text:
For Industry
Pilot 1: CMA Pilot 1 Evaluation and Pilot 2 Preliminary Evaluation Studies -- Final Report
Since introducing the Pilot 1 program in October 2003, FDA accepted 11 applications. This relatively small number of products does not allow in-depth statistical analyses to substantiate findings. Thus, the evaluation and corresponding recommendations are based on both the quantitative results and qualitative observations of FDA review participants, sponsor Pilot participants, and several sponsors eligible to participate, but who chose not to apply or participate.
The key findings of the Pilot are presented in the following four sections:
3.1 Sponsors Motivations for Participation-Presents a summary of the sponsor motivations and program expectations based on interview findings
3.2 Impact-Discusses the potential benefits (first-cycle approval rate, amendments triggering extensions, number of communications, etc.) of the program that were evaluated quantitatively and qualitatively
3.3 Incremental Effort for Sponsors and FDA-Presents the evaluation of the incremental effort to implement the Pilot
3.4 Summary/Recommendations-Discusses the findings and the reasoning behind the final recommendations
4.1 Sponsor Motivations for Participation
FDA's commitment to an earlier review with a 6-month review clock was the primary motivator for companies to participate. Additionally, sponsors cited a number of desired outcomes that made the Pilot opportunity attractive. These were mostly related to the potential for increased communication and publicity, and the prospect of expedited review beyond a non-Pilot review (Exhibit 4–1). In contrast, sponsors that were eligible for Pilot 1 enrollment but chose not to participate, noted that current access to the FDA under the Fast-Track/Rolling Review process was satisfactory and therefore found no additional incentives to enroll.
Exhibit 4–1. Sponsor Motivations for Pilot 1 Participation
4.2 Impact
The themes that emerged during the evaluation are addressed in the following four areas:
- Program Outcomes-first-cycle approvals, application quality, and overall communications
- RU Interdependencies
- Timing of RU Submissions
- Early Review
4.2.1 Program Outcomes
Meeting the specific Pilot expectations/goals was a key evaluation factor. The analysis examined first-cycle approval rates, quality of applications, number of deficiencies and effectiveness of communications. The first-cycle approval rate was of high interest since it is a highlighted PDUFA III goal as a means to ensure earlier access of new promising products that address a high unmet medical need. Because of the Pilot 1 eligibility criteria, a majority of the products enrolled fit into this high unmet medical needs category.
Of the 11 Pilot products, one was withdrawn by the sponsor due to lack of efficacy shortly after the first RU was submitted. As a result, only 10 products were included in the analyses. Seven of the 10 Pilot 1 products received first-cycle approval (70%), compared to a 50% first-cycle approval rate comparison cohort products. The Pilot result is similar to the first-cycle approval rate observed for New Molecular Entities (NMEs) submitted between 2002-2004, that received priority review (62%). Because of the low number of products in the Pilot and the comparison cohort, the larger comparison group of priority reviewed NMEs addressing high unmet medical needs were included to provide an additional perspective on the first-cycle approval trends for Pilot 1 products (Exhibit 4–2).
Exhibit 4–2. First-Cycle Approval Rate for Pilot 1 Products, the Fast-Track/Rolling Review Comparison Cohort, and Priority NMEs (FY02-FY04)
While the first-cycle approval results are not materially higher for Pilot 1 products, it is important to note that the 3 products that did not receive a first-cycle approval failed to demonstrate efficacy. Therefore, an early review would not be expected to provide significant benefit given the long lead times necessary to plan and conduct additional studies - a frequent requirement for such deficiencies. In contrast, analyzing multiple cycle priority applications (Exhibit 4-2) from a previous study [1], factors influencing multiple cycles included: application quality, CMC and safety issues. These deficiencies were either not observed and/or were adequately addressed in the case of Pilot 1 products with first-cycle approvals. While this may imply that the Pilot's early review structure has a positive influence, the impact of the small sample size remains unknown.
In addition to first-cycle approvals, the Pilot 1 evaluation also analyzed the impact on application quality. Using proxy indicators, quality was assessed through:
- Number of amendments leading to goal extensions
- Number of issues communicated between FDA and sponsors.
Applications that did not require amendments were considered complete and hence of higher quality compared to submissions that involved amendments. Similarly, fewer number of communications, for example to discuss deficiencies and FDA requests for information, was used as a proxy indicator of higher quality submissions.
Two of the 10 Pilot 1 products had amendments that required goal extensions. In these cases, the amendments requiring extensions were triggered by FDA requests for further information that would have occurred regardless of Pilot status (i.e., they were not the result of a discipline review letter). This is consistent with the comparison cohort and the broader comparison group of priority NMEs, suggesting that there is no change in application quality (Exhibit 4–3).
Exhibit 4–3. Products with Amendments Requiring Goal Extensions
Furthermore, the Pilot did not have an impact in terms of number of deficiencies, requests for information from FDA to sponsors, and other clarification communications (Exhibit 4–4). This may suggest that application quality neither increased nor decreased based on what could be observed. Moreover, FDA interviews further confirmed that they did not perceive an impact on quality for Pilot 1 applications.
Exhibit 4–4. Number of Issues Identified for Pilot Products Versus the Comparison Cohort As An Indicator of Application Quality
From the sponsor's perspective, a key outcome/expectation was the 6-month feedback for each RU submitted. The FDA was able to meet the 6-month review commitment for early submissions for all Pilot 1 products (Exhibit 4–5).
Exhibit 4–5. FDA Met Pilot 1 Six-month Feedback Expectations
The secondary desired outcome expressed by sponsors, was to have increased communication with FDA during the Pilot 1 process. As Exhibit 4–6 displays, in comparison to other Fast-Track/Rolling Review products, Pilot 1 products appear to have similar number of communications with FDA.
Exhibit 4–6. Average Number of Meetings and Communications for Pilot 1 Products Versus the Comparison Cohort
4.2.2 RU Interdependencies
At the onset of the Pilot 1 program, a concern for both FDA and sponsors was the impact of a segmented review, resulting in incomplete submissions or the need to repeat analysis of previously reviewed sections. Therefore, the evaluation examined the perceptions of the interdependencies of the RUs for both FDA and sponsors, for example:
- What difficulties did FDA encounter in reviewing RUs in isolation?
- What challenges did sponsors encounter submitting RUs prior to having the entire application ready for submission?
- Did the submission of separate RUs benefit the process in any way?
In the case of the ten Pilot 1 applications, the four RUs were typically:
- Chemistry, Manufacturing, and Controls
- Nonclinical Pharmacology and Toxicology (P/T)
- Clinical
- BioPharm (in many cases, this section was included as part of another RU).
In general, both FDA and sponsors agreed that CMC was the most independent RU and should be submitted as one of the first RUs. The Clinical section on the other hand was broadly considered to be rate-limiting in most product development programs, and relying most heavily on other sections of an application. Exhibit 4–7 summarizes the FDA and sponsor interview findings in regards to the interdependence of the RUs.
Exhibit 4–7. Reviewable Unit Interdependencies
The Reviewable Unit Interdependencies are rated on a scale of "0" for "Not
Interdependent" to "4" for "Very Interdependent".
• Clinical incorporates final label inputs from all disciplines
• Availability of clinical data is the rate determining step in most development programs
|• Pharm/Tox often interacts with Clinical and BioPharm; however, Pharm/Tox is commonly ready to submit first
|• BioPharm interacts heavily with Clinical and is often submitted at the same time
|• The CMC section would benefit most from early submission (e.g., manufacturing inspections could be scheduled earlier, especially if in a foreign country)
While early CMC submission was desirable, most sponsors expressed several practical constraints:
- Sequencing and timelines of development programs in general will not allow CMC (or most other sections) to be ready that far ahead of other sections
- Shelf-life expirations would not allow early batches to be produced too far in advance if they are to be marketed (if approved)
- Sponsors will delay manufacturing/plant investment decisions until a complete NDA/BLA is certain
These considerations are further magnified in the case of biologics due to the relatively higher manufacturing costs, need for validation lots and often shorter shelf-lives. The consensus among sponsors was that in general, CMC sections could not be prepared significantly earlier than 3-6 months prior to the rest of the submission.
Similar practical constraints were also noted for other sections, implying that the 12 month submission window between first and last sections of an application can rarely be fully leveraged (Exhibit 4–8).
Exhibit 4–8. Limitations of Submitting Early Reviewable Units
• Submitted as late as possible for shelf-life considerations and sale concerns
• Stability data often not ready more than 3 months prior to full submission
• Biologics: More validation lots, shorter shelf-life (stability), global shortage of bioprocess capacity, difficult to optimize full-scale production
• Most interdependent section, rate limiting
• Early clinical results may become out-dated, submission/resubmission of updated information may trigger extension
|• Decision to conduct expensive carcinogenicity studies are generally started as late as possible to mitigate costs
4.2.3 Timing of Reviewable Unit Submissions
Of the Pilot 1 products, only one sponsor was able to submit a RU greater than 6 months prior to the complete submission. More than half of the participating companies submitted the first RU only within 3-6 months prior to the complete submission, and only a few of the companies submitted their first RUs within 0-3 months of the complete submission. Sponsors noted that the uncertainty of product development and the challenges of preparing a comprehensive RU too far in advance of the complete submission impacted RU submission timing. In addition, FDA's CMA Pilot guidance specified that no more than four RUs would be accepted per application. One sponsor submitted four RUs-a majority submitted between two to three RUs (Exhibit 4–9).
Exhibit 4–9. Timing of Reviewable Units in Relation to the Complete Submission of the Pilot 1 NDA/BLA
|Timeline of RU Submissions Prior to Complete Submission (Mos)
|# of RUs
|Time First-Last RU (mos)
|12 & 8
|4.5 & 3
|4.5, 4 (2 RUs), &1.5
|2 & 1
|3 (3 RUs)
|1 (2 RUs)
|2.5 & .5 (2 RUs)
4.2.4 Early Review Analysis
Although there seems to be a positive trend in first-cycle approvals for Pilot 1 products versus the comparison cohort (Exhibit 4–2), this may not be solely due to the review of early submitted portions of an application and subsequent feedback. Some other factors may come to play that contribute to the first-cycle approval include:
- Timing of RU submissions relative to the complete application
- Number of major application deficiencies and identification timeframe
- Product indication/medical need
- Product efficacy/safety profile.
A review of Pilot 1 product outcomes suggests that other factors beyond early review may have contributed to favorable first-cycle outcomes, irrespective of Pilot participation. The early RU review for Product C for example, had no critical deficiencies that could have led to a delay in approval (Exhibit 4–10). In the case of Product G, the majority of deficiencies were identified with the complete submission and not in the early submitted RUs (Exhibit 4–10). Of the products analyzed, it appears that only Product E benefited significantly from early CMC RU review, which increased the time available for the sponsor to address the issues within the first-cycle (Exhibit 4–10).
Exhibit 4–10. Factors Beyond the Pilot 1 Process Effecting First-cycle Review Outcome
|Pilot 1 Benefit?
|• CMC delayed and filed as final RU - several issues were identified requiring an amendment, and triggering a 3-month goal extension
|• Only minor issues were discussed during the review; did not provide a basis for an approval delay
|• One RU, CMC, was submitted four months before the complete submission; early submission allowed CMC issues to be addressed easily
|• Major issue in CMC discipline which was the RU submitted - there was no added benefit from the pilot
|• Product addresses high unmet need; would have received high attention regardless of filing/review designation
|• CMC issues elevated a little sooner due to early RU; timing of other issues, e.g., immunogenicity, was similar to a regularly filed priority review
|• Product addresses high unmet need; would have received high attention regardless of filing/review designation
The outcome of three Pilot 1 products that did not receive first-cycle approval is likely to also be independent of the review process, since all three failed to adequately demonstrate efficacy: a deficiency that typically requires significantly longer resolution time than afforded by early feedback under Pilot 1 (Exhibit 4–11).
Exhibit 4–11. Multi-cycle Pilot 1 Products Would Have Had The Same Outcome Regardless of Pilot Status
|Pilot 1 Benefit?
|Failed to meet non-inferiority criterion for primary efficacy; new study required
|Failed to demonstrate efficacy due to an unacceptable study population; not approvable
|Failed to meet clinically meaningful endpoints; new study required
In comparison, several of the Fast-Track/Rolling Review products that received early review and feedback prior to the complete submission, as identified by a FDA request for information, also received 1st-cycle approval. Similar to the Pilot products however, additional factors may have influenced the outcome, such as the unmet medical need (Exhibit 4–12).
Exhibit 4–12. Some Fast-Track/Rolling Products Received Early Review and Feedback
In general however, it is not clear whether an early review of Rolling Submissions occurs consistently. Using FDA's request for information (RFI) as an indicator, 3 of 8 Fast-Track applications that submitted rolling portions of the application received an early review (Exhibit 4–12). For the other 5 applications, it is difficult to ascertain whether or not a review began before the complete submission since the first RFI was not communicated until after the complete submission (Exhibit 4–13).
As with the Pilot products, the comparison cohort shows that the impact of early review on first-cycle approvals is still unclear. Of the 4 comparison cohort products that received first cycle approval, only 2 received early review. This again demonstrates that factors in addition to or independent of early review and subsequent feedback contribute to a favorable first-cycle outcome.
Exhibit 4–13. Fast-Track/Rolling Products With Limited Evidence of Early Review
4.3 Incremental Pilot 1 Effort for Sponsors and FDA
This section analyzes the incremental effort to implement Pilot 1 for sponsors and FDA. The incremental effort is related to activities specifically conducted to prepare and review products under the Pilot program above what would typically be expended for a Fast-Track/Rolling review product The assessment of these additional activities was the basis for estimating the incremental effort related directly to the Pilot.
4.3.1 Sponsor Effort
Sponsors that participated in the Pilot program noted that the majority of activities related to application preparation and submission would have been performed irrespective of the submission route. Only few additional activities were reported with minimal incremental effort (Exhibit 4–14). These were comprised of:
- Internal meetings to decide whether to participate in the Pilot
- Preparation of the Pilot enrollment application
- RU submission schedule negotiation with the FDA
Exhibit 4–14. Major Fast-Track Activities Versus Additional Pilot-specific Activities Reported by Participating Sponsors
Major Sponsor Fast Track Activities
Request for Fast-Track Designation
Respond to FDA RFIs
EOP1 Meeting
Submit Amendments (if applicable)
EOP2 Meeting
Receive Action Letter (at 6-10 months)
Pre-NDA/BLA Meeting
Prepare Application Sections
Submit Complete Sections
Additional Sponsor Pilot-Specific Activities
|Pilot-specific Activities
Incremental Effort
(# Labor Hours)
|Pilot Application Preparation
|Sponsors reported the Pilot 1 application effort was minimal
|Internal Meetings
|Sponsors reported 1-3 additional meetings
|Meetings with FDA
|Sponsors reported no Pilot-specific meetings with FDA
Furthermore, many sponsors mentioned that the Pilot helped with internal workload distribution, a benefit especially highlighted by smaller companies with limited resources dedicated to application preparation and interfacing with the FDA review team. Specifically, sponsors noted some pre-submission and post-submission workload benefits resulting from the Pilot:
- Pre-submission: ability to prepare each unit separately helped focus on one area at a time, reduced complexity, reduced the need to coordinate multiple resources at the same time
- Post-submission: more efficient resource management through earlier re-deployment once individual discipline reviews were completed
- Focused attention on resolving discipline-specific issues raised in the discipline review letter
Overall, the sponsors perception of Pilot 1 was that the effort involved was not burdensome and there was no downside to participating in the program.
4.3.2 FDA Effort
Similar to the effort analysis conducted for sponsors, the Pilot effort for FDA was measured in terms of additional activities that FDA reviewers needed to perform beyond what is typically necessary for the Fast-Track/Rolling reviews. The activities included start-up efforts, additional filing meetings, Pilot admittance/RU schedule negotiations, acknowledgement/discipline review letter writing and review, additional internal FDA meetings, and RU re-work. The additional Pilot-specific activities for FDA are described below and are also summarized in Exhibit 4–15.
Start-Up Effort
As this was a new program, each Division receiving a Pilot 1 product incurred start-up efforts associated with establishing how to approach the reviews, for example, by creating appropriate letter templates and/or ensuring the review team were aware of the requirements of the Pilot for review purposes. By design, the CMA guidance did not specify Pilot implementation, therefore, each Division addressed this separately. Divisions that had multiple Pilot 1 products noted that this effort was mostly incurred with the first Pilot submission. Subsequent Pilot products accepted into the same review Division required minimal additional startup effort.
Additional Filing Meetings
In a typical Fast-Track/Rolling review, FDA review Divisions will hold one filing meeting after the complete submission. Under the Pilot, two of the Divisions interviewed held a filing meeting for each RU in addition to a filing meeting after the complete submission. Other Divisions continued to hold one filing meeting upon receipt of the complete submission; however, a determination whether each RU is substantially complete and meets the conditions of the Agency agreement within 60 days must still occur.
Pilot Admittance/RU Schedule Negotiations
FDA incurred costs for reviewing each request for Pilot participation in order to determine eligibility. For products that were ultimately accepted, some review team members reported minimal negotiation time with sponsors regarding the most appropriate RU schedule.
Acknowledgement/Discipline Review Letters
The FDA incurred additional costs for letters acknowledging the receipt of RUs or reporting the results of discipline reviews. These included direct costs associated with developing the communications as well as multiple levels of review.
Internal FDA Meetings
Aside from start-up meetings to ensure that the review team was aware of the review process under Pilot 1, there were not many additional Pilot-specific meetings reported. However, there were a few instances where a typical internal meeting that may only happen once during the course of a non-Pilot review, happened two or more times due to the review of multiple RUs plus the complete submission under the Pilot.
RU Re-work
A concern voiced by FDA reviewers was the potential for duplicative review efforts-initially upon receipt of the RU, and again during review of later sections that required a reference to prior RUs. Alternatively, certain deficiencies identified upon early RU review be resolved by the sponsor in time for re-submission during the first action. In practice however, there was only one product where some incremental RU rework was required. Most reviewers noted that RU reviews did not differ in terms of level of effort or approach compared to any product review with a 6-month clock. In particular, it was noted that RUs were typically not reviewed more than once. Two of the Pilot products had amendments to RUs that triggered clock extensions, but these amendments likely would have occurred regardless of Pilot status. Therefore, the re-review work on the amendments was not viewed as a Pilot-specific incremental effort.
Exhibit 4–15. Major FDA Fast-Track Review Activities Versus Additional Incremental Pilot 1-specific Activities
Major Sponsor Fast Track Activities
Grant Fast-Track Designation Request
Filing Meeting
EOP1 Meeting
Discipline Reviews
EOP2 Meeting
Mid-cycle review Meeting
Advisory Committee Meeting (if applicable)
Pre-NDA/BLA Meeting
Discipline Review Complete/Leadership Signoff
Labeling (if applicacble)
Action Letter
Additional Sponsor Pilot-Specific Activities
|Pilot Activities
|Recurring Activities
|"Startup" Activities
|Additional Filing meeting
Some divisions have filing meeting for each RU
|Additional meetings to clarify Pilot process for the review team
|Pilot Admittance/RU Schedule neg.
Additional meetings to determine eligibility of applications and to negotiate RU schedule
|Establishing which meetings (e.g., Filing) were necessary by RU
|Ack/Discipline Letters
Sending an acknowledgement and discipline review letter for each RU
|Pilot acceptance decision-making process
|Internal FDA meetings
Typical internal meetings may happen for each RU instead of only once in standard review
|Generating letter templates
|RU Re-work (RU were typically only reviewed once per cycle except amendments)
Revisiting a discipline review in case of long lags between submissions (1 instance for 11 applications)
While the incremental Pilot-specific activities did not occur for every Pilot product, in order to estimate the potential incremental effort for FDA, the analysis assumed a scenario in which the all the incremental activities would take place (i.e., worst-case/conservative scenario). To quantify the incremental effort, FDA data sources such as interviews, time tracking data, and the document storage system were used to capture those involved in the various Pilot activities. For each activity, the effort for discipline reviewers, regulatory project managers, team leaders, Division directors/deputy, office directors/deputy was estimated based on, for example, meeting preparation time, actual meeting time, and post-meeting efforts such as writing/reviewing meeting minutes for each review team member.
Based on this analysis, the total incremental effort for the Pilot was estimated to be between 190-360 direct labor hours per application. This effort is above what would typically be expended for a non-Pilot, Fast-Track/Rolling reviewed product in those Divisions included in the evaluation (i.e., experienced the Pilot 1 process). The breakdown by Pilot-specific activity is presented in Exhibit 4–16. The effort is displayed as a range, where the lower bars on the chart represent the low end range and the upper bars the high end range of effort as reported by review team members involved in the various activities.
Exhibit 4–16. Incremental Effort for FDA of Pilot-Specific Activities per Application (1 cycle)
Baseline effort= Non-pilot Fast-Track/rolling submissions within divisions with pilot products
|FDA Activities
|Additional Filing Meetings
|Pilot Application/ Negotiation
|Acknowledgement/ DR Letters
|Additional Internal Meetings
|Start Up Effort
|RU Re-work
|Total Range
|Lower Limit Effort
|Upper limit Effort
The effort is not distributed evenly among the review team members (Exhibit 4–17). Most of the incremental effort impacts the Regulatory Project Managers (RPMs), in charge of coordinating key review activities including: sponsor communications, scheduling reviewers, FDA-sponsor meetings, internal product-specific meetings and document reviews, and tracking PDUFA deadlines.
Exhibit 4–17. Incremental Effort of Pilot-Specific Activities by Function (1 cycle)
Baseline effort= Non-pilot Fast-Track/rolling submissions within divisions with pilot products
|FDA Roles
|Team Leaders
|Division Director/Deputy
|Office Director/Deputy
|Total Range
|Lower Limit Effort
|Upper limit Effort
For the Divisions that participated in Pilot 1, Exhibit 4–18 shows the incremental effort for these Divisions to perform a Pilot 1 style review on all of their Fast-Track product applications. The estimated incremental effort increase is between 1,520-2,880 direct labor hours (based on the average number of Fast-Track applications submitted to those Divisions between FY 2003-2005).
Exhibit 4–18. Extrapolation of the Incremental Pilot Effort to the Average Number of Fast-Track Products Submitted to Divisions with Pilot 1 Experience
The estimated incremental Pilot 1 effort may not be evenly distributed among the Divisions with Pilot experience based on historical Fast-Track submissions. For example, between FY2003-FY2005, the Anti-infective and Ophthalmology and Drug Oncology Divisions received approximately 56% of all Fast-Track applications submitted in those fiscal years (Exhibit 4–19). Based on interviews with reviewers in those Divisions, to accommodate for this influx of Fast-Track applications, they strive to perform a six month review on all products considered a high priority, irrespective of the review designation. Because many of the procedures for early feedback and accelerated review have already been integrated, these Divisions may incur less Pilot 1 implementation effort (in the lower part of the range; Exhibit 3-18) compared to other Divisions. The estimated incremental increase may not be transferable to Divisions that did not have a Pilot 1 product or who do not have significant experience reviewing Fast Track applications. To understand the broader potential impact of expanding Pilot 1, FDA may consider prospectively monitoring the Pilot 2 products still in drug development and give sponsors the option to submit their applications as Pilot 1 products (if an application is submitted for those products). This would allow for further evaluation of the Pilot 1 effort, including the evaluation of 2 additional Divisions that were not included in this Pilot 1 evaluation.
Exhibit 4–19. Three Year Total Fast-Track Submissions by Divisions (FY2003-2005)
There is a possibility that the number of Fast-Track requests will increase if sponsors value the commitment of early review. This would obviously increase the estimated incremental effort shown in Exhibit 4–18.
If this increase were to occur, a major FDA concern is that important work without a PDUFA goal deadline may be shifted to a later date. Consequently, delaying such activities may have a negative impact on public health issues and other FDA responsibilities.
On balance, this workload prioritization challenge is a broader concern for the FDA, one that exists regardless of this Pilot program and especially with product reviews with a 6-month clock. The interviewed FDA Pilot participants did not report challenges completing other critical work specifically because of the Pilot. To caveat this finding, interviewees were primarily asked to compare the Pilot effort to their experiences with other Fast-Track, priority reviewed products and were not specifically asked about the shifting of non-PDUFA work. This is not to say, however, that high workload demands were not a concern, they were just not directly attributed to the implementation of the Pilot.
While this evaluation cannot validate or rule out the impact of non-PDUFA work being displaced, it is likely a broader concern for all products receiving a priority review. Therefore, additional evaluation may be warranted to determine the impact of the displacement of non-PDUFA work for products receiving a priority review.
4.4 Summary/Recommendations
Overall, this evaluation of the CMA Pilot 1 program does not confirm nor does it discard the possible positive impact on first-cycle approvals and reducing time to approval for important drug/biologic products. The FDA also incurred some additional effort from implementing and administering the Pilot program; however, it is recognized by the FDA that earlier communication of issues has potential value (this was also concluded in the Retrospective study cited earlier).
Specifically, FDA and sponsor Pilot 1 interviews as well as an earlier retrospective product application analysis, show that CMC issues have the greatest potential to be resolved quickly. Given earlier notification, the Sponsor would have a better chance of resolving such issues within the first cycle. Further, earlier detection and communication of issues is generally a prudent practice that may, over time, yield shorter times to approval.
From an FDA perspective, Pilot 1 did not offer robust positives; however, FDA reviewers involved in the Pilot program mentioned that the program was not overly burdensome and that the discipline reviews were effectively the same in terms of experience and effort (as compared to the Fast Track Program). The most significant FDA concerns are related to the increase in RPM workload, and the potential for non-PDUFA work (e.g., review of annual reports, new protocol reviews) being de-prioritized as a result of the review. In response to this general concern, reviewers who participated in the Pilot program did not explicitly express difficulty in fulfilling their responsibilities because of the Pilot. Further, the effects of re-prioritizing work for early submitted RUs may not be dramatic, as the FDA would have received portions of the application at a maximum, 12 months, but typically only less than 4-6 months earlier.
While largely not observed as part of this analysis, there is a possibility of additional work for reviewers within the first cycle Pilot 1 review as a result of conducting a fragmented review (blue circle, Exhibit 4–20) or if Sponsors rapidly address deficiencies identified early on, and submit amendments to resolve issues within the first review cycle (red circle, Exhibit 4–20). For the first scenario, only one reviewer of a Pilot product reported the need for such a re-review. This finding is likely the exception as the RU was received 13 months prior to complete submission which from both the FDA and Sponsors' perspective is rarely feasible. If under the second scenario early feedback ultimately leads to a first-cycle approval, then the increased first-cycle effort, may be off-set by not incurring the effort/costs of subsequent cycles (red circle, Exhibit 4–20).
Even if the need for a second review cycle is inevitable, a Pilot 1 submission may still reduce time to approval by offering more time to address deficiencies identified in early RUs. For the Sponsor, preparing the resubmission may be expedited while the FDA can potentially conduct a more focused second cycle review with a lower staff burden.
Exhibit 4–20. Scenarios on Potential FDA Re-Work
Sponsors mostly value the FDA commitment to provide early review/feedback. This not only offers additional time to address issues but also improves workload distribution and resource management. This benefit was of particular value to resource-constrained sponsors. Drawbacks included the uncertainty of product development preventing the sponsor from submitting timely RUs and the difficulty of preparing a comprehensive RU too far in advance.
In summary, due to several factors (e.g., the small sample size of the Pilot and the comparison cohort and the high unmet medical need nature of many of the products), there is no conclusive finding that indicates whether the Pilot 1 program should continue or be terminated. The key findings of the evaluation showed:
- Pilot 1 offers some positive aspects:
- Sponsors valued FDA's 6-month RU review commitment
- Helped distribute sponsors' workload
- Additional time to address issues for early submitted RUs is a review process benefit
- FDA Pilot-participants were not overly burdened by the Pilot
- Both the Pilot 1 products and the comparison cohort products showed:
- A strong first-cycle approval rate
- Similar level of application quality
- Similar levels of communication.
Given that this evaluation focused on the comparison of the Pilot 1 program to the Fast Track/Rolling Review program, many Pilot participants offered their perceptions of the Fast Track program. Industry strongly valued the subtle differences that Pilot 1 offered over the Fast Track/Rolling Review program where FDA remained more neutral.
While there is no resounding reason to continue the Pilot as a separate program, there may be merit to integrating some positive attributes/lessons-learned from the Pilot 1 program into the existing Fast-Track/Rolling Review structure. For example, some challenges with the current Fast Track/Rolling Review program are:
- Rolling submission requirements are not specifically defined; therefore, sponsors do not have to submit complete rolling submission sections to FDA
- FDA may or may not review a rolling submission prior to the complete application submission, depending on workload demands.
For these particular challenges, the Pilot 1 structure offers potential improvements over the Fast Track/Rolling Review program that include:
- Requiring a well-defined, complete RU submission
- Committing the FDA to a 6-month review of the early submitted RU.
If the Fast Track/Rolling Review program were modified with these Pilot 1 attributes, this would allow the FDA to plan better for reviews because they can expect a complete section for early review; early review would be conducted consistently across FDA divisions for early submissions; and issues would be identified earlier, and in some cases, may lead to resolution prior to the first action date, or may help reduce the time between cycles if sponsors can begin addressing deficiencies earlier.
Some considerations before deciding to make any modifications may include:
- With the intent of further understanding the impact of and improving features of the Pilot 1 program, the FDA may consider prospectively monitoring the current Pilot 2 products, especially those in FDA Divisions that did not have a Pilot 1 product. Also, ensure there is a mechanism to actively track metrics such as submission quality, review outcome, unforeseen additional FDA effort, and possible displacement of non-PDUFA work).
- Conduct a detailed evaluation of the Fast Track program to determine if it merits a change.
Additionally, if modifications are implemented, other considerations may include:
- If RUs are submitted close (e.g., 1 or 2 months) to the complete application submission, build in flexibility to allow the review to be conducted under the complete submission PDUFA clock rather than a separate 6 month RU clock.
- Consider requiring electronic submissions for early submissions to be electronic.
Further, if the FDA decides to implement any modifications, additional resources would be required since the Agency would incur most of the additional workload burden. If implemented, the FDA may incur, in addition to the incremental costs described in this report, additional costs during the transition phase as this program is rolled out more broadly to the Divisions which in parallel need to complete reviews of applications currently under review. It is imperative that the FDA receive additional resources commensurate with the effort incurred to transition to and maintain the new process, in order to ensure that review Divisions are not overburdened


text: ISLAMABAD : A two day Pakistan Oil and Gas Summit will start here on Wednesday (Mar 19) and will be a platform for discussion among the major international oil and gas operators. The summit is being held in collaboration with Energy Lawyers Association of Pakistan and the International Gas Association Cedigaz, CNPC's subsidiary BGP, Quantum Energy and Veritas Academy. Minister of Petroleum and Natural Resources Shahid Khaqan Abbasi, Minister of State for Petroleum and Natural Resources Jam Kamal Khan, Minister of Water and Power Khawaja Muhammad Asif and Minister of Planning and Development Ahsan Iqbal will deliver with keynote speeches, said a pres release.The executives from oil and gas operating companies including the Oil & Gas Development Company of Pakistan, Polish Oil & Gas Company, Ocean Pakistan, Byco Petroleum, Premier Oil, Heritage Oil & Gas, Government Holdings, Tullow Pakistan Developments, MOL Pakistan Oil & Gas and OMV along with leading service provider companies such as CNPC's subsidiary BGP, Quantum Energy and Veritas Academy will participate in the summit.

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Today we are exactly one week away from the XXX Olympiad being held in London. As usual, there is a lot of excitement, but there is also evidence of much nervous tension too. Everyone wants the Games to go well so badly, the critics have no trouble finding as many faults as they wish, while the supporters fret and angst for good measure. But the truth is definitely in the middle of those two extreme positions.
Whatever problems there are (mainly around security which was not organised effectively), must be set against the background of our culture. We are a laid back country. We don't do paranoia and suspicion. We are mainly for trust, hope and optimism, behind a stiff upper lip and fingers crossed. The builders have done our country proud: raising a beautiful Olympic village and venues out of nothing, regenerating one of the worst parts of London at the same time, not to mention the creation of jobs and the pride we are all feeling to be hosting the games. Everyone involved have worked their pants off over the past 6 years to bring you the awesome spectacle lined up for you. Anyway, for those worried about security, it's now under the command of the Army and Police, so that problem has been sorted.
Everything is now in place for a most amazing month, including many FREE cultural events of unbelievable innovation and creativity, which have been sponsored by the irrepressible Mayor of London, Boris Johnson. As an Olympic Ambassador, I can feel the enthusiasm among fellow Ambassadors and the keenness to get on with the job meeting, greeting and welcoming the millions of visitors we expect during the games, so I thought I would start my duties right now, right here, for your benefit. :o)
What can the visitor to London expect from July 27th, the day of the Opening Ceremony, to the end of the Paralympic Games in September? LOTS.
1. Your local Ambassador (that's your very own Ms Cyprah!!) will be based at Paddington Station to welcome you. She will be reserving her most charming smile for all her social media friends should they wish to grace her shores with their presence! (Read more about her base here)
2. There will be 32 sporting games at 12 different venues, with the Olympic Park hosting the most popular sports. (See here for the venues and for a great schedule of events, including medal ceremonies)
3. Visitors will be able to watch the Olympic sporting events free of charge in Hyde Park and Trafalgar Square on the BT Live big screens. A nice picnic in the park with some Games would go very well together!
4. Described as "brilliant, breathtaking, amazing, brilliant, fun, free and unmissable", there will be a showcase of cultural events where you need no money at all to attend them: from music, dance, festivals, iconic sights, bridge illuminations, music showtime - including opera on the canal, to surprise pop up performances (involving the public in some random Shakespearean theatre) and countless other attractions laid on for your benefit. (Download a copy of the FREE Guide here to have a look at what's on offer)
5. An Inclusive GUIDE to all sorts of amenities in the capital, like great hotels, restaurant, pubs etc.
(Visit the website and download a copy of their Guide here)
6. And what about TICKETS? Some are still available but you have to register with this website to be informed.
It is all here, ready and waiting for your patronage. Even the athletes have begun to arrive from all over the world, though we do not expect the majority of them to be here before next Thursday. In fact, there was a news item on the BBC about two Somalian athletes whose presence at the Games, despite incredible obstacles like poverty and war to contend with in their country, reminded us of just what the Olympics mean to those developing countries. We can all be blasé about such events when we are living in plenty. But to see the impact, the potential and the sheer difference it makes to some athletes is beyond belief and very moving.
I will be covering any worthwhile news each day and I look forward to your company at the 2012 Olympic Games. I hope this has been of help.
Welcome to London 2012 and I do hope you have the most amazing time! :o)


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We get lots of pitches for holiday tech gift ideas when we put together our annual guide. Here's a bunch of oddball, offbeat or just plain unique products that were either sent to us or suggested to us.
Related stories: 25 Tech Gift Ideas: Cool Yule Favorites Gadgets of Christmas' Past: 10 Years of Cool Yule Tools
Republished with permission from Network World (view original version)


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Adam O'Donnell '12
Founder and CEO of Quantifize, Raleigh, NC and President of Cardinal Applications, LLC
Adam O'Donnell graduated from H-SC in 2012 with a degree in Economics. He has served as a resident advisor and a student senator, and is a member of ODK. Adam has founded two pressure-washing companies that operate in Tennessee, Virginia, Louisiana, and North Carolina. His senior year he founded Campus-Delivery.com, a service that delivers McDonalds to the H-SC campus. By the time of his graduation, Adam had plans to grow and expand his most recent venture, Cardinal Application, a smartphone application-development business.
Hampton Howerton '07
Music lawyer, Nashville, TN; President, Tour to Teach
Hampton majored in Economics and was a member of the Society of '91, a Hobbie Business Ethics scholar, and president of Sigma Alpha Epsilon fraternity. After college, Hampton through-hiked the Appalachian Trail before completing the JD-MBA program at Campbell University. He works in Nashville as an artist manager at The Artists Organization.
Justin Wisz '07
Founder and CEO, AdvisorLeap, Inc., New York, NY
Justin majored English at Hampden-Sydney. Upon graduation, he moved to Silicon Valley to work with Fisher Investments, a money management firm for high net worth individuals and Fortune 500 institutions. He then relocated to New York to pursue institutional sales for SNL Financial. During his time there, Justin worked on a concept to provide an accessible marketing solution to the nation's 30,000+ independent investment advisors. AdvisorLeap, Inc. is the refinement of this concept. Justin is also a board member, co-founder, and investor with several technology start-ups aimed at further disrupting the financial services and fashion industries.
Jake Dwyer '05
CEO, Active Nutrition, Los Angeles, CA
Jake Dwyer graduated with a degree in Political Science. As a student he wrote movie reviews for the Tiger and The Farmville Herald. Upon graduation, he moved to Los Angeles and began working in film production. Eighteen months later, 40 pounds heavier, broke, and over-worked, he decided to start a small nutrition consulting business. Five years later, he and his partners have 6 locations on the west coast, and they have plans for future expansion. "Because I'm my own boss," he says, "I get to travel, work when I want, and have an amazing lifestyle!"
Randy Ashton '01
CEO, Collared Greens (American, Eco-Friendly Clothing Brand), High Point, NC
Randy majored in history and was an All-American lacrosse player at Hampden-Sydney. Upon graduation, he moved west to the Rocky Mountains to pursue his interest in photography; he published two books picturing rivers and fly-fishing around the world. HRH Prince Charles wrote the foreword to his second book. In 2008, he founded Collared Greens in Ketchum, Idaho, as an eco-friendly clothing company for trendsetting and fashionable folks. The thriving business employs several fellow Hampden-Sydney alumni. Randy relocated his headquarters to High Point, NC, in 2011.
Andy Freitas '92
President, Colonel's Limited, LLC, Papa John's Franchisee, Washington DC.
Andy majored in psychology, was a student senator, and station manager at the Tiger radio station. Upon graduation, he and his father, who had just retired from the military (he was in charge of war plans during the Gulf War), became the first Papa John's franchises in the DC area. Over the next eight years, Andy and his father went to work nearly every day except Thanksgiving and Christmas, but enjoyed the satisfaction of becoming the most successful Papa John's franchisee in the world while operating in one of the country's most competitive markets. Andy operates 54 stores in the Greater DC metro area. He is a Hampden-Sydney Trustee and a judge in the annual entrepreneurship contest.
Todd Flemming '85
President and CEO, Advantor Systems, Co-Founder, Infrasafe
Todd double-majored in Economics and Biology and was the treasurer of Theta Chi social fraternity. He earned his MBA from the Fuqua School of Business at Duke University and began his career in management for companies in the security industry. Todd is currently the President and CEO of Advantor Systems, a company of approximately 180 employees which provides security products and services to the US Federal Government worldwide. Todd co-founded Infrasafe, the parent company of Advantor Systems, and now runs the subsidiary. He is also a managing member of Otis LLC, a private investment firm.
If you would like to speak with men like these, please contact the Career Education and Vocational Reflection Office at (434) 223-6106 or email@example.com.


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Archie Comics Takes The Variant Cover Plunge With 'Jughead' #200
A few months back we found out that "Robot Chicken/Titan Maximum" c0-creator/writer/producer Tom Root would be penning a special backup story for Archie's pal's landmark 200th issue in March. Now, it turns out readers will have another first to celebrate – Archie Comics' very first variant cover, which will ship to shops for free in a 1:3 regular cover ratio.
Newsarama's got Archie's official press release, which amusingly mentions "Robot Chicken's" Archie-meets-"Final Destination" mashup. I say "amusingly" because the parody isn't included on RC's Season 2 DVD collection and supposedly it's been replaced with another segment for its on-air broadcasts (and it's seemingly absent from the Internet). Let me throw out some crazy unfounded speculation and say that maybe Root caused a stir just so they'd take notice and give him a writing gig? Doesn't look like it, but according to the press release:
"The Archie Comics characters are comedy icons," said Root. "Each character's personality has been so well-defined over the course of nearly 70 years that it was a lot of fun to shake them up and present them with new challenges. Mostly, though, I just wanted to write a funny issue. I hope Archie fans like it!"
Since the story is about Archie trading his metabolism for a cheeseburger via the powers of "A spellbinding guest star' (Sabrina the Teenage Witch, y'all!), I am going to go out on a limb and say that, yes, I think I'm going to love it.
See you in March Jughead – Nay! – Variant Jughead!


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Christmas discounts at the ImagineShop, including half price games™ eMag
Place an order in the ImagineShop before 14th December and receive a massive 10% off your total purchase. But that's not the only way Imagine Publishing is spreading Christmas cheer. Oh no, ho ho; there's also a ton of other cool stuff up for grabs, including a massive 50% off the gamesTM issues 1-50 eMag compilation.
iPad & iPhone Games Directory Vol. 1 could be the perfect stocking filler to accompany that shiny new Apple gadget you hope you're going to find under the tree.


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Click on a thumbnail to go to Google Books.
Amy Moves In (original 1958; edition 1958)
by Marilyn Sachs, Ruth Sanderson (Cover artist)
Work details
Amy Moves In by Marilyn Sachs (1958)
No current Talk conversations about this book.
I recall having this book many years ago, but had forgotten much of the story.
Nine year old Amy and her older sister, Laura, move with their family into a new neighborhood in NYC. From day one things get exciting, with the revelation of a notorious killer dog on the ground floor, and an incident with a rude girl who not only hits Amy with a ball but then hits her, and the mothers wind up getting into it as well...
...funny, entertaining, all ages.
This is one of the three Amy and Laura books--I loved these books when I was a child. In this one, Amy and Laura move to a new neighborhood and Amy finds it to be particularly hard to make friends. As she tries to make friends with the other girls, she notices that they go out of their way to make fun of another girl, Rosa, to the point of emotional bullying. Amy doesn't like the way Rosa is treated, but she thinks she has to ignore it or the other girls won't like her. Just as she begins to feel she has been accepted, however, something happens that causes her to feel very ashamed of herself and of the other girls. Sachs captures the concerns most all girls who face during the junior high years without preaching to her readers.
From the back cover: "they're laughing at me, those stupid girls. I hate them!" Amy decides. "And I hate this new neighborhood. Everybody is so mean and unfriendly. Wh why did we ever have to move!"
Suddenly a ball hits amy on the head. A loud voice calles, "Hey kid..." And then things begin to happen fast.
References to this work on external resources.
Wikipedia in English
Amazon.com Product Description (ISBN 0595175899, Paperback)The first in a series of highly praised books about a poor, Jewish family living in the Bronx in the 1940s. Amy moves into a new neighborhood, and learns to choose the right kind of friends, and the consequences of lying.
(retrieved from Amazon Thu, 12 Mar 2015 18:20:28 -0400)
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Important Note: The author: Vincent Pardieu is an employee of GIA (Gemological Institute of America) Laboratory Bangkok since Dec 2008. Any views expressed on this website - and in particular any views expressed by Vincent Pardieu - are the authors' opinions and do not necessarily reflect the opinions of GIA or GIA Laboratory Bangkok . GIA takes no responsibility and assumes no liability for any content on this website nor is GIA liable for any mistakes or omissions you may encounter. GIA is in particular not screening, editing or monitoring the content on this website and has no possibility to remove, screen or edit any content.
This website is home for "Shameless Travel Addicted Gemologist" Vincent Pardieu (B.Sc., GGA, G.G.). Vincent is "Supervisor, Field Gemology" at GIA Laboratory Bangkok. He is a gemologist specialized on "origin determination of gemstones".
This is also home for Vincent's regular traveling companions: David Bright, Jean Baptiste Senoble, Richard W. Hughes, Guillaume Soubiraa, Walter Balmer, Michael Rogers, Kham Vannaxay and many others like recently: Philippe Ressigeac, Oliver Segura , Flavie Isatelle and Lou Pierre Bryl.
We are gemologists (gemmologists) sharing a passion for gemstones, gemolology (gemmology), gem people and traveling.
You will find in this website gemological expedition reports and some studies of gemological interest.
Visiting many gem mining areas we saw that people in remote mining and trading areas have difficulties to access to gemological publications. As today the Internet can be accessed in most of these gem mining areas and trading centers, the author started to build this website to give gem people living there the opportunity to see the result of the gemological expeditions they were associated in. It is a way to thanks them for their time and collaboration and to help them to get access to more gemological information.
At the same time the author hope that these expedition reports will please the people from consuming countries interested in gemstones and fascinated by their mysterious origins. Our purpose here is to help people facing difficulties to get quality first hand information about gems and their origins to get the information they need through this website and its links.
With our field expeditions to gemstone mines and gem markets around the world, we intend also here to share our passion for photography, gems and our fascination for the work of the "Gem People" bringing gemstones from the ground to magnificent jewelry.
From the gems external beauty to the intimate beauty of gemstone inclusions, from gem lore to the mines, the people and the landscapes gems origin from, we expect to share with you our passion for gemstone beauty.
We also invite you to join us on some gemological forums we are active in as they are convenient tools to get rapid answers to your questions as they are regularly visited by many other passionate gemologists, jewelers, hobbyists and professionals willing to learn more and share their knowledge about gemstones.
About the Author
Oct. 2007: Expedition to Tanzania gem mines:- Part 1: Gems from central and south Tanzania
- Part 2: Gems from North Tanzania
- Feb. 2005: A visit to Thailand, Cambodia with the AFG (Association Francaise de Gemmologie) (under construction) - 2002-2007: Expeditions to Pailin (Cambodia), Chanthaburi Kanchanaburi (Thailand) Houay Xai (Laos) Mogok, Namya (Burma) (under construction) - 2001: Expeditions to Namya, Hpakant and then Mogok with Ted and Angelo Themelis and Hemi Englisher (under construction)
about gems, gemology, field expeditions, studying gemology, minerals, jade, pearls or jewelry?We recommend these FORUMS where the author is contributing:
The photos and articles on fieldgemology.org are licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 3.0 United States License.Feel free to use the photos and articles with links and credits. No commercial use without permission.All the best,
GIA FE22 (GIA Laboratory Bangkok Field Expedition 22): Jan. 24, 2011 -Jan. 28, 2011:
Each last Wednesday of the month, the GIA Laboratory Bangkok and the GIA Thailand School join their forces to organize events called the "GIA Gemstone Gatherings" at the Crowne Plaza Hotel (previously known as Pan Pacific hotel) on Rama IV road in Bangkok. On November 24th, 2010, Flavie Isatelle, a young French geologist/gemologist who travelled for one year around the world visiting gem mines was given the opportunity to give a public presentation about Emeralds from Colombia as during summer 2010 she spent nearly a month in Colombia living for several weeks in an emerald mine in Muzo in order to study its geology. Thanks to the interest generated worldwide by that presentation, she was contacted by Gemfields, an important company mining emeralds in the Kafubu deposit in Zambia (one of the world's largest emerald deposit) and was invited to give again her presentation in Zambia. That was a great opportunity for her to visit that mining operation one of the world largest colored stone mines. Remembering the help that the author provided her in her numerous expeditions in Asia, Africa and South America, she was nice to ask the me if I was interested to travel with her in Zambia... There are some proposals that are very difficult to refuse.
For more information about the GIA Gemstone Gatherings please visit the "news" page on GIA Laboratory Bangkok website. There you will find, details about the next event. Using the calendar at the bottom of the page you will also find written reports and photos of the previous GIA gemstone gatherings.
Thanks to Flavie, I was also invited by Gemfields and at the end of Januray 2011 I was on my way to Zambia. We arrived in Zambia on January 24th for a three days long visit at the Kagem mine. For once I was not to be the expedition leader: Flavie was the boss and I became for few days her assistant and personal photographer. This blog and the following photos will then simply reflect that fact. Of course as official photographer of the expedition I took many photos where Flavie was not part of the landscape, but we have decided to keep these photos for the future publications. Soon you will be able to read our first report in "Gem News International" of the next issue of "Gems and Gemology" and later (probably around August 2011) you will find a more extensive and illustrated report on the following websites: www.gems-geology.com, www.fieldgemology.org, www.giathai.net and www.gia.edu.websites.
(Geologist Robert Gessner explaining to Flavie Isatelle the mining at the Kagem Gemfields main emerald mining pit.)
Photo: V. Pardieu / GIA Laboratory Bangkok, 2010)
We were welcomed at the Kagem / Gemfields mine by geologist Robert Gessner. Robert took us around for the following days from the main mining pit to the fascinating underground mining operation he is managing and also to the washing plant and the sorting house, where we could see some interesting emerald samples and meet with several local gemologists. The visit was very interesting particularly as it is very rare to encounter such high level of organization in the colored gemstone mining operation.
(Underground at the Kagem Gemfields mine in Zambia geologist Robert Gessner explains to Flavie Isatelle the local geological setting. Photo: V. Pardieu / GIA Laboratory Bangkok, 2010)
Visiting the mine with Robert Gessner was a real pleasure as Robert, besides being a very knowledgeable geologist (and a great tour guide), is also sharing with us a passion for gemology (Robert is currently studying gemology at GIA using the GIA distance education program) and photography as you can discover on "RoGe ImaGes" .
(Robert Gessner explaining to Flavie Isatelle how the emeralds are getting manually sorted at the Kagem Gemfields emerald mine in Zambia. As most emeralds are still attached to some matrix, manual and visual sorting was prefered to techniques using gravity or optics.
Photo: V. Pardieu / GIA Laboratory Bangkok, 2010)
Most of the young gemologist/geologists interested in gemstones who regularly contact the author for advice using the Internet might found Robert background interesting: After studying geology in South Africa, he graduated in 2004. Robert started then working as geologist at the Tanzanite One mine in Merelani, Tanzania. There he got some serious experience about the specificities of underground gem mining. In Jan 2009 he moved to emerald mining in Zambia to work on a very interesting and challenging project: Pioneering underground mining at the Kagem Gemfields emerald mine, a mine which is traditionally and historically an opencast mine. The main difficulty for most young geologist/gemologist is to find a first job as most companies prefer to hire people with experience... So my advice is the following: Be smart and work hard to get the right skills/profile. Then do your best to get the right first job, the one that will enable you to get the experience you need in order to be lucky later receiving a proposal to become what you have all your life dreamed to become.
Hard work is much more efficient if you work smartly.
(Finally one photo without Flavie and Robert... Zambian gemologist Jackson Mtonga working as superintendant at the Kagem Gemfields sorting house is presenting one of the emeralds from the company master set. Photo: V. Pardieu / GIA Laboratory Bangkok, 2010)
The visit at the Kagem Gemfields mine was very interesting as there are very few colored gemstone mining operations where gems are mined in such a way using modern geological and mining techniques. It was a great opportunity for me to visit that mine and meet there many interesting characters: Geologists, gemologists, miners, security officers and managers.
Very special thanks to Flavie Isatelle to have given me the opportunity to travel with her to Zambia. Flavie is currently searching for some job as mining engineer in a colored gemstone mine and is searching some ways to finance her PHD. For more information about Flavie and her profile, please visit her website: www.gem-geology.com
I want also to thanks all the people from Gemfields for their invitation and their welcome in Zambia. It was truly a real pleasure to visit the mine and have the opportunity to share some knowledge with each other. I hope that I will soon have the possibility to return to the mine in Zambia and work on some projects together.
All the best,
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Important Note: Vincent Pardieu is an employee of GIA (Gemological Institute of America) Laboratory Bangkok since Dec 2008. Any views expressed on this website - and in particular any views expressed by Vincent Pardieu - are the authors' opinions and do not necessarily reflect the opinions of GIA or GIA Laboratory Bangkok. GIA takes no responsibility and assumes no liability for any content on this website nor is GIA liable for any mistakes or omissions you may encounter. GIA is in particular not screening, editing or monitoring the content on this website and has no possibility to remove, screen or edit any content.


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Guyana, US finalise agreement on USAID democracy project
After being put on hold for months to facilitate discussions, the Guyana and United States governments yesterday announced that the Leadership and Democracy Project (LEAD) has been finalised and will be implemented soon.
"The governments of the United States of America and the Republic of Guyana have reached final agreement on the design and implementation mechanisms of the USAID Leadership and Democracy Programme," US Charge d Affaires of Brian Hunt stated at the Office of the President yesterday.
Hunt represented his country while Head of the Presidential Secretariat Dr. Roger Luncheon was Guyana's spokesman on the project.
Hunt said that despite modifications, the project's fundamental objectives remain the same and stressed that it had been tweaked to involve more government participation.
"A large part of our effort was to ensure that the Government of Guyana's viewpoint was reflected, that the government felt that government institutions were fully participating in the programme, ensuring that the government had – as is quite rightly the case- a significant and in some cases a leading role in making sure that the programme activities were working towards the benefit of Guyanese people," Hunt noted.
"The newly designed LEAD programme appropriately recognises that Guyana's democratic future is one that must, at its core, be shaped by Guyanese. It seeks not to define that democratic future but rather to support Guyanese stakeholders in defining it for themselves… the programme will act to support Guyanese stakeholders in being the driving force in identifying relevant issues and with developing solutions to identified problems," he also stated.
Further, Hunt pointed out that during the debate that ensued around LEAD some had stated that the programme has a "possible hidden US Government agenda" but he stressed that the claims were untrue. He also dismissed claims that the programme would provide support for opposition political parties. Government had stated that it was uncomfortable with an aspect of the programme, which it had said would give support to political parties. "Let me be very clear: There is no component of assistance to political parties that makes up part of the LEAD programme," he stressed.
"I want to make it absolutely clear to all Guyanese that no such agenda ever existed. The programme's only agenda was to assist Guyanese in charting and strengthening the democratic future that they, themselves, identify for their country," he further asserted.
Hunt also made public and committed to the private pledge that he had given to Luncheon pertaining to the project's transparency. "All activities undertaken as part of the LEAD programme will be transparent, open to public scrutiny, coordinated within the agreed upon framework, and responsive to the identified needs of stakeholders and for the benefit of all Guyanese," he said.
'Allaying fears'
Luncheon said that government was relying more on the process that has been agreed to but would still keep its eyes open about the role of the US International Republican Institute (IRI) in implementing the project on behalf of the financier, the US Agency for International Development (USAID).
He explained that the changes made deal with more content being added to the programme and fuller elaboration on the implementation process. "Indeed, whilst one cannot dispense with those instances, one cannot dispense with those sentiments; certainly process, a fairly well-established process, contributes enormously towards allaying fears on the one side and concerns about the use of fear on the other side," Luncheon said.
The row over the project had strained ties between the two countries and saw severe attacks by government officials on former US Ambassador Brent Hardt. At one point, Guyana cancelled the work permit for the IRI head of the project, Glen Bradbury.
Yesterday both countries stated that Bradbury was working as the head of the programme and that his work permit had been sorted out.
Luncheon said that Bradbury's permit was rescinded on the ground that he could not hold a permit for a job that was not extant, since the programme had not been seen as a legitimate one by government.
The first component of the $300M project endeavours to encourage consensus-building in the National Assembly and facilitate more effective interaction between the Assembly and citizens. It envisages cross-party negotiation workshops, speaker evenings for Members of Parliament, workshops on issue-based policy development, and multi-party issue fora where all parties select a representative to speak about a topic of public interest.
The second component seeks to bolster the effectiveness of the National Assembly and broaden citizen engagement with parliament.
LEAD also seeks to support the establishment of a "Women's Parliamentary Caucus," consisting of women from each of the parties represented in the Assembly. The caucus would offer a forum for the discussion of women's issues in Guyana and a means to bring such issues to the Assembly in a collaborative way. There is also a proposed internship programme for University of Guyana law students to provide research and drafting support to the National Assembly.
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by Staff Writers
Rochester, NY (SPX) Jan 02, 2015
In what they call a "weird little corner" of the already weird world of neutrinos, physicists have found evidence that these tiny particles might be involved in a surprising reaction.
Neutrinos are famous for almost never interacting. As an example, ten trillion neutrinos pass through your hand every second, and fewer than one actually interacts with any of the atoms that make up your hand. However, when neutrinos do interact with another particle, it happens at very close distances and involves a high-momentum transfer.
And yet a new paper, published in Physical Review Letters this week, shows that neutrinos sometimes can also interact with a nucleus but leave it basically untouched - inflicting no more than a "glancing blow" - resulting in a particle being created out of a vacuum.
Professor Kevin McFarland is a scientific co-spokesperson with the international MINERvA collaboration, which carries out neutrino scattering experiments at Fermilab McFarland, who also heads up the Rochester team that was primarily responsible for the analysis of the results, compares neutrino interactions to the firing of a bullet at a bubble, only to find the bubble was left intact.
"The bubble - a carbon nucleus in the experiment - deflects the neutrino 'bullet' by creating a particle from the vacuum," McFarland explains. "This effectively shields the bubble from getting blasted apart and instead the bullet only delivers a gentle bump to the bubble."
Producing an entirely new particle - in this case a charged pion - requires much more energy than it would take to blast the nucleus apart - which is why the physicists are always surprised that the reaction happens as often as it does. McFarland adds that even painstakingly detailed theoretical calculations for this reaction "have been all over the map."
"The production of pions from this reaction had not been observed consistently in other experiments," McFarland said. By using a new technique, they were able to measure how much momentum and energy were transferred to the carbon nucleus - showing that it remained undisturbed - and the distribution of the pions that were created.
"After analyzing the results, we now have overwhelming evidence for the process," McFarland says.
The two members of the collaboration who were primarily responsible for analyzing the results were Aaron Higuera, at the time a postdoc at Rochester and now at the University of Houston, and Aaron Mislivec, one of McFarland's Ph.D. students.
Working with Higuera, Mislivec wrote the computer code that allowed them to sift through the results and get a picture of the reaction. "Our detector gave us access to the full information of exactly what was happening in this reaction," Mislivec explains.
"Our data was consistent with the unique fingerprint of this reaction and determined how these interactions happen and how often." The key to identifying the reaction was finding undisturbed carbon nuclei and then studying the two resulting particles - the pion, which is responsible for shielding the nucleus, and the muon.
Understanding this reaction, McFarland states, "is not going to make a better mousetrap, but it is exciting to learn that this weird reaction really does take place."
Researchers in the MINERvA collaboration measure low energy neutrino interactions both to support neutrino oscillation experiments and study the strong dynamics of the nucleon and nucleus that affect the interactions.
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Office of Institutional Research, Effectiveness and Planning
Data Request Guidelines and Form
The Office of Institutional Research has reports available online at www.sipi.edu/about/research/. If the information you are looking for cannot be found in any of these reports, please review the following guidelines for requesting information before completing the Research Data/Report Request Form.
- Plan ahead. When making a request, take into account the time required to capture and report the information you are requesting, especially if you need the information by a certain date.
- Identify the critical questions you want to answer. Be specific. Do you need enrollment or headcount, duplicated or unduplicated? Are you wanting GED students included, or credit students only? And for what time period - fall, spring, summer of the current year and/or for a specific previous academic year? The more specific you are about the questions you are trying to answer, the more useful the information you receive will be.
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Best Of :: Food & Drink
When this past year saw the opening of George Abdallah's new all-shish kebab, all-the-time self-serve eatery, it saw something fine and good happen. This spotless, cheerful little operation allows a Houstonian to visit the Levant, dine at a very reasonable cost on a Thousand and One Nights menu, pick up a little box of terrific loukoum for the habibi at home and be asleep in one's own bed the same evening -- all without using up one of your three extremely valuable wishes proffered by a jinni of terrible visage. There are lamb kebabs grilled to order, of course, but also quail kebabs and vegetarian KBs. The BYOB policy (Will Rogers Elementary School is across the street from the corner eatery) allows one to have a glass of wine with dinner for the most reasonable cost possible. Next door is the Edward's 24-screen Cinema at Weslayan and Portsmouth, making the spot convenient for theatergoers before or after meals.
Zimm's has been a wine bar; it's been a coffee-and-wine bar; it's been all but burned out in a fire last year; and it's been flooded by Tropical Storm Allison. Still, it endures, and it makes a damn good martini. The drinks are helped by the seductive ambience of the place -- dark and agreeably louche, with not-too-loud music, which one staffer describes accurately as "always calm and sexual and jazzy." The crowds on the weekends can get a little too pretentious for some tastes, but the weeknight vibe is more amenable and the martinis are just as good.
These sublime concoctions are undoubtedly best enjoyed alfresco, and to do so there is no place better than the Guatemalan/Mexican surf-and-turf, El Pueblito Place. First, there's the marg itself, which is tartly delicious as any in town and comes in large, extra large, and call-a-cab sizes. Then there are the cabana-comes-to-Montrose surroundings of the restaurant's new back patio, in which riots of pastel shades delight human eyes, and hanging plastic bags full of water bamboozle those of the flies. Accompanied by the restaurant's legendary pineapple salsa (or its severely underrated red companion) and the relatively cool breezes of the Gulf Coast evening, the El Pueblito Place alfresco margarita experience is not to be missed.
Houston's unique brand of spontaneous fusion is in full flower on Telephone Road. Formerly home to the white middle class, now part Asian and part Hispanic, Telephone crosses all the lines. Shipway began its life as a run-of-the-mill doughnut shop, and then it was purchased by a Hispanic family who expanded the place. So now the glass cases are filled with the usual chocolate-frosted and plain-cake doughnuts, along with brightly colored Mexican pastries. There's also a full menu of Mexican breakfast items like bacon-and-egg tacos, chorizo and egg plates. You can also order a tres leches cake for your kid's birthday party. And if that's not enough of a selection, Shipway also sells some of the best homemade pork or chicken tamales in the city on Friday afternoons and Saturday mornings. A hot foil package containing a dozen tamales sells for $5. Better get two: one to eat on the spot, slathered with hot sauce, and one to take home for the family.
Old-timers remember the era when Sunday afternoons meant post-church meals where anything but fried chicken would constitute outright heresy. Now the special repast is almost strictly the domain of fast-food joints. Fox Diner pays due homage to the heritage of fried chicken on Sunday. While the cooks of past eras never would have dreamed of coating the chicken in corn flakes, they'd be more than a little pleased at how this place does it with spectacular results -- the crust is properly crunchy and tasty. And the chicken itself stays oh-so-moist and flavorful. Have faith. This is one Fox you want in the henhouse.
When we say plantains, we aren't talking about those crunchy chips you find in a bag of trail mix. No, we're talking plantains here, the ones you peel and fry up in a pan. Most restaurants will serve up slabs of fruit from plantain purgatory, soft and pretty yellow on the outside, with a stiff, flavorless center. But Cafe Piquet is a place that understands Caribbean cooking. The tostones, fried when the fruit is still green, are thick and dry, and add the right touch to certain dishes. But the maduros are what keep us coming back. Sweet and gooey, they almost glisten as they drip off the fork. They aren't much to look at, with none of the pretty cinnamon sprinkles or frilly garnish. They're misshapen, blackened lumps that leave it to your taste buds to be the final jury. But don't let the discoloration scare you -- that's proof that this place knows the one secret to serving up good soft plantains: Pick 'em when they're ripe.


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Tue 12th Mar 2013 | News
Autodesk will showcase its desktop software and mobile apps at GDC this year.
The latest versions of its Gameware (includes UI, AI, lighting and animation middleware) and Digital Entertainment Creation Software will be on display at the Autodesk booth (#1240), along with 123D Creature and SketchBook Express mobile apps that enable developers to design on the go.
Gameware Sessions
Autodesk will hold four sponsored sessions in Esplanade Ballroom 301, where attendees can learn from industry experts and see first-hand how Autodesk Gameware and Digital Entertainment Creation software positively impact game development.
Autodesk sessions include:
Leveraging the 3rd dimension: 3D pipelines for 2D mobile/casual games
What: A panel of developers from Zynga, Go-Time, Industrial Toys, Phyken Media, and Subatomic Studios will explore the benefits of using 3D art creation tools in casual, social and mobile game development
When: Wednesday, March 27, 2:00pm-3:00pm
Gameware Navigation 2014
What: An overview of modern game AI including live debugging demos
When: Wednesday, March 27, 3:30pm-4:30pm
The Importance of Sculpture and Structural Motivation in Rigging
What: A look at the artistic side of rigging and why sculpting is vital to the process with Game Character Academy Co-Founder Judd Simantov
When: Thursday, March 28, 2:30pm-3:30pm
Scaleform for Multi-Platform Mobile Game Development
What: An in-depth analysis of user interface creation for multi-platform games with Mark Geigel, Chief Technology Officer ISOTX and Ankur Mohan, Autodesk product manager
When: Thursday, March 28, 3:00pm-4:00pm
Applications of Autodesk Technology
Offering real-life examples as to how Autodesks DEC software and Gameware products are used in game development, an assortment of titles created with help from Autodesk tools will be featured in the booth, including: You Dont Know Jack (Jellyvision), Flick Tennis, (Rolocule), Fieldrunners 2, (Subatomic Studios) and Autodesks proof-of-concept game Starforce Battlement, originally developed to showcase the capabilities of the Scaleform Mobile SDK.
Developers Showcase Projects
Autodesk will host a number of customers at the Autodesk booth to discuss how Autodesk technology helps them create true-to-life characters, while staying on schedule. Guest presenters include:
Creation of Naughty Dogs Last of Us trailer using Maya and Mudbox
Guest: Judd Simantov, Co-Founder, Art Technical Lead
Company: Game Character Academy
Products: Maya and Mudbox
When: Wednesday March 27th, 3:30-4:00pm
The Use of Scaleform at ISOTX
Guest: Mark Geigel, Chief Technology Officer
Company: ISOTX
Product: Scaleform
When: Thursday March 28th, 10:30-11:00am
Autodesk MasterClasses
A full list of Autodesk MasterClasses offered at GDC will be available closer to the show.
Related links:


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Let us know when your receive great advice so we can thank our lawyers and point others with similar questions in the right direction.Got it!
If there is an unpaid judgment and the person trying to collect is not the judgment holder, will the bankruptcy still order that judgment payable and not dischargeable?
Bankruptcy will not order a judgment payable. Whether the original owner/holder of the judgment or a successor in interest has no bearing on whether a debt is discharged via bankruptcy.
See 11 USC 523 for a description of exceptions to discharge (aka debts that may be deemed non-dischargeable).
NOTE: This answer is made available by the lawyer for educational purposes only. By using or participating in this site you understand that there is no attorney client privilege between you and the attorney responding. This site should not be used as a substitute for competent legal advice from a licensed professional attorney with whom you have established an attorney client relationship. The law changes frequently and varies from jurisdiction to jurisdiction. The information and materials provided are general in nature, and may not apply to a specific factual or legal circumstance described in the question.Ask a similar question
A chapter 7 bankruptcy will discharge the debt whether the debt belongs to the original creditor or whether the debt has been transferred to another creditor and this holds true even after a judgment has been entered. In other words it doesn't matter who is trying to collect, the debt will be wiped out.
The information provided herein is general information only and not legal advice. The information provided herein does not create an attorney client relationship and is not a substitute for having a consultation with an attorney. It is important to have a consultation with an attorney as the information provided in this forum is limited and cannot possibly cover all potential issues in a given situation.Ask a similar question
Are you talking to your bankruptcy attorney? They are in the best place to answer this question.
Did someone file an objection to discharge in your case? Your question suggests this.
What debts are and are not dischargable are spelled out in the bankruptcy code. It depends on factors such as which chapter you filed, the type of debt, and the age of the debt.
Many debts are sold. So the first creditor may not own it any more. Additionally, creditors hire people and/or companies and even attorneys to collect the debt.
Good luck.
This does not create an attorney/client relationship. I am licensed to practice law in Kansas and Missouri only. I only represent clients with a signed contract and who have either paid a fee or I agree to represent through the VAP project at Legal Aid of the Western District of Missouri. This is not legal advice.Ask a similar question
The facts in your narrative are way too sparse.
This depends on the nature of the judgment as what it is for as in what was done to lead to the judgment. Was this a batter? Is it for spousal support? DUI with injuries? A fine or penalty? Or is it just for money owed on a credit card?
In order for a creditor to remove the judgment from the discharge the creditor has to sue under 11 USC 523 and object to the discharge of their judgment. The only other objection is to all debts under 11 USC 727.
Without knowing more, no one can even address this.
This is a public forum. Any questions or answers published here should not be construed as the giving or receiving of legal advice or the formation of any attorney-client relationship. You should consult with a competent attorney in the jurisdiction where your legal issues are pending and get good, solid legal advice. This being a public forum, those answers you do read are merely given for informational purposes only.Ask a similar question
Post a free question on our public forum.Ask a Question
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text: Located in the popular Paradise Valley area of Phoenix, you can enjoy the excitement of the city, while coming home to a relaxing, lush, green landscaped community. Our pet friendly apartment homes offer modern kitchens, scenic courtyard views and open living spaces. Residents enjoy swimming pools, laundry facilities, picnic areas with BBQ grills and planned monthly events. We are conveniently located minutes to Paradise Valley Mall and Stonecreek Golf Club. Don't compromise on experiencing the best in apartment living… experience Park Ridge!


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Not every September addition to baseball's expanded rosters is a youngster looking to make a good first impression.
Some are grizzled professionals, grateful for a chance and proving it's more important to be persistent than a spring chicken.
Take Oakland A's left-hander Bobby Cramer, who made his major league debut Monday and, at 30, earned the 3-1 victory, pitching 5 1/3 innings of four-hit ball against Kansas City.
Cramer, who turns 31 next month, became the oldest starting pitcher to debut for the the A's since Steve Gerkin did it for the Philadelphia A's, May 13, 1945.
"Just getting here was amazing in itself," said Cramer, a former substitute math teacher and pipeline maintenance worker when he was out of baseball in 2005-06 following his release by Tampa Bay.
"There were times I felt this was an uphill battle, that I may never get over that hump. Now that I'm here, I want to pitch well."
Manager Bob Geren was impressed enough to guarantee Cramer another look.
"When you travel a road as tough as the one he has, I think he's more appreciative of this opportunity, a little older, more mature, tougher mentally sometimes than a young kid," Geren said. "I'm very happy with him going that deep into the game and keeping a lead. You'll definitely see him again."
Cramer said he quit the game physically but never mentally. He launched his comeback with the A's in 2007 and was 21-11 in the Oakland system before beginning this season with the Tigres de Quintana Roo (Cancun) of the Mexican League. He went 13-3 with a 2.95 ERA, earning a promotion to Class AAA Sacramento where he was 2-2, 1.97 in seven games.
"When I got released in '05, I tried to convince myself I was done," Cramer said. "Tampa at the time was a struggling organization that would give young guys a chance and promote you if you played well. I couldn't even get out of A ball with them."
He got the chance to show his stuff Monday, taking Vin Mazzaro's turn in the rotation. The only run he allowed Monday came on a homer by Kansas City's Mike Aviles.
Cramer isn't alone when it comes to players who are pushing or beyond 30 years of age and getting their first chance in the majors.
By Seth Livingstone
Daily Pitch is a baseball fan's destination for breaking news, emerging trends and enlightening banter. With a veteran group of reporters positioned in three time zones, we provide a balanced, comprehensive glimpse at our national pastime, with a nod to both the passion and complexities that make the sport irresistible to many. More about our reporters


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About us
At Kent Occupational Therapy we are committed to providing an outstanding service to the people we work with.
We are State Registered Occupational Therapists with extensive experience working with older adults and, in particular, those with memory difficulties including dementia and Alzheimers disease.
We believe that everyone has potential, whatever their individual situation.
We continually work towards enabling those we work with to create positive change and to live fulfilling lives in the environment in which they live.


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YORKSGEN-L ArchivesArchiver > YORKSGEN > 2005-08 > 1123769451
Subject: Re: [YKS] Common forename?
Date: Thu, 11 Aug 2005 10:10:51 EDT
In a message dated 11/08/2005 11:56:47 GMT Standard Time,
Not sure about Yorkshire but in Derbyshire it was neither common nor rare.
Being a biblical name I would expect it to have been in wide usage.
I have done a search of the IGI for the periods 1790 to 1810 using just the
forename mark and the county of Yorkshire and there are over 1000 entries
( Before I got bored counting them) so it looks to have been fairly common
Perhaps by county but I don't have one in my 5,000+ tree or my one name
study. We cover many counties so perhaps we were not religious enough to
warrant that name.
Best wishes
This thread:
|Re: [YKS] Common forename? by


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Loom Bands 2" Capsules (50 ct/Capsule)
$ 46.95
Loom Bands (50 Per Cap) 2 inch capsules - Colorful rubber bands that you turn into creative bracelets, rings, hair bands, necklaces, anklets, earrings and even handbags!! Each capsule has 50 bands and 4 clasps. The possibilities are infinite.
Availability: Usually ships within 1-2 business days.


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Reporters Badly Beaten Bringing News To The World
If you are a FOX News watcher then you know Greg Palkot; he is a very straight forward, expressionless, no frills reporter. He has recently, like many reporters, been in Egypt during the protesting. He and his cameraman, Olaf Wiig, were forced to flee their hotel and were both badly beaten by Egyptian government supporters.
The two were both severely beaten — to the point they had to be hospitalized. The two have now returned to London, and in their first interview since the incident, recounted the danger they experienced.
CNN reporter Anderson Cooper was also beaten as have many other reporters who are just trying to report on the events going on in that nation. I realize that there is much going on in Egypt but when you get a mass of emotional people together it turns to "mob mentality". Most of the protests have been peaceful but a few Mubarak supporters have turned things ugly and violent. They forget these people are just reporting, they have nothing to do with the government or how it is run. They are just bringing the event to people all over the world, it's sad and scary that they turned to this kind of violence against innocent people. I'm glad these guys, as well as other reporters, are alive; and God Bless them for bringing news, good or bad, to everyone all around the world.


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This star rating is the opinion of the property owner only. A Self-Rated hotel has not been assessed by the AA or Visit Britain, whose official star ratings we use across LateRooms.com.
Ashwood Manor Motor Lodge4 Self rated
16 Thackeray Street, Hamilton Central, 3204
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About the hotel
Welcome to Ashwood Manor, where we take pride in ensuring you enjoy your business or holiday visit. We are perfectly positioned between the city centre and lake hamilton less than five minutes walk to the city centre, Hamilton's shops, cafes, restaurants, and bars are within easy reach. we are also a short walking distance to hamilton hospital, medical centre, polytech, and courts.
Experience our modern spacious units. Guests have a choice of spa or non-spa units, including access units. all units are serviced daily. a choice of breakfasts is available. Guest laundry, sky tv, wireless broadband, and cooking facilities are available. all rooms are non-smoking. *Free WiFi (conditions apply)*. Our conference room caters for up to 10 people with catering available. Your hosts Dianne and Bill look forward to welcoming you.
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- Car parking available onsite
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- In-room Broadband, In-room Modem Hook up
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- [Channels] News, [Channels] Sky Sports, [Channels] Movies (Free), [Channels] Music
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