tess Doezema Philip Timmerman
Arizona State University Lauro Moretto European Bioanalysis Forum
Academia Nacional de Farmácia
Marité Faria Gary Valaskovic
Amgen Michael Murgu New Objective
Waters Technologies do Brasil
Saul Fink Peter van Amsterdam
Bristol-Myers Squibb Viviane Nascimento Abbott
Thermo Fisher Scientific
Jane Finzi Naidong Weng
Thermo Fisher Scientific Shane Needham Janssen Research & Development
Alturas Analytics
Larissa Fontes José Xavier
Aché Laboratórios Farmacêuticos Randall Nelson Agilent Technologies
Arizona State University
Miller Freitas Nathan Yates
Aché Laboratórios Farmacêuticos José Emílio Neto University of Pittsburgh
Icon Clinical Research
Roberto Gois Ismael Zamora
GC-2 Kátia Pastre Molecular Discovery
MAGABI
Caroline Green
Waters Technologies do Brasil Adriano Peron
SCIEX
Mark Hayward
ITSP Solutions
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.
August 13 - 15, 2018 3
EXHIBITORS Thank You! Thank you to all of the vendors participating in the CPSA BRASIL 2018 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.
www.moldiscovery.com
MetaSite/MassMetaSite/MassChemSite/Webmetabase
Vendor neutral. Multiple
Acquisition Modes (DDA, IDA,
Mse, IMS, SWATH, AIF, Al,
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Data
I \
Knowledge Information
...... Defining the field in Mass Spectrometry
• Structure elucidation for bio and chemical
research in small and peptide molecules
• Lipidomics analysis
Where Technology and Solutions Meet!
Where Technology and Solutions Meet
Where Together We Progress Where East Meets West
Patient Focused Patient Focused
Solutions for the Patient Technology for the Patient
Patient Focused
Standardization for the Patient
Mark your calendar!
August 13-16, 2018 October 15-18, 2018 February 5-8, 2019 March 11-13, 2019 April 10-12, 2019 May 2019
Sao Paulo, Brazil Philadelphia, PA USA London, U.K. Gainesville, FL 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 Chair Program Chairs Program Chair Program Chair Program Chairs
Thaigo Mares Guia Alla Kloss Neil Spooner Tim Garrett Min Liu Alla Kloss
Bionovis Sanofi Spooner Bioanlytical University of Florida Merck Sanofi
Solutions
Amanda Berg
Ismael Zamora New Objective
Molecular Discovery
© 2018 Milestone Development Services
All rights reservedPRE-CONFERENCE WORKSHOPS
Monday August 13
NOTE: Workshops are not held at the Club Transatlântico. They are each held at unique locations as specified below.
WORKSHOP WORKSHOP
The Technological Era of Innovation in Drugs R&D Drugs and Degradation Products
Sponsored by Sponsored by
Location: Location:
Anfiteatro Luiz Trabulsi, no ICB3 Rua Julio González
Instituto de Ciências Biológicas, USP 132, 14º andar
Butantã, São Paulo - SP Barra Funda, São Paulo – SP
9:00 am - 12:15 pm 8:30 am - 1:00 pm
Welcome & Opening Remarks Welcome coffee served
Daniel Lebre, CEMSA The meeting will focus on Drugs, focusing on
Big Data and the Pharmaceutical Industry: Degradation Products and will be a great opportunity
Innovation and Analyzes for you to learn new ways to improve your research, as
Profa. Regina Cantele, FIAP MBA Coordinator well as exchange experiences.
MONDAY, AUGUST 13
Organs on a Chip:
Advance in the Pre-clinical Research Phase
Dr. Adilson Kleber Ferreira, Division of Non-Clinical WORKSHOP
Assays, Alchemy, Innovation, Research & Development
Ltda. Development of Innovative Biologic Drugs and
Coffee Break & Networking Biosimilars: Advances and Challenges
High Content Screening: Sponsored by
Challenges and Opportunities
Dr. Débora Levy, HCFMUSP - USP
Nanomaterials and Nanodevices in Location:
Drugs and Diagnostics Butantan Institute
Dr. Cecília de Carvalho Castro e Silva, MackGraphe,
Graphene and Nanomaterials Research Center, 2:00 pm - 6:00 pm
Mackenzie Presbyterian University Welcome & Opening
Tellurium and Selenium Chemistry in Daniel Lebre, CEMSA
New Drug Candidates Analytical Comparability in Biosimilars:
Prof. Alcindo Aparecido dos Santos, IQ-USP What Are the Essential Steps?
Roundtable Discussion with Speakers and Guests Fernanda Kapritchkoff, GetBio
Closing Remarks Examples of Characterization of Biosimilars Using MS
Daniel Lebre, CEMSA
Processing of Biopharmaceutical and Biosimilar Analysis
Data: Transforming Complex Data into Information
Michael Murgu, Waters Corporation
Coffee Break & Networking
Scientific Evidence of Efficacy and Safety: Do We Need
to Carry Out Substitution Studies Between Original and
Biosimilar Products?
Camile Rodrigues da Silva, Inovatie
Butantan and GSK Partnership in Search of New
Therapeutic Targets: Challenges and Recommendations
Ana Marisa Chudzinski Tavassi, Inst. Butantan
Closing Remarks
August 13 - 15, 2018 5PROGRAM AGENDA
Tuesday August 14
8:30 AM – 9:30 AM REGISTRATION & CONTINENTAL BREAKFAST
9:30 AM – 10:00 AM OPENING REMARKS
Transatlântico Welcome
Mike Lee, Milestone Development Services
Objectives, Format, and Opening Remarks
Thiago Mares Guia, Bionovis
10:00 AM – 10:45 AM PLENARY LECTURE
Transatlântico The Future of Human Health: Where Will Biotechnology Take Us?
Denise Golgher
Biotechnology/Human Health Consultant
11:00 AM – 2:00 PM CPSA BRASIL EXPO & POSTER SESSION
Bremen / Lobby Where Technology and Solutions Meet. Where Together We Progress.
TUESDAY, AUGUST 14
11:15 AM – 12:45 PM SYMPOSIUM SESSION 1
Transatlântico Pharma & Biotech Radical Innovation in Brazil: Are We There Yet?
Chairs: Denise Golgher, Biotechnology/Human Health Consultant and Thiago Mares Guia,
Bionovis
ffRadical Innovation at Aché Laboratórios
Hatylas Azevedo, Aché Laboratórios
ffAdvances in the Pharmaceutical Industry, the Challenges of the Past, Present and
Future Trends
Fabio Barros, Vita Nova Institute & EMS
ffFostering Pharma & Biotech Innovation in Brazil
Paulo Lacativa, Biozeus
ffGlobal Tendencies in Pharma Innovation
Antero Macedo, Clarivate Analytics
12:45 PM – 2:00 PM SPONSORED LUNCH & ROUNDTABLES
Transatlântico / Terraco Sponsored by New Objective
Biopharmaceuticals and Biotechnology for Health:
New Trends, Opportunities, Diagnostics and Beyond
ffCurrent Challenges on the Development and Adoption of Biosimilars
Thiago Mares Guia, Bionovis
ffLaboratory Challenges and Clinical Trials
Carlos Kiffer, GC2
6 Where Technology and Solutions Meet. Where Together We Progress.PROGRAM AGENDA
Tuesday August 14
2:00 PM – 3:30 PM JABUTICABA SESSION 1
Transatlântico Diagnostics & Analytics for Clinical Trials: Focus in Biotech
Chair: Carlos Kiffer, GC-2
ffA Focus on Cell-Based Methods
Marcos Valadares, Pluricell Biotech
ffA Focus on Genomic-Based Methods
David Schlesinger, Mendelics Lab
ffFocus on Genomics and Point-of-Care
John Katz, Scheme Lab
3:30 PM - 5:00 PM JABUTICABA SESSION 2
Transatlântico Advances in Clinical Research:
How to Accomplish Regulatory Demands and Get Prepared for the Future
Chair: Camille Rodrigues da Silva, Inovatie
Patient-Centered Clinical Trials:
ffWhat Is the Evolution So Far?
TUESDAY, AUGUST 14
Glauce Nunes, PRA
ffHow to Fit the Regulatory Demands
Camille Rodrigues da Silva, Inovatie
ffAudit in Brazilian Research Centers: Which Are the 10 Major Improvement Points
Eleuza Cerbara, Consultoria - Quality Training
5:00 PM - 6:00 PM VENDOR SESSION
Transatlântico Chair: Daniel Lebre, CEMSA
ffThe Simpler and Faster Solution for Routine Biopharmaceutical Characterization
Douglas de Andrade, Ph.D.
SCIEX Field Application Specialist, Brazil
Vendors and participants are invited to present their organization in 5-minutes or less!
August 13 - 15, 2018 7PROGRAM AGENDA
Wednesday August 15
8:30 AM – 9:30 AM REGISTRATION & CONTINENTAL BREAKFAST
9:30 AM – 10:15 AM PLENARY LECTURE
Transatlântico Catching up with the Biotechnology Frontier in Brazil: Some Ways Forward
Andrew Simpson
Orygen Biotecnologia
10:30 AM – 12:30 PM SYMPOSIUM SESSION 2
Transatlântico Pharmaceutical Biotechnology in Brazil:
From Biosimilars to Innovative Biopharmaceuticals
Chair: Thiago Mares Guia, Bionovis
The speakers will talk about their vision of Pharmaceutical Biotechnology in Brazil, considering
the current experience of each company but also about the future of this sector in the
country. After each presentation the speakers will engage in a debate, with the participation
of the audience.
WEDNESDAY, AUGUST 15
Odnir Finotti, Bionovis
Márcia Martini, Libbs Farmacêutica
José Fernando Perez, Recepta Biopharma
To Be Announced, Biomm
11:00 AM – 2:00 PM CPSA BRASIL EXPO & POSTER SESSION
Where Technology and Solutions Meet. Where Together We Progress.
12:45 PM – 2:00 PM SPONSORED LUNCH & ROUNDTABLE
Transatlântico / Terraco Sponsored by Thermo Fisher Scientific
Ion Chromatography Solutions for Pharmaceutical Applications
Parul Angrish, Thermo Fisher Scientific
2:00 PM – 3:30 PM JABUTICABA SESSION 3
Transatlântico Analytical Methods Focus in Biotech
Chair: Daniel Lebre, CEMSA
ffProtein Glycosylation Analysis in Biopharmaceuticals
Giuseppe Palmisano, University of San Paolo
ffAnalytical Methods for HCP Detection: ELISA, New Trends and Opportunities
Vanda Magalhães, Eurofarma
ffPractical Examples of Reverse Phase HPLC Applied to Biotechnology
Carlos Roberto Jorge Soares, Instituto de Pesquisas Energéticas e Nucleares,
IPEN – CNEN/SP
ffBiocalorimetry in the Development of Drugs
Rogério Sassonia, Universidade Federal do Tocantins-Araguaína
8 Where Technology and Solutions Meet. Where Together We Progress.PROGRAM AGENDA
Wednesday August 15
3:30 PM - 5:00 PM JABUTICABA SESSION 4
Transatlântico Challenges in the Regulatory Landscape for Biologics and Biosimilars
Chair: Gustavo Mendes Lima Santos, ANVISA
ffDevelopment of Innovative Biopharmaceuticals In Brazil
Sonia Dainesi, Recepta Bio
ffTo Be Announced
Suéllen Silva, Apsen Farmacêutica
ffChallenges in the Regulation of Biosimilars
Gustavo Mendes Lima Santos, ANVISA
3:30 PM - 5:00 PM ANNOUNCEMENTS, AWARDS & CLOSING REMARKS
Transatlântico Thiago Mares Guia, Bionovis and Mike Lee, Milestone Development Services
ffFounders Awards & Program Chair Recognition
Mike Lee, Milestone Development Services
ffCPSA BRASIL 2019 - Program Chair Announcement
Thiago Mares Guia, Bionovis
ffClosing Remarks
Thiago Mares Guia, Bionovis and Mike Lee, Milestone Development Services
ffAdjourn
August 13 - 15, 2018 910 Where Technology and Solutions Meet. Where Together We Progress.
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