1. www.wockhardt.com
Research is in our genes
Recent Strategies in Pharmaceutical Innovation
Dr Mandar Kodgule
Vice President, Global IP & Strategic Planning
Presented to
Post Graduate Students
The Bombay College of Pharmacy, Kalina

2. www.wockhardt.com
Research is in our genes
Trends in Diabetes Medicines in US- 1984-2013
Biguanides –
Metformin
Insulin –
Bovine,
Porcine
Sulphonyl
Ureas
Insulin –
Recombinant
Insulin
Analogues –
Short, Medium
& Long Acting
“Innovation distinguishes between a
leader and a follower” – Steve Jobs

3. www.wockhardt.com
Research is in our genes
Trends in Diabetes Medicines in US- 1984-2013
Glitazones
GLP-1
Analogues –
Exenatide,
Liraglutide
etc
DPP-IV
Inhibitors –
Sitagliptin,
Saxagliptin
etc
SGLT-4
Inhibitors -
Canagliflozin

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Research is in our genes
4
Strategy is the art of creating superior performance
What is Strategy?
Copyright - Global IP, Wockhardt Ltd
Strategy –
Creating
“Sustainable
Competitive
Advantage”
Strategy –
Avoid been
“Best” and
making choices
to be “Unique”
OR “Different”
Strategy -
“Positioning” to
achieve
desired
performance

5. www.wockhardt.com
Research is in our genes
Strategic Trends in Pharma Innovation
Copyright - Global IP, Wockhardt Ltd
Huge
reductions
in mortality
from critical
diseases
Increased
Life
expectancy
Fewer side
effects
and/or
improved
tolerability
Faster
recovery
Significant
progress in
quality of
life

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Research is in our genes
New Drug Development Phases
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Research is in our genes
7
Pharma Sector – Highest R&D Spend
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The research-
based Pharma
industry spends
over USD 100
billion on R&D.
Five of the 10
leading global
R&D firms in 2010
were Pharma,
accounting 19% of
of the top 1,400.

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Research is in our genes
8
Innovation Strategies – Drivers for
Changing face
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Research is in our genes
9
What happens in 2018?
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Research is in our genes
10
Pharma Innovation Spend
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Research is in our genes
11
Pharma Innovation Challenges
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Time
Consuming &
High Failure
Rates
Rising Cost
Regulatory &
Compliance
Innovation
Capacity
Tough
Patent Laws
Funding
Issues
Rising
Expectations
Me Too
Strategies
Incremental
Innovation
Drying
Pipeline

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Research is in our genes
12
Recent Trends
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New Chemical Entity
Research
• Identifying new
molecular targets
• Improving profiles
of existing drugs
• Finding new use of
discarded products
New Combination
Research
• Synergistic Effect
• Reduced doses
• Improving care
• Altering side-
effects

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Research is in our genes
13
Recent Trends
Copyright - Global IP, Wockhardt Ltd
Patient Compliance
• Reducing dosing frequency
• Improving abuse potential
• Improved delivery devices
• Personalized Medicines
• REMS
Natural Products
• Tissue culturing to produce
actives
• Setting up QA &
Regulatory Std.
• Rationalizing the delivery

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Research is in our genes
14
Recent Trends
Copyright - Global IP, Wockhardt Ltd
Matured Therapies
• Cardiovascular
• Anti-infective
• CNS
• Pain Management
• Acid reflux (ZES)
Emerging Therapies
• Diabetes & Endocrinology
• Oncology
• Anti-viral (HIV, Hepatitis)
• Monoclonal Antibodies
• Immunological
• Obesity
• Pulmonary

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15
Current Trends
NCE
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Synthetic
strategies
Combinatorial
chemistry
Salts/ Ester/
Prodrug
Particle
modification
New Targets
Controlling
release
Oral
absorption

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Research is in our genes
16
Current Trends
Dosage Form
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Dose reduction
Combination
Patient
compliance
Abuse deterrent
Transdermal
Pulmonary
Circadian
rhythm
NDDS
Targeted
delivery
Injectable to
Oral

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Research is in our genes
17
Current Trends
Devices & Packaging
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Painless
Injections
Single dose
packs
Transdermal
Delivery
Child resistant
packs
Compliance
Kits
Auto-injectors
DPI / MDI

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Research is in our genes
18
Current Trends
Allied Areas
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Technology
management
Logistic control
Strategic Planning
Intelligence tracking
Intellectual Property
QbD teams
Project
Management
Regulatory
Quality
Compliance
Pharmacovigilence

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19
Current Trends
Anti-infective
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Combination
Therapies
- BLI + Drug
Treating
Resistant
Strains
- MRSA
- HAP
Development
of Vaccines
- Hepatitis
- Malaria

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Research is in our genes
20
Current Trends
Oncological
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Monoclonal
Antibodies (Mab)
Early
identification of
the disease
Targeting Drug
Delivery to
Cancer Cells
Identifying
requirements of
Cancer cells
different from
normal cells

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Research is in our genes
21
Current Trends
CNS
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Longer acting
- Pegylation
- Depot injection
- Patches
Improving the patient
care through
combinations with life
style drugs
- Depression
- Schizophrenia
- Alzheimer’s
- Parkinson’s
- Epilepsy
- Multiple sclerosis

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Research is in our genes
22
Current Trends
Pain
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Newer Therapies
- Fibromyalgia
- PHN
- Rheumatoid /
Osteoarthritis
- Cancer pain
Abuse Deterrent
- DETERx®
- INTAC®
- Use of Antagonist
Acute v Chronic
- Quick Onset
- Longer duration
- Delivery@site
- Combinations

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Research is in our genes
23
Current Trends
Diabetes
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Patient Care
- Monitoring
- Early
identification
- Special programs
Patient
Compliance
- Long / Short /
Medium acting
- Injectable
devices
- Kits for testing
Newer Therapies
- GLP-1 agonist
- SGLT-4 Inhibitors
- Combination of
Injectable with Oral

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Research is in our genes
24
Current Trends
Obesity
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Improved
dietary controls
Fitness &
Exercise
Centrally acting
Combinations
Anorexic Drugs
Satiety
inducers

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Research is in our genes
25
Current Trends
Orphan Diseases
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Focused
attention on
treatment and
prophylaxis
Over 1200
diseases with
no or few
medicines
Affecting less
than 100,000
patients

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Research is in our genes
26
Current Trends
Biotech & Biosimilar
Copyright - Global IP, Wockhardt Ltd
Establishing
safety &
efficacy
Tissue culture
MAb
Structure
elucidation
Gene mapping
Stem cell
Recombinant
technology

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Research is in our genes
27
Change Agents in Innovation
Disruptive Technology
• Technology that creates major disruption
in the way the current technology
functions.
Breakthrough Technology
• Technology which changes the entire
sector or field for significantly better
outcome
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Research is in our genes
28
Predicting 2016..
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Research is in our genes
29Copyright - Global IP, Wockhardt Ltd
Thank You Dr Mandar Kodgule
+91-9881062118
mkodgule@wockhardt.com