Conference Program


Day 1

8.30 - 9.30

Registration & Refreshment



9.30 - 9.40

Chair Person's Opening Remarks

Shelley Gandhi
Strategic Advisor Pharmacovigilance and Drug Safety
NDA Reg

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. 

Panelist :
Xavier Frapaise, Shun Luo, Steinar Madsen, Pippa

Moderator Shelley Gandhi



14:30 – 15:00

CMC Considerations for Biosimilar Drug Development 

Ulrike Konrad
Business Development Manager
Protagen Protein Services GMBH - Sponsor Speaking Slot

15:00 – 15:20

Afternoon Tea Break, Refreshments and Networking Session 



15:20 – 15:50

Who is prescribing biosimilars and why?

John Storey
Business Unit Director
AplusA Research

15:50 – 16:15

Nanosimilars, What can we learn from Biologics?

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

16:15 - 16:45

Role of a qualified person under Product life cycle

Arvind Baskar
QP Consultant
Lupin Pharmaceuticals

Day 2

8.30 - 9.30

Registration & Refreshments



9.30 - 9.40

Chair Person's Opening Remarks 

Shelley Gandhi
Strategic Advisor Pharmacovigilance and Drug Safety
NDA Reg

9.40 - 10.20

Unlocking the value of biosimilars in Europe – the Commercial Perspective

Adam Levyson,
Global Head Market Access Biogen Biosimilars
Biogen

10:20 - 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 – 12:00

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

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

12:00 – 12:30

The UK's capabilities to deliver biosimilar clinical trials

Theo Christie
Business Development Manager,
NIHR

12:30 – 13:00

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

Louis Boon,
Chief Scientific Officer,
Bioceros

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 

  • 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

Panelist :
Louis Boon, Aaron Barzey, Narayan Gopal

Moderator Shelley Gandhi



15:00 – 15:30

Afternoon Tea Break, Refreshments and Networking Session



15:30 – 16:00

Brexit and it's impact on the pharmaceutical industry

 Aaron Barzey

CEO, ADB Medical



16:00 - 16:30

The role of competition and IP law in early access to market for Biosimilars

  • Overview of Competition Law
  • Barriers to entry and expansion facing biosimilars
  • Competition Authorities track record in pharma
  • Strategic use of competition and IP law

 

Natasha Pearman
Managing Associate
Mishcon de Reya LLP

16:30 - 17:00

Assessing payer and physician perceptions of biosimilars over time

  • Shifts in physician sentiment toward biosimilar extrapolation
  • Juxtaposition of three specialists: Rheums, Derms and Gastros
  • Importance of biosimilar endorsement criteria

 

Amanda Baskett
Associate Director, Global Autoimmune Portfolio
Ipsos Healthcare

16:35 - 16:40

Chair Persion 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