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CPhI Pharma Business International Program
Date: June 21, 2017
Venue: Shanghai New International Expo Centre


Business activity in the pharmaceutical, chemistry & healthcare sectors in China are growing non-stop. Activity in Mergers and Acquisitions (M&A) is very high, both domestically and from a cross-border perspective.


Top international and domestic Chinese pharmaceutical companies - as well as a host of smaller players - are moving to secure market share along with drug development permissions and capabilities in the context of China's evolving regulatory regime.

The prospect of greater protection for intellectual property is also a factor in the broader context of what is emerging as the world's next great market for patented drugs.

The International Business Program at CPhI China during the China Pharma Week gives an in-depth perspective to international visitors from SME companies, who want to develop their business or sourcing in China.


The programme invited world top consulting and law firms to interpret China's latest pharma market updates and share industry cases on patenting and intellectual protection. The technical conference hosts esteemed industry experts and top researches on the latest trends and innovations.


Agenda

Workshops
Hall E2 Meeting Room M17

10 – 11 am

Patenting in China – which patents have a higher chance to survive invalidation challenges and to be enforceable.

Module A

Workshop leader:

Dr. Oliver Lutze
Principal - Manager Shanghai Office, SPRUSON & FERGUSON (ASIA)

o Increasing patent value through focused patent drafting
o Guidance for China-specific freedom-to-operate analysis
o China's recently proposed new regime for patent linkage & data protection

Co-presenters:
1. Dr. Jian (Jennifer) Kang, Principal, Spruson& Ferguson, Beijing Office
2. Mr. Hongqiang (Alex) Liu, Head of IPR, Bayer (China) Ltd.

1.00- 2.20 pm

Contract Manufacturing of Finished Dosage Forms in China

Module B

Workshop leader:

Dr. Dittmar Nerger
Director, Nerger Consulting Co., Ltd.

12 Years FDF Contract Manufacturing in China: 2005-2017 – from the eyes of international customers and local manufacturer, A review and discussion of experts.

Co-presenters:
1. Ms. Angela Ye Jin, Pharmascience, Canada/China Office
2. Messrs. Zhang Dai Ming (Chairman) and Mr. Peng Xin Wen (Head of International Contract Mfg. Business) of Shandong Xinhua Pharm., Zibo/Shandong
3. Mr. Thomas Tang (Int'l. Business Head) of Apeloa Kangyu Pharm./Hengdian Group, Hangzhou/Zhejiang

2.30- 3.30 pm

The Changing Dynamics of Global API Manufacturing

Module C

Workshop leader:
Hui Zhang
Team Leader, Product Solution & Service Consultant, Clarivate Analytics

• While still a vibrant and growing sector, API manufacturing continues to be impacted by multiple forces that are often global in nature
• Regulators tightening GMP rules, increasing costs through user fees and pushing traceability downstream in the process
• A heightened focus on mergers and acquisitions, particularly driven by CDMO consolidation in recent times
• Increased competition, price sensitivity and the need for differentiation through efficiency, regulatory compliance or building new capabilities in biosimilars, HPAPI or ADCs

3.40- 4.40 pm

Challenges & Solutions of Quality & Safety in Global Supply Chain

Module D

Workshop leaders:
Vera Hang, GMP audit supervisor, Intertek
Drewy Zhang, EHS consultant, Intertek
Francesco Zhou Fei, CODEMA China Representative, CODEMA

Technical Conferences
Powered by American Chemical Society (ACS)
Hall E1 Meeting Room M13

10.30 – 11. 30 am

Perspective on a green alternative

Module A

Jianguang Zhou, Chemical & Analytical Development Novartis - Reaction in water: perspective on a green alternative

Pengfei Guo, Chemical & Analytical Development Novartis - Chemistry in Surfactant Water

1.00 – 2. 00 pm

Green by Design through innovation

Module B

Jingjun Yin, External Discovery Process Chemistry Lead, MSD

MSD supports the development of sustainable and environmentally friendly processes for its commercialized products.

Green by Design is a privileged opportunity for innovation, with the goal of designing and developing the most efficient, cost effective, and environmentally benign API process.

2.15- 3.15 pm

Advances in Electrochemistry and Flow Chemistry for Pharmaceutical Manufacturing

Module C

Dr. Denghui Bao, Group Leader Asymchem Life Science (Tianjin) Co., Ltd.

Continuous processing enables a promising new business model that could radically improve quality control, decrease cycle time, allow for faster release of new products, increase energy efficiency, reduce waste and develop a safer, better process control.

3.30- 4.30 pm

Chemistry and Work Flow Optimization in Greener Research Labs

Module D

Liang Sun, Director, Chemistry Service Unit, WuXi AppTec (Tianjin) Co., Ltd.

The optimization of chemistry and work flow were applied with high efficiency in research labs for less solvent. 

A new work flow of workup and purification was also developed in our research labs. 

This strategy provides a good example for the green chemistry in research labs.



Speakers Introduction & Speech Abstracts:
Dr. Oliver Lutze
Principal - Manager Shanghai Office, SPRUSON & FERGUSON (ASIA)

Oliver Lutze is the Chief Representative in Spruson & Ferguson (Asia) Shanghai where he advises on patent matters with a special focus on China activities. Oliver's practice primarily involves providing advice in relation to global patent matters including validity and enforcement, patent drafting, patent strategy and infringement. Oliver has considerable experience in advising on patent matters in the field of life sciences, pharmaceuticals and chemistry having worked in-house for a German multinational company as a Senior Patent Counsel for over 15 years. Oliver was the leader of this multinational's Intellectual Property Rights Team for Greater China. He is a well-known expert on IP strategy and patent practice in China, including advising on IP support issues for local R&D centres. In Shanghai, Oliver chaired the Intellectual Property Working Group of the European Chamber of Commerce in China until September 2013.
Qualifications
•Doctoral Degree (Dr. rer. nat. Germany) in Chemistry - University of Muenster Germany
•Master of Science (equivalent) in Chemistry
•European Qualified Patent Attorney
•German Qualified Patent Attorney

Dr. Oliver, Lutze, will share his experiences in obtaining and enforcing patents with a specific focus on Chinese Patent Law and Patent Practice. The workshop will help patentees to understand what is needed to minimize invalidation threats to their Chinese patents and to have the best claims to ensure enforceability.

The Workshop on the other hand will also show how these findings effect the evaluation of third part patents as threats for own activities. Specifics of the Chinese patent law will be analysed with its effect on drafting opinions on patent scope and validity of patents of third parties.

 

Dr. Dittmar Nerger
Director, Nerger Consulting Co., Ltd.


Following a career in academia and industry, Dr. Nerger established 2013 a consultancy company serving the pharmaceutical industry in business development, M&A, strategy, R&D and technology, supporting Chinese, Korean companies and Western business partners.
He worked 30 years at Bayer in R&D, Technical Operation and Commercial Operations in Europe, US, Korea and China, since 2014 serves as Shandong Xinhua's non-executive board member/Int'l. Chief Scientific Officer.
Dr. Nerger received various awards, served as editor of scientific journals, and enjoys working with teams of different cultural background, splitting his time between Europe and Far East.

With the change of pharmaceutical regulations in 2004 the contract manufacturing of FDF in China had been permitted by authorities allowing integration forward in the supply and value chain from APIs to FDF. However, different from the earlier experience in APIs, FDF contract manufacturing had been adopted reluctantly except by few pioneers, e.g. Shandong Xinhua Pharm. Co. Only since 2010 contract manufacturing has been pursued by more and more Chinese manufacturers with extensive investments notably in SD manufacturing capabilities and capacities. In this work shop, we will review the development and learnings, explore opportunities, trends and issues in the view of both the manufacturer and the customer.


Hui Zhang
Team Leader, Product Solution & Service Consultant, Clarivate Analytics

Hui Zhang is responsible for providing professional product solution & consulting service to ensure that Clarivate Analytics (formerly the IP & Science business of Thomson Reuters) meets the business growth and intelligence needs of Chinese customers. She is expert in product strategy for the widely used Newport® generics business development and API sourcing products and is involved in supporting all manner of exciting consulting projects for customers in many diverse fields in the generics and API business. With more than 15 years of R&D professional experience in pharmaceutical industry, much of it as a management consultant in China, EU & US, she has held position in Clarivate Analytics and ChiaTai TianQing Pharma. She worked as a Senior Manager in Strategic Marketing Dept. for her expertise lies in regulation and policy, therapeutic areas and indication selection, project screening, portfolio management and strategic market analysis. Hui holds a Master of International Pharmaceutical Engineering Management from Peking University.

 

Vera Hang
GMP audit supervisor, Intertek

Mrs. Vera Hang is working for Intertek as the role of GMP audit supervisor. She is focus on GMP project consultant and third-party audit of API & Excipients and medical device.
She has more than 10 years Quality Management professional working experience in Schering-Plough and Boehringer-ingelheim. The experiences include supplier audit for pharmaceutical API & Excipients, packaging materials; quality control lab management; SAP key user and design & establishment of microbiological lab.
She is good at: API & Excipients audit according to EU GMP part II, ICH Q7, Quality control management; analytical method validation, ISO 13485 Medical Device Auditor.

 

Drewy Zhang
EHS consultant, Intertek

Ms. Drewy Zhang has a Master degree in Sustainable Development and Organization from University Paris Dauphine and a Bachelor degree in Environmental Engineering from Guizhou University.
She is a registered National Safety Engineer, 9 years' HSER professional working experience in EHS Experts Services in Intertek, AUO and RB Windtek.
Project leader and member of ISO14001 and OHSAS18001. Auditor for Roche, Apple and Merck, PHA member of HAZOP analysis for local tollers of Roche, Novartis and Merck.



Francesco Zhou Fei
CODEMA China Representative, CODEMA

Francesco Fei Zhou is the China Representative of CODEMA, in charge of developing the CODEMA rating system and more generally promoting the activities of CODEMA in China.
Before his current role with CODEMA, Francesco had served as business development manager and chief financial officer for leading companies and start-ups in Asia and Europe.
A global minded Italian-Chinese executive with East-West background, Francesco is an MBA Graduate of Peking University and had previously obtained a Business Administration Master Degree from Bocconi University in Milan.
Francesco is native speaker of Italian and Chinese, fluent in French and English and conversational in German.

 

Jingjun Yin
External Discovery Process Chemistry Lead, MSD

The pharmaceutical industry is expected to meet the needs of patients around the world at a cost they can afford while minimizing the environmental footprint.
MSD is deeply committed to supporting the development of sustainable and environmentally benign processes for its commercialized products. We strive to develop synthetic processes according to the 12 principles of Green chemistry and engineering.
In addition we consider Green by Design as a privileged opportunity for innovation, with the goal of designing and developing the most efficient, cost effective, and environmentally benign API process. At MSD we seek to have the ultimate manufacturing process for the launch of our products. This relies on breakthrough synthetic transformations as well as Green by Design concepts to API process development, including:
•Atom economy - convergency, catalysis, minimizing protecting groups
•Productivity – increasing throughput, avoiding isolations, process intensification, continuous processing
•Environmental impact – sustainability and the use of less hazardous solvents and reagents
Several examples from different programs in our pipeline, demonstrating MSD's commitment to sustainable and benign processes, will be discussed using Process Mass Intensity (PMI) as the main tool to measure success.

 

Dr. Denghui Bao
Group Leader Asymchem Life Science (Tianjin) Co., Ltd.


The oxidation of allylic systems has played a prominent role in this context as possibly the most widely applied C–H functionalization, owing to the utility of enones and allylic alcohols as versatile intermediates, and their prevalence in natural and unnatural materials. Despite many attempts to improve the efficiency and practicality of this transformation, the majority of conditions still use highly toxic reagents (based around toxic elements such as chromium or selenium) or expensive catalysts (such as palladium or rhodium). These requirements are problematic in industrial settings; currently, no scalable and sustainable solution to allylic oxidation exists. Here we describe an electrochemical C–H oxidation strategy that exhibits broad substrate scope, operational simplicity and high chemoselectivity. It uses inexpensive and readily available materials, and represents a scalable allylic C–H oxidation, enabling the adoption of this C–H oxidation strategy in large-scale industrial settings without substantial environmental impact.
Continuous processing has been claimed to enable a promising new business model that could radically improve quality control, decrease scale-up issues and cycle time, allow for faster release of new products, increase energy efficiency, reduce waste and process inventories, develop a safer process and provide better process control.
Asymchem has developed different types of equipment to support a wide range of reaction types and implemented processes on a wide range of scales. Recently, a continuous stirred tank reactor (CSTR) process was successfully developed for the continuous production of pharmaceutical intermediate, bearing the benefits in reduced solvent volume, low scale-up risk and improved yield.

 

Liang Sun
Director, Chemistry Service Unit, WuXi AppTec (Tianjin) Co., Ltd.

The optimization of chemistry and work flow were applied with high efficiency in our research labs for less solvent. The reaction conditions are systematically screened based on our experience with less waste produced. The non-orthogonal screening could help us to optimize the condition with high efficiency. In most cases, the reactions are scaled up with 3~10 times higher concentration and 10%-50% less reagents than the literature conditions.
A new work flow of workup and purification was also developed in our research labs. The successful application in the small scale reactions saves huge amount of solvents, especially dichloromethane, considering the large group of organic chemists in WuXi (total >4,000).
Overall, > 50% of total solvents (and 80% of dichloromethane) could be saved in the reactions plus the subsequent workup and purification (with lower PMI) each year. Our strategy provides a good example for the green chemistry in research labs.


Jianguang Zhou

Chemical & Analytical Development, Novartis

Jianguang Zhou, obtained his PhD from University of Rochester in 2005. He worked at the Chemical & Analytical Development department of Suzhou Novartis Pharmaceuticals Technology for 10 years. He earned the Novartis VIVA Award and the title of Novartis Leading Scientist in 2015. At Novartis, he has been a key leader in the the catalysis/biocatalysis technology platform, holds the responsibilities to develop green and robust chemical processes for developmental drug candidates, and provide drug substance supplies for both pre-clinical and clinical needs.

Presentation title: Reaction in water: perspective on a green alternative

Abstract: Solvents have been significant percentage of whole mass consumption in the pharmaceutical industry, which contributed to heavy burden of waster treatment. With increasing pressure from environmental regulations, the pharmaceutical industry is facing the judicious replacemnt of a number of commonly used solvents especially polar aprotic solvents. The efforts of investigation of reaction in water will be discussed with Novartis example.

 

Pengfei Guo
Chemical & Analytical Development, Novartis

Pengfei Guo, obtained his PhD in organic chemistry from University of Delaware in 2010. After 2 years’ postdoc in Columbia University, he started his industrial career and worked at the Chemical & Analytical Development department of Suzhou Novartis Pharmaceuticals Technology. As a major contributor, he earned the award “Novartis Technical R&D Invention of the Year 2015”. At Novartis, he has grown up to be a Drug Substance Project Leader, who leads the drug substance supply to support both pre-clinical and clinical trials. Meanwhile he also functions a technical lead for surfactant technology application.

Presentation title: Chemistry in Surfactant Water: Recent applications in Novartis projects
Abstract: The identification of sustainable harmless solvent to be used for general purposes has been an area of focus by many chemistry groups globally in the last few decades. One approach towards the replacement of undesirable polar aprotic solvents was developed by Professor Lipshutz, disclosing his latest application on the benign-by-design surfactant chemistry. However, preliminary successes of this technology were combined with huge challenges, namely emulsion problems, oiling out, or precipitation resulting in mediocre conversions, and too limited generality. The further efforts to address this challenge and resulting successful scale-ups for Novartis project delivery will be shared in this presentation.

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