May 27 2015

Advances in Biopharmaceutical Technology in India

International Biopharma Spotlight

Advances in Biopharmaceutical Technology in India

A Society for Industrial Microbiology and BioPlan Associates co-publication

Advances in Biopharmaceutical Technology in India can provide you the most up-to-date news and perspective on events and trends in this rapidly-changing biopharmaceutical industry. Whether you require basic information, or extensive support in partnering with the right companies in India, BioPlan will work with you to meet your needs.

Publication date: January 2008
BioPlan Associates, Inc. and Society for Industrial Microbiology
ISBN: 978-1-934106-07-5

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Introduction: Biotechnology in India, Dr. P. K. Ghosh President-Biotechnology Cadila Pharmaceuticals Ltd
A Window into India’s Biopharmaceutical Sector, N. Kulkarni, Biospectrum Asia
Indian Biopharmaceutical System and Policies, Yennapu Madhavi, Ph. D, Scientist, National Institute of Science Technology and Development Studies
Government Support for Biotech and Biopharmaceutical Industry, Dr. B. M. Gandhi, CEO, Neo BioMed Services
Biopharmaceutical Products in India, Dr. Scott Wheelwright, Dr. Hazel Aranha, President, Strategic Manufacturing Worldwide, Inc.
Biogeneric Manufacturing in India, Dr. Ashesh Kumar, General Manager M J Biopharm Pvt. Ltd.
Biopharmaceutical Market Situation, Dr. Merlin Goldman President, Magnetical, U.K.
Contract Research Industry in India, Dr. Umakanta Sahoo & Dr. Faiz Kermani, Managing Director, Chiltern International Private Ltd.
Regulatory Landscape for Clinical Trials in India, Dr. Romi Singh, Executive Director, Global Regulatory Affairs, Amgen Inc.
Life Sciences Education in India, Dr. Dipti Sawant Dr. Umakanta Sahoo, Chiltern International Private Ltd.
Vaccines Industry in India, Dr. PS Kulkarni Dr. SS Jadhav, Deputy Medical Director /Executive Director, Serum Institute of India Ltd.
Development of plasma-derived biopharmaceuticals in India: issues and opportunities, Dr. John Curling, President, John Curling, Consulting AB
Bioprocess Technology in India, Dr. David Mousdale, Managing Director Beocarta Ltd., U.K.
Potential Applications of Recent Advances in Immunology to Develop Novel Therapeutic Products in India, Dr. Kumar Shah, President, Endocrine Technology, LLC
Early Stage Key R&D for Successful Development of Protein Products, K. Madduri, Ph.D Dow AgroSciences LLC
Understanding Ayurveda Medicine, Dr. Sampada Mahajan, Chiltern International Private Ltd.
Biopharmaceutical Outsourcing: A comparative Overview of the Landscape in India and China, Minna Damani Editor, CanBiotech
Biopharmaceutical Research Collaboration between Western and Indian Life Science Organizations, Dr. Steve Ferguson, Director, Dr. Uri Reichman, Dr. Bharat Khurana, NIH Office of Technology Transfer
Outsourcing R&D to India, Sajai Singh, Probir Roy J. Sagar Associates
Venture Capital Financing, Sajai Singh Probir Roy Chodhur J. Sagar Associates
Pre Clinical and Clinical Trial in India, V.K.Srinivas, Ph.D, General Manager, R&D, Bharat Biotech International Limited
Outsourcing Biopharma R&D to India, Jim Schnabel, Senior Research Associate, BioPlan Associates, Inc. Technology Transfer: Impact and Importance for Indian Biotechnology Growth, Susan Kling Finston, Founder and Principal, Finston Consulting, LLC

May 27 2015

Advances in Biopharmaceutical Technology in China, 2nd ed.

International Biopharma Spotlight

Society for Industrial Microbiology and Biotechnology
and BioPlan Associates

Advances in Biopharmaceutical Technology, 2nd ed – A new opportunity exists in working with Chinese companies to establish scientific and business partnerships, and to create effective strategies. However, success in Asia will require changes in partnerships between Western and Asian companies.

Every company faces the question “What should our China strategy be?”

This volume, published by BioPlan Associates, Inc., in cooperation with the Society for Industrial Microbiology and Biotechnology (SIMB) provides an overview of the biopharmaceutical industry, and the state of technology in China. A peer-reviewed, ready reference for all aspects of biopharmaceuticals in China, including an understanding of the China biopharma current situation, and future opportunities. Readers receive a comprehensive assessment of the state-of-the-industry, trends and analysis. information on all types of organizations involved in biopharma in China, whether they are domestic. multinational or government.

Readers will be able to:

Assess the state of biopharmaceutical development in China
Understand general business practices
Analyze business opportunities and identify potential partners

Published by BioPlan Associates, Inc., and Society for Industrial Microbiology and Biotechnology (SIMB)
October 2018
ISBN: 978-1-934106-34-1

Download PDF Brochure [PDF 649k]

Hardcover	Electronic Global License Copy
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By the Numbers:

102 Internationally Recognized Authors
9 Sections, 55 Chapters
21 Peer-Reviewers
1,139 Pages
70 Translated Sections
7 Case Studies and China Briefs
200+ Tables and Figures
300+ References
Over 2,000 Index Entries

Download Table of Contents [PDF 1 MB]

Chapters:

PREFACE – Study Overview

SECTION 1: Introduction to Advances in China Biopharmaceuticals
• Introduction: A China Biopharmaceuticals Strategy

SECTION 2: Innovation in China Biopharmaceuticals: Historical and Current Climate
• Chapter 2: Biologics Innovation in China: Historical and Current Drivers
• 2-1: Chinese Innovation in the Biopharmaceutical Industry, 2007 to 2016
• 2-2: Scientific Strategy in China: Starting with Biosimilar Platforms
• 2-3: Development of Innovative Therapeutics in China
• 2-4: Opportunities and Challenges for Drug Innovation in China
• 2-5: Pathway for Access to China Markets for Innovative Therapeutics
• 2-6: China on the Biopharmaceutical Fast Track? Challenges to Innovation
• 2-7: Advances in R&D for mAb Therapeutics Development
• 2-8: Current Status and Future of China’s mAb Therapeutics
• 2-9 Brief: Challenges and Opportunities in Innovative Drug Development in China
• 2-10 Brief: Launching Biologics in China: From Biosimilar to Innovative Molecules. Key Considerations for MABs and Biologicals
• 2-11 Brief: Accelerating R&D of Biological Drugs in China
• 2-12 Brief: China’s Biopharma Innovation–Creating Opportunities
• 2-13 Brief: Tech Advances in Biopharma

SECTION 3: Biopharmaceuticals and Healthcare Systems and Structure in China
• Chapter 3: Overview and Review of the Chinese Biological Pharmaceutical Markets
• 3-1: Reform of Drug and Medical Device Review and Approval Systems
• 3-2: China’s Regulatory Reform in Healthcare: Achievements and Challenges
• 3-3: China Food and Drug Administration Reform in China
• 3-4: Reforms and Trends in China’s Healthcare Insurance System
• 3-5: New Drug Evaluation Systems in China
• 3-6: Approval Process for Biologics: A US-China Comparison

SECTION 4: Biopharmaceutical Manufacturing in China: Operational and Quality Trends
• Chapter 4: Introduction to BioManufacturing in China
• 4-1: Manufacturing of Biopharmaceuticals in China
• 4-2: Historical Development of Good Manufacturing Practices in China
• 4-3: Current Challenges in Biopharma Quality Management in China
• 4-4: National Standards for Chinese Biological Products
• 4-5: Advances in China Pharma Manufacturing
• 4-6: Recombinant Protein Drug Quality Control
• 4-7: GMP Implementation: The “Made in China 2025” Plan
• 4-8: Single-Use Technology in China’s Biomanufacturing
• 4-9: Biologics Manufacturing Costs in China
• 4-10: Impact of CFDA Reform on CMC Strategy at IND Stage
• 4-11: Overview of Biopharmaceutical Contract Manufacturing Organizations in China
• 4-12: Establishing a Management Pattern for Pharmaceuticals Using the Enterprise Resource Planning System
• 4-13: Bioprocessing Equipment Strategy in mAb Manufacturing in China
• 4-14: Tech Transfer in mAb Manufacturing
• 4-15 Brief: Advances in the Biopharmaceutical Manufacturing Industry in China

SECTION 5: Advances in Biological Development in China
• Chapter 5: Introduction to Biological Development in China
• 5-1: Monoclonal Antibody Drug Development in China
• 5-2: Development of Antibody-Drug Conjugates in China
• 5-3: Therapeutic Developments for Rare Diseases in China
• 5-4: CarT-China: Advances in Personalized Medicine
• 5-5: RNAi in China: Novel Therapeutics in China
• 5-6: Clinical Trials and Regulatory Oversight of Mesenchymal Stem Cell Therapies in China

SECTION 6: Vaccine Industry in China
• Chapter 6: Introduction to China’s Vaccine Industry
• 6-1: Historical Review of China Vaccines: 2007-2016
• 6-2: Innovative Developments in China’s Vaccine Industry
• 6-3: China’s Vaccine Industry: Current Landscape and Key Product Segments
• 6-4: Current State and Overview of the Chinese Vaccine Market

SECTION 7: Biopharma Contract Services and Clinical Trials in China
• Chapter 7: Introduction to China’s Services to the Biopharma Industry
• 7-1: Conducting International Multicenter Clinical Trials in China
• 7-2: Current and Future Development of CROs in China
• 7-3: Future of CRO’s in China: An Investor’s Point of View

SECTION 8: Doing Business in China: Investment and Intellectual Property
• Chapter 8: Introduction to Investing in China Pharma and Biopharma Industry
• 8-1: IP and Biopharma in China
• 8-2: Trends and Characteristics of Intellectual Property in China’s Biopharmaceutical Industry
• 8-3: Investing in the Biopharmaceutical Industry in China
• 8-4: An Invitation to Invest in Biomedicine in China
• 8-5: China’s Investment Outbound in the Global Biopharmaceutical Industry
• 8-6: International Status and Path Analysis of China’s Pharmaceutical Products
• 8-7: China Licensing Deals for Biologics
• 8-8: Legal Issues: Commercial Bribery in Pharmaceutical Companies in China
• 8-9: Marketing Authorization Holder Options Under Cost Control
• 8-10: Industrial Policy and Technology Transfer in China’s Biopharma Industry
• 8-11: Slow Transformation: An Overview of China Pharmaceutical Business
• 8-12 Brief: Intellectual Property Trading in China’s Pharmaceutical Industry
• 8-13 Case Study: Doing Business in China

SECTION 9: Future of China’s Biopharma Industry
• 9-1 Brief: Future Prospects for China Biopharma

Appendices
• Appendix A: Directory of Biologics on Market & Clinical Development in China
• Appendix B: Directory: Top 60 Biopharmaceutical Manufacturers in China

Author Organizations

• Amgen Asia Research and Development Center
• Anhui Anke Biotechnology (Group) Co., Ltd.
• AstraZeneca/MedImmune
• AutekBio
• BeiGene (Suzhou) Co., Ltd.
• Beijing Minhai Biotechnology Co., Ltd.
• Beijing University
• Betta Pharma Co., Ltd.
• Boehringer Ingelheim China
• CanSino Biologics Inc.
• Celgene Pharma
• Cellyan Therapeutics (Wuhan) Co., Ltd.
• Changzhou High-Tech Research Institute of Nanjing University
• China National Center for Biotechnology Development (CNCBD)
• China Technology Exchange
• Chinese Academy of Sciences
• Chinese Pharmacopoeia Commission
• Complya Asia Co., Ltd.
• CStone Pharmaceuticals
• Dacheng LLP
• Doer Bio
• Fudan University
• Genor BioPharma
• Guangzhou Nanotides Pharmaceuticals, Co. Ltd.
• Hengrui Pharma
• Hua Medicine
• Huaota Biopharma
• ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd.
• Innova Med Biotechnology Co., Ltd.
• Innovent Biologics
• Jiangsu TargetPharma Laboratories Inc.
• Jiayu (Suzhou) Biomedical Incorporated
• Jilin University
• L.E.K. Consulting
• Macau University of Science and Technology
• Nanjing University
• Peking University
• Perkins Coie, LLP
• PersonGen
• Pharmcodia
• Pullan Consulting
• Qiming Venture Partners
• Quacell Biotechnology Company Ltd.
• Renmin University
• SDIC Fund
• Shanghai Institutes for Biological Sciences
• Shenzhen Polytechnic University
• Shenzhen Research Institute of Nanjing University
• Sichuan University
• Sinolink Securities Institute
• Suzhou Sirnaomics Pharmaceuticals, Co. Ltd.
• Tasly Sants Pharmaceutical
• Tianjin International Joint Academy of Biomedicine
• Tot Biopharm Co., Ltd.
• VenturePharma
• Walter Biotech Consultancy
• Wuhan YZY Biopharma Co., Ltd.
• WuXi Biologics
• Xiamen Wantai Canghai
• XingYe Securities
• Yusen Capital
• Zai Lab.
• Zensun (Shanghai) Sci & Tech Co., Ltd.
• Zhejiang Hisun Pharmaceutical Co., Ltd.
• Zhejiang Teruisi Pharmaceutical Inc.

May 27 2015

Directory of Top 60 Biopharmaceutical Manufacturers in China

BioPlan’s Directory of Top 60 Biopharmaceutical Manufacturers in China

Completely updated, comprehensive Top 60 Directory provides detailed profiles of China biopharmaceutical facilities: Capacity, history, products, scale, management, business focus, products, R&D, business and partnering strategies, strengths and weaknesses, and future objectives. Highlights upcoming expansions and facilities; key marketed and clinical trial products.

Keep up-to-date as the bio industry expands; stay aware of key participants, new facilities.

May 27 2015

A Quick Guide to Clinical Trials

A Quick Guide to Clinical Trials, 2nd Ed. – This book provides a unique view of the clinical trial process.

Clinical trials that are well designed and appropriately executed are at the heart of the successful development of all new medicines for patients. Keeping it all straight continues to be challenging. This second edition, edited and written by Dr. Madhu Davies and Dr. Faiz Kermani, has been extensively revised and re-written to include additional topics and new subject matter experts to increase the breadth of discussion of this fascinating discipline. This textbook continues to demystify the topic in an exceptionally reader-friendly, yet authoritative format.

“A Quick Guide to Clinical Trials”, 2nd ed. allows readers, both academic and professional, to get a firm grip on the topic, with just enough detail to ensure a comprehensive understanding. Each chapter also stands alone as a ‘quick dip’ foundation or refresher. The chapters in this book are written by industry experts, carefully chosen for their abilities to clarify complex topics and make them interesting for everyone.

Leo Cai Yang, Project Manager

Leo Cai Yang, Project Manager, has sales and marketing experience in the biotech and pharma segments, including nearly 10 years in marketing and market research. He has worked with several western equipment manufacturers in the pharmaceutical and medical device industries. He is familiar with how western and Chinese business work together and can navigate the […]

Lynn Johnson-Langer, Advisory Member

Dr. Lynn Johnson-Langer works with biotechnology and life sciences organizations to improve clients’ management systems, including human resources and marketing management. Provide analysis of current management systems and develop customized programs to maximize effectiveness. As Director, Market Planning, BioCarb Inc., she was responsible for market planning and market research for international biopharmaceutical diagnostics and therapeutics […]

China Biopharma Distributors

NEW! Directory: Top 60 Distributors of Bioprocessing Supplies in China: Opportunities for Global Biopharma Suppliers to Find and Manage Local Distributors in China Comprehensive China Biopharmaceutical Equipment and Suppliers Distributors Directory 2020 provides detailed profiles of China’s Equipment and Supply Distributors industry. Competitive landscape in China’s bioprocess equipment and consumables segment, with comprehensive information on […]

China CMO

NEW! Growth of Biopharmaceutical Contract Manufacturing Organizations in China: An In-depth Study of Emerging Opportunities Comprehensive In-depth Study provides detailed analysis of the CMO industry, its recent development and trends. Profiles of China’s Contract Manufacturing Organizations (CMOs) and Contract Development Manufacturing Organizations (CDMOs), including their capacity, history, products, scale, management, business focus, products, R&D, business and […]