Experience

Cyprotex

• United Kingdom
• Research Services
• 100 - 200 Employee

• Senior Director Business Development

  • Apr 2020 - Present

  Cyprotex is a pre-clinical CRO with a 100% focus on in vitro, in silico and in vivo ADME-Tox/DMPK (absorption, distribution, metabolism, excretion, toxicity, pharmacokinetics). A highly automated screening platform allows for cost-effective and fast 5–10 days turnarounds. Robust and industry-validated protocols recognize the newest regulatory guidelines. These compound screening capabilities are complemented by a full array of in vitro DDI packages following the newest FDA/EMA guidelines and supporting later stage IND/NDA enabling studies. Metabolite profiling and structural elucidation studies are supported by the newest high resolution accurate mass spectrometry.



Sunbright

• Advisor

  • Jun 2019 - Present

  Supports biotechnology validation, company formation and transfer of international assets to the US market. Development of pre-clinical and clinical drug development and strategic plans. Supports biotechnology validation, company formation and transfer of international assets to the US market. Development of pre-clinical and clinical drug development and strategic plans.



Pharmaron US Lab Services

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Business Development Manager

  • Apr 2018 - Mar 2020

  Absorption Systems is a Contract Research Organization (CRO) founded on sophisticated transporter assays - its CellPort Technology platform. This allows Absorption Systems to assist pharmaceutical and medical device companies in identifying and overcoming ADME (Absorption, Distribution, Metabolism, Excretion and Toxicity) barriers in development of drugs and medical devices. The company's mission to continually develop innovative research tools that can be used accurately to predict or to explain unanticipated human outcomes led to the development of a comprehensive program with focus in three main areas, where complete IND packages including all in vivo tests can be obtained:Small molecules:- Lead Optimization and Candidate Selection Services- Bioanalytical Support from discovery through clinical (GLP and Non-GLP) studies- Comprehensive IND and NDA-Enabling studies- Sophisticated in vitro programs that allow for FDA Waivers of In Vivo Bioavailability and Bioequivalence studiesLarge Molecules:- Wide range of cGMP or GLP methods for basic R&D, development/optimization, qualification, or validation - Customized tests for Immunogenicity, PK/PD, FACS, NADA, Potency assays, ELISA etc.Gene Therapies:- GMP Analytical Testing Capabilities - Potency tests for CAR T cell and viral vectors based therapyMedical Devices:- Ocular devices, glucose monitor devices, cardiovascular devices etc.- 510k Submissions- 505 (b) (2) Submissions



TargetRNA Inc.

• Pharmaceutical Manufacturing

• Founder and COO

  • Jul 2017 - Mar 2018

  TargetRNA is a biotechnology company that discovers novel small molecule drugs that act directly on disease-causing RNA. Our discovery platform uniquely integrates high throughput biophysics, machine learning, NMR spectroscopy, and molecular modeling to search previously unexplored chemical diversity space for fragments that bind to discrete pockets in folded RNA structures. Computational and medicinal chemistry optimization cycles are guided by atomic-level structural information to design selective, high affinity lead molecules. This increases the success rate of leads in phenotypic, cell-based assays and pre-clinical animal models.► Responsible for the development of company's pre-IND, IND and clinical program► Developed, managed and communicated R&D portfolio strategy & pipeline► Lead the development, refinement, communication, and execution of disease area and functional area strategies► Responsible for pre-Proof of Concept portfolio prioritization process and portfolio growth strategy within Research and Early Development► Responsible for tracking internal and external resource allocation across the pipeline



Cambridge Biomedical Inc.

• Senior Research Scientist

  • Apr 2015 - Jul 2017

  Responsible for drug validations and clinical sample testing to confirm small molecule and large molecule treatment effect. Developed and validated Flow Cytometry Diagnostic tests to monitor immune responses for drug treatments. ► Lead re-validation project for all areas of the Clinical Diagnostic Laboratory (41 diagnostic tests)► Acted as Principal Investigator/Study Director►Developed in vitro tests to validate Bruton's Tyrosine Kinase inhibitor's drug’s efficacy in an ELISA for peripheral blood mononuclear cell (PBMC), Bone Marrows and Lymph Nodes►Developed tests to measure protein drug specific T cell activation in PBMC of patients by Flow Cytometry, and quantitated and identified the activated T cells using FlowJo software► Acted as advisor to management in evaluation of project requirements and budget preparation► Directed the design, development, execution and implementation of scientific projects that supported the discovery, development and optimization of biotechnology, clinical diagnostic, and pharmaceutical assays ► Investigated the feasibility of applying a variety of scientific concepts to potential projects and problems► Participated in the development of patentable technology► Oversaw the adherence to laboratory and departmental policies and procedures to include quality control, quality assurance, and safety► Oversaw the completion of all assignments according to Study Protocols, SPOs, and applicable GLP/CAP/CIA regulations and principles



Excel-Pharma

• Canada
• Human Resources Services
• 1 - 100 Employee

• Founder, CEO and CSO

  • Aug 2013 - Mar 2015

  Hands-on approach to immunmodulatory drug evaluation. Responsible for the immune-modulatory drug development of two small and one large molecule. Specialist for in vivo infection models in mice and rhesus macaques. Was responsible for business development, NIH grants and licensing.► Developed microbicide protein nanoparticle/gel formulations for in vivo testing in BLT mice► Developed of intra-nasal protein formulations and performed in vivo testing in an influenza H1N1 infection model► Prepared IND plans for an HSV and influenza A anti-viral drug► Developed anti-HSV protein treatment solutions for eye treatment and "cold sore" testing in mice



Acceleration BioPharmaceuticals, Inc.

• Founder, CEO and CSO

  • Jun 2001 - Jul 2013

  Hands-on approach to immunomodulatory drug evaluation. Working experience in an early start-up environment to bring early stage biologics to the Phase I/IIb development stage. Won the second price in the Harvard Business Plan competition. Was responsible for business development, fundraising, licensing and M&A.► Developed new nanoparticle formulations for biotherapeutics► Identified antiviral host cell factors using whole genome expression array/software-supported interactome analysis► Developed IND plans for new HIV, HCV, HSV-1, HSV-2 and Influenza Virus H1N1 treatments ► Facilitated external collaborations with US and European CROs and organized FDA and EMA meetings► Sourced and licensed technology to expand pre-IND infectious disease platforms► Raised 6 NIH preclinical drug development grants. ► Partnered with academic institutions and CROs.



Beth Israel Deaconess Medical Center

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Group Leader

  • Apr 2005 - Oct 2010

  Group leader for biomarker development for virus/host interactions and vaccine vector evaluation. (1) Led a group to test new anti-viral biologics against more than 20 different viruses from more than 10 different virus families. Identified new intrinsic host cell biomarkers responsible for HIV and HCV viral inhibition through Signal Transduction Pathfinder™ and Affymetrix gene arrays™. Tested anti-viral profile of biologics in mice and non-human primates models. Developed new immunoliposome formulation to target specific cells. (2) Developed novel applications of In Vivo Imaging System (IVIS) to evaluate antigen-expression of the following vaccine vector systems: Adenovirus 5, poxviruses (vaccinia, MVA) and plasmid DNA. Identified that the biomarkers cytokine MCP-1 and TGF-β are responsible for plasmid DNA vaccine potency. Worked under the world-renowned Principal Investigator Norman Letvin, M.D.Accomplishments:► Characterized vaccine immune response by flow cytometry with intra-cellular markers and cell receptors on T-cells, NK and NKT cells ► Analyzed genes for host/virus interaction and drug efficacy studies through RT-PCR Pathfinder Signal Transduction and Affymetrix gene arrays► Measured efficacies of anti-viral activities of biologics and small molecule drugs in vivo and in vitro for HIV, HCV and influenza virus► Propagated viruses in mammalian cell lines and purified these through gradient centrifugation► Performed gene expression profiling on isolated mice muscle to identify genes responsible for vaccines’ antigen clearance gene array and used data mining tools► Blocked target genes for vaccine’s antigen clearance and virus/host interactions by RNA interference (RNAi) in vivo and in vitro► Prepared sterical stabilized anti-HLA-DR immunoliposomes encapsulating an innate factor to target virus-infected cells in rhesus macaques. ► Established NOD/scid/b2mnull mice and measured in vivo anti-HIV-1 activity



Massachusetts General Hospital

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Post-doctoral Fellow

  • May 1997 - Jun 2001

  Key recruit in the effort to discover anti-viral biologics of T cells. Supervised the thesis work of a Ph.D. student, trained and supervised technicians. Prepared and delivered presentations at scientific conferences and meetings. Served as a critical reviewer for the work of other scientific teams and for NIH grants in the field of immunology. Worked under the world-renowned Principal Investigator Bruce Walker, M.D.Accomplishments: ► RT-PCR gene-expression array and biochemical purification methods to find biomarkers correlated with anti-HIV activity from CD8+ T cells of Long-Term Non-progressors► Over-expressed innate proteins in T-cell lines to block HIV infection in T cells ► Performed cDNA cloning into baculovirus expression system for recombinant protein production► Developed new ELISAs for chemokine and cytokine quantification► Measured intra-cellular NFκ-B pathway activity ► Performed amino acid alignment for protein fragments after mass spectroscopy using SWISSPRO database