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TRENDS IN PHARMACEUTICAL

INDUSTRYBy:Darya Osman HusseinEman Salah AwadMoaz Ahmed Adam

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OVERVIEW

• Trend:• General development or change in conditions or

practices.

• In pharmacy:• Pharmaceutical growth or development to revolutionize

the health care system.

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• Advances in pharmaceutical industry generally targeted at improving efficiency of drug delivery, decreasing cost and improving bioavailability

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BIOSIMILARS

• A.K.A. follow-on biologic or subsequent entry biologic

• A medical product which is almost an identical copy of an original product manufactured by a different company

• Same idea as the “generic” type drugs but related to biological products (e.g. monoclonal antibodies, colony stimulating factors, etc.)

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• Issues may arise from several aspects:

1. It is difficult and costly to recreate biologics because the complex proteins are derived from living organisms that are genetically modified

2. Every biological (or biopharmaceutical products) displays a certain degree of variability, even between different batches of the same product, which is due to the inherent variability of the biological expression system and the manufacturing process

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3. It is currently tougher to get a biosimilar product past FDA regulators than their counterparts

4. Medical community concerned with complications, naming and licensing guidelines

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• Use of biosimilars may allow for 20-30% cheaper versions of biologic drugs therefore research into them is currently underway

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DIGITAL PHARMA

• Technological innovation allow patients to monitory their health and symptoms outside the clinical environment

• The importance of ‘beyond pill’ services allow better catering to patients needs

• ‘Digital medicine’ brought on various advances in drug composition

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• Example is the anti-psychotic drug Abilify (Aripiprazole) includes an ingestible sensor attached to pill

• Allows for monitoring of patient adherence to drug and will therefore allow for better clinical outcome

• Digital collaborations between pharma and tech are becoming more common everyday

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ADVANCEMENT IN DRUG DELIVERY

• Include research and development in various types of drug delivery and routes of administration

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DEVELOPMENTS IN INJECTABLE DELIVERY

• Injectable agents currently outnumber oral agents by approximately 30%

• In general this route considered as an unpleasant experience by many patients

• Generally tailoring involves consideration into two parameters:• Formulation• Device

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•Delivery device• Smaller needle• auto injectors

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MICRO ELECTRO MECHANICAL SYSTEM (MEMS)

• Preloaded with lyophilized/freeze dried drug in silicone rubber reservoir

• Drug delivered by processing device against skin for few seconds

• Drug pushed through microneedles into skin and absorbed via interstitial fluids into the bloodstream

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•Formulation alteration :

1. Can reduce frequency of administration

2. Reduce volume needed for injection

3. Reduce side effects (e.g. immunogenicity)

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PEGYLATING

• Significantly increases in vivo half life• Prevents attack by proteolytic enzymes

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HEPAROSAN CONJUGATES

• Heparosan polysaccharide sequences make up about 30% of the body's heparin sulfate (found in most cells/tissues) and heparin

• has no heparin sulfate or heparin-like biological activity.

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• By attaching synthetic heparosan to a drug molecule, an extended-release formulation similar to PEGylating can be created but with much less risk of an immunogenic reaction.

• Additionally, the half-life of a drug-heparosan conjugate can be easily customized by simply altering the defined size of the polymer

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MUCOSIS VACCINES

• Dutch biotechnology company developing trans mucosal administration of vaccines• Method is more patient friendly and give

superior immune response to vaccine

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• Theory is that vaccine is given via same route as pathogen invasion resulting in response similar to natural immune response

• Mucosally administered vaccines also elicit systemic and local immune response translating to improved protection.

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E.g. SynGEM – vaccine against RSV currently in preclinical testing

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TARGETED DRUG DELIVERY

• Improving delivery involves lower cost than discovery of new molecule

• Increase commercial opportunity by protecting product from “me too” drugs

• Allows branded drugs to be distinguished from generic competition

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ADVANCED COATING TECHNOLOGY

• Allow for delivery of targeted medications causing reduction of drug degradation, systemic side effects and more effective treatment • E.g. Multi Matrix MMX for

IBD• Uses pH resistant coating to

delay release of drug until reaches lower digestive tract

• Provides topical treatment at site of inflammation

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LIPOSOMAL DRUG DELIVERY

• Liposomal packaged drugs exhibit reduced toxicity and enhanced effectiveness

• Altered pharmacokinetics also allow for drug targeting and accumulation at disease sites reducing distribution

• Allows for sensitive tissue target delivery of drugs

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MONOCLONAL ANTIBODIES

• Act by binding to a specific antigen and inducing immunological response

• May prove to be very useful in targeting cancer cells while reducing harm to normal body cells

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NANOPARTICLE BASED DRUG DELIVERY

• Drug can be targeted to a precise location

• Results in increased effectiveness and reduced chance of possible side effects

• Nanocariers include:• Nanoparticles• Nano tubules • Nano shells

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SIGNIFICANT ADVANCES IN NANO DELIVERY

1. One dose a day Cipro using nanotechnology

2. Tumor targeted Taxol using nanoparticles

3. Improved ophthalmic delivery using smart hydrogel nanoparticles

4. Oral insulin using nanoparticle carriers

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CHALLENGES

1. Protect drugs from biological degradation

2. Effective targeting

3. Patient compliance

4. Cost effectiveness

5. Product life extension

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CARBON NANOTUBE

• Adept at entering the nuclei of cells and may one day be used to deliver drugs and vaccines

• So far only able to carry a small peptide into the nuclei of fibroblast cells

• Potential use in new anti-cancer treatments, gene therapies and vaccines

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GOLD NANOPARTICLES

• Used in cancer chemotherapy and act via free radical generation

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NANOERYTHROSOMES

• Resealed erythrocytes that carry protein, enzymes and macromolecules

• Used in treatment of liver, tumor and parasitic disease.

• Biocompatible (b/c use patients own erythrocytes), nontoxic and large space available for drug due to anucleation

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DENDRIMER

• Dendritic macromolecules (highly branched) which are used to encapsulated individual drug molecules (unimolecular Nano capsule)

• Can also act as attachment ‘hubs’ for large numbers of drug molecules attached via covalent bond

• E.g. anticancer agents 5-fluorouracil with polyaminoamine dendrimers

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MODIFIED BUCKY BALL

• Deliver radioactive atoms to cancerous cells

• Radiation is transferred within the ball therefore minimizing damage to healthy tissue

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NANO-ROBOTS

• Used in treatment of cancer

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• Designed to find and destroy only cancer cells

• Healthy cells remain unharmed

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FUTURE OPPORTUNITIES AND CHALLENGES

1. Nano-drug delivery systems that deliver large but highly localized quantities of drugs to specific areas to be released in controlled ways

2. Controllable release profiles, especially for sensitive drugs;

3. Materials for nanoparticles that are biocompatible and biodegradable;

4. Architectures / structures, such as biomimetic polymers, nanotubes

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5.  Functions (active drug targeting, on-command delivery, intelligent drug release devices/ bioresponsive triggered systems, self-regulated delivery systems, systems interacting with the body, smart delivery)

6. Virus-like systems for intracellular delivery

7. Nanoparticles for tissue engineering; e.g. for the delivery of cytokines to control cellular growth and differentiation, and stimulate regeneration; or for coating implants with nanoparticles in biodegradable polymer layers for sustained release

8. Advanced polymeric carriers for the delivery of therapeutic peptide/proteins (biopharmaceutics),

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