Peter is the Acting Associated Director for medical products investigation based in the US Food and Drug Administration’s China Office in Beijing. Peter gained his Master’s degree in Analytical Chemistry from San Francisco State University, and has previous experience working in pharmaceutical manufacturing. Prior to joining FDA’s China Office, he spent two and a half years working in the US FDA India Office based in New Delhi. He has been performing pharmaceutical inspections on behalf of the US Food and Drug Administration around the world since 2008.
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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 chemo selectivity. 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.
Dr. Wenliang Chen received her Ph.D. in Mechanical Engineering from The New Jersey Institute of Technology in 2002. After graduation, she worked five years in the center of Engineering Particulates as a Research Associate in NJIT. Before coming to the United States, she was an Assistant Professor at Shanghai Jiaotong University from 1992 to 1997. Prior to joining PTI, she worked as a mechanical engineer for Springfield Precision Company, a manufacturing company that produces measurement instruments. Dr. Chen joined PTI in 2008, supporting the research and development team as well as the manufacturing and production departments. Her expertise and focus have primarily been air-borne ultrasound Seal-Scan® technology, vacuum decay test method development specific to package integrity testing, as well as developing new inspection technologies. In the past years, she has provided timeless support to customer and local agent offices primarily in Asian and European global markets. By the end of 2015, she was appointed as Principle Application Engineer/Quality Manager
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Dr. Antony Fake has worked with the WHO Prequalification Team since 2010. He is the focal point for API-related assessments within the Prequalification Team – Medicines Assessment (WHO), based in Geneva. This includes oversight of the API Prequalification procedure and API assessment in direct support of Finished Pharmaceutical Products seeking Prequalification.
Before joining WHO he was Team Leader Prescription Medicines at the New Zealand Medicine Regulator (Medsafe) in 2000. He is a Chemist by training.
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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.
Dr. Han obtained his PhD in Pharmaceutics from the University of Minnesota. He is the Dean and Professor of Insititute of BioPharmaceutical Research of Liaocheng University and the director of Shandong Engineering Research Center for Nanomedicine and Drug Delivery Systems, etc. He obtained a BS in pharmacy from the Second Military Medical University. Dr. Han is an expert in pharmaceutical product development and had 20 years’ academic and industry experiences with Sanofi, Pfizer, Abbott, Novartis and Teva/Barr, etc.
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.
Mrs. Hua YIN has worked with WHO prequalification of medicines programme as an assessor since 2006. Before joining WHO, she worked as a scientist in the National Institute for Food and Drug control of China and Chinese Pharmacopoeia Commission successively, in the area of quality control of pharmaceutical products and developing of pharmacopeial monographs.
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Graduated from Shanghai University of Engineering & Technology major in Organic Chemical Engineering in 1992, currently in GSK for pharmaceutical packaging management work. Prior to GSK, worked separately in J&J, Roche Pharma and Dow Corning, accumulated technical, quality and packaging experiences in pharmaceutical industry for 16 years, packaging development experiences in household and chemical industry for 9 years, be a packaging professional in these fields.
Dr. Kane has more than 25 years of experience in the science and business of taking molecules through the entire drug development process. His extensive knowledge spans early stage development to scale-up and commercial manufacturing, and includes technical transfers between global sites and drug life cycle management.
In his current role as Executive Director, Dr. Kane leads the formulation group at global sites, provides leadership to all global PDS sites in the complete development of novel lead compounds and line extensions. He works directly with customers to progress their molecules to the next stage of development by helping them to define scientific strategies in early development, clinical development and life cycle management. He is also responsible for evaluating drug delivery technologies to support the business.
Want to register for 2017 CRO & CMO Seminar?
Date: 20th June 2017
Location: Hall E2, Meeting Room M17
Time: 10:10 - 15:40
It's easy: gotocphi.com/registerforconference
Former Executive Director, WuXi Apptec, Former Collaboration Team Lead, Merck
Walter Liu, graduated in 2007 from Shanghai University of Traditional Chinese Medicine, acquired doctorate degree. Walter has many years’ experience on drug manufacturing and R&D. In year 2008, Walter began the work of technical support for pharmaceutical excipients. Now, Walter is technical manager, Greater China, for pharmaceutical excipients, Ashland.
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.
•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.
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.
Folker Steden graduated as a Chemist from the Rheinische Friedrich-Wilhelms University in Bonn Germany. After finishing his awarded PhD doctoral thesis in inorganic Chemistry at the Universities of Bonn Germany and the Fredericton New Brunswick in Canada he worked as a post-doc at the Department of Chemistry at the Technical University of Dresden. After that period he transferred as the Head of R&D of the green high temperature resistant inorganic fiber manufacturer at belchem, responsible for R&D management, product development and ramp up. Ten years ago he joined SCHOTT as a scientific Consultant for technical and pharmaceutical tubing applications. In the years 2010 to 2012 he was located in Shanghai responsible for Scientific Consulting, Business Development and B&I activities in Asia. Since 2012 he is leading the Product Management Team of the tubing division of SCHOTT. With his excellent scientific background and profound intercultural communication skills he is working world wide as a “missing link” between customers and local R&D units, focusing on future customer needs and presents frequently on international conferences on subjects related to special glass for technical and pharmaceutical applications.
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.
Thebaud is Sales Director at Nemera for International & Emerging markets. In this role she is responsible with her team for growing Nemera’s business in LATAM, APAC, MENA and Russia, in line with Nemera’s strategy. Aurélie joined Nemera 8 years ago, previously named Rexam Healthcare Devices. At Nemera she held positions as Key Account Manager Scandinavia, Global Account Manager and Sales Director North America. Aurélie holds an MBA in Change Management from the McCallum Graduate School in Boston, MA. In her previous career she worked as a consultant in strategy and organizational change, as well as a partner for a start-up company in the recycling industry.
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.
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.
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.
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.