Recent Trends in Pharmaceutical Innovations_22nd Aug 2013_BCP_Dr MMK

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


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


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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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


Strategic Trends in Pharma Innovation


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


New Drug Development Phases



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Pharma Sector – Highest R&D Spend


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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Innovation Strategies – Drivers for Changing face



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What happens in 2018?



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Pharma Innovation Spend



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Pharma Innovation Challenges


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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Recent Trends


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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Recent Trends


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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Recent Trends


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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Current Trends

NCE


Synthetic strategies

Combinatorial chemistry

Salts/ Ester/ ProdrugParticle

modification

New TargetsControlling

releaseOral

absorption


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Current Trends

Dosage Form


Dose reductionCombination

Patient compliance

Abuse deterrentTransdermalPulmonaryCircadian

rhythm

NDDSTargeted delivery

Injectable to Oral


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Current Trends

Devices & Packaging


Painless Injections

Single dose packs

Transdermal Delivery

Child resistant packs

Compliance Kits

Auto-injectorsDPI / MDI


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Current Trends

Allied Areas


Technology management

Logistic controlStrategic Planning

Intelligence tracking

Intellectual PropertyQbD teams

Project Management

RegulatoryQuality

CompliancePharmacovigilence


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Current Trends

Anti-infective


Combination Therapies

- BLI + Drug

Treating Resistant Strains- MRSA- HAP

Development of Vaccines- Hepatitis- Malaria


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Current Trends

Oncological


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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Current Trends

CNS


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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Current Trends

Pain


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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Current Trends

Diabetes


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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Current Trends

Obesity


Improved dietary controls

Fitness & Exercise

Centrally acting

Combinations

Anorexic DrugsSatiety

inducers


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Current Trends

Orphan Diseases


Focused attention on

treatment and prophylaxis

Over 1200 diseases with

no or few medicines

Affecting less than 100,000

patients


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Current Trends

Biotech & Biosimilar


Establishing safety & efficacy

Tissue cultureMAb

Structure elucidation

Gene mappingStem cell

Recombinant technology


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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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Predicting 2016..



29Copyright - Global IP, Wockhardt Ltd

Thank You Dr Mandar Kodgule+91-9881062118

[email protected]

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