CPSA BRASIL 2016

Pharmaceutical Innovation: Collaborating from Bench to Bedside

Preliminary Program Agenda

Updated July 18, 2016

Monday 1 August

8:00 am to 4:00pm

Sindusfarma
Rua Alvorada 1289
Vila Olimpia
São Paulo

Pre-Conference Workshop One

Sponsored by SCIEX

AB Sciex

SCIEX pre-conference workshop At Sindusfarma

Click HERE for More Information

  • QTRAP Technology and LightSight Software Applied to the Study of Degradation Products
  • The use of mass spectrometry for degradation product analysis: sharing thoughts and analytical experiences regarding the implementation of this technique in routine activities
  • Recent Advances in Biologics Analysis by Mass Spectrometry
  • Using in-silico tools to support your degradant identification workflow for RDC 53
  • Degradation Products and Impurity Analysis using high resolution and mass accuracy LC/MS/MS system
  • Degradation and Impurity Product Profiling with LC/MS
  • 8:00 am to 4:45pm

    Club Transatlântico
    Rua José Guerra
    130, Entrada C
    Chácara Santo Antônio
    São Paulo

    Pre-Conference Workshop Two

    Sponsored by Thermo Fisher Scientific

    Thermo

    BioPharma Challenges: From Drug Development To Quality Control Strategies
    Register Here

  • Staying Ahead in Biopharma
  • New Rapid and Reproducible Peptide Mapping Workflow
  • New Chromtographic Workflow for Charge Variant Profiling, intact mAb Analysis and DAR determination
  • LUNCH & LIVE Show - Product demonstration
  • Challenges on Product Analysis of Biopharmaceuticals
  • Using HRAM GC-MS/MS for Extractable, Leachable and Intermediate Impurity Profiling
  • Seperation Science That’s Built for Biopharma: How To Convert Your Method For QC/QA
  • 9:00 am to 5:30pm

    Trabulsi Auditorium
    Institute of
    Biomedical Sciences
    Av. Prof. Lineu Prestes
    1730 - Cidade Universitária
    Butantã

    Pre-Conference Workshop Three

    Sponsored by CEMSA

    AB Sciex

    The Momentum And Perspectives Of Drug Discovery And Development In Brazil
    PDF Information

  • Science, Innovation And Education: Companies And Universities, An Alliance For A Better Future
  • From Drug Repositioning To Natural Products: Search For Novel Candidates Against Neglected Protozoan Diseases
  • The Drug Discovery Process & The Role Of Computational Chemistry
  • Advancing Drug Discovery And Cell Biology Research With High- Content Screening
  • Contributions Of Simbio-LINS Group To Medicinal Chemistry
  • ADME And Pharmacokinetics In The Development Of New Drugs
  • Clinical Trials In Cancer-Bearing Dogs And Their Impact On The Development Of New Cancer Therapies
  • Bridging The Innovation Gap: Building Academic-Pharma Consortia In Brazil
  • Discovery Of New Drug Candidates In Brazil: How To Innovate?
  • Bridging The Gap Between Academia And Industry: Radical Innovation From Brazilian Discoveries
  • Clinical Research: Can We Make It Faster And Cheaper?
  • Tuesday 2 August

    7:30 am - 8:30 am

    Registration & Continental Breakfast

    8:30 am - 9:00 am
    Ballroom

    Welcome & Opening Remarks

    Mike Lee

    Welcome
    Mike S. Lee
    Milestone Development Services

    Carlos Kiffer

    Format, Objectives, Opening Remarks
    Carlos Kiffer
    GC2/UNIFESP

    9:00 am - 9:45 am
    Ballroom

    Plenary Lecture

    Peter Van Amsterdam

    When GCP Meets GLP: How These Two 'Worlds' Come Together And What The Implications May Be?
    Peter van Amsterdam
    Abbott Healthcare Products B.V.

    9:00 am - 5:00 pm

    Poster Hall Open

    10:15 am - 11:45 am
    Ballroom

    Symposium Session

    Biologics/Biosimilars: In Vitro and In Vivo Testing of Biosimilars - What Have We Learned so Far?
    Chair: Gustavo Mendes Lima Santos, ANVISA

  • Production and Quality Control of Biologics/Biosimilars
    Rodrigo Martins Bretas, ANVISA

  • Challenges and Advances in Biologics/Biosimilars: Brazilian Regulations
    Marcelo Mário Matos Moreira, ANVISA

  • Analytical Techniques for Pharmacokineitics and Characterization of Large Molecules
    Fabio Barros, EMS
  • 11:00 am - 2:00 pm

    CPSA Brasil Expo

    Where Technology and Solutions Meet!

    12:00 pm - 1:00 pm

    Sponsored Lunch & Roundtable Event
    Sponsored by Sciex

    SCIEX

  • BioPharmaView™ Software 2.0: A New Tool for Routine and Advanced Biologics Characterization Workflow
  • Yi Zhang, SCIEX

  • BioBA - Biologics Bioanalysis Made Easy.
  • Alana Figueiredo, SCIEX

    1:30 pm - 3:00 pm

    Ballroom

    Parallel Sessions

    Drug Development: Best Practices from Development Plan, Trial Design to Agency Interactions
    Chair: Gabriela Barreiro, Eurofarma

  • In Vitro Solutions in the Preclinical Development of Drugs
    Miriana Machado, InnVitro

  • Overview of Intellectual Property Issues on Drug Development in Brazil
    Iolanda Fierro, INPI

  • Recent Collaborations with the Drugs for Neglected Diseases Initiative (DNDi) and with Medicines for Malaria Venture (MMV) in the Area of Parasitic Tropical Diseases
    Luis Carlos Dias, UNICAMP



  • Jabuticaba Session


    Incremental Innovation
    Chairs: Natália Bellan, Inteligência Sanitária and Suellen Silva, EMS

  • Fixed Drug Combination

  • New Pharmaceutical Forms

  • Regulatory Aspects of Nasal Sprays

  • 3:30 pm - 5:00 pm

    Ballroom

    Parallel Sessions

    Bioanalysis: Where Are We and Where Should We Go? Local Bioanalysis Laboratories in Post-Generic Era
    Chair: Daniel Lebre, CEMSA

  • TBA
    Maria Francesca Riccio, CAEP

  • Bioequivalence facilities in Brazil Challenges and perspectives for the years to come
    José Pedrazzoli Junior, UNIFAG

  • TBA
    Leonardo de Souza Teixeira, ICF



  • Jabuticaba Session
    Hanover


    PK/PD Studies for Large Molecules (Biologics/Biosimilars)
    Chairs: Gustavo Mendes Lima Santos, ANVISA and Faboio Barros, EMS

    Biomarkers

    Bioanalytical Method Validation

    Pharmacodynamic Endpoints



    Jabuticaba Session
    Dresden


    Industry and University Partnerships for Drug Development
    Chairs: Camille Rodriguez, MD PhD, Pharmagenix and Laura Cardeal, GC2

    Why Do We Need Partners For Drug Development

    Successful Models and Results

    Challenges and Opportunities


    5:30 pm - 6:30 pm
    Ballroom

    Wednesday 3 August

    7:30 am - 8:30 am

    Registration & Continental Breakfast

    8:30 am - 9:15am
    Ballroom

    Plenary Lecture

    Thiago Mares Guias

    Biopharmaceuticals' Development, Regulatory and Laboratory Scenario, Where Do We Stand?
    Thiago Mares Guia
    Bionovis

    9:00 am - 5:00 pm

    Poster Hall Open

    9:45 am - 11:15 am
    Ballroom

    Symposium Session

    The Impact of Partnering Models and Outsourcing Strategies in Pharmaceutical Innovation
    Chair: Ana Paula Ruenis, ABRACRO

  • CRO Perspective
    Vitor Harada, Quintiles

  • National Pharma Perspective

  • Multinational Pharma Perspective
    Waleuska Spiess, Roche

  • 11:00 am - 2:00 pm

    CPSA Brasil Expo

    Where Technology and Solutions Meet!

    11:45 am - 12:45 pm

    Sponsored Lunch & Roundtable Event
    Sponsored by Thermo Fisher Scientific

    Thermo

  • Six Analytical Strategies for Glycosylation Studies with Biologicals
  • Marc Chalom and Viviane Nascimento, Thermo Fisher Scientific

    1:15 pm - 2:45 pm

    Ballroom

    Parallel Sessions

    Toxicological Risk And Pharmaceutical Development: New Frontiers
    Chair: Larissa Fontes, GC-2

  • In Silico Toxicological Risk Assessment
    Larissa Fontes, GC-2

  • Qualification Of Degradation Products: In Vivo And In Vitro Assays To Assess The Toxicity Of Degradants During Product Development
    Mariah Ultramari, Aché

  • Using In-Silico Tools to Support Your Degradant Identification Workflow for RDC 53
    Alison Reeves, Lhasa Limited



  • Jabuticaba Session


    Drug Development - Scientific Validation
    Chairs: Peter van Amsterdam, Abbott Healthcare Products B.V. and Carlos Kiffer, GC-2/UNIFESP

  • Pre-Clinical Tests

  • GLP in Drug Development

  • Laboratory Accreditation

  • 3:15 pm - 4:45 pm

    Ballroom

    Parallel Sessions

    Scientific Validation
    Chair: Philip Timmerman, Janssen Research & Development

  • Tiered Approach/Scientific Validation – Past, Present and Future, Including Feedback From AAPS/JBF/EBF Joint Discussions
    Philip Timmerman (on behalf of EBF)

  • Panel Discussion: The Value of Scientific Validation For The Global Bioanalytical Community
    Panelists:
    Rafael Barrientos, Eurofarma
    Peter van Amsterdam, Abbott Healthcare)
    Philip Timmerman (on behalf of EBF)



  • Jabuticaba Session


    Outsourcing Models
    Chairs: Ana Paula Ruenis, ABRACRO, Renato Piemonte Ribeiro, Accutest and Jose Emilio Neto, Quintiles

  • Best Practices

  • Time And Budget Optimization

  • CRO Service Model

  • 5:00 pm - 5:30 pm
    Ballroom

    Wrap Up & Adjourn

    Carlos Kiffer, GC2/UNIFESP and Mike Lee, Milestone Development Services

  • Sponsor's Toast

  • Program Chair Recognition
    Mike Lee, Milestone Development Services

  • CPSA BRASIL 2017 - Program Chair Announcement
    Carlos Kiffer, GC2/UNIFESP

  • Founder's Award

  • Adjourn
  • 6.30 pm

    Football & Barbecue