23 feb 2012 IIBA Pharma/Biotech SIG Webinar

© International Institute of Business Analysis

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IIBA® Pharma/Biotech SIG Monthly Webinar

The Role of a Business or

Systems Analyst in

Clinical/Medical/Regulatory

23 Feb 2012

Sanjay Sahoo,MedImmune


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Make sure you look at the Notes Pages for more information about how to use the template.

IIBA® Pharma/Biotech SIG Monthly Webinar

The Role of a Business or

Systems Analyst in

Clinical/Medical/Regulatory

23 Feb 2012

Sanjay Sahoo,MedImmune

Agenda


• Welcome & Announcements

• The Role of a Business or Systems Analyst in Clinical/Medical/Regulatory

Sanjay Sahoo, MedImmune

• Q&A

Welcome


• Speakers

Sanjay Sahoo, MedImmune

• IIBA Pharma/Biotech SIG Staff

Host – Michael Calluori (Sanofi), VP of the Community

Question Moderator – Carol Scalice (Pfizer), President

Webinar Administrator – Matt St. Louis (Pfizer), VP of Marketing

Join the Community


• Starting April 2012

Closed webinars (not public)

Must be an IIBA® member

• Join the Community

http://community.iiba.org/pharmabiotechsig

No additional cost

http://community.iiba.org/pharmabiotechsig

Certification Credit


• PDUs/CDUs for SIG Events

1 webinar = 1 CDU

Recertification only

* As per IIBA® Certification team *

Volunteer


• Open Interim Board Positions

VP of Communications

VP of Event Planning

• Filled Interim Board Positions

VP of Sponsorship – Leah Estberg, USDA APHIS Veterinary Services

VP of Technology – Jim Blay, Covance

Who to Contact


Please contact one of the acting board members listed below:

Carol Scalice: [email protected]

Mike Horn: VP, [email protected]

Matthew St. Louis: VP, Marketing [email protected]

Michael Calluori: VP, [email protected]

Next Webinar


• “What about ...? What I wished I had asked the regulatory and testing people.”

Griffin Jones, Congruent Compliance

Monday, March 19th, 12-1p

Register Today

https://www2.gotomeeting.com/register/823957186

• Call for Speakers

Send us your topic ideas and submissions today!


The Role of the BA or Systems Analyst in Clinical/Medical/Regulatory


• Speaker Sanjay Sahoo

Business Analyst, MedImmune

• Q&A “Raise Hand” Chat Window

The Role of a Business/System Analyst in Clinical/Medical/Regulatory Space

Sanjay KumarA Health Informatics Technology Specialist,

IIBA Pharma/Biotech SIG Member

Learning Objectives:

I. Basic understanding of BA/SA roleII. Is there a boundary for BA/SA role by industry?III. How pharma/bio-tech BA/SA roles differentiate from

other industry?IV. Does BA/SA require any special skill sets?V. Does prior experience in pharma/bio-tech matters?VI. Understand birds eye view of clinical drug

development processVII. How clinical/medical/regulatory systems are aligned

with the process?VIII. What are the industry standards? IX. How to be informed about pharma/bio-tech

industry?X. What are next steps for BA/SA role in pharma/bio-tech

industry?

About Me


Sanjay Kumar is a Senior Business/System Analyst at MedImmune LLC. (A subsidiary of AstraZeneca PLC)., where he plays a role of Sr. IS/IT Specialist of the Clinical/Medical/Regulatory domain. Prior to joining to MedImmune, he had an extensive experience with Health Informatics Technology (HIT) which includes implementation, design, business analysis, systems analysis and IT strategy planning for US Government agencies such as National Institute of Health, National Cancer Institutes, Division of Aids (NIAID) and Pharmaceutical/Bio-Tech companies. Overall Mr. Sanjay has 15 years of experience in the bio-informatics field providing enterprise solutions for pharma/bio-tech industry. He had a recent success implementing e-Clinical program at MedImmune LLC. He has a strong educational background, includes Bachelors of Science in Physics, Master of Science in Computer Science, and Master in Business Administration from Johns Hopkins University, USA.”

Business/System Analysis Role


Business/System Analyst role is the techniques used to work as a liaison among organization stakeholders in order to understand people, processes, technology, regulations, policies, and work instructions for operations of an organization, and propose best approaches or solutions that enable organizations to achieve organizational goals

• Works in the context of an organization• Understand Business• Understand Business Processes• Determine process improvement• Define the business/functional requirements• Understand IT eco Systems• Implement by assisting Technical Team

Process

Technology

People

BA/SARole

Industry Boundary?Answer is NO…

Business/Systems analyst position for healthcare domain, there are lot

of expectations from the business/systems analyst candidate.

Healthcare domain is a complex domain and requires a good working

background in the industry to know in detail its business process and

internal workings.


How BA/SA role differentiate?

• Gather Requirement • Perform Systems Analysis• Manage Team i.e. technical,

creative, and production, external vendor and contractors

• Scope the requirement• Align to the budget• Direct development lifecycle

from inception to completion• Assist Programming team• Use best practice ensuring

consistency and stability• Develop wireframe or demo

application for concept© International Institute of Business Analysis

• Performs all as described in General BA/SA role PLUS below

• Work with Doctors, RN, Scientists, Lab Technician

• Understand GXP includes GCP guidelines

• Understand Frequent Changes in Regulatory Agencies Rules

• Required a depth knowledge on Health Informatics - Mandatory

• Attend Conferences, Training frequently

• Need to have people skills• Negotiation and Agreements

General BA/SA Role Clinical/Medical/Regulatory BA/SA

Special Skill Sets Required• Requirement Methodologies• Testing Methods – Regression, Unit Test, Blackbox • Software Development Framework - SDLC• Clinical Trial procedures and terminology• Knowledge in tools like SAS, eCTMS, EDC, IVRS, Safety

System• Knowledge of GXP Assessment• Regulatory Agencies Guidelines• Knowledge of 21CFR Part 11• Industry Standards like ICH, MedDRA, CTC, CDISC,

BRIDGE, HL7, LOINC• XML with eSubmission processes


Prior Experience Required?

• Both “Yes” and “No”• If “Yes” – easier to adapt to the

environment quickly• Else required extensive training• Both cases you need to be open to

adapt the complex world


Clinical Drug Development Process


NDA – New Drug ApplicationBLA – Biologic License AgreementIND – Investigational New Drug ApplicationIDE – Investigational Device ExceptionsNDA – Supplemental New Drug ApplicationCTA – Clinical Trial Authorization File in EU

Efficacy

Quality

Safety

Drug Discovery~5000-10000 Compounds

Pre-ClinicalAnimal Trial~250 Compounds

Phase I~20-100Human Trial ~5 Compounds)

Phase II~100-500 Human Trial 1 Compound

Phase III1000 and moreHuman Trial1 Compound

Phase IVPost Marketing

Clinical Development Space Pharmacovigilance SpaceR&D Space

~ 14 years in total to market

File IND/CTA With FDA

File BLA/NDA/sNDA With FDA

Phase 0~10-15Human Trial

Disclaimer – The use of images in this presentation are abstracted from www.google.com. The purpose of these images are ONLY for learning/academic. This is NOT for any commercial or marketing use.

List of Systems for Clinical Space


Efficacy

Quality

Safety

CLINICAL REGULATORY MEDICAL

Clinical Trial Management System

Clinical Forecasting System

Clinical Project Planning

Protocol Authoring Tool

Electronic Data Capture

Interactive Voice Recognition Tool

Paper Based Trial

Statistical Programming (SAS)

Electronic Trial Master File

Clinical Trial Transparency

Patient Safety System

Drug Supply Management

Central Medical Coding System

Investigator Management Tool

eClinical Data Hub

Central Study Designer

Central Document Management

eSubmission Planning & Tracking

Commitment Tracking

Submission Publishing

Product Registration Management

Correspondence Tracking

Product Complaints Tracking

eCTD Reviewer

Business Event Tracking

Product Detail Management

Information Request Management

Information Request Content Management

Reprint Tracking

Compliance Reporting Management

ePublication Management

Grant Management

Investigator Initiated Trial Mgmt

Key Opinion Leader Management

Medical Library Management

Mobile Request Management

Scientific Communication Tracking

Industry Standards


Regulations GuidelinesStandards

Referencing Dictionaries

Messaging Coding Metadata

21CFR 11 (Audit) ICH E2A (Efficacy Guidelines) CDISC (Clinical Data Standard) MedDRA (Med Coding ISO/IEC 11179 (Information Technology - Metadata registries (MDR)

HL7 + HL7 CVX (vaccine form)

45 CFR164 (Security) ICH E2B (Data Transfer) LOINC (Lab Code) WHO-ART (Rational Coding AE)

LOINC (Lab Code)

HIPAA (Patient Info) ICH E2BM (Clinical Safety Data Management)

DICOM (Digital Imaging and Comm) WHO Drug

NDF-RT (National Drug File Reference Terminology)

Section 508 (Disability) ICH E5 (Ethnic Factors in the Acceptability of Foreign Clinical Data)

HL7 (Health Level 7) SNOMED-CT Systemized Nomenclature of Medicine - Clinical Term)

EVS (NCI Enterprise Vocabulary Services)

FDAAA (Trial Transparency) ICH E6 (GCP)

eCTD (Electronic Submission)

NDC (National Drug Code)

OMB Directive 15 (Race and Ethnic Standard)

EudraCT ICH M1 (MedDRA MSSO)

CTC AE (Common Toxicity Criteria Adverse Event)

ISO 639 (Language)

ICH M2 (MedDRA eCTD Spec)

ISO 3166 (Code name for Countries)

How to be informed?

• Be part of IIBA Pharma/Biotech SIG www.iiba.org

• Enroll to DIA www.diahome.org• Subscribe clinical trial magazines• Be a member of HIMSS group

www.himss.org• The best way to have friends from

health industry


http://www.iiba.org/

http://www.diahome.org/

http://www.himss.org/

Next Step for a BA/SA role• Project Lead• Project Manager• Subject Matter Expert• Process Engineer• Process Architect• Enterprise Process Engineer• Business Manager• System Director• Health Informatics Technology Consultant


Q/A


Thank you

If you have any question, please contact me [email protected]

Thank you for attending!


• Next Webinar “What about ...? What I wished I had asked the regulatory and

testing people.” - Griffin Jones, Congruent Compliance Monday, March 19th, 12-1p Register: https://www2.gotomeeting.com/register/823957186

• Contact the President: [email protected] Topic ideas and speaker submissions Volunteering – Communications, Event Planning Joining the Community
