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Proudly created and produced by

The FIRST and ONLY vaccine

conference in the MENA & CIS region!

18th

– 20th

November 2014

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EXECUTIVE SUMMARY

The vaccine industry in Russia & CIS, Turkey & Central Asia, (MENA) Middle East and North Africa has witnessed fast growth in the last five years, evident by multiple events of local tie-ups with multinationals, innovation and expansion plans of local players in the region, just to name a few:

MSD, Saudi Biopharma Sobol signed a long-term exclusive agreement to establish a manufacturing plant for certain types of vaccines in Aug 2012

Pfizer opened a pneumococcal conjugate vaccine (PCV) production plant in Istanbul in November 2012

Nanolek announced plans to become the first manufacturer of a VLP (virus-like particle)-based flu vaccine in Russia in May 2013

Israeli vaccine company SciVac is seeking U.S. approval for a widely used hepatitis B vaccine for global expansion in July 2013

GlaxoSmithKline (GSK) has announced plans to produce vaccines in Turkey with local company IDOL in November 2013

However, the vaccine industry in this region is not receiving the deserved attention globally because of information barriers, political situations and market fragmentation. Vaccine World Summit MENA and CIS 2014 is unique as the ONLY vaccine conference focusing on this region, continuing its success from Vaccine World Summit CIS and CEE 2013, held in Moscow in November. It target to bring together industry leaders from regulatory agencies, multinational companies, local manufacturers, as well as technocrats and innovators, to craft market growth strategies, shape future immunisation strategies, as well as explore partnership opportunities and exchange insights and best practices in R&D, clinical trials, manufacturing, cold chain and operational excellence. It’s an unique opportunity for Vaccine leaders from MENA and CIS to showcase themselves to the world, and for the world vaccine leaders to meet and do business with vaccine regulators and leaders from the MENA and CIS region. I look forward to meeting you in November.

Chamindika Konara Conference Manager –Vaccine World MENA and CIS 2014

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WHO IS YOUR AUDIENCE?

By Geography

Middle East

CIS Region

Europe

AustralAsia

USA

By Job Title

Scientists andEngineers

VPs and Directors ofR&D

CEOs/CSO/CTO/MDs

VPs and Directors ofManufacturing

Others

By Industry VaccineManufacturers

TechnologyVendors

CROs

Academic andResearchInstitutesDistributors

NGOs

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AGENDA AT A GLANCE

Pre Conference Day: 5th November 2014

Main Conference Day 1: 6th November 2014

Main Conference Day 2:7th November 2014

Workshop: Developing a Strategic Vaccine Master

Project Plan & Commissioning,

upgrading or expanding a vaccine manufacturing

facility: Practical considerations in MENA

and CIS

IMAPAC’S Welcoming Remarks IMAPAC’S Welcoming Remarks

Chairman’s Opening Remarks Chairman’s Opening Remarks

Key Note CEO Plenary Session: Gain Insights into the CIS and MENA current market landscape through Key Opinion Leaders in the Industry

Best Practises and Manufacturing Economics: Technical and Manufacturing Collaboration in MENA and CIS Region, Facility Design, Engineering Solutions and Fill and Finish Strategies

Speed Networking and morning refreshments

Morning Refreshment

New Vaccines, New Opportunities: Look into Novel Research & Development of Vaccines for the MENA and CIS Region (ex: Collaborating with Academia, Polio and Influenza vaccines)

Vaccine Supply Chain Dialogue: Meeting Vaccine Demand for EPIs and UPIs, Forecasting and Managing supply and State of the art cold chain solutions

Chairman’s Closing Remarks

Networking Lunch and Technical Seminars

Networking Lunch and Technical Seminars

IMAPAC’S Welcoming Remarks New Vaccines, New Opportunities: Look into Novel Research & Development of Vaccines for the MENA and CIS Region (ex: MERS and Meningococcal vaccines)

Chairman’s Opening Remarks

Making inroads into MENA and CIS Vaccine Market: Overview of Regulatory Framework in MENA and CIS Region and Market Access, Entry Strategies

Round Table Discussions: What factors to consider in developing a Robust and Innovation driven pipeline

Afternoon Refreshments and Exhibition Visit

Afternoon Refreshments and Exhibition Visit

Round Table Discussions: Looking into current partnership models, key considerations before entering the market

Vaccine Scale Up and Process Design Strategies: Optimizing cell culture, Cost – benefit analysis of Single use systems Fill & Finish Round Table Discussions: Manufacturing economics and cost efficient processing

Chairman’s Closing Remarks Chairman’s Closing Remarks

Cocktail Reception

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CONFRIMED SPEAKERS & ADVISORS TO DATE

Dr. Stanley C. Erck, Chief Executive Officer, Novavax Inc, USA

Dr.O.Mutlu Topal, Managing Director, Keymen Ilac, Turkey

Prof.Dr.Bulent Gumusel, Dean of Pharmacy Faculty, Hacettepe University – Ankara, Turkey

Dr. Reinhard Glück, Chief Scientic Officer Zydus Cadila, India

Dr. Kutub Mahmood, Scientific Director, Polio Vaccine Development Project, PATH, USA

Dr.Marc LaForce, Director - Technical Services, Serum Institute of India, USA

Prof. Sayadyan Khachik, CEO Abiolek company & Director of Science, NTpharma, Russia

Prof. Dr.Mustafa Hacımustafaoğlu, Department of Pediatrics, Faculty of Medicine, Uludag University, Turkey

Dr. Bernd Eisele Chief Executive Officer, Vakzine Projekt Management, Germany

Mrs. Beril Tezcanli, Mefar Ilac, Turkey

Ms. Syedah Maria Bokhari, Regional Vaccines Commercial Head - Middle East North Africa & CIS , GSK, Turkey

Dr. Daniel D. Adams, Executive Chairman & Global Head of Business Development, Protein Sciences Corporation

Ms. Eman Aly, Vice President, Business Unit Head, Turkey, Middle East and North Africa, Sanofi Pasteur, Turkey

Mr. K. V Balasubramanium, Managing Director, Indian Immunologicals, India

Viktor Dmitriev, General Director, ARFP, Russia

Syed Ahmed, CEO, Technovation, India

Weining Meng, QA Manager, Sinovac Biotech, China

Natalia Bastrikova, Director, Business Development and Clinical Research, Selecta, Russia

Mr. Atin Tomar, Vice President, Hilleman laboratories, India

Cagdas Balci, Strategic Planning and Marketing sales operations director, Novartis, Turkey

Gihan Hamdy El-sisi , Head of HPA, Central Administration for Pharmaceutical Affairs, Ministry of Health & Population, Egypt

M. Berat Battal (CEO & President), Turk Ilac, Turkey

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DETAILED AGENDA

Pre-conference Day: 18th November 2014 13.00 Registration Commences Overview of Regulatory Framework in MENA and CIS Region and Market Access, Entry Strategies 13.30 Vaccine Industry in the MENA region: Challenges and Recommendations

Gihan Hamdy El-sisi , Head of HPA, Central Administration for Pharmaceutical Affairs, Ministry of Health & Population, Egypt

14.00 Panel Discussion: Streamlining vaccine regulatory pathway to meet changing demand Overcoming challenges in Implementing sustainable vaccine development programs in developing

countries Role of partnerships in policy strategizing and implementation. Addressing the gaps in understanding of regulations Moderator: Syed Ahmed, CEO, Technovation, India Panelists: Cagdas Balci, Strategic Planning and Marketing sales operations director, Novartis, Turkey Dr Heba Wali, Director Technical Affairs, Vacsera, Egypt Invited: Prof.Dr.Secil Ozkan, Director of Public Health Directorate of Turkey Ankara, Turkey Natalia Chirun, Head of Medical Department, NPO Petrovax Pharm, Russia

14.45 Afternoon Refreshments and Networking 15.15 Testing commercial-ability of introducing vaccines into MENA and CIS market: MNC Perspective

Challenges and opportunities in the MENA and CIS market Analysis of competitiveness and partnership opportunities for the CIS region

Ms. Syedah Maria Bokhari (Confirmed) Regional Vaccines Commercial Head - Middle East North Africa & CIS , GSK, Turkey

15.45 Establishing and managing long distance partnerships Analysis of competitiveness for the MENA and CIS region Criteria that is looked into before entering a particular market Case studies

Dr. Bernd Eisele (Confirmed) Chief Executive Officer, Vakzine Projekt Management, Germany

Round Table Discussion 16.15

Round Table 1: Entering Emerging MENA and CIS Market Opportunities, Major challenges and how to avoid common pitfalls Commercial and operational considerations of successfully navigating the evolving regulatory

framework Round Table 2: Balancing Cost Benefits of Venturing into New Market. Balancing Cost Benefits of Venturing into New Market. Best time and phase in vaccine development to start engaging distribution partners Criteria for choosing the right Distributors

17.00 Cocktail Reception

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Conference Day 1: 19th November 2014 08.15 Registration Commences 08.55 IMAPAC’s welcome remarks 09.00 Chairman’s opening remarks Key Note Panel Discussion 09.10 Key Note Round table: Gain Insights into the CIS and MENA current market landscape through Key

Opinion Leaders in the Industry Overview of MENA and CIS Vaccine Market: Trends and opportunities Look into growth opportunities for this region How to position your company in the next 5 years and analyzing what need to be done to achieve

continuous growth in MENA and CIS vaccine industry

Confirmed Panellists Dr.O.Mutlu Topal, Managing Director, Keymen Ilac, Turkey Viktor Dmitriev, General Director, ARFP, Russia M. Berat Battal (CEO & President), Turk Ilac, Turkey

10.00 Morning Refreshments and Speed Networking New Vaccines, New Opportunities: Focus on Vaccine Research and Development in MENA and CIS Region 10.45 Forecasting vaccine demand & supply in MENA and how does it affect vaccine manufacturers &

distributors Price point pressures along the vaccine manufacturing process and how it impede growth of new

vaccine development Role of NGOs: Pricing concerns in ensuring a sufficient vaccines supply Possible new initiatives or programs that can bridge supply gap

Dr Emin Turan (Confirmed) General Manger, Turkey and Iran, Sanofi Pasteur, Turkey

11.15 Promoting R&D in the MENA region by collaborating with Academia Look into Novel Research & Development of Vaccines for the MENA and CIS Region Case Study

Prof. Dr. Bulent Gumusel (Confirmed) Dean of Pharmacy Faculty, Hacettepe University – Ankara, Turkey

11.45 Mid-day Prayers and Networking Lunch Session 12.45 Polio: Battling a versatile foe

Advancement of IPV vaccine development Eradication of polio in the MENA region? What needs to be done in the coming years and role of

regional vaccine manufactures and distributors

Dr. Kutub Mahmood (Confirmed) Scientific Director, Polio Vaccine Development Project, PATH, USA.

13.15 Vaccines for the Future Session I – Focus on Influenza Vaccine Importance of Influenza Vaccination for the Middle East and CIS region Look into Novel Research & Development of Vaccines for the Influenza Case Study: AdeVac-Flu

Prof. Saiadian Khachik (Confirmed) CEO Abiolek Company & Director of Science, NTpharma, Russia

13.45 Vaccines for the Future Session I – Focus on MERS Vaccine Importance of MERS Vaccination for the Middle East region Look into Novel Research & Development of Vaccines for the MERS Case Study: nanoparticle vaccine for MERS-CoV by Novavax

Russell P. Wilson, Senior Vice President, Business Development , Novavax Inc, USA

14.15 Prayer Break and Afternoon Refreshment 14.45 Vaccines for the Future Session II – Importance of Meningococcal Vaccines

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Importance and of Meningococcal vaccination in the Middle Eastern region Prof.Dr.Mustafa Hacımustafaoğlu (Confirmed) Department of Pediatrics, Faculty of Medicine, Uludag University, Turkey

Round Table Discussions 15.15 What factors to consider in developing a Robust and Innovation driven pipeline

How to ensure that your research is economically viable in the vaccine industry Collaborative advantages of research and manufacturer partnerships Co-development partnerships and Technology Transfers: helping you to take your product to masses

Vaccine Scale Up and Process Design Strategies 15.45 Evaluation of use of Single Use Technology

Pros and cons of using disposable systems in upstream and downstream, small and large-scale processing

Managing single use technology in clinical and commercial development; scaling up and down Testing and risk management of extractable and leachable in single use bioreactors

Confirmed: Weining Meng, QA Manager, Sinovac Biotech, China

16.15 The right attitude and equipment to ensure vaccine of the highest quality Implementing QBD in the vaccine development cycle Choosing the best suited technological systems for a low cost high volume production Case Study

Dr. Reinhard Glück (Confirmed) CSO, Zydus Cadila, India

16.45 Vaccine manufacturing capabilities, challenges and opportunities in the MENA region

Mrs. Beril Tezcanli (Confirmed) Quality Group Director, Mefar Ilac, Turkey

Round Table Discussions 17.15 Manufacturing economics and cost efficient processing

Designing downstream facilitates to align with upstream manufacturing strategies Cutting-edge automation, controls to increase downstream productivity Economic analysis of facility utilization, cost vs. product yield & purity

17.45 Chairman’s Closing Remarks

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MOVING FORWARD As the speaker invitees are consolidating, we welcome feedback and topic suggestions to be included in Vaccine World CIS and MENA 2014. For more details on the specific topics planned in the agenda, please feel free to contact me. The program agenda is in the process of perfecting, so do look out for new updates.

Conference Day 2: 20th November 2014 08.30 Registration Commences 09.00 Chairman’s opening remarks Best Practises and Manufacturing Economics 09.00 Trends & Challenges in Technical and Manufacturing Collaboration in MENA and CIS Region

Identifying the right partner Evaluating platform technology, therapeutic focus & geographical focus Exploring manufacturing partnership structures: co-development, licensing opportunities &

pitfalls to avoid Dr. Daniel D. Adams (Confirmed) Executive Chairman and Global Head of Business Development, Protein Sciences Corporation

09.30 tSVP technology: Using this technology for creating a new adjuvant and improving existing vaccines. Natalia Bastrikova, Director, Business Development and Clinical Research, Selecta, Russia

10.00 Fill and Finish Strategies – should we outsource? Outsourcing fill and finish functions – advantages, disadvantages and cost benefit analysis

Challenges faced during fill and finish process and how to overcome them Dr.O.Mutlu Topal (Confirmed) Managing Director, Keymen Ilac, Turkey

Vaccine supply and partnerships for regional sucess 10.30 Morning Refreshments 11.00 Partners in vaccines for developing nations

Partnerships for regional challenges Case studies for enhances Rotavirus and Cholera Vaccines Polysaccharide conjugate vaccine developments to meet regional needs

Mr. Atin Tomar, Vice President, Hilleman laboratories, India

11.30 Thermal stability of conjugate vaccines: the advantages of being able to take vaccines outside the cold chain

MenAfriVac case study Dr. Marc LaForce (Confirmed) Director - Technical Services, Serum Institute of India, USA

12.00 Chairman’s Closing Remarks 12.10 End of Conference Prceedings

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ABOUT IMAPAC %

IMAPAC is a social enterprise based in Singapore that is on an unrelenting mission to make a difference in businesses of today. We believe that businesses are not only meant to do well, but also to do good. We want companies to find business opportunities at our conferences as well as something good to aim for. IMAPAC’s international conferences are where you join other organisations such as governments, NGOs, businesses, academics, and other stakeholders who are standing up collectively to make a difference, to attest to the fact that businesses can and do make a positive impact on the world we live in. At IMAPAC, we take pride in delivering the best quality product catering to the real and complex needs of our industry executives. We do not believe in vendor-led low-value conferences; we do not believe in short term profit gain by sacrificing our content, but instead focus on forging long term partnerships and providing real value and meaning to our customers through our cause-driven conferences. We aim to provide the most comprehensive marketing plans with the highest ROIs in the conference industry for our speakers, delegates and sponsor