This document provides information about the "Biosimilars & Biobetters USA 2014" conference to be held on April 7-8, 2014 in Iselin, New Jersey. The conference will focus on regulatory issues, commercialization strategies, and product development for biosimilars and biobetters in the US market. It includes an agenda with speaker information, session topics, and registration details. There will also be two post-conference workshops on April 9th on differentiation strategies for generics and launching biosimilars. The document aims to provide attendees with up-to-date insights and networking opportunities in the biosimilars industry.
This document summarizes an upcoming conference on biosimilars and biobetters to be held in London from September 29-30, 2014. The conference will include presentations and discussions on accelerating biosimilar drug development, regulatory pathways for biosimilars in Europe and the US, proving biosimilarity to reference products, and perceptions of biosimilars among doctors, patients, and payers in Europe. Attendees can also participate in two interactive workshops on biosimilar regulations and the commercial potential of biosimilars. Various industry experts will speak at the event to provide insights on this emerging field.
SMi Group's Pre Filled Syringes West Coast 2016 conferenceDale Butler
This document provides information about an upcoming conference on pre-filled syringes on the West Coast in San Diego from June 6-8, 2016. It includes details about registration discounts if registering by certain dates, conference chairs and speakers, session topics, and sponsorship opportunities. Some of the session topics include regulatory updates on pre-filled syringes, challenges in developing devices for viscous formulations, application of quality by design principles, and challenges in pre-filled syringe manufacturing. There is also information provided about a half-day post-conference workshop on human factor engineering for pre-filled syringes and autoinjectors.
SMi Group's 3rd annual Biosimilars North America 2016Dale Butler
This document provides information about the "3rd Annual Conference on Biosimilars North America" event happening on November 15-17, 2016 in Iselin, New Jersey. It includes details about pre-conference workshops, the speaker lineup, and session topics which will address regulatory considerations, commercialization strategies, and technological developments for biosimilars in the US. Registration discounts are offered before June 30th and September 30th. The event is aimed at solving challenges and accelerating commercialization of biosimilars in North America.
This document provides an agenda for the "2nd Biosimilars & Biobetters USA" conference happening on November 16-17, 2015 in Iselin, New Jersey. The conference will focus on the evolving regulatory landscape and commercialization of biosimilars, and will include presentations and panels on topics such as the FDA approval process, the European experience with biosimilars, and determining interchangeability. It lists speakers from companies such as Sandoz, Merck Serono, Dr. Reddy's Laboratories, and the FDA. Workshops on November 18th will focus on regulatory updates and the development and commercial needs for biosimilars globally.
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
Tracks focus on R&D strategies, Biomarker development, Immuno-oncology, CDx development, AI and Big data analysis and approaches – Attending this Summit will provide you with the opportunity to mix and interact with experts working in all facets of Precision Medicine through the individual, panel and roundtable discussions on offer.
Join us in learning the newest trends and technical advances in the use of Polymeric Materials in Medical Applications; speakers are from premier institutions such as the world-class Ronald Reagan Medical Center at UCLA, ABBOTT Vascular, JOHNSON & JOHNSON-Cordis, BOSTON SCIENTIFIC, MEDTRONIC, REVA Medical, MiMEDX, BECKTON DICKINSON, ROCHE Diagnostics and more.
For Registration / Sponsorship / Details, please CLICK the link below:
http://www.MediPlastConference.com
Ochocientos años. El paso de la cristiandad a la increenciaBright Brains S.C.
El hombre vive actualmente como si Dios no existiera. Hemos sido manipulados por las grandes revoluciones: Revolución Francesa, Revolución sexual, Revolución cultural gramsciana.
Este documento presenta un curso de concientización sobre el sectarismo destinado a agentes de pastoral y pequeñas comunidades católicas. El objetivo es fortalecer la fe de los católicos y dar razón de su fe, cuestionando a los hermanos separados de manera caritativa. El curso abordará temas como la fundación e historia de la Iglesia católica, la salvación, la Biblia, los sacramentos y la acción pastoral, con el fin de mostrar que la Iglesia que Cristo fundó es la Iglesia Cat
This document summarizes an upcoming conference on biosimilars and biobetters to be held in London from September 29-30, 2014. The conference will include presentations and discussions on accelerating biosimilar drug development, regulatory pathways for biosimilars in Europe and the US, proving biosimilarity to reference products, and perceptions of biosimilars among doctors, patients, and payers in Europe. Attendees can also participate in two interactive workshops on biosimilar regulations and the commercial potential of biosimilars. Various industry experts will speak at the event to provide insights on this emerging field.
SMi Group's Pre Filled Syringes West Coast 2016 conferenceDale Butler
This document provides information about an upcoming conference on pre-filled syringes on the West Coast in San Diego from June 6-8, 2016. It includes details about registration discounts if registering by certain dates, conference chairs and speakers, session topics, and sponsorship opportunities. Some of the session topics include regulatory updates on pre-filled syringes, challenges in developing devices for viscous formulations, application of quality by design principles, and challenges in pre-filled syringe manufacturing. There is also information provided about a half-day post-conference workshop on human factor engineering for pre-filled syringes and autoinjectors.
SMi Group's 3rd annual Biosimilars North America 2016Dale Butler
This document provides information about the "3rd Annual Conference on Biosimilars North America" event happening on November 15-17, 2016 in Iselin, New Jersey. It includes details about pre-conference workshops, the speaker lineup, and session topics which will address regulatory considerations, commercialization strategies, and technological developments for biosimilars in the US. Registration discounts are offered before June 30th and September 30th. The event is aimed at solving challenges and accelerating commercialization of biosimilars in North America.
This document provides an agenda for the "2nd Biosimilars & Biobetters USA" conference happening on November 16-17, 2015 in Iselin, New Jersey. The conference will focus on the evolving regulatory landscape and commercialization of biosimilars, and will include presentations and panels on topics such as the FDA approval process, the European experience with biosimilars, and determining interchangeability. It lists speakers from companies such as Sandoz, Merck Serono, Dr. Reddy's Laboratories, and the FDA. Workshops on November 18th will focus on regulatory updates and the development and commercial needs for biosimilars globally.
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
Tracks focus on R&D strategies, Biomarker development, Immuno-oncology, CDx development, AI and Big data analysis and approaches – Attending this Summit will provide you with the opportunity to mix and interact with experts working in all facets of Precision Medicine through the individual, panel and roundtable discussions on offer.
Join us in learning the newest trends and technical advances in the use of Polymeric Materials in Medical Applications; speakers are from premier institutions such as the world-class Ronald Reagan Medical Center at UCLA, ABBOTT Vascular, JOHNSON & JOHNSON-Cordis, BOSTON SCIENTIFIC, MEDTRONIC, REVA Medical, MiMEDX, BECKTON DICKINSON, ROCHE Diagnostics and more.
For Registration / Sponsorship / Details, please CLICK the link below:
http://www.MediPlastConference.com
Ochocientos años. El paso de la cristiandad a la increenciaBright Brains S.C.
El hombre vive actualmente como si Dios no existiera. Hemos sido manipulados por las grandes revoluciones: Revolución Francesa, Revolución sexual, Revolución cultural gramsciana.
Este documento presenta un curso de concientización sobre el sectarismo destinado a agentes de pastoral y pequeñas comunidades católicas. El objetivo es fortalecer la fe de los católicos y dar razón de su fe, cuestionando a los hermanos separados de manera caritativa. El curso abordará temas como la fundación e historia de la Iglesia católica, la salvación, la Biblia, los sacramentos y la acción pastoral, con el fin de mostrar que la Iglesia que Cristo fundó es la Iglesia Cat
This document provides information about a conference on biosimilars taking place from September 30th to October 1st, 2015 in London. The conference will discuss the evolving regulatory landscape for biosimilar approval in the US and Europe, market access challenges, protein characterization, and analytical comparability. It includes an agenda with sessions on the regulatory processes, patent litigation, pharmacovigilance, clinical development strategies, and analytical techniques for assessing biosimilarity. Pre-conference and post-conference workshops will provide more in-depth discussions of these topics.
Pressure BioSciences is presenting their pressure cycling technology instruments and consumables. Their flagship product is the Barocycler 2320EXTREME instrument, which uses high pressure cycling to prepare biological samples for analysis. They have over 270 PCT systems installed worldwide and publications highlighting the advantages of PCT in biopharma sample preparation from discovery to clinical use. The company is poised for growth with their exclusive marketing agreement with SCIEX, expanded sales team, and focus on the multi-billion dollar biopharma market.
SMi Group's European BioNetworks SummitDale Butler
This document is a program for the "European BioNetworks Summit" conference on July 7-8, 2014 in London. The summit will bring together representatives from pharmaceutical, biotechnology, academic, and funding organizations to discuss strategic partnerships and collaborations. Over 12 speakers from companies like Novartis, Bristol-Myers Squibb, Bayer, and Johnson & Johnson will provide presentations on topics like developing business strategies, academic partnerships, pricing and reimbursement, and financing options. Attendees can network and learn how to create successful partnerships to increase innovation and research outcomes. A post-conference workshop on July 9th will focus on clinical development pathways.
SMi Group's Superbugs and Superdrugs USA 2016Dale Butler
This document provides information about the "Superbugs & Superdrugs USA" conference happening from November 14-16, 2016. It advertises the opportunity to register for the conference at discounted rates by certain deadlines. The conference will focus on developing new drugs to combat antibiotic resistance and will feature expert speakers from organizations like the WHO, BARDA, NIH, Pfizer and others. An interactive workshop on animal models in pre-clinical drug development will also be held.
Why you should attend:
1. Learn from in-depth case studies on strategic partnering and effective collaboration
2. Explore new business opportunities and strategies to reach the biosimilars market in the region
3. Gain insights into the regulatory landscape for biosimilars in China, India, Korea, Taiwan and more
4. Gather the latest market intelligence and analysis and identify new trends and opportunities in Biosimilars R&D, contract manufacturing and commercialization in Asia
报名参加的五大理由
1. 深入学习有关与亚洲公司建立战略合作和有效协作的案例研究
2. 探索新的商机和战略,以便进入当地的生物仿制药市场
3. 深入了解中国、印度、韩国、台湾以及更多国家或地区的生物仿制药监管形势
4. 收集最新的市场情报和分析,确定生物仿制药研发、合同制造和商业化在亚洲的新趋势和机会
Hear about:
Biopharma Regulatory Updates and Development
Victoria Elegant, VP Medical & Regulatory Affairs, Baxter, China
Andrea Laslop, Head of Scientific Office, Austrian Agency for Food and Health Safety, Austrian Member, European Medicines Agency
Arvind Mishra, Global Head of Quality & Regulatory & Head of Strategic Business Unit, Biologicals, Cadilla Pharmaceutical, India
Advances in Biosimilars R&D
Jeffrey Su, CSO, Cytovance Biologics, USA
Wenzhi Tian, CEO, Huabo Biopharma, China
Ming Wang, President and COO, Gan & Lee Pharmaceuticals, China
Feng Li, CEO, Beijing Mabworks, China
Shaligram Rane, Vice President for Quality, Intas Pharmaceuticals, India
Understanding Obstacles and Hurdles for Entering the Biosimilars Market
Khai Meng Ang, Vice President Asia, Hospira, China
Jason Li, Senior Director, Genor Biopharma, China
Sachidananda Moorthy, Vice President - Clinical Research, Medical and Regulatory Affairs, Avesthagen, India
Sameer Agarwal, Senior Vice President, Business Center Strategic Marketing, Business Unit Generic Drugs & Standard Solutions, Fresenius Kabi, Germany
What can Asia Learn from Global Biosimilars Development and Litigation?
Li Cai, Regional R&D Counsel, Pfizer, China
Vivek Mittal, Head – Legal, Lupin, India
Viren Mahurkar, Managing Director, HitechnRock Advisors, Singapore
http://www.biosimilarsasia.com
Pre-Conference Special Focus Day, 20 May 2014
Clinical Development for Biosimilars
Post-Conference Workshops, 23 May 2014
A: Challenges in Demonstrating Biosimilarity and Interchangeability of Biosimilar Products
B: Successfully Bringing Biosimilars to Market
会前特别关注日,2014 年 5 月 20 日
生物仿制药的临床开发
会后研讨会,2014 年 5 月 23 日
A:在展示生物仿制药产品的生物相似性和可互换性方面所面临的挑战
B:成功地将生物仿制药推向市场
SMi Group's 7th annual Biosimilars Europe 2016 conferenceDale Butler
This document provides information about two pre-conference workshops for the 7th Annual Biosimilars Europe conference.
The first workshop focuses on maximizing intellectual property and regulatory rights related to biosimilars. It will cover topics like regulatory data protection, orphan drug exclusivity, supplementary protection certificates, and pediatric rewards. The workshop leaders are partners at Bristows LLP.
The second workshop examines how the payer environment for biosimilars is evolving. It will provide insight into pricing, reimbursement, and formulary access processes. Case studies will also be presented on successful biosimilar launches. The workshop leader is the director of RJW & Partners Ltd, a pricing and market
What’s NEW in 2015’s program?
• More case studies on successful commercialization
• Insights on developing biosimilars under new CFDA guideline
• Emerging business models in regulated and developing markets
• New and timely topics on:
o Valuating biosimilars investments
o Successful technology transfer
o Key criteria in gaining approval
Also, NEW Expert Faculty includes:
Dr Shin Jae Chang, Vice President, Celltrion, Korea
Ira Jacobs, Global Oncology Lead, Biosimilars, Pfizer, US
Paul Thomas, Business Unit Head – Biosimilars, Biocon, India
Dr. Martina A. Sersch, Global Clinical Lead, Oncology Global Development, APAC Biotherapeutics Lead, Genentech, Inc. / F. Hoffmann-La Roche Ltd.
Raj Kannan, Vice President, Commercial Head, Biosimilars, Merck, Switzerland
Huiguo (Forrest) Hu, General Manager of International Business, Shanghai CP Guojian Pharmaceutical Co., Ltd, China
Ko Chung Lin, Chief Executive Officer, PharmaEssentia Corporation, Taiwan
Wen Yong, Vice Director, Drug Research Institutes, Biopharmaceutical Institute, Jiangsu AoSaiKang Pharmaceutical Co Ltd, China
http://www.biosimilarsasia.com
This document provides an agenda for the "Successfully Navigating the Biosimilars Landscape and Shaping Opportunity in 2015 and Beyond" conference taking place from 19-22 May 2015 in Shanghai, China. The conference will cover topics related to the current global biosimilars landscape, emerging business models and investment opportunities, regulatory developments and approvals in China, the US, and Europe, and technological advances in biosimilars development. Speakers will include representatives from pharmaceutical companies, regulatory agencies, and investment firms. The agenda lists keynote panels, roundtable discussions, and presentations covering these topics over the course of the three-day conference.
The document advertises the 8th annual Pre-Filled Syringes Americas conference and exhibition taking place from March 31st to April 2nd, 2014 in Iselin, New Jersey. The conference will bring together over 85 key decision makers from leading biotechnology and pharmaceutical companies to discuss developments in pre-filled syringes and injection devices over the course of two days of presentations, panel discussions, and workshops. Attendees will have the opportunity to network with industry leaders, evaluate solutions from exhibitors, and return to their businesses with the information and contacts needed to make decisions for their products.
Pbio Investor Presentation Global Online Growth Conference - Oct 2016RedChip Companies, Inc.
This investor presentation discusses Pressure BioSciences, Inc. (PBIO), a company that develops and sells instruments and consumables for biological sample preparation using pressure cycling technology (PCT). The presentation provides an overview of PBIO's business, leadership, financials, and growth opportunities. Key points include PBIO having over 275 PCT systems installed, generating $1.8 million in revenue in 2015, closing a $5 million investment to strengthen its balance sheet, and partnering with SCIEX, a leader in mass spectrometry, to co-market PCT sample preparation solutions. The presentation outlines PBIO's focus on the estimated multi-billion dollar markets for sample preparation and mass spectrometry and its goal to achieve
Oral Drug Formulation Innovations 2014Simon Curtis
The Oral Drug Formulation Innovations Summit will examine and showcase the industry's latest formulation and delivery technologies for enhancing solubility and maximizing bioavailability. Leading global formulation experts in both industry and academia will share unique strategies on how to effectively develop poorly soluble drugs into scientifically unique, compliant, patient-centric formulations. Additionally, innovative strategies to significantly reduce product development timelines will be shared, and the latest regulatory requirements will be discussed.
International and regional experts coming together
to discuss strategies and opportunities in the Medical
Affairs function
• Unique insights and case studies on experiences in
the Asia market, successful programmes and best
practices
• Detailed and practical workshop to complement
your learning and networking experience
SMi Group's 4th annual Biosimilars North America 2017 conferenceDale Butler
This document provides information on two half-day pre-conference workshops taking place on November 14, 2017 related to biosimilar drug development. The first workshop, from 8:30am-12:30pm, will discuss strategies for biosimilar development and establishing biosimilarity, including regulatory requirements, formulation development, analytical development and comparability studies. The second workshop, from 1:30pm-5:30pm, will examine considerations for clinical trials of orphan and non-orphan biosimilars, including study design, case studies, immunogenicity testing and extrapolation strategies. Both workshops aim to provide an interactive forum for discussing challenges in biosimilar development.
This document provides information about the "Biosimilars & Biobetters" conference being held on October 1-2, 2013 in London. The conference will discuss guidelines for biosimilars and biobetters from regulatory bodies, market access pathways, intellectual property, clinical development processes, and case studies on successful products. It will also feature two half-day workshops on developing marketing plans and the commercial realities of biosimilars. The conference is aimed at professionals in areas like regulatory affairs, clinical development, marketing, and intellectual property for pharmaceutical and biotechnology companies.
This investor presentation summarizes Pressure BioSciences' business and technology. PBI develops and sells instruments and consumables for sample preparation using its patented Pressure Cycling Technology platform. Key points include that PBI has over 275 PCT systems installed, has accomplished revenue growth and debt reduction in recent years, and signed a marketing agreement with SCIEX to co-promote its PCT-SWATH technology for mass spectrometry applications. The presentation outlines PBI's technology applications, market opportunities, customer base, and near-term growth drivers including the SCIEX partnership and new product releases.
This presentation by Pressure BioSciences discusses their Pressure Cycling Technology platform for biological sample preparation. Some key points:
- PCT uses ultra-high pressure to break up cell walls and extract biomolecules, achieving better results than mechanical methods.
- The market for biological sample preparation is multi-billion dollars. PCT addresses the need for improved sample prep methods.
- Over 275 PCT systems have been installed at over 150 customer sites. There are over 100 publications highlighting PCT's advantages.
- Recent accomplishments include a co-marketing agreement with SCIEX, a leader in analytical technologies, and sales of their new Barocycler 2320EXTREME system.
BioPharma Medical Affairs Congress, West Coast WorldCongress
Medical Affairs teams face persistent challenges to be the interface between their company, product, KOL external experts, and prescribers. Evolving restrictions for compliance and limited commercial resources have placed greater emphasis onto Medical Affairs teams. BioPharma has greatly restricted resources and must rely greatly on these teams to communicate medical information and promote value. This summit focuses on strategies for engagement and success for medical affairs organizations to meet current and future organization needs.
This document provides information about the 2nd annual conference on Pre-Filled Syringes America taking place on April 27-28, 2015 in Iselin, New Jersey. The conference will focus on assessing the future of pre-filled syringes to improve innovation and device development. It will include keynote speeches and sessions on human factors studies, safety assessments, enhancing device development, and critical issues surrounding pre-filled syringes. Attendees can learn about topics like patient needs, regulatory requirements, extractables and leachables testing, compatibility challenges, and ensuring safety of needle devices. There will also be opportunities for networking including a lunch and roundtable discussions.
Biomanufacturing in China: Technologies and Facility DesignRita Barry
Join us as we DISCOVER, ANALYZE and LEARN the current state of the global biomanufacturing industry and the future growth potential and recent developments in Asia.
Some of the Key Highlights You Won’t Want to Miss Include
USA
Smart & Flexible Manufacturing Solutions in Multi-Product Facilities
Franz Walz, Executive Director Global Manufacturing, Science and Technology & Network Coordination, BOEHRINGER INGELHEIM
EUROPE
MAb Manufacturing Facilities for China & Automated Single-Use Processing to Bring Control & Flexibility to Manufacturing
Pauline Nicholson, Global Product Manager, Allegro Single-Use Systems, PALL
Niels Guldager, Senior Technology Partner, NNE PHRAMAPLAN
KOREA:
How to Bring Global Biopharmaceutical Capability through its Fully-Integrated Production Facilities?
Jeremy Caudill, Global VP Business Development, SAMSUNG BIOLOGICS
SINGAPORE
What do Investors Look for When Investing in Biologics Manufacturing?
Steven Lee, Global Head of Biologics Tech Operations & Managing Director, DR. REDDY'S LABORATORIES
INDIA
Developing a Multiproduct Facility for Biosimilars & Engineering & Biomanufacturing of Enzymes for Different Applications
Arvind Mishra, Global Head of Quality & Regulatory & Head of Strategic Business Unit, Biologicals,
CADILLA PHARMACEUTICALS
Ravindra Wagh, Vice President, ZYDUS BIOLOGICS
Rajeev Soni, Senior Manager, R&D, NOVOZYMES
HONGKONG
What are the Experiences & What is the Future for the Investors in the Biomanufacturing Space?
Ramesh Rajentheran, Head of Asian Healthcare Investment Banking, BARCLAYS
Jason Mann, Managing Director, FENEX CAPITAL MANAGEMENT
INDONESIA
Improving Quality Control & Maintenance of Global Biological Product Distribution
Galatia Chandra, Head of Sales & System, Global Operation, KALBE INTERNATIONAL PTE LTD
http://www.biomanufacturing-asia.com
Colorado BioScience Association (CBSA) is introducing new BioTalk segments at BioWest 2014 in Denver. These are eight fast-paced presentations about the Big and Bold ideas in the Bio Industry. There are both morning and afternoon sessions of BioTalks scheduled.
SMi Group's Pharmaceutical Microbiology West Coast 2020 conferenceDale Butler
This document provides information on the Pharmaceutical Microbiology West Coast conference happening June 17-19, 2020 in San Diego. It outlines the chairs, speakers, highlights and agenda for the event. The conference will focus on novel approaches and best practices for tackling current industry contamination control challenges, and will include sessions on contamination control, guidance and regulations, detection and identification methods, and supporting pharmaceutical facilities and novel therapeutics. There will also be an optional pre-conference workshop on data integrity in environmental monitoring.
SMi Group's Pre-filled Syringes West Coast 2020 conferenceDale Butler
This document provides an agenda for the 5th annual Pre-Filled Syringes West Coast conference taking place June 15-17, 2020 in San Diego, CA. The conference will focus on innovations in device design and technology, advances in human factors engineering, combination product regulatory insights, and design controls and risk management. It will feature presentations from industry leaders at companies like Genentech and AstraZeneca as well as regulators from the FDA. There will also be two post-conference workshops on June 17th focusing on navigating FDA requirements for connected devices and digital health, and post-market safety reporting for combination products.
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Similar to SMi Group's Biosimilars & Biobetters conference USA
This document provides information about a conference on biosimilars taking place from September 30th to October 1st, 2015 in London. The conference will discuss the evolving regulatory landscape for biosimilar approval in the US and Europe, market access challenges, protein characterization, and analytical comparability. It includes an agenda with sessions on the regulatory processes, patent litigation, pharmacovigilance, clinical development strategies, and analytical techniques for assessing biosimilarity. Pre-conference and post-conference workshops will provide more in-depth discussions of these topics.
Pressure BioSciences is presenting their pressure cycling technology instruments and consumables. Their flagship product is the Barocycler 2320EXTREME instrument, which uses high pressure cycling to prepare biological samples for analysis. They have over 270 PCT systems installed worldwide and publications highlighting the advantages of PCT in biopharma sample preparation from discovery to clinical use. The company is poised for growth with their exclusive marketing agreement with SCIEX, expanded sales team, and focus on the multi-billion dollar biopharma market.
SMi Group's European BioNetworks SummitDale Butler
This document is a program for the "European BioNetworks Summit" conference on July 7-8, 2014 in London. The summit will bring together representatives from pharmaceutical, biotechnology, academic, and funding organizations to discuss strategic partnerships and collaborations. Over 12 speakers from companies like Novartis, Bristol-Myers Squibb, Bayer, and Johnson & Johnson will provide presentations on topics like developing business strategies, academic partnerships, pricing and reimbursement, and financing options. Attendees can network and learn how to create successful partnerships to increase innovation and research outcomes. A post-conference workshop on July 9th will focus on clinical development pathways.
SMi Group's Superbugs and Superdrugs USA 2016Dale Butler
This document provides information about the "Superbugs & Superdrugs USA" conference happening from November 14-16, 2016. It advertises the opportunity to register for the conference at discounted rates by certain deadlines. The conference will focus on developing new drugs to combat antibiotic resistance and will feature expert speakers from organizations like the WHO, BARDA, NIH, Pfizer and others. An interactive workshop on animal models in pre-clinical drug development will also be held.
Why you should attend:
1. Learn from in-depth case studies on strategic partnering and effective collaboration
2. Explore new business opportunities and strategies to reach the biosimilars market in the region
3. Gain insights into the regulatory landscape for biosimilars in China, India, Korea, Taiwan and more
4. Gather the latest market intelligence and analysis and identify new trends and opportunities in Biosimilars R&D, contract manufacturing and commercialization in Asia
报名参加的五大理由
1. 深入学习有关与亚洲公司建立战略合作和有效协作的案例研究
2. 探索新的商机和战略,以便进入当地的生物仿制药市场
3. 深入了解中国、印度、韩国、台湾以及更多国家或地区的生物仿制药监管形势
4. 收集最新的市场情报和分析,确定生物仿制药研发、合同制造和商业化在亚洲的新趋势和机会
Hear about:
Biopharma Regulatory Updates and Development
Victoria Elegant, VP Medical & Regulatory Affairs, Baxter, China
Andrea Laslop, Head of Scientific Office, Austrian Agency for Food and Health Safety, Austrian Member, European Medicines Agency
Arvind Mishra, Global Head of Quality & Regulatory & Head of Strategic Business Unit, Biologicals, Cadilla Pharmaceutical, India
Advances in Biosimilars R&D
Jeffrey Su, CSO, Cytovance Biologics, USA
Wenzhi Tian, CEO, Huabo Biopharma, China
Ming Wang, President and COO, Gan & Lee Pharmaceuticals, China
Feng Li, CEO, Beijing Mabworks, China
Shaligram Rane, Vice President for Quality, Intas Pharmaceuticals, India
Understanding Obstacles and Hurdles for Entering the Biosimilars Market
Khai Meng Ang, Vice President Asia, Hospira, China
Jason Li, Senior Director, Genor Biopharma, China
Sachidananda Moorthy, Vice President - Clinical Research, Medical and Regulatory Affairs, Avesthagen, India
Sameer Agarwal, Senior Vice President, Business Center Strategic Marketing, Business Unit Generic Drugs & Standard Solutions, Fresenius Kabi, Germany
What can Asia Learn from Global Biosimilars Development and Litigation?
Li Cai, Regional R&D Counsel, Pfizer, China
Vivek Mittal, Head – Legal, Lupin, India
Viren Mahurkar, Managing Director, HitechnRock Advisors, Singapore
http://www.biosimilarsasia.com
Pre-Conference Special Focus Day, 20 May 2014
Clinical Development for Biosimilars
Post-Conference Workshops, 23 May 2014
A: Challenges in Demonstrating Biosimilarity and Interchangeability of Biosimilar Products
B: Successfully Bringing Biosimilars to Market
会前特别关注日,2014 年 5 月 20 日
生物仿制药的临床开发
会后研讨会,2014 年 5 月 23 日
A:在展示生物仿制药产品的生物相似性和可互换性方面所面临的挑战
B:成功地将生物仿制药推向市场
SMi Group's 7th annual Biosimilars Europe 2016 conferenceDale Butler
This document provides information about two pre-conference workshops for the 7th Annual Biosimilars Europe conference.
The first workshop focuses on maximizing intellectual property and regulatory rights related to biosimilars. It will cover topics like regulatory data protection, orphan drug exclusivity, supplementary protection certificates, and pediatric rewards. The workshop leaders are partners at Bristows LLP.
The second workshop examines how the payer environment for biosimilars is evolving. It will provide insight into pricing, reimbursement, and formulary access processes. Case studies will also be presented on successful biosimilar launches. The workshop leader is the director of RJW & Partners Ltd, a pricing and market
What’s NEW in 2015’s program?
• More case studies on successful commercialization
• Insights on developing biosimilars under new CFDA guideline
• Emerging business models in regulated and developing markets
• New and timely topics on:
o Valuating biosimilars investments
o Successful technology transfer
o Key criteria in gaining approval
Also, NEW Expert Faculty includes:
Dr Shin Jae Chang, Vice President, Celltrion, Korea
Ira Jacobs, Global Oncology Lead, Biosimilars, Pfizer, US
Paul Thomas, Business Unit Head – Biosimilars, Biocon, India
Dr. Martina A. Sersch, Global Clinical Lead, Oncology Global Development, APAC Biotherapeutics Lead, Genentech, Inc. / F. Hoffmann-La Roche Ltd.
Raj Kannan, Vice President, Commercial Head, Biosimilars, Merck, Switzerland
Huiguo (Forrest) Hu, General Manager of International Business, Shanghai CP Guojian Pharmaceutical Co., Ltd, China
Ko Chung Lin, Chief Executive Officer, PharmaEssentia Corporation, Taiwan
Wen Yong, Vice Director, Drug Research Institutes, Biopharmaceutical Institute, Jiangsu AoSaiKang Pharmaceutical Co Ltd, China
http://www.biosimilarsasia.com
This document provides an agenda for the "Successfully Navigating the Biosimilars Landscape and Shaping Opportunity in 2015 and Beyond" conference taking place from 19-22 May 2015 in Shanghai, China. The conference will cover topics related to the current global biosimilars landscape, emerging business models and investment opportunities, regulatory developments and approvals in China, the US, and Europe, and technological advances in biosimilars development. Speakers will include representatives from pharmaceutical companies, regulatory agencies, and investment firms. The agenda lists keynote panels, roundtable discussions, and presentations covering these topics over the course of the three-day conference.
The document advertises the 8th annual Pre-Filled Syringes Americas conference and exhibition taking place from March 31st to April 2nd, 2014 in Iselin, New Jersey. The conference will bring together over 85 key decision makers from leading biotechnology and pharmaceutical companies to discuss developments in pre-filled syringes and injection devices over the course of two days of presentations, panel discussions, and workshops. Attendees will have the opportunity to network with industry leaders, evaluate solutions from exhibitors, and return to their businesses with the information and contacts needed to make decisions for their products.
Pbio Investor Presentation Global Online Growth Conference - Oct 2016RedChip Companies, Inc.
This investor presentation discusses Pressure BioSciences, Inc. (PBIO), a company that develops and sells instruments and consumables for biological sample preparation using pressure cycling technology (PCT). The presentation provides an overview of PBIO's business, leadership, financials, and growth opportunities. Key points include PBIO having over 275 PCT systems installed, generating $1.8 million in revenue in 2015, closing a $5 million investment to strengthen its balance sheet, and partnering with SCIEX, a leader in mass spectrometry, to co-market PCT sample preparation solutions. The presentation outlines PBIO's focus on the estimated multi-billion dollar markets for sample preparation and mass spectrometry and its goal to achieve
Oral Drug Formulation Innovations 2014Simon Curtis
The Oral Drug Formulation Innovations Summit will examine and showcase the industry's latest formulation and delivery technologies for enhancing solubility and maximizing bioavailability. Leading global formulation experts in both industry and academia will share unique strategies on how to effectively develop poorly soluble drugs into scientifically unique, compliant, patient-centric formulations. Additionally, innovative strategies to significantly reduce product development timelines will be shared, and the latest regulatory requirements will be discussed.
International and regional experts coming together
to discuss strategies and opportunities in the Medical
Affairs function
• Unique insights and case studies on experiences in
the Asia market, successful programmes and best
practices
• Detailed and practical workshop to complement
your learning and networking experience
SMi Group's 4th annual Biosimilars North America 2017 conferenceDale Butler
This document provides information on two half-day pre-conference workshops taking place on November 14, 2017 related to biosimilar drug development. The first workshop, from 8:30am-12:30pm, will discuss strategies for biosimilar development and establishing biosimilarity, including regulatory requirements, formulation development, analytical development and comparability studies. The second workshop, from 1:30pm-5:30pm, will examine considerations for clinical trials of orphan and non-orphan biosimilars, including study design, case studies, immunogenicity testing and extrapolation strategies. Both workshops aim to provide an interactive forum for discussing challenges in biosimilar development.
This document provides information about the "Biosimilars & Biobetters" conference being held on October 1-2, 2013 in London. The conference will discuss guidelines for biosimilars and biobetters from regulatory bodies, market access pathways, intellectual property, clinical development processes, and case studies on successful products. It will also feature two half-day workshops on developing marketing plans and the commercial realities of biosimilars. The conference is aimed at professionals in areas like regulatory affairs, clinical development, marketing, and intellectual property for pharmaceutical and biotechnology companies.
This investor presentation summarizes Pressure BioSciences' business and technology. PBI develops and sells instruments and consumables for sample preparation using its patented Pressure Cycling Technology platform. Key points include that PBI has over 275 PCT systems installed, has accomplished revenue growth and debt reduction in recent years, and signed a marketing agreement with SCIEX to co-promote its PCT-SWATH technology for mass spectrometry applications. The presentation outlines PBI's technology applications, market opportunities, customer base, and near-term growth drivers including the SCIEX partnership and new product releases.
This presentation by Pressure BioSciences discusses their Pressure Cycling Technology platform for biological sample preparation. Some key points:
- PCT uses ultra-high pressure to break up cell walls and extract biomolecules, achieving better results than mechanical methods.
- The market for biological sample preparation is multi-billion dollars. PCT addresses the need for improved sample prep methods.
- Over 275 PCT systems have been installed at over 150 customer sites. There are over 100 publications highlighting PCT's advantages.
- Recent accomplishments include a co-marketing agreement with SCIEX, a leader in analytical technologies, and sales of their new Barocycler 2320EXTREME system.
BioPharma Medical Affairs Congress, West Coast WorldCongress
Medical Affairs teams face persistent challenges to be the interface between their company, product, KOL external experts, and prescribers. Evolving restrictions for compliance and limited commercial resources have placed greater emphasis onto Medical Affairs teams. BioPharma has greatly restricted resources and must rely greatly on these teams to communicate medical information and promote value. This summit focuses on strategies for engagement and success for medical affairs organizations to meet current and future organization needs.
This document provides information about the 2nd annual conference on Pre-Filled Syringes America taking place on April 27-28, 2015 in Iselin, New Jersey. The conference will focus on assessing the future of pre-filled syringes to improve innovation and device development. It will include keynote speeches and sessions on human factors studies, safety assessments, enhancing device development, and critical issues surrounding pre-filled syringes. Attendees can learn about topics like patient needs, regulatory requirements, extractables and leachables testing, compatibility challenges, and ensuring safety of needle devices. There will also be opportunities for networking including a lunch and roundtable discussions.
Biomanufacturing in China: Technologies and Facility DesignRita Barry
Join us as we DISCOVER, ANALYZE and LEARN the current state of the global biomanufacturing industry and the future growth potential and recent developments in Asia.
Some of the Key Highlights You Won’t Want to Miss Include
USA
Smart & Flexible Manufacturing Solutions in Multi-Product Facilities
Franz Walz, Executive Director Global Manufacturing, Science and Technology & Network Coordination, BOEHRINGER INGELHEIM
EUROPE
MAb Manufacturing Facilities for China & Automated Single-Use Processing to Bring Control & Flexibility to Manufacturing
Pauline Nicholson, Global Product Manager, Allegro Single-Use Systems, PALL
Niels Guldager, Senior Technology Partner, NNE PHRAMAPLAN
KOREA:
How to Bring Global Biopharmaceutical Capability through its Fully-Integrated Production Facilities?
Jeremy Caudill, Global VP Business Development, SAMSUNG BIOLOGICS
SINGAPORE
What do Investors Look for When Investing in Biologics Manufacturing?
Steven Lee, Global Head of Biologics Tech Operations & Managing Director, DR. REDDY'S LABORATORIES
INDIA
Developing a Multiproduct Facility for Biosimilars & Engineering & Biomanufacturing of Enzymes for Different Applications
Arvind Mishra, Global Head of Quality & Regulatory & Head of Strategic Business Unit, Biologicals,
CADILLA PHARMACEUTICALS
Ravindra Wagh, Vice President, ZYDUS BIOLOGICS
Rajeev Soni, Senior Manager, R&D, NOVOZYMES
HONGKONG
What are the Experiences & What is the Future for the Investors in the Biomanufacturing Space?
Ramesh Rajentheran, Head of Asian Healthcare Investment Banking, BARCLAYS
Jason Mann, Managing Director, FENEX CAPITAL MANAGEMENT
INDONESIA
Improving Quality Control & Maintenance of Global Biological Product Distribution
Galatia Chandra, Head of Sales & System, Global Operation, KALBE INTERNATIONAL PTE LTD
http://www.biomanufacturing-asia.com
Colorado BioScience Association (CBSA) is introducing new BioTalk segments at BioWest 2014 in Denver. These are eight fast-paced presentations about the Big and Bold ideas in the Bio Industry. There are both morning and afternoon sessions of BioTalks scheduled.
Similar to SMi Group's Biosimilars & Biobetters conference USA (20)
SMi Group's Pharmaceutical Microbiology West Coast 2020 conferenceDale Butler
This document provides information on the Pharmaceutical Microbiology West Coast conference happening June 17-19, 2020 in San Diego. It outlines the chairs, speakers, highlights and agenda for the event. The conference will focus on novel approaches and best practices for tackling current industry contamination control challenges, and will include sessions on contamination control, guidance and regulations, detection and identification methods, and supporting pharmaceutical facilities and novel therapeutics. There will also be an optional pre-conference workshop on data integrity in environmental monitoring.
SMi Group's Pre-filled Syringes West Coast 2020 conferenceDale Butler
This document provides an agenda for the 5th annual Pre-Filled Syringes West Coast conference taking place June 15-17, 2020 in San Diego, CA. The conference will focus on innovations in device design and technology, advances in human factors engineering, combination product regulatory insights, and design controls and risk management. It will feature presentations from industry leaders at companies like Genentech and AstraZeneca as well as regulators from the FDA. There will also be two post-conference workshops on June 17th focusing on navigating FDA requirements for connected devices and digital health, and post-market safety reporting for combination products.
SMi Group's Military Robotics and Autonomous Systems USA 2020 conferenceDale Butler
This document advertises the Military Robotics and Autonomous Systems USA conference happening on June 22-23, 2020 in Arlington, Virginia. Attendees can save $400 by registering by February 28, $200 by registering by March 31, and $100 by registering by April 30. The conference will discuss topics like US Army robotics programs, Australian Army robotics development, unmanned vehicle programs, robotics supporting warfighters' mobility and sustainability, and integrating robotics into ground formations. Speakers will include representatives from the US and Australian militaries as well as academics working on relevant research.
SMi Group's Future Soldier Technology USA 2020 conferenceDale Butler
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SMi Group's Military Space USA 2020 conferenceDale Butler
This document provides an agenda for the 2nd Annual Military Space USA Conference supporting the US military space enterprise. The conference will include presentations from senior leaders in the US Space Force, Air Force, and other allied militaries on topics such as space acquisition reform through SMC 2.0, training the future space warfighting force, and leveraging disruptive commercial space technologies. A separate focus day will explore experimental smallsat capabilities, export controls for space technologies, advanced propulsion concepts, using LEO mega-constellations for bandwidth, in-orbit manufacturing, and accelerating commercial innovation. The event aims to connect disruptors and innovators with government to integrate new technologies rapidly into military space operations.
This document summarizes a conference focused on helicopter technology for Central and Eastern Europe being held in Budapest, Hungary on May 20-21, 2020. It will feature keynote speeches from military leaders from Hungary, Slovakia, Romania, Germany, and Croatia on developments and modernization efforts of their national helicopter fleets. Technical experts from the US, UK, Netherlands, and Czech Republic will also present. Sessions will discuss regional cooperation and interoperability, training standards, and enhancing capabilities like search and rescue. The goal is focused discussion on challenges facing helicopter program managers and informal networking for participants.
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SMi Group's Unmanned Maritime Systems 2020 conferenceDale Butler
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SMi Group's Military PNT 2020 conferenceDale Butler
The document summarizes the agenda for the "Military PNT 2020" conference to be held on May 18-19 in London. The event highlights include briefings from the US DoD on GPS and NTS-3 programs, understanding requirements for operating in degraded PNT environments, and engaging with industry and military leaders. The agenda covers topics such as UK PNT strategies, warfighter PNT considerations, legal perspectives on PNT resilience, and GNSS interference case studies. Keynote speakers include representatives from the US Air Force, Lockheed Martin, UK MoD, DGA, NPL, and BHO Legal.
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SMi Group's Pre-filled Syringes East Coast 2020 Dale Butler
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SMi Group's Air Mission Planning and Support 2020Dale Butler
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The document announces Space Week, consisting of the Small Satellites Conference from April 27-28 and the Military Space Situational Awareness Conference from April 29-30 in London. It provides details on the conferences, including chairpersons, speakers from various space agencies, companies, and militaries, and topics to be discussed such as small satellites, space insurance, disruptive approaches to space, space data, and military space situational awareness. The document aims to invite colleagues to participate in Space Week to explore developments in small satellites and how to track and manage space assets.
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How to Create a More Engaging and Human Online Learning Experience
SMi Group's Biosimilars & Biobetters conference USA
1. BO AN 20T BO
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“A thoroughly interesting and very informative conference with
excellent chairs and presenters. More of the same please.”
Biosimilars & Biobetters Europe 2013 Attendee
7th - 8th
Biosimilars & Biobetters USA APRIL
SMi present their inaugural conference on…
Creating an Innovate Plan for the USA
Biosimilars Market
Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
2014
Chairperson
Dr Richard Dicicco, Chairman,
Harvest Moon Pharmaceuticals
Key Speakers Include:
• Dr John Pakulski, Senior Director, and Head US
Biopharmaceutical Regulatory Affairs, Sandoz
• Rodeina Challand, Executive Director, Biosimilars Development,
Scientific Affairs, PRA International
• Dr Stanley (SeungSuh) Hong, President, Research and
Development, Celltrion, Inc.
• Paul Ashton, President & CEO, pSivida
• Peter Pitts, President, Center for Medicine in the Public Interest
(Former FDA Associate Commissioner)
• Douglas M. Long, Vice President, Industry Relations, IMS Health
• and many more!
Benefits of attending:
• Gain up to date insight into the regulatory landscape and
how it is effecting the industry
• Evaluate commercialization and development strategies to
gain a competitive advantage
• Calculate possible revenue streams from biosimilar production
• Discover what lessons have been learned so far and what the
future holds
• Boost your industry knowledge and relationships by networking
and learning from key industry and academic leaders
PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS
Wednesday 9th April 2014, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
A: Differentiation Strategies for the
Generics Industry
Workshop Leader: Asa Cox, Founder & CEO, Generic Pharma 2.0
8.30am - 12.30pm
B: Launching a Biosimilar in
an Innovator v. Generic World
Workshop Leader: Kristie Kuhl, JD, Executive Vice President, Health Practice, Makovsky
1.30pm - 5.30pm
Sponsored by
www.biosimilars-usa.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUPS DISCOUNTS AVAILABLE
2. Biosimilars & Biobetters USA
www.biosimil
Day One I Monday 7th April 2014
8.30
9.00
COMMERCIALIZATION & PRODUCT DEVELOPMENT STRATEGIES
(PART 1)
Registration & Coffee
Chairman's Opening Remarks
Dr Richard Dicicco, Chairman, Harvest Moon
1.30
Pharmaceuticals
• Reviewing the European experience of biosimilar production
- barriers to entry
OPENING ADDRESS
- market opportunities
Biosimilars and specialty products: current status and future
- competitive response
• Understanding how the global pharmaceutical market is becoming
- differences in the biosimilars versus biobetter route
more specialized and precise
• Identifying what the experience on follow on biologics, generics
and biosimilars has been so far
Professor Joseph Fuhr, Professor of Economics, Widener University
2.10
• Assessing what role follow on biologics, generic biologics and
biosimilars play in the future
Insights into the structure function relationship of monoclonal
antibodies (mAbs) with respect to their evaluation of biosimilarity
• Ensuring quality CMC is in place before embarking on mAb
Douglas M. Long, Vice President, Industry Relations, IMS Health
9.50
• Examining the balance between innovation and competition
• Analysing potential entry into the USA market
REGULATORY AND MARKET REVIEW (PART 1)
9.10
Considering the impact of biosimilars on competition
production to achieve successful biosimilarity
• Considerations for building a pipeline of mab biosimilars
Ensuring that interchangeability does not thwart US innovation –
legislation at both federal and state level and FDA’s expectations
• Understanding why US mAbs will be an important target for the
• Understanding the basis for interchangeability at state and federal
Dr Magdalena Leszczyniecka, President and CEO, STC Biologics
development of biosimilar therapeutic products
• Assessing the risk of interchangeability to biologic innovation
level
• Analyzing the variations in state-level legislation governing biosimilar
substitution
2.50
Physician's perspective on biosimilars: the importance of
pharmacovigilance
• Understanding why patient safety is paramount
• Reaching a consensus on interchangeability - how and when should
this be permitted
• Realizing that information is power: the more doctor's have, the
• Determining whether physicians should be notified when
better it is for patients
pharmacies substitute biosimilar for brands
• Examining why manufacturers must be transparent for physician's to
considerations for interchangeable products
Dr Richard Dolinar, Chairman, Alliance for Safe Biologic Medicines
• Preparing for future FDA guidance regarding safety and quality
have confidence in the product
Dr John Pakulski, Senior Director and Head US Biopharmaceutical
Regulatory Affairs, Sandoz
10.30
10.50
3.30
PRICING & COST RETURNS
Morning Coffee
Biosimilars - the state of the union
3.50
• Reviewing current regulatory concerns
• An update on biobetters and biosimilars
• Profit margins in biosimilar production
Peter Pitts, President, Center for Medicine in the Public Interest (Former
• Evaluating biosimilar unit floor prices in a hyper-competitive market
FDA Associate Commissioner)
Ready, set, go! …… but watch out for IP hurdles along the way in an
• Reviewing the impact of patent laws on biosimilar production
• Identifying and overcoming the potential patent pitfalls biosimilar
applicants may encounter pertaining to:
- development
- marketing
- approval
production
• Presenting a biosimilar sales forecast from a manufacturing view
• Analysing cost versus quality
age of post-patent medicine!
Evaluating the potential revenue streams achievable from biosimilar
• Biosimilar investing: what to expect for a return on investment (ROI)
• Discussing the EU experience
11.30
Afternoon Tea
Dr Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
4.30
THE
TE
D EB A
What is the state of play! Highlighting what lessons have been learned
to date and where the industry is heading
• Discussing industry insights and what work you should be planning to do
• What opportunities are awaiting the market
• Deciding which models to use for successful biosimilar launch
• What benchmarks can be learned from biosimilar development in
Europe
• Evaluating how to challenge patents and potential patent
Rodeina Challand, Executive Director, Biosimilars Development,
Dominic Adair, Senior Associate, Patent Litigation, Bristows
Dr Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals
Scientific Affairs, PRA International
extensions from innovator companies
12.10
Networking Lunch
Sponsored by
5.10
Chairman's Closing Remarks and Close of Day One
*Subject to final confirmation
As a leading CRO, PRA is transforming clinical trials through our people, innovation and transparency. We combine therapeutic and operational
expertise with local knowledge to serve clients across all phases of drug development. PRA’s dynamic services and forward-thinking approach are
making a difference to healthcare patients worldwide. www.prainternational.com
pSivida (PSDV, NASDAQ) is a leading provider of innovative sustained-release drug delivery products. Our proven proprietary technologies enable
us to achieve highly focused, long-term delivery of therapeutics. We have developed three of the only four products approved by either the US or
EU for the long-term, sustained-released delivery of drug to treat chronic eye disease. We are now working a long term sustained delivery system
(Tethadur®) for large molecules (including anti-bodies) for the eye. This fully bioerodible delivery system can be readily applied to virtually any site
in the body and can be used for systemically administered products. pSivida has a long history of successfully working with partners and with
licensing agreements with companies of various sizes such as Pfizer, Bausch and Lomb, Alimera Sciences. pSivida's intellectual property portfolio
consists of over 150 issued patents in countries including the U.S., Europe, Japan, China and Australia. www.psivida.com
Register online at: www.biosimilars-usa.com • Alternatively fax yo
3. Biosimilars & Biobetters USA
lars-usa.com
8.30
9.00
Day Two I Tuesday 8th April 2014
Registration & Coffee
• Identifying which products have significant potential for ‘biosuperior’
development
• Developing biosuperior protein therapeutics that address sub-optimal,
in-market characteristics of currently licensed biologics
• Examining current active projects in research and development of
biosimilar and novel biobetter/biosuperior therapeutic proteins
Dr Rakesh Dixit, Vice President, R & D Head, Global Biologics Safety
Assessment, MedImmune (AstraZeneca Biologics)
Chairman's Opening Remarks
Dr Richard Dicicco, Chairman, Harvest Moon
Pharmaceuticals
REGULATORY REVIEW - PART 2
9.10
9.50
10.30
10.50
11.30
12.10
1.30
OPENING ADDRESS
What is in a name! Reviewing the ongoing debate in the biosimilars
naming process to ensure appropriate pharmacovigilance!
• Presenting an update on the FDA’s naming preference - determining
their stand on distinctive International Nonproprietary Names (INNs) for
biosimilars
• Assesing the options for long-term biosimilar naming:
- Common non-proprietary name
- Shared root or prefix
- Distinct non-proprietary name
• Recognizing the need for clear naming principles to avoid patients
receiving the incorrect product and reduce confusion among
healthcare providers
Rodeina Challand, Executive Director, Biosimilars Development,
Scientific Affairs, PRA International
Exploring the European (EU) biosimilars landscape to determine what
lessons and ‘take homes’ the US market can employ
• Analyzing current regulatory requirements for biosimilar approval in
Europe and the future path of this legislation
• Reviewing the variations between the EU and US law and regulations
• Implementing strategies for harmonizing US and EU developments to
avoid program duplications
Liz Fuller, Partner, Bird & Bird
2.10
2.50
Morning Coffee
Essential infrastructure for successful mAb biosimilar development
• Introduction of biosimilars and how to secure the comparability to
reference products
• Highlighting key global opportunities of mAb biosimilars
• Understanding the key infrastructure for successful biosimilar
development
• Approval of world’s first mAb biosimilar from both developed and
emerging countries
• Utilizing bridging studies to enable the application of already
generated data
Dr Stanley (SeungSuh) Hong Ph.D. President, Research and
Development, Celltrion, Inc.
3.30
3.50
MARKET ACCESS FOR BIOBETTERS
Biosimilars vs. biobetters! Determining the implications for product
developers in the pharmaceutical industry
• Biobetters claim that they are a better product, but what evidence is
there to prove this?
• Discussing the regulatory status pertaining to production of biobetters
• Analyzing which features can be improved by utilizing biobetters
• Evaluating whether biobetters are better than biosimilars based on
efficacy, safety and delivery
Paul Ashton, President and CEO, pSivida
Networking Lunch
Can biobetters or biosuperiors meet the challenges of best in class
molecules and cheaper biosimilars
• Reviewing the challenges and opportunities in developing
relatively cost effective biosimilars
• Innovations in improving the existing biologics therapies in
diseases with unmet medical needs
• Making biobetters or biosuperiors successful and cost effective
through advances in protein engineering and pioneering
technologies - case studies of biosuperior vs. biosimilars
4.30
EL
PAN ION
USS
DISC
5.10
COMMERCIALIZATION AND PRODUCT DEVELOPMENT
STRATEGIES (PART 2)
Identifying how to create a truly marketable product! Assessing
commercialization considerations for biosimilars
• Understanding the role of partnerships in the development and
delivery of commercially successful biosimilars to secure specific
capabilities
• What are the various partnership models to consider in cocommercializing
• Providing relevant preclinical and clinical data for marketing
authorization
• Honing marketing tactics to achieve accelerated biosimilars sales
• Ensuring sufficient manufacturing capability and human capital to
produce and commercialize biosimilars
Dr Branimir Cvetkovic, Global Strategy Lead – Biosimilars, Novartis
Designing effective strategies to achieve excellence in clinical trials
• Identifying the key operational considerations for delivering high
quality trials on time and budget :
- What size should the trial be
- How many patients should be exposed to the drug
• What trial design should be used
• Developing strategies to optimize patient recruitment and retention in
clinical trials
• Examining the benefits of investigator/ patient education
• Implementing non clinical and clinical data to guarantee
pharmacovigilance for biosimilars
Session reserved for Pfizer further to final speaker confirmation *
Afternoon Tea
Creating effective strategies to control the manufacturing process and
address the unique challenges facing biosimilar producers
• Overcome challenges in developing biosimilars through formulated
testing strategies:
- analytical and bioanalytical method development
capabilities
- defined characterization programs
• Implementing procedures to prepare your manufacturing lifecycle for
each step of product development
• Applying the fundamentals of process analytical technology (PAT)
• Discovering how a small difference in the manufacturing process
may create a different product
• Understanding the importance of supply-chain expertise procurement
and quality assurance to speed up development
Dr Steve Flatman, Head Biosimilars Research and Development, Lonza
Biologics plc
The optimal manufacturing strategy! - Exploring what is shaping the
strategic biosimilar manufacturing plan of today's leading companies
• Discovering how to build or procure this manufacturing base in a cost
effective way
• Evaluating where should this manufacturing base be located and why
• Analysing how competition from new players is changing the
landscape
Kristopher Howard, Managing Director, Operational Excellence Leader,
NRL Enterprise Solutions
Chairman’s Closing Remarks and Close of Day Two
Supported by
our registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
*Subject to final confirmation
4. HALF DAY POST CONFERENCE WORKSHOP A
Wednesday 9th April 2014 I 8.30am – 12.30pm
Renaissance Woodbridge Hotel,
Iselin, New Jersey, USA
Differentiation Strategies for the
Generics Industry
Workshop Leader:
Asa Cox, Founder & CEO, Generic Pharma 2.0
Overview of workshop:
This workshop will help to develop an expert
understanding of the differentiation strategies used in
worldwide markets, to explore new ideas and
opportunities for differentiation, plus possible
requirements demanded by industry evolution.
Why you should attend:
Gain insights into the future of the generic industry
and how differentiation might be the only option for
success.
Programme:
8.30
Registration & Coffee
9.10
Session 1: Current differentiation tactics
9.50
Session 2: The challenges that
10.30
Coffee Break
9.00
Introductions and opening remarks
in global markets
differentiation brings
11.00
11.40
Session 3: Ideas for differentiation
Session 4: The future of the industry and
why differentiation is needed
12.20
12.30
Closing remarks
Workshop ends
About the workshop host:
Asa has been involved in the generic pharma sector
for over 16 years; covering all aspects of the industry,
both commercial and technical. Asa launched
genericlicensing.com in 2008. The platform now
manages more than 9000 products and is used by
generic companies the world over. Asa created
Generic Pharma 2.0 in 2010 as a vehicle to convert
substantial market intelligence into a dedicated
consulting company. The firm now consults with
clients on portfolio strategy, international market
entry and pharmagination models.
About Generic Pharma 2.0
Generic Pharma 2.0 are ‘masters of business
development & marketing’. Established in 2008,
Generic Pharma 2.0 has built a global network of
30,000 companies; achieved by combining ferocious
business development and the latest web
technologies. It offers clients both access to a
network and the intelligence gained from a unique
perspective. We work with companies of all sizes,
locations and product categories. We partner with
clients. We create together. We have a lot of fun.
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and
branding packages, uniquely tailored to complement
your company’s marketing strategy. Prime
networking opportunities exist to entertain, enhance
and expand your client base within the context of an
independent discussion specific to your
industry. Should you wish to join the increasing number
of companies benefiting from sponsoring our
conferences please call:
Alia Malick, Director on+44 (0) 20 7827 6168
or email: amalick@smi-online.co.uk
Want to know how you can get involved?
Interested in promoting your services to this market?
Contact Julia Rotar, SMi Marketing on
+44 (0) 207 827 6088, or email: jrotar@smi-online.co.uk
5. HALF DAY POST CONFERENCE WORKSHOP B
Wednesday 9th April 2014 I 1.30pm – 5.30pm
Renaissance Woodbridge Hotel,
Iselin, New Jersey, USA
Launching a Biosimilar in an
Innovator v. Generic World
Workshop Leader:
Kristie Kuhl, JD, Executive Vice President,
Health Practice, Makovsky
Overview of workshop:
This interactive workshop will discuss the unique
aspects of successfully launching a biosimilar in the
United States. Topics to be discussed include:
• Filing a BLA or sBLA – when to determine the path
to approval
• Government affairs – likely allies and foes of
biosimilars, what regulations to expect
• Marketing – what level of support will biosimilars
need
• Revenue discussion – what will reimbursement
look like. How will the major biologics be
impacted and when
Why you should attend:
Attendees of this interactive workshop will have the
opportunity to learn the pluses and minuses of
various approaches about new products that fall
between an innovator and a generic.
Programme:
1.30
Registration and coffee
2.10
Session 1: BLA v sBLA
2.00
2.50
3.30
4.00
4.40
5.20
5.30
Introductions and opening remarks
Session 2: USA regulation & substitution
update – friends and foes
Coffee Break
Session 3: Marketing
Session 4: Revenue and reimbursement
Closing remarks
Workshop ends
About the workshop hosts:
Kristie Kuhl, JD is Executive Vice President and Deputy
Practice Head at Makovsky Integrated Communications.
Her experience as a regulatory communications attorney
and counselor on biosimilar challenges started in 2005. She
is a sought-after expert on biosimilars, and has served as a
panelist and/or session leader at more than 10 biosimilars
conferences since 2006. She was instrumental in creating
and executing the Pfizer Genotropin communications
strategy when the company feared biosimilar entry in
Europe would collapse the growth hormone market. Kristie
has been hailed for her knowledge of legal
communications, media strategy and account-team
management. She bridges the divide between public
relations and public affairs. Utilizing her legal and public
relations background, Kristie is a counselor on
communications strategy.
About Makovsky
Makovsky is a leading healthcare communications
company in its ongoing mission to improve the lives of
patients served by biotech, pharmaceutical and device
manufacturing companies. Through giving voice to
patients in advocacy programs, brand communications
and disease education, Makovsky connects audiences via
social media, news coverage and engagement at thought
leader events such as TEDMED, Prix Galien and medical
congresses such as ACOG, ASCO and AHA. The Makovsky
team lives with intent; fostering deep knowledge of the
underlying science, a profound understanding of the
regulatory space, and a sensitivity to the complex
interactions between patients, physicians, researchers and
regulatory agencies. In 2013 alone, Makovsky received 11
healthcare communications industry awards, including
“Best in Healthcare,” “Best Education/Public Service
Campaign,” and “Best of the Best” across other industry
sectors.
6. BIOSIMILARS & BIOBETTERS USA
Fee
$2997.00
$2398.00
$1799.00
$1198.00
$599.00
$999.00
Conference: Monday 7th April & Tuesday 8th April, 2014, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA I Workshops: Wednesday 9th April 2014, New Jersey
4 WAYS TO REGISTER
ONLINE www.biosimilars-usa.com
FAX your booking form to +44 (0) 870 9090 712
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