Joshua Sharlin, Ph.D.

Summary: Dr. Sharlin has practical hands-on experience in many aspects of drug, biologic and medical device development including; regulatory affairs, protocol development, design and execution of studies, data collection, data management, data reporting, statistical analysis, software programming and validation, technical writing, and FDA compliance.

Highlights of Skills, Services & Experience

• FDA drug reviewer, FDA statistician, instructor for SAS Institute
• Experience with drugs, biologics and medical devices
• Authority in 21 CFR Part 11 compliance and assessment
• Teach audioconferences and customized onsite training classes
• Audit CROs, sponsors and vendors for FDA compliance
• Regulatory affairs and GCP compliance expert
• Write and improve SOPs

Consulting Services

Write SOPs

Applied my compliance knowledge and insight into the expectations of auditors and FDA reviewers to write and improve SOPs on a wide variety of regulatory and technical topics. Wrote SOPs about all aspects of good clinical practice (GCP), software validation and 21 CFR Part 11 compliance and all elements of information technology infrastructure.

Perform Audits for Compliance and Capability

Conducted capability audits of CROs for sponsor companies. Performed mock audits of sponsor companies to provide assurance that they will pass an FDA audit. Evaluated CRO compliance in advance of customer audits.

Audited for GCP compliance, information technology infrastructure and all elements necessary for the collection, analysis, interpretation and presentation of information to FDA.

Validate Software

Wrote SOPs and created the required documentation so in-house developed software or software intended for sale to FDA-regulated companies met all requirements in 21 CFR Part 11.

Conduct Training

Developed over 40 classes on a wide-range of technical and regulatory topics including safety reporting, 21 CFR Part 11 validation, SAS programming and statistical topics. Have trained tens of thousands of people from thousands of FDA-regulated companies. Developed customized classes for company staff while solving problems and producing deliverables.

Write and Review Protocols, Statistical Analysis Plans and Study Reports

Reviewed and wrote protocols and statistical analysis plans. Improved their content and structured information to be more useful to FDA reviewers. Predicted problems and issues likely to be raised by FDA reviewers and added information to answer these expected questions.

Execute Statistical Analysis

Provided advise on statistical issues and performed statistical analysis.

Improve SAS Programming Compliance & Write SAS Code

Wrote SOPs for SAS programming. Validated the installation and maintenance of SAS software. Ensured that SAS code and documentation met FDA's compliance expectations. Used SAS to perform data manipulation, reporting and statistical analysis.

Solve Regulatory Problems

Assisted companies in the development of a regulatory strategy. Wrote answers to questions from FDA reviewers. Developed solutions to regulatory and information problems identified by FDA. Presented information at meetings attended by FDA reviewers.

Experience

FDA Reviewer

Managed the drug review process. Instructed firms on how to proceed with drug approval. Summarized outstanding problems and issues with protocols and studies, and determined if deficiencies were adequately addressed. Authored all written communication to the sponsoring firm and integrated comments from other reviewers.

Consultant to FDA-Regulated Industry

Fifteen years of experience working with drug, biologic and medical device companies of all sizes. Solved problems related to regulatory affairs and strategy. Developed reviewer-friendly solutions to technical and compliance problems. Presented information to FDA reviewers. Audited companies and CROs for compliance. Validated purchased software and software developed in-house.

SAS Institute Instructor

Taught programming classes for SAS Institute. Selected and trained new instructors.

Scientist

Designed and conducted scientific experiments in the areas of physiology and toxicology. Hands-on experience with a wide variety of laboratory equipment and lab analysis techniques.

Manager of Large Scale Software Development Projects

While at Marriott Hotels, supervised a staff of 21 programmers that developed a new system to manage all information and services for Marriott's frequent guest program. The project was completed on time and within budget. For five years, managed code development for the Consumer Price Index for the U.S. Bureau of Labor Statistics.

Statistician

Worked as a statistician for the U.S. Department of Agriculture and for the FDA. Taught statistical analysis and study design to scientists.

Trainer and Course Developer

Developed training for scientists in computerization and analysis of data. Created and taught instructor-led classes in SAS validation and FDA compliance. Wrote and taught over 40 different audioconference classes on a wide variety of FDA regulatory, technical and compliance topics. Taught FDA compliance to students in India using Skype.

Employment History

Education