The Programs

This program is set up for the purpose of understanding the structural obstacles to immediate drug access, and, in the case of facilitating additional drug supply, for the purpose of evaluating and complying with FDA standards for Expanded Access Approval and for continuing drug trial development.  If the opportunity arises to make the drug available internationally, research must be done with regulatory agencies of those countries where access is sought.

U.S. Code of Federal Regulations, FDA internal guidelines, and FDA testimony in the U.S. Supreme Court have clearly established the need and appropriateness of Compassionate Use of developmental drugs in the treatment of immediately life threatening diseases.  That means the regulatory restrictions must be minimal when terminally ill patients and their doctors decide to pursue drugs that are not yet FDA approved for marketing.  It also means the criteria for evidenced efficacy and safety are low in the case of immediately life threatening disease and where the patient has no other effective treatment options.  Nevertheless, the level of required investigatory approval and the often-capricious nature of FDA decision can make it difficult to pursue Expanded Access Programs (EAP), Phase 3 clinical trials, and ultimately full marketing approval.

Program activities include the study of FDA code and Federal Regulation Code relating to Compassionate Use of investigational drugs.   The program also consists of meetings and information gathering from FDA offices, contract research outsourcing (CRO), and other public interest organizations.

This program has been underway since June 2009, and, at the time of PCUT incorporation, represents 40% of the time dedicated to program activities.  Over time, this allocation should decline to about 15% of company resources.  An advisory committee member may in the future assist in the leadership of this program.
 

This program is in place for the purpose of exploring manufacturing and administration requirements for the developmental drug production.  It also covers the analysis of empirical and anecdotal trial data, as well as safety and efficacy documentation.  The ongoing analysis in this program will drive the operational planning and execution of any drug production sponsored by PCUT.

This program has been underway since July 2009, and, at the time of PCUT incorporation, represents 20% of program activities.   There will be periods of time when this program takes the majority of the organization’s focus, but over the first 12 months Science Research should constitute about 15% of PCUT’s resource allocation. It is expected that an advisory committee member will take over the management of this program in the near future.
 

This program is set up for the purpose of exploring various ways in which PCUT can partner with other companies and organizations to achieve drug access solutions for its beneficiaries.   In particular cases, PCUT will work closely with the commercial manufacturer to arrange a new production facility in a fair and effective way.   Program activities include the judicious use of confidential drug manufacturing data, licensing and training, and negotiation with contract manufacturing organizations (CMO’s) and drug trial administrators.  When dealing with for-profit companies, PCUT will uphold its fiduciary responsibility to the beneficiary population of gravely ill patients, and will ensure that all resources PCUT provides to these companies be employed exclusively for the collaborative drug production project.

This program has been underway since July 2009, and, at the time of PCUT incorporation, represents 20% of program activities.   There will be periods of time when this program takes the majority of the organization’s focus, but over the first 12 months Science Research should constitute about 15% of PCUT’s resource allocation.  It is expected that advisory board members will be involved in this group’s strategy and leadership. There may be volunteer assistance in the operation of this program.
 

PCUT’s greatest asset is its ability, as a non-profit group, to raise money through charitable foundations and health care ventures for the express purpose of facilitating drug production for those who need it.   Whether the new production capacity is achieved through an outsourced supplier selected jointly by PCUT and the original production company, or the new venture is entirely undertaken by PCUT, funding commitments of significant sums must be gathered.

Program activities include early round discussions with charitable trusts and foundations,  grant proposal writing,  the management of a book of conditional future commitments, and management of a trust account for earmarked assets.

At the time of PCUT incorporation, this program has not yet begun. It is anticipated that special purpose fundraising will at times take up to 100% of time and operating resources.  But overall, for the year, the program should represent about 20% of PCUT’s time and operating costs.  It is likely the program will be managed by a volunteer executive staff member or an advisory committee member, with oversight from Executive Director, Jess Rabourn.
 

As a non-profit public service, PCUT may be in position to achieve lab space, technician time, production material, and manufacture license on a discounted or fee-waived basis.

The program’s activities include approaching research institutions and requesting that space and/or equipment and on-site expertise be provided without significant cost to the organization.  An attempt will be made to infuse charitable considerations into the acquisition of all elements of drug production.

At time of incorporation, this program is not yet underway.  It is expected that over the first 12 months the program will require about 15% of PCUT’s time and operating budget.  It is likely the program will be managed by a volunteer executive staff member or an advisory committee member, with oversight from Executive Director, Jess Rabourn.
 

The fundraising program provides a budget for the general operations of PCUT, including legal, technological, business advisory, and other administrative expenses.  The program also defrays the cost of travel and presentation material directly associated with PCUT’s activities.

Fundraising activities will include the administration of donation pages on the website, trust account administration, and recognition of tax deductibility of donations under IRS section 501(c)3 .

Depending on the budget, program activities may in the future include advertising through print and electronic media, as well as direct mail and email solicitation.  Efforts will also be made to partner with other health care service organizations for collective advertising and sub-allocation of charitable donations.

At the time of incorporation, the program is not yet underway.  It is expected that during the first year the program will require about 5% of PCUT’s time and operating budget.
 

The Education and Outreach Program disseminates information and original analysis on issues of developmental drug access.   Awareness in local and federal government and in patient and health care communities is essential to the public discussion, and is essential to building a broad partnership to make effective drugs available to dying patients who have no other treatment options.

The activities include telephone and in-person meetings with FDA officials and Congressional representatives and staffers.   The program also builds relationships with individual patient support and patient advocacy groups around the country in an effort to raise awareness of developmental drug issues.  Participation in public events and awareness days will also be a part of this program.  The organization’s website and other internet outreach efforts are part this program.

The program began in May of 2009, and at time of incorporation constitutes about 20% of PCUT’s resources.  Over the first 12 months, Education and Outreach will together be about 15% of the organizations activities.