Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Writer: Aviva Lev-Ari, PhD, RN

6/5/2013

Mr. Lerner has learned from our Team, the following points:

1.  Dr. Pearlman has Three Novel Product Concepts

Two for the Critically ill, the periops and the post Surgery of Medical patients: Two product solutions for the Institutional Market

PiNO

SiNO

One product solution for the HomeCare market

Bx – HiNO

The Product concept involve administration of NO which will be treated as a

Drug and will require Clearance as a drug and  the Device, it  will require

Clearance as a Device for use in the Adult Patient Market.

Product Concepts require development of the following phases:

–   Definitions and Product Design Specs

–   Construction of a Product Prototype per specifications

–   Proof of Concept Testing – Planning of Testing SOPs

–   FDA application for Clinical Trial – Research Design

–   FDA application for 501k – External Use of a  Medical Device

2.  Dr. Pearlman has a fully flagged vision of required/desirable product

features, including alternative Product Models with transferable

technologies among the three Potential prototypes

3.  Dr. Lev-Ari has presented opportunities in the Institutional market for

the Adult Surgical Patient, periops, @ Operating Room, post ops

At Tertiary Hospitals in the US, currently use of inhaled Nitric Oxide for

the Adult patient are in Off-LABEL USE for the following Primary Surgical Procedures:

BiVAD – biventricular assist device;

CABG – coronary artery bypass grafting;

LVAD – left ventricular assist device;

MVR – mitral valve replacement or repair;

OHT – orthotopic heart transplantation;

OLT – orthotopic lung transplanatation;

RVAD – right ventricular assist device;

AVR – aortic valve replacement;

Other Cardiac

Other valve (tricuspid)

Thoracic surgery

Other surgery

Other Transplants (Liver, Kidney, Pancreas)

Dr. Lev-Ari considered of the results of the ONLY study of its kind in existence, performed at the Department of Surgery, Division of

Cardiothoracic Surgery, Columbia University College of Physicians and Surgeons, and Departments of Respiratory Therapy and Anesthesia and Critical Care, Columbia-Presbyterian Medical Center, New York, NY

Ann Thorac Surg 2006;82:2161-2169

This study is the first to describe outcomes and cost of iNO therapy in an unselected population of critically ill adult patients in a tertiary care center. These study results demonstrate that (1) outcomes after iNO vary substantially based on clinical indication of use, (2) iNO may benefit transplant patients more than other patients, and (3) iNO does not appear to alter the natural history or long-term clinical course of hypoxemic respiratory failure. This study also identifies the medical patient population with respiratory failure as one with substantial morbidity whose high mortality after iNO precludes prolonged therapy.

http://ats.ctsnetjournals.org/cgi/reprint/82/6/2161

Based on this study, Dr. Lev-Ari concluded that ALL the Surgical Adult Patients in the US, approved for any of the above listed surgical procedures constitute a UNIVERSE to be targeted for an alternative device to the INOMAX® delivery systems, the only device of its kind, in institutional use, currently, used OFF-LABEL for all above surgical procedures.  This device is approved by FDA for Newborns, full-term and nearly full-term infants, only, and its use is reimbursable per Aetna Policy for that population, only, for several respiratory system related indications.

Another UNIVERSE of Adult Patients for the Inhaled Nitric Oxide products is the Medical Patient with a diagnosis of Hypoxemia, on a Medical or ICU Units.

Dr. Lev-Ari, expressed interest in the HomeCare Market. She is the designer of a multimarker biomarker product for HomeCare for the Cardio-Metabolic, Diabetic Adult Patient. She noted technology transfer opportunity from her design to the following market for inhaled Nitric Oxide for the Adult Patient.

B1. HiNO —            LPBI’s PORTABLE inspiratory pulsing device with option

to turn off pulsing feature

B2. HiNO  —            LPBI’s Home Care Facial Inhaling Device

a.                 COPD

b                  Unstable Angina

Dr. Lev-Ari is seeking the advice of Dr. Jeremy Feldman, Pulmonologist, Pulmonary Artery Hypertension Specialist, Phoenix, AZ in regard to the selection of targeting the design efforts for the institutional or the HomeCare Markets.

Mr. Lerner taught the Team the following points:

1.  ASI’s interest is in the HomeCare Market

2.  Development of a product to embed ASI sensor would involve the following:

–  Proof of Product Concept

–  Business Plan

– New start up company to demonstrate Leadership in:

–  Management

–  Technology and

–  Operations (Zvika Gildone’s expertise in development of Medical Devices was mentioned by Aviva)

–  Team is on its own in finding funding for the new start up

NEXT STEPS:

Mr. Lerner will provide the Team with the following:

– Sensor Parameters for the Team to compare the sensor with alternatives for the applications at hand

– Competitive analysis ASI has available on their market

Dr. Pearlman will carry his Products Concept to the next level

Dr. Williams will prepare few concept pieces related to:

–   Clinical Trial Design

–   Feasibility of Sensor technology for Product Prototype Design

–   a document on potential collaboration on Cancer related Detection Sensing products

Dr. Larry will compare the C-PAP and B-PAP machines to the B1, B2, below

B1. HiNO —            LPBI’s PORTABLE inspiratory pulsing device with option

to turn off pulsing feature

B2. HiNO  —            LPBI’s Home Care Facial Inhaling Device

a.                 COPD

b                  Unstable Angina

Dr. Tilda will prepare concepts of Nanotechnology relevant to:

–   Bx – HiNO,

–   B1 and

–   B2, above

Dr. Lev-Ari expressed the facts that she has experience in launching and incorporating an S-Corporation in MA and she has worked at several Start ups on Technology commercialization. She was President, VP R&D and was involved in Business Development, IP Licensing and Operations.

Dr. Lev-Ari’s priorities are:

1.   Foster Joint Ventures emerging from e-Book Publication, Nitric Oxide, is a case in point

2.  BioMed e-Book Series of EIGHT Titles for Amazon-Kindle

3.  by 12/2014

Finding a Scientific Publisher or a Pharma to buy the Journal.

On 6/5/2013 – site statistics:

190,836

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974

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URL    Clicks

ncbi.nlm.nih.gov    1,232

nature.com    645

4.  running an Equity Sharing Organization with an EXIT, as for 3, above

A.  a tight ship of Experts, Authors, Writers (EAWs)

B.  the tightest ship of gifted Editors for e-Books and Journal Content Curation

C.  providing BioMed Content Syndication Leadership and Mentorship to EAWs and e-Book Editors

Dr. Lev-Ari will schedule a Google Hangout Session for the Team to prepare the next steps with ASI.