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DETAILED BUDGET FOR INITIAL BUDGET PERIOD

DIRECT COSTS ONLY

 

FROM

01/01/05

THROUGH

12/31/05

PERSONNEL (Applicant organization only)

 

%

 

DOLLAR AMOUNT REQUESTED (omit cents)

 

 

NAME

 

ROLE ON

PROJECT

TYPE

APPT.

(months)

EFFORT

ON

PROJ.

INST.

BASE

SALARY

 

SALARY

REQUESTED

 

FRINGE

BENEFITS

 

 

TOTAL

TBA (MD or Ph.D.)

FDA Sponsor, Principal Investigator, RAC Reviewer

 

 FORMTEXT 12

50

120,000

60,000

19,200

79,200

TBA

Clinical Coordinator.

 FORMTEXT 12

100

75,000

      75,000

      24,000

99,000

TBA

Molecular Biologist

12

100

55,000

55,000

17,600

    72,600

TBA

Research Scientist

12

50

55,000

27,500

8,800

    36,300

TBA

Technician

12

100

45,000

45,000

14,400

     59,400

                                              SUBTOTALS

262,500    

84,000

346,500

CONSULTANT COSTS

Biostatistician (100 hrs X $150.00 per hour)

 

$ 15,000

                   

 

EQUIPMENT  (Itemize)

 FORMTEXT      

Available

 

       FORMTEXT      

SUPPLIES  (Itemize by category)

$ 400,000

Molecular biology, Cell culture, Cloning and Packaging supplies (DNA included)

 

Rodents Studies (350 total)

 

Primates Studies (20 total)

 

 

TRAVEL

 

 

 

 

PATIENT CARE COSTS

INPATIENT  (N/A)

 

 

 

OUTPATIENT  (N/A)

 

 

 

OTHER EXPENSES  (Itemize by category)

 

 

 FORMTEXT      

 

SUBTOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD

 763,500

 

CONSORTIUM/CONTRACTUAL

DIRECT COSTS

 

 

COSTS

 FACILITIES AND ADMINISTRATIVE COSTS]

 

 

TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD  (Item 7a, Face Page)

763,500

 

TOTAL DIRECT COSTS FOR 2 YEARS BUDGET $763,500  X 2 [ from 01/01/06 to 12/31/06]

$ 1,527,000

 

LETTER FROM DR. PAOLA LEONE, DIRECTOR OF CELL & GENE THERAPY AT UMDNJ / RWJ Medical School in New Jersey.

Dear Sherri,

I am sorry if I took so long to reply to you but I have been in-and-out of
town and awfully busy.

I would like to clarify that unfortunately my laboratory does not have any
ongoing research efforts for the gene transfer project for Tay Sachs mainly
because we do not have any funding for this project. The only funding
support that I received from the NTSAD nearly 2 yrs ago was to test the
efficacy of anti-inflammatory drugs on Tay Sachs and Sandhoff Diseases (i.e.
$45,000). This funding has now ran out.

The major two problems that we are facing with any clinical development for
Tay Sachs are time and funding. With the Canavan project the families joined
efforts several years ago and have raised 1.2 M. In 2 1/2 yrs we were able
to complete the preclinical studies and receive approval to go ahead.
However we did not have any funding to actually start the clinical study. We
applied for a NIH grant and we were able to start the clinical protocol only
after receiving approval for funding (i.e the awarded federal grant was 2.3
M for three years).

The clinical data collected in the Canavan patients that received gene
transfer are clearly showing that the therapy has much more effect in less
affected (younger) patients. In other words I want you to know that the gene
therapy does not do miracles but definitely has improved the quality of
life of the youngest patients.

I hope you are all well.
Warm regards,

Paola Leone

 

 

               

     

                   

         

 

 

 

 

         

           

 

 

            

  

 

    

           

 

                               

 

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