DESENVOLVIMENTO MEDICAMENTOS BIOLÓGICOS : DESAFIOS E OPORTUNIDADES HERALDO MARCHEZINI

CEO BIOMM S.A.

I N OVA Ç Ã O E M FÁ R M A C O S E M E D I C A M E N TO S N O B R A S I L : A N EC E S S I DA D E D E I N T E R A Ç Ã O E N T R E U N I V E R S I DA D E S E E M P R E SA S

F LO R I A N O P O L I S

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Fabrica Biomm 2017

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Universities publishing the highest proportions of their research output in collaboration with industry

Rank Institution Country Proportion of publications that are industry collaborations

1 Pohang University of Science and Technology (POSTECH) South Korea 22.982 National Institute of Applied Sciences of Lyon (INSA Lyon) France 18.013 China University of Petroleum China 14.774 Norwegian University of Science and Technology Norway 11.035 University of East Anglia UK 10.236 Chalmers University of Technology Sweden 9.147 Eindhoven University of Technology Netherlands 8.968 Sungkyunkwan University (SKKU) South Korea 8.849 Institute of Cancer Research UK 6.8810 CentraleSupélec France 6.18

Source: Clarivate Analytics, based on research articles and reviews indexed in the Web of Science Core Collection databases between 2007 and 2016.

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GEN (Genetic engineering and biotech News) ranks regions based on five criteria:

• NIH funding—Taken from the publicly available NIH RePORT database, for the current federal fiscal year,

from its start on October 1, 2016, through May 23, 2017.

• Venture Capital (VC) funding—Taken from 2016 and Q1 2017 figures furnished by the publicly available

MoneyTree Report.

• Patents—Based on the number of patents containing the word “biotechnology” awarded since 1976 in

namesake cities and suburbs where key companies are located.

• Lab space—Based on total-size-of-market figures, in millions of square feet, furnished by the commercial

real estate brokerage JLL in its U.S. Life Sciences Outlook report for 2016.

• Jobs—Based on JLL’s report. While job numbers are ranked this year compared with last year’s Top 10 US

Clusters list, less weight had to be given to job totals in regions where GEN has found widespreaddiscrepancies in job figures. However, workforce size was factored in when deciding the ultimate position of a region.

#1 Boston \ Cambridge

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#1. Boston / Cambridge, MA

A decade after then-Gov. Deval Patrick (D) enacted the Massachusetts Life Sciences Initiative, his successor has yet to announce what support the

state will offer the industry when the $1 billion, ten-year measure expires next year. However, Gov. Charlie Baker (R) has committed the state to

growing life sciences companies through workforce development programs and funding for drug R&D. Supporting biopharma is also the goal of the

region’s incubators and accelerators—including the first Chinese-owned bioincubator, the Qilu Boston Innovation Center (QBIC), which opened May

19. QBIC was founded by Qilu Pharmaceuticals, a $2 billion-a-year Chinese drug developer that opened within the incubator its first branch company,

cancer immunotherapy developer QLB Biotherapeutics.

Not surprisingly, the region leads the nation in NIH funding (2,169 awards totaling nearly $1.055 billion), lab space (19.9 million square feet), and

2016 VC funding (78 deals totaling $3.06 billion), though Boston/Cambridge finished second to the San Francisco Bay Area in Q1 with 19 deals

totaling $534 million. Biopharma growth is fueling a wave of speculative lab space development in and around Boston and Cambridge; King Street

Properties, for example, is building the $200 million, 145,000-square-foot 828 Winter Street adjacent to an existing lab building owned by the

developer, and slated for completion in 2018. The region is also second in patents (6,496), but third in jobs with 86,235 according to JLL, though

industry group Massachusetts Biotechnology Council (MassBio) reported 63,026 last year.

Aprovações FDA 1993 – 2016

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Biopharma investment in China

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443–446

(2017)

Nature Reviews Drug Discovery

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443–446

(2017)

Desafios Globais

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• Cadeia Produtiva – P&D, Pesquisa Clínica, Serviços Analíticos, CMO’s, CRO’s, matérias primas;

• Financeiros – Produto Novo (US$ 1 bilhão, 8-12 anos), Biosimilar(US$100 - 300 milhões, 3-5 anos);

• Regulatórios – Processos complexos e longos para a aprovação;

• Processo produtivo – complexidade;

• Pessoal qualificado

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Source: IMS Market Prognosis, Oct 2016Global medicine spending will reach nearly $1.5 trillion by 2021

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