プロフィール詳細

プロジェクトを作成

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Raksha R.に依頼

Sweden

Biotech Strategist with 3+ years in pharma | Competitive Intelligence, KOL Mapping & APAC Regulatory

プロフィール概要

I am a biotech strategy consultant specializing in competitive intelligence, regulatory pathways, and market access strategy for rare disease therapeutics. Currently, I serve as the founder of VectraGen Advisory while completing a strategic internship at Cereno Scientific AB, a Swedish pharmaceutical company focused on rare cardiovascular diseases. At Cereno Scientific, I have executed 13 high-impact strategic projects supporting executive decision-making for their pulmonary arterial hypertension (PAH) portfolio. My work spans competitive landscape analyses, multi-country regulatory pathway mapping, KOL profiling, epidemiological modeling, and market access strategy across Europe and Asia-Pacific markets. Prior to my strategic consulting work, I built a strong foundation in molecular biology and biomedical research through positions spanning translational medicine, molecular diagnostics, and bioinformatics across multiple international research institutions. Core Expertise & Skills: Market & Competitive Intelligence: Comprehensive competitive landscape analysis for novel therapeutics Mechanism-of-action differentiation and therapeutic positioning Clinical trial data synthesis and endpoint evaluation Pricing and reimbursement strategy analysis Patient advocacy and stakeholder landscape mapping Regulatory Affairs & Market Access: Multi-country regulatory pathway analysis (China NMPA, Japan PMDA, Korea MFDS, EMA, FDA) Orphan drug designation strategy and accelerated approval pathways Breakthrough therapy and Sakigake designation feasibility assessment Market access and reimbursement dynamics in single-payer systems Regulatory intelligence gathering and precedent analysis Clinical Development & Research: KOL identification, profiling, and influence mapping Epidemiological modeling and prevalence/incidence analysis Clinical trial design evaluation and feasibility assessment Scientific literature review and meta-analysis Medical and scientific writing for various audiences Regional & Therapeutic Area Expertise: Pulmonary arterial hypertension (PAH) and rare cardiovascular diseases Orphan drug development and rare disease strategy Asian pharmaceutical markets (Japan, China, Korea) Nordic healthcare systems and regulatory environments Technical Capabilities: Database mining (ClinicalTrials.gov, regulatory databases, scientific literature) Competitive intelligence platforms (AlphaSense, Cortellis) Data analysis and visualization Strategic presentation development for C-suite audiences Cross-cultural stakeholder engagement Previous & Ongoing Research Projects: Cereno Scientific AB | Strategy & Business Development Intern (2024) Project 1: PAH Competitive Landscape Analysis Conducted comprehensive competitive intelligence on sotatercept (Merck's WINREVAIR) and seralutinib (Gossamer Bio), analyzing mechanism differentiation, clinical trial design, endpoint selection, and market positioning Evaluated activin signaling inhibition, PDGF receptor modulation, and HDAC inhibitor mechanisms versus standard-of-care PAH therapies Delivered strategic recommendations on competitive positioning and differentiation strategies Project 2: Japan PMDA Regulatory Strategy Mapped regulatory pathways for PAH therapeutics in Japan, including orphan drug designation requirements, Sakigake breakthrough designation criteria, and conditional approval pathways Analyzed sotatercept's 24-month Sakigake timeline to project accelerated pathways for CS014 HDAC inhibitor Reverse-engineered Japan NHI pricing models (¥400K-¥1.2M monthly range) to predict reimbursement windows for new entrants Project 3: Global KOL Mapping Profiled 38 key opinion leaders across PAH research in US, Europe, and Asia-Pacific Mapped KOL influence across regulatory advisory committees (FDA, EMA, PMDA), clinical trial participation, and guideline development Identified regulatory decision-makers and their published positions on novel mechanism therapies Project 4: Multi-Country Regulatory Pathway Analysis Executed comparative analysis of orphan drug approval processes across China NMPA, Japan PMDA, and Korea MFDS Documented submission timelines, designation requirements, clinical data expectations, and post-marketing commitments Created decision frameworks for geographic expansion prioritization Project 5: Epidemiological Market Sizing Developed prevalence and incidence models for PAH across Japan, China, Korea, and European markets Conducted patient journey mapping and healthcare resource utilization analysis Supported market access and commercial forecasting initiatives Project 6: Patient Advocacy Landscape Analysis Analyzed 24 global patient advocacy organizations focused on PAH and rare cardiovascular diseases Assessed organizational influence, patient reach, funding sources, and strategic partnerships Identified collaboration opportunities for patient-centric development strategies Project 7: CS014 HDAC Inhibitor Scientific Communications Developed scientific posters and mechanism-of-action presentations for CS014 Created executive summaries translating complex preclinical and clinical data for business audiences Supported investor relations and partnership discussions with scientific content Ongoing Project: Clinical Trial Cost Modeling Building cost frameworks for Phase 2/3 trials in rare cardiovascular indications across multiple geographies Analyzing CRO pricing, site selection, patient recruitment timelines, and regulatory milestone costs Ongoing Project: Asian Market Entry Strategy Developing comprehensive market entry frameworks for Western biotech companies targeting China, Japan, and Korea Evaluating partnership models, regulatory pathways, pricing negotiations, and local manufacturing requirements VectraGen Advisory | Founder & Principal Consultant (2024-Present) Project: Fierce Biotech Annotation Partnership (In Negotiation) Developing tiered annotation service for rare disease and Asian regulatory developments Creating competitive context annotations, deep-dive therapeutic area reports, and predictive regulatory calendars Building expertise-driven content that bridges scientific accuracy with commercial relevance Consulting Services Offered: Competitive intelligence reports for biotech and pharmaceutical clients Regulatory pathway analyses for orphan drug development KOL mapping and stakeholder engagement strategy Market access and pricing strategy consulting Scientific literature reviews and evidence synthesis Educational Background: Master of Science in Biomedical Sciences University of Sydney, Australia Advanced training in molecular mechanisms of disease, translational medicine, and clinical research methodologies Thesis work focused on cardiovascular pathophysiology and therapeutic interventions Master of Science in Molecular Biology M.S. Ramaiah University of Applied Sciences, India Specialized training in molecular diagnostics, genetic analysis, and bioinformatics Research experience in cellular and molecular mechanisms underlying disease processes Research Experience: Molecular diagnostics and biomarker discovery Translational medicine and preclinical research Bioinformatics and computational biology applications Cross-institutional collaborative research across multiple countries What I Can Deliver for Kolabtree Clients: Competitive Intelligence & Market Research: Comprehensive competitive landscape reports (therapeutic area analyses, mechanism differentiation, clinical trial benchmarking) Target product profile development and positioning strategy Pricing and market access feasibility assessments Regulatory & Clinical Strategy: Multi-country regulatory pathway analysis with timeline and cost projections Orphan drug designation strategy and breakthrough therapy pathway evaluation Clinical trial design review and endpoint selection guidance Regulatory precedent research and submission strategy Scientific Research & Analysis: Systematic literature reviews and meta-analyses KOL identification and influence mapping Epidemiological modeling and patient population analyses Scientific writing (white papers, slide decks, regulatory documents, abstracts) Business Development Support: Partnership opportunity assessment Due diligence support for investors and acquirers Market entry strategy for Asian markets (China, Japan, Korea) Commercial feasibility analyses Working Style & Availability: I deliver high-quality, evidence-based analysis with meticulous attention to sourcing and documentation. My background in both rigorous academic research and fast-paced pharmaceutical strategy enables me to balance scientific depth with commercial pragmatism. I am based in Sweden (CET timezone) and work flexibly across global time zones. Typical project turnaround ranges from 1-2 weeks depending on scope, with rush projects accommodated when feasible. I prioritize clear communication, structured deliverables, and actionable recommendations that drive decision-making. All work is backed by comprehensive references from peer-reviewed literature, regulatory documentation, and industry databases.

専門分野

• ☆ Computational Biology
• ☆ Evolutionary Biology
• ☆ Microbiology
• ☆ Microbiome Research
• ☆ Phycology/Algae
• ☆ Mycology/Fungi
• ☆ Parasitology
• ☆ Virology
• ☆ Coronaviruses
• ☆ Coxsackie B Virus
• ☆ Noroviruses
• ☆ Enteroviruses
• ☆ Zika Virus
• ☆ Retrovirology
• ☆ Cytomegaloviruses
• ☆ Adenoviruses
• ☆ Molecular Virology
• ☆ Industrial Microbiology
• ☆ Microbiological Assays
• ☆ Bacteriology
• ☆ Gram-Negative Bacteria
• ☆ Gram-Positive Bacteria
• ☆ Agricultural Microbiology
• ☆ Biostatistics
• ☆ Biochemistry
• ☆ Immunoassay
• ☆ Biochemical Assays
• ☆ Structural Biology
• ☆ Apoptosis
• ☆ Oxidative Stress & Mitochondrial Function
• ☆ Antioxidants
• ☆ Enzyme Activity Assays
• ☆ Binding Assays
• ☆ Molecular Biology
• ☆ Biomarkers
• ☆ Genetics
• ☆ Microarrays
• ☆ Omics
• ☆ Transcriptomics
• ☆ Comparative Genomics
• ☆ Lipidomics
• ☆ Proteomics
• ☆ Metabolomics
• ☆ Genomics
• ☆ Molecular Evolution
• ☆ Chromatin
• ☆ Epigenetics
• ☆ PCR
• ☆ Molecular Cloning
• ☆ Next Generation Sequencing (NGS)
• ☆ ATAC-Seq
• ☆ DNA Sequencing
• ☆ Synthetic Genomics
• ☆ Protein Sequencing
• ☆ Genome Sequencing
• ☆ Microinjection
• ☆ Mutagenesis
• ☆ Exome Sequencing
• ☆ Recombinant DNA
• ☆ RNA Synthesis
• ☆ RNA Sequencing
• ☆ DNA/Gene Synthesis
• ☆ Oligonucleotide Synthesis
• ☆ Plasmid DNA
• ☆ DNA Damage & Repair
• ☆ ChIP-Seq
• ☆ Kinases
• ☆ Monoclonal Antibody Production
• ☆ Molecular Ecology
• ☆ Cell Biology
• ☆ Cell-Based Assays
• ☆ Cytochemistry
• ☆ Cytogenetics
• ☆ Cell Signaling Pathways
• ☆ Membrane Biology
• ☆ Gene Regulation
• ☆ Stem Cell Research
• ☆ Mycology
• ☆ Sociobiology
• ☆ Comparative Physiology
• ☆ Basic Immunology
• ☆ Adjuvant & Antigen Research
• ☆ Biophysics
• ☆ Histology
• ☆ Biotechnology & Bioengineering
• ☆ Recombinant Protein Expression
• ☆ Nanobiotechnology
• ☆ Microbial Biotechnology
• ☆ Biomedical Engineering
• ☆ Biological Systems Engineering
• ☆ Microscopy
• ☆ Cryosectioning
• ☆ Light Microscopy
• ☆ Electron Microscopy
• ☆ Fluorescence Microscopy
• ☆ Scanning Probe Microscopy
• ☆ Pathogenesis
• ☆ Clinical Microbiology
• ☆ Biomarker Discovery
• ☆ Cell Culture
• ☆ Primary Cells
• ☆ Cell Banking
• ☆ Cell Line Engineering
• ☆ Large Scale Cell Culture
• ☆ Cell Surface Receptors
• ☆ 3D Cell Culture
• ☆ Plasma Technology
• ☆ Industrial Biotechnology
• ☆ Synthetic Biology
• ☆ Microbial Fermentation
• ☆ Biomolecular Engineering
• ☆ Gene Synthesis
• ☆ Genetic Engineering
• ☆ Gene Editing/CRISPR
• ☆ Protein/Enzyme Engineering
• ☆ Antibody Engineering
• ☆ Gene Delivery
• ☆ Biological Taxonomy/Classification
• ☆ Blotting
• ☆ Immunohistochemistry
• ☆ Phylogenetics
• ☆ Population Genetics
• ☆ Tissue Engineering
• ☆ Cytometry
• ☆ Cell Aging
• ☆ Medical Technologies
• ☆ Assistive Technology
• ☆ Pharmacy
• ☆ Clinical Pharmacy
• ☆ Drug Discovery
• ☆ High Throughput Screening (HTS)
• ☆ Drug Target Identification
• ☆ Hit-to-Lead & Lead Optimization
• ☆ Phenotypic Assays
• ☆ High Content Screening/Imaging
• ☆ Medicinal Chemistry
• ☆ Drug Design
• ☆ Combinatorial Chemistry
• ☆ Structure-Activity Relationship (SAR) Studies
• ☆ Drug Development
• ☆ Drug Formulation
• ☆ Small Molecule Drug Development
• ☆ Biologic & Biosimilar Development
• ☆ Drug Substance Characterization
• ☆ Biosafety Testing
• ☆ Microbiology Testing
• ☆ Bioanalytical Testing
• ☆ Drug Stability Testing
• ☆ Preclinical ADME/PK/PD
• ☆ Drug-Drug Interactions
• ☆ Preclinical Research
• ☆ Pharmacogenomics
• ☆ Preclinical Pharmacology
• ☆ In vitro Preclinical Toxciology
• ☆ In vivo Preclinical Toxicology
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Drug Efficacy Testing
• ☆ Antibiotic Development
• ☆ Bioavailability
• ☆ Vaccine Development
• ☆ Pharmaceutical Manufacturing
• ☆ Pharmaceutical Process Development
• ☆ Bioprocess Development
• ☆ Small Molecule Manufacturing
• ☆ Biologic & Biosimilar Manufacturing
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials Data Analysis
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Allergy & Clinical Immunology
• ☆ Clinical Immunology
• ☆ Human Biology
• ☆ Precision Medicine
• ☆ Cardiovascular Disease
• ☆ Vascular Medicine
• ☆ Pacemakers
• ☆ Clinical Cardiac Electrophysiology
• ☆ Interventional Cardiology
• ☆ Cardiovascular Disease Management
• ☆ Pediatric Cardiology
• ☆ Pulmonology/Respiratory Disease
• ☆ Lung Cancer
• ☆ Tuberculosis
• ☆ Severe Acute Respiratory Syndrome (SARS)
• ☆ Respiratory Therapy
• ☆ Rare Diseases
• ☆ Amyloidosis
• ☆ Regulatory Affairs
• ☆ Immunotherapy
• ☆ Gene Therapy
• ☆ Psychoactive Drugs
• ☆ Inflammation
• ☆ Pharmaceutical Management
• ☆ Drug Delivery Technologies
• ☆ Liposomes
• ☆ Pharmaceutical Technology
• ☆ Concept Development
• ☆ Product Launch Support
• ☆ Hypothesis
• ☆ Peer Review
• ☆ Research Methodology
• ☆ Survey Design & Methodology
• ☆ User Research
• ☆ Quantitative User Research
• ☆ Qualitative User Research
• ☆ Meta-Research
• ☆ Feasibility Studies
• ☆ Technology Scouting
• ☆ Fact Checking
• ☆ Literature Search
• ☆ Gap Analysis
• ☆ Gray Literature Search
• ☆ Presentation Design
• ☆ Animation & Illustration
• ☆ Scientific Animation & Illustration
• ☆ Medical Illustration
• ☆ Process Design
• ☆ Instructional Webinars
• ☆ Skills Training
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Clinical Evaluation Reports (CER)
• ☆ Premarket Notification/510(k) Submission
• ☆ Investigational Device Exemption (IDE)
• ☆ PreMarket Approval (PMA) Applications
• ☆ CMC Documentation
• ☆ NDA/BLA Applications
• ☆ Nonclinical Study Documentation
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ SEO Medical Writing
• ☆ Healthcare Communications
• ☆ Patient Education Materials
• ☆ Research Summaries & Abstracts
• ☆ Cochrane Reviews
• ☆ Investigational New Drug (IND) Application Writing
• ☆ Medical Copywriting
• ☆ Technical & Scientific Writing
• ☆ Journal Selection
• ☆ Manuscript & Journal Article Writing
• ☆ Instructional Materials
• ☆ Release Notes
• ☆ Experimental Protocols
• ☆ SOP & Protocol Writing
• ☆ White Papers
• ☆ Spec Sheets
• ☆ Case Studies
• ☆ Textbook Content Writing
• ☆ Science Communication
• ☆ Literature Review
• ☆ Traditional/Narrative Literature Review
• ☆ Systematic Literature Review
• ☆ Copywriting
• ☆ Emails & Newsletters
• ☆ Marketing Copy
• ☆ Social Media Copy
• ☆ Web Copy
• ☆ Blog Posts
• ☆ Public Relations Writing
• ☆ Scientific Proofreading & Editing
• ☆ Proofreading & Editing
• ☆ Creative Writing
• ☆ News Writing
• ☆ Course Content Writing
• ☆ Grant Writing
• ☆ Human Resources
• ☆ Employee Training
• ☆ Workplace Investigations
• ☆ Business Operations
• ☆ Business Strategy
• ☆ Business Statistics
• ☆ International Business
• ☆ Public-Private Partnership
• ☆ Small Business
• ☆ Entrepreneurship
• ☆ Business Intelligence
• ☆ Nonprofit Organization Administration
• ☆ Innovation Management
• ☆ Management Information Systems
• ☆ Crisis Management & Emergency Preparedness
• ☆ Project Management
• ☆ Corporate Governance
• ☆ Risk Management
• ☆ Public Relations
• ☆ Management Consulting

サービス

• Writing

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting, Creative Writing, Newswriting, General Proofreading & Editing

職務経験

Founder and Chief Biotech Strategist

VectraGen Advisory

8月 2025 - 現在

Strategy and Business Development Lead

Cereno Scientific AB

8月 2025 - 1月 2026

Research Lab Specialist

The University of Sydney HealthCare Club

2月 2023 - 4月 2024

Research Lab Specialist

Credora Life Sciences

2月 2022 - 11月 2022

PRIMA DIAGNOSTICS

Junior Lab Associate

2月 2019 - 2月 2022

学歴

Master's degree (Research), Biomedical Sciences: Infection and Immunity

University of Sydney, Australia

2月 2023 - 3月 2024

Master's degree, Cell/Cellular and Molecular Biology

M. S. RAMAIAH UNIVERSITY OF APPLIED SCIENCES

8月 2020 - 5月 2022

Bachelor's degree, Microbiology and Immunology

Tumkur University

6月 2016 - 5月 2019

認定資格

• Market Analyst of the month

  Cereno Scientific

  https://dochub.com/raksha-ravi/1XEpyxzwNxNrJPxKQZGd38/certificate-png

  10月 2025 - 現在