Day Two Thursday 1 March 2012

Day One Wednesday 29 February 2012 ›

Day Two Thursday 1 March 2012 ›

last modified: 24 February '12

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8.50am

Opening remarks from the chair

Dr Fred Pritchard

As Vice President of Global Drug Development at Celerion, Dr. Pritchard leads a global team of drug development and regulatory affairs experts, project management professionals and alliance managers that work actively with clients to bring their...

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› Dr Fred Pritchard, Vice President, Global Drug Development, Celerion

CLINICAL TRIALS

9am

Clinical trial requirements – is the extent and depth of trial requirements necessary?

Dr Deven Parmar MD

• 8 years of academic experience of teaching in Medical colleges • 19 years of professional experience in the Pharmaceutical Industry • More than 50 scientific publications in national and international journals • More than 20 Guest Lectures in...

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What could the clinical environment of tomorrow look like?
Do patient’s benefit from the current clinical environment or is existing data being repeated?
Trial size requirements
Statistical considerations for clinical trials
Abbreviated trials

› Dr Deven Parmar MD, Vice President - Global Clinical Research, Wockhardt

9.30am

Early stage studies of biosimilars

Dr Raymond Farmen

As Vice President of Global Bioanalytical Services, Dr. Farmen leads one of the preeminent bioanalytical groups in the industry. In this role he is responsible for the bioanalytical groups in Lincoln, NE USA and Zurich, Switzerland. These groups...

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• Comparability in the pre-clinical stage
• In vitro & in vivo analysis
• Considerations for the bioanalytical assays
• PK/PD studies
• Immunogenicity considerations

› Dr Raymond Farmen, Vice President, Global Bioanalytical Services, Celerion

10am

Challenges in clinical trial design for biosimilars

Janet van Adelsberg at Biosimilar Drug Development World

• Key challenges in the reliable clinical trial design for the analysis of similarity between a biosimilar and originator in the global industry

› Janet van Adelsberg, Senior Director, Merck & Co.

10.30am

Morning refreshments

11am

Global biosimilar clinical trials programme

Stanley Hong

Dr. Stanley Hong is currently a Senior Vice President of Celltrion, Inc. in charge of R&D including biosimilar development. He has many experience in development of biopharmaceutical area as well as industrial enzymes. Dr. Hong joined Celltrion...

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Experience of developing biosimilars and conducting "global clinical trials" for our candidates
Global trends for biosimilar development
Desirable strategy and global clinical trials for biosimilar candidates

› Stanley Hong, SVP, R&D, Celltrion, Inc

11.30am

Acceptable quality attributes of biosimilar molecule

Brian Hosung Min

Brian Hosung Min is currently Vice President of Strategic Business Development at Samsung Group. He is in charge of biosimilar process development and business development for antibody manufacturing and biosimilars. Before moving to this...

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General biosimilarity concept
Case study - a Samsung molecule as an example
Clinical data from a FIH study

› Brian Hosung Min, Vice President, Samsung

BIOSIMILAR PHARMACOVIGILANCE

12pm

Pharmacovigilance for biosimilars – preclinical and clinical safety considerations in development of biosimilars

Rakesh Dixit at Biosimilar Drug Development World

Utilising non clinical and clinical data to plan pharmacovigilance for biosimilars
Biosimilar Risk Management Plans
Exploring known risks from the originator to develops risk management strategy
Safety specification and pharmacovigilance plan documentation requirements
Operational challenges in undertaking late phase studies (including observational studies, registries and surveillance)

› Rakesh Dixit, Vice President, R and D; Global Head Biologics Safety Assessment, Medimmune

12.30pm

Lunch

BIOSIMILAR IMMUNOGENICITY

1.30pm

Immunogenicity of biosimilars

Meenu Wadhwa

Meenu Wadhwa is Head, Cytokines and Growth Factors Section in the Biotherapeutics Group at the National Institute for Biological Standards and Control (NIBSC). She is responsible for a number of diverse projects in the cytokine and growth factor...

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Overview of Immunogenicity
Immunogenicity testing – strength/weaknesses of different analytical techniques

› Meenu Wadhwa, National Institute for Biological Standards and Control (NIBSC), Hertfordshire, UK. Expert of the BMWP, EMA, UK., NIBSC

BIOSIMILAR BEST PRACTICE

2pm

Biobetters

Dr Rustom Mody at Biosimilar Drug Development World

Strengths and weaknesses of launching a product as a biobetter not biosimilar
Scientific considerations in the development and manufacture of biobetters
Differentiation challenges and strategies to making your product stand out from the originator

› Dr Rustom Mody, Biosimilar development lead, Intas Biopharmaceuticals

2.30pm

Cold chain management for biosimilars

Mr. Rajiv Dua

Rajiv Dua is currently Analytical and Stability coordinator, at Lupin Ltd (Biotech division), India. He is responsible for designing and conducting stability studies involved in multiple projects, coordinating in exploratory and comparative...

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Stability studies of biotherapeutic proteins
Evaluating temperature excursions and biopharmaceutical product stability (cold chain management)

› Mr. Rajiv Dua, Analytical & Stability Coordinator, Lupin Biotech

3pm

Afternoon refreshments

3.30pm

Biosimilars – the devil is in the detail

Prof Heinz Haenel

03.11.55: Born in Offenbach, Germany 1974: High school diploma (Abitur) 1974-1975: Army service, Germany (15 months) 1977-1981: Student of biology, J.W. Goethe Univ. Frankfurt 1979-1982: Assistant...

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Biosimilars of insulins are never identical to the originator product by: possible immunogenicity, by products, synthesis, manufacturing process, organism to produce it and tertiary structure