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A recording of the January 23, 2012 IIBA Pharma/Biotech Special Interest Group webinar. Presented by Connie Cotter and Jim Blay of Covance. [Note: we apologize for periods of poor audio quality between 10:14-10:47 and 11:25-16:04.]
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© International Institute of Business Analysis
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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
© International Institute of Business Analysis
• Open Interim Board Positions
VP of Communications
VP of Event Planning
VP of Sponsorship
VP of Technology
• Official Elections – April 2012
Who to Contact
© International Institute of Business Analysis
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
© International Institute of Business Analysis
• 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
CONFIDENTIAL11
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
CONFIDENTIAL12
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
CONFIDENTIAL13
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
CONFIDENTIAL14
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
CONFIDENTIAL15
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
CONFIDENTIAL16
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
CONFIDENTIAL17
Common Business Analysis Practices
• Elicitation of requirements
• Documentation of requirements
• Requirements validation
• Requirements management
• Solution selection
• Solution implementation
CONFIDENTIAL18
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
CONFIDENTIAL19
Documentation of Requirements
• Forms of documentation – Database / Requirements Tools– Spreadsheet – SharePoint – Textual document
• Approval– Wet Signature– Electronic Signature
CONFIDENTIAL20
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.
CONFIDENTIAL21
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
CONFIDENTIAL22
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
CONFIDENTIAL23
Differences based on Industry
• Regulatory Compliance
• Security
• Confidentiality
• Business Model
CONFIDENTIAL24
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)
CONFIDENTIAL25
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)
CONFIDENTIAL26
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
CONFIDENTIAL27
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
CONFIDENTIAL29
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
CONFIDENTIAL30
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