Drug Delivery, Device and Diagnostics I

"Drug Delivery Technologies: What's Old is New (and Better) through Drug Delivery"
Gwilym Atwell, Principal, Fish & Richardson P.C., moderated the session.

Unfortunately, I arrived in the session late and missed the first speaker, Troy Harmon, Vice President, Business Development for Eurand, entirely.

Second was Dr. James Gilligan, Vice President of Development for Unigene, who addressed Drug Delivery of Polypeptides.

He detailed the advancement of drug delivery systems, in order of increasing convenience and patient compliance:
1. Injectables
2. Depot
3. Transdermal
4. Pulmonary
5. Nasal
6. Buccal
7. Oral

However, several hurdles exist that hamper the development of oral delivery for polypeptides.
1. Cost of active pharmaceutical ingredients
2. The supply of the inactive ingredients
3. The gastric environment
4. Intestinal protease activity
5. Intestinal permeability barrier


Third on deck was Shawn O'Brien, President & CEO of Profectus BioSciences, Inc, who discussed how drug delivery platforms can create value:

1. able to achieve TPP of a NCE or Biologic
-Symbicort Inhaler Technologies
2. extend patent life with new formulations
-Seroquel SR: However, difficulty exists in having to repeat all of the trials all over again
3. enter new indications, LCM
4. Improve existing profile with existing indications
-Effexor
5. re-purpose off patents drugs with new formulations and different delivery systems.

Successful product development/TPP must answer "Yes" to 3 questions
1. That the clinical/performance outcome is better than the competition now and in the future
2.That the payors will pay for this improved outcome
3.That the patients/caregivers will be compliant to the therapy. (ex. cholesterol drugs have about 6 mo compliance, but they're designed for a lifetime of use.)

Technology has evolved to improve the original product - electophoration - sending electric charges through the cells in conjunction with drug administration, for example, has greatly increased the efficacy profile of DNA as a vaccine.
BUT will patients be willing to volunteer for electric shock to undergo this treatment for a preventative vaccine? Probably not, but if it's ever implemented in conjunction with therapeutic vaccines, compliance would most likely be higher.

Some interesting drug deliveries in development include
Phase Bio - developing the ELP biopolymer platform
This brings polymers and proteins together - They are liquid at room temp. but becomes a solid at body temp. to deliver a drug over time.

Dr. Joachim Kohn from the New Jersey Center for Biomaterials at Rutgers, the State University of New Jersey wrapped up the session with a discussion, "What is old, new and better in drug delivery to the eye."

The old: eye drops, which date back to 2000 B.C. and today is used mostly for minor irritations.
As a pharmaceutical dosage form, eye drops have serious limitations - dexterity, hard to get used to, and the majority of dose is washed from the eye. They're also particularly difficult for elderly or the handicapped. Also, the structure of the eye makes the eye drop ineffective for delivery to many of its' parts.

The new: modern eye drops include agents to increase viscosity - in gels or films. They are better, but still not ideal for anything other than superficial eye diseases.

Some eye diseases have no pharmaceutical treatment options, for example, keratoconus- a disease of the cornea that can only be treated with corrective lenses, corneal implants or surgery.

Some major eye diseases require better treatment options, retinal diseases, inflammatory and autoimmune diseases. The treatment of these diseases can be onerous, and patients are quick to drop out of compliance.

Retisert for treatment of uveitis is first intra-vitreal implant approved by FDA, but it's non-biodegradable and must be surgically removed. Dr. Kohn is working on a Lux-Rutgers research project that will develop an implant for vocolosporin. This is ideal - it reaches are of the eye that were previously inaccessible while increasing compliance at the same time.


By Danielle Kozich
on behalf of Pennsylvania Bio
kozich@thebravogroup.com

I apologize if there are any errors in this post; I am a layperson and many of these terms are out of my field of expertise.