5TH ANNUAL SYMPOSIUM Clinical & Pharmaceutical Solutions through Analysis Where Technology and Solutions Meet Where Together We Progress Milestone Development Services 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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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 WELCOME Inspiration. Collaboration. 2018


PROGRAM CHAIR Thiago Mares Guia Bionovis 2018 ORGANIZING COMMITTEE COMMITTEE MEMBERS Douglas Andrade SCIEX Gabriel Araújo University of São Paulo Gabriela Barreiro Eurofarma Laboratórios S.A. Rafael Barrientos Eurofarma Laboratórios S.A. Natália Bellan Inteligência Sanitária Gisela Bellinello Agilent Technologies Chad Briscoe PRA Health Sciences Jair Calixto Sindusfarma Mateus Campos SCIEX Dulce Casarini Universidade de Federal SP Marc Chalom Testo SE Lucas V. Crofi USP Tess Doezema Arizona State University Marité Faria Amgen Saul Fink Bristol-Myers Squibb Jane Finzi Thermo Fisher Scientific Larissa Fontes Aché Laboratórios Farmacêuticos Miller Freitas Aché Laboratórios Farmacêuticos Roberto Gois GC-2 Caroline Green Waters Technologies do Brasil Mark Hayward ITSP Solutions Lucinda Hittle Merck Ivan Jonaitis Agilent Technologies Carlos Kiffer GC-2 / UNIFSEP Rick King PharmaCadence Analytical Svcs Daniel Lebre CEMSA Laboratories Ken Lewis OpAns Lídia Lima Federal University of Rio de Janeiro Mauricio Magalhães EMS Vanda Magalhães Eurofarma Helio Martins SCIEX Cristina Mendes Instituto Nacional de Propriedade Industrial Marcelo Moreira ANVISA Lauro Moretto Academia Nacional de Farmácia Michael Murgu Waters Technologies do Brasil Viviane Nascimento Thermo Fisher Scientific Shane Needham Alturas Analytics Randall Nelson Arizona State University José Emílio Neto Icon Clinical Research Kátia Pastre MAGABI Adriano Peron SCIEX Paula Ribiero Shimadzu Renato Ribiero Accutest Research Laboratories Camille Rodrigues da Silva Inovatie Renato Romano U.S.

Pharmacopeia Cristina Ropke Phytobios Ana Paula Ruenis ABRACRO Nalini Sadagopan Agilent Technologies Daniel Saidemberg Shimadzu Gustavo Santos ANVISA Priscila Scheinberg Shimadzu Suéllen Silva Apsen Farmacêutica Leonardo Teixeira Instituto de Ciências Farmacêuticas Philip Timmerman European Bioanalysis Forum Gary Valaskovic New Objective Peter van Amsterdam Abbott Naidong Weng Janssen Research & Development José Xavier Agilent Technologies Nathan Yates University of Pittsburgh Ismael Zamora Molecular Discovery LOGISTICS & MANAGEMENT Communications & Media Carla Marshall-Waggett New Objective Management & Correspondence Mike Lee Milestone Development Services 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. 3 August 13 - 15, 2018


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.


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: O que acontece nos laboratórios torna-se parte de nossas vidas.

Pharmaceutical & Life Sciences | Food | Environmental | Clinical | Chemical Materials ©2012 Waters Corporation. Waters and The Science of What’s Possible are trademarks of Waters Corporation.

MEETING PROGRAM MetaSite/MassMetaSite/MassChemSite/Webmetabase Vendor neutral. Multiple Acquisition Modes (DDA, IDA, Mse, IMS, SWATH, AIF, Al, BBA) 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! Patient Focused Technology for the Patient Patient Focused Standardization for the Patient Patient Focused Solutions for the Patient Where Together We Progress Where East Meets West Mark your calendar! © 2018 Milestone Development Services All rights reserved August 13-16, 2018 Sao Paulo, Brazil Program Chair Thaigo Mares Guia Bionovis October 15-18, 2018 Philadelphia, PA USA Program Chair Alla Kloss Sanofi February 5-8, 2019 London, U.K.

Program Chairs Neil Spooner Spooner Bioanlytical Solutions Ismael Zamora Molecular Discovery March 11-13, 2019 Gainesville, FL USA Program Chair Tim Garrett University of Florida April 10-12, 2019 Shanghai, China Program Chair Min Liu Merck May 2019 Boston, MA USA Program Chairs Alla Kloss Sanofi Amanda Berg New Objective Where Technology and Solutions Meet

MONDAY, AUGUST 13 WORKSHOP The Technological Era of Innovation in Drugs R&D Sponsored by Location: Anfiteatro Luiz Trabulsi, no ICB3 Instituto de Ciências Biológicas, USP Butantã, São Paulo - SP 9:00 am - 12:15 pm Welcome & Opening Remarks Daniel Lebre, CEMSA Big Data and the Pharmaceutical Industry: Innovation and Analyzes Profa. Regina Cantele, FIAP MBA Coordinator Organs on a Chip: Advance in the Pre-clinical Research Phase Dr. Adilson Kleber Ferreira, Division of Non-Clinical Assays, Alchemy, Innovation, Research & Development Ltda.

Coffee Break & Networking High Content Screening: Challenges and Opportunities Dr.

Débora Levy, HCFMUSP - USP Nanomaterials and Nanodevices in Drugs and Diagnostics Dr. Cecília de Carvalho Castro e Silva, MackGraphe, Graphene and Nanomaterials Research Center, Mackenzie Presbyterian University Tellurium and Selenium Chemistry in New Drug Candidates Prof. Alcindo Aparecido dos Santos, IQ-USP Roundtable Discussion with Speakers and Guests Closing Remarks WORKSHOP Development of Innovative Biologic Drugs and Biosimilars: Advances and Challenges Sponsored by Location: Butantan Institute 2:00 pm - 6:00 pm Welcome & Opening Daniel Lebre, CEMSA Analytical Comparability in Biosimilars: What Are the Essential Steps? Fernanda Kapritchkoff, GetBio 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 WORKSHOP Drugs and Degradation Products Sponsored by Location: Rua Julio González 132, 14º andar Barra Funda, São Paulo – SP 8:30 am - 1:00 pm Welcome coffee served The meeting will focus on Drugs, focusing on Degradation Products and will be a great opportunity for you to learn new ways to improve your research, as well as exchange experiences.

NOTE: Workshops are not held at the Club Transatlântico.

They are each held at unique locations as specified below. 5 August 13 - 15, 2018 PRE-CONFERENCE WORKSHOPS Monday August 13

TUESDAY, AUGUST 14 6 Where Technology and Solutions Meet. Where Together We Progress. PROGRAM 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. 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 f f Radical Innovation at Aché Laboratórios Hatylas Azevedo, Aché Laboratórios f f Advances in the Pharmaceutical Industry, the Challenges of the Past, Present and Future Trends Fabio Barros, Vita Nova Institute & EMS f f Fostering Pharma & Biotech Innovation in Brazil Paulo Lacativa, Biozeus f f Global 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 f f Current Challenges on the Development and Adoption of Biosimilars Thiago Mares Guia, Bionovis f f Laboratory Challenges and Clinical Trials Carlos Kiffer, GC2

TUESDAY, AUGUST 14 7 August 13 - 15, 2018 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 f f A Focus on Cell-Based Methods Marcos Valadares, Pluricell Biotech f f A Focus on Genomic-Based Methods David Schlesinger, Mendelics Lab f f Focus 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: f f What Is the Evolution So Far? Glauce Nunes, PRA f f How to Fit the Regulatory Demands Camille Rodrigues da Silva, Inovatie f f Audit 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 f f The 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!

WEDNESDAY, AUGUST 15 8 Where Technology and Solutions Meet. Where Together We Progress. 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.

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 f f Protein Glycosylation Analysis in Biopharmaceuticals Giuseppe Palmisano, University of San Paolo f f Analytical Methods for HCP Detection: ELISA, New Trends and Opportunities Vanda Magalhães, Eurofarma f f Practical Examples of Reverse Phase HPLC Applied to Biotechnology Carlos Roberto Jorge Soares, Instituto de Pesquisas Energéticas e Nucleares, IPEN – CNEN/SP f f Biocalorimetry in the Development of Drugs Rogério Sassonia, Universidade Federal do Tocantins-Araguaína Wednesday August 15 PROGRAM AGENDA

9 August 13 - 15, 2018 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 f fDevelopment of Innovative Biopharmaceuticals In Brazil Sonia Dainesi, Recepta Bio f fTo Be Announced Suéllen Silva, Apsen Farmacêutica f f Challenges 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 f fFounders Awards & Program Chair Recognition Mike Lee, Milestone Development Services f fCPSA BRASIL 2019 - Program Chair Announcement Thiago Mares Guia, Bionovis f fClosing Remarks Thiago Mares Guia, Bionovis and Mike Lee, Milestone Development Services f f Adjourn Wednesday August 15 PROGRAM AGENDA

10 Where Technology and Solutions Meet. Where Together We Progress.

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