Molekule Firm Dossier: 2017 Perspectives

STRATEGIC INTELLIGENCE CAPABILITIES
CAPABILITIES
MOLEKULE
ALIGNED INTELLIGENCE. FOCUSED RESULTS.
Molekule Firm Dossier: 2017 Perspectives
CONFIDENTIAL
Molekule Capabilities
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The Molekule Difference
Core Capabilities
70+ years combined experience "within-the-walls" of Blue Chip
pharma and generics competitive insights functions, including
group leadership
R&D & Commercial Competitive Intelligence Services:
• Focused launch logistics including go-to-market strategy
assessments
• Strategic pricing and access, contracting and reimbursement
reseach
• Launch prioritization and segmentation research
• Pipeline Optimization and Competitive Assessments
• Licensing and M&A Support
Strategy & Competitive Scenario Planning
• War Gaming
• Positioning
• Franchise strategy and FMEA (failure mode effects analysis)
• Biopharmaceutical Strategic Consulting
•
Molekule delivers long-term consultative partnerships with insights,
pricing and market access, franchise and brand partners across
the global pharma matrix to develop and deliver insights against
brand and franchise strategic imperatives
•
We maintain a broad and growing, actively managed, global
persistent human source network
•
We offer highly customized CI training programs and help educate
internal customers and contributors on the value of CI
Generics and Biosimilars; Manufacturing
and Supply Chain Logistics
• Pre- and Peri-LOE Assessments
• Manufacturing & COGS Analyses
• Manufacturing and Technology Assessments of Competitor
Facilities, Equipment and Technologies
• Supply Chain Logistics Assessments
• Regulatory Landscape Assessments Regarding Generics and
Biosimilar Threats
• Generic/Biosimilar Landscape Monitoring – Proactive research
CONFIDENTIAL
Molekule Capabilities
Molekule Consulting, LLC
By the Facts and Numbers
O U R I N C O R P O R AT I O N
O U R STA F F I N G M O D E L
US footprint
• HQ in Miami Florida 2012
• Chicago office
• NJ Office
Employs FTE subject matter experts and seasoned pharmaceutical
and management consulting industry professionals. Contractor and
affiliates on long-term and ad-hoc engagements as required
EU business based in London, UK est. 2014
India operations launched in 2016
M O L E KU L E & C L I E N T PA RT N E RS
M O L E KU L E & ACT I O N A B I L I T Y
DELIVERED
Molekule drives excellence in strategic competitive intelligence and
competitive workshopping
Continually devoted to client centricity
O U R G LO BA L O P E R AT I O N S
Subsidiaries: physical operations in the EU, CIS/ CEE, Asia-Pacific,
LATAM and Israel “Boots-on-the- ground” in 7 core geographies,
fluent in 17 languages
M O L E KU L E &
COMPETITIVE INTELLIGENCE
Employs intelligence industry experts,
MDs, Ph.D.s, Pharm.D.s, MBAs and experienced business
professionals
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CONFIDENTIAL
Molekule Capabilities
The Molekule Way
OUR VISION:
We aspire to be the premier competitive intelligence and strategy consulting company in the life science
industry delivering actionable insights and recommendations to our clients, essential for decision
making, strategy development, and execution.
OUR VALUE PROPOSITION:
Molekule Consulting is a proactive and dedicated partner that leverages its industry leading CI expertise,
deep area knowledge and its extensive global network to provide world-class competitive intelligence
and strategy services.
As a trusted consultant, Molekule conducts its business in an ethical manner with the
highest level of integrity. Molekule Consulting will never compromise on these values.
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Molekule Capabilities
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Molekule Consulting's Proprietary Ethical Research Methodology and Disclosures
Code of Conduct
Molekule Consulting is committed
to the highest standard of ethics
throughout its global offices and
worldwide consulting staff.
As a firm, Molekule strictly complies
with all global, regional and local laws
and regulations. Molekule complies
with all SCIP rules, regulations
and guidelines, globally, across all
office locations and human capital
resources.
Molekule Consulting neither has
active, pending, nor prior litigation or
litigious activity against it as a legal
entity.
IN PARTICULAR
We will CONDUCT all business according to the following standards unless the client requests more restrictive
constraints, in which case, those standards take precedence.
We will NOT LIE (by giving any false information, misrepresenting ourselves or using false pretexts).
We will NOT CHEAT (by attempting to bypass any company’s attempts to protect their information).
We will NOT STEAL (by misappropriating or fraudulently obtaining, intellectual property).
We will NOT provide inducements (honoraria or gifts) of any kind in exchange for information since this could be
interpreted as a bribe to violate confidentiality agreements.
We will NOT tape source interviews without the source’s permission.
We will NOT use intrusive methods (technical or surreptitious means to penetrate private space or private
conversations).
We will NOT engage in activities that will cause harm to individuals, companies, or markets.
Code of
Conduct
We will NEVER reveal a client’s identity.
We will ALWAYS protect the confidentiality of sources.
We will SPEAK UP immediately regarding any legal or ethical concerns.
We will NEVER accept work that would create a conflict of interest for the company or our clients.
We will ALWAYS report truthfully and will provide honest conclusions and recommendations to clients.
We UNDERSTAND that it is better to “fail” than to violate legal and ethical guidelines and thereby create risk for
Molekule Consulting and its clients.
MRK 55 Analog Assessment of the Competitive Vaccines Market
Molekule Consulting &
Competitive Intelligence
ALIGNED INTELLIGENCE. FOCUSED RESULTS.
CONFIDENTIAL
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Molekule Capabilities
Competitive Intelligence Enables Thorough “Drill Down” via Multiple Levels of Asking
Key Intelligence Questions (“KIQs”)
Analytics of
the secondary domain
Thorough interviews with
competitors, key stakeholders
and KOLs
Multi-point and multiperspective
interviews with high value and
reliable stakeholders/sources
Multiple iterative refinements
of CI interviewing with multiple
sources/stakeholders
HIGH VISIBILITY
•
Publicly disclosed information
•
Non-proprietary data
•
Sales and revenue figures
•
Audits and reviews
“A BOV E T H E R A DA R ”
•
Proprietary custom research elucidating theories and/or opinions. i.e.threat levels, impact factors, enthusiasm levels
“ H I G H VA LU E TA RG E TS”
– PA RT I A L I M M E RS I O N
•
Granular elucidation of specific competitor actions, deployments and/or
manifestations
•
Real-time and/or near-term competitive insight and intelligence
“ D E E P D I V E S”
– F U L L I M M E RS I O N
•
Competitor initiatives, strategies and tactics
•
Forward-looking competitor logistics
•
Competitive long-range planning
•
Highly detailed depiction of the competitive landscape
•
Synthesis and translatability
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Molekule Capabilities
Molekule Consulting's Three-Step "CAS"
Competitive Intelligence Refinement Funnel
COMPETITIVE DATA ALONE IN A VACUUM ARE
NOT INTELLIGENCE . . . ACTIONABLE PRIMARY
COMPETITIVE INTELLIGENCE IS DERIVED FOR
ROBUST CONTEXTUALIZATION, ANALYSIS AND
SYNTHESIS.
FILTER #1
CONTEXTUALIZATION
FILTER #2
ANALYSIS
KEY:
FILTER #3
SYNTHESIS
Intelligence Signal
Potential Intelligence Signal
Competitive Noise
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CONFIDENTIAL
Molekule Capabilities
CI Strengthens One’s Competitive Position VIA
Accurate, Timely and Actionable Insight
TIME
Accuracy & Precision
of Intelligence Findings
Timeliness of
Competitive Insight
Actionability of
Intelligence Developed
PharmaCo's Competitive
Position Bolstered, Robustly
Sustainable Success and Measurable ROIs
Conferred in Support of PharmaCo
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Molekule Capabilities
Competitive Intelligence Dissipates the
“Fog of War” & Enables One to Win, Decisively
The synthesis and actionability conferred by accurate and granular primary competitive intelligence
in biopharmaceuticals enables key stakeholders to drive informed strategic initiatives thus enabling
them to win, decisively.
Leveraging secondary reports and data alone – in a vacuum
– leads to measurable misconceptions, mistakes and missteps
Aggregating multiple “high quality” triangulated primary
human sources who have reason to know the information sought
drives a level of informed understanding and insight
When rationalized and combined together, the sum total
of primary competitive insights and implications become palpable,
meaningful and actionable competitive intelligence
“If you know the enemy and know yourself, you
need not fear the results of a hundred battles.”
– Sun Tzu
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Molekule Capabilities
Competitive Forces Exerted Upon Biopharmaceutical Players Necessitates
Robust Competitive Intelligence Assessments
• Competitor Corporate Strategy
• Innovation and R&D strategies
• Competitor Brand Strategy, product positioning and repositioning
• Co-development and technology transfers
• Emerging markets and growth opportunity identification
• Competitor M&As and Industry Consolidation
• Lifecycle Management
• Competitive Generics Growth
• Internal asset portfolio defense strategies and blunting
tactics
• IP and patents
• Pricing and reimbursement strategies
• Regulatory affairs
• Overarching healthcare systems and payers
• Sales and marketing
• Marketing and branding strategies
• Internal alliances, partnerships and M&As
• Sales force effectiveness
• R&D and licensing (both in- and out- licensing)
• Competitive analysis and landscaping
C OM PE T I T I V E FORC E S COMMONLY EXERT ED ON PHA RM AC OS
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Molekule Capabilities
Fact: Competitive Intelligence Persists Throughout
The Pharmaceutical and Medical Device Lifecycle
A
Primary & Secondary CI
Conference Coverage
Scenario Analysis
Business Assessments
Pipeline & Portfolio Optimization
Corporate Strategy
Products & Portfolio Strategy
PRE-CLINICAL
PHASE 1
PHASE 2
PHASE 3
B
Business Development & Licensing
Technology & Product Evaluations
MARKETED
LCM
C
Generics & Biosimilars
Product Marketing & LCM
Brand Planning
Market Analysis
Brand Strategy Solutions
D
Clinical Development Support
R&D Support
E
Comprehensive Landscape Monitoring
Market Assessments
Competitive Benchmarking
F
Asset Valuations
G
Strategy Workshops
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MRK 55 Analog Assessment of the Competitive Vaccines Market
Sample Engagement
Team Profiles
ALIGNED INTELLIGENCE. FOCUSED RESULTS.
CONFIDENTIAL
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Molekule Capabilities
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David L. Alderman
President & Partner
David founded Molekule Consulting with
an ethos of strategic and actionable
competitive insight combined with
client centricity. He is responsible for
numerous engagements with varied
scopes and objectives in the competitive
intelligence and primary market research
areas. Project scopes range from preclinical through launch and lifecycle
management (“LCM”) to supporting
clients in clinical and commercial
strategy development. His major therapy
expertise is in oncology, ophthalmology,
cardiovascular, diabetes, autoimmune,
and CNS. David attends numerous major
medical congresses and scientific
congresses globally
Prior to founding Molekule, David held
progressive roles in biopharmaceutical
and market intelligence executive
leadership, conducting business
development, managing projects and
personnel, as well as developing primary
intelligence in support of client
engagements. David has extensive
experience developing clinical and
marketing strategies for both
pharmaceutical and biotechnology
companies, leveraging his skills in
intelligence needs identification,
collection, analysis and dissemination
David holds a B.S. in Biology from Trinity
College in Hartford, CT, and a M.Sc. in
Biomedical Science from Columbia
University College of Physicians and
Surgeons in New York, NY. Additionally,
David pursued doctoral study in Genetic
Research, Genomics and the Molecular
Biology of Disease at Emory University
School of Medicine in Atlanta, GA.
THERAPY AREA &
SUBJECT MATTER
EXPERTISE
Generics & Biosimilars
Pre- and Peri-LOE Strategy
Manufacturing Intelligence
Supply Chain Logistics
Intelligence
Oncology
ACADEMIC
QUALIFICATIONS
Doctoral Training & Research
Emory University School of
Medicine
M.Sc.
Columbia University College of
Physicians and Surgeons
B.S.
Trinity College
CNS
Ophthalmology
Cardiovascular
Competitive Simulation
Workshops
LANGUAGES
SPOKEN
English
Spanish
CONFIDENTIAL
Molekule Capabilities
Dr. Daniel Pascheles
CEO & Partner
Dr. Pascheles joined Molekule Consulting
in early 2017 as Chief Executive Officer
and has over 20 years of experience in
building world-class global competitive
intelligence. As manager of large CI
teams, Daniel oversaw and led during
his successful career in the
biopharmaceutical industry hundreds
of primary CI projects, competitive
simulations and strategic planning
sessions.
Prior to joining Molekule Consulting, Dr.
Pascheles was Vice President and Head
of Global Competitive Intelligence at
Merck & Co /MSD for the last 12 years.
Before that he worked for Aventis and
its predecessor company (Hoechst
Marion Roussel, Marion Merrell Dow) for
14 years in various positions such as
Global Head of CI, European Head of
Sales and Marketing Administration,
European Head of Strategic Planning
and General Manager Switzerland.
Dr. Pascheles studied Pharmacy at the
Swiss Federal Institute of Technology
(ETH) in Zurich, Switzerland. He received
his Ph.D. in Pharmaceutical Technology
from the same university. He did
additional studies at the University of
Kansas in Lawrence, Kansas. Daniel is
Past-President and a current Board
member of the Pharmaceutical Business
Intelligence & Research Group (PBIRG). He is also a member of the Society of
Competitive Intelligence Professionals
(SCIP) and the Licensing Executive
Society (LES). He is a well-known
speaker/chairman of International
Conferences on Competitive
Intelligence. He is a member of the
Editorial Advisory Board member of the
Pharmaceutical Executive magazine and
publishes regularly in various trade
magazines. Daniel is also Visiting
Professor at the Rey Juan Carlos
University in Madrid teaching a Master
Class in CI.
THERAPY AREA &
SUBJECT MATTER
EXPERTISE
CI Process Consulting and CI
Training
Competitive Benchmarking
Generics & Biosimilars
Diabetes
Competitive Simulations &
Strategic Planning
Early Warning Programs &
Monitoring
ACADEMIC
QUALIFICATIONS
Ph.D.
Swiss Federal Institute of
Technology (ETH) in Zurich,
Switzerland
M.Sc.
Swiss Federal Institute of
Technology (ETH) in Zurich,
Switzerland
Harvard Business School
Executive Education on
Leadership and Strategy
Pre- and Peri-LOE Strategy
Cardiovascular
LANGUAGES
SPOKEN
English
German
French
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Molekule Capabilities
Hezekiah Blake
Vice President
Hezekiah Blake is a competitive
intelligence functional expert with over
15 years of relevant experience. He has
extensive management experience at
Novartis, and Bayer having built teams
and managed multi-millions in support
of blockbuster assets.
Holding various global pharma roles and
working across cultures while living in
India, he is adept at building rapport and
delivering value across culture and
geography in the global, matrixed
pharma environment. On the consulting
side, Hezekiah has built, managed and
delivered engagements against brand
and franchise strategic imperatives.
Typical projects include clinical
assessments,
competitive
benchmarking, risk assessments,
competitor opinion leader and
publication heat-maps, strategic and
tactical scenario planning workshops.
Hezekiah’s therapeutic areas of expertise
include Hemophilia, Virology,
Immunology, Oncology, MS & the orphan
disease space.
Prior to joining Molekule, at Bayer,
Hezekiah was responsible for proactive
CI defense including corporate security,
formalizing partnership between legal
and CI, develop and launch of an
enterprise wide insight portal, and
insights lead of $2B+ franchise.
Previously, Hezekiah served Novartis as
a Function Head for the CI group. There
he directly managed a team of 14
associates and transitioned the
organization to a service-based delivery
system.
Mr. Blake holds a Masters of Bioscience,
Business of Bioscience focus, from The
Keck Graduate Institute of Applied Life
Sciences, a member of the Claremont
Colleges and a Bachelor of Science in
Biology from The University of California
San Diego. Hezekiah served as the
student body president for his graduating
Masters class.
THERAPY AREA &
SUBJECT MATTER
EXPERTISE
Competitive Simulation
Workshops
Immunology
Orphan Disease
Arthritides
ACADEMIC
QUALIFICATIONS
M.B.S.
Keck Graduate Institute of
Applied Life Science
B.S.
University of California, San
Diego
Hematology
Virology
Nephrology
CNS
LANGUAGES
SPOKEN
English
Spanish
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Molekule Capabilities
Alexander Price
Director - Europe
Alexander Price is a competitive
intelligence functional expert with over
20 years of relevant experience. He has
extensive management experience in
healthcare research consultancies,
having supported numerous operational,
project, and resource requirements.
Furthermore, he has held various global
pharma roles and is skilled at building
high performing teams and delivering
value across culture and geography in
the global, matrixed pharma
environment.
On the consulting side, Alex has sold,
managed and delivered engagements
against brand and franchise strategic
imperatives. Typical projects include
clinical assessments, competitive
benchmarking, risk assessments,
quantitative market research, strategic
and tactical scenario planning
workshops. Alex’s therapeutic areas of
expertise include Neurology (particularly
MS, Alzheimer’s Disease, Parkinson’s
Disease, and Dementia), Diabetes,
Rheumatoid Arthritis, Psoriasis and
related autoimmune diseases,
Respiratory (COPD, Asthma, Allergic
Rhinitis), Virology, and Generics.
On the industry side, Alex has held CI
functional expertise positions at Roche
Pharma HQ (Switzerland), and GE
Healthcare HQ (UK). Key initiatives
delivered as part of these roles include
supporting the role out of an organization
wide insight portal, elevating CI
processes to the corporate level
including corporate security,
development of a CI agency vetting
program, and insights lead of $1B+
franchise.
Mr. Price holds a Bachelors and Masters
Degree in Health Administration from
The Pennsylvania State University and
participates in local CI chapter meetings.
THERAPY AREA &
SUBJECT MATTER
EXPERTISE
Neurology
Arthritides
Virology
ACADEMIC
QUALIFICATIONS
M.S.
Pennsylvania State University
B.A.
Pennsylvania State University
Biopharmaceutical Intellectual
Property
Diabetes
Respiratory
(COPD, Asthma, Allergic Rhinitis)
Generics and Biosimilars
Competitive Analysis and
Simulation Workshops
LANGUAGES
SPOKEN
English
Spanish
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Molekule Capabilities
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Dr. Michael Marlatt
Associate Director
Michael is a uniquely experienced
competitive intelligence (CI) and
therapeutic area expert, having led
significant engagements with both
pharmaceutical and biotechnology
clients. A seasoned project manager,
Michael has a breadth of experience
with competitive landscaping, product
differentiation, launch preparedness,
l i fe c yc l e
management,
and
organizational development. His major
therapeutic expertise is in CNS,
oncology, rare, and infectious diseases.
He brings first-hand experience
delivering clinical and commercial
insights for pipeline and marketed
products to a breadth of clients, ranging
from Top-20 pharma companies to
privately held biotech firms.
Michael is a research scientist by
training, who began his career with
Merck Research Labs in Neuroscience
Drug Discovery. Following his PhD,
Michael joined Deallus Consulting, a
global CI and strategy firm based in
London, where he developed further as
project manager and functional CI
expert. At Deallus, he held major
responsibility for delivering global CI
and strategy projects across therapeutic
areas and diagnostics. From Deallus,
Michael was recruited to Occam Global,
a retained executive search and strategy
firm based in New York, specializing in
organizational development for venture
capital backed healthcare and
technology companies.
Michael completed his BS and MS at
Case Western Reserve University in
Biochemistry and Pathology respectively.
He completed his PhD through a Marie
Curie Fellowship at the University of
Amsterdam (The Netherlands) and
National Institutes of Health (USA).
THERAPY AREA &
SUBJECT MATTER
EXPERTISE
CNS
Oncology
Rare Disease
Virology
Immunology and Inflammation
ACADEMIC
QUALIFICATIONS
Ph.D.
University of Amsterdam, The
Netherlands
M.S.
Case Western Reserve University
B.S.
Case Western Reserve University
Diagnostics
Regulatory Strategy
Life Cycle Management
(Pre- and Peri-LOE strategy)
Competitive Simulation
Workshops
Sales Force Effectiveness
LANGUAGES
SPOKEN
English
CONFIDENTIAL
Molekule Capabilities
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Patricia Garcia
Engagement Manager
Patricia manages competitive
intelligence engagements across the
biopharmaceutical arena. She develops
actionable insights based on analysis
and synthesis of primary and secondary
research findings.
Patricia has extensive experience in the
biopharmaceutical ecosystem. Prior to
joining Molekule Consulting, she has
been working as an independent
consultant after a decades-long career
in the pharmaceutical industry in
positions of increasing responsibility.
She has had significant roles in the drug
development lifecycle, having worked
across multiple functions from R&D to
commercialization. Patricia worked for
15 years at Sanofi in market analytics
and competitive intelligence roles across
multiple therapy areas, where she was
a valued member of early brand teams,
joint ventures of varying complexities,
and project teams. Prior to joining
Sanofi, she launched a proprietary
database in the US as Product Manager
for IMS International. Her background
includes market research at BristolMyers Squibb, business planning and
clinical research at Wyeth (now Pfizer),
and pre-clinical research at Roche.
Patricia is skilled in understanding the
needs of scientific and commercial
stakeholders in bringing a new drug to
market, and assisting them in
understanding the competitive
environment to
optimize the
performance of existing brands.
THERAPY AREA &
SUBJECT MATTER
EXPERTISE
New Product Launch
Licensing Assessments
Strategic Alliances
Long-Term Strategic Planning
ACADEMIC
QUALIFICATIONS
M.B.A.
New York University, Stern School
of Business
B.S.
Biology Pace University, New York
Immunology and Inflammation
Diabetes
CNS
Anti-Infectives
Anti-Virals
Biologics
Cardiovascular
LANGUAGES
SPOKEN
Neurology
Psychiatry
Drug delivery
English
Spanish
French
CONFIDENTIAL
Molekule Capabilities
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Jayant Rana
Consultant
Jayant is a Competitive Intelligence
functional expert with significant blue
chip pharma experience at Novartis,
Abbott, and Eli Lilly. He is adept in
generating market and competitor
insights across global matrixed pharma
organizations for brand, franchise and
senior leadership.
As part of the Global CI team at Novartis,
Jayant delivered insights to global and
country brand teams across the globe
in support of multiple blockbuster
brands. As part of the Commercial
Excellence team at Abbott, Jayant
supported the leadership team in diverse
projects related to sales force
effectiveness, customer relationship
management, and business analytics to
achieve strategic objectives profitably
and sustainably. At Lilly, Jayant
developed market research expertise in
support of the Diabetes brand team.
Jayant holds an MBA from the Indian
Institute of Foreign Trade, with a
concentration in International Business,
and a Bachelor of Technology degree in
Biotechnology from the Jacob School
of Biotechnology & Bioengineering.
THERAPY AREA &
SUBJECT MATTER
EXPERTISE
Neurology
Cardiology
Diabetes
Respiratory
ACADEMIC
QUALIFICATIONS
M.B.A.
Indian Institute of Foreign Trade
B.TECH Biotechnology
Jacob School of Biotechnology &
Bioengineering
Competitive Analysis
Sales Force Effectiveness
Emerging Markets
Generics & Biosmilars
LANGUAGES
SPOKEN
English
Hindi
MRK 55 Analog Assessment of the Competitive Vaccines Market
Client Testimonials
ALIGNED INTELLIGENCE. FOCUSED RESULTS.
CONFIDENTIAL
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Molekule Capabilities
Client Testimonials
“It takes a lot of coordination and effort to drive home
consistency and quality in terms of high impact
deliverables and high quality, accurate and precise
intelligence. The folks over at Molekule Consulting have
an amazing ability to do that time in and time out.”
“I must compliment Molekule [Consulting] on their
ability to develop sources and track down individuals,
globally, who are difficult-to-reach. As a firm, Molekule
[Consulting] can develop some of the best primary
[competitive intelligence] out there and they synthesize
it quite well. Their deliverables are well refined and to
the point of a ‘MBB-style’ consultancy.”
“It takes a lot of coordination and effort to drive home
consistency and quality in terms of high impact
deliverables and high quality, accurate and precise
intelligence. The folks over at Molekule Consulting have
an amazing ability to do that time in and time out.”
– Associate Director, Global Commercial
Strategy, MNC Biopharmaceutical Company,
U.S.
– Director, Global Commercial Insights, Top-5
Pharmaceutical Company, U.S.
– Director, Business Analysis and Insights,
Top-15 Biopharmaceutical, U.S.
“Wargaming may no longer be politically correct – but
let us be true – it is a war game. Strategy workshops
conducted by Molekule Consulting are standout – they
are well prepared and facilitated. The level of engagement
with our internal key stakeholders was extreme and the
key takehomes was solid. Overall, I was very impressed
with the job the Molekule group did and would definitely
re-engage with them”
“There are few and far between [competitive intelligence]
agencies that do the job ethically and right - collecting
solid intelligence findings and reporting it properly,
strategically and actionably. Molekule Consulting does
just that - after 23 years in the industry on the client-side,
inside the walls of Pharma, I can wholeheartedly endorse
the Molekule [Consulting] team.”
“The dedication and real, two-way communication
between the Molekule team and us was stellar - and helped
better fulfill the engagement objectives, significantly.
Communication is key in any services industry - even
down to the consultancy level - and they knocked it out
of the park in terms of the intelligence and deliverables
- when you get that synergized with the communication,
it is great!”
– Sr.Manager, Top 5 Global Pharmaceutical
Company, Switzerland
– Sr. Director, Global Competitive
Intelligence, Major Pharma, Europe
– Associate Director, Competitive Strategic
Insights, Top-10 Biotech, U.S.
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MRK 55 Analog Assessment of the Competitive Vaccines Market
Sample Framework
ALIGNED INTELLIGENCE. FOCUSED RESULTS.
CONFIDENTIAL
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Molekule Capabilities
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Rationalizing Therapy Area Competitive Landscapes Elucidates
Strengths, Opportunities, Weaknesses and Threats
EXHIBIT Q
High Impact of Competitor
New Commercial Offerings
1. CompetitorA
2. Competitor B
3. Competitor C
4. Competitor D
5. Competitor E
6. Competitor F
7. Competitor G
1
6
2
In-line RA Player
Pipeline RA Player
(Note: approved for nonRA indications)
Note: Competitor 1 and 2 are considered standouts
among rheumatologists due to overt initiatives
performed to garner enthusiasm. Although their
respective RA assets in the EU28 are considered
“mature…” rheumatologists claim Competitor 1 and
2 continue to drive measurable excitement via new
initiative develo ment on a yearly basis
Low Impact of Competitive
Asset Label Expansion
7
5
Low Impact of Competitor
New Commercial Offerings
4
High Impact of Competitive
Asset Label Expansion
3
“Competitor 1 just seems to get what I want to have happen and every year they drive new and transformational programming
for prescribers who treat RA. Humira is a great drug and when they [Competitor 1] come to the gate with new offerings and
programs to boot, how can they be beat?”
– KOL, The Netherlands
CONFIDENTIAL
Molekule Capabilities
Competitive Commercial Manufacturing and
Scalability Dashboard
EXHIBIT X
The approximate tonnage of API 1 produced globally by
competitors is
~175 metric tons
COMMENTS
•
Competitor 7 produces API 1 at its Montreal, Canada
based facility, but sources a bulk of its API 1 from
Competitor 3
•
Competitor 5 produces API 1 in Andhra Pradesh, India at
a facility with
approximately 300% up-scalability relative to current
capacity
•
•
Competitor 12’s API 1 is produced in Reykjavik, Iceland
at a facility with approximately 125% up-scalability relative
to current capacity
•
Competitor 13’s API 1 is produced in Andhra Pradesh at
a facility with ~65% up-scalability
MAX I MUM AP I 1 CAP ACI TY
Competitor 2
~25 MT
Competitor 10
~7.5 MT
Competitor 3
~50 MT
Competitor 12
~30 MT
Competitor 5
~25 MT
Competitor 9
~10 MT
Competitor 7
~10 MT
Competitor 13
~5
MT
25
CONFIDENTIAL
Molekule Capabilities
26
KOL Mapping Dashboard
NEEDS
•
Reduce relative cost of psoriasis biologics to a more
“reasonable,” customer-friendly price
•
Drive long-term investment into public/academic
psoriasis clinical and translation research
•
Foster the growth of overall psoriasis disease state
awareness and understanding among non-medical
professionals
N EED S
WANTS
Understanding the interplay among pharmacos and striving
for industry-psoriasis HCP transparency
•
Facilitating novelty in terms of initiatives and programs
sponsored by leading psoriasis pharmacos will “bridge
the gap” for prescribers
•
Leverage an EU28 centralized model for psoriasis biologics
than a geography- or country- variant model
WA N TS
ASPIRATIONS
•
Seek better overall relationship with industry – necessitates
“partnership for tomorrow”
•
Wants to link data transparency via open-access psoriasis
clinical data consortium
•
Keen on understanding pharmacos’ lifecycle management
and long-range planning to be aligned in terms of how
to better manage patients in the long-term
A SPIR ATION S
“Psoriasis pharmaceutical companies are not all bad, but they certainty are not all good. I personally and we as
dermatologists have multiple unmet needs to care well for the psoriatic patient, but so too do we have dimensions we strive
for. Pharma, please help us!”
– KOL, Belgium
CONFIDENTIAL
Molekule Capabilities
Competitor 1’s Sources its Insulins in a Ready - Made Form From Denmark Across all
EM-8 Geographies
Competitor 1: Supply Chain for Emerging Markets
Russia
China
Competitor 1 plans to
build a fill/finish
production facility for
insulins, which will be
completed within
3-4 years
Competitor 1’s Tianjin
plant produces
competitor 1 Pen 3
and fill/finish capacity
for China and AP
region years
Poland
Turkey
Mexico
Finished
Product
API/bulk insulin
Source site for Insulin
and/ orAPI
Brazil
Competitor 1 is constructing
a new manufacturing facility
north of Minas Gerais which will
have cartridge fillingcapacity
27
CONFIDENTIAL
Molekule Capabilities
Manufacturing Capacity Investments Target China, Russia and Brazil with Major LongTerm R&D Investment in India
Competitor 1: Planned Headcount Expansions
Country
Country
CHINA
2012/2013
Expansion Plans
2014 or beyond
expansion plans
No expansion plans
Sales
Force
Marketing R&D
Mfg
Comments
• Plans to expand overall headcount from 1700
(2008) to 3000 by 2012
• Beijing R&D staff to increase to 150 staff
• Tianjin manufacturing headcount to increase
from 350 to 500 staff by 2012
INDIA
Competitor 1’s sales force in India is to increase
headcount by 50 to support Victoza launch
RUSSIA
Competitor 1 intends to increase its investment in
Russia manufacturing; however, d oes not intend
to increase headcount across sales, marketing
and R&D
POLAND
There are no plans to increase headcount in the
Polish market
S. KOREA
Competitor 1 plans to increase sales force
headcount to increase share of voice for Levemir
TURKEY
There are no plans to increase headcount in the
Turkish market
MEXICO
Presently, there are no plans to increase
headcount in the Mexican market
BRAZIL
Brazilian manufacturing facility is actively
expanding headcount throughout 2012-2013
28
MRK 55 Analog Assessment of the Competitive Vaccines Market
Molekule Case Studies
ALIGNED INTELLIGENCE. FOCUSED RESULTS.
CONFIDENTIAL
29
CONFIDENTIAL
Molekule Capabilities
Molekule Case Studies: In Support Of A
Top - 10 Ethical MNC Biopharma
S I T UAT I O N
Our client faced near-term direct competition from both generic and novel FDC HIV ARV assets
ACT I O N
In support of a Top-10 ethical MNC biopharma player, Molekule
conducted a comprehensive landscape monitoring of the HIV
market for FDC ARV generics – either direct ANDA competitors
to established brands of novel FDCs of generics components.
We worked with a Director of Strategic Planning to assess the
impact and implications of generic threats to established ARV
agents, as well as novel FDC ARV agents.
MOLEKULE CONDUCTED COMPREHENSIVE
LANDSCAPE MONITORING
Inclusive of:
– Congress Coverage
– KOL Interviews
– Competitor interviews
– Regulatory Stakeholder Interviews
– Payer Interviews
R E SU LTS
Molekule accurately identified a short list of key generic competitors poised to enter the FDC ARV market.
Accordingly, our client was able to correlate its manufacturing of product to scale with the forthcoming
genericization, conterring significant cost savings to our client.
30
CONFIDENTIAL
Molekule Capabilities
Molekule Case Studies: In Support Of A
Top - 5 MNC Ethical Pharma
S I T UAT I O N
Our client sought high value antibiotic targets for in-licensing, acquisition and/or partnership.
ACT I O N
Molekule was engaged by a Top-5 MNC U.S.-based ethical
pharmaceutical player to conduct a targeted assessment of the
market dynamics and associated implications of novel antibiotics
and associated potential licensing partnerships/ agreements
in select markets including the U.S., Big-5 EU and Japan. Our
client was an Associate Director of Business Development and
Licensing and the overall engagement enabled our client to
elucidate BD&L opportunities in the U.S., Big-5 EU and Japan
markets for key antibiotic assets.
MOLEKULE CONDUCTED A BUSINESS
DEVELOPMENT & LICENSING DUE DILIGENCE
TARGETED CI ASSESSMENT
Inclusive of:
– KOL Interviews
– BD&L Target Interviews
– Congress Coverage
R E SU LTS
Molekule accurately identified a short list of key generic competitors poised to enter the FDC ARV market.
Accordingly, our client was able to correlate its manufacturing of product to scale with the forthcoming
genericization, conterring significant cost savings to our client.
31
CONFIDENTIAL
Molekule Capabilities
Molekule Case Studies: In Support Of A
Specialty Biopharma
S I T UAT I O N
Our client is engaged in the highly competitive IBD space and needed a focused and robust universe of
KIT/Qs answered to better address emerging competitive dynamics.
ACT I O N
Molekule was engaged by a specialty gastroenterology player to
conduct comprehensive congress coverage of the UEGW and
ACG congresses in support of a blockbuster anti-TNF asset. Our
client was a Senior Manager of Global Competitive Intelligence;
engaging together, Molekule depicted clear answers to the
client’s high, medium and low priority KIT/Qs, enabling the
client company to position itself for robust success in the
gastroenterology space, forward-looking in the U.S. and EU.
MOLEKULE WAS ENGAGED TO CONDUCT
COMPREHENSIVE CONGRESS COVERAGE
Inclusive of:
– Congress Coverage
– Competitor interviews
– KOL Interviews
R E SU LTS
Molekule furnished our client high impact, accurate, timely and actionable strategic insight and intelligence
leveraging congressess as venues flush with high value human source resulted in our client hardening
competitive pinch points and elucidating blind spots.
32
CONFIDENTIAL
Molekule Capabilities
Molekule Case Studies: In Support Of A
Major EU Biopharma
S I T UAT I O N
Our client wanted to understand competitive commercial strategies across global mid-sized
biopharmaceutical players.
ACT I O N
Molekule was engaged by a large cap EU-based biopharmaceutical
player to conduct a targeted assessment of novel strategic
implementation models across mid-sized (i.e.- $300MM –
$750MM market capitalization) biopharmaceutical players
approaches to global market access and go-to-market strategy.
Our client was a Senior Director of Marketing Analytics and
Business insights.
MOLEKULE WAS ENGAGED TO CONDUCT A
TARGETED CI ASSESSMENT MARKET ACCESS &
GO-TO-MARKET STRATEGY ASSESSMENT
Inclusive of:
– Competitor interviews
– Internal Stakeholder Interviews
– KOL Interviews
R E SU LTS
Partnered together, Molekule and client developed keen insights and market intelligence regarding middle
market capitalization competitors’ global market access and go-to-market access strategies, worldwide.
33
CONFIDENTIAL
Molekule Capabilities
Molekule Case Studies: In Support Of A
Top - 3 MNC Biopharma
S I T UAT I O N
Our client sought market intelligence regarding competitive blunting strategies
and tactics across key players and markets
ACT I O N
Molekule was engaged by a global Top-3 ethical MNC
biopharmaceutical player to conduct an elucidation of competitor
strategies and tactics that are leveraged to driver and/or blunt
market uptake and traction of novel biopharmaceutical products
in North America, LATAM and the Big-5 EU markets. Our client
was a Senior Manager of Global Commercial Insights.
MOLEKULE CONDUCTED COMPETITIVE
LANDSCAPE MONITORING & CONGRESS
COVERAGE
Inclusive of:
– Competitor interviews
– Internal Stakeholder Interviews
– KOL Interviews
R E SU LTS
Molekule developed clear, concise and actionable intelligence regarding the drivers and key factors leverageable
to blunt market uptake and traction of competitor novel biopharmaceutical assets in North America, LATAM
and Big-5 EU markets.
34
CONFIDENTIAL
Molekule Capabilities
Molekule Case Studies: In Support Of A
Boutique Biotech
S I T UAT I O N
Our client sought overall firm-wide diversification via
a new business and commercial model.
ACT I O N
Molekule was engaged by a niche/specialist U.S.-based
biopharmaceutical company with a mid-sized market
capitalization to develop a new business plan for strategic
diversification from a “one-stop-shop” biopharmaceutical player
into a diversified specialty pharmaceutical company. Our client
was a VP of Global Strategy.
MOLEKULE CONDUCTED A COMPETITIVE
CORPORATE STRATEGY ASSESSMENT
Inclusive of:
– Internal Stakeholder Interviews
– External Competitor Stakeholder Interviews
– Subject Matter Expert Interviews
– Therapy Area Expert Interviews
R E SU LTS
Partnered together, Molekule and client developed a concerted growth and development plan including
decisive diversification for the client across three (3) key therapeutic areas of potential pipeline growth
opportunity.
35
CONFIDENTIAL
Molekule Capabilities
Molekule Case Studies: In Support Of A
Product Protection Department at Leading Japan Pharma
S I T UAT I O N
Our client sought a comprehensive assessment of pharmaceutical counterfeiting and illegal diversion of
several key products throughout the globe
ACT I O N
Molekule was engaged by a major MNC pharmaceutical player to
understand and elucidate the scope, scale and impact of global
biopharmaceutical counterfeiting, parallel trade and illegal
diversion as it pertains to several of its high profile products in
Emerging Markets in A-P, EEMA and LATAM. Our client was a
Director of Global Product Protection.
MOLEKULE CONDUCTED COMPREHENSIVE
LANDSCAPE MONITORING
Inclusive of:
– Review of secondary domain
– Primary interviews with relevant stakeholders
– Global product flow mapping
R E SU LTS
Molekule developed a comprehensive assessment of product security issues affecting the client’s key products
globally. The assessment highlighted the impact of illicit activities for each product, listed the main players
involved, and provided illicit product flow mapping to better understand regional risks. The report was used by
the client to prioritize and focus its investigative efforts as well as plan out appropriate supply chain security
measures to mitigate risks.
36
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1395 Brickell Avenue, Suite 800
Miami, FL 33131
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ALIGNED INTELLIGENCE. FOCUSED RESULTS.
/ +1 786 600 2410
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[email protected]