Gw Attachment A

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PAXIL ADVISORY BOARD MEETINGA PROPOSAL FOR O NE PSYCHIATRIST ADVISORY BOARD MEETING

Program Date: November 5-7, 1993

Proposed to:Bonnie Rossello

SmithKline Beecham

Proposed by:John A. Romankiew icz, PharmD

Scientific Therapeutics Information, Inc

RevisedOctober 1, 1993

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TABLE OF CONTENTS

PagePurposeCost SummaryDescription Agenda and FacultyAdvisory Board MembersServices0Meeting Editorial Costs 1Meeting Report3Background Papers4Payment Schedule5

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1PURPOSE

The purpose of this proposal is to outline a description, services,timing, and costs for organizing and running one psychiatrist advisoryboard meeting with members of the PAXIL Advisory Board. The firstmeeting will be held from November 5-7, 1993 in Palm Beach Florida.

The purpose of the Advisory Board Meeting is to assemble the members ofthe PAXIL Advisory Board to provide an exchange of scientific andmarketing information regarding PAXIL and related topics. Comments onthe information concerning quality, application, and practicalsuggestions on the best vehicle for distribution, will be solicited. Inaddition, helpful ideas and advice on issues faced by the PAXILMarketing Team will be sought.

The information obtained at these meetings will be recorded in a reportthat will highlight key points and will serve as a reference source forfuture use.

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COST SUMMARY

Developmental fees, attendanceexpenses for STI. time, estimated travel $37,400

Meeting with Chairman, October 11 $2,800 Slide development, estimated $13,000 Advisory Board airfares, estimated $40,000 Meeting Report $12,500 Background paper preparation: 4 topics $12,000

TOTAL: $117,700

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DESCRIPTION

A description of the key components of the Advisory Board Meetinginclude:

1. The meeting will be held over a three-day period. Day I will be atravel day with a dinner reception held in the evening. Day IIand Day III will each have a half-day session held in the morning,concluding with lunch. Departure will be scheduled for theafternoon of Day III.

2. The meeting program will consist of a combination of lectures anddiscussions. Ample opportunity will be provided for discussion ofconcepts, new research, and new areas of direction for PAXIL.

3. Selected Advisory Board members may be asked to prepare apresentation relevant to the specific meeting.

4. Each meeting will be a closed meeting. The audience will consistof the Advisory Board members (up to 15), individuals fromSmithKline Beecham, and two editors from STI.

5 .ach Advisory Board member will receive an honorarium.WB 085324

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4AGENDA AND FACULTY

A formal agenda for each meeting will be prepared in advance of eachmeeting after consultation with SmithKline Beecham. The agenda includedbelow is a sample agenda for the 1993 Advisory Board Meeting. Topics areincluded without faculty. Briefings on the data available with PAXILand issues that SmithKline Beecham wants to address are necessary. Thisagenda will be completed after consultation with the sponsor.

SM1TH K LINE BEECHAM PSYCHIATRIST ADVISORY BOARD MEETINGNovember 5 - 7, 1993

Ritz Carlton HotelPalm Beach , Florida

Friday, November 5Afternoon Arrival and Hotel Check-in7:00 PMocktail Reception8:00 PMinnerWelcoming Remarks byDavid Brand, Vice President,

SmithKline Beecham

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AGENDA AND FACULTY (continued)

Saturday, November 67:00 AMreakfast8:00 AMgenda and ObjectivesCharles B. INImeroff, MD, PhD, Chairman8:10 AM

Strengthen Paxil profile Identify competitor deficits/strengths Evaluate clinical research/promotionalprograms Generate information for use inpromotion/education Strategize to reach primary care physiciansOverview of Paxil Market Experience and SuccessBonnie Rossello, Paxil SeniorProduct Manager, SmithKline Beecham

8:30 AMomparison of Paxil with Marketed and Investigational SSRIsJerrold F. Rosenbaum, MD (suggested) Pharmacology Pharmacokinetics Indications/efficacy Adverse effects9:00 AM Advisory Board Reaction and CommentCharles B. Nemeroff, MD, PhD, Chairman, Moderating

Comments Controversies Summarize strengths/weaknesses of all agents

9:30 AMoffee BreakWB 085326

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Saturday, No vemb er 6 (continued)10:00 AM Review of Paxil Clinical Research ProgramDavid E. Wheadon, MD, Vice President,

SmithKline Beecham Recently completed studies Ongoing studies Future studies

11:00 AM Advisory Board Reaction and CommentCharles B. Nemeroff, MD, PhD, Chairman,

Assessment of research programModerating

Suggestions for use of data Recommendations for future studies,indications

11:30 AM Review of Paxil PromotionBrian Lortie, Paxil Product Manager,SmithKline Beecham

Overview of Paxil promotional program compare/contrast with competitors' promotionalefforts

12:00 PM Advisory Board Reaction and CommentCharles B. Nemeroff, MD, PhD, Chairman,

Assessment of promotional program - bypsychiatrists versus primary care physicians

Moderating

Assessment of competitors' promotion Suggestions for additional programs/futuredirections

12:30 PM Luncheon

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7AGENDA AND FACULTY (continued)

Saturday, November 6 (continued)

1:30 PM Open Forum:ong-Term Outlook for Depression TreatmentCharles B. Nemeroff, MD, PhD,0 Unmet needs in therapy Chairman0 Impact of health care reformRole of psychiatrists, primary care physicians What is industry involvement?0 Future treatment of depression

2:15 PM Adjourn2:30 PM Afternoon at leisure7:00 PM Cocktails8:00 PM Dinner

Sunday, November 77:00 AMreakfast8:00 AMreakout into WorkshopsWorkshop 1 Paxil versus Competitors

Facilitated by Charles B. Nemeroff, MD, PhDGoals: Differentiate Paxil from competitors onbasis of P45 0, dose titration, sedation,activation, weight loss/gain, sexual dysfunction

Workshop 2 Profile of Paxil PatientsFacilitated by James C. Ballenger, MDGoals: Identify 4 or 5 patient subtypessuitable for treatment with Paxil

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Sunday, Novem ber 7 (continued)Workshop 3 Reaching the Primary Care Physician

Facilitated by *Psychiatrist with knowledge ofprimary care and presentation of depression inthis settingGoals: Generate recommendations for educatingprimary care physicians about depression,appropriate treatment, and use of Paxil

8:00 AM

9:15 AM9:30 AM

10:45 AM11:00 AM

12:15 PM1:30 AM

Workshop 1: Paxil versus Competitors (Group A)Workshop 2: Profile of Paxil Patients (Group B)BreakWorkshop 3: Reaching the Primary Care Physician (Group A)Workshop 1: Paxil versus Competitors (Group B)BreakWorkshop 2: Profile of Paxil Patients (Group A)Workshop 3: Reaching the Primary Care Physician (Group B)LuncheonDeparture for all

* For these sessions, STI in conjunction with SmithKline Beecham andthe Moderator will develop a series of questions on key issues withPAXIL that are aimed at acquiring information.

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9

ADVISORY BOARD MEMBERS*

ADVISORY BOARD OF PSYCHIATRISTS(confirmed as of September 29, 1 993 )James C. Ballenger, MDChairman, Dept of PsychiatryDirector, Institute ofPsychiatryMedical University of SouthCarolinaCharleston, SC 29425John G. Csernansky, MDGregory B. Couch AssociateProfessorDepartment of PsychiatryWashington University MedicalSchoolSt. Louis, MO 6311 0Joseph Deltito, MDDirector, Anxiety andMood Disorders ProgramAssoc Professor of ClinicalPsychiatryNew York HospitalCornell Medical CenterWhite Plains, NY 10 605David L. Dunner, MDProfessor and Vice Chairmanfor Clinical ServicesDept of Psychiatry andBehavioral SciencesUniversity of WashingtonSeattle, WA 9810 5Robert Hirschfeld, MD /ChairmanDept of Psychiatry andBehavioral SciencesUniversity of Texas -Medical BranchGalveston, TX 775 55

Charles B. Nemeroff, MD, PhDProfessor and ChairmanDept of Psychiatry andBehavioral SciencesEmory University School of MedicineAtlanta, GA 30322Charles F- Reynolds, III, MDDirector, Sleep Evaluation CenterProfessor of Psychologyand NeurologyWestern Psychiatric Instituteand ClinicPittsburgh, PA 15213Jerrold F- Rosenbaum, MDAssociate Professor of PsychiatryHarvard Medical SchoolChief, ClinicalPsychopharmacotherapy UnitMassachusetts G eneral HospitalBoston, MA 0211 4Steven Schleifer, MDProfessor and ChairmanDept of PsychiatryUMDNJNewark, NJ 0710 3David V. Sheehan, MDProfessor of PsychiatryDirector, Clinical ResearchUniversity of South FloridaPsychiatry CenterTampa, FL 36613

* Additional Advisory Board Members are being recruited.

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10SERVICES

The services and costs for this Advisory Board meeting assume thatSmithKline Beecham will provide all logistical arrangements. STI willprovide program design and content, editorial development, and facultyliaison services.

STI Editorial Services

STI will work in conjunction with SmithKline Beecham to provide thefollowing:

Identify and develop program content/agenda.

Identify and recruit Advisory Board Members

Research and prepare background material for mailing to AdvisoryBoard prior to meeting.

Provide slide services as needed for presenters.

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1 1MEETING EDITORIAL COSTS

Our costs are based on program development work, editorial activity,writing, proofreading, correspondence ( usually express mail) withAdvisory Board members, SmithKline Beecham and others as needed toinsure a high quality, credible, and useful program for SmithKlineBeecham and Advisory Board members. Costs are as follows:

EditorialDevelopment:

Liaison with board members including recruitment andtravel arrangements of board members and SmithKlineBeecham, content outline development, preparation ofmoderator for meeting, authoring one presentation(Rosenbaum) and discussion questions (fee).

COST:30,000STI Airfarewo STI editors (coach).Expenses:OST:2,000tPer Diemwo STI editors: 3 days each.Expenses:OST:1,500STI Meetingwo editors onsite, plus travel time (fee).Attendance andssumes three days.Travel Time:OST:3,900Consultingp to 20 Advisory Board members as follows:Fee:hairman - $5,000; 3 presenters/moderators@ $4,0 00 each; 16 (estimated) a $2,500 each.(SB TO PAY)SlideTI will work with the faculty to develop highDevelopmentuality and professional presentation slides. Ourcosts for slides are $13 0.0 0 per slide if we have 2

weeks or more to work with and $17 0.0 0 if we have lessthan two weeks to work. We estimate 10 0 slides forthis program.

COST:13,000*t Pass through cost* STI will bill for the actual number of slides developed.WB 085332

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12MEETING EDITORIAL COSTS (continued)

Meeting withne visit with Chairman in Atlanta on October 11,Chairman:993. Two editors @ $650 each (fee) plus travel

expenses estimated at $1,500 (air and groundtransport)2,800Board Travelirst Class air travel for 20 Advisory BoardExpenses:embers.40,000t93,200t Pass through cost.

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13MEETING REPORT

STI will transcribe the audiotapes (meeting plus one of each workshop)and provide a synopsis of the key points from the meeting. The reportwill be issued within one month of the meeting. We estimate the reportto be up to 50 doublespaced typewritten pages. An executive summarywill be included.

COSTS:12,500WB 085334

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BACKGROUND PAPERS

Purpose:e propose to develop succinct background papers that willprovide a literature based review of the facts regardingissues associated with Paxil. These papers will outline theinformation needed to come to a consensus on the specificissues that will be discussed in the workshops.

Description:

Costs:

Each background paper will be up to 1 0 typewritten, doublespaced pages in length and will include pertinentreferences. A statement of the issue will initiate thepaper with a detailed analysis of data supporting orrefuting the issue to follow. Background papers will bedeveloped on the following topics:1. P45 0 and drug interactions with SSRIs2. Identification of patient types for Paxil therapy3. Dose titration needs with SSRIs4. Sedation and SSRIs

The costs associated with development of these backgroundpapers include literature research, technical writing andediting, client review and comments, preparation of twodrafts, timing (one month), word processing, copy editingand proofreading, distribution to advisory board members inadvance of meeting, and management needed to develop thesebackground papers on a timely schedule.3,500OST (4 papers):12,000** A discount is provided for development of all four developedsimultaneously because we can take advantage of economies of scale.

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PAYMENT SCHEDULE

To be invoiced immediately $58,850To be invoiced upon completion of the meetingNovember 4-5, 1993 $58,850

$117,700

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Documents

Gw Attachment A