1<!DOCTYPE html>
2
3Anonymous
4/bestp
5/bestp/domrep.nsf
68E6F3CF6F4084C3D652583AD00360CA3
8
9
10
11
12
13
140
15
16
17/bestp/domrep.nsf/products/best-practices-pharma-launch-playbook
18
19
2035.172.217.174
21
22
23www.best-in-class.com
24/bestp/domrep.nsf
25BMR




» Products & Services » » Product Launch » Product Launch Excellence

Best Practices Pharma Launch Playbook

ID: PB-100


Features:

248 Info Graphics

244 Data Graphics

6350+ Metrics

74 Narratives


Pages: 570


Published: 2021


Delivery Format: Shipped


 

License Options:


Buy Now

 

919-403-0251

  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • KEY FINDINGS
  • VIEW TOC AND LIST OF EXHIBITS
The pharmaceutical launch paradigm has evolved over the years, and with it has risen the complexity of orchestrating a successful new product launch. In an industry characterized by greater development costs, shorter patent windows, shrinking product pipelines and a growing emphasis on clinical efficacy; launching a new product requires meticulous planning and execution at all levels.


Video Brief:


Even the most experienced organizations have been known to produce launch debacles in this industry, further validating the fact that there is no one-size fits all approach to launch success in the pharmaceutical industry.

So, the question arises - what does it take to launch a successful product in the pharmaceutical industry?

Best Practices, LLC has worked with many of the leading pharmaceutical organizations in the past two decades to help them successfully bring their drugs to market. We have created the ultimate pharma launch playbook - providing years of insights from effective launches, and showcasing where exactly many of the renowned brands missed the mark - through our extensive primary benchmarking research studies and secondary research.

This playbook covers a myriad of factors that go into the launch of a successful product – including the critical launch activities and their timing; use of digital technologies; involvement level of various functions such as regulatory, commercial, managed markets, medical affairs, market research, sales, etc.; staffing; budgeting; key competencies; and internal collaboration. It also looks at many case studies of successful and unsuccessful launches.

If looking for a comprehensive guide to a successful launch in the pharmaceutical industry, this Best Practices, LLC playbook is all you need. This playbook not only provides you with all the success factors for an effective launch but also delves into the pitfalls you must certainly avoid.


Industries Profiled:
Health Care; Pharmaceutical; Diagnostic; Biotech; Medical Device; Biopharmaceutical; Manufacturing; Consumer Products; Chemical; Consulting; Media; Clinical Research; Laboratories


Companies Profiled:
Abbott; AbbVie; actavis; Actelion; Alcon; Alkermes; Allergan; Almirall; Altus Biologics; Amgen; Arbor; Astellas; AstraZeneca; Auxilium; Axon Pharma; Baxter BioScience; Baxter Healthcare; Bayer; Bayer Healthcare; Beltone; Biogen Idec; Boehringer Ingelheim; Bristol-Myers Squibb; Celgene; Centocor Ortho Biotech Inc.; Cochlear; Cutanea Life Sciences; Daiichi Pharmaceutical Co.; Ltd.; Eisai; Eli Lilly and Company; EMD Serono; Ethicon Endo-Surgery Inc.; Genentech; Genzyme; GlaxoSmithKline ; Grifols; Grunenthal; Human Genome Sciences; Incyte; Inspire Pharmaceuticals; Insyght; Insys Therapeutics; Ipsen; Janssen; Jazz Pharmaceuticals; Johnson & Johnson; LFB; Lundbeck; MannKind Corporation; Medi-Media; Medunik Canada; Merck; Merz Pharma; Nektar Therapeutics; Novartis; Noven Therapeutics; Novo Nordisk; Onyx Pharmaceuticals; Ortho Biotech; OTSUKA; Pfizer; Pharmacyclics; Phillips; ProStrakan; Purdue Pharma; Regeneron; Roche; Sanofi; Sanofi-Aventis; Sebela; Servier; Shire; Solvay Pharmaceuticals; Stiefel; Takeda Pharmaceuticals; Teva Pharmaceutical Industries Ltd; Theravance; Ther-Rx; UCB Pharma; Upsher-Smith; Valeant; Victory; Xenoport; Zydus Cadila

Study Snapshot

This comprehensive pharma launch playbook from Best Practices, LLC delivers a medley of insights required for a successful new product launch, right from the development stage to post-launch. Benchmarks and insights presented in this playbook have been collated from many of Best Practices, LLC’s benchmarking research studies around launch excellence in the pharmaceutical industry.

Key Findings

Select key insights uncovered from this report are noted below. Detailed findings are available in the full report.

  • Top Methods for Working with FDA: Building strong formal relationships with the FDA and utilizing external communication techniques are integral to the success of working with the FDA during asset development and NDA milestones.
  • Begin Building Digital Infrastructure & Analytics in Phases II & III: Best-in-class companies incorporate a digital strategy component for new assets early on (e.g., Phase II analytics and internal training). This allows NPI teams to leverage successful approaches from other recent launches and franchises, inform asset development plans, and begin building critical digital infrastructure and capability within product teams.
  • MSL Staffing Levels Affected by Existing Knowledge Level: Existing knowledge within a therapeutic area influences the number and timing of KOL relationship building, which in turn affects Medical Affairs MSL staffing levels.
  • Brand Strategy Activities: Global Brand Strategy groups first engage on generic naming activities in Phase I and then commence trade name and positioning activities in Phase II. The US Brand Team commences most brand strategy activities in Phase III.
  • Create Competitive Assessments for Both New & In-line Products: Though competitive and clinical landscape assessments are crucial to the success of new products, it is important to keep executive committees, boards, and investors informed about established products. Currently 83% of companies produce competitive assessments for both new and in-line products alike.

Table of Contents

Sr. No.
Topics
Page No.
I.
CRITICAL ACTIVITIES & TIMING
Driving Launch Success & Avoiding Common Failure Points Across Development
5
Critical Activities & Their Sequence: From Early Asset Development Through Launch
23
Optimizing the Medical and Marketing Mix
46
Medical Affairs’ Key Roles During Early Market Shaping to Launch
63
II.
STAFFING & TALENT
Putting Launch Talent in Place: Medical & Marketing Staffing Benchmarks Across the Asset Timeline
104
Skills, Roles, & Training to Build Elite Launch Teams: Talent Essentials for Medical & Commercial Functions
116
Benchmarking Oncology New Product Launch: Talent & Staffing
166
III.
INVESTING TO WIN
Investment Benchmarks: What It Takes to Develop and Launch A Successful New Biopharma Product
187
Benchmarking Oncology New Product Launch: Investment
215
IV.
MARKET ARCHETYPES
Field Tested & Actionable Market Archetypes: Key Considerations that Shape Resources & Activity Planning
235
New Product Investment & Staffing Patterns by Market Archetype
239
Benchmarking Oncology New Product Launch: Market Situations & Line Extensions
262
V.
CATALYSTS FOR SUCCESS
Positioning & Differentiation Factors: Benchmarking Their Relative Value with Stakeholders
298
Leveraging Digital Technologies to Enable Medical & Commercial Launch Roles
321
Using Key Performance Dashboards for Assets in Development
352
Current & Emerging Areas of Launch Risk in 2020
383
VI.
COLLABORATION, STRUCTURE, & TEAMS
Evolution of U.S. Product Teams from Asset Development to Launch
390
Aligning Global & U.S. Franchise Teams
396
Collaborations Between Global & U.S. Teams Across the Timeline
414
Creating Agile U.S. Launch Teams that Thrive in Rapidly Changing & Potentially Hostile Markets
432
VII.
LESSONS LEARNED
Lessons Learned from Successful & Failed Product Launches
447
Lessons Learned: New Commercial & Scientific Frontiers in Launch
469
Key Observations from High-Performing Launches
519
Covering the “White Space” Created in New Business Development Opportunities
553