Presented at the 3rd New Product Planning Summit. The presentation was designed to help professionals in New Product Planning to present a case for why commercial strategy input is needed early in the process of developing new therapeutics. The presentation also includes suggested approaches and tools to help with effective engagement with Research teams.
Building a Business Case for New Product Planning in a Small Company EnvironmentAnthony Russell
Presented at the 2nd New Product Planning Summit by ExL Events in Boston (Dec 8, 2017). An overview of why commercial strategy is needed early in product development. As pressures continue to mount in drug development (crowded markets, payer and access issues, etc.), it is becoming critical to focus on the early stages of drug development. Working early with research and development teams to evaluate the commercial viability of programs will benefit companies of all sizes to maximize their portfolio of therapeutic candidates.
Lifecycle Management in the Pharmaceutical IndustryAnthony Russell
Presented to students in the Drug Development and Product Management program at UC San Diego. Covers the rationale for lifecycle management is important. Includes case studies of successful implementation of lifecycle management. Presentation date: 2/5/2019.
Making Key Decisions in New Product Planning When “Perfect” Information is No...Anthony Russell
Presentation given at New Product Planning Summit 2021.
Learning Objectives:
* Review the types of decisions typically made in New Product Planning
* Discuss the nature of information available to support decision-making in New Product Planning
* Review the impact and context of decision-making in New Product Planning
* Review potential approaches to assist in New Product Planning decision-making
How and When to Kill a Program in New Product PlanningAnthony Russell
Presented at the 4th New Product Planning Summit in Boston (Dec 2 -3 , 2019). Presentation covers why weak programs should be cut from pharmaceutical and biotech pipelines, what defines a "weak" program, and describes objective methods to evaluate programs to help prioritize assets.
Performing Competitive Intelligence in a Pharmaceutical CompanyAnthony Russell
Workshop presented in the Competitive Intelligence and Pricing course as part of the University of Southern California Master of Science in Healthcare Decision Analysis program. Presented on Nov 4, 2018 at USC. The workshop gives an overview of what competitive intelligence is and how it is done in pharmaceutical companies. The workshop includes a couple of non-pharmaceutical exercises to help students learn how to write key intelligence questions and to work through a market simulation exercise. The workshop ends with a discussion on the various career pathways available within the competitive intelligence field.
A workshop presentation for Medical Affairs Strategic Summit West held in San Diego on September 23, 2019. The workshop covered the following learning objectives:
* Understand the factors involved in selecting and prioritizing indications
* Understand the importance of strategic market segmentation
* Understand how Medical Affairs can be involved in the process of new product planning
New Product Planning in the Pharmaceutical IndustryAnthony Russell
Lecture presented in the Competitive Intelligence and Pricing course as part of the University of Southern California Master of Science in Healthcare Decision Analysis program. Presented on June 14, 2020 at USC via Zoom. The lectures gives an overview of what new product planning is in the pharmaceutical industry, what tools are used during new product evaluations, and the key elements of a new product business case. The lecture includes a couple of case studies to be worked on by the class.
Building a Business Case for New Product Planning in a Small Company EnvironmentAnthony Russell
Presented at the 2nd New Product Planning Summit by ExL Events in Boston (Dec 8, 2017). An overview of why commercial strategy is needed early in product development. As pressures continue to mount in drug development (crowded markets, payer and access issues, etc.), it is becoming critical to focus on the early stages of drug development. Working early with research and development teams to evaluate the commercial viability of programs will benefit companies of all sizes to maximize their portfolio of therapeutic candidates.
Lifecycle Management in the Pharmaceutical IndustryAnthony Russell
Presented to students in the Drug Development and Product Management program at UC San Diego. Covers the rationale for lifecycle management is important. Includes case studies of successful implementation of lifecycle management. Presentation date: 2/5/2019.
Making Key Decisions in New Product Planning When “Perfect” Information is No...Anthony Russell
Presentation given at New Product Planning Summit 2021.
Learning Objectives:
* Review the types of decisions typically made in New Product Planning
* Discuss the nature of information available to support decision-making in New Product Planning
* Review the impact and context of decision-making in New Product Planning
* Review potential approaches to assist in New Product Planning decision-making
How and When to Kill a Program in New Product PlanningAnthony Russell
Presented at the 4th New Product Planning Summit in Boston (Dec 2 -3 , 2019). Presentation covers why weak programs should be cut from pharmaceutical and biotech pipelines, what defines a "weak" program, and describes objective methods to evaluate programs to help prioritize assets.
Performing Competitive Intelligence in a Pharmaceutical CompanyAnthony Russell
Workshop presented in the Competitive Intelligence and Pricing course as part of the University of Southern California Master of Science in Healthcare Decision Analysis program. Presented on Nov 4, 2018 at USC. The workshop gives an overview of what competitive intelligence is and how it is done in pharmaceutical companies. The workshop includes a couple of non-pharmaceutical exercises to help students learn how to write key intelligence questions and to work through a market simulation exercise. The workshop ends with a discussion on the various career pathways available within the competitive intelligence field.
A workshop presentation for Medical Affairs Strategic Summit West held in San Diego on September 23, 2019. The workshop covered the following learning objectives:
* Understand the factors involved in selecting and prioritizing indications
* Understand the importance of strategic market segmentation
* Understand how Medical Affairs can be involved in the process of new product planning
New Product Planning in the Pharmaceutical IndustryAnthony Russell
Lecture presented in the Competitive Intelligence and Pricing course as part of the University of Southern California Master of Science in Healthcare Decision Analysis program. Presented on June 14, 2020 at USC via Zoom. The lectures gives an overview of what new product planning is in the pharmaceutical industry, what tools are used during new product evaluations, and the key elements of a new product business case. The lecture includes a couple of case studies to be worked on by the class.
Developing High-Impact Communication Forms to Brief Senior Leaders: Optimizin...Best Practices
Competitive Assessments and Clinical Landscape Assessments are crucial to the success of new products in the pharmaceutical industry. In order to inform busy executives quickly and effectively, market intelligence and analytics leaders must develop briefing templates that are clear, concise, and impactful.
This study identifies winning strategies for effectively informing senior leaders through Competitive Landscape Summaries and Clinical Development Profile Maps. The research will help executives to understand what the important elements to include are, and what are the best formats for two critical healthcare briefing templates: : 1) the Competitive Landscape Summary Map and 2) the Development Landscape Profile Map (often described as the Data Disclosure or Clinical Trials Progress Summary).
Read more at: http://www.best-in-class.com/bestp/domrep.nsf/products/developing-high-impact-communication-forms-to-brief-senior-leaders-optimizing-competitive-assessment-data-disclosure-summaries?OpenDocument
How early is too early for pharmaceutical market insights and product forecasts. A discussion on pipeline product research during early product development
International Pharmaceutical Industry: Feasibility Is Not (Anymore) A Plain S...KCR
Investigational Sites
The sole term ‘feasibility’ has multiple definitions in a clinical environment, leading to certain bias with all stakeholders involved, including pharma companies (sponsors) and all types of contract research organizations (CROs). The most common perception is related to a never-ending argument between pharma outsourcing departments and CRO commercial groups, with sponsors expecting CROs to run a (non-defined) feasibility study prior to proposal submission and CROs undertaking a series of schematic actions to create an impression of fulfilled expectation.
How does the licensing process differ for in-licensing and out-licensing comp...daisyrmuzzio
PHARMA & BIOTECH LICENSING & PARTNERING:
Filling the Pipeline & Growing Market Share Through Strategic Deal-Making-- March 2-3- San Diego California
Effective Pharmaceutical Life Cycle Management Planning: Optimizing Product V...Nick DeSanctis
Developing an effective drug life cycle management plan is critical for maximizing the value of a pharma product over the course of its commercial lifespan. Drawing from our deep expertise of pharmaceutical product lifecycle management, RxC International, a life sciences management consulting firm, has identified key success factors and industry best practices as well as common pitfalls to avoid when developing and implementing LCM plans.
This is part of the MaRS BioEntrepreneurship series.
Speaker: Lynne Zydowsky, Ph.D., Managing Principal Zydowsky Consultants
* Explore the development of regulated drugs and devices
* Understand where and how value is generated in the pharmaceuticals industry
* Appreciate the interplay between science and business in a biotech company
To download a copy of the audio for this presentation, please go to:
http://www.marsdd.com/bioent/oct16
For the event blog and Q+A, please see:
http://blog.marsdd.com/2006/10/17/bringing-together-art-and-science/
Creating a Comprehensive Drug Development PlanCovance
This white paper provides an overview of creating an integrated drug development plan, overcoming common development challenges and devising strategies that increase the likelihood of delivering a new, approved medicine to patients.
Developing High-Impact Communication Forms to Brief Senior Leaders: Optimizin...Best Practices
Competitive Assessments and Clinical Landscape Assessments are crucial to the success of new products in the pharmaceutical industry. In order to inform busy executives quickly and effectively, market intelligence and analytics leaders must develop briefing templates that are clear, concise, and impactful.
This study identifies winning strategies for effectively informing senior leaders through Competitive Landscape Summaries and Clinical Development Profile Maps. The research will help executives to understand what the important elements to include are, and what are the best formats for two critical healthcare briefing templates: : 1) the Competitive Landscape Summary Map and 2) the Development Landscape Profile Map (often described as the Data Disclosure or Clinical Trials Progress Summary).
Read more at: http://www.best-in-class.com/bestp/domrep.nsf/products/developing-high-impact-communication-forms-to-brief-senior-leaders-optimizing-competitive-assessment-data-disclosure-summaries?OpenDocument
How early is too early for pharmaceutical market insights and product forecasts. A discussion on pipeline product research during early product development
International Pharmaceutical Industry: Feasibility Is Not (Anymore) A Plain S...KCR
Investigational Sites
The sole term ‘feasibility’ has multiple definitions in a clinical environment, leading to certain bias with all stakeholders involved, including pharma companies (sponsors) and all types of contract research organizations (CROs). The most common perception is related to a never-ending argument between pharma outsourcing departments and CRO commercial groups, with sponsors expecting CROs to run a (non-defined) feasibility study prior to proposal submission and CROs undertaking a series of schematic actions to create an impression of fulfilled expectation.
How does the licensing process differ for in-licensing and out-licensing comp...daisyrmuzzio
PHARMA & BIOTECH LICENSING & PARTNERING:
Filling the Pipeline & Growing Market Share Through Strategic Deal-Making-- March 2-3- San Diego California
Effective Pharmaceutical Life Cycle Management Planning: Optimizing Product V...Nick DeSanctis
Developing an effective drug life cycle management plan is critical for maximizing the value of a pharma product over the course of its commercial lifespan. Drawing from our deep expertise of pharmaceutical product lifecycle management, RxC International, a life sciences management consulting firm, has identified key success factors and industry best practices as well as common pitfalls to avoid when developing and implementing LCM plans.
This is part of the MaRS BioEntrepreneurship series.
Speaker: Lynne Zydowsky, Ph.D., Managing Principal Zydowsky Consultants
* Explore the development of regulated drugs and devices
* Understand where and how value is generated in the pharmaceuticals industry
* Appreciate the interplay between science and business in a biotech company
To download a copy of the audio for this presentation, please go to:
http://www.marsdd.com/bioent/oct16
For the event blog and Q+A, please see:
http://blog.marsdd.com/2006/10/17/bringing-together-art-and-science/
Creating a Comprehensive Drug Development PlanCovance
This white paper provides an overview of creating an integrated drug development plan, overcoming common development challenges and devising strategies that increase the likelihood of delivering a new, approved medicine to patients.
Get Your Development Program Started on the Right FootBrook White, PMP
You think you have a potential pharmaceutical or biotechnology product based on animal or in vitro data—what is the next step? Two documents you need at an early stage are the Target Product Profile (TPP) which defines expectations for your potential medicine and an Integrated Product Development Plan (IPDP) which describes the activities required through approval of your marketing application.
Feedback from peersThanks so much for your response. Very welChereCheek752
Feedback from peers
“Thanks so much for your response. Very well done!
I like the competitive forces model and the broad factor analysis which are models that other students have not really discussed.
All of these models can add value. The important thing if the company has the resources in an ideal world is perhaps use both models or multiple models.
If you know anything about research if you do different types of research focused on the same topic and come up with the same answers then you know you've done a good job!”
__________________________
“Great post, I enjoyed reading about the competitive forces model and the broad factors analysis. I agree with you that this is a great tool to use to include the internal and external factors. Politics should certainly be understood before entering into a foreign country and setting up camp. Learning about the macro-environmental factors would indeed need to be known to understand the impact of the environmental surroundings of where you would intend to expand globally (Corporate Finance Institute, 2021).
The competitive forces model is also extremely pertinent as you mention. Knowing the competition and the current market is crucial to the success of the organization. I appreciate that you talk about how difficult entry gives you a competitive advantage. I don't know if I understood that before, but you make a very good point in that regard. So with the difficult entry the contract agreement, is longer and there are better benefits offered? “
__________________________
PEER Discussion post
After reviewing the response of Deborah, I also collaborate with her opinion that there are still more positive ideas that can lead to improvements in the global market planning strategies. The adoption of technology can lead to various promotions in conjunction with the local production at the international business. Different decisions made by the stakeholders are mostly triggered by the level of competition that exists on the organization's premises. Moreover, the present-day global competition entails some aspects which evaluate the market share. On most occasions, several organization strategies, including the multinational rivals, do not differ looking at the approaches, productivity, and experience.
Following the previous meeting with Deborah, I learned various aspects which as a team, we should all bear in mind, and these aspects entail the most suitable approaches concerning the movement in connection with more formal analysis (Harrison, Freitas, Drinnan, Campos, Masci, di Maria & Whitaker, 2019). With the traditional analysis approaches, one can better understand because the visual elements pictorial are always running in one's mind. Although the formal analysis aspect takes much or longer time to express certain information, it provides evaluations and definitions which don't require clerical explanations (Turkmen, den Hartog, Ranise, & Zannone, 2017).
Following the Tiffany and mike suggestion ...
1st Riyadh Marketing Club (Introduction to Business Development Management) ...Mahmoud Bahgat
#Mahmoud_Bahgat
#Marketing_Club
Join us by WhatsApp to me 00966568654916
*اشترك في صفحة ال Marketing Club* عالفيسبوك
https://www.facebook.com/MarketingTipsPAGE/
*اشترك في جروب ال Marketing Club* عالفيسبوك
https://www.facebook.com/groups/837318003074869/
*Marketing Club Middle East*
25 Meetings in 6 Cities in 1 year & 2 months
Since October 2015
*We have 6 groups whatsapp*
*for almost 600 marketers*
From all middle east
*since 5 years*
& now 10 more groups
For Marketing Club Lovers as future Marketers
أهم حاجة الشروط
*Only marketers*
From all Industries
No students
*No sales*
*No hotels Reps*
*No restaurants Reps*
*No Travel Agents*
*No Advertising Agencies*
*Many have asked to Attend the Club*
((We Wish All can Attend,But Cant..))
*Criteria of Marketing Club Members*
•••••••••••••••••••••••••••••••••••••
For Better Harmony & Mind set.
*Must be only Marketer*
*Also Previous Marketing experience*
●Business Managers
●Country Manager,GM
●Directors, CEO
Are most welcomed to add Value to us.
■■■■■■■■■■■■■■■■
《 *Unmatched Criteria*》
Not Med Rep,
Not Key Account,
Not Product Specialist,
Not Sales Supervisor,
Not Sales Manager,
●●●●●●●●●●●●●●●●●●
But till you become a marketer
you can join other What'sApp group
*Marketing Lover Future Club Group*
■■■■■■■■■■■■■■■■
《 *Unmatched Criteria*》
For Conflict of Intrest
*Also Can't attend*
If Working in
*Marketing Services Provider*
=not *Hotel* Marketers
=not *Restaurant* Marketers
=not *Advertising* Marketer
=not *Event Manager*
=not *Market Researcher*.
■■■■■■■■■■■■■■■■
■■■■■■■■■■■■■■■■
*this Club for Only Marketers*
Very Soon we will have
*Business Leaders Club*
For Sales Managers & Directors
Will be Not for Markters
●●●●●●●●●●●●●●●●●●●●
■ *Only Marketers* ■
*& EPS Marketing Diploma*
●●●●●●●●●●●●●●●●●●●●
Confirm coming by Pvt WhatsApp
*To know the new Location*
*#Mahmoud_Bahgat*
00966568654916
*#Marketing_Club*
http://goo.gl/forms/RfskGzDslP
*اشترك بصفحة جمعية الصيادلة المصريين* عالفيسبوك
https://lnkd.in/fucnv_5
■ *Bahgat Facbook Page*
https://lnkd.in/fVAdubA
■ *Bahgat Linkedin*
https://lnkd.in/fvDQXuG
■ *Bahgat Twitter*
https://lnkd.in/fmNC72T
■ *Bahgat YouTube Channel*
https://www.Youtube.com /mahmoud bahgat
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https://lnkd.in/fmWPXrY
■ *Bahgat SnapChat*
https://lnkd.in/f6GR-mR
*#Mahmoud_Bahgat*
*#Legendary_ADLAND*
www.TheLegendary.info
Ateneo School of Medicine and Public Health Grading System for the Marketing Management Module designed by Prof. Remigio Joseph De Ungria of the Ateneo Graduate School of Business
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...Yavuz Silay
Strategies for Conducting New Product Scientific Assessment - Due Diligence - New Strategies for Successful Licensing Acquisitions , DIA , Session Panel, June 22 2008,
Sharpen existing tools or get a new toolbox? Contemporary cluster initiatives...Orkestra
UIIN Conference, Madrid, 27-29 May 2024
James Wilson, Orkestra and Deusto Business School
Emily Wise, Lund University
Madeline Smith, The Glasgow School of Art
This presentation, created by Syed Faiz ul Hassan, explores the profound influence of media on public perception and behavior. It delves into the evolution of media from oral traditions to modern digital and social media platforms. Key topics include the role of media in information propagation, socialization, crisis awareness, globalization, and education. The presentation also examines media influence through agenda setting, propaganda, and manipulative techniques used by advertisers and marketers. Furthermore, it highlights the impact of surveillance enabled by media technologies on personal behavior and preferences. Through this comprehensive overview, the presentation aims to shed light on how media shapes collective consciousness and public opinion.
This presentation by Morris Kleiner (University of Minnesota), was made during the discussion “Competition and Regulation in Professions and Occupations” held at the Working Party No. 2 on Competition and Regulation on 10 June 2024. More papers and presentations on the topic can be found out at oe.cd/crps.
This presentation was uploaded with the author’s consent.
Have you ever wondered how search works while visiting an e-commerce site, internal website, or searching through other types of online resources? Look no further than this informative session on the ways that taxonomies help end-users navigate the internet! Hear from taxonomists and other information professionals who have first-hand experience creating and working with taxonomies that aid in navigation, search, and discovery across a range of disciplines.
0x01 - Newton's Third Law: Static vs. Dynamic AbusersOWASP Beja
f you offer a service on the web, odds are that someone will abuse it. Be it an API, a SaaS, a PaaS, or even a static website, someone somewhere will try to figure out a way to use it to their own needs. In this talk we'll compare measures that are effective against static attackers and how to battle a dynamic attacker who adapts to your counter-measures.
About the Speaker
===============
Diogo Sousa, Engineering Manager @ Canonical
An opinionated individual with an interest in cryptography and its intersection with secure software development.
Acorn Recovery: Restore IT infra within minutesIP ServerOne
Introducing Acorn Recovery as a Service, a simple, fast, and secure managed disaster recovery (DRaaS) by IP ServerOne. A DR solution that helps restore your IT infra within minutes.
How to Work Effectively with Research Teams in New Product Planning
1. Working Effectively with Research Teams
in New Product Planning
TONY RUSSELL , PHD, MBA
SENIOR DIRECTOR, PRODUCT STRATEGY AND COMMERCIAL PLANNING
THERAVANCE BIOPHARMA US, INC.
1
2. Disclaimer
The views and opinions expressed are solely those of the speaker and do not represent those of
my current or previous employers
2
3. Tony Russell, PhD MBA
Background and Experience
Year Company Position
2015 – Present Theravance Biopharma US, Inc. Product Strategy and Commercial Planning
2010 – 2015 Alder BioPharmaceuticals Commercial Strategy
2007 – 2010 ZymoGenetics (acq. BMS) Medical Affairs
2006 – 2007 ICOS (acq. Eli Lilly) Strategic Marketing
2004 – 2006 Corus Pharma (acq. Gilead Sciences) Product Management
2000 – 2004 Amgen Medical Affairs
1999 – 2000 Baxter Global Marketing
1998 University of Washington PhD (Physiology and Biophysics)
1998 Seattle University MBA
3
https://www.linkedin.com/in/arussellbiotech/
4. Key Topics to be Covered
Challenges in New Product Planning
Working Effectively with Research Teams
Tools and Approaches to Use
Mini Case Study
Summary / Areas for Improvement
4
6. 0
10
20
30
40
50
60
1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Count
BLA Approvals NDA Approvals Filings
Increasingly Crowded Markets in the US
with More Drugs Approved Over Time
Source: http://fortune.com/2016/12/15/fda-new-drug-approvals-plunge/
7. Increasingly Crowded Markets in the US
with More Drugs Approved Over Time
7
0
100
200
300
400
500
600
700
800
900
1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Count
Cumulative BLA Approvals Cumulative NDA Approvals Cumulative Filings
Adapted from: http://fortune.com/2016/12/15/fda-new-drug-approvals-plunge/
Note: 1993 is set as a “reference”
year for subsequent years to
assess the cumulative effect of
additional approvals and filings
8. Crowded Markets Can Impact Ability to
Differentiate and Achieve Market Share
More challenging to demonstrate higher quality:
Efficacy thresholds can increase as technology improves (e.g. better MOA’s, better target engagement,
etc.)
Safety issues can be minimized with newer generation therapies (e.g. decreased off-target toxicity)
More challenging to achieve substantial market share as a late entrant:
8
Source: Cha and Yu. “Pharma’s first-to-market advantage.” McKinsey & Co. (https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/pharmas-first-to-market-advantage)
Key Aspects:
• Best to be 1st to Market
• Odds for better market share improve if:
• 2nd to market
• Fast follower (launch within same year or 1
year after 1st entrant
• Marketed by a large pharma company
• Establish meaningful differentiation
9. Drug Development and Evolving Goals –
Obtaining FDA Approval is Not Enough
9
“Biopharmaceutical Research and Development: The Process Behind New Medicines” PhRMA (http://phrma-docs.phrma.org/sites/default/files/pdf/rd_brochure_022307.pdf)
Past Goal
Current Goal
10. Frequent Drug Price Increases Were the
Historical Norm in Pharma
10
Average Annual Cost of Brand Name Drugs
Source: “Drug Costs for Older Adults Still Soaring”
https://www.aarp.org/health/drugs-supplements/info-
2016/drug-costs-for-older-adults-still-soaring-cs.html
EpiPen Price History
Source: “How EpiPen came to symbolize corporate greed”
https://money.cnn.com/2016/08/29/investing/epipen-price-rise-
history/index.html
List Price of Humalog Insulin
Source: “Why treating diabetes keeps getting more expensive”
https://www.washingtonpost.com/news/wonk/wp/2016/10/31/
why-insulin-prices-have-kept-rising-for-95-
years/?noredirect=on&utm_term=.eecdb9ce844e
11. Recent Examples Show Emerging Drag
Forces on Pricing
11
Struggle of the PCSK9 mAb Class to Reach Blockbuster Status
Compounded: $10-20 / injection; K-V Product: $1,500 / injection
Zaltrap 2X the cost of Avastin; similar
median survival
Oct 25, 2018: “Amgen Slashes Cholesterol Drug Price 60% to Match
Rival Regeneron”
Apr 2, 2011: “KV Pharmaceutical… announced that it was
reducing the price of the drug, sold as Makena, to $690 an
injection”
12. Emerging Political Pressures on Pricing
12
Money (Jul 25, 2018)
New York Times (Jul 23, 2018)
Forbes (Aug 7, 2018) Bloomberg (Jul 16, 2018)
13. Pressures of Small-to-Mid Sized
Pharmaceutical Companies
Limited Resources and Institutional Knowledge
Pressures of Being Publicly Traded
Pressure of Asymmetrical Valuation
13
14. Limited Resources
Constant start-up budgets
Founder-based limitations
Fewer FTEs available (wearing “multiple hats”)
Lack of institutional knowledge / experience memory
Constant need for fundraising
Irrational exuberance (“only need to get 1% of the market to be successful”)
14
15. Pressure of Stock Outperforming the
General Market
15
NASDAQ Biotechnology ETF
DJIA / S&P 500
If decisions are made in the short-term
to bolster stock performance, then long-
term returns may suffer.
Reference: “Short-term profit can be dwarfed by longer-term losses” The Guardian (Jul 7, 2011)
https://www.theguardian.com/sustainable-business/short-term-profit-long-term-losses
16. Challenge of Asymmetrical Valuation – One
Program Can Dictate Total Value in a Company
16
Development
Candidate
Stage
Phase 1 Phase 2a
Asset #1
Asset #2
Asset #3
Asset #4
Based on article by LifeSciVC “Solving Biotech’s “Asymmetry of Maturity” Challenge” (https://lifescivc.com/2011/12/solving-biotechs-asymmetry-of-maturity-challenge/; accessed Aug 10, 2018)
• If the lead program (Asset #1) does well and drives an exit (e.g. buyout, M&A), it
typically drives about 95% of deal
• If the lead program (Asset #1) fails, it can wipe out about 95% of the value of the
company (“lead program brings down the house”)
17. Proposal for New Product Planning
Challenges in New Product Development Come From Multiple Sources
Crowded markets
Ability to demonstrate differentiation is increasingly challenging
Pricing pressures
Expect further public scrutiny and changes in the future
Small company pressures can limit multiple “shots on goal”
Important as New Product Planners to Treat the Challenges as Opportunities
Establish meaningful differentiation
Select and curate assets carefully
Build the value story for programs early in development
Sounds good, but how?
17
19. Challenges of Working Early with
Research – Overcoming Historical Norms
19
Where We Were
Where We
Need to Be
Image from http://nmtpharma.com/en/drug-development-stages/
20. Approaches and Tools for Working with
Research Teams Early in Development
20
• How should we work together?
Integration and
Norms
• What target / indication should we pursue?
Decision
Framework
• What do we need the final product to look like?
• What properties does the compound need to have?TPPs / TCPs
• How do we deal with potential uncertainty in
development (i.e. “what if” discussions)?
Scenario
Planning
• How can we define our potential competitive
strengths?
Competitive
Mapping
TPP: Target Product Profile; TCP: Target Compound Profile
21. Integration and Setting Norms
Setting Norms Up-Front
Goals – define shared goals early in engagement
Expectations – “Fail fast; Fail early” leading to iteration and critical learning
Discussions – need for open and honest interactions
Include Research as Part of the Commercial Evaluation Journey
Include in KOL discussions
Include in design and execution of market research
Review the competitive landscape together
Importance of Research “Buy-In”
Critical for the plan to be a collaboration
22. Decision Framework – Indication
Assessment Example
22
For illustrative purposes only; not intended to reflect an actual set of specific indications
Indication Assessment Worksheet (EXAMPLE)
[Product X]
Primary Corporate Goal: Indication that Can Be Served With a Small Dedicated Commercial Footprint
Notes Fit with Primary Goal Notes Fit with Primary Goal
Brief description of indication
Clinical Assessment
Size of target patient population (prevalence) Notes Notes
Precedence of clinical development pathway Notes Notes
Surrogate endpoint (disease BMx) Notes Notes
Time to endpoint (POC) Notes Notes
Recruitment rate (pts/site/mnth) Notes Notes
Preferred form/device Notes Notes
Form appropriate for POC study Notes Notes
Research / Nonclinical Assessment
Available proof-of-concept data (animal or human) Notes Notes
Literature data available on pharmacologic class (if available) Notes Notes
Regulatory Assessment
Precedence of regulatory pathway Notes Notes
Regulatory exclusivity options Notes Notes
Regulatory hurdles Notes Notes
Legal Assessment
Patentability Notes Notes
Patent infringement Notes Not Eval. Notes Not Eval.
Commercial Assessment
Current standard of care Notes Notes
Degree and nature of unmet need(s) Notes Notes
Key compounds in development (Phase 1 - Phase 3) Notes Notes
Value Proposition for Product X Notes Notes
INDICATION #1 INDICATION #2
Key Points:
Clear objectives are critical
(keep the end in mind)
Iterative process with multiple
rounds of evaluation
Use market research and KOL
discussions to pressure test
assumptions
Develop treatment flow
diagram to illustrate positioning
Develop the value proposition
Clearly outline the risks and
plans to manage the risks
23. Target Product Profile / Target
Compound Profile Template Examples
23
Key Team Question:
Can the Target Compound Profile Deliver on the TPP?
For illustrative purposes only; does not reflect any actual compound or program
24. Mapping Assumptions and Scenario Planning
24
Example Questions / Assumptions to Include:
• Is our compound sufficiently differentiated? Are there other ways to differentiate?
• Are there other indications to allow for faster time to market?
Assumption Relationship Mapping Scenario Planning and Logic Flow
25. Strategic Competitive Mapping
25
Mapping by Subpopulations Mapping by Attributes
For illustrative purposes only; does not reflect any actual compound or program
27. Case Study: Disease #1 or Disease #2?
Background Discussion*:
Science Team: We can make a good mAb to Target #1. Therefore, we believe Disease #1 is a
good indication for us to pursue. Can you tell us how big the opportunity is?
NPP: Let’s talk with some KOLs first to gauge interest.
KOLs: We don’t need new drugs for treating Disease #1 as our current therapies work well.
Science Team / NPP: [silent disappointment]
Science Team / NPP: What patients are you struggling to treat?
KOLs (unanimously, individually): Disease #2. We have no good therapies to treat patients.
Science Team: We can make a mAb for Target #2 for Disease #2
NPP: Let’s work together on the evaluation for Senior Management review
mAb: monoclonal antibody; NPP: new product planning; KOL: key opinion leader
* Case is presented in an overly-simplified fashion for illustrative purposes
28. Case Study: Building the Case for New Indication
28
FINAL PLAN
& GUIDANCE
Draft TPP /
TCP
•Critical Thresholds
Needed
Value
Proposition
•Impact of an
Effective New
Therapy
Economics of
Unmet Need
•Cost of Substandard
Treatment
Competitor
Map
•Current & Pipeline
Competitors
Current SOC
•Treatment Flow and
Gaps
Market
Sizing
•Epidemiology
Analytics
Key Lessons
1. Challenge Assumptions Early
2. Find Opportunities to Pivot
3. Having Research Team as a “Partner” was Critical
4. Use a Defined Evaluation Process
5. Seek Continuous Feedback (Internal & External)
End Result: Support by Senior Leadership and Board of Directors to Pursue as a Development Candidate
SOC: standard of care; TPP: target product profile; TCP: target compound profile
30. Areas for Improvement
Challenges exist and will continue to be present
Need to constantly look for ways to adapt to the evolving landscape
Opportunities:
Increase capabilities in defining subpopulations where treatment gaps exist
Continue to explore improvements in translational models (de-risking of
programs early)
Development of economically-efficient “sandboxes” to test ideas early with
minimal investment and select the winners for further development