Forum Booklet

Event Overview

The 11th KAIMRC Annual Research Forum Themed “COVID-19 Vaccine: Global Challenges and Prospects Forum” to discuss COVID19 Vaccines. The Forum is a vital event as it provides a hub for leading COVID-19 vaccine scientists, regulators, developers, and distributors to learn about COVID-19 vaccines in development, make decisions about the best vaccines to use, and develop appropriate plans for global distribution and pricing. The COVID-19: Global Efforts for Development, Clinical Trials and Distribution Symposium will bring together leading scientists, clinicians, pharma, decision makers, academic institutions and businesses to present and discuss the vaccines that are being currently developed for the COVID19. This event is being held to shed light on these vaccines as many are at the late stage of Phase III clinical trials and ready to be marketed. This follows the confusion that few vaccines are being produced and pushed into phase III without sharing all the necessary data preventing the scientific and clinical community to judge its efficacy and safety. This event will also allow a discussion into the challenges in the distribution, pricing and accessibility of the vaccines. Moreover, the symposium will discuss the importance to invest in Biotech-Pharma to combat and overcome any future health crisis. The discussion will focus on Saudi Arabia leading initiatives as front runner in the field among G20 members.

About Us We are leading scientists, health providers, entrepreneurs, regulators and humanitarian workers who have coordinated in organizing this global symposium. We aim to educate the population and decision makers on the best COVID19 vaccines to consider based on scientific facts and to urge vaccine producers to care about the low-income populations and countries when pricing and distributing these vaccines.

Vision Scientifically Driven Decision on Best COVID19 Vaccines to Consider and Lessons Learnt; Public Health Comes First.

Mission The Symposium aims to be the hub for the leading COVID19 vaccines scientists, regulators, developers and distributors to conclude on the best vaccines to use and the appropriate path for its global distribution and pricing.

Objectives of the Symposium

Review the current COVID19 vaccines and therapeutics being developed, the clinical trials data and associated challenges

• Enable the scientific community, clinicians, decision makers, businesses and leaders to address concerns about these vaccines and discuss them directly with the producers.

• Verify the integrity of the published data and claims about these vaccines through discussion, presentation and questions directly addressed to the scientists and clinicians developing these vaccines.

• Intuitive discussion on challenges facing the global distribution of the COVID19 vaccines and to care about the low-income population and countries when pricing and distributing the COVID19 vaccines.

• Enhance public confidence of the COVID19 vaccines on the routes that are being taken to develop them to save lives and give expert opinions on their efficacy and safety

• Wake up call to all decision’s makers to invest in BioHealth research to serve better their populations.

Organizers & Sponsors

• Ministry of National Guard Health Affairs • G20 Secretariat • King Abdullah International Medical Research Center (KAIMRC). • king Saud Bin Abdulaziz university for health sciences • Bring Hope Humanitarian Foundation. • Deep Knowledge Group. • MRI Global, Kansas City, Missouri • Oxford University, UK • Kellog College, University of Oxford, UK • Zoom Video Communications, Inc • Nature Research • Informa

Collaborators • Saudi Health Council • Coalition for Epidemic Preparedness Innovations (CEPI)

Patronage His Royal Highness Prince Abdullah bin Bandar bin Abdulaziz, Minister of National Guard, Kingdom of Saudi Arabia

President Dr. Ahmed Askar, Executive Director of KAIMRC

Organizing Committee Dr. Mohamed Boudjelal Symposium Chairperson Director Drug Discovery and Development Chairman of Medical Research Core Facility KAIMRC-Ministry National Guard Health Affairs Riyadh, Kingdom of Saudi Arabia

Dr. Faisal Almajed General Director - University Relations and Media Affairs Director – King Abdullah Arabic Health Encyclopedia (KAAHE) Assistant Professor – Molecular Medical Microbiology King Saud bin Abdulaziz University for Health Sciences, Riyadh, KSA

Dr. Ahmed M. Salman Co-Chairman BSc, MSc, DPhil (Oxon) Senior Immunologist-Vaccinologist at The Jenner Institute, University of Oxford. Fellow and Advisor of Clinical Medicine at Kellogg College and Immunology Instructor at University of Oxford, UK.

Dr. Naif Alharbi Co-Chairman Director of Vaccine Development, King Abdullah Internatinal Medical Research Center, Riyadh, Saudi Arabia

Dr. Gene Garrard Olinger Principal Advisor, Science; Global Health Surveillance & Diagnostic Division

Dr. Margaretta Colangelo Co-Founder & Managing Director Deep Knowledge Group, San Francisco, California

Dr Mariwan Baker Founder and Chairman, Bring Hope Humanitarian Foundation, SWEDEN

Dr. Ahmed Aljedai Assistant Deputy Minister, Therapeutic Affairs, Saudi MOH & Founding President of the Saudi Society of Clinical Pharmacy

DR. BARRAK AL SOMAIE Operations Director, King Abdullah International Medical Research Center (KAIMRC), Ministry of National Guard - Health Affairs (MNG-HA), Riyadh, Kingdom of Saudi Arabia

Dr. Bader Aldebasi Assistant Professor of Radiology, College of Applied Medical Science, KSAU- HS, Deputy Head of Research Training & Development Section, KAIMRC, Riyadh

Dr. Ibraheem A. Bushnak Head of Research Training & Development Section, KAIMRC, Riyadh Head and Research Scientist of Nanomedicine Department, KAIMRC, Riyadh

Dr. Julia Michelotti Principal Scientist at MRIGlobal, USA

Dr. Abdelali Haoudi, Managing Director, Medical Biotechnology Park, Head, Strategy and Business Development, King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia

Dr. Majed Alghraibi Chairman Infectious Diseases Research Department KAIMRC, KSA.

Topics to be discussed • COVID19 Vaccines: Preclinical and Clinical Data • Vaccination Campaign • Vaccine Affordability and Pricing • Challenges in the Vaccine Distribution • Plans to ensure vaccine supply into low income population and countries • Lesson Learnt: Focus on “Biotech-Pharma Investment Come First”

Confirmed Speakers Prof. Bali Pulendran, Institute for Immunity, Transplantation and Infection Stanford University School of Medicine.

Prof. Dan Barouch, Medicine Harvard Medical School Ragon Institute of MGH, MIT, andHarvard, Director, Center for Virology and Vaccine Research, USA.

Prof. Robin Shattock, Faculty of Medicine, Department of Infectious Disease, Imperial College.

Prof. Barney S. Graham, Deputy Director, Vaccine Research Center, Chief, Viral Pathogenesis, NIH, USA.

Prof. Lianpan Dai, Institute of Microbiology, Chinese Academic of Sciences, China.

Dr. Kate Broderick, Senior Vice President R&D at Inovio Pharmaceuticals Inc.San Diego, California.

Dr. Yasser Al Obaidaa, CEO of SudairPharma, Riyadh, KSA.

Dr Mariwan Baker, Founder and Chairman, Bring Hope Humanitarian Foundation, MINC.

Dr. Naif Alharbi, Director of Vaccine Development, King Abdullah International Medical Research. Center, Riyadh, Saudi Arabia

Prof. Ziyad Memesh, director of medical research at KSMC and the chair of ID scientific, Committee, Kingdom of Saudi Arabia.

Dr. Holger Kanzler, Senior Program Officer, Vaccines & Human Immunobiology at Bill & Melinda Gates Foundation, Seattle, WA, USA.

Dr. Richard Wilder, CEPI, A global coalition for a global problem, General counsel & Head of Business Development.

Dr. Abdullah Algaissi, Jazan University in Saudi Arabia

Dr. Tal Zaks, Chief Medical Officer, Moderna, Affiliation

Professor Aleksandr GINTSBURG,Director, Gamaleya National Research Center for Epidemiology and Microbiology, Academician of the Russian Academy of Sciences

Dr. Denis LOGUNOV, Deputy Director for Science, Gamaleya National Research Center for Epidemiology and Microbiology, Corresponding Member of the Russian Academy of Sciences, Doctor of Biological Sciences

Dr. Iman Almansour, Assistant Professor in Microbiology, Imam Abdulrahman Alfaisal University, Dammam.

Professor Adrian Hill, Professor of Human Genetics; Director of the Jenner Institute; Co-Director, Oxford Martin Programme on Vaccines; Fellow of Magdalen College.

Prof. Maria Elena Bottazzi, Ph.D., FASTMH, Associate Dean, National School of Tropical Medicine, Co-Section Head, Pediatric Tropical Medicine Professor, Pediatrics & Molecular Virology & Microbiology, Baylor College of Medicine and Texas Children’s Hospital.

Peter Hotez, MD, PhD, FASTMH, FAAP, Dean, National School of Tropical Medicine. Professor, Departments of Pediatrics, Molecular Virology & Microbiology. Co-Head, Section of Pediatric Tropical Medicine. Health Policy Scholar, Baylor College of Medicine.

Dr. Anwar Hashem, Deputy Director and Associate Professor in Immunoglogy, King Fahad Medical Research Center (KFMRC), King Abdulaziz University

Dr. Catherine Taylor, Vice President, EMEA Medical Affairs, Therapy Area Strategy at Janssen Europe, Middle East & Africa (EMEA).

Dr. Mashal M. Alshazi, B.Pharm, Ph.D. Assistant Professor of Pharmaceutical Biotechnology King Saud University, College of Pharmacy ,Riyadh, Saudi Arabia.

Welcome Messages

Bandar AlKnawy, MD, FRCPC Chief Executive Officer, Ministry of National Guard-Health Affairs. President, King Saud Bin Abdulaziz University for Health Sciences.

I am honored to welcome you to the 11th Annual Forum for Medical Research: “COVID-19 Vaccine: Global Challenges & Prospects forum.” The event is one of the most important events in its field in this year. It aims to bring together leaders in the field of COVID-19 vaccine development and production, health institutions, academic institutions, businesses and world organizations to discuss the latest updates on COVID-19 vaccine development and possible availability to the public. This two-day global forum is structured to represent all aspects of the vaccines in development for COVID-19 to ensure global participation from experts, decision makers, news agencies, health workers and the public in general. We thank the speakers who accepted to present, collaborators, sponsors and the organizing committee members of the event. We are looking forward to seeing you all on the 4th-5th of November 2020.

Dr. Ahmed Alaskar Executive Director, KAIMRC. President of 11th KAIMRC Annual Forum for Medical Research.

On behalf of King Abdullah International Medical Research Center (KAIMRC), it is an honor to welcome you to the 11th Annual Forum for Medical Research with the theme “COVID-19 Vaccine: Global Challenges & Prospectss Forum”. KAIMRC organized the forum to review the status of vaccine development in the context of the current COVID-19 pandemic. The event is unique and significant, enabling the scientific community, health workers, governmental and non-governmental institutions and the public to be informed regarding the progress of COVID-19 vaccines, and discuss concerns and issues. We thank all the prominent speakers who are presenting during the forum, the organizing committee, the collaborators and sponsors who made it possible. In alignment with the Saudi Arabia Vision 2030, KAIMRC is leading a transformation in biomedical research in the Kingdom to transfer basic research in tangible products. KAIMRC’s vision is to lead innovation and technology development in medical and health research, with an impact on the economic and healthcare development in the Kingdom of Saudi Arabia. Infectious diseases are a major R&D focus area at KAIMRC, with a key strategic focus on vaccine development. This strategic drive to develop an excellent vaccine R&D and innovation program, has led to several vaccine initiatives, in collaboration with world-renowned academic and industrial partners, some of whom will be presenting during this forum.

Dr. Mohamed Boudjelal COVID19 Forum Chairperson. Director DrugDiscovery and Development, Chairman of Medical Research Core Facility and Platforms. KAIMRC-Ministry National Guard Health Affairs.

We invite participants to network, exchange thoughts and build collaborations during the forum to enable us to control and end the COVID-19 pandemic. We would like to welcome you attend the “COVID-19 Vaccine: Global Challenges and Prospects”. We believe this forum is vital and the most awaited event by all in such, individuals, health providers, scientists, decision makers and charities would benefit from the presentations and discussions to be carried out, to make the right choice of the vaccines and learn how to access to them. The COVID19 forum is one stop shop to review the front runners of these vaccines to be presented by the original developers. We thank all the prominent speakers who are presenting during the forum, the organizing committee, the collaborators and sponsors who made it possible. In addition to reviewing the latest data of these vaccines, Coalition for Epidemic Preparedness Innovations (CEPI), Gates Foundation and Bring Hope Humanitarian Foundation are presenting their plan in helping distributing the vaccines in needy parts of the world. We look forward to your participation.

Dr. Naif Alharbi Forum Co-Chairman. Director, Vaccine Development Unit at King Abdullah International Medical Research Center (KAIMRC), Riyadh, Saudi Arabia.

It is an immense honor to welcome people from all over the world to our global event that will highlight the international efforts for reaching a vaccine for COVID-19 pandemic. This is the annual KAIMRC forum that comes this year focusing on “COVID-19 Vaccine: Global Challenges and Prospect”. It brings together many of the international pharmaceutical and academic vaccine developers to discuss what the humanity has achieved so far on fighting the pandemic through vaccine development. It is unprecedented time of history to have a number of vaccines in phase III clinical testing only within a year from discovering the causing virus of the pandemic and we will be glad to host this discussion in the forum. At KAIMRC, we dedicate this forum to discuss scientific and logistic vaccine development for COVID-19, to hear about the importance of vaccination and immunity for COVID-19, to discuss what are the main lessons that we, together as humanity, have learned so far. This forum features many of the most prominent vaccinologists in the world at academia as well as many of the front-runner Pharma companies. In addition, vaccine-enabling organisations such as CEPI will be explaining their efforts and initiatives (along with international partners such as WHO and Gavi) for better funding and fair distribution of vaccines. We look forward to your participation, We hope you find it a productive and informative event.

Dr. Ahmed M. Salman Forum Co-Chairman. BSc, MSc, DPhil (Oxon). Senior Immunologist- Vaccinologist at The Jenner Institute, University of Oxford. Fellow and Advisor of Clinical Medicine at Kellogg College and Immunology Instructor at University of Oxford, UK.

The global catastrophic impact of COVID-19 pandemic calls for the urgent development of safe and effective vaccines against the virus. Researchers worldwide are moving at unprecedented speed to identify and develop viable vaccine candidates hoping to curtail the pandemic. On behalf of our organizing committee members, prestigious sponsors and bright speakers; I am very pleased and honoured to welcome you to attend the “COVID-19 Vaccine: Global Challenges and Prospects” virtual conference. All audience sectors from all over the world are welcomed including audience from academia, industrial, media, public, etc. We are aiming in this conference to highlight all the related issues and updates about the Global Efforts on COVID-19 Vaccines Development, Clinical Trials, Funding, Manufacturing and Distribution. We are honoured to have many high-profile speakers representing the most advanced COVID-19 vaccines in Phase-3 clinical trials globally including speakers from Oxford/AstraZeneca, Moderna, Johnson & Johnson, NIH, Gamaleya and others, in addition to different international funding organizations as CEPI, GATES Foundation, charities and vaccine manufacturers. COVID-19 vaccines can save millions of lives. The global collaboration and mutual assistance beyond borders are the keys to tackle this health crisis and facilitate the equitable access and distribution of these vaccines to protect people in all countries. To ensure you have the latest information about the global efforts for the COVID-19 vaccines work and clinical trials, please register for free and join us from anywhere in the world remotely but active via internet with the possibility of taking part in lively, fruitful, and constructive discussions.

Program

Day one: 4 November 2020 Theme: COVID19 Vaccines Efficacy and Current Status

Time (Riyadh) OPENING CEREMONY 13:00 – 13:30 Welcoming Remarks: • H.E. Dr. Bandar Knawy, Chief Executive Officer, Ministry of National Guard-Health Affairs President, King Saud Bin Abdulaziz University for Health Sciences • Dr. Ahmed Alaskar, Executive Director, King Abdullah International Medical Research Center • Margaretta Colangelo, Co-Founder & Managing Director, Deep Knowledge Group, San Francisco • Dr. Mohamed Boudjelal, Symposium Chairman, KAIMRC

13:40-14-30 Keynote Presentation: •Chair-Moderator: Dr. Majed Alghraibi Chairman Infectious Diseases Research Department KAIMRC, KSA.

Systems biological analysis of immunity to infection and vaccination (30 min) • Prof Bali Pulendran; Institute for Immunity, Transplantation and Infection Stanford University School of Medicine

Discussion (20 min)

14:40 – 16:20 Track: Non-Replicating Viral Vector Vaccines •Chair: Dr. Ahmad Salman The Jenner Institute, University of Oxford, UK.

Oxford-AstraZeneca Vaccine: Development of the ChAdOx1 nCoV- 19/AZD1222 vaccine (20 min) • Professor Sarah Gillbert Vaccinology in the Nuffield Department of Medicine at the University of Oxford BIDMC and Johnson & Johnson (J&J) Vaccine: An Ad26 Vector-Based Vaccine for SARS-CoV-2 (20 min) • Prof. Dan Barouch Medicine Harvard Medical School Ragon Institute of MGH, MIT, and Harvard, Director, Center for Virology and Vaccine Research, USA

Russian: Sputnik V - Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations (20 min) • Professor Aleksandr GINTSBURG Director, Gamaleya National Research Center for Epidemiology and Microbiology Academician of the Russian Academy of Sciences • Dr. Denis LOGUNOV Deputy Director for Science Gamaleya National Research Center for Epidemiology and Microbiology Corresponding Member of the Russian Academy of Sciences Doctor of Biological Sciences

Discussion (30 min) 16:30 – 17:30 Track: RNA based vaccines •Chair: Margaretta Colangelo Co-Founder & Managing Director, Deep Knowledge Group, San Francisco

RNA Vaccine: Self-amplifying RNA Covid-19 vaccine - Update and potential advantages (20 min) Prof. Robin Shattock, Faculty of Medicine, Department of Infectious Disease, Imperial College

NIH Vaccine: Prototype Pathogen Approach for Pandemic Preparedness:

Applying New Technologies for Vaccine Antigen Design and Platform Manufacturing to Address COVID-19 (20 min) • Barney S. Graham, MD, PhD, Deputy Director, Vaccine Research Center, Chief, Viral Pathogenesis Discussion (20 min)

17:40 – 18:40 Track: DNA/Protein based vaccines •Chair: Dr. Julia Michelotti; MRIGlobal, USA

Zhiefie Vaccine: Development of betacoronavirus vaccines against COVID-19, MERS and SARS, Anhui Zhifei Longcom (20 min) • Prof. Lianpan Dai, Institute of Microbiology, Chinese Academic of Sciences, China

Inovio COVID19 Vaccine (20 min) • Dr. Kate Broderick; Senior Vice President R&D at Inovio Pharmaceuticals Inc. San Diego, California

Discussion (20 min) 18:50 – 20:20 Track: Other Virus based Vaccines •Chair: Dr. Manal Alaamery; Chairman of Innovation and Entrepreneurship Department KAIMRC, MNGHA, KSA

MODERNA : The Development of mRNA-1273 to Prevent COVID-19 (20 min) • Dr. Tal Zaks; Chief Medical Officer, Moderna,

Johnson and Johnson COVID Vaccine efforts –our commitment to the patient (20 min) • Dr. Catherine Taylor; Vice President, EMEA Medical Affairs, Therapy Area Strategy at Janssen Europe, Middle East & Africa (EMEA)

Baylor-India Vaccine: A Yeast-derived COVID-19 Recombinant Protein Vaccine for Global Health (20 min) • Prof. Maria Elena Bottazzi, Associate Dean, National School of Tropical Medicine, Co-Section Head, Pediatric Tropical Medicine Professor, Pediatrics & Molecular Virology & Microbiology Baylor College of Medicine and Texas Children’s Hospital

Discussion (30 min)

20:30 – 21:00 Panel Discussion and Recommendations (30 min) Dr. Mohamed Boudjelal KAIMRC, KSA Dr. Ahmad Salman The Jenner Institute, University of Oxford, UK Margaretta Colangelo Co-Founder & Managing Director, Deep Knowledge Group, San Francisco

Day 2: 5 November 2020

Theme A: COVID19 Vaccine Research in Saudi Arabia.

Time (Riyadh) Presenter 14:00 – 15:30 Track: Saudi Academic Efforts for COVID-19 Sciences and Vaccines •Chair: Dr. Majed Aljeraisy Head of KAIMRC Research Office, Head of Clinical Trials Office

KAIMRC/Oxford MERS Vaccine Development: Setting the stage for COVID-19 Vaccine development. (15 min) • Dr. Naif Alharbi Director of Vaccine Development, King Abdullah Internatinal Medical Research Center, Riyadh, Saudi Arabia

Rapid Development of several SARS-CoV-2 vaccines based on recombinant plasmid DNA and adenovirus vector serotype 5 (15 min) • Dr. Anwar Hashem Deputy Director and Associate Professor in Immunoglogy, King Fahad Medical Research Center (KFMRC), King Abdulaziz University

Serological evaluation and impact on COVID-19 vaccines (15 min)

• Dr. Abdullah Algaisi

Assistant Professor in Virology and Vaccinology, University of Jazan/ Visiting at University of Texas Medical Branch.

Newly developed pDNA vaccine for COVID-19 (15 min) • Dr. Iman Almansour Assistant professor at the Department of Epidemic Diseases Research Imam Abdulrahman Bin Faisal University

Development of mRNA based vaccine candidate against COVID19 (15 min) Mashal M. Alshazi, B.Pharm, Ph.D. Assistant Professor of Pharmaceutical Biotechnology King Saud University, College of Pharmacy ,Riyadh, Saudi Arabia

Discussion (15 min) 15:40 – 17:10 Track: Accessibility to the Vaccine Chair: Dr. Faisal Almajed; General Director – University Relations and Media Affairs, King Saud bin Abdulaziz University for Health Sciences, Riyadh, KSA

CEPI and CoVax initiative to advance vaccine accessibility (20 min) Dr. Richard Wilder; CEPI, A global coalition for a global problem, General counsel & Head of Business Development

Challenges in Vaccine Distribution in Needy Community (20 min) • Dr Mariwan Baker, PhD; Founder and Chairman, Bring Hope Humanitarian Foundation, MINC

Global response to COVID-19 (20 min) • Dr. Holger KanzlerSenior; Program Officer at Bill & Melinda Gates ,Foundation, Seattle, Washington

Discussion (30 min)

Day Two: 5 November 2020

Theme B: COVID19 Vaccines: Efficacy and Availability

Time (Riyadh) Presenter

17:20 – 18:50 Track: Challenges Facing COVID19 Selection and Vaccination Chair: Dr. Gene Garrard Olinger Principal Advisor, Science; Global Health Surveillance & Diagnostic Division

Principle to Select Best Vaccine to Acquire (20 min) • Prof. Ziyad Memesh Director of medical research at KSMC and the chair of ID scientific, Committee, Kingdom of Saudi Arabia SUDAIRPHARMA (20 min) • Dr. Yasser Al Obaidaa CEO of SudairPharma, Riyadh, KSA

COVID-19 Vaccines in a Time of Anti-Science Disinformation • Peter Hotez, MD, PhD, FASTMH, FAAP, (20 min) Dean, National School of Tropical, Medicine, Professor, Departments of Pediatrics, Molecular Virology & Microbiology, Co-Head, Section of Pediatric Tropical Medicine, Health Policy, Scholar, Baylor College of Medicine Discussion (30 min) 19:00 – 19:30 CLOSING Presentation

Some Learnings from COVID-19 for vaccines (30 min) • Professor Adrian Hill Director of the Jenner Institute; Lakshmi Mittal and family Professor of Vaccinology; Fellow of Magdalen College, Oxford University 19:40-20:00 Recommendations and Closing Remarks • MNGHA CEO & KAIMRC ED • Symposium Chairperson

Systems biological analysis of immunity to infection and vaccination

Prof. Bali Pulendran Institute for Immunity, Transplantation and Infection Stanford University School of Medicine

Abstract: Although the development of effective vaccines has saved countless lives from infectious diseases, the basic workings of the human immune system are complex and have required the development of animal models, such as inbred mice, to define mechanisms of immunity. More recently, systems biological approaches have been developed to directly explore the human immune system with unprecedented precision. We discuss how these approaches are advancing our mechanistic understanding of human immunology and are facilitating the development of vaccines against infections such as COVID-19.

Oxford-AstraZeneca Vaccine: Development of the ChAdOx1 nCoV-19/AZD1222 vaccine

Professor Sarah Gilbert Vaccinology in the Nuffield Department of Medicine at the University of Oxford

Abstract: The presentation will summarise the approach to preclinical and clinical development of the ChAdOx1 nCoV-19/AZD1222 vaccine, including clinical immunogenicity data from phase I.

ChAdOx1 nCoV-19 vaccine prevents SARS-CoV-2 pneumonia in rhesus macaques Neeltje van Doremalen, Teresa Lambe, […] Vincent J. Munster Nature volume 586, pages578–582(2020) Cite this article.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in December 20191,2 and is responsible for the coronavirus disease 2019 (COVID-19) pandemic3. Vaccines are an essential countermeasure and are urgently needed to control the pandemic4. Here we show that the adenovirus- vector-based vaccine ChAdOx1 nCoV-19, which encodes the spike protein of SARS-CoV-2, is immunogenic in mice and elicites a robust humoral and cell- mediated response. This response was predominantly mediated by type-1 T helper cells, as demonstrated by the profiling of the IgG subclass and the expression of cytokines. Vaccination with ChAdOx1 nCoV-19 (using either a prime-only or a prime–boost regimen) induced a balanced humoral and cellular immune response of type-1 and type-2 T helper cells in rhesus macaques. We observed a significantly reduced viral load in the bronchoalveolar lavage fluid and lower respiratory tract tissue of vaccinated rhesus macaques that were challenged with SARS-CoV-2 compared with control animals, and no pneumonia was observed in vaccinated SARS-CoV-2- infected animals. However, there was no difference in nasal shedding between vaccinated and control SARS-CoV-2-infected macaques. Notably, we found no evidence of immune-enhanced disease after viral challenge in vaccinated SARS-CoV-2-infected animals. The safety, immunogenicity and efficacy profiles of ChAdOx1 nCoV-19 against symptomatic PCR-positive COVID-19 disease will now be assessed in randomized controlled clinical trials in humans.

An Ad26 Vector-Based Vaccine for SARS-CoV-2

Prof. Dan Barouch, , M.D., Ph.D. Medicine Harvard Medical School Ragon Institute of MGH, MIT, and Harvard, Director, Center for Virology and Vaccine Research, USA

Abstract: A safe and effective vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may be required to end the coronavirus disease 2019 (COVID-19) pandemic 1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 . For global deployment and pandemic control, a vaccine that requires only a single immunization would be optimal. Here we show the immunogenicity and protective efficacy of a single dose of adenovirus serotype 26 (Ad26) vector-based vaccines expressing the SARS-CoV-2 spike (S) protein in non-human primates. Fifty-two rhesus macaques (Macaca mulatta) were immunized with Ad26 vectors that encoded S variants or sham control, and then challenged with SARS-CoV-2 by the intranasal and intratracheal routes 9 , 10. The optimal Ad26 vaccine induced robust neutralizing antibody responses and provided complete or near-complete protection in bronchoalveolar lavage and nasal swabs after SARS-CoV-2 challenge. Titres of vaccine-elicited neutralizing antibodies correlated with protective efficacy, suggesting an immune correlate of protection. These data demonstrate robust single-shot vaccine protection against SARS-CoV-2 in non-human primates. The optimal Ad26 vector-based vaccine for SARS-CoV-2, termed Ad26.COV2.S, is currently being evaluated in clinical trials.

Russian: Sputnik V - The First Registered Human Adenovirus Vector-Based COVID-19 Vaccine

Professor Aleksandr GINTSBURG Director, Gamaleya National Research Center for Epidemiology and Microbiology Academician of the Russian Academy of Sciences

Dr. Denis LOGUNOV Deputy Director for Science, Gamaleya National Research Center for Epidemiology and Microbiology Corresponding Member of the Russian Academy of Sciences Doctor of Biological Sciences

Abstract: The presentation will summarise the approach to preclinical and clinical development of the Gamaleya Research Institute Non- Replicating Viral Vector Adeno-based (rAd26-S+rAd5-S)data from Preclinical to Phase III

Background: We developed a heterologous COVID-19 vaccine consisting of two components, a recombinant adenovirus type 26 (rAd26) vector and a recombinant adenovirus type 5 (rAd5) vector, both carrying the gene for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike glycoprotein (rAd26-S and rAd5-S). We aimed to assess the safety and immunogenicity of two formulations (frozen and lyophilised) of this vaccine.

We did two open, non-randomised phase 1/2 studies at two hospitals in Russia. We enrolled healthy adult volunteers (men and women) aged 18-60 years to both studies. In phase 1 of each study, we administered intramuscularly on day 0 either one dose of rAd26-S or one dose of rAd5-S and assessed the safety of the two components for 28 days. In phase 2 of the study, which began no earlier than 5 days after phase 1 vaccination, we administered intramuscularly a prime-boost vaccination, with rAd26-S given on day 0 and rAd5-S on day 21. Primary outcome

measures were antigen-specific humoral immunity (SARS-CoV-2-specific antibodies measured by ELISA on days 0, 14, 21, 28, and 42) and safety (number of participants with adverse events monitored throughout the study). Secondary outcome measures were antigen-specific cellular immunity (T-cell responses and interferon-γ concentration) and change in neutralising antibodies (detected with a SARS-CoV-2 neutralisation assay). These trials are registered with ClinicalTrials.gov, NCT04436471 and NCT04437875.

Between June 18 and Aug 3, 2020, we enrolled 76 participants to the two studies (38 in each study). In each study, nine volunteers received rAd26-S in phase 1, nine received rAd5-S in phase 1, and 20 received rAd26-S and rAd5-S in phase 2. Both vaccine formulations were safe and well tolerated. The most common adverse events were pain at injection site (44 [58%]), hyperthermia (38 [50%]), headache (32 [42%]), asthenia (21 [28%]), and muscle and joint pain (18 [24%]). Most adverse events were mild and no serious adverse events were detected. All participants produced antibodies to SARS-CoV-2 glycoprotein. At day 42, receptor binding domain-specific IgG titres were 14 703 with the frozen formulation and 11 143 with the lyophilised formulation, and neutralising antibodies were 49·25 with the frozen formulation and 45·95 with the lyophilised formulation, with a seroconversion rate of 100%. Cell-mediated responses were detected in all participants at day 28, with median cell proliferation of 2·5% CD4+ and 1·3% CD8+ with the frozen formulation, and a median cell proliferation of 1·3% CD4+ and 1·1% CD8+ with the lyophilised formulation.

The heterologous rAd26 and rAd5 vector-based COVID-19 vaccine has a good safety profile and induced strong humoral and cellular immune responses in participants. Further investigation is needed of the effectiveness of this vaccine for prevention of COVID-19.

Self-amplifying RNA Covid-19 vaccine - Update and potential advantages

Prof. Robin Shattock Faculty of Medicine, Department of Infectious Disease, Imperial College

Abstract: Self-amplifying RNA (saRNA) is an attractive platform for both nucleic acid vaccines and therapeutics, representing a highly scalable, low dose technology, able to rapidly respond to global pandemics. Derived from an alphavirus genome, saRNA retains the non-structural proteins that encode the alphaviral polymerase enzymes, but substitutes the structural proteins of the virus, downstream of the subgenomic promotor, with a vaccine immunogen of choice. Intracellular amplification of the saRNA by the encoded polymerase machinery leads to high and prolonged expression of the gene of interest. This process has the potential to elicit strong immune-stimulatory potency against the selected immunogen due to its intrinsic adjuvant activity. We have developed a saRNA encoding the SARS-CoV-2 spike protein encapsulated within a lipid nanoparticle (LNP) as a novel vaccine candidate (VGH111). We have observed rhigh and dose-dependent SARS-CoV-2 specific antibody titers in preclinical models, as well as robust neutralization of both a pseudo-virus and wild-type virus. Upon further characterization, we find that the neutralization is proportional to the quantity of specific IgG and of higher magnitude than recovered COVID-19 patients. saRNA LNP immunizations induce a Th1-biased response in mice, and there is no antibody- dependent enhancement (ADE) observed. Finally, we observe high cellular responses, as characterized by IFN-γ production, upon re-stimulation with SARS-CoV-2 peptides. These data provide important insight into the vaccine design and evaluation of immunogenicity that have enable rapid translation to the clinic. Our VGHsa111 vaccine is currently under evaluation in phase I/II clinical trials.

Prototype Pathogen Approach for Pandemic Preparedness: Applying New Technologies for Vaccine Antigen Design and Platform Manufacturing to Address COVID-19

Barney S. Graham, MD, PhD Deputy Director, Vaccine Research Center, Chief, Viral Pathogenesis

Abstract: While the frequency of pandemic threats seems to be increasing, we fortunately have new tools and technologies to make vaccines with more precision and speed and that support a more proactive approach to pandemic preparedness and response. There are ~25 virus families associated with human infection from which the next pandemic threat will likely arise. Within each relevant virus family, a database of information with accompanying reagents, assays, and animal models could be developed for prototypic viruses based on properties of tropism, transmission routes, and other distinguishing features of pathogenesis. Candidate vaccine approaches could be designed based on virus structure, transmission dynamics, entry requirements, and replication strategy.

The prototype pathogen approach for pandemic preparedness has been applied to MERS CoV over the last 7 years. It was informed by structure- based immunogen-design concepts established for RSV F subunit vaccines, and focused on solving coronavirus spike structures, defining mechanisms of CoV neutralization, and evaluating MERS CoV vaccine candidates in collaboration with a commercial mRNA manufacturer. Prior spike protein engineering experience resulted in rapid sequence selection and using the mRNA manufacturing platform provided rapid GMP production a COVID-19 mRNA vaccine in record time. This candidate was tested in mice in ~25 days and humans in ~65 days from the time sequence was released. The product has been shown to be immunogenic and protective in mice, hamsters, and NHP and no safety

signals have been noted. Phase 1 and 2 clinical trials demonstrated that mRNA-1273 is well tolerated and immunogenic. These data supported initiation of a 30,000 subject Phase 3 trial on July 27th, 198 days from sequence availability. The proactive preparation not only facilitated rapid vaccine development and evaluation but provided stabilized spike protein reagents that were the basis for developing serological assays and isolating potent human neutralizing mAbs being clinically evaluated for prevention and therapy.

Development of betacoronavirus vaccines against COVID-19, MERS and SARS

Prof. Lianpan Dai Institute of Microbiology, Chinese Academy of Sciences, China

Abstract: Vaccines are urgently needed to control the ongoing pandemic COVID-19 and previously emerging MERS/SARS caused by coronavirus (CoV) infections. The CoV spike receptor-binding domain (RBD) is an attractivevaccine target but is undermined by limited immunogenicity.We describe a dimeric form of MERS-CoV RBD that overcomes this limitation. The RBD-dimer significantly increased neutralizing antibody (NAb) titers compared to conventional monomeric form and protected mice against MERS-CoV infection. Crystal structure showed RBD-dimer fully exposed dual receptor-binding motifs, the major target for NAbs. Structureguided design further yielded a stable version of RBD-dimer as a tandem repeat single-chain (RBD-sc-dimer) which retained the vaccine potency. We generalized this strategy to design vaccines against COVID-19 and SARS, achieving 10- to 100-fold enhancement of NAb titers. RBD-sc-dimers in pilot scale production yielded high yields, supporting their scalability for further clinical development. The framework of immunogen design can be universally applied to other beta-CoV vaccines to counter emerging threats. The COVID-19 vaccine designed here has shown protective efficacy in animal models and have finished phase II clinical trials in human.

INO-4800: A DNA-based vaccine against COVID-19

Dr. Kate E. Broderick Senior Vice President R&D at Inovio Pharmaceuticals Inc., San Diego, California, USA

Abstract: We will review the progress of INO-4800, a DNA-based vaccine against COVID-19, since its design in January using our proprietary computer algorithm, through preclinical testing and into the clinic. We will also discuss the global scale up of manufacturing plans for INO-4800.

The Development of mRNA-1273 to Prevent COVID-19

Dr. Tal Zaks Chief Medical Officer, Moderna, Affiliation

Abstract: The severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) emerged in late 2019 and spread globally, prompting an international effort to accelerate development of a vaccine. The candidate vaccine mRNA-1273 encodes the stabilized prefusion SARS- CoV-2 spike protein.

We conducted a phase 1, dose-escalation, open-label trial including 45 healthy adults, 18 to 55 years of age, who received two vaccinations, 28 days apart, with mRNA-1273 in a dose of 25 μg, 100 μg, or 250 μg. There were 15 participants in each dose group. After the first vaccination, antibody responses were higher with higher dose (day 29 enzyme-linked immunosorbent assay anti–S-2P antibody geometric mean titer [GMT], 40,227 in the 25-μg group, 109,209 in the 100-μg group, and 213,526 in the 250-μg group). After the second vaccination, the titers increased (day 57 GMT, 299,751, 782,719, and 1,192,154, respectively). After the second vaccination, serum- neutralizing activity was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum specimens. Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events.

The mRNA-1273 vaccine induced anti–SARS-CoV-2 immune responses in all participants, and no trial-limiting safety concerns were identified. These findings support further development of this vaccine.

A Yeast-derived COVID-19 Recombinant Protein Vaccine for Global Health

Prof. Maria Elena Bottazzi Associate Dean, National School of Tropical Medicine, Co-Section Head, Pediatric Tropical Medicine Professor, Pediatrics & Molecular Virology & Microbiology Baylor College of Medicine and Texas Children’s Hospital

Abstract: In a collaboration between Baylor College of Medicine, Texas Children’s Center for Vaccine Development and Biological E (Hyderabad, India) a new recombinant protein vaccine produced in Pichia pastoris is under development, production, and clinical testing. By using a low-cost technology similar to that used for the recombinant hepatitis B vaccine it is anticipated that the vaccine can be made widely available, especially for the world’s low- and middle-income.

KAIMRC/Oxford MERS Vaccine Development: Setting the stage for COVID-19 Vaccine development

Dr. Naif Alharbi Director of Vaccine Development, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia

Abstract: Since the emergence of MERS-CoV in 2012 and the major outbreaks of MERS in Saudi Arabia 2015, KAIMRC has been working on multiple projects on MERS. In collaboration with Oxford, KAIMRC has co- developed the ChAdOx1 MERS vaccine in camel studies and in a phase I clinical trial, the first ever in Saudi Arabia. This presentation summarises this vaccine development, presenting safety, immunogenicity, efficacy data in mice and camels as well as safety data in KAIMRC phase I clinical trial. These efforts and works have resulted in a better prepared world for establishing and accelerating COVID-19 vaccine developments.

Rapid Development of several SARS-CoV-2 vaccines based on recombinant plasmid DNA and adenovirus vector serotype 5

Dr. Anwar Hashem Associate Professor in the Department of Medical Microbiology & Parasitology, Faculty of Medicine, King Abdulaziz University

Abstract: The ongoing Coronavirus Disease 2019 (COVID-19) pandemic due to the emergence of the novel SARS-CoV-2 is causing unprecedented morbidity and mortality globally requiring the development of effective and safe prophylactic or therapeutic measures. The spike (S) glycoprotein represents a major antigenic viral protein, and plays a crucial role in the virus pathogenicity and entry into host cells. Thus, the S protein is targeted by most experimental vaccines in development. In our response to this threat, we developed several vaccine candidates using recombinant DNA or adenovirus vector (serotype 5) expressing the full S protein or the S1 subunit only. These vaccines were designed and developed very early during the pandemic based on our established platforms and used for immunogenicity testing in mouse models using multiple immunization routes.

Rapid Development of serological assays for SARS-CoV- 2 seroprevalence studies and vaccine evaluations

Dr. Abdullah Algaissi Assistant Professor in Virology and Vaccinology University of Jazan, Saudi Arabia/Visiting at University of Texas Medical Branch

Abstract: As COVID-19 pandemic, which is caused by SARS-CoV-2, continues to spread globally causing significant rates of morbidity and mortality, there is an urgent need for effective and safe vaccines to limit the unprecedented spread of this pandemic. Additionally, it is also very important to determine the immunity in SARS-CoV-2 infected patients and recovered individuals which can aid in vaccine development strategies. While molecular assays are used to detect viral genetic material for the diagnosis of acute infection, reliable serological assays are needed to measure immunity against SARS-CoV-2.

In response to the emergence of SARS-CoV-2, our group has been working in developing serological assays for SARS-CoV-2. The highly infectious nature of SARS-CoV-2 is a bottleneck to study this virus. To meet this challenge, we have developed a safe and convenient method to detect virus specific neutralizing antibodies in serum samples under biosafety level-2 conditions using a recombinant pseudovirus on bearing SARS-CoV-2 S protein. Additionally, we have developed an in-house enzyme-linked immunosorbent assay (ELISA) that detects antibodies against SARS-CoV-2 S and N proteins. Both these tests have been well- validated and used for evaluation of immune response of SARS-COV-2 vaccine candidates as well as for seroprevalence studies in populations.

Immunogenicity of pDNA vaccines candidates against COVID-19

Dr. Iman Almansour Assistant Professor at the Department of Epidemic Diseases Research Institute for Research and Medical Consultations (IRMC) Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia

Abstract: Vaccination has been proven as the most effective measure to control and prevent pandemics. At present, no licensed vaccine to protect from infection with SARS-CoV-2, the causative agent for COVID- 19 exists. There is a global demand for the development of a prophylactic vaccine that is safe and efficacious. Plasmid DNA vaccine offers several features that are ideal in pandemic situation. These include: selectivity to contain a single gene of interest, ability to elicit both humoral and cellular immune responses, and high stability. Here, we described preclinical development of plasmid DNA vaccines encoding different forms of the spike glycoprotein of SARS-CoV-2. Seven C57BL/6 mice groups were immunized intramuscularly with different pDNA vaccine candidates and at different doses. The immunogenicity studies evaluated the binding, neutralizing antibodies, and cytokines levels. Overall, the study indicates that three doses DNA vaccine encoding S. FL effectively elicited high level of protective antibodies mediated responses that supports further translational study.

Development of mRNA-based vaccine candidate against COVID19

Mashal M. Alshazi, B.Pharm, Ph.D. Assistant Professor of Pharmaceutical Biotechnology King Saud University, College of Pharmacy, Riyadh, Saudi Arabia

Abstract: Covid-19 is newly emerging infectious disease, which is caused by SARS-CoV-2. It is the threat number one for the whole world with cases and fatalities increasing exponentially every day. Until now, there is no vaccine available against SARS-CoV-2 in the clinic. To accelerate the development and ensure success of the SARS-CoV-2 vaccine, an innovative platform technology, known as mRNA-based vaccine, will be utilized to revolutionize vaccine development. We will target the spike protein and RBD to develop mRNA-based vaccine. The innovation of this technology includes: 1) accelerates development of vaccine against SARS-CoV-2; 2) employs a new vaccine technology, which can be used for future development of vaccines against other epidemics; 3) Our vaccine will be based on the spike protein and RBD sequences isolated from patients in Saudi Arabia and neighbouring regions.

Equitable Access to COVID-19 Vaccines; Agreements Between CEPI and Manufactures and Implementation through COVAX Facility

Mr. Richard Wilder General Counsel and Head of Business Development, Coalition for Epidemic Preparedness Innovations (CEPI)

Abstract: Starting in January 2020 CEPI established a portfolio of projects to develop vaccines against SARS-CoV-2 (the virus that causes COVID-19). Developing the agreements and their implementation has been driven by the overarching need for Speed, Scale and Access. The agreements to start the projects have been put in place rapidly and have called for work normally done in sequence to be done in parallel to ensure that vaccines once developed are widely available quickly. Given the global nature of the COVID-19 pandemic CEPI and its development partners agreed that vaccine doses would be needed quickly and in large quantities. It was also agreed from the beginning that the vaccines once developed would need to be available quickly and at scale across the globe - including for low-income countries. With the advent of the ACT- Accelerator and the COVAX Facility CEPI has worked with the WHO, GAVI, and our development partners to move the projects rapidly from stages of development and clinical studies to manufacture at scale and to global procurement and distribution.

Challenges in the delivery of COVID-19 vaccines to people in need

Dr. Mariwan Baker, PhD Founder and Chairman, Bring Hope Humanitarian Foundation, MINC

Abstract: The COVID-19 outbreak, highly contagious virus, is one of the worst pandemics in human history. The hope for developing an effective and safe vaccine to combat the spread of this virus is crucial, since, in human history, vaccines have been the world’s great success stories and most cost-effective prevention in reducing mortalities, morbidity and substantial disability of high-burden diseases. Immunization has nearly eradicated many diseases; however, there have been challenges to accomplish global vaccinations. Vulnerable people in developing countries remain the weakest groups during pandemics. Alas, there are still millions of children across the world who are not vaccinated against common diseases such as; smallpox, measles, poliomyelitis, tetanus, and other vaccine preventable diseases.

There are multiple attempts, worldwide, in progress committed to intense efforts to develop a safe and effective COVID-19 vaccine, despite many scientific uncertainties including age-based effectiveness, duration of the protection, primary immunization or required boosters, adverse side effects, nuances of the virus spread, factors affecting the transmission, risk for reinfection, virus mutation, and establishment of risk categories for social and personal vulnerabilities.

Once a safe and effective COVID-19 vaccine is developed, access to it, for the most vulnerable groups, such as people in war zones, refugee camps, slums, and the remotest areas, will remain extremely limited, if not impossible to access. These groups and the many governments

trying to address the populations affected might suffer from financial barriers, poor health-care systems, fragile supply chains, limited human resource capacity, political and social instabilities, and improper logistics, in terms of warehousing, cold chain equipment management, and maintaining data monitoring. This will, subsequently, disrupt delivery of vaccines and strain the fragile systems available to keep up with the required large volumes necessary to ensure effective vaccinations on a large scale.

Another crucial issue is cultural perception, where critical attitudes of local landlords, warlords, and religious and tribal leaders towards vaccination must be taken into consideration. In the case of COVID-19, the skepticism and lack of trust towards the possible vaccine has been increased worldwide, especially in developing countries. However, optimal control of COVID-19 through vaccination of people in developing countries can be facilitated by vaccines that do not require cold chain, and do not require delivery through needle or syringe. It is also critical that there is collaboration between vaccine developers, regulators, governments, manufacturers, vaccination financiers, and public private sector deliverers, on one side, and local various ministries and local leaders, as well as local logistical partners to build the trust required to optimize the complex vaccination system and achieve self- sufficiency.

Principle to Select Best Vaccine to Acquire

Prof. Ziad Memish Director of Research & Innovation Center at King Saud Medical City, Ministry of Health. Professor at the College of Medicine in Al Faisal University, Riyadh, Saudi Arabia

Abstract: As of mid-October 2020, more than 30 million people have been infected with severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) and more than one million lives have been lost worldwide. The threat of this virus to health, the economy and to society is so great that the wish for a fast track vaccine is understandable. The different vaccine platforms being tested are DNA and RNA-based vaccines, inactivated vaccines, protein subunits, and viral vectors. Each platform offers advantages and have disadvantages making the choice of the right vaccine platform extremely difficult. Several phase three clinical trials are ongoing with coronavirus-vaccine and they could announce game-changing results in the coming months. There are many concerns whether the vaccines will clear safety and efficacy trials. We have already seen some bad signs with the UK trial of a leading vaccine candidate developed by the University of Oxford and pharmaceutical company AstraZeneca restarted after a six-day pause to investigate safety concerns in early October. To many experts, the development of a vaccine against SARS-CoV-2 will be the way to restore normality to civil life in this time of a devastating pandemic.

Saudi Biotech Pharma Landscape

Dr. Yasser Al Obaida CEO, Sudair Pharmaceutical Company (SPC)

Abstract: Timeliness in investing in Pharmaceuticals has never been more emphasized than what we have witnessed in these past few months, where Globally lives had been affected due to unexpected disease that somehow crippled the economy and brought challenges to our healthcare systems and our lives. In this, lessons had been learned that Health is the most precious commodity for everybody, and to ensure that health is not compromised, Healthcare and Pharmaceutical must become one of the top priorities of any country.

KSA Pharmaceutical is one of the most important sectors in the Kingdom. It is the largest spender on healthcare across the Middle East and North Africa. The 2018 government budget allocated more than $39 billion to “Health and Social Development” in a market that enjoys an annual growth rate of approximately 5.6. Yet, the KSA Pharma market is driven by imports amounting to 80% of its total pharmaceutical market.

Revolutionizing pharmaceutical through slowly introducing Biopharmaceutical in the Kingdom is one of the keys to combat future challenges of the healthcare systems. Investing in such sophisticated avenue requires Great Cost and met with other challenges such as Limited national clinical research capabilities Regulatory Framework Limitation and Limited skilled/Trained manpower resources among others. Although with all these challenges, it cannot hinder us in trying to at least study the feasibility of establishing Biopharma in the kingdom. As the government with its Vision 2030 ensuring support for local manufacturers of pharmaceutical products and giving attractive opportunity for the foreign pharmaceutical companies to put up a pharmaceutical manufacturing facility in partnership with Saudi Nationals. It is high time, to start looking into the possibility of establishing in the Kingdom a Biopharmaceutical Industry.

COVID-19 Vaccines in a Time of Anti-Science Disinformation

Peter Hotez, MD, PhD, FASTMH, FAAP Dean, National School of Tropical Medicine Professor, Departments of Pediatrics, Molecular Virology & Microbiology Co-Head, Section of Pediatric Tropical Medicine, Health Policy Scholar, Baylor College of Medicine

Abstract: New surveys indicate a significant percentage of Americans will refuse COVID-19 vaccines even if they are licensed and made available. This reflects a growing antivaccine movement that re- energized beginning in 2015 and now under the banner of “health freedom” or “medical freedom” campaigns against masks, contact tracing and social distancing. The anti-science movement has accelerated and expanded into Europe, linked to political extremism. We will discuss ways to slow or halt anti-science activities to promote vaccine acceptance.

Biographies

Prof. Bali Pulendran Violetta L. Horton Professor, Institute for Immunity, Transplantation and Infection, Department of PathologyDepartment of Microbiology and Immunology, Fellow at ChEM-H (Chemistry, Engineering and Medicine for Human Health), Stanford University School of Medicine, Stanford University.

Bali Pulendran is the Violetta L. Horton Professor at the Stanford University School of Medicine, and a member of the Institute for Immunology, Transplantation and Infection, and the Departments of Pathology and Microbiology & Immunology at Stanford University. He is also an adjunct professor at Emory University and the Yerkes National Primate Center, and director of the NIH Center for Systems Vaccinology, at Emory University in Atlanta. He received his undergraduate degree in the Natural Sciences Tripos from Queens’ College, Cambridge University, and his Ph.D., from the Walter & Eliza Hall Institute in Melbourne, Australia, under the supervision of Sir Gustav Nossal. He then did his post-doctoral work at Immunex Corporation in Seattle. Dr. Pulendran’s research is focused on understanding the mechanisms by which the innate immune system regulates adaptive immunity and harnessing such mechanisms in the design of novel vaccines. More recently, his laboratory pioneered the use of systems biological approaches to predicting the efficacy of vaccines and deciphering new molecular correlates of protection against infectious diseases. Dr. Pulendran’s research is published in front line journals such as Nature, Science, Cell, Nature Medicine, and Nature Immunology. Furthermore, Dr. Pulendran is the recipient of numerous grants from the National Institutes of Health, and from The Bill and Melinda Gates Foundation, serves on many editorial boards, and is the recipient of two concurrent MERIT awards from the National Institutes of Health. Dr. Pulendran serves on many advisory boards including that of Keystone Symposia and on the Immunology Network of GSK. He is listed on Thomson Reuter’s list of Highly Cited Researchers (ranked amongst top 1% of researchers most cited for their subject during the past decade).

Prof. Sarah C. Gilbert Jenner Institute, University of Oxford

Sarah Gilbert is Professor of Vaccinology in the Nuffield Department of Medicine at the University of Oxford. She completed her undergraduate studies at the University of East Anglia and her doctoral degree at the University of Hull. Following four years as a research scientist at the biopharmaceutical company Delta Biotechnology she joined Oxford University in 1994 and became part of the Jenner Institute (within NDM) when it was founded in 2005. Her chief research interest is the development of viral-vectored vaccines that work by inducing strong and protective T and B cell responses. She works on vaccines for many different emerging pathogens, including influenza, Nipah, MERS, Lassa, Crimean-Congo haemorrhagic fever, and SARS-CoV-2. Working with colleagues in the Jenner Institute research labs, the Clinical Biomanufacturing Facility and Centre for Clinical Vaccinology and Tropical Medicine, all situated on the Old Road Campus in Oxford, she is able to take novel vaccines from design to clinical development, with a particular interest in the rapid transfer of vaccines into manufacturing and first in human trials. She is the Oxford Project Leader for ChAdOx1 nCoV-19, a promising vaccine against the novel coronavirus, SARS-CoV-2.

Prof. Dan Barouch, M.D., Ph.D. William Bosworth Castle Professor of Medicine Harvard Medical School Ragon Institute of MGH, MIT, and Harvard Director, Center for Virology and Vaccine Research Beth Israel Deaconess Medical Center Boston, MA 02215

Dr. Dan Barouch received his Ph.D. in immunology from Oxford University and his M.D. from Harvard Medical School. He is currently the William Bosworth Castle Professor of Medicine and Professor of Immunology at Harvard Medical School, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, a member of the Ragon Institute of MGH, MIT, and Harvard, and part of the Bill & Melinda Gates Foundation Collaboration for AIDS Vaccine Discovery. His laboratory focuses on studying the immunology and virology of HIV-1

infection and developing novel vaccine and eradication strategies. His group has also applied their vaccine expertise to preclinical and clinical studies of other infectious diseases of global significance, including Zika virus, tuberculosis, and most recently SARS-CoV-2.

Professor Aleksandr GINTSBURG Director, Gamaleya National Research Center for Epidemiology and Microbiology Academician of the Russian Academy of Sciences

Since 1982, Professor Gintsburg has worked at the National Research Center for Epidemiology and has been its Director since 1997. Since 2000, he has been the Head of the Department of Infectious Diseases at the Faculty of Medicine and Preventive Medicine for postgraduate professional education at Sechenov University. Also, in 2000, he was elected a corresponding member, and in 2013, he became an academician of the Russian Academy of Sciences. He is a winner of the Russian Government Award and was awarded the Medal of P. Ehrlich.

Dr. Denis LOGUNOV Deputy Director for Science, Gamaleya National Research Center for Epidemiology and Microbiology Corresponding Member of the Russian Academy of Sciences, Doctor of Biological Sciences

Dr. Logunov is the author of over 140 scientific papers, including one monograph, a chapter in a book, 82 articles in peer-reviewed journals, 21 patents, and six guidelines and recommendations. He leads the development of vector platforms for the creation of recombinant viral vaccines and gene therapy drugs. Four Ph.D. theses have been defended under his supervision.

Dr Logunov is also the head of the development team for the Russian coronavirus vaccine. The first Russian vaccine against COVID-19 Sputnik V was developed under his supervision at the Gamaleya Center. By the Decree of the President of the Russian Federation of June 13, 2019, he was awarded a medal of the Order of Merit for the Fatherland (II degree) for valuable contributions to the development of healthcare and medical science and meticulous long-term work.

Prof. Robin Shattock, Faculty of Medicine, Department of Infectious Disease, Imperial College

Professor Robin Shattock is the Head of Mucosal Infection and Immunity within the Department of Medicine at Imperial College London. Professor Shattock’s research focuses on the mechanisms of mucosal infection and the development of novel preventative strategies appropriate to a developing world setting. This has led to the establishment of international collaborations aimed at preclinical identification, development and selection of HIV microbicide and vaccine candidates prior to formal clinical efficacy trials. Professor Shattock oversees a portfolio of research that is supported by 26 members of staff including researchers, PhD students, clinical trial managers and project managers. Professor Shattock has published over 160 peer reviewed articles in this area and secured funding from the European Commission, Bill and Melinda Gates Foundation, Wellcome Trust, MRC and the NIH.

Prof. Barney S. Graham, MD, PhD Deputy Director, Vaccine Research Center Chief, Viral Pathogenesis Laboratory

Dr. Graham is Deputy Director and Chief of the Viral Pathogenesis Laboratory at the NIAID Vaccine Research enter. He has a BA from Rice University, an MD from the University of Kansas School of Medicine, and a PhD in Microbiology &

Immunology from Vanderbilt University School of Medicine. His primary interests are vaccine development for viral diseases, viral pathogenesis, mechanisms of immunity, and pandemic preparedness. His laboratory has developed novel vaccines for RSV, influenza, Zika, and coronaviruses including the first COVID-19 vaccine and monoclonal antibody products to enter clinical testing.

Lianpan Dai, PhD Principle Investigator at Institute of Microbiology, Chinese Academy of Sciences.

He received his bachelor degree from Wuhan University, China, his master's degree from the Institute of Microbiology, Chinese Academy of Sciences, and his doctor's degree from Technical University of Munich, Germany. His research is mainly focused on: the structural basis of main antigen proteins of major infectious diseases; Structure-based innovative vaccine design and development; Study on protective immune response mechanism; Transformation of basic research results into clinical trials. He developed novel coronavirus vaccine candidates and novel Zika virus vaccine candidate.

Dr. Kate E. Broderick

Senior Vice President R&D at Inovio Pharmaceuticals Inc., San Diego, California, USA

Dr Broderick has a broad background in the product development and device development DNA therapeutic and drug delivery field, with specific expertise in in vivo DNA therapeutic animal studies and product development in relation to DNA delivery. Her particular area of focus is infectious diseases with an emphasis on emerging targets and those from a bio- threat potential. On the bio-engineering side, Dr Broderick leads the device design

efforts specifically pertaining to tissue delivery and she has been central to the development of Inovio novel prototypes and designs. Dr Broderick leads a diverse team of researches which encompasses early discovery work through to IND enabling studies and she is subsequently involved in the clinical and regulatory development of these products. Dr Broderick has authored and co-authored over 70 peer reviewed article and her group regularly publish their findings and present their work in the public forum at conferences. Due to her expertise in the area, Dr Broderick has been invited to participate in WHO advisory meetings related to DNA vaccines and their delivery. Dr Broderick is also a co-inventor on multiple patents related to DNA vaccine delivery and is principal investigator on grants, awards and contracts from funding bodies such as The Gates Foundation, NIH, Department of Defense and SBIR. She was recently awarded a contract of $56 million from CEPI to fast-track DNA based vaccine candidates for Lassa and MERS through clinical testing. Dr. Broderick received her PhD from the University of Glasgow in Scotland and performed her post-doctoral research at the University of California, San Diego. She joined Inovio Pharmaceuticals in 2006 where she currently leads a diverse research group focused on enhanced delivery techniques for gene-based therapeutics as the Senior Vice President, Preclinical R&D.

Tal Zaks, M.D., Ph.D. Chief Medical Officer

As Chief Medical Officer, Tal Zaks oversees clinical development and regulatory affairs across Moderna. Prior to joining Moderna, Dr. Zaks was senior vice president and head of Global Oncology at Sanofi, where he was responsible for all aspects of oncology drug discovery, development and commercialization. Dr. Zaks began his industry career at GlaxoSmithKline in the genetics research group, where he built the oncology translational medicine team and led translational research on lapatinib as well as the in-licensing and clinical development of foretinib. In addition to his industry work, Dr. Zaks is associate professor of medicine at the University of Pennsylvania, and has served as a volunteer physician at the

Philadelphia Veterans Administration Medical Center, treating patients with genitourinary cancers. Dr. Zaks holds a M.D. and Ph.D. and conducted post-doctoral research at the U.S. National Institutes of Health. He completed his clinical training in internal medicine at Temple University Hospital followed by a fellowship in medical oncology at the University of Pennsylvania. Dr. Zaks serves on the Board of Directors of Adaptimmune Therapeutics plc.

Dr. Catherine Taylor Vice President, EMEA Medical Affairs, Therapy Area Strategy at Janssen Europe, Middle East & Africa (EMEA)

Prior to that she worked in the Middle East as the Regional Medical Director, EMEA Emerging Markets for Janssen-Cilag Middle East Ltd. Between 2016-2019 she was the Medical Affairs Therapeutic Area Lead in Haematology for Janssen Oncology across the EMEA (Europe, Middle East and Africa) region. Dr Taylor holds an MD from King’s College London and is a member of the UK Royal College of Physicians.

Prior to joining the pharmaceutical industry, she trained and practiced in Clinical Oncology in London for 7 years. She also holds the Diploma in Pharmaceutical Medicine and has completed her UK specialty training in Pharmaceutical Medicine.

Prior to joining Janssen in 2015, she held positions in UK, EMEA regional and global medical affairs at Pfizer and Astellas.

Maria Elena Bottazzi, Ph.D., FASTMH Associate Dean of the National School of Tropical Medicine, Professor of Pediatrics and Co-director of Texas Children’s Center for Vaccine Development at Baylor College of Medicine in Houston, Texas.

She is an internationally recognized vaccinologist with more than two decades of experience advancing product development partnerships. She has built sustainable biotechnology capacity building alliances and successfully transitioned several neglected tropical diseases (NTDs) and emerging disease vaccines from bench to clinical trials. As global thought-leader she has received national and international highly regarded awards, has more than 150 scientific papers and participated in more than 250 conferences worldwide. She is Member of the National Academy of Science of Honduras and an Emerging Leader in Health and Medicine Scholar of the National Academy of Medicine in the US. Dr. Bottazzi currently serves as Co-chair of the New Vaccines and Therapeutics Taskforce of the Lancet Commission on COVID-19. She is also a Fellow of the American Society of Tropical Medicine and Hygiene (ASTMH), the Executive Leadership in Academic Medicine (ELAM), the Leshner Leadership Institute Public Engagement and Sr. Fellow of the American Leadership Forum (ALF). In August 2020, Forbes LATAM selected Dr. Bottazzi as one of 100 Most Powerful Women in Central America. Dr. Bottazzi obtained her bachelor’s degree in Microbiology and Clinical Chemistry from the National Autonomous University of Honduras and a doctorate in Molecular Immunology and Experimental Pathology from the University of Florida. Her post- doctoral training in Cellular Biology was completed at University of Miami and Pennsylvania.

Dr. Naif Alharbi Director of Vaccine Development, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia

Dr. Alharbi is working at King Abdullah International Medical Research Center (KAIMRC) as an associate research scientist; Director of Vaccine Development Unit; Head of Research Quality Management; and Head of Biosafety Office. He is a visiting academic at the University of Oxford; Member in CEPI/WHO taskforces and groups for MERS and COVID-19 vaccines and serology. Final Judge in the Saudi National Scientific Olympics; member of Pandemic Preparedness Leading team in the HWG at Saudi G20 Submit; Consultant to a Biopharmaceutical Company; Member of the Saudi COVID-19 Vaccine National Scientific Committee; Member of Lab Biosafety Committee in MoD, KSA. He is certified by Saudi Commission for Health Specialities. Furthermore, Dr. Alharbi has been involved in academic teaching activities in different universities since 2012 to present. Dr. Alharbi completed his B.Sc. in Medical Microbiology at Qassim University, Saudi Arabia, Master degree in Molecular Medical Microbiology at the University of Nottingham, UK, and a DPhil (Oxon) degree in Clinical Medicine (Molecular Virology and Vaccinology) at the University of Oxford focused on viral vector vaccines. He continued his postdoctoral fellowship at the University of Oxford where he co- developed ChAdOx1 MERS vaccine with Prof. S. C. Gilbert and team. Dr. Alharbi continues the development of this vaccine from mice, through camels and human clinical trials. He has published 15 papers, a book chapter, presented more than 20 presentations in international conferences and seminars and several presentations in national conferences. Dr. Alharbi is a Principal Investigator (PI) and Co-Investigator (Co-PI) on various research grants on vaccines, viruses, and immunology.

Dr. Anwar Hashem, Associate Professor in the department of Medical Microbiology & Parasitology, Faculty of Medicine, King Abdulaziz University

Dr. Anwar Hashem has a MSc/PhD in Microbiology and Immunology from the faculty of medicine at the University of Ottawa. Currently, Dr. Anwar Hashem is an associate professor in the department of Medical Microbiology & Parasitology, Faculty of Medicine, King Abdulaziz University where he also acts as the deputy director of King Fahd Medical Research Center and leads the vaccine and immunotherapy research unit at the center.

Dr. Anwar Hashem is an immunovirologist trained in the fields of virology and vaccine development with a long-term research interest in biologics, viral vectors, vaccines and immuno- and viro-therapeutics development against pathogens and cancers. Dr. Hashem has more than 60 publications and supervised more ~20 MSc and PhD students and post-doctoral fellows.

Dr. Abdullah Algaissi Assistant Professor in Virology and Vaccinology University of Jazan, Saudi Arabia/Visiting at University of Texas Medical Branch

Dr. Algaissi has a MS in virology from the New York Medical College in NY and a PhD also in virology from the University of Texas Medical Branch (UTMB) at Galveston, Texas and an MPH in epidemiology of infectious diseases from the same university. During his PhD, he worked on the pathogenesis and vaccine development for emerging coronaviruses MERS-CoV and SARS-CoV at the high containment laboratory at the Galveston National Laboratory in UTMB. His research interest includes the epidemiology, pathogenesis and development of medical countermeasures for emerging and re-remerging viruses.

Currently, Dr. Algaissi is an assistant professor of virology at Jazan University in Saudi Arabia. He is also leading the emerging and re-emerging infectious diseases research lab at the medical research center at Jazan University.

Dr. Iman Almansour Assistant Professor at the Department of Epidemic Diseases Research (IRMC) at Imam Abdulrahman Bin Faisal University.

She earned her Ph.D. degree in Biomedical Engineering and Biotechnology from University of Massachusetts. Her Ph.D. research focused on novel strategy to produce panel of HA-expressing pDNA vaccines from antigenically divergent influenza H1N1 strains and evaluated the magnitude and breadth of binding and neutralizing antibodies responses. Results demonstrated in the study have explored the potential to develop subtype-specific influenza vaccine that can induce broadly cross-neutralizing antibodies against divergent H1N1 strains.

Almansour’s current research is focused on developing nucleic acid vaccines (NAV) against emerging and re-emerging viruses. By combining interdisciplinary approaches of synthetic biology, immunology, and bioinformatics, Almansour seeks to design, develop, and evaluate of NAV vaccines candidates against SARS-CoV-2, MERS-CoV, and Zika. Besides, Almansour is interested in establishing integrative bioinformatics resources and applying computational methods for monitoring virus evolution, viral immune surveillance, and rational design of vaccines. Her recently founded resources include IRAM, MMRdb, and hCoronaviruses. Almansour is also an academic member of the European Virus Bioinformatics Center (EVBC) in Germany.

Mashal M. Alshazi, B.Pharm, Ph.D. Assistant Professor of Pharmaceutical Biotechnology, King Saud University, College of Pharmacy, Riyadh, Saudi Arabia

Mashal M. Alshazi earned his bachelor degree in Pharmaceutical Sciences from King Saud University in 2006 and his Ph.D. in Pharmaceutical Biotechnology from the University of Illinois, USA in 2015. During 2014, he joined AstraZeneca, Infection BioScience, Boston, where he worked in development of in-depthpharmacokinetic/pharmacodynamics (PK/PD) profiles of drugs against clinical isolates using in vitro hollow fiber infection model. During 2017-2018, he joined a fellowship program at Department of Pediatrics National School of Tropical Medicine, Baylor College of Medicine and Texas Children’s Hospital Center for Vaccine Development - Product Development Partnership. During his time at Center for Vaccine Development, he participated in development of vaccines against MERS-CoV and leishmaniasis. He was trained at different vaccines and biologics units including discovery unit, process development unit (upstream and downstream processes), formulation and analytical unit and quality control and quality assurance units. Dr. Alshazi is having several research grants from Saudi Ministry of Education (MOE), Ministry of National Guard, Saudi Ministry of Health (MOH) and King Saud University (KSU) for development of RNA and protein-based vaccines against MERS and COVID19. Currently, Dr. Alshazi is working as assistant professor of pharmaceutical biotechnology at College of Pharmacy, KSU. Since 2011, Dr. Alshazi authored and co-authored several peer-reviewed articles, and supervised, co-supervised and examined a number of undergraduate and graduate students. Dr. Alshazi has authored many standard operating procedures based on FDA and EMA regulations. He received several awards including Grand Challenges grant Award in 2020 and Van Doren Scholar Award in 2015. Dr. Alshazi interests include pharmaceutical and biopharmaceutical R&D, industry and regulation especially in the fields of vaccines, biologics and biosimilars. Dr. Alshazi is working with several governmental bodies as vaccines and biologics consultant including Saudi Food and Drug Authority (SFDA).

Mr. Richard Wilder General Counsel and Head of Business Development, Coalition for Epidemic Preparedness Innovations (CEPI)

Mr. Wilder is General Counsel and Director of Business Development at the Coalition for Epidemic Preparedness Innovations. There he and his team are responsible for drafting and negotiating legal instruments necessary to progress CEPI’s mission and to support its administrative requirements. He and his team also support external engagement with the wide range of actors that form the CEPI coalition. He previously had a similar role in the Global Health Program at the Bill & Melinda Gates Foundation. Prior to that, he was Associate General Counsel for Intellectual Property Policy at Microsoft Corporation where he was responsible for defining and driving the company-wide policy in all areas of intellectual property. Mr. Wilder spent years as a partner in a global law firm, where he specialized in international trade law and practiced in the field of global public health. There he advised the Global Fund to Fight AIDS, Tuberculosis, and Malaria, the World Health Organization, the Medicines for Malaria Venture, the Global Alliance for TB Drug Development, the U.S. Agency for International Development, and the Bill & Melinda Gates Foundation. Mr. Wilder is a former Director of the Global Intellectual Property Issues Division of the World Intellectual Property Organization – a specialized agency of the United Nations in Geneva. He has taught law – including until recently at Georgetown University and earlier at the University of Malaya, Malaysia. Mr. Wilder has an engineering degree from the University of Washington and practiced as a power generation engineer for several years before attending law school. He has a Juris Doctorate degree from the School of Law of the University of New Hampshire.

Dr. Mariwan Baker Chairman and Founder of Bring Hope Humanitarian Foundation, MINC Anckagripsgatan 3 211 19 Malmö, SWEDEN Tel: +46-(0) 76 190 9108 E-mail: [email protected] WWW.BRINGHOPEFOUNDATION.ORG

Dr. Mariwan Baker, Chairman and Founder of Bring Hope Humanitarian Foundation (BHHF), has been involved in various humanitarian efforts since the late 1990’s. A PhD graduate from Technical University of Denmark (DTU), Copenhagen, he has Master’s Degrees in Physics and Medical Physics in radiation cancer therapy. Dr. Baker was born in Northern Iraq in 1973 at the height of the oil crisis. As a result of the Kuwait war, he became a Kurdish refugee, trapped in the mountain area between Iraq and Iran. At age 19, following his struggle for survival he managed to migrate to Sweden. For three years and living in eight different refugee camps outside of the city of Stockholm, he remained a refugee. In 1995 Dr. Baker was awarded an asylum permanent residence by the Swedish Government. Seeking higher education, Dr. Baker studied during the day and worked at night. In 2001 he received an MSc in a joint collaboration between the University of Florida and the Royal Institute of Technology (KTH). In 2004 he received a second MSc from Karolinska Institute and Stockholm University. He received his PhD in 2016. Dr. Baker’s life experiences had a profound impact on him personally. Seeking to create change and improve lives for others he started Bring Hope Humanitarian Foundation which was a culmination of work he started as early as 1999 when he became more established and improved his economic condition. As a personal witness and survivor of the 8-year Iran-Iraq war, the chemical attack on Halabja, the Kuwait war and massive Kurdish exodus during the first Gulf War, Dr. Baker sought to always provide assistance to others in need. Vowing to help those struggling, not just the social victims of poverty but the ill and infirm and especially vulnerable children and women; people with cancer or students whose schooling was in jeopardy for lack of funding, Dr. Baker did all he could to come to the aid of people who were in desperate need, in one way or another. In 2015, Dr. Baker abandoned a decade of clinical career in treating cancer patients in Scandinavia, and dedicated his full-time work to helping less fortunate worldwide through the foundation of BHHF.

Dr. Holger Kanzler Senior Program Officer at Bill & Melinda Gates Foundation, Seattle, Washington

Prof. Ziad A. Memish, MD, FRCPC, FRCPE, FRCPL, FACP, FFPH

Ziad Memish is currently senior consultant in infectious diseases and Director of research & Innovation Center at King Saud Medical City, Ministry of Health. Professor at the College of Medicine in Alfaisal University, Riyadh, Saudi Arabia; and Adjunct Professor in the Hubert Department of Global Health, Rollins School of Public Health, Emory University, Georgia, USA. Professor Memish obtained his MD from the University of Ottawa, Ottawa, Canada in 1987 and is Board certified by the American Board of Internal Medicine, the American Board of Infectious Diseases as well as a Fellow of the Royal College of Physicians (Canada, Edinburgh and London) and the American College of Physicians. He is widely recognized as a pioneer in Mass Gathering Medicine and Infection Control & established the WHO collaborating center for mass gathering medicine in the Ministry of Health and WHO Collaborating Center for Infection Control in the Saudi Ministry of National Guard (Health Affairs). He was the first Deputy Minister of health for public health, KSA (2009-2014). He has presented many abstracts and plenary talks internationally and published more than 700 peer reviewed papers and book chapters. He is the editor-in-chief of 2 journals: Journal of Epidemiology & Global Health indexed in PubMed & Dr. Sulaiman Alhabib Medical Journal both published by Atlantis Press. He is a recipient of the King Abdulaziz Medal from the First Degree, the highest National award in Saudi Arabia for achievements in the field of infectious diseases and infection control.

Yasser Al Obaida, Ph.D., CPHQ CEO, Sudair Pharma Company (SPC)

Dr. Yasser Al Obaida had been working in the Government Sector specifically in Healthcare for the past 22 years since 1993 until 2015. He started his career as pharmacist staff in one of the KSA Government hospitals until he paved his way to be working at the top management as the Asst. Director General for Executive Affairs, Security Forces Hospital, Riyadh. He was also directly involved in decision-making on establishing the two other Ministry of Interior hospitals e.g. Security Forces Hospitals Dammam and Makkah. Throughout his stint in the public sector, he was also committed with the private sector, whereby he worked as a consultant in the field of insurance and healthcare. He provided services to the NCCI (an insurance company), Al Hammadi Hospital, and Elite Medical Center, among others. He also served as board member for CBAHI (Central Board of Accreditation for Healthcare Institution) and Surveyor for AC (Accreditation Canada), which both organizations’ main task is to provide Accreditation to Hospitals. Currently, he is Chief Executive Officer at Sudair Pharma Company (SPC) since Yr2014 until Present. He is one of the Founders of the Sudair Pharma Company. Among his objectives in founding the SPC, which is a Saudi based pharmaceutical manufacturing company is to help augment and address the drug security in the Kingdom, make the medicine more affordable and easily accessible to all in needs and to be of service to our patients. Dr Al Obaida is also a Board Member of NUPCO, SFDA (Saudi Food & Drug Authority), and NEOM. He is a Vice Chairman of National Committee for Pharmaceutical Industries at the Council of Saudi Chambers (CSC). He is also a member of the Advisory Board of the College of Pharmacy at the King Saud University, KSA. Dr. Al Obaida, one of the Top 100 Healthcare Leaders recognized by IFAH in YR2019, is great catalyst of Quality and Safe Medication as it is evident in promoting such cause in his academic and professional presentations in Kingdom and abroad.

Prof. Peter Hotez, MD, PhD, FASTMH, FAAP Dean, National School of Tropical Medicine Professor, Departments of Pediatrics, Molecular Virology & Microbiology

Co-Head, Section of Pediatric Tropical Medicine, Health Policy Scholar, Baylor College of Medicine Prof. Peter Hotez MD PhD is professor of pediatrics and molecular virology at Baylor College of Medicine, where he is also co-director of the Texas Children’s Center for Vaccine Development. He is the author of more than 500 scientific papers and four single-authored books, including Vaccines Did Not Cause Rachel’s Autism (Johns Hopkins Univ Press) and his newest one that will be published in 2021 entitled: Preventing the Next Pandemic: Vaccine Diplomacy in a Time of Anti-Science (Johns Hopkins Univ Press). He is an elected member of the US National Academy of Medicine and American Academy of Arts and Sciences. https://peterhotez.org/

Professor Adrian Hill Professor of Human Genetics; Director of the Jenner Institute; Co-Director, Oxford Martin Programme on Vaccines; Fellow of Magdalen College

Adrian V. S. Hill is the Lakshmi Mittal Professor of Vaccinology and Director of the Jenner Institute at Oxford University. current lead malaria vaccine has shown high efficacy in clinical trials in the UK and Africa and is likely to be the first widely used vaccine to impact on the great disease burden of malaria in Africa. In 2005 he founded the Jenner Institute at Oxford, an initiative aimed at accelerating public sector vaccine development for a range of infectious diseases, and partnered with the Pirbright Institute on veterinary vaccine development. The Jenner Institute is now the largest academic vaccine centre globally with clinical- stage vaccine programmes against thirteen diseases.

Recently the Jenner Institute has initiated a major effort towards rapid development of a COVID-19 vaccine. A clinical trial of which he is the Oxford principal investigator is in progress. He has published 600 research papers with over 68,000 citations and co-founded several vaccine companies.

Organizing Committee & Moderators Margaretta Colangelo Co-Founder & Managing Director, Deep Knowledge Group, San Francisco USA

Margaretta Colangelo is Co-founder and Managing Director of Deep Knowledge Group, an international consortium active in DeepTech and Frontier Technologies. She is Managing Partner of Longevity Capital, Managing Partner of AI-Pharma Capital, Co-founder of Deep Knowledge Analytics, and Co-founder & CEO of Jthereum, an Enterprise Blockchain company. She has a deep and multifaceted understanding of business, science, and technology and is highly adept at tracking and forecasting innovation in technology. She is co-author of Longevity Industry 1.0: Defining the Biggest and Most Complex Industry in Human History. She has published over 100 articles on DeepTech, AI, FinTech, and AI for Drug Discovery with over 40,000 subscribers. Since January 2020 Margaretta has summarized and shared over 500 medical research papers on COVID-19 that have been viewed and shared by over 5 million people.

Margaretta has been at the forefront of emerging technologies for over 30 years. In the 1990s she was a core member of the team that developed the first Java based messaging software for stock trading platforms, and she's been a core member of teams that have influenced important technical specifications including JMS and JDBC that have helped advance the technology industry. She serves on the advisory boards of the Longevity Artificial Intelligence Consortium at King's College London, the AI Precision Health Institute at the University of Hawai‘i Cancer Center, and NaNotics a nanomedicine company. She serves on the Board of Directors of the Bring Hope Humanitarian Foundation.

Social Media Links Linkedin https://www.linkedin.com/in/margarettacolangelo/

Twitter https://twitter.com/RealMargaretta Company https://www.dkv.global

Dr. Mohamed Boudjelal COVID19 Symposium Chairman

Dr. Mohamed Boudjelal, Chairman of KAIMRC Core facility/ Director of Drug Discovery and Development, Dr. Boudjelal has more 20 years experience in Drug Discovery, Medical Research and Management Dr. Boudjelal is currently employed by National Guard at King Abdullah International Medical Research Center(KAIMRC), in Riyadh, Kingdom of Saudi Arabia. Prior Joining KAIMRC, Dr.Boudjelal was an employer of GlaxoSmithKline as a Group leader in the Biological Reagents and Assay Development for pre-clinical drug discovery programs. Prior joining GSK, Mohamed held a position as an Associate Director for preclinical drug discovery in Incyte (Pfizer) pharmaceutical, and worked as a Scientist in Institute of Genetic and Molecular and Cellular Biology, Strasbourg, France, and as a senior research associate (permanent position) at the University of Michigan, USA. Mohamed holds a Ph.D. in Biochemistry and Molecular Biology from University of Leeds, UK, and a diploma in International Business and vocal education from University of California in San Diego. Dr. Boudjelal is recipient of several awards for scientific research excellence from Dermatology foundation, American Association for Cancer Research and GSK exceptional science award.

Gene Garrard Olinger, Jr. Ph.D. MBA

Dr. Olinger is a passionate scientist that relishes the opportunity to collaborate with high performing teams using converging disciplines to innovate and solve life’s most demanding health challenges. He seeks opportunities to combine scientific experience with business acumen to translate science into solutions that benefit human health. As a Principal Science Advisor with MRIGlobal, he leads internal and external teams on the diverse science mission areas including studies conducted in internal laboratories, partner laboratories, and deployed field operations. In the past two years, his efforts have focused on TB research collaboations in India, and Latin America (South and Central America). He is a subject matter expert in virology and immunology with an emphasis on viral hemorrhagic fevers, antimicrobial resistance, assay development, and agricultural pathogens with special emphasis on protecting against biological threats, emerging, re-emerging and nefarious. He has demonstrated tenacity with over 23 years’ experience coordinating, executing, and analyzing in vitro and in vivo studies conducted in complex BSL2, BSL3, and BSL4 laboratories with high hazard human and animal pathogens. In currently and past roles, he has overseen and conducted numerous projects focused on the development of countermeasures from discovery, to pre-clinical, and human clinical trials. For greater than 15 years, his focus has been on highly lethal viral hemorrhagic fever viruses (VHFV). He is intently aware of the challenges and opportunities in developing diagnostics, vaccines, and medical treatments for these rare, often neglected pathogens. As such, he has utilized his business acumen to build collaborations between government agencies, academic institutions, industry partners, NGOs, and consortiums to deliver solutions to protect the nation and the globe. As a government microbiologist and prinicipal investigator (USAMRIID), Dr. Olinger was the lead in the transition of a vaccine candidate for filovirus from basic to applied and early pre-clinical studies aimed at preventing disease caused by emerging pathogens and state-sponsored offensive biological weapons. In that role, he was a member of intra-government, regional, national, and international committees focused on countering biological threats. During that same period, Dr. Olinger was an integral member and science lead in utilizing immunotherapy against VHFV, despite the dogma that the approach was futile. Using his skills as an immunologist, he focused on the development of murine and humanized monoclonal antibody and emerging plant-based production methods against Ebola Zaire virus. With limitd support, he maximized limited DOD and NIH funding to drive the approach forward with his corporate and international partners. Ultimately, this work was instrumental in the development of the ZMapp™

immunotherapeutic for Ebola, with human-use in the West African Ebola Outbreak in 2014-2015. Continuing the effort to develop therapeutics against VHFV, Dr. Olinger’s team began to screen small molecules to identify novel antivirals in 2007. These drug discovery efforts have identified novel therapeutic molecules for nine viral emerging and biodefense diseases with subsequent robust and productive government, academic, and industry partnerships. Dr. Olinger has extensive field experience which spans from outbreak response to capacity building efforts. He has served as science leader and laboratory member coordinating diagnostic, serological, and other clinical assays to monitor patients during and following outbreaks. He is actively seeking solutions that will predict and prevent outbreaks in the future. Dr. Olinger has served as a subject matter expert for multiple domestic and internatinol commitees related to biodefense, emerging viral pathogens, infectious diseases research, biological safety and security training. As an adjunct Associate Professor Faculty member of Boston University’s School of Medicine, Department of Medicine, and Division of Infectious Diseases, National Emerging Infectious Diseases Laboratory (NEIDL) he is the associate director of maximum containment laboratory training, overseeing staff training for operations in the NEIDL BSL4 laboratory. As part of the Collaborative Core at the NEIDL, he continues his efforts to build collaborations and coalitions for global health. http://profiles.bu.edu/Gene.Olinger https://www.linkedin.com/in/gene-garrard-olinger-jr-ph-d-mba-11344b9/

Bibliography https://www.ncbi.nlm.nih.gov/myncbi/browse/collection/52655665/?sort=date&direc tion=ascending

DR. BARRAK AL SOMAIE Operations Director King Abdullah International Medical Research Center (KAIMRC), Ministry of National Guard - Health Affairs (MNG-HA), PO Box 3660 Riyadh 11481 Riyadh, Kingdom of Saudi Arabia

Dr. Barrak Al Zomia, was born and raised in the Kingdom of Saudi Arabia. He earned his Bachelor’s Degree in Radiological Sciences at King Saud University in 1995. He finished his Master’s and PhD in Medical Physics in the UK.

He had his internship for Radiological Imaging Technology at Riyadh Medical Complex, under the supervision of the College of Applied Medical Sciences. After his PhD, he started working at the Imaging Department, King Abdulaziz Medical City- Riyadh as Medical Physicist and Radiation Officer. During his practice he was responsible in the Quality Assurance of Equipment, Monitoring Personnel and Patient’s Radiation Doses. He works closely in the implementation of the national and international radiation and safety regulations within the department. He joined KAIMRC in 2009; he supervised the KAIMRC Scholarship Program until 2012. During the first quarter of 2012, he transitioned the role of the Deputy Operations Director. And in 2014 up to the present, he is the Operations Director for KAIMRC. He gave lectures for Radiology at the King Saud Bin Abdulaziz University for Health Sciences. After receiving his joint appointment recently, as an Assistant Professor, he started giving lectures in Radiological Sciences at the College of Applied Medical Sciences, KSAU-HS. Despite his busy schedule he was able to accomplish his research projects and participates in committees as a chairperson. He also attended and presented in various national and international conferences/symposia.

Dr. Bader Aldebasi

PhD in Medical Imaging from University of Nottingham, England, UK, 2014. Masters in Medical Imaging from University of Leeds, England, UK, 2005. BSc in Applied Medical Sciences in the field of Radiological Sciences, from Weber State University, USA, 2001 Assistant Professor of Radiology, College of Applied Medical Science, KSAU-HS, Deputy Head of Research Training & Development Section, KAIMRC, Riyadh Postdoctoral Researcher at KAIMRC, Riyadh.

Dr. Ibraheem A. Bushnak

Undergraduate studies at the University of the Pacific, CA, USA 2001 Masters in Medical Physics from University of Surrey, UK, 2002-2003 PhD in Bio Material Physics (Nano) from University of Surrey, 2004-2008. Postdoctoral Fellowship from University of Alberta, Canada, 2010- 2014Visiting Professor at the National Institute of Nanotechnology, Canada 2010-2014. Currently, Head of Research Training & Development Section, KAIMRC, Riyadh Currently, Head and Research Scientist of Nanomedicine Department, KAIMRC, Riyadh. Main interests are in the applications of Bionanomaterials in Medicine: as a Therapeutic and Diagnostics Agents Research studies on short peptide self-assembly and its applications in Medicine

Dr. Ahmed M. Salman,

BSc, MSc, DPhil (Oxon) Senior Immunologist-Vaccinologist at The Jenner Institute, University of Oxford. Fellow and Advisor of Clinical Medicine at Kellogg College and Immunology Instructor at University of Oxford, UK.

Dr. Ahmed M. Salman is a senior Immunologist and Vaccinologist working in Professor Adrian Hill’s Lab at the Jenner Institute, University of Oxford. Dr. Salman’s work is mainly to identify and assess new target antigens as vaccine candidates for infectious diseases caused by human and veterinary pathogens (including Malaria and COVID-19) using advanced immunology, vaccinology, molecular biology, genome editing, protein expression, and vaccine manufacturing technologies. The promising antigens are used as target antigens and expressed either as viral vector vaccines to mainly induce cellular immune response or as viral like particle (VLP) to induce a massive humoral immune response. Dr Salman took his BSc degree in Biochemistry at Ain Shams University in Cairo, Egypt in 2006 and from then until late

2011 was an instructor at the Department of Biochemistry, Faculty of Science, Ain Shams University. He completed a successful Master’s degree there on tuberculosis immunology in 2011. Most of that laboratory work was done while he worked at Statens Serum Institut in Copenhagen, Denmark, which is a major centre for mycobacterial vaccine research. In 2011 Dr Salman won a PhD scholarship at the European Virtual Malaria Institute programme “EVIMalaR” funded by the European Commission and EMBL at Heidelberg, Germany. In 2012 Dr. Salman started his D.Phil (PhD) in clinical medicine at the University of Oxford in Professor Adrian Hill’s Lab in Jenner Institute in collaboration with Professor Chris Janse and Professor Shahid Khan at the Leiden University Medical Centre in The Netherlands aiming for the identification and assessment of novel human malaria vaccines. Dr Salman produced his DPhil thesis in October 2014 and the DPhil degree in Clinical Medicine was awarded to him in May 2015 from the University of Oxford. The most important recent impact of his work has been on antigen down-selection for vaccine clinical trials. Three novel antigens have been funded to go to GMP manufacture and clinical trials. This work has been filed in a Malaria vaccination’s patent with an application number: PCT/GB2014/053077 (URL: https://patents.google.com/patent/WO2015052543A3/en). In addition he has a major contribution on another promising new P. vivax malaria sporozoite vaccine that is about to move to GMP manufacture and clinical trials. Since April 2020 Dr. Ahmed Salman became a part of the broad Jenner Institute research group working on the SARS-Cov-2 vaccine.

Dr. Julia Michelotti Principal Scientist

As a Principal Scientist at MRIGlobal, Dr. Michelotti performs science and technical work on projects involving global health and applied research with international clients. She contributed to science management of a DTRA CBEP program in Kazakhstan, working on multiple projects that supported Kazakhstani researchers in their efforts to study zoonotic diseases in wild or farm animal populations. Dr. Michelotti is also a technical trainer for BSL-2/3 biosafety and biosecurity, and molecular diagnostics in OCONUS austere settings. As part of this work, she has deployed to the West African states of Guinea, Senegal and Liberia. On a previous long-term contract working at the NIAID, Integrated Research Facility at Fort Detrick, MD, she performed hands-on technical work in the BSL-4 laboratory including clinical study support. During the 2014 Ebola virus disease outbreak, she traveled to Liberia on a combined mission between NIAID and the U.S. Army to mentor local scientists and perform molecular diagnostics at the national reference lab. Dr. Michelotti holds a Ph.D. in Cell Biology from Stanford University and a B.A. in Biology from Colby College. Earlier in her career, she focused on research studies in cell and molecular biology, virology, immunology, and cell-based assay development. She has also acquired skills in the general management of biological laboratories, including their compliance with local and national biosafety regulations.

Dr. Abdelali Haoudi,

Managing Director, Medical Biotechnology Park, Head, Strategy and Business Development, King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia

Dr. Majed Al Ghoribi

Chairman, Infectious Disease Research Department at King ﻛﯿﻤﺎرك ) Abdullah International Medical Research Center KAIMRC)

• Kingdom of Saudi Arabia

Dr. Majed Al Jeraisy Head of KAIMRC Research Office, Director of KAIMRC Clinical Trial Unit Dr. Majed Al Jeraisy obtained his Bachelor of Science in Pharmacy from King Saud University, Riyadh in 1991; he then completed a Master of Science degree in Clinical Pharmacy from the same university in 1996. In 1999, Dr. Al Jeraisy pursed his Doctor of Pharmacy from University of Tennessee, USA in, followed by two years of residency and fellowship in pediatric pharmacotherapy from the same place. Dr. Al Jeraisy has also completed a Master of Science in Medical Education from King Saud bin Abdulaziz University for Health Sciences, Riyadh in 2009. Dr. Jeraisy has authored and co-authored numerous and relevant scientific research projects in the field of Pediatrics, Pharmacotherapy, General Medicine, Biochemistry, Pharmacology and Toxicology that were published in reputable Journals Currently, Dr. Al Jeraisy is working as Clinical Pharmacy consultant in Pediatrics at King Abdulaziz Medical City, National Guard and assistant professor, college of pharmacy, King Saud Bin Abdulaziz University for Health Sciences; in addition, he is the chairman of the Research Office at King Abdullah International Medical Research Center.

Manal Alaamery, PhD

Chairman of Innovation and Entrepreneurship Department KAIMRC, MNGHA, KSA Dr. Manal Alaamery, is currently the Chairman of Innovation and Entrepreneurship Department (IED) and Head of the Developmental Medicine Department (DMD) at the King Abdullah International Medical Research Center (KAIMRC) at the Ministry of National Guard-Health Affairs (MNGHA). She is also the director of the satellite lab for the National Saudi Genome Program at KAIMRC, and a Principal Investigator at the Center of Excellence for Biomedicine (CEBM) at King Abdulaziz City for Science and Technology (KACST) and Brigham Woman’s Hospital (BWH) in association with

Harvard Medical School. Formerly, she was an instructor at the Harvard Medical School and Children’s Hospital Boston. As the chairman of IED, she is responsible for the ongoing Innovation activities at KAIMRC/KSAU-HS and the MNGHA. The IED was established in 2019 to serve the Kingdom’s vision 2030 and further enhance its resources and economic stability. Dr. Alaamery provides leadership in the identification and KAIMRC-wide adoption of innovation metrics to optimize KAIMRC’s research and innovation portfolio. Some of the IED activities include: creating Innovation and entrepreneurship programs specifications, documentation, and materials, registering patents, and trademarks at patent offices around the world, patent licensing and commercializing, maximizing research return on investment through supporting the creation of Spin-offs. As the Head of DMD, Dr. Alaamery’s research investigates the causes of different genetic disorders such as understanding the genetic causes of Intelecultal disabilities and non syndromic congental heart defect in the Saudi population with the goal of identifying novel genes and therapeutic targets for rare disorders. In addtion, with the collaborators from BHW and KACST, she and her team are studying the role of sphingolipid metabolism in neurodegeneration to identify candidate targets for therapeutic intervention for different neurdegenrtaive disorders such as multiple sclerosis. Furthermore, Dr. Almaamery is interested in developing nanoparticles that can overcome the problems of drug delivery through oral or intravenous routes such as the difficult penetration of BBB, low bioavailability, short half-life and prolonged treatment in different diseases. Dr. Alaamery received her clinical and postgraduate training at Harvard Medical School Genetics Program. She completed her clinical training at the Laboratory of Molecular Medicine (LMM) at Harvard focused on the areas of Hypertrophic and Dilated Cardiomyopathies, Neurological disorders, Muscular disorders, Hearing loss, Noonan spectrum, Pharmacogenetics. Dr. Alaamery also holds a Doctoral (Ph.D.) degree in Molecular Genetics/Biology from Boston College and a Master of Science degree in Clinical Microbiology from Thomas Jefferson University. During Dr. Alaamery’s work and career, she has established herself as a research leader, and published in prestigious peer-reviewed scientific journals as well as patenting a number of novel ideas. Dr. Alaamery also taught several courses, led many initiatives and held several committee positions. In addition, Dr. Alaamery is the recipient of several awards including the Dubai Harvard Foundation for Medical Research Award, Harvard Partners In Excellence Award for team work, the Donald J. White Teaching Award at Boston College, and the Ambassador Award for academic excellence.