NEWSLETTER SPRING - 1999

ROSTER OF RPSC OFFICERS FOR 1999-2000 ...... ……...... ….….…1 MEMBERS OF RPSC STANDING COMMITTEES ...... ……...... ……...2 PRESIDENT’S ADDRESS ...... ……...... ……….……...3 PAST-PRESIDENT’S ADDRESS ...... ……...... ………4 MINUTES OF THE B.O.D. MIDWINTER MEETING, FT. LAUDERDALE……...... 4 REPORT: HIGH COUNTRY MEETING, VAIL, …………………………………..…6 SYMPOSIUM: MEDICAL UNIV. OF S. CAROLINA, WASHINGTON DC………..7 MINUTES FROM HOUSE OF DELEGATES MEETING, FT. LAUDERDALE……..9 ELECTIONS ’99: CANDIDATE BIO-SKETCHES……………………………….….13 RPSC PROGRAM FOR ANNUAL SNM.....…...... …..……………….18 REMINDER: UPCOMING MEETINGS ...... …….……..…...19 TREASURER’S REPORT...... ………………….…..22 **OFFICIAL ELECTION BALLOT**…….…………………………………………..…...23

ROSTER OF RPSC OFFICERS FOR 1999-2000

President John W. Babich, Ph.D. Biostream, Inc. 160 2nd Street Cambridge Cambridge, MA 02142 Phone: 617- 492-5554 FAX: 617-492-5664 E-mail:

President-elect Mark M. Goodman, Ph.D. Emory University Hospital, Radiology Dept. 1364 Clifton Rd. NE Atlanta GA 30322 Phone 404-727-9366 Fax: 404-727-4366 E-mail:

Past-President James Kronauge, Ph.D. Brigham and Women's Hospital, Radiology Department 75 Francis Street, Boston, MA 02115 Phone: 617-732-7171 FAX: 617-734-4757 E-mail:

Secretary/Treasurer Katherine Seifert, RPh, BCNP Syncor International Corporation 20001 Prairie St., Chatsworth, CA 91311 Phone: 818-717-4514 FAX:818-717-4514 E-mail: Board of Directors (1996-1998)

John Lister-James Ann Warbick-Cerone Yu-Shin Ding, Ph.D. Diatech Inc. Health and Welfare Brookhaven National Labs 9 Delta Drive 775 Brookfield Rd. Chemistry Dept. Londonderry, NH 03053 Ottawa K1a 1C1 Upton, NY 11973 Phone: 603 437-8970 Ontario, CA Phone: 516-344-4366 FAX: 603-437-8977 Phone: 613-954-6704 Fax: 516-344-7902 Fax: 613-941-5841 [email protected]

Board of Directors (1997-1999)

Carolyn Anderson F. F. “Russ” Knapp Robert Wolfangel (314) 362-8427 (615) 574-6225 (314) 895-2203 e-mail: andersoncj@ e-mail: [email protected] e-mail: [email protected] mirlink.wustl.edu

Representative SNM House of Delegates (June 1997- June 1999)

Suresh Srivastava (516) 344-4459 e-mail: [email protected]

Members of RPSC Standing Committees Following is a list of the standing committees dictated by the council’s by-laws with names and phone numbers of their corresponding chairmen and members. If anyone has suggestions, questions or comments concerning the duties performed by these committees they are encouraged to contact the chair or a member.

Program Communication Members & Finances Nominating John Babich Mark Goodman Kathy Seifert Jim Kronauge [email protected] [email protected] [email protected] Per Bremer Alan Packard Ron Crowe per.bremer@ [email protected] ron [email protected] isopharma.no Pat Gallagher Steve Mattmuller Henry Van Brocklin [email protected] Tim McCarthy [email protected] A three-day seminar was held on March 10- MESSAGE FROM THE PRESIDENT 13 on "Accomplishments with Medical ". This conference was a mix Presidents message of policy discussions and scientific Spring 1999 presentations. The issue at hand was the role of government with regard to research Dear Colleagues, involving isotopes and breakthroughs in medical sciences as a result of that research. Welcome back to the renovation of the A number of SNM members participated on Council Part II. In our first installment we different panels. Dr Bob Atcher has kindly mentioned the increasing role the council provided us with a synopsis of this meeting. will be expected to play in the Society. The Dr. Kronauge will report on the annual High roles of advisor, leader, expert, lobbyist and Country meeting, a gathering that usually supporter. The execution of these roles heralds the coming of new appears to hinge on the establishment of a . The implications of more clearly defined mission for the council Jim's report are intriguing to me and may be and a further clarification of the roles of its to you as well. members, directors and executives. This will be the focus of Phase II. The interval between newsletters has seen the passing of two important figures in the There are definite tasks that the council must field of chemistry related to our field, Dr. engage in. We are adding significantly to the Glenn Seaborg and Dr. Al Wolf. Dr. Wolf large educational commitment of the council has been a central figure in the development and, consequently, the council is attempting of P.E.T. and many of the field's leaders to set up more structured roles for its have been mentored by him or worked membership, board of directors and closely with him. His will be missed by executives. Dr. Henry Kramer of CORAR many. has been kind enough to help me establish an understanding of how CORAR has set up I want to take this opportunity to thank Pat it's "response team" to deal with regulatory Gallagher, Jason Lewis, Tim McCarthy and and other governmental issues. I hope to be Henry Van Brocklin for doing such an able to present an outline of our strategy for outstanding job in putting together our implementing a similar plan at the annual educational program for the upcoming business meeting. Between newsletters I meeting. Jim Kronauge should be have tried to use e-mail to engage the commended for finding those of you council members in assisting in some of courageous enough to throw your hat into these processes. In this regard, we have been the election arena. I also need to contacted by Dr. Fletcher, President of acknowledge Mark Goodman's patience in the Society of Nuclear , Dr. dealing with the president and his writers Silberstein, Chairman of the Commission on block! Radiopharmaceuticals, as well as the Government Relations office and have been I look forward to seeing many of you in made aware of the need to weigh in on June. certain FDA and NRC issues. To date only a hand full of individuals have responded to John Babich requests made by the council. Message from the Past-President moment of silence began the meeting in recognition of Dr. Al Wolf for his many Join the fun: contributions to the field. Dr. Suresh Srivastava noted the establishment of a As you may know, the scholarship fund in Dr. Wolf’s memory, and Science Council is dictated by its bylaws to the group suggested the Council hold elections every year for officers to commemorate Dr. Wolf’s years of service serve for two year terms. Next year, being with something more formal, perhaps at the an odd year, there will be openings for three Categorical Seminar in June. members to serve as Board of Directors of the science Council. Nominations for The minutes of the meeting were printed in candidates are made at the mid-winter the Newsletter, and approved by vote of the meeting by the nominating committee and committee. The group was informed that ballots mailed to all members in the spring the RPSC-sponsored Categorical Seminar newsletter. RPSC Board members are scheduled for June 6, 1999 is entitled expected to attend the business meeting and “Neuropharmacology.” Members of the some SNM committee meetings held the day Council may also be interested in another before the national meeting. They may also Categorical Seminar to be held the same day be asked to represent the Council as a voting entitled “Recent Developments in member on another Society’s’ committees. Therapeutic ” and is This is the best way to learn what the sponsored by the Council. Society does and express your opinions on the future of the profession. It is also fun to Dr. Babich led a discussion on the evolving learn what is going on and to develop new role of the Radiopharmaceutical Science and better friendships. At the risk of setting Council and its relation to the Society of an unheard of precedent, we would like to Nuclear Medicine. This evolving role is start the process early this year and extend related to the SNM Policy Discussion paper the offer for members to volunteer to run for which seeks grass roots input and office. Hopefully, this will avoid the participation from a wide group on policy inevitable last minute rush and open up the development. The concomitant change council leadership roles to more members. anticipated for RPSC is a modification in the If you are interested in running for office, primary mission for the Council from an please contact any member of the educational focus to a source for specific nominations committee or myself. Looking expertise and associated policy input. Dr. forward to seeing you all in LA. Babich proposed a more structured Council with specific individuals assigned to projects James F. Kronauge, Past President RPSC or areas. These areas would be somewhat narrow, with many members participating, Minutes from the Radiopharmaceutical limiting the time commitment for any Science Council Midwinter Meeting, individual to a manageable level, February 6, 1999 encouraging participation. Areas or projects will be identified, similar to a list CORAR The February 6, 1999 meeting of the has developed, and Council members are Radiopharmaceutical Science Council was encouraged to “step up to the plate” and called to order by President John Babich identify area(s) where they are willing to with approximately 20 members present. A support the Council with their area of (OMB) recommendation on the DOE budget expertise. was to drop the funds designated to the Mo- 99 initiative due to the fact that Sandia A current issue serves as an example of this production facilities are intended to be concept and a need for RPSC contribution. transferred to the private sector. An RFP on An article appearing in Nuclear Medicine & this will be appearing in the Federal Register Biology proposes various parameters to be soon. tested in pre-clinical studies, toxicology and clinical trials for a radiopharmaceutical. DOE’s FY2000 budget proposal also There are aspects of the article that should includes $2.5 million for the Advanced be refuted, and one way to do so would be Nuclear Medicine Initiative. This initiative through a Letter to the Editor in JNM. SNM is intended to support peer-reviewed leadership asks representatives of the RPSC research to further advance nuclear medicine to submit such a document. technology in the US. It would support nuclear science through direct research Another agenda item discussed was the idea grants and through making isotopes of establishing a website for the available for research at affordable prices, Radiopharmaceutical Science Council. This establish scholarships, fellowships, and would include items of interest to Council internships at certain institutions, and initiate members. Possible topics to include were a focused program to apply alpha-emitters this newsletter, mission, training, for therapy. The Council is requested to regulations, and perhaps a chat room or review this proposal and give guidance to bulletin board. Another possibility would be DOE on this proposal. hot links to other areas of interest, such as graduate programs. Further work will be Members of RPSC were informed that the needed to make this a reality, but it is a issue of availability has been concept to explore and is considered one subsumed into the Council, and the Council aspect of the evolution of the Council and was requested to establish a task force to our utilization of today’s technology. deal with this issue.

The group discussed isotope availability The nominating committee of the RPSC issues, particularly the DOE budget for announced candidates for three Board FY2000. Additional funds of $3.3 million Member positions and a representative to are proposed in the budget, intended for SNM House of Delegates. Nominated for developing and improving isotope Board Member are Dennis Eshima, Henry production and services that enable medical Van Brocklin, Leslie Kawlhi, Tim diagnoses and therapy. The Nuclear Energy McCarthy, Suzanne Smith, and Robert Resource Advisory Committee (NERAC) Mach. Nominated for House of Delegates has influence on how these funds are spent, are Don Hnatowich and Alun Jones. but its membership is primarily nuclear engineers and its focus is primarily energy. The committee was notified of various Opportunity could exist to nominate upcoming events, including a seminar in someone from the nuclear medicine Washington entitled “Accomplishments community to this committee, and efforts with Isotopes” to be held March 10-13 and are underway to encourage that outcome. upcoming NRC meetings scheduled for The Office of Management & Budget February 18-19 on the training and education requirements in the proposed procedures and thus secure third party changes to Part 35. payment for them. Emphasis was placed on clinical study design to establish the value of The meeting was adjourned. Nuclear Medicine in diagnostic paradigms. The afternoon session, organized by Respectfully Submitted, representatives of the industry sponsored organization CORAR (Council on Katherine L. Seifert and Radiopharmaceuticals), Secretary/Treasurer presented in painful detail the economics associated with the NDA submission process. They also detailed the discouraging Report & Commentary on the High lack of progress in achieving reductions in Country Nuclear Medicine Meeting, Vail, toxicity and clinical testing requirements for Colorado, February 26-March 3, 1999 new diagnostic radiopharmaceuticals as mandated in the Food and Report & Commentary on the High Country Modernization (FDAMA). Nuclear Medicine Meeting, Vail, Colorado, February 26-March 3, 1999 Sunday's sessions, as has been the case in recent years, were dedicated to "New I was excited to be able to attend the High Directions in Nuclear Cardiology". These Country Nuclear Medicine Meeting again sessions, organized by Drs. Daniel Berman this year because, although the ski and Robert Hendel, were very well attended, conditions were only good (I get bored with but it appears, at least from these packed powder, sun, and 50 degree presentations, that the future of Nuclear temperatures), this meeting brings out the Cardiology lies primarily in instrumentation Scions of the Nuclear Medicine Industry and not radiopharmaceutical development. The even a few government regulators. It importance of this topic was exemplified by therefore has a track record of being a the substantial representation of the sounding board for new clinical products instrument companies at the conference. from both industry and academia. So, as a Unfortunately, there was not as much Radiopharmaceutical Chemist, I waited with interest in new myocardial imaging agents baited breath to see what the future of (e.g., antimyosin, MIBG or hypoxia agents) Nuclear Medicine held in store. This years as there was in new non-nuclear imaging meeting was, however, somewhat different modalities. from previous High Country meetings. It's not that there is not a lot going on in Nuclear Monday's session returned to the topic of Medicine these days, but the information "Clinical Study Design and Outcomes that was presented at the meeting was rather Assessment" with talks ranging from sobering. (A concept I do not enjoy on a industry presentations on regulatory affairs persistent basis). issues to reports on progress in reimbursement and cost-effectiveness The meeting began Saturday morning with a studies. In the afternoon, Drs. Naomi session organized by Drs. James Fletcher, Alazraki and Angelika Bischof-Delaloye Frank Papatheofanis and Leslee Shaw on (President of the EANM) chaired a session Technology and Outcomes Assessment as on non-approved indications and tools to validate specific Nuclear Medicine international perspectives for harmonizing non-approved indications. This was were followed by presentations by Ms. Ruth followed by presentations from Tesar and Drs. Coleman and Lamb on representatives from the FDA on QC future O-18 availability, regional FDG requirements for IND and NDA submissions distribution networks, other PET and moderated by Dr. Jim Lamb . Jim Lamb how long HCFA will withhold and Kenneth Breslow also presented an reimbursement for PET. update on the ongoing guideline development process with the FDA for FDG I stayed on for another day with a group of and PET radiopharmaceutical production. five friends; chemists, radiopharmacists and entrepreneurs who have become an Tuesday morning was dedicated additional incentive to attend this meeting. "Radiotherapy with Unsealed Sources" We skied and discussed the week's moderated by Drs. Homer Hupf and Aldo presentations and the future of Nuclear Serafini. Although no new agents were Medicine in general and introduced, Drs. Serafini, Rich Wahl, and radiopharamaceutical development in Gerald DeNardo presented a concise review particular. Having all been in this field for of the three radiolabeled antibodies now in many years and having attended the High clinical trials for non-Hodgkin's lymphoma. Country meeting many times, we were not This was followed by presentations by Dr. surprised with the meeting's emphasis but Sumil Patel's on the use of I-131-chTNT-1/0 are worried about the escalating barriers for treating recurrent gliomas and Dr. Sally (both financial and regulatory) to the DeNardo on RIT in the treatment breast and discovery and commercialization of new prostate CA. Dr. Russ Knapp closed the diagnostic and radiotherapeutic agents. It's session with a presentation on the use of not that there are not a lot of interesting beta emitters for coronary restenosis projects out there to work on, it's just that therapy. many of them target such a small patient population that there is little industrial Tuesday afternoon was organized by Drs. incentive to pursue them, particularly in the Mike Devous and Tom Hill and focused on context of the high cost of obtaining the "Acute Stroke, Data Analysis, and data necessary to support an NDA. Some of Functional Imaging Techniques". Again, these agents fall under the auspices of the the emphasis was on instrumentation FDA Orphan Drug program, but we are not development, especially in non-nuclear sure that the FDA has the budget to support modalities such as functional MRI and the development of all that many new drugs MEG, and image analysis and statistics. No under the auspices of this program. I hope new developments in neuroreceptor I'm wrong and just being a worrywart. It radiopharmaceuticals, neuropharmacology would be nice to be wrong, another concept or psychiatry were presented. I do not enjoy on a regular basis.

The final session on Wednesday morning, Again, gleefully submitted by: organized by Drs. Rich Wahl and Ernest Garcia, was devoted to the status of clinical James Kronauge and Alan Packard PET. This session included a wide variety of issues including presentations by Drs. Wahl, Coleman and Garcia on the current clinical status of PET in the U.S. These staff from FDA or NRC in evidence. Thus, Symposium: Medical University of South most of the discussion will have little impact Carolina, Washington, D.C.: on decision making by any of the agencies “Accomplishments With Isotopes in with respect to either funding of research, or Medicine” regulatory issues.

This meeting exclusively focused on nuclear Also: medicine and therapy issues. The meeting ranged from formal presentations The Nuclear Energy Research Advisory from physicians and scientists on scientific Committee of the Dept. of Energy has advancements in nuclear medicine to a established a subcommittee chaired by roundtable discussion of whether the Richard Reba to look into the Isotope government was doing enough to cure Production capability within the DOE cancer. As a major sponsor, the DOE system. In addition to the Missouri Univ. Isotope Production office used one of the Research Reactor and International Isotopes sessions to review what is going on in the Inc., the DOE sites include Brookhaven area of isotope production. As you would National Laboratory, Los Alamos National expect, members of that office were well Laboratory, Oak Ridge National Laboratory, represented in the audience. Pacific Northwest National Laboratory and Sandia National Laboratory. The capabilities In my view, the three most interesting talks examined include enriched stable isotopes, were given by people outside of the field of reactor-produced radioisotopes, and nuclear medicine. A cardiologist talked accelerator-produced radioisotopes. about radiotherapy to prevent re-stenosis after angioplasty. A radiotherapist talked contributed by- Robert W. Atcher about using radioisotope implants for focusing on I-125 and Pd-103. Finally, a surgeon who is working AL WOLF AWARD on the use of labeled somatostatin receptor binding compounds for therapy talked about As many of you are probably aware Al Wolf their work utilizing Auger emitters for died on December 17th. His stature in the therapy. In the latter case, isotope field was unique both as a scientist and an availability was a major problem. educator. In recognition of his contributions to the field, a fund has been set to support There were cancellations by advertised an Al Wolf lectureship and Al Wolf speakers including VP Gore, Sen. Hollings student International fellowships at the and Under Secy. of Energy Moniz. Rep. series of meetings "Symposium on "Doc" Hastings from Washington spoke on Radiopharmaceutical Chemistry" (ISRC). Isotope Availability issues and Sen. Breaux Dr. Wolf organized the first meeting in this spoke on the Medicare Commission. series held at Brookhaven in 1976 and always expressed the opinion that they were A disturbing aspect of the meeting was the the "most important meetings in the field". fact that only one member of the Medical Science Division of DOE was present for The fund will be administered through The the meeting. In addition, no member of the Stony Brook Foundation of Brookhaven program staff of NIH was present, nor were National Lab with a five person advisory committee of which two would be Report of the House of Delegates Meeting Brookhaven staff selecting the awardees. The other members would be from the A meeting of the House of Delegates was founding committee of ISRC. held on February 7, 1999, during the Mid- Winter SNM meeting in Fort Lauderdale, FL. As is usually the format for these Contributions should be made to: meetings, a number of diverse issues, action items, and proposals were considered, Stony Brook Foundation/ Al Wolf Award discussed, and voted upon. Although there and mailed to:- were no specific issues that might Jean Peterson significantly impact RPSC, one general Chemistry Dept outcome from the meeting was that the Brookhaven National Lab SNM in the future is going to increasingly Upton NY 11973-5000 look up to the various Councils for input and help, and more regularly seek expert advice Contributions are tax deductible in the USA. in a proactive fashion. If you have any questions please contact either Mike Welch ([email protected]) The meeting was well attended with 75 or Joanna Fowler ([email protected]) percent of the membership present. The day-long meeting included a number of agenda items for discussion. The highlights GLENN SEABORG are summarized below.

Glenn Theodore Seaborg, Nobel Laureate SNM Strategic Plan chemist, discoverer of 10 atomic elements including and one that now bears High on the agenda at the meeting was a his name, Associate Director-at-Large of the discussion of the SNM draft Strategic Plan Lawrence Berkeley National Laboratory, recently unveiled by the Strategic Planning University Professor of Chemistry for the Committee. While a number of editing University of California, and co-founder suggestions were made, the primary focus of and chairman of the Lawrence Hall of the draft seemed to have fairly wide Science, died February 25, 1999. endorsement. The draft plan now goes to the Board of Directors where suggestions For more information visit The Seaborg made at the Mid-Winter Meeting will be Website: His Life and Contributions online taken into account and a final draft prepared at: for further member comment and final http://www.lbl.gov/seaborg/http://www.lbl.g House of Delegates consideration at the ov/seaborg/ Annual Meeting in Los Angeles.

Photographs of Seaborg online at http:// SNM Policy Process www.lbl.gov/Science-Articles/Archive/ seaborg-photo-gallery.html http://www. The agenda included a public forum on the lbl.gov/Science-Articles/Archive/seaborg- strategic plan as well as an extensive photo-gallery.html. discussion about the need and format of a formal policy process for the Society. Using a draft discussion paper prepared by staff, the House directed the formation of a special SNM Procedure Guidelines task force to review the staff paper and make specific recommendations to the Board and It was approved to have the revision of 22 House for the implementation of the current SNM Procedure Guidelines and approach suggested in the paper, with three guidelines as presented in House appropriate refinements. Dr. Carretta, agenda background material, available at the incoming president of the SNM, has been SNM website. appointed to chair the task force that was to report to the Board of Directors in late Nominations March. The House also directed that a review be conducted of all current SNM The Society Nomination Committee, chaired policies and recommendations made to the by Dr. William Strauss, announced House of their continuing efficacy. candidates for national office and the House of Delegates. Candidates for Vice President Alliance With Other Organizations Elect are Dr. Hani H. Abdel-Nabi and Dr. Alan H. Maurer, and Historian candidates The House also approved a resolution are Dr. Richard J. Campeau, Jr. and Dr. authorizing the formation of a task force to Dennis D. Patton. House of Delegate enter into discussions with the American Delegate-at-Large candidates include Dr. College of Nuclear Physicians (ACNP) Kevin J. Donohoe (New England), Dr. regarding the development of a strategic Michael J. Guiberteau (Southwest), Dr. alliance between the two organizations Robert E. Henkin (Central), Dr. James L. which would feature consolidating Littlefield (Missouri Valley), Dr. Martin L. administrative and staffing resources for the Nusynowitz (Southwest), Dr. D. Bruce two organizations under the auspices of the Sodee (Central), and Dr. James M. SNM. The task force, if approved by the Woolfenden (Southern California). ACNP Board of Reagents (which initiated the request for discussions), was directed to Awards report back to both respective boards with a draft letter of understanding no later than the The Awards Committee, headed by Dr. SNM meeting in June. William J. MacIntyre announced that Dr. Walter Wolf would be the recipient of the In a related but separate resolution, the 1999 Paul C. Aebersold Award, Dr. Esther House approved entering into discussions Lim won the 1999-2000 Mallinckrodt with the American College of Nuclear Fellowship, and Dr. Carol Marcus would Medicine (ACNM) for the development of a receive the Distinguished Service Award. strategic alliance that would maximize the effectiveness of the educational program Latin American Guests associated with the Mid-Winter Meeting. Discussions were expect to begin shortly. Several representatives from Latin American By a majority vote, the House also endorsed countries were guests of SNM President Dr. the AMA Collaborative Intent which James Fletcher at the Mid-Winter Meeting establishes goals for the AMA Federation of and also attended the meeting of the House Medicine. of Delegates. These included Dr. Horacio Amaral of Santiago, Chile, President of the World Federation of Nuclear Medicine and Biology; Dr. Marco Villanueva-Meyer, enforcement left to the states and with President of the Association of Latin Boards of Medicine and Pharmacy assuming American Societies of Biology and Nuclear their rightful roles in regulating Medicine (ALASBIMN), from Lima, Peru, professionals; and further, that Dr. Patricio E. Gonzalez, Secretary General implementation of this policy be referred to & Scientific Chair of the WFNM&B 2002 the SNM Government Affairs Committee.” Congress in Santiago; Dr. Silvia Vazquez, President of the 1999 ALASBIMN Congress A few other informational items that may be in Buenos Aires this year; Dr. Sonia of interest to the RPSC membership Merlano, President, Colombian Society of (excerpts from the periodic “Leadership Nuclear Medicine, Bogota, Colombia; Dr. Reports”, sent by the SNM Executive Carlos Martinez-Duncker, former president Director, Bill Bertera) are reproduced of the Mexico Society of Nuclear Medicine; below. and Dr. Edward E. Camargo, former president of the Brazilian Society of Nuclear SNM Website Medicine and ALASBIMN. These various representatives made brief statements to the Those of you who use the SNM website House of Delegates, mainly to convey their have noticed a number of changes over the greetings and appreciation for having been last few months designed to make the site asked to participate, and to extend a general easier to use and more useful. We continue invitation to all SNM members to attend the to make changes to it as the result of your various upcoming scientific meetings in comments. Mei Wang, our full time web South America. master, updates the site daily. As with all sites that are as complex as ours, navigation Statutory Authority for Nuclear Medical, is a continual challenge. We are constantly and Biomedical balancing the need for more information Research Use of Byproduct Materials against the need for easier access...sometimes the two are not entirely It was moved, seconded and voted that, “It is compatible. Still, the Society is investing in the policy of the Society of Nuclear the web as a key communications tool for Medicine to achieve, through all appropriate the future. Please contact Mei at means, a regulatory environment which [email protected] for comments, maximizes the ability of physicians to suggestions or questions. provide full access and quality nuclear medicine service to patients”. It was further SNM/ACNP Discussions moved in support of the original motion, that, “It is the policy of the Society of A joint task force of representatives of the Nuclear Medicine to vigorously seek Society of Nuclear Medicine (SNM) and the legislative relief from the Nuclear American College of Nuclear Physicians Regulatory Commission’s regulation of (ACNP) was set to meet in Washington on nuclear medicine, nuclear pharmacy and the April 16th to begin discussions on an biomedical research use of byproduct agreement to consolidate administrative materials, while leaving intact the basic services for both organizations under the standards of 10 CFR Part 20 applying to auspices of the SNM. Drs. Jim Fletcher, workers, members of the public, and the Bob Carretta and Jonathan Links environment; with interpretation and represented the SNM and Dr. Jim Woolfenden, Dr. Don Podoloff and Bill adequate protection from non-radioactive, Ehmig represented the ACNP. Executive toxic material in MLLW. We are also in directors for both organizations participated. agreement with EPA’s exemption for Both ACNP and SNM have formally MLLW, which permits to adopted resolutions authorizing and occur on site. This exemption would not endorsing the talks which are expected to hinder safety results and would incur no lead to a signed letter of agreement in June extra cost. To read the comment letter, visit of this year. The move is designed to reduce the SNM web-site at www.snm.org. unnecessary duplication, improve communication and eliminate unnecessary Advanced Nuclear Medicine Initiative: Only expenses not directly related to providing a month ago, the Society of Nuclear goods and services to members. Medicine and the Department of Energy were heralding the Advanced Nuclear Miscellaneous Medicine Initiative. This $2.5 million initiative was the first of its kind and would Bill Uffelman joined the staff on April 1st as have focused on increased availability of the new Director of Public Affairs/General radioisotopes used in research to fight Counsel, replacing David Nichols who has such as breast cancer and non- taken a position with a D.C. Lobbying Hodgkin’s lymphoma. But before the firm...Registrations and exhibit space sales Department of Energy can actually put these for the 1999 Annual Meeting are matching funds to their intended uses, it must first those of last year at this time, indicating a receive them, and that may be harder than it very strong annual meeting in Los Angeles. first appeared. Send in your Registrations now to get the hotel of your choice...A list of accepted In 1997, in order to balance the budget and Annual Meeting Abstracts is on the SNM reduce federal spending, spending caps were website. Look under “Hot Topics.” Also on imposed. The caps worked and the budget the website under “Hot Topics” are the was balanced four years ahead of schedule. candidates for SNM office for the coming However, the spending limits have not been year. removed. As it stands now, any spending above the caps would be using money that SNM/ACNP Comment on Mixed Low-Level many members of both the House and Regulation: ACNP and Senate feel should be used to safeguard SNM were very supportive of the Social Security. In order to keep the Environmental Protection Agency’s plan to spending level at the desired level, Congress upgrade its mixed low-level radioactive will have to take a policy of “no new waste (MLLW) regulations. As programs,” and the Advanced Nuclear stakeholders in this area, we have long Medicine Initiative could be cut from the appreciated the peculiar status MLLW holds budget despite having the support in the within the regulatory confines of radioactive Presidential budget. In the end, the battle and non-radioactive toxic waste. As such, will be played out in the appropriation we support any effort by EPA to improve committees, in this case, the House Energy the present situation. In our comment letter and Sub-Committee chaired by to EPA, ACNP/SNM said that the Nuclear Representative Ron Packard (CA), and the Regulatory Commission’s regulations for Senate Energy and Water Development Sub- on-site storage to decay were more than Committee, chaired by Pete V. Domenici (NM). We will keep you posted, as more helped open a new department of nuclear information becomes available. medicine at the University of Massachusetts Medical Center where I am now If any of you have questions or need more Professor of Radiology and Director of the information/clarification on the above items Radiopharmacy. Along the way, I got my particularly those discussed and debated at name on 120 publications, organized one the House of Delegates meeting in Fort international symposium and several Lauderdale, please contact me (S.C. categorical seminars, became section Srivastava, Tel: (516) 344-4459, Fax: (516) editor of the Quarterly Journal of Nuclear 344-5962, e-mail: [email protected]) and I medicine, served on the editorial boards of will attempt to respond as best as I can. several journals, consulted for the NIH, Also, if anyone wishes to suggest submitting IAEA, other funding agencies and industry, a(ny) resolution for review and/or action by reviewed articles for numerous journals and the House during the SNM meeting, let me held offices in the International Association know and I will try to help. Unfortunately, of Radiopharmacology. My research the deadline for submission is May 10, 1999 interests continue to be the development of and as such, resolutions submitted after this 99mTc-labeled agents but are now date will be considered only as potential increasingly focused on molecular “new business” items on the agenda at the biology in an attempt to catch the wave of June meeting. the revolution in molecular medicine. I have been a member of the SNM since Elections 1999: Bio-sketches for 1970 but I first became involved in the Radiopharmaceutical Science Council RPSC only in 1984 when I was elected to Candidates. the Board of Directors. More recently, I was privileged to serve as President-Elect and FOR HOUSE OF DELEGATES: then President of the RPSC from 1992-1996. I just rotated off as Past-President last June. Donald J. Hnatowich, Ph.D. These were exciting times, especially as a After receiving my doctorate in 1968 from number of changes occurred within the MIT in nuclear/, I spent 1 1/2 SNM which impacted on the RPSC. In years as a Visiting Scientist at CERN in particular, the SNM underwent its Geneva, Switzerland pursing pure research restructuring and the Councils were given in decay scheme analysis. However, a long- representation in the House of Delegates standing curiosity about the applications of (HOD). In addition, a Radiopharmaceutical radioactivity to medicine led me to a Commission was established to coordinate postdoctoral position in the laboratory of Al radiopharmaceutical issues among the SNM Wolf at Brookhaven National Laboratory. and other concerned organization. At times Once infected with a love of it was a struggle to keep the spotlight radiopharmaceutical development, it must focused on the RPSC as the body within be forever. I went on to my first real job as which much of the expertise on radiopharm- a Research Associate under Gordon aceutical matters resides. I think success Brownell using both the MGH and was achieved. In my view, the responsibility MIT reactor. activation analysis, of our HOD delegate is to represent the 18F target development, 68Ga radiopharm- RPSC in the HOD by acting in accordance aceutical development, 191Os generator with the wishes of the RPSC membership as development, etc. occupied my time for a determined by its officers. Implicit is the satisfying eight years. Finally, in 1978, I need to stay current regarding the issues 1989, I became President-Elect of the before the SNM which are likely to affect Council and President in 1990. Since 1992 I the RPSC membership and, whenever have been a Councillor in the New England necessary, to bring these issues to the Chapter of the SNM. In 1993, I became a attention of the RPSC. I believe I can be co-recipient of the Paul C. Aebersold Award helpful in projecting the RPSC's interests from the Society. In running for this office, I within the HOD and I would welcome an would like to see the importance of the opportunity to do so. Council and the roles being played by its members become better recognised within Alun G. Jones, Ph.D. the Society and would actively try to find new ways to encourage talented scientists I am a Professor of Radiology at the Harvard and pharmacists to enter this exciting field Medical School and at Brigham and of medicine. Women’s Hospital, Boston. I am also Director of the Radiopharmacy of the Joint FOR BOARD OF DIRECTORS: Program in Nuclear Medicine at the medical school, an organization that involves five of Dennis Eshima Ph.D., RPh., BCNP the major teaching hospitals. Approximately 80% of my time is spent in research, I received my B.Sc. in Pharmacy and primarily in studying the basic chemistry Business from the University of Colorado, and radiopharmaceutical chemistry of after which I obtained Board Certification as technetium and rhenium. In this, I have a Nuclear Pharmacist through the American collaborated extensively with Professor Alan Pharmaceutical Association. I subsequently received my PhD from the University of Davison from the Department of Chemistry Utah in Pharmaceutics where my graduate at M.I.T. I have published 195 refereed work focused on the development of new journal articles and am listed on 8 patents. Tc-99m renal tubular function agents, in In terms of clinical and teaching particular MAG3. responsibilities, the JPNM Radiopharmacy supplies routine and non-routine After completing my PhD., I continued with radiopharmaceuticals to four of the Harvard a post-doctoral fellowship at the University teaching hospitals and also plays a central of Utah where we continued to work on the role in supporting clinical trials at each development of an improved renal tubular institution. The unit also provides function agent. In 1986, I relocated to internships and practical experience for Emory University in Atlanta where I had a trainee nuclear pharmacists and nuclear position as an Assistant Professor of technologists from the Massachusetts Radiology and was the Associate Director of College of Pharmacy, and training for the Radiopharmaceutical Research nuclear medicine residents. Laboratory. In 1989, I accepted a position as an Assistant Professor of Pharmacy at the University of New Mexico, in their Nuclear Within the Society of Nuclear Medicine, I Pharmacy Program. In 1992 I returned to have served over the years in several Emory University Center for capacities as a reviewer of abstracts, Emission Tomography as an Associate organizer of continuing education sessions Professor of Radiology and PET and of categorical seminars, and on the Radiopharmacist. As the program expanded Board of Directors of the I was appointed the Director of the Radiopharmaceutical Science Council. In Radiopharmaceuticals services program which covered both PET and Nuclear RPSC and I welcome the opportunity to Medicine at Emory University. In 1996 I serve as a member of its Board of Directors. accepted my current position as the Director Thank You. of Research at Resolution Pharmaceuticals, where our goal is the development of new Suzanne V Smith, Ph.D. diagnostic and therapeutic radio- pharmaceutical agents. I have been a I was educated at James Cook University of member of the Society of Nuclear Medicine North Queensland in Australia; completing a for approximately 15 years where I have science degree with a double major in functioned in various capacities including; chemistry and biochemistry. and a PhD in ad hoc reviewer for the Journal of Nuclear inorganic chemistry in 1990.. In 1989 I was Medicine, serving on the Members and Finance Committee for the offered a permanent full-time position at Radiopharmaceutical Sciences Council, a ANSTO in the Biomedicine and Health grant reviewer for the Education and Program. In 1992 I held a research Research Foundation, and an abstract fellowship position at Harvard Medical reviewer and judge for scientific poster School where I was fortunate to work in Dr. presentations. I am also a member and Jim Adelstein's laboratories and in the Dana participate in several other radiopharm- Faber Cancer Center with Bill Kaplan. On aceutical organizations some of which are returning to ANSTO I was appointed Group the Institute for Clinical PET, International Leader for the Biopharmaceutical Group. Association of Radiopharmaceutical This group's main focus has been to develop Scientists and the Canadian Association of radiolabelling technology for various Radiopharmaceutical Scientists. molecular recognition units for the diagnosis,. prognosis and treatment of Candidate’s Statement cancer. More recently I have been investigating technology for the It would be an honor for me to serve on the enhancement of cyclotron operations, by Board of Directors for the Radiopharmaceutical Sciences Council. I developing methods to increasing yields for have been fortunate to have been active in a output, novel separation wide variety of different aspects of Nuclear processes, new target designs and reducing Medicine including: dispensing radiopharm- radioactive contamination and waste. Our aceuticals for routine nuclear medicine Research and Development Group has been procedures and for PET., teaching incorporated into the Radiopharmaceutical radiopharmacy to pharmacy students, Division of ANSTO and is now directly nuclear medicine residents and fellows., linked to Australian Radioisotopes, the sales research in academic and industrial and marketing arm, and the National environments and involvement in the Medical Cyclotron. The Division has a Society of Nuclear Medicine organization. strong focus to bring products to the market With this broad base I feel that I can make a place and as whole. has considerable positive contribution to the organization and experience in clinical trials, regulatory I would enjoy the challenge and opportunity affairs and commercial operations. to work with the other members of the Radiopharmaceutical Sciences Council. My recent appointments. include membership of the Organizing committee of In summary, I believe my background and commitment to Nuclear Medicine would the Pacifichem 2000 Symposium on allow me make positive contributions to the Therapeutics, to be held in Hawaii and Treasurer for the 2003 International Atomic Radiation Research Conference to be held in pharmaceutical companies. He currently is Brisbane, Australia. A position on the the holder of many patents and has Board of Directors of the published many articles in the field of Radiopharmaceutical Council would provide monoclonal antibodies. me with a unique Opportunity to learn how the Society of Nuclear Medicine operates, in Robert Mach, Ph.D. aspects particularly related to regulatory affairs and government relations. It would Dr. Mach received a B.A. degree in also provide Opportunity to transfer Chemistry from the State University of New knowledge and experience gained to York, College at Potsdam in 1978 and a researchers in my region which is in many Ph.D. from the Department of Medicinal respects still young in the field. Chemistry of the State University of New York at Buffalo in 1985. Dr. Mach received Leslie A. Khawli, Ph.D. his training in radiopharmaceutical chemistry in the laboratory of Dr. Hank Dr. Khawli received his Bachelors of Kung of the University of Pennsylvania. Dr. Sciences degree from the American Mach was a member of the Cerebrovascular University of Beirut and his Masters of Research Institute of the University of Sciences from San Diego State University. Pennsylvania from 1988 to 1992 prior to He spent three years as a research chemist moving to the Wake Forest University at Calbiochem, La Jolla before receiving his School of Medicine, where he currently Ph.D. in Bio-Organic Chemistry in 1986 at holds the title of Associate Professor in the the University of Southern California, Los Departments of Radiology and Physiology Angeles. After a two-year NIH postdoctoral & . His research interests fellowship at Harvard Medical School, he include the development of fluorine-18 joined the faculty at the University of labeled receptor imaging agents and the use Southern California School of Medicine, as of PET to study brain. function in non- Assistant Professor of Pathology in 1989, human primate models of . Dr. Mach which position he held until becoming is also the Scientific Director of Anasazi Associate Professor in 1995. BioMedical Research, Inc., a Biotechnology Dr. Khawli has been a member of the Company aimed at developing receptor- Society of Nuclear Medicine for over 10 based radiopharmaceuticals for imaging years and been a member of the RSPC for cancer. Dr. Mach has published over 40 most of that time. His research interests are articles in peer-reviewed journals and. has focused on the production and purification 46 published. scientific abstracts. of novel conjugates intended for diagnosis and therapy Henry VanBrocklin, Ph.D. applications. His involvement with other scientists and clinicians has enabled the Henry F. VanBrocklin, Ph.D. is Head of the movement of two radiolabeled monoclonal Radiopharmaceutical Chemistry program in antibodies from the bench to the clinic. the Center for Functional Imaging at Lawrence Berkeley National Laboratory. In addition to his main research activity, he He also holds an appointment as an adjunct has continued to teach and use his assistant professor in the Department of administrative skills. Dr. Khawli has been Radiology at the University of California also consultant to many biotech and San Francisco (UCSF) medical school. He received his BS (1984) and MS (1986) in wealth of leadership and organizational Chemistry from Rensselaer Polytechnic experience and is interested in integrating Institute and a Ph.D. (1990) in the expanding opportunities for isotope Radiopharmaceutical Chemistry from production and radiopharmaceutical Washington University St. Louis under the chemistry into the goals for this council. mentorship of Prof. Michael Welch.. He received a US Department of Energy Tim McCarthy, Ph.D. Alexander Hollander Distinguished Postdoctoral Fellowship to attend the Tim McCarthy obtained his B.Sc. in University of Illinois for studies in the Chemistry from the University of Liverpool, laboratory of Prof. John Katzenellenbogen. England in 1986. He continued his studies in Dr. VanBrocklin's current research interests Liverpool and graduated with a Ph.D. in include: cyclotron and generator isotope Organic Chemistry in 1989. After production, automation for radiosynthesis as completing postdoctoral research at Florida well as the development of imaging agents State University, he moved to St. Louis in for neuro-degenerative diseases, 1991 and joined the research group of Mike neuroreceptors, tumor growth factor Welch at Washington University as a post- receptors, angiogenesis and cardiac doctoral associate. He is currently an ischemia. He has published 34 refereed Assistant Professor in the Department of journal articles, 2 book chapters and has Radiology at Washington University. Tim's authored or co-authored 75 abstract research interests cover all aspects of PET presentations. radiopharmaceutical development from isotope production and purification to in Dr. VanBrocklin is an active member of vivo analysis of novel radiopharmaceuticals. several professional organizations including the SNM, the American Chemical Society Outside of research Tim is actively involved (ACS) and the Society for Nuclear Imaging in a number of important areas related to in Drug Development (SNIDD). He has radiopharmaceutical chemistry; he is a co- worked closely with the RPSC President and organizer (with Henry VanBrocklin of this Dr. Tim McCarthy over the past year to years SNM categorical seminar; he has also organize the RPSC categorical seminar. He served as the secretary of the Society of is a member of the ACS Division of Nuclear Nuclear Imaging in Drug Development Chemistry and Technology's Education since June 1996. A significant portion of this Committee and participates annually as a year has been devoted to the “Meetings in lecturer for the DOE/ACS sponsored Saint Louis”, both as a member of the global Summer School at San steering committee and as chairman of the Jose State University. He is also currently local organizing committee for the the Chair of the SNIDD Communications Workshop on Targetry and Target Committee. In addition, he serves on two Chemistry. community non-profit boards. He brings a Program for the RPSC Categorical Seminar at the Annual SNM meeting in Los Angeles, Sunday June 6, 1999:

" Neuroimaging: A Tool for Neuropharmacology and Drug Discovery "

Sponsored by: Radiopharmaceutical Science Council Moderators: Timothy J. McCarthy, Henry F. VanBrocklin, John Babich

8.30-9.05 Anat Biegon "The potential of brain imaging in CNS drug development"

9.05-9.40 Nora Volkow "Imaging the Effects of Psychostimulants in the Human Brain"

9.40-10.15 Joe Steiner "Development of novel therapeutic agents for Parkinson's Disease"

10.15 - 10.30 Coffee

10.30-11.05 Malcolm Cooper "Quantitative Neuroimaging in Drug Development"

11.05-11.40 Alan Fischman "PET Imaging in psychiatric drug development"

11.40-12.45 Lunch

12.45-1.20 Dean Wong "Neuroreceptor imaging: understanding mechanisms and drug interactions in the human brain"

1.20-1.55 Richard Frank "Physiologic and Functional Imaging in CNS Drug Development"

1.55-2.30 Michael Phelps "Future Horizons in Pharmacologic Imaging"

Educational Objectives Upon completion of this course, attendees will be able to:

1. Understand the current “state of art” of neuropharmacology.

2. List applications of nuclear imaging in the study of specific disease states such as Parkinson’s disease.

3. Identify new therapeutic agents for Parkinson’s disease. 4. Describe how a fundamental understanding of neuropharmacology has helped in the treatment of drug addiction. 5. Understand how neuropharmacologic techniques are utilized in the drug discovery process.

6. List several applications of nuclear imaging to the drug discovery process.

7. Understand the paradigms available to CNS drug development through nuclear imaging techniques, particularly PET.

Summary: This categorical seminar will bring together the realms of neuropharmacology and nuclear imaging. The purpose of this continuing education program is to increase the participant’s knowledge of the unique capabilities of nuclear imaging in the study of neuropharmacology and specifically to introduce the audience to the application of this modality to the development of new therapeutic drugs. The program will begin with a general introduction to the key issues involving neuropharmacology today. Following this, individual focus will be given to areas such as, Parkinson’s disease and drug addiction, in which examples will be given that highlight how the development of radiotracers for neuroimaging have led to a deeper understanding of neuropharmacology and vice-versa. In addition this concept will be extended to demonstrate how development of radiotracer technology may assist the drug development process. Particular attention will be given to the types of information that are needed to fully characterize a new drug candidate and how careful selection of the correct radiotracer can provide various types of information not possible with classical drug development techniques.

GLOBAL NEWS If anyone would be interested in contributing to the next newsletter please contact me at;

Reminder: Upcoming time schedule for events/meetings.

8TH Symposium on the Medical Applications of (5/99) (Turku, Finland) For further information please contact Pekka Tenhonen Turku PET Centre PO Box 52 FIN-20521 Turku, Finland Tel 358-2-261-8191; FAX 358-2-261-8191

SNM 46TH Annual Meeting (Los Angeles, CA) (6/6/99-6/10/99) Brain 99 and BrainPET 99 - XIX International Symposium on Cerebral Flow and Metabolism; IV International Conference on Quantification of Brain Function with PET (Copenhagen, DENMARK ) (6/13/99-6/17/99) For further information please contact Congress Secretariat FAX: 45 4492 5050

5th International Conference on Functional Mapping of the Human Brain Duesseldorf, GERMANY (6/23/99-6/26/99) For further information please contact Congress Secretariat FAX: (49-211-81-18469 E-mail:

8th Workshop on Targetry and Target Chemistry (St. Louis, MO) (6/24/99-6/27/99) 11th International Symposium on Radiopharmacology (St. Louis, MO) (6/24/99-6/27/99) 13th International Symposium on Radiopharmaceutical Chemistry (St. Louis, MO) (6/27/99- 7/1/99) For further information please contact: Michael, J. Welch, PhD. Mallinckrodt Institute of Radiology, 510 South Kingshighway Boulevard St. Louis, MO 63110 FAX 314-362-8399 E-mail:

1999 RDS Users Meeting (Atlanta, GA)(9/30/99-10/2/99) For further information, please contact: LISA BAIRD CTI 810 Innovation Drive Knoxville, TN 37932-2571 E-mail: [email protected] Radiopharmaceutical Science Council Statement of Activity as of 1/31/99

Current YTD Prior YTD FY 1999 Actual Actual Annual Budget REVENUE Member Dues 3830 3314 4500 Seminar 0 0 0 Other Income 0 0 0 Total Revenue 3830 3314 4500

EXPENSES Seminar 0 0 0 Newsletter 331 613 4000 Salary 484 484 1500 Travel 0 0 1700 Printing 0 0 200 Mailing/shipping 1 4 100 Meeting Food/Bev 0 0 1500 Reproduction Exp 0 0 100 Telephone Exp 0 0 100 Honorariums 0 0 2300 Total Expenses 816 1101 1917

Net 3014 2213 -7000

Net Assets-- Beginning 10/1/98 Administration 10,944 10,893 Seminar 4833 5671 Newsletter -7771 -6470 Beginning Net Assets 8,006 10,094

Net Assets 1/31/99 11,020 12,307 The Society of Nuclear Medicine Radiopharmaceutical Science Council OFFICIAL ELECTION BALLOT, 1999

1. SNM House of Delegates Representative (Vote for one)

Donald J. Hnatowich, Ph.D. [ ]

Alun G. Jones, Ph.D. [ ]

Write-in ______

2. Board of Directors (Vote for three)

Dennis Eshima, Ph.D. [ ]

Suzanne Smith, Ph.D. [ ]

Leslie A. Khawli, Ph.D. [ ]

Robert Mach, Ph.D. [ ]

Henry VanBrocklin, Ph.D. [ ]

Tim McCarthy, Ph.D. [ ]

Write-in ______

Voting Instructions:

1. Mark the ballot for candidates of your choice and referendum question. 2. Print your name on the line below (If no name is given, your vote will not be counted). 3. Fax the ballot to the SNM Central Headquarters no later than May 23, 1999 to:

Lynn K. Butler Society of Nuclear Medicine Fax #: (703) 708-9013)

Print RPSC Member Voter Name: ______(Verification of active membership status)