Adam Hacker

Adam Hacker Email and Phone Number

Co-Chair European Platform for Regulatory Science Research @ European Medicines Agency
London, GB
Adam Hacker's Location
London, England, United Kingdom, United Kingdom
Adam Hacker's Contact Details

Adam Hacker work email

Adam Hacker personal email

About Adam Hacker

Highly effective blue-chip pharmaceutical regulatory affairs leader, operating at Vice President and above level since June 2012. I have extensive experience leading regulatory affairs departments in vaccines, hematology, and oncology therapeutic areas.Currently, I lead in the field of vaccines regulatory affairs and public health, overseeing a substantial portfolio of vaccines in various stages of development and utilizing different technologies.My experience at CEPI has enabled me to develop and engage with a significant network of contacts in regulatory authorities across high, middle, and low-income countries. I continue to have extensive first-hand engagements with regulators, discussing product development strategies and regulatory innovations to accelerate vaccine development in preparation for future outbreaks.My career has been driven by increasingly strategic roles, with expertise spanning a diverse range of departments and therapeutic areas. I have worked with innovative technologies and product classes in both regional and global roles.I excel in driving Quality and Compliance strategies by providing oversight and leadership to manufacturing and R&D organizations.In parallel to my existing role at CEPI, I was appointed as Chair of the Review Panel (MHRA) in January 2024, where I am accountable for statutory and non-statutory reviews of proposals, decisions, and provisional decisions taken by the MHRA.I am also an experienced public speaker, panellist, chair, and moderator at numerous scientific meetings and conferences

Adam Hacker's Current Company Details
European Medicines Agency

European Medicines Agency

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Co-Chair European Platform for Regulatory Science Research
London, GB
Website:
ema.europa.eu
Employees:
1654
Adam Hacker Work Experience Details
  • European Medicines Agency
    Co-Chair European Platform For Regulatory Science Research
    European Medicines Agency
    London, Gb
  • Medicines And Healthcare Products Regulatory Agency
    Chair Of The Mhra Review Panel
    Medicines And Healthcare Products Regulatory Agency Jan 2024 - Present
    London, England, Gb
    Accountable for statutory and non-statutory reviews of proposals, decisions and provisional decisions taken by the MHRA
  • Cepi (Coalition For Epidemic Preparedness Innovations)
    Head Of Global Regulatory Affairs And Quality
    Cepi (Coalition For Epidemic Preparedness Innovations) Jan 2021 - Present
    Oslo, No
    Accountable for regulatory oversight of all CEPI partner projects providing regulatory oversight to 30 plus vaccine development programmes (COVID and non-COVID portfolio). Oversee the end to end development of awardees' vaccines from a regulatory perspective, including support for regulatory authority meetings and license applicationsCo-Chair of the COVAX Regulatory Advisory Group (co-chair with WHO Head of Regulatory Pre-Qualification) working with fourteen worldwide regulatory authorities and driving alignment and consensus on key COVID related topicsClose one on one working relationship with senior regulators in critical agencies including, US FDA (CBER), MHRA, EMA, Health CanadaResponsible for developing CEPI's regulatory pandemic preparedness plan and driving all vaccine development acceleration initiatives
  • Autolus Ltd.
    Svp Global Head Regulatory Affairs And Quality
    Autolus Ltd. Aug 2018 - Jan 2021
    London, Gb
    Autolus Executive Committee member, accountable to Autolus CEO and BoardChair of Autolus' Development CommitteeResponsible for leading and building out the Regulatory Affairs, QA and QC departments in a rapidly growing CAR-T gene therapy biotech company.Leading and validating Autolus' clinical and CMC development strategies with global regulatory authorities.Overseeing the establishment of Autolus' quality management system, moving to a state of inspection readiness, including hosting a successful MHRA GMP inspection.Responsible for selection and implementation of multiple electronic systems including eQMS, Quality System, electronic document management system
  • The Janssen Pharmaceutical Companies Of Johnson & Johnson
    Vp, Head Of Vaccines & Scientific Innovation Projects, Global Regulatory Affairs
    The Janssen Pharmaceutical Companies Of Johnson & Johnson Jun 2015 - Jul 2018
    Raritan, New Jersey, Us
  • The Janssen Pharmaceutical Companies Of Johnson & Johnson
    Ebola Projects Oversight Leader, Vice President, Global Regulatory Affairs
    The Janssen Pharmaceutical Companies Of Johnson & Johnson Dec 2014 - Jun 2015
    Raritan, New Jersey, Us
  • The Janssen Pharmaceutical Companies Of Johnson & Johnson
    Vice President, Emea Therapeutic Area Leader Haematology / Oncology, Emea Medical Affairs
    The Janssen Pharmaceutical Companies Of Johnson & Johnson Jun 2012 - Dec 2014
    Raritan, New Jersey, Us
  • Johnson And Johnson
    Senior Director, Emea Regulatory Therapeutic Area Lead Oncology / Haematology
    Johnson And Johnson Jul 2008 - Jun 2012
    New Brunswick, Nj, Us
    In addition I am the Regulatory Representative on EMEA Market Access Leadership Team with responsibilities across the portfolio
  • Biogen Idec
    Associate Director, Regulatory Affairs
    Biogen Idec Sep 2004 - Jun 2008
    Cambridge, Ma, Us
  • Amersham Health
    Regulatory Advisor
    Amersham Health Jun 2002 - Sep 2004
  • Glaxosmithkline
    Regulatory Project Manager
    Glaxosmithkline 1998 - Jun 2002
    Brentford, Middlesex, Gb

Adam Hacker Skills

Oncology Regulatory Affairs Medical Affairs Therapeutic Areas Pharmaceutical Industry Market Access Hematology Regulatory Submissions Strategy Clinical Development Drug Development Pharmacovigilance Biotechnology Gcp Clinical Research Clinical Trials Good Manufacturing Practice Regulatory Requirements Vaccines

Adam Hacker Education Details

  • National Institute For Medical Research
    National Institute For Medical Research
    Molecular Developmental Biology
  • University Of Oxford
    University Of Oxford
    Pure And Applied Biology

Frequently Asked Questions about Adam Hacker

What company does Adam Hacker work for?

Adam Hacker works for European Medicines Agency

What is Adam Hacker's role at the current company?

Adam Hacker's current role is Co-Chair European Platform for Regulatory Science Research.

What is Adam Hacker's email address?

Adam Hacker's email address is ad****@****hoo.com

What schools did Adam Hacker attend?

Adam Hacker attended National Institute For Medical Research, University Of Oxford.

What skills is Adam Hacker known for?

Adam Hacker has skills like Oncology, Regulatory Affairs, Medical Affairs, Therapeutic Areas, Pharmaceutical Industry, Market Access, Hematology, Regulatory Submissions, Strategy, Clinical Development, Drug Development, Pharmacovigilance.

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