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Improving Collaboration with Regional Affiliates

Veeva R&D Global Summit Philadelphia, PA

October 21st 2014 Presented by: Steve Gens, Managing Partner

1. Highlight the latest Regulatory Information Management (RIM) and Affiliate research

2. Provide benchmarks to where companies are investing to improve the central/regional/local collaboration

3. Explore the local / global dilemma for RIM tools and processes; how does industry view the current suppliers?

4. Provide a viewpoint on 2nd generation global Regulatory Capabilities geared towards global collaboration

Session Goals

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These materials are provided for your internal organization. Permission may be granted to utilize benchmark information (with proper citation and

credit) outside your organization upon written

permission (see contact information in the back)

Referenced Survey’s and Demographics

1. 43 affiliates offices from multiple large bio-pharmaceuticals representing regulatory activities in at least 72 countries (2013)

2. 2013 RIM Industry Survey (N = 37)

3. 2014 RIM and Regulatory Intelligence Survey (interim, n = 35 out of 42)

Asia Pac 23%

East EU 12%

Latin / South America

23%

ME/AF 12%

NA 5%

West EU 25%

Regions Represented N=72

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N=37

Context: RIM Evolution

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• Focused on US, EU, Japan markets

• Initial “e” push via Document Management and Publishing technologies

• Driver: Reduce time to Agency / Market (Operational Efficiency)

• Rapid global expansion

• ICH standards

• Regional hub investment

• Global Regulatory Capabilities 1st generation

• Driver: Global Scalability

• Global connectivity and collaboration

• Emerging market health authority sophistication

• Information aggregation

• Evolving Data Standards

• Global Regulatory Capabilities 2nd generation

• Driver: Global Efficiency

2004 Inflection

Point

2012 Inflection

Point

Central (1990’s – 2004)

Central + Regional Hubs (2005 – 2011)

Global Affiliate Network 2012 +

Formal RIM emergence RIM as an Enterprise Asset

Global Virtualization Impact

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1st Generation Regulatory Capability Model Central System Push (not sustainable)

Central Send Info (dossier) Request Info (status) Verify Info (compliance)

Regional Layer Local Affiliate

Product Registration

Submission EDMS

Planning Regulatory Intelligence

(RI)

Submission Archive

Label Content Correspond

ence (CSP)

Publishing

Hub #1

Office #1

Hub #2

Hub Nth

Office #2

Office Nth

(RI)

(RI)

(RI)

(RI)

Built for Central Operations and Big

Markets

Asked to participate in global systems, but need to keep

local tools

CSP

CSP

CSP

Push Model

• #1 = Central Regulatory and Official Local Affiliates / Manufacturing / Supply Release • #2= Safety

What collaboration areas are target for improvement? Both are critical affiliate activities (supply release / safety)

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91% 91% 88%

2014 – Interim (stats may shift)

Source: 2014 Gens and Associates Industry Survey

Heavy Investment in Global Capabilities; but what about the local affiliate day to day?

• High industry investment in achieving global authoritative sources of regulatory information, however…….

– Affiliates continue to use and depend on local tools (e.g. xls) in addition to central systems

RIM Component Central Perspective: Authoritative Source Current or Planned by 2016

Affiliate Perspective: Avg. # of Tools / Most Common

Product Registration Management • 2.7: Excel ; SharePoint / Network drives

Submission Planning & Tracking • 3.3: Excel; SharePoint / Network drives

R&D Document Management • (no data)

HA Commitment Management • 2.5: Excel; Email

HA Q&A / Correspondence • 3.5: Email; Excel; Paper; Network drives

Labeling • 3.4: Word; Network drives; Excel

100% 0%

= % projected in 2016

91%

91%

91%

85%

88%

94%

52%

45%

61%

46%

48%

48%

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<

<

<

<

<

<

= 2014 (interim analysis only)



Dilemma: Central Systems AND Local Tools Why are local tracking tools used?

Why Local Tools? • Local information not in central systems

• Local information is more accurate

• Easier to use and provide more flexibility / “agility”

• More convenient to access – e.g. performance and availability

• Can be integrated with other departments in the affiliate

• Better support for local HA regulatory compliance

Why Central Tools? • Provide global authoritative

management of key regulatory products, submission and label information

• Eliminate duplicate data entry

• Provide access to global data – see information from other affiliates

• Reduce the “status” queries from HQ

• Aggregate information quickly for decision-making and audit support

The “Dilemma”

Affiliates want central systems

BUT They must satisfy local requirements and be

easy to use

Affiliates size is significant, we typically segment the affiliate population into four cohorts (# = Reg. headcount)

Large (>10): May have robust internal systems and dedicated ops staff

Medium (5 – 9): mixture of tools and may have dedicated operational support

Small (<5): basic tools, “jack of all trades”, embraces global support for e-subs and global tools

Agent/distributor: Complexity of information management with 3rd party

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Affiliates do prefer to manage product, submission and label information in a central system

Typically found in central

• Full product descriptions and global registration status and history (e.g. formulations, packaging, labeling)

• Full dossier submission history and content

• Submission tracking (ongoing progress) • Planned submission dates and estimated

dates for dossier / docs delivery • Information to support PV and regulatory

audits • Non-regulatory information including

patent dates and reimbursement information

Local Info required to “decommission”

• Local timelines for submissions, renewals • HA meetings – scheduling and contact

reports • Filing fees • Annual notifications • Pricing and reimbursement • Certificates (CPP, GMP) • Shelf life and storage conditions • Dates related to manufacturing change

control and packaging components • Detailed local project tasks

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Top 3 Today – (61%) Product Registration – (48%) HA Commitments, Safety, and

R&D Document Management

What RIM capabilities will be most used at the affiliate level?

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Top by 2016 – (97%) Product Registration – (88%) HA Commitments – (76%) R&D Document Management, ,

Submission Planning, Labeling, and Correspondence

Significant



Productivity: Local Affiliate spend 40% (on average) Managing Regulatory Information

• Affiliates are spending a significant amount of time in non-value add activities

– Managing duplicate sets of information

– Responding to HQ requests for local status (no “trusted” authoritative source)

– Wide variety of tools to manage local information (Excel, SP, custom)

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75%

15%

6% 4%

Breakdown of 40% time spent managing Regulatory Info.

RIM Tool Usage

HQ Info Requests

Duplicate Data Entry

Finding Info

Non-Value Added

• There is widespread support for moving to central systems

– Usability, performance, and local requirements are key needs

– Local control over their information is very important; it is a clear requirement to be able to directly enter and manage their own information

• Affiliates state a preference for single “integrated” tools that support multiple RIM functions

– 37% of the affiliates have a local COTS or custom developed tool to support 3 or more RIM functions

Source: 2013 Gens and Associates Industry Surveys

What else is changing at the affiliate level?

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• More companies are utilizing third parties for affiliate marketing submissions as those nationalities transition to e-submissions

• Increased utilization of third parties requires a “re-think” on Submission Content Management



What are the biggest challenges when using a third party for dossier compilation?

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• #1 = Technology and document download speed • How can Cloud based solutions mitigate these challenges?



Usability: Prime area for Solution Provider Investment

• It’s about Usability Period! • Affiliate, Mobile, and Casual Users need a

“simple interface” for “just their task”

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What are views towards cloud solutions?

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The Future: Global Capability, not Individual Solution Focus

Registration / Product

Mgmt.

Submission Forecasting

and Planning

HA Transactions (Correspondence

and Q&A)

Compliance, Inspections,

and Analytics

Enterprise Regulatory Information (Master Data) Data Quality & Governance

Authoring, Content Mgmt. &

Publishing

User Experience Layer (illustrative)

Process Engine / Basic Transactions

Analytics, Reporting and

Metrics

Personal Views Visualization

and Dashboards

Single Access Point

Smart Search

Casual User

Daily or Core User

XEVMPD Dossier

Implemented over next two

years

Evolve over the next 3 – 5 years

Vendor Investment

Dilemma

Next Generation CM

emerging

Balance Affiliate / Central Operational Needs

Native Application for experts, basic activities in portal / workflow

• Usability for the infrequent user community

• High usability = low change management need

Easy access + Ease of Use = Low Change Management Cost

Significant reduction (they don’t all go away) of “niche systems” & xls

Strict adherence to industry data standards (oil in the engine)

• Enables “cost effective” and “real-time” information exchange

Complete re-think on training in our video world

So what does a 2nd Generation Regulatory Capability look like?

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Do you have the proper balance of functional and geographic stakeholders in your requirements analysis?

Do you understand “daily life” at the Affiliate Level?

Has your IT group experienced performance/access benefits of alternative approaches to internal systems?

Have you thought through the right data entry / verification model; do you have the flexibility in models between regions?

What is your mindset (global or central first); do you have cultural understanding of the different styles across the globe?

Have you budgeted for one “everyone in a room” event

Helpful Tips!

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Conclusion

1) The world is getting smaller; daily local affiliate collaboration is “the norm”

2) Global systems are evolving, but need further usability investment to accommodate local needs (so they can simplify)

3) Administrative burden is rising at the local level where resources are the most constrained

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Contact Information: • 267-614-0935 • [email protected] • www.gens-associates.com

Reliable source for Industry Benchmarks & Independent Advice

improving collaboration with regional affiliates › cn › wp-content › uploads › 2014 ›...

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