プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Pradip F.に依頼

India

R & D Expert, Scientific Advisor/Strategist/consultant with >20 years of experience in Lifesciences and Healthcare Ind

プロフィール概要

I am managing R & D project for in-vitro diagnostics, in-vitro drug screening, medical device, and vaccine development. I look into all aspects of product development, from conceptualization to regulatory document submission to regulatory agencies like ISO, NABL, CAP, CLIA, CE-IVD, and FDA. I also conduct clinical trial for product safety and efficacy studies.

専門分野

• ☆ Drug Discovery
• ☆ High Throughput Screening (HTS)
• ☆ Drug Target Identification
• ☆ Hit-to-Lead & Lead Optimization
• ☆ High Content Screening/Imaging
• ☆ Drug Development
• ☆ Biosafety Testing
• ☆ Microbiology Testing
• ☆ Bioanalytical Testing
• ☆ Drug Stability Testing
• ☆ Preclinical ADME/PK/PD
• ☆ Preclinical Research
• ☆ In vitro Preclinical Toxciology
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Drug Efficacy Testing
• ☆ Vaccine Development
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Manufacturing
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ In vitro Diagnostic Design
• ☆ Point-of-Care Devices
• ☆ Biomarker Analysis
• ☆ Lab-on-a-Chip Devices
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials Data Analysis
• ☆ Medical Genetics
• ☆ Immunogenetics
• ☆ Infectious Disease
• ☆ Viral Diseases
• ☆ Respiratory Syncytial Virus (RSV)
• ☆ Epstein-Barr Virus (EBV)
• ☆ Ebola
• ☆ West Nile Virus
• ☆ COVID-19
• ☆ Chikungunya
• ☆ Eastern Equine Encephalitis Virus
• ☆ Syphilis
• ☆ Antibiotic Resistance Research
• ☆ Antibiotic Stewardship
• ☆ Sexually Transmitted Infections (STI)
• ☆ HIV/AIDS Treatment
• ☆ Tropical Medicine
• ☆ Malaria
• ☆ Dengue
• ☆ Clinical Laboratory Science
• ☆ Clinical Pathology
• ☆ Molecular Pathology
• ☆ Cytopathology & Histopathology
• ☆ Clinical Biochemistry
• ☆ Regulatory Affairs
• ☆ Tissue Microarray
• ☆ Cytopathology
• ☆ Immunotherapy
• ☆ Zoonoses
• ☆ Cancer Research
• ☆ Cancer Biology
• ☆ Carcinogenesis
• ☆ Medical Equipment & Supplies
• ☆ Product Evaluation
• ☆ Material Sourcing
• ☆ Inventory Control
• ☆ Stability Testing
• ☆ Shelf-Life Testing
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Concept Development
• ☆ Regulatory Writing
• ☆ CMC Documentation
• ☆ NDA/BLA Applications
• ☆ Nonclinical Study Documentation
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Medical Writing
• ☆ Healthcare Communications
• ☆ Research Summaries & Abstracts
• ☆ Investigational New Drug (IND) Application Writing
• ☆ Technical & Scientific Writing
• ☆ Journal Selection
• ☆ Manuscript & Journal Article Writing
• ☆ Experimental Protocols
• ☆ SOP & Protocol Writing
• ☆ White Papers
• ☆ Spec Sheets
• ☆ Case Studies
• ☆ Textbook Content Writing
• ☆ Science Communication
• ☆ Scientific Proofreading & Editing
• ☆ Proofreading & Editing
• ☆ Grant Writing

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, General Proofreading & Editing

Research Meta-Research, Feasibility Study, Technology Scouting, Fact Checking, Gap Analysis, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Data & AI Image Processing, Image Analysis, Text Mining & Analytics

Product Development Recipe Development, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development

職務経験

Deputy General Manager

Datar Cancer Genetics (India)

12月 2016 - 現在

学歴

M.Sc. (Zoology)

Rashtrasant Tukadoji Maharaj Nagpur University

6月 1997 - 6月 1999

認定資格

• 認定資格の詳細は未入力です。

出版物

JOURNAL ARTICLE

Crook T, Leonard R, Mokbel K, Thompson A, Michell M, Page R, Vaid A, Mehrotra R, Ranade A, Limaye S, et al.(2022). Accurate Screening for Early-Stage Breast Cancer by Detection and Profiling of Circulating Tumor Cells . Cancers.

Page R, Patil D, Akolkar D, Murthy SS, Bendale K, Patil R, Fulmali P, Adhav A, Puranik S, Apurwa S, et al.(2022). Circulating tumor cell assay to non-invasively evaluate PD-L1 and other therapeutic targets in multiple cancers . PloS one.

Akolkar D, Patil D, Fulmali P, Puranik S, Apurwa S, Patil R, Adhav A, Mene P, Paranjape P, Golar S, et al.(2020). BIOM-35. MULTI ANALYTE ASSAY FOR NON-INVASIVE DIAGNOSIS OF BRAIN TUMORS . Neuro-oncology.

Gaya A, Crook T, Plowman N, Ranade A, Limaye S, Bhatt A, Page R, Patil R, Fulmali P, Datta V, et al.(2020). Evaluation of circulating tumor cell clusters for pan-cancer noninvasive diagnostic triaging . Cancer cytopathology.

Akolkar D, Patil D, Crook T, Limaye S, Page R, Datta V, Patil R, Sims C, Ranade A, Fulmali P, et al.(2019). Circulating ensembles of tumor-associated cells: A redoubtable new systemic hallmark of cancer . International journal of cancer.

Akolkar D, Patil S, Mhase V, Devhare P, Fulmali P, Patil R, Srinivasan A, Datta V, Schuster S, Bhatia J, et al.(2019). INNV-26. IN VITRO CHEMO RESISTANCE PROFILES OF CIRCULATING GLIAL CELLS REPLICATE CHEMO CHARACTERISTICS OF TUMOR TISSUE . Neuro-oncology.

Patil D, Akolkar D, Schuster S, Govardhan H, Datta V, Bhatia J, Patil R, Puranik S, Apurwa S, Srinivasan A, et al.(2019). PATH-43. DIAGNOSIS OF GLIOMAS USING CIRCULATING GLIAL CELLS . Neuro-oncology.

Lee I, Scarpace L, Hunt R, Nelson K, Patil D, Datta V, Akolkar D, Apurva S, Fulmali P, Puranik S, et al.(2019). PATH-64. PROSPECTIVE, BLINDED PLASMA BASED ANALYSIS FOR DIAGNOSIS OF NEWLY DIAGNOSED GLIOMA . Neuro-oncology.

Lee I, Scarpace L, Nelson K, Patil D, Datta V, Akolkar D, Apurva S, Fulmali P, Puranik S, Snyder J, et al.(2018). PATH-37. LIQUID BIOPSY FOR IDENTIFICATION OF NEWLY DIAGNOSED GLIOMA . Neuro-oncology.

Akolkar D, Ranjan A, Chirmade S, Mandal S, Devhare P, Fulmali P, Apurva S, Ray A(2015). GENO-01MOLECULAR INTERROGATION OF GLIOBLASTOMA MULTIFORME TUMORS IDENTIFIES A COMPLEX NETWORK OF CELL SIGNALLING PATHWAYS WITH POSSIBLE THERAPEUTIC IMPLICATIONS . Neuro-oncology.

Sapkal GN, Harini S, Ayachit VM, Fulmali PV, Mahamuni SA, Bondre VP, Gore MM(2011). Neutralization escape variant of West Nile virus associated with altered peripheral pathogenicity and differential cytokine profile . Virus research.

Fulmali PV, Sapkal GN, Athawale S, Gore MM, Mishra AC, Bondre VP(2011). Introduction of Japanese encephalitis virus genotype I, India . Emerging infectious diseases.

Bondre VP, Sapkal GN, Yergolkar PN, Fulmali PV, Sankararaman V, Ayachit VM, Mishra AC, Gore MM(2009). Genetic characterization of Bagaza virus (BAGV) isolated in India and evidence of anti-BAGV antibodies in sera collected from encephalitis patients . The Journal of general virology.

Sapkal GN, Bondre VP, Fulmali PV, Patil P, Gopalkrishna V, Dadhania V, Ayachit VM, Gangale D, Kushwaha KP, Rathi AK, et al.(2009). Enteroviruses in patients with acute encephalitis, uttar pradesh, India . Emerging infectious diseases.

Fulmali PV, Walimbe A, Mahadev PV(2008). Spread, establishment & prevalence of dengue vector Aedes aegypti (L.) in Konkan region, Maharashtra, India . The Indian journal of medical research.

Gopalkrishna V, Patil PR, Kolhapure RM, Bilaiya H, Fulmali PV, Deolankar RP(2007). Outbreak of acute hemorrhagic conjunctivitis in Maharashtra and Gujarat states of India, caused by Coxsackie virus A-24 variant . Journal of medical virology.

Mavale MS, Fulmali PV, Ghodke YS, Mishra AC, Kanojia P, Geevarghese G(2007). Experimental transmission of Chandipura virus by Phlebotomus argentipes (diptera: psychodidae) . The American journal of tropical medicine and hygiene.

Mavale MS, Fulmali PV, Geevarghese G, Arankalle VA, Ghodke YS, Kanojia PC, Mishra AC(2006). Venereal transmission of Chandipura virus by Phlebotomus papatasi (Scopoli) . The American journal of tropical medicine and hygiene.

Mavale MS, Geevarghese G, Ghodke YS, Fulmali PV, Singh A, Mishra AC(2005). Vertical and venereal transmission of Chandipura virus (Rhabdoviridae) by Aedes aegypti (Diptera: Culicidae) . Journal of medical entomology.

Mahadev PV, Fulmali PV, Mishra AC(2004). A preliminary study of multilevel geographic distribution & prevalence of Aedes aegypti (Diptera: Culicidae) in the state of Goa, India . The Indian journal of medical research.

Malhotra KC, Chakraborty R, Bhanu BV, Fulmali PM(1980). Variations on dermal ridges in nine population groups of Maharashtra, India. I. Intra- and interpopulation diversity . Human heredity.

Malhotra KC, Mutalik GS, Bhanu BV, Kate SL, Fulmali PM(1974). Incidence of colourblindness among four endogamous nomadic groups: an example of natural selection . Heredity.

PREPRINT

Limaye S, Chowdhury S, Rohatgi N, Ranade A, Syed N, Riedemann J, Page R, Patil D, Akolkar D, Datta V, et al.(2022). Accurate Prostate Cancer Detection based on Circulating Tumor Cell Profiling .

Crook T, Patil D, Akolkar D, Ranade A, Limaye S, Page R, Datta V, Fulmali P, Apurwa S, Schuster S, et al.(2022). Accurate Screening for Early-Stage Breast Cancer by Detection and Profiling of Circulating Tumor Cells .

Page R, Patil D, Akolkar D, Murthy SS, Bendale K, Patil R, Fulmali P, Adhav A, Puranik S, Apurwa S, et al.(2022). Circulating Tumor Cell Assay to Non-Invasively Evaluate PD-L1 and Other Therapeutic Targets in Multiple Cancers .