Eddy Sayeed
Edison,NJ
Summary
- Eddy Sayeed is a distinguished CMC Leader with three decades of expertise in vaccine research and development, process innovation, and GMP manufacturing across various vaccine platforms. Has successfully led teams, managed substantial budgets, and collaborated internationally with regulatory agencies and scientific partners.
- Extensive Vaccine Development Experience: Mr. Sayeed has spearheaded the development of over 60 biologic's, including nucleic acid, viral, protein vaccines, and broadly neutralizing antibodies, from bench and advancing many to clinical trials.
- Leadership and Team Building: Has built and mentored a 14-person CMC team at IAVI, fostering expertise in diverse vaccine technologies and GMP manufacturing.
- Project and Manufacturing Management: Mr. Sayeed has directed technology transfer and scale-up processes for vaccines such as VSV-Lassa, and managed contract manufacturing organizations and GMP audits.
- Regulatory Expertise: Has prepared and defended CMC strategies with agencies including the US FDA, MHRA, EMA, and others, supporting multiple IND and IMPD submissions.
- Collaborative Grant Leadership: Dr. Sayeed has successfully secured funding from organizations such as the Bill & Melinda Gates Foundation, World Bank, NIH/NIAID, CEPI and BARDA for vaccine projects.
- Early Career Vaccine Manufacturing: Has managed large-scale production of licensed measles, mumps, rubella, and rabies vaccines at the Serum Institute of India, including commissioning new production facilities and implementing automation.
- Scientific and Technical Qualifications: Mr. Sayeed holds PhD, MPhil, MS, and BS degrees in Biotechnology, underpinning expertise in vaccine science and manufacturing.
- Strong Communication and Multicultural Leadership: Demonstrates excellent interpersonal skills and cultural sensitivity in managing international teams and partnerships.
Overview
31
31
years of professional experience
Work History
Executive Director, Product Development and Manufacturing
International AIDS Vaccine Initiative
New York, New York
02.2002 - Current
- Total 30-years' experience in the Research, Vaccine Development, Process Development & GMP Manufacturing and Testing of New candidate and Licensed vaccines.
- Leading the CMC Team on multiple Project teams for supporting HIV candidate vaccine product development (projects include R&D, early-stage development, and Phase I / II clinical trials in human spanning multiple platforms namely plasmid DNA, mRNA, six viral vectors (MVA, Adenovirus, Sendai, AAV, CMV and VSV), development of broadly neutralizing antibodies and HIV ENV immunogens. Have supported the development of over 60 biologic's; 26 have advanced into clinical studies.
- Contract manufacturing: Proven expertise in procurement and management of over 24 Contract Development and Manufacturing Organizations (CDMOs) for undertaking cell line development, process, analytical and formulation development along with GMP manufacturing of drug substance and drug product and managing stability studies.
- GMP Audits and Reviewing Manufacturing batch record documentation, QC test reports, Certificate of analysis and deviation reports for technical release of vaccine for Clinics.
- Project Management & Leadership: Driving project activities related to manufacturing and Quality testing according to milestone & project plans.
- CMC-Regulatory: Preparing CMC sections for product submissions to different Regulatory agencies (US-FDA, MHRA, EMA, Indian FDA, and South African regulatory agencies). Participating on Pre-IND, IND meetings with the US-FDA as well as Scientific meetings with Regulatory agencies in UK, Germany, Belgium & India.
- Brief list of Successful grant applications:
- O World Bank (development of a Sendai Vector based HIV vaccine)
- O NIH/DMID/NIAID (NIAID Process and Analytical Support for Development of HIV Vaccines-NIH Contract HHSN272201600111, Manufacturing and Characterization Services for Vaccines and Other Biologic's for Infectious Diseases Contract No. HHSN272201800001I)
- O CEPI (A Vaccine for Prevention of Lassa Fever based on a Live Vesicular Stomatitis Virus-Lassa Virus Chimera)
- O BAA-18-100-SOL-00003 This proposal aims to develop a prophylactic vaccine product (rVSVAG-SUDV-GP) based on the VSVAG chimeric virus platform for the prevention of disease caused by Sudan ebolavirus and transition the rVSVAG-MARV-GP vaccine program currently in development with the Department of Defense, Defense Threat Reduction Agency for the prevention of disease caused by Marburg virus.
- O RFP Title: Preclinical and Translational Vaccine Development Support for HIV and Other Candidate Agents RFP Number: 75N93019R00023
Scientist CSL Level 4
CSL Ltd. Australia
Melbourne
04.2001 - 01.2002
- The Influenza Project group tasked with completing the Validation program required for scaling up the production campaign from 45,000 eggs to 70,000 eggs.
Deputy Manager Production
Serum Institute of India Ltd
08.1994 - 11.2000
- The organization is an internationally renowned company, involved in the manufacturing of human vaccines, antiserum & anti-cancer drugs. As part of the Universal Immunization Program (UIP), the MMR and DTP group of vaccines continue to be distributed globally to over 140 countries through the World Health Organization (WHO), the Pan-American Health Organization (PAHO) and the UNICEF. I have 6 years manufacturing experience leading the Production department of the Viral vaccine group. The group had an annual target of manufacturing about 500 million doses of live Measles vaccines, around 100 million doses of Mumps and Rubella vaccines. Experienced in the Preparation of Manufacturer's Master & Working Cell bank (MWCB) and the Production Seed lot virus, Production planning, overall supervision and day-to-day execution of production activities as per GMP standards of the WHO and the pharmacopoeia requirements, Maintaining high level of productivity, Trouble shooting at all stages of Production, Interacting with the Quality control and Quality Assurance departments for ensuring GMP at all stages of product manufacturing, Presenting production reports to the Management committee on a regular basis and Training new staff as per cGMP guidelines and ensuring high level of accountability in the production facility.
- Area of Work: Development of two Rabies vaccine for human use.
- Accomplishments:
- Accomplished the development of a Manufacturer's Master and Working Cell Bank and the Virus Seed Lot as per WHO requirements.
- Developed two Rabies vaccines for human use. These vaccines have successfully undergone Phase III trials in human. Standard Operating Procedures (SOP), for these vaccines have been prepared and approved by the National Regulatory Authorities. Product dossiers for these vaccines have been prepared.
- During the developmental stages, in addition to the production activities, I had to conduct the QC & QA activities and have gained skills in the same. Later I trained additional Staff on the manufacturing process, scale-up and improving virus productivity of the Rabies vaccine.
- Also involved in the drafting and implementing the bio-safety guidelines and maintaining GLP & GMP in the department for Rabies vaccine. My assignments included keeping a strict vigilance on the protective antibody titers of the operating staff.
Education
PhD - Biotechnology
MPhil - Biotechnology
MS - Biotechnology
BS - Science
Skills
- Management of diverse global CDMO partnerships
- Collaborative strategy development
- Project management
- Budget management
- Team leadership
- Cultivating collaborative partnerships
- Stakeholder management
Training
I have undergone specialised training at, “The Automation Partnership,” in the United Kingdom on operating the Cellmate Robotic System. I have successfully standardized the operation of the Cellmate in the production facility at the Serum Institute of India. The Cellmate commissioned for achieving high virus productivity and reduced failure rate.
Commissioning Vaccine Production Unit
In 1998, I lead the overall operations of the new production facility for the MMR production. During this assignment, I have gained experience in validating the production unit, with respect to biosafety designing for handling infectious material, the air quality requirements, pressure gradients within the production area, autoclave cycle validation, validation of incubators and equipment as per GMP norms. The vaccine production facility was qualified and made fully operational for the manufacturing around 500 million doses of Measles vaccine annually.
Commissioning of a Novel Scale-up Platform for Licensed Rubella Vaccine
In 1996, led the R&D effort on adapting a Novel Scale-up Platform, “The Cell Cube,” to transfer a roller bottle manufacturing to a smaller foot-print manufacturing platform to reduce CAPEX and OPEX for manufacturing licensed Rubella Vaccine.
Ongoing Research & Development Support
- Role: GMP Manufacturing, Drug Product Management and Stability Assessment. CMC Lead on the last 10 Regulatory submissions
- 1. IND 27351: VSV-LASSA: Replication-competent Vesicular Stomatitis Virus Lassa fever virus (rVSV-LASV) Josiah Chimera Vaccine.
- 2. IMPD Submission: Replication-competent Vesicular Stomatitis Virus Lassa fever virus (rVSV-LASV) Josiah Chimera Vaccine.
- 3. IND NUMBER 16264: rAd26-MOS1.HIV-Env
- 4. IND 14401: A Phase I double-blinded, placebo-controlled, randomized trial in HIV-uninfected, healthy adult volunteers to evaluate the safety and immunogenicity of F4co adjuvanted with AS01a or AS01, administered with Ad35-GRIN
- 5. IND 14406: A Phase I placebo-controlled, double-blind, randomized trial to evaluate the safety and immunogenicity of Ad26-ENVA and Ad35-ENV HIV vaccines in healthy HIV-uninfected adult volunteers.
- 6. IND 14770: A Phase I Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Multiantigen HIV (HIV-MAG) plasmid DNA (pDNA) Vaccine co-administered with Recombinant Human IL-12 pDNA (GENEVAX IL-12) followed or preceded by Recombinant Ad35-GRIN/ENV HIV Vaccine in HIV-Uninfected, Healthy Volunteers
- 7. IND # 13876-Ad35 GRIN/ENV: Phase 1 Clinical Studies ongoing using a Ad35 Vector encoding an HIV insert currently on-going in US.
- 8. IMPD submission: EudraCT number: 2012-004431-23, Protocol code: IAVI S001, Title: A Phase I double-blind, randomized, placebo-controlled, dose-escalation trial to evaluate the safety and immunogenicity of a Sendai HIV vaccine SeV-G(NP) given intranasally and Ad35-GRIN administered intramuscularly in prime-boost regimens in HIV-uninfected, healthy adult volunteers.
- 9. IMPD Submission: EudraCT number: 2013-002268-14, Protocol code: IAVI A003/ CHOP HVDDT 001 Title: A Phase 1, randomized, blinded, dose-escalation study of rAAV1-PG9DP recombinant AAV vector coding for PG9 antibody in healthy male adults at risk of HIV infection.
- 10. BB-IND NUMBER 126807 (2016): PGT121 monoclonal antibody for prevention and treatment of HIV-1 and BB-IND NUMBER 134270 (2017): PGDM1400 monoclonal antibody for prevention and treatment of HIV-1
Timeline
Executive Director, Product Development and Manufacturing
International AIDS Vaccine Initiative
02.2002 - Current
Scientist CSL Level 4
CSL Ltd. Australia
04.2001 - 01.2002
Deputy Manager Production
Serum Institute of India Ltd
08.1994 - 11.2000
MPhil - Biotechnology
MS - Biotechnology
BS - Science
PhD - Biotechnology
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