regulatory outsourcing: ''to or not to"

Regulatory Outsourcing : Thought Leadership webinar

Thanks for joining! Stay tuned ..

Introductions

Alan’s wisdom

MakroCare’s market view

Q/A

What we’ll cover

About speakers today !

40 Years Pharma / RA Exp(25 in Big Pharma)Pharma International, Switzerland

15+ years ExperienceBD Director, MakroCare

I’m Alan & my topics …

• Overview and Objectives • Rationale • Sponsor/ Manufacturer• Regulatory Affairs Vendor• Compare and Contrast• Summary• The best way forward

Overview

To Outsource or Not to Outsource•Should you consider outsourcing or not•What to Outsource & what not to•Hybrid Models possible•Sharing practical experiences

Objective

RA Vendor

• Practical implications• Suggestions

Sponsor/Manufacturer

Compare & Contrast

Rationale

• Regulatory affairs- a basic essential• Workloads• Time-frames• Priorities• Regulatory compliance• Risk management• Strategic objectives

Sponsor / Manufacturer

• Research and develop business ideas• Use available resources and “ know-how” • Competitive advantage • “Fast-Track” Activities• Costs• Training• Timeframes• Positive advantages

Sponsor / Manufacturer

• Contractual obligations• Confidentiality agreements • Terms and conditions• Milestone payments• Exclusivity

Reg Affairs Vendor

• Knowledge and experience• Resources• Flexibility• Speed & efficiency• Prioritisation• Regulatory intelligence• Benchmarking

Reg Affairs Vendor

• Contractual agreements• Liability issues• Time constraints• Milestone payments• Regulatory Authorities

Pros & Cons for both ..

•In-House•On-site•Collaborative•Hourly rates

•Outsourced•External venue•Independent•Pauschal payments

Looking Out

Looking In

Additional Factors(1)

• Mergers and acquisitions• Restructuring • Optimisation endeavours• Tender business• Budgets• Confidentiality• Human resources• Market comparisons

Additional Factors(2)

• Recommendations

• «Small is beautiful» ?

• Local / Regionl / International / Global

• Cultural aspects

Practical Experiences

•From the large company looking for support

•From the smaller consultancy offering help

•From within the hybrid situation

Summary of the Situation

• Where are we at present?

• Have additional aspects been covered?

• Areas of interest uncovered?

• General agreement / Differing opinions

MakroCare’s market view

18© 2015 MakroCare. All Rights Reserved. www.makrocare.com

AwardsYear

Established

Over 15 years of Life Sciences Core Consulting experience

1996(HQ:NJ,USA) Privately held

Global Access

14 Global Offices

Clients

8 of Global Top 20150+ Small/Mid-level

ISO 9001 ISO 14155ISO 27001 ISO 20000

Employees

650+ FTEs140+ Consultants

Proprietary Frameworks/Tools

NAVAVistaarRIMtrackjarTreeTULAClinMetanoiamNAAMmEDCmIRT

Costs Global Headcount

•Lower margin products maintenance• Smaller affiliates support•Routine / established tasks• Low end work

• Expansion•Local Liaison• International reg intel• Mergers

•Headcount freeze•Sporadic peaks•RA seen as cost center• Short-term niche help

Outsource only for these reasons ..

Established products life cycle Labeling Operations Publishing BPO (eg.. xEVMPD data entry)

Large

HA advisory in new regions Regulatory Strategy Regional/Local representation Localization (Labeling / Dossier formats)

Midsize

Regulatory Strategy Dossier development CMC advisory HA liaison / Pre-Meets

Small

Vendor OptionsBest-of-Breed or Global ??

Global Consulting firms

Regional RA Vendors

CROs / BPOs

Independent consultants

Each comes with their baggage, what bag you need ?

Current Outsourcing trends

What type of vendor ?

Vendors need to fit “ in” your vision & your goals. Not other way round.

If « Outsourcing » word is not comfortable in your company,

you can name it as ….

Strategic Partner

Insourcing

Consulting

Staffing

SOW

FTE work

Low High

•Pick based on your needs•Pick based on your company goals•Pick based on your budgets

How much to outsource?

Good Luck

on your RA journey

For any questions, please email towebinar@makrocare.com