| Agenda |
8.30 Registration
9.00-9.25 Bridging the Gulf in Pharma- A Global and MENA Perspective
Andrew Jack, Pharmaceuticals Correspondent, Financial Times
9.25-9.25 Government/Policy Forum: The Role of Biotechnology in Transforming Healthcare in MENA- Reducing Costs, Improving Access
Recognising the vital role that a vibrant biotechnology industry can play in creating modern knowledge based economy, and the role in particular that a strong local industry can play in reducing import dependency and escalating healthcare bills, governments across the MENA region are taking measures to encourage the growth of their national biotech industries. Yet despite increased investment in the sector and measures to encourage biomedical research and production, the expected industry growth has largely failed, as yet, to materialise. What are the impediments to growth and what measures are government across the region taking to address these challenges? What are the government priorities for drug development? How can governments work in partnership with the private sector to accelerate the development of the industry? What are the lessons from other markets such as Singapore which have built world class biotechnology industries?
Leonard Lerer, Senior Vice President and Co-Founder, Innovative Finance Foundation
Professor Tawfik Khoja, Director General, Health Ministers Council for Cooperation, SGH
James Greenwood, President & CEO, BIO
Ayesha Mohammed Abdullah, Managing Director, Dubai Healthcare City Regulator (DHCR)
10.25-10.50 Networking Coffee Break
10.50-11.20 Keynote Address/CEO Interview
Dr Ayman Sahli, Chief Executive Officer, Julphar-Gulf Pharmaceutical Industries
in conversation with:
Andrew Jack, Pharmaceuticals Correspondent, Financial Times
11.20-12.30 The Emerging Global Market for Biosimilars-Opportunities, Challenges, Strategies
The recent approval of the first monoclonal antibody biosimilar in Europe is viewed as a watershed moment for the biotechnology and biosimilar industry. Although the US has still to finalise its guidelines for interchangeability of biologics, the stage now looks set for rapid growth of this nascent industry .The MENA region has the potential to play a significant role. Yet despite the potential, doubts have been cast on the eventual size of this market with many citing the complexity, significant development costs, defensive strategies from innovators and regulatory uncertainties as possible impediments to growth. Will biosimilars have the same affect on markets erosion as their traditional generic counterparts have on the innovator market? Will payer and clinical concerns (costs, safety) act as a constraints on growth? Can emerging markets, including MENA markets, lead in biosimilars, or are the costs too great? What are the strategies to succeed in this market?
Session Keynote:
Christopher Hansung Ko, Chief Executive Officer, Samsung Bioepis
Georges Kahwati, Head of Commerical Operations Emerging Markets, Biopharma,and Oncology Injectables, Sandoz
Carolyn Gauntlett, Senior Consultant, Thought Leadership, IMS Health
Virginia Acha, Director, Regulatory Affairs, Amgen
Ayman Sahli, Chief Executive Officer, Julphar-Gulf Pharmaceutical Industries
Mazen Darwazah, Vice-Chairman and CEO, MENA, Hikma Pharmaceuticals
12.30-13.50 Networking Lunch
13.50 -15.10 The Regulators Forum: Advancing the Biotechnology Industry in MENA-Creating a Framework for Innovation
The development of a strong and sustainable biotechnology sector in MENA will depend critically on the existence of a robust and stringent regulatory framework which both supports the growth and safety of complex biologics and biosimilars and builds on best practice from regulatory regimes around the world. What constitutes an appropriate pathway for the approval of complex biologics and biosimilars in MENA? How are regulatory regimes for biologics and biosimilars in the EU, US and other key markets evolving, and what are the lessons and best practice which can inform the establishment of rules for the MENA region? What are the prospects for regulatory harmonisation and standardisation across the region/across the markets globally?
Session Keynote
Thomas Lönngren, Strategic Adviser, NDA Regulatory Science, Former Executive Director, European Medicines Agency (EMA)
Saleh Bawazir, Vice Presdent for Drug Affairs, Saudi Food and Drug Authority
Anders Neil, Principal Consultant, PAREXEL Consulting
Amin Hussain Al Amiri, Undersecretary for Medical Practice and License, UAE Ministry of Health
Hiiti Sillo, Director General, Tanzania Food and Drug Authority
Lina Bajjali, Drug Director's Assistant for Technical Affairs, Jordan Food and Drug Administration
Marie-Christine Bielsky, Senior Medical Assessor, Biologicals and Biotechnology Unit, Licensing Division, Medicines and Healthcare Products Regulatory Agency, MHRA, UK
15.10-15.35 Overview: Deciphering the MENA Opportunity-Market Potential and Challenges
Jo Pisani, Partner, Pharmaceuticals & Life Sciences Strategy, PricewaterhouseCoopers
15.35-16.00 Networking Coffee Break
16.00-17.00 Industry and Investors Forum
The views and experiences of the industry’s ‘front- line’ participants and investors can play a vital role in informing the debate and ensuring that rules,regulations and incentives are adopted which are appropriate, informed, balanced and which encourage the long- term growth and sustainability of the emerging biotechnology industry in MENA. What do local and international investors and biotechnology leaders see as the challenges ahead, and the solutions for advancing the development of the industry in MENA?
Elcin Ergun, Senior Vice President, Head of Intercontinental Region, Merck Serono
Helmut Schühsler, Chairman and CEO, TVM Capital MENA
Ahmed Emara, CEO and Managing Director, ReAya Holding
Joe Henein, President and CEO, NewBridge Pharmaceuticals
17.00-17.05 Closing Remarks from the Chair
17.05 Networking Reception
9.00-9.25 Bridging the Gulf in Pharma- A Global and MENA Perspective
Andrew Jack, Pharmaceuticals Correspondent, Financial Times
9.25-9.25 Government/Policy Forum: The Role of Biotechnology in Transforming Healthcare in MENA- Reducing Costs, Improving Access
Recognising the vital role that a vibrant biotechnology industry can play in creating modern knowledge based economy, and the role in particular that a strong local industry can play in reducing import dependency and escalating healthcare bills, governments across the MENA region are taking measures to encourage the growth of their national biotech industries. Yet despite increased investment in the sector and measures to encourage biomedical research and production, the expected industry growth has largely failed, as yet, to materialise. What are the impediments to growth and what measures are government across the region taking to address these challenges? What are the government priorities for drug development? How can governments work in partnership with the private sector to accelerate the development of the industry? What are the lessons from other markets such as Singapore which have built world class biotechnology industries?
Leonard Lerer, Senior Vice President and Co-Founder, Innovative Finance Foundation
Professor Tawfik Khoja, Director General, Health Ministers Council for Cooperation, SGH
James Greenwood, President & CEO, BIO
Ayesha Mohammed Abdullah, Managing Director, Dubai Healthcare City Regulator (DHCR)
10.25-10.50 Networking Coffee Break
10.50-11.20 Keynote Address/CEO Interview
Dr Ayman Sahli, Chief Executive Officer, Julphar-Gulf Pharmaceutical Industries
in conversation with:
Andrew Jack, Pharmaceuticals Correspondent, Financial Times
11.20-12.30 The Emerging Global Market for Biosimilars-Opportunities, Challenges, Strategies
The recent approval of the first monoclonal antibody biosimilar in Europe is viewed as a watershed moment for the biotechnology and biosimilar industry. Although the US has still to finalise its guidelines for interchangeability of biologics, the stage now looks set for rapid growth of this nascent industry .The MENA region has the potential to play a significant role. Yet despite the potential, doubts have been cast on the eventual size of this market with many citing the complexity, significant development costs, defensive strategies from innovators and regulatory uncertainties as possible impediments to growth. Will biosimilars have the same affect on markets erosion as their traditional generic counterparts have on the innovator market? Will payer and clinical concerns (costs, safety) act as a constraints on growth? Can emerging markets, including MENA markets, lead in biosimilars, or are the costs too great? What are the strategies to succeed in this market?
Session Keynote:
Christopher Hansung Ko, Chief Executive Officer, Samsung Bioepis
Georges Kahwati, Head of Commerical Operations Emerging Markets, Biopharma,and Oncology Injectables, Sandoz
Carolyn Gauntlett, Senior Consultant, Thought Leadership, IMS Health
Virginia Acha, Director, Regulatory Affairs, Amgen
Ayman Sahli, Chief Executive Officer, Julphar-Gulf Pharmaceutical Industries
Mazen Darwazah, Vice-Chairman and CEO, MENA, Hikma Pharmaceuticals
12.30-13.50 Networking Lunch
13.50 -15.10 The Regulators Forum: Advancing the Biotechnology Industry in MENA-Creating a Framework for Innovation
The development of a strong and sustainable biotechnology sector in MENA will depend critically on the existence of a robust and stringent regulatory framework which both supports the growth and safety of complex biologics and biosimilars and builds on best practice from regulatory regimes around the world. What constitutes an appropriate pathway for the approval of complex biologics and biosimilars in MENA? How are regulatory regimes for biologics and biosimilars in the EU, US and other key markets evolving, and what are the lessons and best practice which can inform the establishment of rules for the MENA region? What are the prospects for regulatory harmonisation and standardisation across the region/across the markets globally?
Session Keynote
Thomas Lönngren, Strategic Adviser, NDA Regulatory Science, Former Executive Director, European Medicines Agency (EMA)
Saleh Bawazir, Vice Presdent for Drug Affairs, Saudi Food and Drug Authority
Anders Neil, Principal Consultant, PAREXEL Consulting
Amin Hussain Al Amiri, Undersecretary for Medical Practice and License, UAE Ministry of Health
Hiiti Sillo, Director General, Tanzania Food and Drug Authority
Lina Bajjali, Drug Director's Assistant for Technical Affairs, Jordan Food and Drug Administration
Marie-Christine Bielsky, Senior Medical Assessor, Biologicals and Biotechnology Unit, Licensing Division, Medicines and Healthcare Products Regulatory Agency, MHRA, UK
15.10-15.35 Overview: Deciphering the MENA Opportunity-Market Potential and Challenges
Jo Pisani, Partner, Pharmaceuticals & Life Sciences Strategy, PricewaterhouseCoopers
15.35-16.00 Networking Coffee Break
16.00-17.00 Industry and Investors Forum
The views and experiences of the industry’s ‘front- line’ participants and investors can play a vital role in informing the debate and ensuring that rules,regulations and incentives are adopted which are appropriate, informed, balanced and which encourage the long- term growth and sustainability of the emerging biotechnology industry in MENA. What do local and international investors and biotechnology leaders see as the challenges ahead, and the solutions for advancing the development of the industry in MENA?
Elcin Ergun, Senior Vice President, Head of Intercontinental Region, Merck Serono
Helmut Schühsler, Chairman and CEO, TVM Capital MENA
Ahmed Emara, CEO and Managing Director, ReAya Holding
Joe Henein, President and CEO, NewBridge Pharmaceuticals
17.00-17.05 Closing Remarks from the Chair
17.05 Networking Reception
