生物治疗药物对许多疾病的治疗带来革命性的变化，而生物仿制药亦在医疗制度中逐渐达到以少许费用发挥相同的治疗效果。

如果生物仿制药在美国开始获得核可，对医疗产业与病患来说，预估在未来10年间将可节省57亿美元。不过，生物制剂尚有制造难度等各种问题，而生物仿制药的开发上更有多于学名药的困难。

此外，畅销药生物制剂制造商今后所面临专利期限到期的问题亦是严重。这些制造商以自家品牌销售产品的营业额超过600亿美元，而这些产品的专利在未来几年内即将到期。

（Biosimilars & Biobetters USA 2015）

生物仿制药和第二代产品的产业，相较于低分子学名药产业，明显被视为活络且具有极大策略重要性，在不断变化的竞争环境和法规环境中，提升弹性与意愿以活用商机将变得重要。

美国的生物仿制药市场在2018年将扩大至20亿美元的规模，而该国开始核可生物仿制药的话，预料在今后10年的核可件数将大幅增加、产业将呈现活络。此外，法规面亦将产生剧烈变化，对于理解在生物仿制药相关指引的架构中，所发生的动向和立法相关的美国与欧洲的合作等变得重要。

在美国举办本学会的目的，为促进对于产品生命周期与生物仿制药研发所有方面的完整理解。

推荐参加理由：

本学会为期2天，将针对以下议题进行热烈讨论和意见交换，并可吸收许多知识。

生物仿制药相关法规面环境以及药品上市后安全监视制度的评价
生物制剂价格竞争与创新法的纷争解决程序之评价与课题
生物仿制药之技术课题的理解与认识
生物制剂制造相关的策略计画建立与创新手法导入
生物制剂的现状－临床开发与持续进步
商业化策略的评价与市场开发的改善
对于第二代产品认知度的提升与其未来性
免疫原性试验无法预期之结果的评价

推荐参加人士
从事下列业务的CSO、CMO社长、副总裁、代表、董事、团队管理者等千万不可错过的学会

生物医药品／生物治疗药物
生技仿制药／蛋白质仿制药／生物仿制药
生物制剂／生物科技／生物学名药
法务／规范问题
智能财产权
医疗经济
价格制定与保险补助
临床免疫学
程序控制与分析技术
解析评价
法规遵守
药品上市后安全监视
医药品的安全性与危机管理
品质问题／品质管理
新产品开发
程序科学
产品种类管理
研究开发
事业开发
事业营运
科学领域的问题
商业领域的问题与策略计画建立
立法与政策的建议

第一天

8.30  报到手续、茶叙

9.00  议长开会致辞

Richard Dicicco,Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

9.10  FDA对生物相似性确立之品质特性统计分析见解

Ravi S. Harapanhall,iRavi S. Harapanhalli, Vice President and Former FDA Senior Executive, Parexel International

9.50  美国可借鉴的欧洲经验

Steinar Madsen,Steinar Madsen, Medical Director, Norwegian Medicines Agency

Nine years of biosimilars in Europe – safety and efficacyWhat are the regulatory differences between Europe and the US?How important  is labelling and naming?Uptake of biosimilars in clinical practice – lessons from Europe

10.30  上午休息

11.00  特别演讲：第一个被FDA批准的BIOSIMILAR

John Pakulski,John Pakulski , Senior Director and Head US Biopharmaceutical Regulatory Affairs, Sandoz Inc.

Looking at this case in detail, how did it progress and how will it developHow did the FDA interpret their own guidelines What can we learn from this first approval?Looking ahead, what’s the future regarding more complex molecules?

11.40  小组讨论：评估全球各地BIOSIMILAR商业化成功的条件

Magdalena Leszczyniecka,Magdalena Leszczyniecka, Founder and CEO, STC Biologics Inc

Robin Chadwick,Robin Chadwick, Principal, Biotechnology, Schwegman Lundberg Woessner

Rakesh Dixit,Rakesh Dixit, Vice President, R&D, Global Head, Biologics Safety Assessment, MedImmune Inc

Gain insights as to what an optimal business model is forglobal commercialization of biosimilars: 1)  stand alone; 2) generic partnered with Big Pharma or Big Bio; 3)geographical or regional licensees; 4) distributors; 5) consortia Which model for which products?   1) first

wave biosimilars 2) second wave biosimilars 3)  Third wave biosimilars and PD-1sGeographical location – Which model for which region?  1) Europe; 2) USA; 3) LATAM; 4) APAC; 5) Russia and CIS   

12.20  午餐

13.30  持续发展的BIOSIMILAR展望

Michael Kleinrock,Michael Kleinrock, Research, Director, IMS Health Inc

The Global Biologic Market: understanding the place of biologics in medicine use around the worldLearning from the biosimilar experience: European experience can offer some insights into the U.S. future (and some confusion too)Looking ahead to the next five years of

biosimilar and biologic evolution

14.10  传统原厂药与学名药之间的模糊界限

Andrea Laslop,Andrea Laslop, Head of Scientific Office, Austrian Agency for Health and Food Safety

Scientific and quality considerations in demonstrating biosimilarity between the biosimilar and the reference product Reviewing the need to show bioequivalence to the innovator drug based on pharmacokinetic parameters such as rate absorption and bioavailability Understanding the complexity of biosimilar models from a clinical perspective

14.50  案例研讨：首个国际参考标准

Michael Tovey,Michael Tovey, INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology, Ecole Normale Supérieure de Cachan

Importance of reference Standards for the Development of biosimilars       First WHO International Standard (IS) for the TNF-alpha sRII receptor-Fc fusion protein (Etanercept). First International Reference (IR) Preparation for anti-drug (anti-Eprex) antibodiesOther WHO IS & IRs for biosimilars currently in development

15.30  下午休息

16.00  最新趋势：BIOBETTER或BIOSUPERIOR接受最佳分子及低价BIOSIMILAR挑战的可能性

Rakesh Dixit,Rakesh Dixit, Vice President, R&D, Global Head, Biologics Safety Assessment, MedImmune Inc

Making biobetters or biosuperiors successful and cost effective through advances in protein engineering and pioneering technologies - case studies of biosuperior vs. biosimilarsEvaluating the current innovations in improving existing biologics therapies in diseases with unmet medical needsIdentifying which products have significant potential for ‘biosuperior’ developmentDeveloping biosuperior protein therapeutics that address sub-optimal, in-market characteristics of currently licensed biologicsExamining current active projects in research and development of biosimilar and novel biobetter/biosuperior therapeutic proteins 

16.40  治疗性抗体的生物机能之醣化影响

Raju Shantha,Raju Shantha, Scientific Director, Biologics Research, Janssen Pharmaceuticals, Inc.

17.20  可互换性相关重要论点

Richard Dicicco,Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

The determination of interchangeability: satisfying the FDA definition to achieve automatic substitution by the pharmacy without physician consultationWill interchangeability minimize the uncertainty of biosimilar adoption?How does INN naming affect automatic substitution?What will the FDA interchangeability guideline look like?Considerations in the design of switching studies #How will interchangeability affect pricing and reimbursement?Differentiation between the designation or practice of interchangeability in the US and EUWhich is more desirable for success: switching existing patients or interchangeability?

18.00  议长总结、第1天闭幕

Richard Dicicco,Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

第二天

8.30  报到手续、茶叙

9.00  议长致辞

Richard Dicicco,Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

9.10  欧洲专利诉讼现况

Dominic Adair,Dominic Adair, Partner, Patent Litigation, Bristows

The patent cliff and the patent hurdle – is it real?

When litigation begins, are the rules different?

Patent challenges in Europe – the EPO and the national courts

The future landscape – the Unified Patent Court

9.50  生物制剂价格竞争及BPCI争议解决流程的替代方法

Jim NelsonJim, Nelson, Senior Principal and Owner, Adversarial 
Proceedings/Pharma & Biotech, Schwegman Lundberg Woessner

Reviewing the use of IPR at the US PTO PTAB as an alternative to the Patent 
Dance of the BPCI Act 

Claim term interpretation, what do these words mean?

Touching on the use of amendments

10.10  于美国取得BIOSIMILAR贩售权之BPCI与FDA所设定要件评估

Robin Chadwick,Robin Chadwick, Principal, Biotechnology, Schwegman Lundberg Woessner

Discussing semi-automated processes to identify and analyze US patents of interest to answer the question whether such patents should be listed on the biosimilar applicant’s proposed list of patents during the BPCI exchange

10.30  上午休息

11.00  案例研讨：透过使用免疫耐受性奈米粒子的免疫原性对策提高疗效与安全性之BIOBETTER开发

Takashi Kei  Kishimoto, Takashi Kei Kishimoto , Chief Scientific Officer, Selecta Biosciences

The forthcoming flood of biosimilars will create a highly competitive, low margin marketplace. There will be a competitive advantage for biobetters that are differentiated based on their efficacy and safety profile

Anti-drug antibodies compromise the utility of many biologic drugs by neutralizing drug efficacy, modulating pharmacokinetics, and/or causing adverse events

We have developed tolerogenic synthetic vaccine particles (SVP) that are capable of inducing durable immune tolerance to biologic drugs. We will present case examples using tolerogenic SVP with adalimumab and pegylated uricase

11.40  指纹辨识法－加促BIOSIMILAR研发

Magdalena Leszczyniecka,Magdalena Leszczyniecka, Founder and CEO, STC Biologics Inc

Because of the very high cost and length of time associated with biologics development, access to biosimilars at a lower cost with shorter development timelines would make these treatments more accessible to a greater number of patients 

To realize cost and time savings from biosimilars, the current development model needs to change to follow the generic product development paradigm which requires only one bioequivalence trial

STC is currently working on fingerprinting approach to obtain approval on a biosimilar antibody product with only one clinial trial through the use of fingerprinting platform. This concept is described in a detailed publication by FDA’s Steve Kozlowski, indicating that a rigorous “fingerprint” like analytical and nonclinical pharmacological similarity could help lift many of the uncertainties/risks of the biosimilar product compared to the originator, which would decrease the burden of clinical trials conducted only to address any“residual uncertainty” not addressable by in vitro studies

12.20  午餐

13.30  美国的商机－2018年前预测

Cliff Mintz,Cliff Mintz, Senior Writer/Correspondent, Life Science Leader
Strengthening long-term strategy to maximise return on investment and to benefit patients

How to seek partnership to develop and execute risk mitigation strategies 
Forecasting market penetration – What are the factoring barriers to entry?

14.10  因应欧美与亚洲多种需求的临床开发与法规遵守策略

Gerry McGettigan,Gerry McGettigan, Founder & Director, Kinesys Consulting

What are the key features of a truly global development programme?

What obstacles should US / EU biosimilars companies be aware of in Asia and emerging markets

What changes do we need in development and regulatory requirements to facilitate truly global developments, and which stakeholders need to make these changes happen?

14.50  降低BIOSIMILAR制造商风险与有助扩大商机的合作关系

Mina  Song,Mina Song, Director- Alliance Management, Biosimilars, Merck and Co.

How approaches could help big and small players to mitigate risks

Different partnering models

Learnings from experience

15.30  下午休息

16.00  案例研讨：BIOSIMILAR产业现况与未来展望

Carsten Brockmeyer,Carsten Brockmeyer, CEO, Formycon AG

Biosimilars will soon become number one products – but how to get there?

Lessons learned from the first European & US biosimilars

Creating a true global biosimilars strategy

Similarity exercise, clinical data, extrapolation

Monoclonal antibodies, a new milestone for the biosimilars market

Why biosimilars have been more successful than biobetters

Challenges and opportunities with third wave biosimilars

16.40  新兴国家市场评估与策略强化

Sean Xue,Sean Xue, Director Portfolio Management, Dr Reddy's Laboratories

How are emerging markets shifting in BRIC countries 

Dealing with cost containment 

How do emerging markets compare to the EU and US regulations

17.20  议长闭幕致辞、第2天闭幕

Richard Dicicco,Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

* 活动内容有可能不事先告知作更动及调整。

Conference：USD 1,799    

Workshop - A Regulatory Perspective for Biosimilar：USD 599    

Workshop -Development, Regulatory and Commercial Needs for Global Biosimilars：USD 599    

Promotional Literature Distribution(UK Local Tax 20% is added),USD 1,598