2015年美国生物仿制药及改良药学会

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