医学交流课件：Respiratory WebEx forum

1、How Medical affairs collaborate with R new carton with QR code in July 2016 China Submission in Q3/Q4 2017 (TBC) Symbicort for mild asthma Symbicort Turbuhaler: COPD moderate (FEV170%) Pneumonia label update Adolescent SMART(1) QR Code China Pharmacopeia Update Submit application by December 1st 201

2、5. Receive response in Q3 2016 4 Late-Stage respiratory new products overview 5 20162017201820192020202120222023 Development timeline (base case)Late stage assets (RE) Updated in Mar 2016 CNPT, C-PRF. (1) FSI depends on study drug available timing and LSPC decision. CNPT will update the timeline in

3、line with C-PRF and GPT updates. (2) China RMCT for LF as back-up plan, CTP-S in end of Jan 2016. (1)FSI in 2017Q1. LPLV in 2018Q1. NDA-S in 2018Q3. COPD IDL-A in 2020Q3 If FSI in Q1 2017, Asthma IDL-A in 2021Q2. COPD IDL-A in 2022Q4 File with Duaklir NDA. COPD IDL-A in 2020Q3 (2)China joins Japan L

4、F trial. COPD LF IDL-A in 2021Q2. EX IDL-A in 2022Q2 Asthma IDL-A in 2022Q4 FSI in May 2016. LPFV in Dec 2016. LPLV in 2017Q2. NDA-S in 2017Q4. COPD IDL-A in 2019Q4 Inhalation Biologics CTP-S in 2016Q2, CTP-A in 2018Q2 CTP-A 2016Q3 CTP-A 2016Q2 CTP-A May 2015 CTP-A Oct 2015 PT003 (Bevespi) pMDI Glyc

5、opyrronium/ Formoterol Duaklir Genuair Aclidinium/ Formoterol Eklira Genuair Aclidinium PT010 pMDI Budesonide/Formoterol/Glycopyrronium Benralizumab PFS Anti-IL-5 receptor mAb Tralokinumab PFS / LVBI Anti-IL-13 mAb Respiratory new product launch readiness What we are doing now 6 1.Accelerate process

6、 of phase 3 registry study operation and new product approval timeline. ( Good case of Medical affairs collaborating with R&D on SYMGA, PT010 study) 2.Keep engage with investigators and patients completed AZ trial. ( understand mild asthma landscape and local unmet medical needs) 3.Biomarker guided

7、asthma & COPD therapy (EOS as biomarker, TH2 inflammation on COPD) 4.Scientific discussion on serve asthma, U-BIOPRED data dissemination, Bring Benra data from ERS to China. 5.LABA/LAMA as backbone of COPD management, Open triple treatment regime in China, characteristic of COPD patients need on ICS

8、 combination treatment (ICS/LABA, or ICS/LABA+LAMA) 6.Co-suspension technology 7.Whole spectrum of asthma and COPD management What need to be done KEE/investigators insights on Product Positioning & competitive landscape in China (Duaklir Genuair, PT003) Epi data on mild asthma in China. (for Symbic

9、ort mild asthma indication) Medical insights on commercialization strategy (LABA/LAMA to ICS/LABA/LAMA or ICS/LABA to ICS/LABA/LAMA) Burden of Serve asthma in China. Exacerbation and hospitalization. (Biologics : Benralizumab) EOS evaluation in clinical setting (Benralizumab) Cultivate Personalized

10、treatment mindset of Chinese physicians 7 Pharm medical affairs 2020 and beyond 8 Enhance patient access to and best use of optimal medical treatment by clearly demonstrating value to practitioners and payers throughout the lifecycle of each product. q Strengthen understanding of local medical pract

11、ices and patient needs and derive relevant insights from it. q Develop clear processes and systems to collect, collate and synthesize insights from different stakeholders and leverage these insights by collaborating with R&D and commercial functions q Relay insights for early life-cycle planning tha

12、t arise from value discussions with internal and external stakeholders q Utilize insights from physician interactions to ensure that brand strategy maximizes the medical benefits for patients and physicians. Embrace patient-centric healthcare by engaging and partnering with a broader range of health

13、care stakeholder q With the rise of consumerism, patients are emerging as an important decision maker in healthcare q Maximize the medical benefits for customers by serving as the primary medical voice of the patient on all internal strategy discussions (for example, advocate for the patient- centri

14、c view as part of life-cycle management strategy). q Embrace and experiment with new technologies in mobility and social media to be well positioned for the future. Facilitate coordination and integration of different medical data and types of knowledge in the company and achieve external recognitio

15、n for providing credible and unbiased medical information. q Drive internal efficiency by integrating relevant medical insights into a central knowledge repository q Increase accessibility to company-generated data for external evaluation and analysis q Leverage scientific and medical discussions to

16、 deepen Medical Affairs focus on defining clinical treatment pathways. q Drive rigorous standards of medical integrity, particularly in medical writing communication of data and interactions with external healthcare providers Acquire and develop the talent to cultivate and build a strong, Multi-faceted Medical Affairs organization that encompasses the new set of competencies required to navigate the future healthcare landscape across the globe q Ensure that current leaders act as inspiring role models and serve as g