Manz Visit July_17

background

• 12 y as Medical Assistant at Blood Marrow Transplant Unit (Referral Public Hospital in São Paulo, SP)
• specialized in onco-hematology – Hospital Brigadeiro, SP - National referral for onco-hematology
• 2 year in onco pediatrics and 2 years in adults (1997)
• Clinical Research since 2002
• Investigator/Co-Investigator (Study Site)
• Medical Manager:
• CRO:
• IBPC/Oncopartners
• RPSinvolved in different tasks:
• Protocol design
• Strategic input to the development of proposals, especially in oncology
• Novartis – Pharmacovigilance - spontaneous adverse event program (MKT + PHV) – support (pre audit)
• Boehringer Ingelheim - Medical Manager in house
• Study Medical Expert (Bayer)

Epidemiology and Incidence: expectative for 2016/2017

• 600.000 new cases
• 420.000
• 180.000 non melanoma

Epidemiology and Incidence: expectati...

Fonte: MS / INCA / Estimativa de Câncer no Brasil, 2016 MS / INCA / Coordenação de Prevenção e Vigilância / Divisão de Vigilância

Activities at glance

April 2014 – July 2017

mapping

Activities at glance

April 2014 – July 20...

Latin America = 1 Institution

• Albert Einstein Hospital (HIAE) – São Paulo/Brazil

• 2 clean rooms – built by Grifols engeneering – European company in comply with EMA, FDA and Brazilian Agency
• Partnership with MD Anderson Institution:
• Prof. EJ SHPALL`s Department – Lucila Kerbauy, MD (Brazilian fellow/HIAE) training in cell manipulation

• HIAE and Masthercell / Ativio CAR-T Cell Therapy Program Collaboration established in Jan 2017
• Space concession agreement and technology transfer to another target than CD19 with a company to have HIAE as a reference Institution in LATAM
• Open Research protocols
• Training, supervision and validation
• Translation of laboratory protocols into the clinic
• Allow for home grown technology
• Facilitate collaborative clinical tria Regulatory Agencies under discussion for cell therapy in human use legislation

waiting starts phase 1

as we believe this, the oncogroup anticipates and seeks to participate with regulatory agencies and scientific leaders to collaborate with legislation, something that is not yet determined in the worldwide

EGFR Frequency in non small ce...

EORTC/ICGC/LCMC

RNPCC - National Network of Clinic...

Benchmarking shows the “Importance of the field preparation”

The status of MA/reimbursement/label  for anti PD-1s based on other Pharma’s experience (BMS and MSD)

• Ipilimumab – indication: melanoma – approved in 2012 (insurance reimburse)

• Nivolumab – indication: melanoma and lung cancer – time for approval  9 months and 3 months to define the price* (insurance reimburse)

• Pembrolizumab – indication: melanoma 1st line, lung cancer 1st line and 2nd line; HD 2nd and 3rd
• around R$ 13.000 – time to approval 9 months around 3 months*(insurance reimburse)

*In Brazil the timelines for biologic is different for the synthetics. According to BMS (BRA) and MSD (BRA), ANVISA is receptive for this new field, these PHARMAs worked so close with them introducing the experts in each field to training and discuss with ANVISA this new therapeutic area.

BRA :

• Clinical trials phase II and III – Ipilimumab, Nivolumab and Pembrolizumab
• EAP - Ipilimumab, Nivolumab;
• CUP – Pembrolizumab (melanoma)