Conference Program


Day 1

8.30 - 9.30

Registration & Refreshment

9.30 - 9.40

Chair Person's Opening Remarks

9.40 - 10.20

The philosophical dimension of Biosimilars adoption

Dr.Xavier Frapaise,
Vice President, Clinical Development,
PV & Medical Affairs,
Merck Serono

10:20 - 11:00

Biomanufacturing of the Future:Configuration,
Integration, and Consortium

Dr Shun Luo,
President,
Jianshun Biosciences China

11:00 - 11:30

Morning Coffee Break, Refreshments and Networking Session

11:30 – 12:00

Real Word Applications of Exatrapolation

Dr.Bernd Liedert,
Sr.Clinical Program Leader Biosimilars at
Boehringer Ingelheim,
Biosimilars Business Unit,
Boehringer Ingelheim GmbH

12:00 – 12:30

Biosimilars – savings and sustainability.
• To switch or not to switch – to be or not to be?
• The winner takes all – the problem of the second entrant
• Are we throwing money out of the window?

Dr.Steinar Madsen,
Director,
Norweigian Medicines Agency

12:30 – 13:30

3 Cource Networking Luncheon by Hilton's Master Chef

13:30 – 14:30

Panel Discussion
Ethics and Biosimilars
Informed consent: do patients really understand what a Biosimilar is?
When access to Avastin, Erbitux and other oncology compounds is limited or even patients would sign any document to get access to these compounds in a clinical trial?
Sponsors assume that Biosimilars are a prior equivalent to the reference compound; however there is not such thing as fingerprint Biosimilar and too often the safety monitoring of Biosimilars trials is "ultra light " and no IDMC is planned.

14:30 – 15:00

Sponsor Speaking Slot

15:00 – 15:30

Afternoon Tea Break, Refreshments and Networking Session

15:30 – 16:00

Nanosimilars, What can we learn from Biologics?
• Specifics of Nanomedicines
• Regulatory difficulties in Authorization of Nanosimilars
• Health Economic Impact of Regulatory Hurdles

Dr.Beat Flumann,
Global Lead Non-Biological Complex Drugs,
Vifor Pharma

16:00 – 16:30

Chair Person's Closing Remarks

16:30 - 18:00

Networking Drinks Reception

Day 2

8.30 - 9.30

Registration & Refreshments

9.30 - 9.40

Chair Person's Opening Remarks

9.40 - 10.20

Unlocking the value of biosimilars in Europe – the Commercial Perspective

Adam Levyson,
Head of Global Market Access,
Biogen

10:20 - 11:00

Fast-to-Market Biosimilars
• Choosing the right molecule out of 50 to get in market fast; A model approach
• FDA/EMA CTD to meet both requirements at lowest cost and shortest time
• Leveraging strategic and tactical partnerships to expand biosimilar distributors

Professor Sarfaraz K. Niazi
Founder & Executive Chairman
Pharmaceutical Scientist Inc, USA

11:00 - 11:30

Morning Coffee Break, Refreshments and Networking Session

11:30 – 12:00

Designing and conducting clinical trials for Biosimilars

Dr. Ekkehard Brockstedt
TCM Biosimilars, Corp. Div. Medicine,
BOEHRINGER INGELHEIM

12:00 – 12:30

Risk management strategies for biosimilars
EU and US perspective of risk management

Dr Niraj Chhaya,
Lead Risk Management, Global Pharmacovigilance,
Boehringer Ingelheim

12:30 – 13:00

The UK's capabilities to deliver biosimilar clinical trials

Theo Christie
Business Development Manager,
NIHR

13:00 – 14:00

3 Cource Networking Luncheon by Hilton's Master Chef

14:00 – 15:00

Panel Discussion:-
Why does the biosimilar market fail to meet the expectations? Hurdles and way forward
Regulatory and Legislative barriers,
Limited number of players in the field
Reasons for low commercial success
Meeting commercial requirements
Competition with established drugs and biologics
Suspicious patients- how to gain the confidence of patients
The challenges of safety monitoring

15:00 – 15:30

Boosting production titers by SPOT
• Upstream process modulation to meet CQAs
• Custom biosimilar bio-assay design

Louis Boon,
Chief Scientific Officer,
Bioceros

15:30 – 16:00

Afternoon Tea Break, Refreshments and Networking Session

16:00 - 16:30

Role of a qualified person under Product Life Cycle.

Arvind VijayBhaskar,
QP Expert,
Lupin Pharmaceuticals

16:30 – 16:40

Chair Person's Closing Remarks and End of Conference

Day 1

8.30 - 9.30 Registration & Refreshment
9.30 - 9.40 Chair Person's Opening Remarks
9.40 - 10.25

The philosophical dimension of Biosimilars adoption
Dr.Xavier Frapaise,
Vice President, Clinical Development,
PV & Medical Affairs,
Merck Serono

10:25 - 11:00

Biomanufacturing of the Future:Configuration,
Integration, and Consortium
Dr Shun Luo,
President,
Jianshun Biosciences China

11:00 - 11:30

Morning Coffee Break, Refreshments and Networking Session

11:30 – 12:10

Real Word Applications of Exatrapolation
Bernd Liedert,
Sr.Clinical Program Leader Biosimilars at
Boehringer Ingelheim,
Biosimilars Business Unit,
Boehringer Ingelheim GmbH

12:10 – 12:50

Topic TBC
Dr.Steinar Madsen,
Director,
Norweigian Medicines Agency

12:50 – 13:50

3 Cource Networking Luncheon by Hilton's Master Chef

13:50 – 14:50

Panel Discussion
Ethics and Biosimilars
Informed consent: do patients really understand what a Biosimilar is?
When access to Avastin, Erbitux and other oncology compounds is limited or even patients would sign any document to get access to these compounds in a clinical trial?
Sponsors assume that Biosimilars are a prior equivalent to the reference compound; however there is not such thing as fingerprint Biosimilar and too often the safety monitoring of Biosimilars trials is "ultra light " and no IDMC is planned.

14:50 – 15:30

Sponsor Speaking Slot

15:30 – 16:00

Afternoon Tea Break, Refreshments and Networking Session

16:00 – 16:40

Nanosimilars, What can we learn from Biologics?
Dr.Beat Flumann,
Global Lead Non-Biological Complex Drugs,
Vifor Pharma

16:45 – 17:00

Chair Person's Closing Remarks

17:00 - 18:30

Networking Drinks Reception

Day 2

8.30 - 9.30

Registration & Refreshments

9.30 - 9.40

Chair Person's Opening Remarks

9.40 - 10.25

Unlocking the value of biosimilars in Europe – the Commercial Perspective
Adam Levyson,
Head of Global Market Access,
Biogen

10:25 - 11:00

Designing and conducting clinical trials for Biosimilars
Dr. Ekkehard Brockstedt
TCM Biosimilars, Corp. Div. Medicine,
BOEHRINGER INGELHEIM

11:00 - 11:30

Morning Coffee Break, Refreshments and Networking Session

11:30 – 12:10

Risk management strategies for biosimilars
EU and US perspective of risk management
Dr Niraj Chhaya,
Lead Risk Management, Global Pharmacovigilance,
Boehringer Ingelheim

12:10 – 12:50

The UK's capabilities to deliver biosimilar clinical trials
Theo Christie
Business Development Manager,
NIHR

12:50 – 13:50

N3 Cource Networking Luncheon by Hilton's Master Chef

13:30 – 14:30

Panel Discussion:-
Why does the biosimilar market fail to meet the expectations? Hurdles and way forward
Regulatory and Legislative barriers,
Limited number of players in the field
Reasons for low commercial success
Meeting commercial requirements
Competition with established drugs and biologics
Suspicious patients- how to gain the confidence of patients
The challenges of safety monitoring

14:50 – 15:30

Boosting production titers by SPOT
• Upstream process modulation to meet CQAs
• Custom biosimilar bio-assay design
Louis Boon,
Chief Scientific Officer,
Bioceros

15:30 – 16:00

Afternoon Tea Break, Refreshments and Networking Session

16:00 – 16:35

Topic TBC
Paul Tredwell,
Chief Operating Officer,
Internis Pharmaceuticals

16:35 - 17:05

Role of a qualified person under Product Life Cycle.
Arvind VijayBhaskar,
QP Expert,
Lupin Pharmaceuticals

17:05 – 17:20

Chair Person's Closing Remarks and End of Conference