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www.wockhardt.comResearch is in our genes
Recent Strategies in Pharmaceutical InnovationDr Mandar Kodgule
Vice President, Global IP & Strategic Planning
Presented toPost Graduate Students
The Bombay College of Pharmacy, Kalina
www.wockhardt.comResearch 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
www.wockhardt.comResearch 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
www.wockhardt.comResearch is in our genes
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Strategy is the art of creating superior performance
What is Strategy?
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Strategy – Creating
“Sustainable Competitive Advantage”
Strategy – Avoid been “Best” and
making choices to be “Unique” OR
“Different”
Strategy - “Positioning” to
achieve desired
performance
www.wockhardt.comResearch 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
www.wockhardt.comResearch is in our genes
New Drug Development Phases
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www.wockhardt.comResearch is in our genes
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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.
www.wockhardt.comResearch is in our genes
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Innovation Strategies – Drivers for Changing face
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www.wockhardt.comResearch is in our genes
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What happens in 2018?
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www.wockhardt.comResearch is in our genes
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Pharma Innovation Spend
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www.wockhardt.comResearch is in our genes
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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
www.wockhardt.comResearch is in our genes
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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
www.wockhardt.comResearch is in our genes
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Recent Trends
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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
www.wockhardt.comResearch is in our genes
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Recent Trends
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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
www.wockhardt.comResearch is in our genes
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Current Trends
NCE
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Synthetic strategies
Combinatorial chemistry
Salts/ Ester/ ProdrugParticle
modification
New TargetsControlling
releaseOral
absorption
www.wockhardt.comResearch is in our genes
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Current Trends
Dosage Form
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Dose reductionCombination
Patient compliance
Abuse deterrentTransdermalPulmonaryCircadian
rhythm
NDDSTargeted delivery
Injectable to Oral
www.wockhardt.comResearch is in our genes
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Current Trends
Devices & Packaging
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Painless Injections
Single dose packs
Transdermal Delivery
Child resistant packs
Compliance Kits
Auto-injectorsDPI / MDI
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Current Trends
Allied Areas
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Technology management
Logistic controlStrategic Planning
Intelligence tracking
Intellectual PropertyQbD teams
Project Management
RegulatoryQuality
CompliancePharmacovigilence
www.wockhardt.comResearch is in our genes
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Current Trends
Anti-infective
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Combination Therapies
- BLI + Drug
Treating Resistant Strains- MRSA- HAP
Development of Vaccines- Hepatitis- Malaria
www.wockhardt.comResearch is in our genes
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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
www.wockhardt.comResearch is in our genes
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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
www.wockhardt.comResearch is in our genes
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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
www.wockhardt.comResearch is in our genes
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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
www.wockhardt.comResearch is in our genes
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Current Trends
Obesity
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Improved dietary controls
Fitness & Exercise
Centrally acting
Combinations
Anorexic DrugsSatiety
inducers
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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
www.wockhardt.comResearch is in our genes
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Current Trends
Biotech & Biosimilar
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Establishing safety & efficacy
Tissue cultureMAb
Structure elucidation
Gene mappingStem cell
Recombinant technology
www.wockhardt.comResearch is in our genes
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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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www.wockhardt.comResearch is in our genes
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Predicting 2016..
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www.wockhardt.comResearch is in our genes
29Copyright - Global IP, Wockhardt Ltd
Thank You Dr Mandar Kodgule+91-9881062118