Being a BA in Biopharma and CROs 2012_01_23

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IIBAIIBA®® Pharma/Biotech SIG Pharma/Biotech SIG Monthly WebinarMonthly Webinar

Being a BA within Pharma/Biotech vs. within a CRO

23 Jan 2012

Connie Cotter & James Blay,

Covance

Agenda

© International Institute of Business Analysis

• Welcome & Announcements

• Being a BA Within a Pharma/Biotech vs. within a CRO

Connie Cotter & James Blay, Covance

• Q&A

Welcome

© International Institute of Business Analysis

• Speakers

Connie Cotter, Senior Business Analyst, Covance

James Blay, Senior Business Analyst, Covance

• IIBA Pharma/Biotech SIG Staff

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

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

Join the Community

© International Institute of Business Analysis

• Starting April 2012

Closed webinars (not public)

Must be an IIBA® member

Notifications to members only

• Join the Community

http://community.iiba.org/pharmabiotechsig

No additional cost

Volunteer

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• Open Interim Board Positions

VP of Communications

VP of Event Planning

VP of Sponsorship

VP of Technology

• Official Elections – April 2012

Who to Contact

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Please contact one of the acting board members listed below:

Carol Scalice: PresidentCarol.Scalice@pfizer.com

Mike Horn: VP, Membershipmichael.horn@astrazeneca.com

Matthew St. Louis: VP, Marketing matthew.v.st.louis@pfizer.com

Michael Calluori: VP, SponsorshipMichael.Calluori@sanofi-aventis.com

Next Webinar

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

Sanjay Sahoo, MedImmune

Thursday, February 23rd, 12-1p

Register Today

https://www2.gotomeeting.com/register/447191258

Being a BA Within a Pharma/Biotech vs. within a CRO

© International Institute of Business Analysis

• Speakers Connie Cotter

Senior Business Analyst, Covance

BA Experience: 15 years

James Blay Senior Business Analyst, Covance

BioPharma IT Experience: 21 years

• Q&A “Raise Hand” Chat Window

CONFIDENTIAL

Being a Business Analyst in Biopharma and CROs

Connie Cotter, Senior Business Analyst

Jim Blay, Senior Business Analyst

Covance

CONFIDENTIAL10

Agenda

• Goals for this Presentation• Definitions and Background• Business Analysis – A definition• Approaches to Business Analysis

– Enterprise vs. Project Analysis

• Application of Business Analysis– Common elements– Unique aspects to Biopharma & CRO

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By the end of this session…

• Understand the definition of business analysis within the context used here

• Understand the common business analysis disciplines and practices that apply across industry segments

• Understand several differences when applying business analysis in Biopharma vs CRO

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Key Definitions

Biopharmaceutical (Biopharma) Company• A company whose goal is to discover, develop, register, manufacture,

and market small molecule (traditional chemistry) and/or large molecule (biotech) compounds for the treatment of human disease

• An newer buzzword for the variety of different companies producing new, high-tech pharmaceutical products

• An amalgamation of traditional ‘big pharma’ and biotech• A few examples: Pfizer, Novartis, Merck, GlaxoSmithKline, Johnson &

Johnson, AstraZeneca, Eli Lilly, sanofi-aventis , Amgen, Genentech

Contract Research Organization (CRO)• Also referred to as a Clinical Research Organization• A service company contracted by a biopharmaceutical company (the

sponsor) to assume various aspects of the research process on behalf of the sponsor

• Examples of activities frequently outsourced to CROs include clinical trials, laboratory services, toxicology studies, analytical testing, early development studies, and other highly specialized studies

• A few examples: Quintiles, Covance, PPD, Charles River, ICON, Parexel, Kendle, PharmaNet Development Group

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Covance Background

• One of the world’s largest and most comprehensive drug development services companies, with annual revenues greater than $2 billion, employees in more than 60 countries, and more than 11,000 employees worldwide.

• NONCLINICAL DEVELOPMENT: Toxicology, Research Products, Analytical Services, Discovery & Translational Services

• CLINICAL DEVELOPMENT: Clinical Pharmacology, Clinical, Central Labs

• PERIAPPROVAL & MARKET ACCESS• www.covance.com

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What is Business Analysis?

• Business analysis is the discipline of identifying business needs and determining solutions to business problems. (Wikipedia)

• In a nutshell, that is the ‘what’ of business analysis• We have found this to be consistent across industry

domains• But ‘how’ is business analysis performed, and how does

that differ across industry segments?• While there are many similarities, we find there are

subtle differences as well.• We are going to discuss both the similarities and the

differences between being a BA in Biopharma vs a CRO

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Enterprise vs. Project Analysis

• Enterprise Analysis– Strategic emphasis– Pan-organization needs analysis and solution

identification– Strong element of portfolio management and

project prioritization– End result is project selection and initiation, not

project execution– Goal is to maximize the value from IT investment– Experienced BA with solid background in the

discipline and strong business domain knowledge

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Enterprise vs. Project Analysis

• Project-focused Business Analysis– Interaction with project-specific Subject Matter

Experts– Detailed requirements development and

management– Focused on delivery of a given capability– Business process development– End result is project execution and delivery– BA experience: entry > junior > senior-level

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Common Business Analysis Practices

• Elicitation of requirements

• Documentation of requirements

• Requirements validation

• Requirements management

• Solution selection

• Solution implementation

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Elicitation of Requirements

• Obtaining the requirements from users, customers, and other stakeholders

• Stakeholders and SMEs vary by industry– Regulatory vs. non-regulatory– Single location vs. global enterprise– Single business system vs. cross-functional system

• Elicitation techniques– Interviews– Document Analysis– Observation (job shadowing)– Prototyping (use cases, screen flows, navigation flow)– Workshops

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Documentation of Requirements

• Forms of documentation – Database / Requirements Tools– Spreadsheet – SharePoint – Textual document

• Approval– Wet Signature– Electronic Signature

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Requirements Validation

• Extremely Critical Step• Timing

– Ideally well before document signature– Too often left until the last minute rushed validation

• Unique aspect to performing within a CRO– Stakeholders span multiple companies– Within the CRO but also within each sponsor company– Sponsors/customers often have their own unique

requirements which can often times conflict with each other– Reconciliation and validation of requirements must be

performed

• The importance of client confidentiality makes this a delicate but yet important step.

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Requirements Management

• Not a single activity – continuous throughout a project• The process of documenting, analyzing, tracing,

prioritizing, and agreeing upon requirements then controlling change and communicating to stakeholders (Wikipedia)– Requirements Management Plan– Traceability Matrix– Software Tools

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Solution Selection & Implementation

• These are the next logical steps beyond requirements– We have the requirements … Now what? Solution Selection– Assist with business process definition … How will we use the

new system?– Requirements logically lead to user acceptance testing …

How do we know it meets our requirements?

• Do Business Analysts own these activities?– Solution Selection is covered by the BABOK, but what about

Implementation?– What role does the BA play? Accountable? Assist? Lead?

Participate? Consult?– Typically falls onto the Business Analyst by default– Within IT, Business Analysts or Business Systems Analysts?

• In our experience, the BA/BSA role is critical to both solution selection and implementation regardless of the organization

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Differences based on Industry

• Regulatory Compliance

• Security

• Confidentiality

• Business Model

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Regulatory Compliance

• Government and nongovernment authorities, responsible for oversight of the effectiveness, safety, manufacture, and distribution of medicines

• Biopharma– compliance through lifecycle of the drug

• CRO – compliance w/ regard for service provided (data)

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Examples of Laws/Regulations

• UK Data Protection Act 1998• U.S. Food and Drug Administration (FDA)• European Medicines Agency (EMEA)• Ministry of Health, Labour and Welfare (Japan)• International Conference on Harmonisation of

Technical Requirements for Registration of Pharmaceuticals of Human Use (ICH)

• Therapeutic Goods Administration (Australia) (TGA)

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Regulatory Compliance Challenges

• Regulatory authority is stakeholder and source of requirements

• Generally, do not have access to a person to provide regulatory requirements– Requirements should be written in acceptable terminology

with all stakeholders (internal and external)

• Receipt of notification of updates to laws/ regulations that require updates to requirements

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Security

• Requirements needed without regard for information stored or processed

• CIA Triad– Confidentiality– Integrity– Availability

• Identification – assertion of who user is

• Authentication – verifying the claim of identity

CONFIDENTIAL28

Confidentiality

• Critical non-functional requirement both in Biopharma and CRO industries

• There are subtle differences however between CROs and Biopharma with respect to confidentiality

• Biopharma– One legal entity or several closely related entities

– Confidentiality within organization is typically not a major concern, but rather protecting trade secrets and intellectual property is the focus

– Patient privacy is critical as well

• CRO– For-fee service work performed for multiple sponsors

– Sponsor confidentiality is of the utmost concern

– Complexity arises from the same work processes and systems being used to handle data and analysis for multiple sponsors

– Patient privacy is critical as well for clinical work

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Business Model

• Fundamental difference in business models• Biopharma

– Inventor and Owner of the intellectual property– Manufacturer and Marketer of the biopharmaceutical– Focus is on innovation and bringing solutions to unmet

medical needs to the market

• CRO– Service provider and Strategic business partner– Focus is on customer service, quality and value added by the

services provided

• Seems minor, but this difference permeates the entire requirements process– Influences overall project governance/selection– Drives differences in requirements themselves

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Summary• Across the Biopharma and CRO domains, there are many

similarities in terms of enterprise analysis and business analysis disciplines and practices. The majority of the best practices can be applied equally well to both domains.

• However, there are several subtle distinctions that are instructive for those doing business analysis within these domains. These distinctions fall into the areas of:– Requirements Validation– Regulatory Compliance– Confidentiality– Business Model

• We hope that learning more about these similarities and differences will help you to be a more successful business analyst, especially for those who work at the boundary of these two business domains.

Thank you!

© International Institute of Business Analysis

• Many thanks to Connie Cotter and Jim Blay!

• Remember to join our community at: http://community.iiba.org/pharmabiotechsig

• Remember to register for the next webinar: The Role of a Business/Systems Analyst in the Clinical/Medical/ Regulatory Space - Sanjay Sahoo, MedImmune - Thursday, February 23rd, 12-1pm https://www2.gotomeeting.com/register/447191258

© International Institute of Business Analysis

Cover this area with a picture related to your presentation. It can be humorous.

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

IIBAIIBA®® Pharma/Biotech SIG Pharma/Biotech SIG Monthly WebinarMonthly Webinar

Being a BA within Pharma/Biotech vs. within a CRO

23 Jan 2012

Connie Cotter & James Blay,

Covance