Roundtable on Vitiligo

Transcription

1 Roundtable on Vitiligo Background The Roundtable on Vitiligo will be hosted by the non-profit VR Foundation. We are firmly committed to expediting and facilitating vitiligo research and ending the suffering of those affected by this much neglected disease. This project will build on the World Vitiligo Symposium (2011) and the World Vitiligo Day (2012) initiatives. An early priority for the VRF was to establish the agendas of three specific panels, that is, which topics and issues should receive priority attention, and thus have resources allocated towards a solution. Date: December 14, 2012 Venue: Winter Consensus Conference of the World Health Academy (Switzerland) Place: Hotel Kempinsky, Kitzbühel, Austria Purpose To gather public, industry, and subject matter expert input that will help in understanding the disease pathogenesis, development of novel therapies and raising global awareness for the benefit of the under-served patient group. Format The Roundtable on Vitiligo includes three Task Forces composed of academic researchers, biotech and pharmaceutical executives, practitioners, and representatives of public advocacy organizations. We are exceptionally honored by the participation of a Nobel Prize winner, who will address different aspects of modern science, society and industry. The Global Awareness Task Force will focus on the World Vitiligo Day 2013 communication and advocacy campaign. The Life Science Task Force session is an invite-only, unbiased discussion on challenging research topics and promising therapies. The CEO Roundtable Task Force session is an invite-only meeting of the CEOs of biotechnology and pharmaceutical companies involved in vitiligo product development. Opening Discussion ( on December 14, 2012) During our opening Go Round, we will discuss what is new in vitiligo R&D, what it means to you, and how your healthcare or patient support organization may respond to it. Presenters include (TBC): - Prof. Torello Lotti; Vitiligo: What s True, What s Not. - Prof. Robert Schwartz; Vitiligo: Illuminating Prospects. - Prof. Charles Townes, Nobel Prize and Templeton Prize Winner; Meeting of Science and Religion in Modern Times. - Mr. Yan Valle; At the Crossroads of Science and Industry: an Interdisciplinary Approach to R&D. - Dr. Igor Korobko; Golden Standard in Bio-banking for Vitiligo and Rare Diseases. Chairperson: Prof. Torello Lotti. Co-Chair: Prof. Robert Schwartz. Roundtable on Vitiligo: Final program, Supplementary Materials, Basic Rules. Aug 30, 2012 Page 1

2 Global Awareness Task Force ( on December 14, 2012) With approximately 100 million people in the world affected by vitiligo, this distressing pigmentary disorder touches every strata of the population, and every sector of the economy. Furthermore, the vitligo sufferer shares its effects with his or her family and, to varying degrees, society in general. The intent of this Task Force is to understand the challenges vitiligo patients and practitioners face in various social or health care settings, and to build an effective public awareness campaign. The objective of the Global Awareness Task Force is to coordinate the World Vitiligo Day campaign and related media activities, in the year The VRF will provide participants with the updated media kit. Chairperson: Mr. Lee Thomas, an award-winning Fox TV anchor/presenter in his hometown Detroit and an international speaker for vitiligo. Co-Chair: Ms. Ogo Maduewesi, CEO VITSAF (Nigeria); Moderator: Mr. Yan Valle, CEO VR Foundation (USA). Life Sciences Task Force ( on December 14, 2012) The Life Sciences Task Force is composed of eminent senior researchers and key opinion leaders from such diverse backgrounds as biochemistry, dermatology, genetics, molecular biology, immunology and oncology. The intention of this Task Force is to stimulate unbiased scientific discussion, ultimately leading to the creation of a balanced and sensible Vitiligo Map. Each of the participants will briefly present his or her vision of vitiligo pathogenesis or the cellular/molecular processes affected in vitiligo, and provisional key targets for treatment. The objective of this session is to identify the most promising research directions, possible leads and hypothetical treatments. Presenters (TBC): - Dr. John Harris; Immune system in vitiligo pathogenesis - Dr. Igor Korobko; Cell biology: faulty melanocyte niche - Dr. Brian Lee; Mechanisms of phototherapy action in vitiligo treatment - Prof. Antonio Salafia; Anti/pro-oxidative properties of different therapies in vitiligo - Prof. Karin Schallreuter; Oxidative stress in vitiligo - Prof. Richard Spritz; Genetics of vitiligo - Dr. Michèle Verschoore, Director at L'Oréal Research & Innovation. Chairperson: Prof. Robert Schwartz. Co-Chair: Prof. Jana Hercogova, Prof. Paulo Cunha, Prof. Torello Lotti, Prof. Karin Schallreuter Observers: Prof. Xing-Hua Gao, Prof. Andy Goren, Dr. Davinder Parsad, Mr. Yan Valle. The discussion will be moderated by the VRF Chief Scientific Director Dr. Igor Korobko, who will provide participants with specific details about this session upon request. Roundtable on Vitiligo: Final program, Supplementary Materials, Basic Rules. Aug 30, 2012 Page 2

3 CEO Roundtable Task Force ( on December 14, 2012) The goal of the CEO Roundtable Task Force is to find potential correlations between social value and cost-effectiveness of prospective vitiligo treatments, and to answer the key questions surrounding it's economics. It is emotionally difficult to put a price tag on suffering, but that is what is already happening in many boardrooms across the pharmaceutical industry. The uncertain financial viability for the sale of prospective anti-vitiligo treatments offers no incentive for associated investments in R&D. Starting at the individual (micro) level, allows work to start on the economic analysis in the absence of complete global prevalence data. The VRF will share its assessment of vitiligo niche markets with fellow Task Force members. The emphasis of this meeting is to come to an agreement on the common components necessary to support cost/benefit analyses of therapy development and individual interventions. The meeting concludes the dedicated Vitiligo day of the World Health Academy congress in an informal setting. Participants (TBC): - Mr. Dmitry Aksenov, Founder and President of VR Foundation (USA) - Dr. Humberto Antunes, CEO Galderma S.A. (Switzerland) - Mr. Stefan Coccoloni, CEO World Health Academy (Switzerland) - Mr. Ken Jones, CEO Astellas Pharma Europe (UK) - Prof. Andy Goren, CEO Dermagenoma (USA) - Mr. Basudeo Narain Singh, Managing Director Alkem Laboratories (India) - Dr. Michèle Verschoore, Director at L'Oréal Research & Innovation (France). Chairperson: Mr. Yan Valle, CEO VR Foundation. Co-Chair: Dr. Medhat Abdelmalek, the WHA Congress President. Expected Outcomes The results of the Roundtable on Vitiligo will be communicated in plain, practical, and easy to understand language, for use by health care providers, researchers, professionals, and officials. Preceding Events As a contribution to the development agenda of the Roundtable on Vitiligo, VRF is sponsoring a masterclass and workshop on November in Shenyang, China. The workshop will be opened with a keynote speech by Professor Torello Lotti, on how scientists in collaboration with practitioners can standardize, aggregate and analyze data to effectively enhance the quality of the research and the quality of life of vitiligo patients. Accreditation The Roundtable includes a broad range of representatives from across the healthcare community, pharmaceutical companies, patient support organizations, the World Health Academy, as well as experts and economists. To inquire about accreditation at the Roundtable on Vitiligo and its Task Forces, please contact Alessandra Fabbri Palmieri at a.palmieri@vrfoundation.org or Please check for updates on this programme. Roundtable on Vitiligo: Final program, Supplementary Materials, Basic Rules. Aug 30, 2012 Page 3

4 DETAILED AGENDAS Global Awareness Task Force (GATF) As the World Vitiligo Day campaign marks six months from it's inception, there is a growing need for communicational support at both international and national levels. Work in many countries has highlighted the need to help national activists raise awareness about this skin disease, address misconceptions and collect signatures for the petition to the United Nations. The GATF team needs to anchor these activities with a coherent strategy for communication and advocacy. A powerful strategy can also create a framework for communication with the World Health Organization and the United Nations. COMMUNICATION STRATEGY A robust strategy will help the GATF build recognition and support beyond top-level awareness of the World Vitiligo Day (WVD) campaign name. It will be based on a deeper understanding of, and affiliation with, the vision and unique strengths of the network of supporters. BASIC ELEMENTS The GATF team will define the following: 1. WVD campaign goals and values 2. Priority themes for communication (issue/action/impact) 3. Key messages 4. Audiences 5. Channels 6. Tools 7. Mechanisms for monitoring and evaluation 8. Roles and responsibilities VRF Secretariat, GATF and network of supporters. In the run-up to the 25th June 2013, the GATF will need to open two-way communications via local support groups, social networks, publications and monthly newsletters. WEBSITE The website remains a critical channel for communicating about the goals and actions of the campaign, its impact and the number of signatures collected to date. An internal review of the site is planned with a view to a revamp in line with the new communication strategy. The review will also provide GATF members with a better understanding of website audiences and current usage of the site. The GATF team will discuss the newsletter with regard to content, distribution and impact, so that this tool is fully integrated within the new communications strategy. Work needs to begin to systematically identify examples of courage in combating vitiligo, so that those people and organizations can be recognized and supported publicly through the newsletter and other communication channels. Roundtable on Vitiligo: Final program, Supplementary Materials, Basic Rules. Aug 30, 2012 Page 4

5 CALENDAR OF EVENTS International conferences and events present important channels for WVD advocacy. The GATF team will be creating a calendar of events and conferences for the year 2013, to represent and promote WVD in the months leading up to the mass-event on June 25 th and beyond. The GATF team will work closely with the Life Sciences Task Force, CEO Roundtable Task Force teams and the VRF Secretariat to develop integrated plans for advocacy, resource mobilization and partnership development, building on the network communications strategy. Chairperson: Mr. Lee Thomas, an award-winning Fox TV anchor/presenter in his hometown Detroit and an international speaker for vitiligo. Co-Chair: Ms. Ogo Maduewesi, CEO VITSAF (Nigeria) Moderator: Mr. Yan Valle, CEO VR Foundation (USA) Life Sciences Task Force (LSTF) The LSTF embraces a multidisciplinary academic approach in a pursuit of a deeper understanding of vitiligo, one of the most common and most neglected skin diseases, for downstream therapy development. The team and observers are eminent senior researchers and key opinion leaders from such diverse backgrounds as biochemistry, dermatology, genetics, molecular biology, immunology and oncology. The data accumulated to date, undoubtedly shows that, despite clinically similar manifestation, molecular pathogenesis of vitiligo is far from being uniform. Different molecular mechanisms are likely to be underlying causes of the disease's onset and progression. Current treatment options are not based on the specifics of the particular patient. OBJECTIVE The objective of LSTF meeting is to discuss the vitiligo variability arising from multi-factorial etiology, underlying disease mechanisms, targets that are amenable to therapeutic intervention, and which attributes could be used to distinguish between patients with visibly similar skin lesions, but distinct biological conditions. FORMAT The format of this discussion is a brief (10 min) yet comprehensive presentation of the each member s view on the vitiligo problem, including triggers, causes, cures, with a subsequent critical discussion of the presentations in a round table format. Provocative questions are welcome, for example: "If melanocyte loss in vitiligo is caused by immune system attack, why does vitiligo show up as restricted maculae rather than affecting the entire skin?" LSTF meeting observers are invited to take part in discussions, bringing expertize from their respective fields of knowledge to the table. This discussion will hopefully result in the unbiased identification of perspective leads in vitiligo R&D and hypothetical vitiligo treatments. Roundtable on Vitiligo: Final program, Supplementary Materials, Basic Rules. Aug 30, 2012 Page 5

6 "NO CONSENSUS" APPROACH We have no intention to host another traditional conference or symposium on vitiligo. LSTF is not about reaching consensus on anything. Instead, everyone s visions and hypotheses are supposed to be not only discussed, but argued, leading to a weighted and sensible understanding of the vitiligo problem. Ultimately, we aim to develop thorough descriptions of disease epidemiology, pathways, mechanisms and targets, collectively called the Vitiligo Map, including: the nature and incidence of various disease subtypes; the relevant targets for therapeutic interventions, for each distinct disease mechanism; the feasibility of identifying biomarkers to distinguish different disease subtypes; the feasibility of developing test systems for predicting a response for different potential therapies; the safety characteristics of different potential therapies. Such Vitiligo Map will allow each LSTF participant to formulate their own hypotheses about the likelihood of being able to alter the course of the disease, through a combination of pharmacological and light therapy interventions. We anticipate that regular LSTF discussions will enable members to develop and pursue more leads, with much greater probability of success and under tighter academic budgets, compared to those of the biopharmaceutical industry. We call it a theoretically induced and empirically guided approach. PARTICIPANTS Presenters: Dr. John Harris; Immune system in vitiligo pathogenesis Dr. Igor Korobko; Cell biology: faulty melanocyte niche Dr. Brian Lee; Mechanisms of phototherapy action in vitiligo treatment Prof. Karin Schallreuter; Oxidative stress in vitiligo Prof. Antonio Salafia; Anti/pro-oxidative properties of different therapies Prof. Richard Spritz; Genetics of vitiligo Dr. Michèle Verschoore, Director at L'Oréal Research & Innovation. Chairperson: Prof. Robert Schwartz. Co-Chair: Prof. Jana Hercogova, Prof. Paulo Cunha, Prof. Torello Lotti, Prof. Karin Schallreuter. Observers: Prof. Xing-Hua Gao, Prof. Andy Goren, Dr. Davinder Parsad, Mr. Yan Valle. FURTHER DETAILS This is invite-only session. The discussion will be moderated by the VRF Chief Scientific Director Dr. Igor Korobko, who will provide participants with specific details about this session upon request. Please forward your inquiries to the address: i.korobko@vrfoundation.org Roundtable on Vitiligo: Final program, Supplementary Materials, Basic Rules. Aug 30, 2012 Page 6

7 CEO Roundtable Task Force (CRTF) The new R&D paradigm is shifting towards desired outcomes that pharmaceutical companies and society are willing to pay for, or more simply put - the cost of treating the disease. OBJECTIVE The goal of the CEO Roundtable Task Force is to find potential correlations between social value and cost-effectiveness of prospective vitiligo treatments, and to answer the key questions surrounding it's economics. It is emotionally difficult to put a price tag on suffering, but that is what is already happening in many boardrooms across the pharmaceutical industry. The uncertain financial viability for the sale of prospective anti-vitiligo treatments offers no incentive for associated investments in R&D. Starting at the individual (micro) level, allows work to start on the economic analysis in the absence of complete global prevalence data. The VRF will share its assessment of vitiligo niche markets with fellow Task Force members. VITILIGO: A RARE DISEASE? Although it seems like never applied for, vitiligo arguably fits Rare Disease designation, as defined by SEC. 526 of the U.S. Federal Food, Drug and Cosmetic Act *21 USC 360bb+, (2)(B). Specifically, The term rare disease or condition means any disease or condition which (A) affects less than 200,000 persons in the United States, or (B) affects more than 200,000 in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug. Such designation may reduce cost of vitiligo R&D for pharmaceutical companies. Orphan drugs have the potential to generate as much lifetime revenue as treatments used for more common health conditions, according to a study published by Thomson Reuters in August Valuations of Manning & Napier, a financial services firm, reflect a broad interest of the financial markets in the orphan disease business model. Despite the smaller patient pool for rare disease R&D, the economics of orphan drug development and potential for commercialization are attractive when compared to their nonorphan counterparts. Researchers found that of the 86 orphan drugs included in the study, 25 were blockbusters; meaning, 29 percent of orphan drugs have annual sales greater than $1 billion. This is comparable to 83 out of the 291 non-orphan drugs that were considered to be blockbusters (which is also 29 percent). MARKET For traditional medicines, a common rule in large pharmaceutical companies is that a drug must show potential for $500-million peak annual sales to justify the costs of discovery, development and marketing. In the current environment, a reasonably successful blockbuster drug with a $1-billion development program and a 10-year patent life will yield a $4-billion gross profit, with 80% gross margin. The global vitiligo therapeutics market is estimated to grow from $1.4 billion in 2011 to $2.7 billion by The existing pipeline for vitiligo drugs is very short. Switch Biotech and Dermira are preparing for Phase I trials with their compounds, while Clinuvel Pharmaceuticals is expecting approval of its' new drug in Roundtable on Vitiligo: Final program, Supplementary Materials, Basic Rules. Aug 30, 2012 Page 7

8 Insurance companies have begun a reluctant move into the vitiligo territory, which was formerly ignored completely. Among the 25 providers known to be reimbursing for Excimer laser treatment of vitiligo in the US are Aetna, United Healthcare, Blue Cross Blue Shield of California and of Texas. The potential number of vitiligo patients a treatment can serve, is no smaller than the number of patients for which a blockbuster therapy can be prescribed. The only problem lies in the geographic distribution of the clients for such a treatment. The incidence of vitiligo worldwide has not been accurately measured so far, but outdated studies in Europe indicate that 0.5% of the population may be affected, whereas in India 4-8.2% incidence rates have been reported. The rough estimate leads to a number of close to 100 million people suffering from vitiligo worldwide. NEW MODELS We anticipate that treatments for vitiligo will have a very different economic model from that of conventional medicines. The combined therapy for vitiligo, which potentially includes novel diagnostic tools, targeted treatments and medical devices, will require a complex manufacturing, a scalable global supply and distribution chains, probably in temperature-controlled packaging due to novel molecular properties. This will also require a provision of support services tailored to the needs of patients taking specific therapies, with a feedback link for improvement of product efficacy and customer experience. Early market entrants might benefit from the marketing of possible diagnostic tools, such as ones predicting treatment response to narrow-band UVB in vitiligo, before the therapeutic solution is found. If a diagnostic is capable of monitoring the progression of a treatment, the value of the diagnostic will be enhanced at least two-fold. Further market expansion occurs as under-served patients enter the market, encouraged by the greater certainty of a positive outcome should they qualify for existing treatment. Some entrepreneurs, most notably in Pakistan and Poland, have already started selling anti-vitiligo packages made by competing manufacturers, in the way the travel or financial industry has been for a long time. They include drugs, over-the-counter products, vitamins, food supplements and medical devices, all wrapped in a questionable treatment protocol. OUTCOME The emphasis of this meeting is to come to an agreement on the common components necessary to support cost/benefit analyses of therapy development and individual interventions. The CRTF meeting concludes the dedicated Vitiligo day of the World Health Academy congress in an informal setting. PARTICPANTS Participants of the CEO Roundtable Task Force include (TBC): Mr. Dmitry Aksenov, Founder and President of VR Foundation (USA) Dr. Humberto Antunes, CEO Galderma S.A. (Switzerland) Mr. Stefan Coccoloni, CEO World Health Academy (Switzerland) Mr. Ken Jones, CEO Astellas Pharma Europe (UK) Prof. Andy Goren, CEO Dermagenoma (USA) Mr. Basudeo Narain Singh, Managing Director Alkem Laboratories (India) Dr. Michèle Verschoore, Director at L'Oréal Research & Innovation (France) Chairperson: Mr. Yan Valle, CEO VR Foundation. Co-Chair: Dr. Medhat Abdelmalek, the WHA Congress President. Roundtable on Vitiligo: Final program, Supplementary Materials, Basic Rules. Aug 30, 2012 Page 8

9 FURTHER DETAILS This is invite-only session. The discussion will be moderated by the VRF CEO Mr. Yan Valle, who will provide participants with specific details about this session upon request. Please forward your inquiries to the address: SUPPLEMENTARY MATERIALS The World Vitiligo Day initiative is designed to reach out to every corner of the planet, and get patients directly involved in vitiligo R&D. Why do we need official recognition by the World Health Organization and the United Nations regarding the vitiligo problem? The answer is: to push governments around the world to increase public funding for this neglected disease. What for? Because it will in turn, trigger a chain of events with positive pay-off at the scientific, economic and social levels. State of Affairs in Vitiligo Vitiligo is a debilitating and neglected skin disease, which result in an irregular loss of pigmentation over the lifetime of the patient. Two thousand years ago, the only positive thing people could say about vitiligo was this: it does not kill it s victim. Things have not changed much since then. Cases are continuously rising worldwide. While it affects up to 8.2% of the population in some regions, systemic research into causes and treatment of this disfiguring disease is surprisingly limited. Lack of effective therapies is directly linked to insufficient funding from either the public or the private sector. What a Difference $1 Can Make Multiple studies indicate that increase in publicly funded medical research leads to a substantial increase in private pharmaceutical R&D (A. Toole, 2011.) An increment of $1 in US public basic research spending is estimated to stimulate $8.38 of private pharmaceutical R&D within an 8-year period. In the UK, 1 extra, spent on public medical R&D in the UK leads to an estimated increase of in R&D by the private pharmaceutical industry. The Social Return on R&D Investment This represents a social rate of return to the total sum of public and private R&D investment that is equivalent to 26% - 34%, applicable to any therapeutic target area of medical research. Independent calculations show that for $1 additional public medical research undertaken this year, the future gain to the national economy would be equivalent to a stream of around $0.30 per year thereafter. Roundtable on Vitiligo: Final program, Supplementary Materials, Basic Rules. Aug 30, 2012 Page 9

10 When Public Funds Are Unavailable As vitiligo cases increase worldwide, new challenges arise too, including the need to step up the surveillance for unreported cases. Current dermatology practice underestimates the number of cases and masks the true dimensions of the vitiligo problem. It causes health care staff to ignore vitiligo cases that can be reported, along with precious data, at the early stage of the disease. National Ministries of Health could help us collect reliable statistical data on vitiligo occurrence in different regions and it's co-morbid diseases and conditions. This reporting does not require additional public funding, but will provide researchers with an invaluable cache of data. The Bottom Line To fight vitiligo to the end, we need to collect and analyze huge amounts of data. We need to know exactly what happens in which biological pathway, what agents and genes are involved, especially as the disease is boosted by environmental change. International recognition of vitiligo will enhance our ability to get reliable data for research and make further inroads. Roundtable on Vitiligo: Final program, Supplementary Materials, Basic Rules. Aug 30, 2012 Page 10

11 Operating Procedures and Meeting Basic Rules General 1. The Roundtable on Vitiligo (round table) is composed of representatives from: academic research institutes, pharmaceutical and biotechnology companies, key vitiligo patient support and advocacy groups, The VR Foundation (VRF) chairperson, and a specific non-vr Foundation facilitator for each major topic area discussed. Membership of the round table may be modified, at the VRF Secretariat's discretion, at any time to further the goals of this project. 2. All round table members are expected to help the Chair achieve its stated goals for this project, and cooperate in assuring the overall conduct of the round table. 3. Prof. Torello Lotti, the Chair of the VRF Board of Directors, will serve as the permanent Chair of the round table. Prof. Robert Schwartz, Chair of the VRF Scientific Committee will co-chair the round table and will serve as Chair in Prof. Lotti's absence. 4. The Chair is responsible for convening the meeting. The members are expected to contribute their individual ideas, perspectives and efforts as requested, to help ensure credible conclusions and results are reached. 5. The round table will typically deliberate in the general plenary session and small working group (dedicated Task Force) meetings. Once established, these smaller working groups may deliberate and report back any key results to the full round table to help inform discussions underway during the round table. 6. Participation: Each person is asked to fully participate in the round table deliberations. VRF is focused on improving (i) quality of life of vitiligo patients, and (ii) quality of research into vitiligo. Participants are therefore primarily requested to be mindful of this strategic objective in contributing to discussions. Participants are strongly discouraged from providing input to discussions that may be interpreted as endorsement for specific products or vendors, unless the agenda specifically calls for this. Any concerns about the progress of the deliberations or the issues being discussed should be fully aired to the group, or to the facilitator in private if appropriate, to ensure that the deliberations are effective. The motivations and intentions of participants will not be impugned. Commitments made should be kept. Disagreements will be addressed as issues to be resolved rather than battles to be won. 7. Round table deliberations are NOT open to the public or observers unless otherwise noted; however, meetings will be publicly announced, generally on the VRF web site. Note: public meetings may be held at a later time. Comments made by participants in the meetings are "not for attribution" unless all participants agree to attribute specific comments to individual participants. 8. Enforcement of the agreed upon meeting procedures is the joint responsibility of the members, the Chair, and co-chair and facilitator(s). Roundtable on Vitiligo: Final program, Supplementary Materials, Basic Rules. Aug 30, 2012 Page 11

12 Participation and Representation 9. Members are selected by the VRF Secretariat and are deemed to be representative of a wide range of stakeholder interests. Members are expected to serve on the round table until the conclusion of the related project or activity. If an individual determines s/he can no longer effectively participate as a member of the round table, a permanent substitute may be chosen. All members will be advised of such requests. The VRF Secretariat will make final decisions about such replacements. 10. Substitutes: Each member is invited to formally identify one "substitute" to represent them at round table meetings when they cannot personally attend. If a substitute cannot attend, the member should not send any other representative. The formal member is responsible for keeping their substitute informed as the processes evolve, so that the substitute can effectively participate in the meetings when needed. 11. Technical experts and resource people: The VRF Secretariat anticipates that during the course of this initiative, there will be a need to bring in "technical experts" or other "resource people" to assist round table members in understanding specific issues. These individuals may be invited to project/activity meetings to provide information to the round table members. 12. Recognized and invited observers, as well as any member of the public may be allowed to attend meetings. When observers and/or the public are present, they will not sit at the meeting table. They will participate in the deliberations only as requested. The VRF will make final decisions about such observers. Agenda development for the next round table meeting 13. Members may assist the VRF Secretariat staff in defining what issues will be addressed by the round table and the priority for addressing these issues. 14. The VRF Chair and co-chair, with the assistance of subject facilitator(s), are responsible for building the agenda for each meeting; circulating this agenda to all members at least 10 working days in advance of scheduled meetings, whenever possible; receiving comments; and presenting the final agenda to round table members in advance of the meeting. 15. Subject facilitators may be called upon to make presentations prior to leading discussions in a particular subject area. In such cases, facilitators are asked to provide a summary of their presentation, formatted according to a circulated VRF secretariat template, at least five working days before the meeting, for inclusion into the meeting welcome brief. 16. Agenda building process: Members will have a chance to identify issues or potential agenda items for the next meeting or for inclusion in meeting proceedings. If members have ideas or suggestions for the upcoming meeting, these should be forwarded to the VRF Secretariat, following the conclusion of each meeting, for consideration by the Chair or facilitator, at least 30 days prior to such meeting. Roundtable on Vitiligo: Final program, Supplementary Materials, Basic Rules. Aug 30, 2012 Page 12

13 Record keeping 17. A round table meeting summary will be jointly prepared by the VRF Secretariat staff and the facilitator following each meeting. This will summarize the key points covered during the meeting as well as any decisions made by round table members related to their deliberations. Meeting summaries will record key points of the discussion without attribution to individual round table members. If all members agree there is a necessity or value in attributing specific comments and ideas to individuals, this procedure can be adjusted to meet members' needs. 18. Draft meeting summaries will be sent to round table members for review and comment following each meeting. Final summaries will be presented to members prior to or at each subsequent meeting, in the form of meeting proceedings. 19. All or parts of meetings, except when noted otherwise, may be recorded digitally by rapporteurs in order to facilitate ease of transcription. 20. All or parts of meeting proceedings will be posted to the VRF website ( and sent to interested parties upon request. The VRF reserves the right to withhold the publication of information that may be misleading to the general public in regard to specific healthcare issues, such as certain disease conditions, untested or prospective treatments, etc. Decision making 21. The VRF Secretariat makes all decisions related to the results or outcomes of these deliberations. The VRF Secretariat decisions will be linked exclusively to the VRF's own planning processes. 22. The round table has been organized to operate collaboratively. However, "consensus" will NOT be sought on key issues under discussion unless specifically called for in the agenda, or by the chairperson. Rather, the VRF Secretariat will seek to fully expose and understand all different perspectives offered by round table members. Where it is important to record the "sense of the entire membership" on specific issues, this will be recorded as part of round table meeting summaries. Document dissemination and use of the VRF website 23. All or parts of the round table meeting proceedings (see #20 above) will be posted to the VRF website and ed upon request to interested parties. 24. All round table documents prepared and disseminated by the VRF Secretariat may also be posted on the VRF website or websites specific to this project/activity. 25. All other documents [e.g. documents supplied by roundtable members] may be posted on the VRF website or websites specific to this project/activity with their permission and without comment by the VRF Secretariat. Hard copies of these documents will not distributed, except to meeting participants in the respective meeting welcome pack. Roundtable on Vitiligo: Final program, Supplementary Materials, Basic Rules. Aug 30, 2012 Page 13

14 Communications with the press or other outside parties 26. Round table members feel that it is important for any member to be able to talk with the press, stakeholders and/or any other interested parties at any point in time regarding their individual participation on this project/activity. Members also agree that no member should attempt to characterize the comments of any other member. Similarly, members should not attempt to characterize how the full round table membership feels about any particular issue, nor should any member attempt to provide an overall status report on the project. The VRF Secretariat, as a member of the round table, should seek concurrence from the round table on any press releases or public notifications it issues specifically related to round table deliberations. [Normal meeting notifications by the VRF Secretariat are exempt from his procedure.] The VRF is under no constraints to disseminate information related to any other aspect of this project/activity. 27. Mrs. Alessandra Fabbri Palmieri will serve as the VRF Secretariat's public contact for this project. Round table members can refer inquiries to Mrs. Palmieri where appropriate. a.palmieri@vrfoundation.org Telephone: Changing or modifying basic rules when necessary 28. If members think that the basic rules need to be modified at any point, they may present proposed revisions to the Chair, co-chair and the other members, and ask for discussion and concurrence. Roundtable on Vitiligo: Final program, Supplementary Materials, Basic Rules. Aug 30, 2012 Page 14