№ files_lp_4_process_3_085877
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Senior Principal Scientist with over 16 years of experience in product development at Merck, focusing on preformulation, materials characterization, and new formulation technologies to improve the delivery of insoluble compounds.
Year:
Not specified
Region / City:
West Point, PA
Field:
Pharmaceutical Sciences, Medicinal Chemistry
Document Type:
Biography
Organization:
Merck
Author:
Wei Xu
Target Audience:
Not specified
Period of Activity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2021
Region / city:
Coral Gables, FL
Topic:
Strategic Management, Corporate Governance
Document type:
Academic CV
Institution:
University of Miami, Miami Herbert Business School
Author:
Wei Shi
Target audience:
Academics, Researchers, Business Professionals
Period of validity:
2021-present
Date of approval:
Not specified
Date of modifications:
Not specified
Year:
2019
Region / City:
Atlanta, Memphis
Topic:
Leadership, Entrepreneurship, Business Growth
Document Type:
Memoir, Business Insights
Organization / Institution:
YPO, Scaling Up
Author:
Verne Harnish
Target Audience:
Business Leaders, Entrepreneurs
Effective Period:
2019
Approval Date:
March 1, 2019
Modification Date:
N/A
Document context:
A tribute to Wei Chen’s life, his entrepreneurial achievements, and the lessons learned from his leadership and business practices.
Year:
2022
Region / City:
Australia
Topic:
Medical treatment approval and submission for pembrolizumab and lenvatinib
Document type:
Submission for drug listing
Organization / Institution:
Pharmaceutical Benefits Advisory Committee (PBAC), Therapeutic Goods Administration (TGA)
Author:
Merck Sharp & Dohme (Australia) Pty Ltd
Target audience:
Medical professionals, health regulators
Period of validity:
2022 onward
Approval date:
August 10, 2021
Amendment date:
Not specified
Year:
2023
Region / City:
Australia
Theme:
Oncology, Pharmaceutical
Document Type:
Submission
Organization / Institution:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Not specified
Target Audience:
Medical professionals, policymakers
Period of Effectiveness:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2023
Region / City:
Australia
Subject:
Oncology / Colorectal Cancer Treatment
Document Type:
Medical submission
Agency / Organization:
Pharmaceutical Benefits Advisory Committee (PBAC)
Author:
Not specified
Target Audience:
Medical practitioners
Effective Period:
Ongoing
Approval Date:
Not provided
Date of Revision:
Not provided
Year:
2024
Region / City:
Australia
Topic:
Oncology / Cancer Treatment
Document Type:
Pharmaceutical Submission
Organization:
Merck Sharp & Dohme
Author:
Merck Sharp & Dohme
Target Audience:
Healthcare professionals, regulatory bodies, pharmaceutical industry
Effective Period:
From September 2024
Approval Date:
Pending
Date of Changes:
September 2024
Context:
A submission by Merck Sharp & Dohme to request a multi-indication listing for pembrolizumab to treat advanced or metastatic cancers under the Pharmaceutical Benefits Scheme in Australia.
Year:
2022
Region / City:
Australia
Theme:
Oncology, Pharmacology
Document Type:
Addendum
Organ / Institution:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Not specified
Target Audience:
Healthcare professionals, regulatory bodies
Period of Validity:
Indication approved on February 7, 2022
Approval Date:
07 February 2022
Change Date:
Not specified
Year:
2022
Region / city:
Australia
Topic:
Early-stage triple negative breast cancer treatment
Document type:
Pharmaceutical submission
Organization / institution:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Not specified
Target audience:
Medical professionals, healthcare providers
Effective period:
From September 2022
Approval date:
2 September 2022
Modification date:
Not specified
Registration status:
Approved by TGA
Background:
Pembrolizumab was approved by the TGA for the treatment of early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment and as monotherapy post-surgery.
Condition:
Triple negative breast cancer
Indication:
Early stage triple negative breast cancer
Restriction:
Section 100 (Efficient funding of chemotherapy), Authority Required – Streamlined
Treatment initiation criteria:
Hormone receptor negative, HER2 negative, preparing for surgery, ECOG status 1 or less, treatment combined with chemotherapy, no previous treatment, not exceeding 24 weeks of therapy
Continuation criteria:
Must have undergone surgery, ECOG status 1 or less, monotherapy for adjuvant phase, no more than 27 weeks of therapy
Grandfathering criteria:
Must have previously received non-PBS subsidised treatment
Price:
$7,881.87 private, $7,733.78 public for neoadjuvant; private and public prices for adjuvant not specified
Number of doses:
7 for neoadjuvant, 8 for adjuvant
Source:
Table 1.1-1, pp12-14
Context description:
A pharmaceutical submission for the approval of pembrolizumab as a treatment for early-stage triple-negative breast cancer, including neoadjuvant and adjuvant therapy details and pricing for PBS listing.
Year:
2021
Region / City:
Australia
Topic:
Pneumococcal vaccine submission
Document type:
Submission for listing on the National Immunisation Program
Author:
Merck Sharp & Dohme (Australia) Pty Ltd
Target audience:
Health professionals, regulatory bodies, policy makers
Period of validity:
Ongoing
Approval date:
16 July 2021 (FDA approval), 14 October 2021 (EMA recommendation)
Date of changes:
Not specified
Context:
A clinical submission for the inclusion of a 15-valent pneumococcal conjugate vaccine (PCV15) on the National Immunisation Program for adults at risk of pneumococcal disease.
Year:
2017
Region / city:
Australia
Theme:
Oncology, Immunotherapy
Document type:
Pharmaceutical Submission
Organization / Institution:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Merck Sharp & Dohme
Target audience:
Healthcare professionals, medical practitioners
Effective period:
Ongoing
Approval date:
March 2017
Changes date:
Not specified
Context:
A pharmaceutical submission for the listing of pembrolizumab for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients, detailing proposed PBS listings, treatment phases, and clinical criteria.
Year:
2023
Region / city:
Australia
Topic:
Pneumococcal vaccination
Document type:
Submission
Agency / organization:
Australian Technical Advisory Group on Immunisation (ATAGI)
Author:
Merck Sharp & Dohme (Australia) Pty Ltd
Target audience:
Healthcare professionals involved in immunization
Period of validity:
Not specified
Approval date:
Expected by 30 April 2023
Date of changes:
9 February 2023
Bezlotoxumab, Solution concentrate for I.V. infusion 1000 mg in 40 mL,Zinplava®, Merck Sharp & Dohme
Year:
2021
Region / City:
Australia
Topic:
Pharmaceutical Approval
Document Type:
Resubmission Request
Author:
Merck Sharp & Dohme
Target Audience:
Medical Practitioners, Healthcare Professionals
Period of Validity:
Not specified
Approval Date:
8 November 2017
Date of Changes:
November 2017
Treatment Phase:
Initial
Indication:
Clostridium Difficile Infection (CDI)
Restriction Level:
Section 100 – Authority Required
Prescriber Type:
Dental, Medical Practitioners, Nurse Practitioners, Optometrists, Midwives
Clinical Criteria:
Confirmed Toxin B Positive CDI, High Risk of Recurrence
Clinical Claim:
Bezlotoxumab more effective than SoC antibiotics in preventing CDI recurrence
Cost Effectiveness:
Comparison with Standard of Care (SoC)
Background:
TGA approved on 8 November 2017 for prevention of CDI recurrence
Context:
Pharmaceutical resubmission seeking authority for listing bezlotoxumab as an option for preventing Clostridium Difficile Infection recurrence in patients at high risk, emphasizing its cost-effectiveness over standard antibiotic treatments.
Year:
2024
Region / City:
Kirkland, Quebec, Canada
Topic:
Artificial Intelligence in Healthcare
Document Type:
News Release
Organization:
Merck Canada
Partner Organization:
Vector Institute
Author:
Marwan Akar, Abhishek Narayan Singh, Tony Gaffney
Target Audience:
General public, healthcare industry, AI research community
Effective Period:
Multi-year agreement starting February 8, 2024
Date of Release:
February 8, 2024
Scope:
Canada and international AI research collaborations
Funding:
Merck Canada investments; Vector Institute funding from Ontario, Government of Canada, industry sponsors
Description:
Press release reporting a partnership between a pharmaceutical company and an AI research institute to collaborate on healthcare innovations and AI research initiatives.
Year:
2018
Region / city:
Australia
Subject:
Pharmaceutical application for diabetes treatment
Document type:
Pharmaceutical submission
Organization / institution:
PBAC, TGA
Author:
Merck Sharp & Dohme (Australia) Pty Ltd
Target audience:
Medical practitioners, healthcare professionals
Validity period:
Ongoing since 2018
Approval date:
16 April 2018
Revision date:
March 2018
Year:
2019
Region / city:
Australia
Theme:
Oncology, Pharmacology
Document Type:
Pharmaceutical Submission
Organization / Institution:
Merck Sharp & Dohme (Australia) Pty Ltd
Author:
Merck Sharp & Dohme (Australia) Pty Ltd
Target Audience:
Healthcare professionals, regulatory bodies
Period of Validity:
Not specified
Approval Date:
16 October 2019
Date of Revisions:
Not specified
PBS Code:
10424P, 10436G, 10475H, 10493G, 11492W, 11494Y
Requested Dose Regimen:
400 mg Q6W
Indications:
Unresectable Stage III or Stage IV malignant melanoma, metastatic non-small cell lung cancer (NSCLC)
Price:
Private $17,434.92, Public $17,118.12
PBAC Outcome:
March 2020 meeting
Regulatory Status:
TGA approval
Clinical Evidence:
Pharmacokinetic modelling data
Clinical Trials:
Not presented for 400 mg Q6W, PK data used
Economic Analysis:
None provided
Year:
2026
Region / City:
Galway
Topic:
Recruitment, Medical Science
Document Type:
Job Application Information
Organization / Institution:
Galway University Hospitals
Author:
Galway University Hospitals Recruitment Team
Target Audience:
Job Applicants
Effective Period:
Ongoing recruitment
Approval Date:
Not specified
Date of Changes:
Not specified
Date of Birth:
14th Jan 1981
Place of Birth:
Jaduguda, Jharkhand (Formerly State of Bihar), India
Nationality:
Indian
Mother’s Name:
Smt. Sudha Pillai
Father’s Name:
Shri. M.R.Shivan Pillai
Permanent Address:
“Aswathy”, P.O. Muttom, Via Haripad, Dist: Alleppey, Kerala-690511
Current Residence Address:
A-4-44, NML Flats, P.O. Agrico, Jamshedpur, Jharkhand-831007
Objective:
Challenging research scientist position specialized with hydrometallurgy and microbial mineral biotechnology in environmental technology & waste recycling with a high-growth engineering research organization engaged in interdisciplinary process and technological solutions in minerals, metals, materials and environment, with keen interest for expertise build-up and practice long-term research initiatives/collaborations
Education:
Ph.D. (Biochem. Engg)- Biohydrometallurgy of Uranium ores, Jadavpur University, INDIA (2012)
Note:
M.Sc. Biotechnology (Mineral Biotechnology), Bangalore University, INDIA (2003), 75.50%
Professional Experience:
Senior Principal Scientist, CSIR-National Metallurgical Laboratory, INDIA (since 2021)
Research Interests:
Biohydrometallurgy, Waste Recycling, Rare Earth Element Extraction, Battery Recycling
Skills:
Web authoring, FACTSAGE, ORIGIN, NCBI, BLAST, MEGA-6
Year:
2021
Type of document:
Request for Expression of Interest
Reference number:
CS/STATS/SCBV/2021/04
Issuing organization:
COMESA Secretariat
Program:
African Information Highway (AIH)
Position title:
Team Leader and Senior Data Scientist
Assignment type:
Individual consultancy
Region:
Africa
Maximum contract budget:
USD 150,000
Submission language:
English
Submission deadline:
18 August 2021
Contract commencement:
Within two weeks of contract signature
Evaluation method:
Technical evaluation and financial compliance
Minimum technical score:
70%
Contact persons:
Ted Peter Luka; Silver Mwesigwa
Date of issue:
28 July 2021
Year:
2020
Region / city:
South East Scotland
Field:
Genetics
Document type:
Job Description
Organization:
NHS Lothian
Author:
Not specified
Target audience:
Healthcare professionals
Effective period:
Not specified
Approval date:
January 2020
Date of changes:
Not specified
Year:
2021–present
Region / City:
Bangalore, India
Topic:
Data Science, Machine Learning, GenAI, Data Analytics, Predictive Modeling
Document Type:
CV
Organization:
Collective-s, Shriram Finance, Onward Technologies, Tata Consultancy Services
Author:
Sandeep Dhekane
Target Audience:
Employers, Recruiters, Industry professionals
Period of Validity:
Ongoing
Approval Date:
N/A
Date of Changes:
N/A