Anneli Savinainen

Vice President, Head of Preclinical Development at Mariana Oncology
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Contact Information
us****@****om
(386) 825-5501
Location
Watertown, Massachusetts, United States, US
Languages
  • English Full professional proficiency
  • Swedish Native or bilingual proficiency

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5.0

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Lijun Wu

While I worked at Resolvyx as the VP of Discovery Research between 2006 and 2009, Anneli was in my group and for the first couple of years reported to me directly. She is definitely a top-notch scientist and a very seasoned and well-rounded scientific leader and manager. Anneli was the first in vivo pharmacologist Resolvyx hired, and mainly responsive for building up both in-house and outsourced capabilities in PK and in vivo pharmacology. She was a high performer and got promoted from Scientist I to Scientist II in due to her exemplary achievement. Managing 1-3 research associates, she and her group carried out all the PK studies, established several in vivo models and tested numerous compounds in these models. These work greatly helped the company to advance the projects from early discovery to late preclinical development and to clinical studies. By actively participating activities in all these stages, Anneli enhanced her experience of the overall drug discovery and development. I consider her fully functioning as a PhD-level scientist. Anneli is a hard worker, efficient, and extremely organized. She thrives in a fast pace and dynamic environment. She is well liked by her colleagues and a pleasure to work with. I would definitely hire her if I had a suitable position.

Benji Manov Gill

For three years I had the pleasure of having Anneli as my manager at Resolvyx.Pharmaceuticals. She gave me my first opportunity in her pharmacology lab, working on inflammation and immunology, when I was an undergrad student at Northeastern University and later as full time member of her team. Anneli not only laid the foundation for the development of my research skills, but showed me how to become a better scientist by thinking critically and analyzing research effectively. She has passion for science. Not only does Anneli design and run her studies with great precision, she also makes sure that junior members of her team understand the science behind the studies to help them learn and grow as scientists. In addition to possessing a clear mastery of science, Anneli is an inspiring leader, who genuinely cares for her team, and allows growth and project ownership. Even after we moved on to different organizations, she has continued to guide me in my career whenever I have reached out for advice. I consider myself fortunate that I had an opportunity to work with and learn from her. She is responsible for instilling passion for research and science in me.

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Experience

    • Biotechnology Research
    • 1 - 100 Employee
    • Vice President, Head of Preclinical Development
      • Mar 2023 - Present

      *Provide strategic and operational leadership for all preclinical development programs *Responsible for establishing departmental vision, setting department goals, and determining headcount and budget requirements * Serve as internal subject matter expert for the design, execution, and interpretation of pharmacology and toxicology experiments *Develop preclinical data packages for both non-GLP and GLP toxicology and pharmacology studies to support project advancement to and through… Show more *Provide strategic and operational leadership for all preclinical development programs *Responsible for establishing departmental vision, setting department goals, and determining headcount and budget requirements * Serve as internal subject matter expert for the design, execution, and interpretation of pharmacology and toxicology experiments *Develop preclinical data packages for both non-GLP and GLP toxicology and pharmacology studies to support project advancement to and through clinical development *Author/ review study reports and documentation for regulatory submissions *Responsible for communicating scientific data internally and externally, identify and manage external research collaborations, and engage with scientific advisors and consultants Show less *Provide strategic and operational leadership for all preclinical development programs *Responsible for establishing departmental vision, setting department goals, and determining headcount and budget requirements * Serve as internal subject matter expert for the design, execution, and interpretation of pharmacology and toxicology experiments *Develop preclinical data packages for both non-GLP and GLP toxicology and pharmacology studies to support project advancement to and through… Show more *Provide strategic and operational leadership for all preclinical development programs *Responsible for establishing departmental vision, setting department goals, and determining headcount and budget requirements * Serve as internal subject matter expert for the design, execution, and interpretation of pharmacology and toxicology experiments *Develop preclinical data packages for both non-GLP and GLP toxicology and pharmacology studies to support project advancement to and through clinical development *Author/ review study reports and documentation for regulatory submissions *Responsible for communicating scientific data internally and externally, identify and manage external research collaborations, and engage with scientific advisors and consultants Show less

    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Vice President, Head of Preclinical R&D
      • Apr 2022 - Mar 2023

    • Senior Director, Head of Preclinical R&D
      • Jul 2019 - Apr 2022

       Provide leadership and the overall strategic direction in all areas of preclinical research and development of Aura’s pipeline  Support clinical development (phase 1-3) and device development (microinjector and laser) by ensuring nonclinical activities are aligned with long term project goals  Responsible for generating pharmacology, toxicology and PK data to ensure nonclinical packages support IND submissions and further clinical development; including development of study protocols,… Show more  Provide leadership and the overall strategic direction in all areas of preclinical research and development of Aura’s pipeline  Support clinical development (phase 1-3) and device development (microinjector and laser) by ensuring nonclinical activities are aligned with long term project goals  Responsible for generating pharmacology, toxicology and PK data to ensure nonclinical packages support IND submissions and further clinical development; including development of study protocols, monitor, document, and interpret nonclinical and clinical study data  Key contributor of nonclinical data package leading to three successful IND submissions (suprachoroidal injection of AU-011 for the treatment of choroidal melanoma, suprachoroidal injection of AU-011 for choroidal metastasis and intramural injection of AU-011 for non muscle invasive bladder cancer)  Responsible for CRO selection and oversight with timely execution within planned budget  Support regulatory strategy and be responsible for preparation of nonclinical sections of regulatory documents (INDs, IBs, fast track, orphan indication etc.) and contribute to the preparation and conduct of meetings with FDA/EMA  Lead scientific affairs activities, including preclinical information and establishing relationships with key KOLs

    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Director Preclinical Pharmacology and Toxicology
      • Aug 2018 - Jul 2019

       Provide leadership and strategy in all areas of preclinical research and development to Syros oncology pipeline  Responsible for generating pharmacology, ADME/DMPK and toxicology data to ensure nonclinical packages support IND’s and further clinical development  Key contributor of IND submission for SY-5609, an orally available CDK7 inhibitor, to support FIH  Project Leader for immune-oncology discovery program in lead optimization  Manage the preparation and/or… Show more  Provide leadership and strategy in all areas of preclinical research and development to Syros oncology pipeline  Responsible for generating pharmacology, ADME/DMPK and toxicology data to ensure nonclinical packages support IND’s and further clinical development  Key contributor of IND submission for SY-5609, an orally available CDK7 inhibitor, to support FIH  Project Leader for immune-oncology discovery program in lead optimization  Manage the preparation and/or presentation of regulatory documents (nonclinical sections of external documents such as Investigator’s Brochure, IND/CTA, PIP, CTD, etc.)  Responsible for CRO selection and oversight Show less  Provide leadership and strategy in all areas of preclinical research and development to Syros oncology pipeline  Responsible for generating pharmacology, ADME/DMPK and toxicology data to ensure nonclinical packages support IND’s and further clinical development  Key contributor of IND submission for SY-5609, an orally available CDK7 inhibitor, to support FIH  Project Leader for immune-oncology discovery program in lead optimization  Manage the preparation and/or… Show more  Provide leadership and strategy in all areas of preclinical research and development to Syros oncology pipeline  Responsible for generating pharmacology, ADME/DMPK and toxicology data to ensure nonclinical packages support IND’s and further clinical development  Key contributor of IND submission for SY-5609, an orally available CDK7 inhibitor, to support FIH  Project Leader for immune-oncology discovery program in lead optimization  Manage the preparation and/or presentation of regulatory documents (nonclinical sections of external documents such as Investigator’s Brochure, IND/CTA, PIP, CTD, etc.)  Responsible for CRO selection and oversight Show less

    • Japan
    • Biotechnology Research
    • 700 & Above Employee
    • Director Pharmacology - Global Nonclinical Development
      • Mar 2018 - Aug 2018

    • Associate Director, Pharmacology - Global Nonclinical Development
      • Jul 2015 - Mar 2018

       Pharmacology Lead for various projects in several therapeutic areas (ophthalmology, neurology, GI/metabolic and rare diseases) and modalities at different stages of development ranging from late discovery, through development to post marketing  Nonclinical Lead for multiple projects in ophthalmology – responsible for strategy and coordination of nonclinical activities (Pharmacology, Toxicology, DMPK, Bioanalysis and Biomarker development)  Key contributor to successful patent filings… Show more  Pharmacology Lead for various projects in several therapeutic areas (ophthalmology, neurology, GI/metabolic and rare diseases) and modalities at different stages of development ranging from late discovery, through development to post marketing  Nonclinical Lead for multiple projects in ophthalmology – responsible for strategy and coordination of nonclinical activities (Pharmacology, Toxicology, DMPK, Bioanalysis and Biomarker development)  Key contributor to successful patent filings and IND submission and FIH of SHP639 – a novel peptide drug for glaucoma  Project lead for preclinical stage program (adRP; autosomal dominant retinitis pigmentosa)  Manage CRO’s and academic collaborations  Manage the preparation and/or presentation of regulatory documents (nonclinical sections of external documents such as Investigator’s Brochure, IND/CTA, PIP, CTD, etc.)  Provide due diligence support and evaluate new opportunities for Business Development  Member of strategic team with the aim to optimize and grow Shire’s Ophthalmic pipeline

    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Principal Scientist, Translational and Biomarker Research
      • Apr 2014 - Jul 2015

       Manager for in-vivo pharmacology group (managed PhD Scientists and Associates) in Multiple Sclerosis and other neurodegenerative diseases which support preclinical and development projects of small molecules, biologics and peptides  Key contributor of preclinical data to guide clinical trial design and biomarker development for Phase II and III for development programs (ONO-4641; an oral S1P agonist and Plovamer Acetate; a second generation peptide copolymer)  Performed statistical… Show more  Manager for in-vivo pharmacology group (managed PhD Scientists and Associates) in Multiple Sclerosis and other neurodegenerative diseases which support preclinical and development projects of small molecules, biologics and peptides  Key contributor of preclinical data to guide clinical trial design and biomarker development for Phase II and III for development programs (ONO-4641; an oral S1P agonist and Plovamer Acetate; a second generation peptide copolymer)  Performed statistical analysis of data and authored preclinical study reports  Provided preclinical expertise and strategy to multi-functional project teams  Led biological characterization of pharmacology disease models in search of robust biomarkers  Led development of novel animal disease models; successfully developed and optimized several in-vivo models for multiple sclerosis to be more target specific (eg Th17 and B-cell dependent models) and/or to provide better translational readouts (biomarkers, imaging, functional, behavioral etc)  Supported due diligence: scientific evaluation of in-licensing opportunities, management of feasibility/validation studies to enable go/no-go decision

    • Senior Scientist II, Translational and Biomarker Research
      • Apr 2010 - Apr 2014

       Manager for in-vivo pharmacology group (managed PhD Scientists and Associates) in Multiple Sclerosis and other neurodegenerative diseases which support preclinical and development projects of small molecules, biologics and peptides  Key contributor of preclinical data to guide clinical trial design and biomarker development for Phase II and III for development programs (ONO-4641; an oral S1P agonist and Plovamer Acetate; a second generation peptide copolymer)  Performed statistical… Show more  Manager for in-vivo pharmacology group (managed PhD Scientists and Associates) in Multiple Sclerosis and other neurodegenerative diseases which support preclinical and development projects of small molecules, biologics and peptides  Key contributor of preclinical data to guide clinical trial design and biomarker development for Phase II and III for development programs (ONO-4641; an oral S1P agonist and Plovamer Acetate; a second generation peptide copolymer)  Performed statistical analysis of data and authored preclinical study reports  Provided preclinical expertise and strategy to multi-functional project teams  Led biological characterization of pharmacology disease models in search of robust biomarkers  Led development of novel animal disease models; successfully developed and optimized several in-vivo models for multiple sclerosis to be more target specific (eg Th17 and B-cell dependent models) and/or to provide better translational readouts (biomarkers, imaging, functional, behavioral etc)  Supported due diligence: scientific evaluation of in-licensing opportunities, management of feasibility/validation studies to enable go/no-go decision

    • Scientist II, In-Vivo Pharmacology
      • Feb 2006 - Apr 2010

       Managed an in-vivo pharmacology group for inflammatory and ophthalmic diseases to support development of Resolvin’s and Neuroprotectin’s  Successfully generated data for lead molecules (RX-10001 and RX-10045) to support decision regarding the choice of therapeutic area for Resolvins (models for evaluation included rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, asthma, diabetes, obesity, lupus and dry eye)  Planned and oversaw all pharmacokinetic studies which… Show more  Managed an in-vivo pharmacology group for inflammatory and ophthalmic diseases to support development of Resolvin’s and Neuroprotectin’s  Successfully generated data for lead molecules (RX-10001 and RX-10045) to support decision regarding the choice of therapeutic area for Resolvins (models for evaluation included rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, asthma, diabetes, obesity, lupus and dry eye)  Planned and oversaw all pharmacokinetic studies which enabled a successful phase 1 study for Resolvin E1 (RX-10001)  Developed preclinical plan (pharmacology, biomarker development and PK) which facilitated effective advancement of pre-clinical candidate through lead optimization to phase I clinical trial  Established and grew the in-vivo pharmacology group, implemented the Institutional Animal Care and Use Committee (IACUC) and actively involved in animal facility buid-up  Selected, managed and monitored CRO’s and collaborators for pharmacology studies Show less  Managed an in-vivo pharmacology group for inflammatory and ophthalmic diseases to support development of Resolvin’s and Neuroprotectin’s  Successfully generated data for lead molecules (RX-10001 and RX-10045) to support decision regarding the choice of therapeutic area for Resolvins (models for evaluation included rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, asthma, diabetes, obesity, lupus and dry eye)  Planned and oversaw all pharmacokinetic studies which… Show more  Managed an in-vivo pharmacology group for inflammatory and ophthalmic diseases to support development of Resolvin’s and Neuroprotectin’s  Successfully generated data for lead molecules (RX-10001 and RX-10045) to support decision regarding the choice of therapeutic area for Resolvins (models for evaluation included rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, asthma, diabetes, obesity, lupus and dry eye)  Planned and oversaw all pharmacokinetic studies which enabled a successful phase 1 study for Resolvin E1 (RX-10001)  Developed preclinical plan (pharmacology, biomarker development and PK) which facilitated effective advancement of pre-clinical candidate through lead optimization to phase I clinical trial  Established and grew the in-vivo pharmacology group, implemented the Institutional Animal Care and Use Committee (IACUC) and actively involved in animal facility buid-up  Selected, managed and monitored CRO’s and collaborators for pharmacology studies Show less

    • Scientist I, In-Vivo Pharmacology - Inflammation
      • Jan 2001 - Jan 2006

       Responsible for designing, developing, validating and executing in-vivo model systems for inflammation and autoimmune diseases for novel as well as established targets and pathways  Key contributor of pharmacology data package to support IND submission of IKK2 inhibitor  In-vivo models included models for rheumatoid arthritis, inflammatory bowel disease, asthma, multiple sclerosis, periodontitis and PK/PD models  Used imaging techniques to assess efficacy in rodent models (XENOGEN… Show more  Responsible for designing, developing, validating and executing in-vivo model systems for inflammation and autoimmune diseases for novel as well as established targets and pathways  Key contributor of pharmacology data package to support IND submission of IKK2 inhibitor  In-vivo models included models for rheumatoid arthritis, inflammatory bowel disease, asthma, multiple sclerosis, periodontitis and PK/PD models  Used imaging techniques to assess efficacy in rodent models (XENOGEN imaging and Micro Computed Tomography (u-CT) imaging)  Established in-house ex-vivo assay capabilities to complement in-vivo experiments and to evaluate new biomarker with potential use in the clinic for anti-inflammatory molecules affecting the NF-κB pathway  Performed extensive analysis, interpretation and documentation of experimental results for the evaluation of pre-clinical candidates (including IND documentation)  Member of the Animal Care and Use Committee (IACUC)  Supervised research assistants  Coauthored and published three papers related to efficacy and mechanism of action of IKK2 inhibitor Show less  Responsible for designing, developing, validating and executing in-vivo model systems for inflammation and autoimmune diseases for novel as well as established targets and pathways  Key contributor of pharmacology data package to support IND submission of IKK2 inhibitor  In-vivo models included models for rheumatoid arthritis, inflammatory bowel disease, asthma, multiple sclerosis, periodontitis and PK/PD models  Used imaging techniques to assess efficacy in rodent models (XENOGEN… Show more  Responsible for designing, developing, validating and executing in-vivo model systems for inflammation and autoimmune diseases for novel as well as established targets and pathways  Key contributor of pharmacology data package to support IND submission of IKK2 inhibitor  In-vivo models included models for rheumatoid arthritis, inflammatory bowel disease, asthma, multiple sclerosis, periodontitis and PK/PD models  Used imaging techniques to assess efficacy in rodent models (XENOGEN imaging and Micro Computed Tomography (u-CT) imaging)  Established in-house ex-vivo assay capabilities to complement in-vivo experiments and to evaluate new biomarker with potential use in the clinic for anti-inflammatory molecules affecting the NF-κB pathway  Performed extensive analysis, interpretation and documentation of experimental results for the evaluation of pre-clinical candidates (including IND documentation)  Member of the Animal Care and Use Committee (IACUC)  Supervised research assistants  Coauthored and published three papers related to efficacy and mechanism of action of IKK2 inhibitor Show less

    • United Kingdom
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Research Associate, Gastrointestinal Pharmacology
      • Jan 1992 - Jan 1999

       Responsible for screening compounds for inhibition of gastric acid secretion in in-vivo models  Performed PK/PD studies  Performed survival rodent surgery  Extensive experience working with Good Laboratory Practice (GLP)  Assisted in preparing Investigational New Drug Applications (INDs)  Member of a project team that successfully brought a molecule to the market (e.g. Nexium)

    • Research Associate
      • Jan 1997 - Jan 1998

       Developed mouse models for Helicobacter pylori infection  Used cell biology techniques; such as cell culture, cell isolations and DNA/RNA purification  Coauthored two papers related to our research of Helicobacter pylori and how it’s affecting the gastric system

Education

  • Northeastern University
    Master Certificate, Clinical Trial and Project Management
    2004 - 2005
  • Harvard University
    2001 - 2005
  • University of Arizona
    Pharmacokinetics and Toxicokinetics for the Industrial Scientist
    2001 - 2001
  • Northeastern University
    Master's degree, Pharmacology
    1999 - 2001
  • University of California

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