PREPARING THE BIOTECH SUPPLY CHAIN FOR 2025

Transcription

1 PREPARING THE BIOTECH SUPPLY CHAIN FOR 2025 BIO SUPPLY MANAGEMENT ALLIANCE Buldng Supply Chan Excellence End o End PLATINUM ponor GOLD ponor bronze ponor aocaon ponor San Francco Roundable Councl of Supply Chan Managemen Profeonal OCTOBER 15, 2015 CROWNE PLAZA FOSTER CITY, CALIFORNIA

2 HOW DET AI LED I SYOURVI EW? Gof arbe y ond emper a ur emon or ngand mpl ec l ma ee x c ur on. Geac ompl e eandh or c al eof n gh ofhow r an por a on pr ov der ar ehandl nggoodw h ny our uppl yc ha na he nd v dual boxandpr oduc l e v el nc l ud ng emp, hum d y, hoc k, l, l gh, and ak eoff/l and nge v en. Thenc ol l abor a ear oundanye x c ur on w hy our r an por a onpar ner oqu c k l y den f yar ooc au eand el m na e hel o. Per manen l y. T o eehowwec anhel py ou, v www. c ar go en e. c om

3 BIO SUPPLY MANAGEMENT ALLIANCE MonSaemen To buld effecve and effcen upply chan STRATEGY for he boech, bopharma, pharma and bomedcal devce ndure by developng, advancng, and demnang be pracce, knowledge, and reearch. To encourage and promoe upply chan INNOVATION whn he boech, bopharma, pharma and bomedcal devce ndure for he hghe qualy and clncal oucome n paen care and welfare. To creae a upply chan COMMUNITY of hough and pracce leader from he bune, profeonal aocaon and academc ecor for nformaon exchange, hared ervce, and collaboraon. ExecuveCommee Devendra Mhra EXECUTIVE DIRECTOR & CO-FOUNDER Dave Malenfan EXECUTIVE VICE PRESIDENT, INDUSTRY LIAISON & TALENT DEVELOPMENT Shankar Suryanarayanan VICE PRESIDENT, STRATEGIC PLANNING & INTERNATIONAL Bll Coakley VICE PRESIDENT, STRATEGIC ALLIANCE Vhal Sngal VICE PRESIDENT, COLD CHAIN & EMERGING MARKETS Pamela Gardner VICE PRESIDENT, SPONSOR SALES Do Yell VICE PRESIDENT, MARKETING, WEBMASTER & DBA Wayne McDonell INDUSTRY LEADER, PwC John Mch LEGAL COUNSEL AdvoryBoard Anderon Aphale Buck Curry Dawe Denecke Kachnky Kamnky Nx Pegel eaback Sharp- Donaldon Paul Anderon, Sr. Drecor, Toll Manufacurng & Supply Chan, Illumna Jayan Aphale, Senor Vce Preden, Techncal Operaon, Serepa Therapeuc Mark Buck, Global Supply Chan and Procuremen Leader, Bo-Rad Laboraore Prence Curry, VP Qualy & Operaon, Ke Pharma Dr. Rchard L. Dawe, Drecor of he Operaon & Supply Chan Managemen Program and he Cener of Operaon Managemen, Golden Gae Unvery Johan Denecke Global Aurance Sr. Drecor, Lfe Scence Soluon, Thermofher Scenfc Mary Kachnky, VP Sraegc Sourcng, Forma Therapeuc Phl Kamnky, Aocae Profeor, School of Indural Engneerng & Operaon Reearch, Unvery of Calforna, Berkeley Nancy Nx, Ph.D, Drecor, Execuve MBA Program, Profeor, Texa Chran Unvery Board Char, Elec Councl Supply Chan Managemen Profeonal Kevn Pegel, Vce Preden, Global Supply Chan USA, Bayer Healhcare - PS Boech Paul Seaback, Head of Global Supply Chan, Glead Scence ngh Somervlle Sopha Sharp-Donaldon, Head of Global Source & Procuremen, Baxala US Inc. Suherland Suryanarayanan Tenerowcz Mahender Sngh, Ph.D., Reearch Drecor, Cener for Tranporaon and Logc, Maachue Inue of Technology Suanne Somervlle, Vce Preden, Supply Chan Norh Amerca Regon, Genenech (A Roche Company) Joel Suherland, Managng Drecor, SCM Inue, Unvery of San Dego Shankar Suryanarayanan, Drecor, Manufacurng Sraegy, Baxer Inernaonal Rob Tenerowcz, Vce Preden, Supply Chan Managemen, BoMarn Rayne Waller, Vce Preden, Global Supply Chan, Amgen Prahan Yadav, Drecor, Healh Care Reerach Inaave, Wllam Davdon Inue Waller Yadav page 3 / bo upply ManaGeMen allance

4 BIO SUPPLY MANAGEMENT ALLIANCE CONFERENCE PROGRAM Ocober 15, :00am - 1:50pm PLENARY SESSION 9:00 9:15am WELCOME ADDRESS Devendra Mhra, Execuve Drecor, BSMA 9:15-9:45am Genomc Innovaon: Shapng he Fuure of Medcne Ingh no how Genomc leveraged o produce nex generaon medcne. The echnology of ung Genomc daa for produc nvenon wll be preened. The cence, knowledge and daa wll be nalyzed o enable greaer effcacy n he overall upply chan. The Illumna Acceleraor program provde fundng, equpmen, lab facle and coachng on how o ake a novel dea for ue of genomc and buld no a bune ha pched o venure nveor. Reul of he effor wll be preened. Amanda Cahn PhD, Drecor of he Acceleraor Program, Illumna 9:45-10:15am Acceleraed Produc Lunch wh FDA: Inegrang Clncal and Commercal Supply Chan Plannng for commercal launch, epecally wh Breakhrough Therapy degnaon, nroduce pecal upply chan challenge due o hgh demand and mng uncerane. In h preenaon, Genenech wll hare how a collaborave parnerhp beween our clncal and commercal upply chan organzaon and he FDA uccefully enabled he acceleraed launch of GAZYVA n Davd Volk, Clncal Supply Chan Managemen (PTDS), Hoffmann- La Roche 10:15-10:45am Bologc Drug Subance Qualy Managemen: Inegrang he Global Supply Chan Provde an ngh no he mporance of Qualy Operaon Managemen acro he produc upply chan o realze producvy, cuomer ervce and governmenal complance, whle achevng rk mgaon and manufacurng advancemen. The cae udy wll provde an example of he mpac of a qualy-drven culure. The mplcaon of havng reponbly acro he upply chan (end-oend) wll be dcued along wh Healh Auhory expecaon for qualy o enure paen afey and negry n he global upply chan. Andrea Goddard, Vce Preden & Head of Global Qualy Bologc Drug Subance, Genenech 10:45-11:15am NETWORK BREAK 11:15-11:45am "Balancng Co, Servce and Rk o Acheve Operaonal Effecvene" Preenaon of he developmen of a new capably for he lfe cence ndury where he Operaonal Effecvene Index a powerful meaure, vualzaon and communcaon approach, operaon decon framework, and a benchmarkng ool. Carl Fnamore, Drecor, Healhcare Indury Advory, PwC 11:45-12:30 pm PANEL: "Indury Advancng he Effcacy and Inegry of he Global Supply Chan" Senor SCM execuve of he bo-pharma ndury wll addre he ubjec of uppler relaon developmen, conrac manufacurng and clncal ral managemen, cold chan echnology challenge, IT deploymen, Bg Daa and analyc, negry n he global upply chan, emergng marke and collaboraon for effcency. Puru of SCM Excellence wll be he objecve n erm of Iue and Anwer. PANELISTS: Andrea Goddard, Vce Preden & Head of Global Qualy Bologc Subance, Genenech Kevn Pegel, Vce Preden, Global Supply Chan USA, Bayer Healhcare Paul Seaback, Head of Global Supply Chan, Glead Scence George O'Sullvan, Sr. Drecor of Supply Chaan & Sraeg Sourcng Ke Pharma Moderaor: Wayne McDonnell, Parner, Lfe Scence Advory, PwC 12:30-1:00pm NETWORK LUNCH 1:00 1:20pm KEYNOTE ADDRESS: Meeng Challenge n Today Global Supply Chan: A Peronal Road Map Global rend and challenge are drvng gnfcan change whch produce huge opporune for ndvdual and upply chan organzaon alke. Preenaon hghlgh wha ake o ge he job done n erm of peronal kll, ru n relaonhp, conenu buldng, communcaon, leaderhp, echnology, and buldng a uanable communy of upply chan profeonal rvng n a rk-laden markeplace. The oucome can be ranformaonal n provdng cuomer ervce from end o end of a upply chan. KEYNOTE SPEAKER: Rck Blagen, Preden and CEO, CSCMP - Councl of Supply Chan Managemen Profeonal 1:20-1:50pm PANEL: "Boech Mee H-Tech: Drvng Innovaon" The cro-pollnaon of experence and knowledge beween execuve of he H-ech and he Boech ndury wll cryallze varaon n upply chan be pracce from he end-o-end upply chan perpecve. The maure global naure of H-ech, wh challenge of reducng co whle achevng manufacurng yeld and overall qualy, wll be dcued for leap-frog mprovemen n boech. PANELISTS: Mark Buck, Global Supply Chan and Procuremen Leader, Bo-Rad Laboraore Davd Gnberg, Vce Preden, Supply Chan, Sonc Manufacurng Tm Jordan, Senor Global Commody Manager, Semen Healhcare Jm Lamer, Drecor, Purchang, Medvaon Moderaor: Rck Blagen, Preden and CEO, Councl of Supply Chan Managemen Profeonal (CSCMP) bo upply ManaGeMen allance 2015 / PAGE 4

5 2:00-5:30pm TRACK 1: CLINICAL SUPPLY CHAIN MANAGEMENT 2:00-2:40pm PANEL: "Reducng Wae, Maxmzng Effcency and Sreamlnng Your Global Clncal Supply Chan" Th panel wll addre how daa capured and ued for managng clncal ude. Topc covered wll nclude forecang, rackng hpmen, managng nvenory, producon plannng and MRP, and performng drug accounably and reconclaon. A wde range of oluon wll be dcued, rangng from manual procee, o auomaed ERP yem, o hybrd oluon ha reflec combnng mulple ool and oluon. PANELISTS: Alya Bychowky, Head, Clncal Supply Chan, Shre Luke Moyer, Supply Chan Soluon Manager, Almac Clncal Servce Malou Berdan, Senor Manager, Clncal Supply Chan, BoMarn Mchael Dallmann, Drecor, Global Clncal Supply Chan, Merck Ma Donnelly, Drecor, Clncal Supply Chan, Genenech Pay Overley, Clncal Supply Execuve, Global BoPharm Soluon Moderaor: Bll Coakley, Drecor, Supply Chan Plannng, Bo-Marn 2:40-3:00pm Enurng Your Supply Chan Doen Sop Unl You Reach he End Uer: The Imporance of he Invegaor Se n Clncal Supply Chan Plannng In he hgh-ake world of clncal developmen, ponor develop proocol wh a focu on eng clncal endpon and, ofen, omewha le apprecaon for he praccal mplcaon of he degn on nvegaor e and paen. A a me when he number and complexy of ral are ecalang, ponor and o reap valuable benef from he praccal ngh of nvegaor e abou he mpac of clncal upple n real-world care eng. The eon wll revew he reul of he global nvegaor e urvey and he mpac of clncal upple on e and paen,analyze challenge faced, denfy opporune o modfy neracon wh nvegaor e o enable beer e performance and hgher paen reenon raege. Fnally, curren ndury rend around paen cenrcy and how compane are akng acon o addre he paradgm hf o a paen-cenrc bune model wll be preened. Amy Muolno, Program Drecor, New Servce Developmen, Fher Clncal Servce 3:00-3:30pm Trend and Technology nnovaon for Effcen Cold Chan Managemen and Drbuon of Clncal Supple The panel wll hare wha, n her opnon, he very lae and mo pernen rend n erm of cold chan daa managemen. Acce o realme daa parcularly mporan, no only o ecure he proecon of IMP produc, bu alo o opmze procee acro, wha can be, a complex upply chan. Invenory vbly alone no enough. Sponor oday eek daa o provde aurance ha emperaure pecfcaon have been mananed whn pulaed gudelne. In addon, he panel wll hare how fa-changng echnology open new poble o he ndury enablng ervce provder o be more reacve wh beer vbly of clncal upple a hey are drbued acro he globe. Sae-of-he-ar echnology combned wh well-defned procee reul n greaer conrol, complance and vbly acro he upply chan. PANELISTS: Marha Dav, Produc Markeng Manager (Clncal Tral), Senech Tom Robnon, Senor Vce Preden, Sraegc Bune Developmen, Inync (ORBCOMM) Bll Rambo, Sale and Markeng Drecor, Prory Soluon Jule Trulon, Drecor CMC Leader, OncoMed Moderaor: Alex Gullen, Global Cold Chan Drecor, Fher Clncal Servce 3:30-4:00pm NETWORK BREAK 4:00-4:20pm " The Journey o Buld a Syem for Managng Clncal Sude" Preenaon of a Cae udy of yem and ool deployed dover wo year for forecang, rackng hpmen, managng nvenory, dong producon plannng and MRP, and performng drug accounably and reconclaon. The ofware oluon ha been uccefully negraed wh ERP, Clncal Drbuon, CTMS and IVR yem. Bll Coakley, Drecor, Global Supply Chan Plannng, BoMarn Pharmaceucal 4:20-4:45pm Auomaed Invenory Conrol and Vbly: Sreamlnng he Clncal Supply Chan Preenng a cae udy of auomaon and yemazaon of crcal clncal upply chan funcon o acheve effcacy, governmenal complance and reamlned commercalzaon. Th a journey of he Plo Plan (API & Formulaon) a Glead Scence o eablh nvenory conrol and vbly for GMP and R&D maeral leveragng her manream ERP yem. Arun Cavale, Supply Chan Proce Degner, NexInfo Sco Hebner, Sr. Manager FPD Plo Plan 4:45-5:10pm "An Informaon Syem o Manage Clncal Operaon - Achevng Co Reducon, Speed o Marke and Complance" Preenaon of a focu on he challenge of forecang, producon plannng, and drug accounably of clncal ude. A ofware oluon a proocol drven framework coupled wh bdreconal negraon o manufacurng yem (ERP), IVR ervce and B2B parner where clncal proocol requremen are ranlaed no accuraely packaged and drbued nvegaonal drug produc. The benef realzed are ncreaed effcency and accuracy and complance of he clncal upply proce n funcon of Plannng, Manufacurng, Packagng and Drbuon, Managemen Conrol and Communcaon. Mchelle Nle, Drecor, Bune Developmen, CLINapp page 5 / bo upply ManaGeMen allance

6 2:00-5:30pm TRACK 1: CLINICAL SUPPLY CHAIN MANAGEMENT (con'd) 5:10-5:30pm ID for Medcnal Produc (IDMP): Meeng he European Deadlne" EMA andard called IDMP creaed by ISO whch ake effec July, One of he purpoe of h regulaon o eablh andard ( conrolled vocabulare ) acro he ndury for bach and lo denfer, coverng 243 arbue and 7 caegore (e.g. drug ubance, drug produc, ec.). Th regulaon wll mpac many funconal group whn pharmaceucal compane (ncludng Supply Chan), and apple o boh clncal and commercal produc. Franck Touan, Managng Drecor, Bolog Europe (Belgum) 2:00-5:30pm TRACK 2: WORKSHOP: CAREER DEVELOPMENT FOR YOUNG PROFESSIONALS IN SUPPLY CHAIN MANAGEMENT 2:00-2:20pm "SCM a a Compeve Edge n Boech: The Praconer' Perpecve" Supply Chan Managemen a cro-funconal layer of managemen whch on op of vercal organzaonal funcon of R&D, Clncal Supply, Commercalzaon, Plannng, Drbuon, Cuomer Servce, QA, Rk Managemen and Governmenal Complance. The role of he Global Supply Chan Offcer o eablh collaboraon o ha procee can be opmzed acro funcon from uppler o paen. The preenaon deal wh organzaonal framework, nrnc boleneck, negraon of bune elemen, deploymen of IT and leaderhp acumen requred o acheve greaer profably and growh n he global markeplace. Kevn Pegel, Vce Preden, Global Supply Chan, Bayer Healhcare 2:20-2:40pm From a Warehoue Supervor o he Global Head of Supply Chan: The Zgzag Journey I he Journey of a Supply Chan Execuve who creaed a Global SCM Group wh over 900 employee a Alcon Laboraore a Vce Preden, afer aumng advancng reponble n warehoung, manufacurng, purchang and maeral managemen over 20 year. He hare h experence n leaderhp and performance excellence hrough new bune opporune capured, be-n-cla procee eablhed, operaonal nnovaon mplemened, co elmnaed, nvenory opmzed and eam engaged and npred. Leon learned from Syem Thnkng-by embracng cro-funconal connecon and nerdependence acro procuremen, logc, manufacurng, ale, and markeng wll be ncluded. Implemenaon of a comprehenve menorng and alen developmen program for all upply chan profeonal a legacy for oher o emulae. Dave Malenfan, Execuve Vce Preden, Indury Laon and Talen Developmen, BSMA, and, Former Vce Preden, Global Supply Chan, Alcon Laboraore 2:40-3:10pm "Supply Chan Profeonal Developmen Program a Inel: A Blue Prn for Acon" Preenaon of he program of he "Supply Chan Maer" profeonal developmen mplemened a Inel wh ucce and endurng value. Inel creaed a job ladder o upplemen her manageral and engneerng job ladder ha pecfcally focued on upply chan profeonal developmen from a career growh perpecve. He wll alo dcu how Inel ued an nerdeparmenal projec o help 2:40-3:10pm "Supply Chan Profeonal Developmen Program a Inel: A Blue Prn for Acon" (con'd) ran he new upply chan maer acro he many area of he upply chan. Jm R. Kello, Profeor of Pracce, ASU Supply Chan Managemen and Inel Supply Chan maer (Rered) 3:10-3:30pm "Developmen of he Low Co Supply Chan Maer Program a Inel - The Mechanc for Change" In her role a he upply chan maer, a ep-by-ep ngh no leadng he fnal degn and deploymen of he "Low Co Supply Chan" for he Aom Mcroproceor for Inel acro he world. Unque focu on how ha cro funconal projec boh added n projec managemen kll n a mul-culural envronmen and he of kll of nfluence and rk akng. Cnde Blackmer, Former Supply Chan Maer, Inel 3:30-5:00pm "WORKSHOP: "Mappng Your Own Career Pah n SCM" The group of profeonal from varou compane, ervng dfferen funcon of Plannng and Forecang, Purchang, Manufacurng, Qualy Aurance, Drbuon, Logc. Cuomer Servce, Bune Proce Managemen, Projec Managemen, Governmenal Regulaon, wll be pl no mall group of le han 8 o enable neracon. Queonnare-baed fac-fndng wll be ulzed o gaher ndvdual career deal, educaonal background, organzaonal characerc, career goal over a me frame, rengh and weaknee, and conran o yeld an aemen of a peronal profle. Ineracon among parcpan wll be profeonally faclaed o analyze he elfaemen. The managemen kll requred o navgae career goal wll be analyzed and he parcpan wll be navgaed o develop ndvdual career pah n erm of he overall journey wh mleone, reource, neworkng, reachng ou o profeonal aocaon and menorhp. FACILITATORS: Rchard Dawe, Drecor, Operaon and Supply Chan, Cener of Operaon Managemen, Golden Gae Unvery Dave Malenfan, Execuve Vce Preden, Indury Laon and SCM Talen Developmen, BSMA Suanne Somervlle, Former Vce Preden, Supply Chan Norh Amerca, Genenech Prahan Yadav, Senor Reearch Fellow and Drecor of he Healh Care Reearch Inave, Wllam Davdon Inue (WDI) bo upply ManaGeMen allance 2015 / page 6

7 2:00-5:30pm TRACK 2: WORKSHOP: CAREER DEVELOPMENT FOR YOUNG PROFESSIONALS IN SUPPLY CHAIN MANAGEMENT (Con'd) 5:00-5:30pm TOWN HALL DIALOG: SCM Career Plannng A Panel of SCM Exper from varou egmen of he ndury wll addre he ue raed by he parcpan n he workhop o provde unque ngh, gudance o deec ceberg-lke organzaonal mpedmen and praccal how-o uggeon o navgae n he urbulen waer. PANELISTS Rchard Dawe, Drecor, Operaon and Supply Chan, Cener of Operaon Managemen, Golden Gae Unvery Jm R. Kello, Profeor of Pracce, ASU Supply Chan Managemen Dave Malenfan, Execuve Vce Preden, Indury Laon and SCM Talen Developmen, BSMA Jennfer Parkhur, Parner, Lfe Scence, PwC Kevn Pegel, Vce Preden, Global Supply Chan, Bayer Healhcare P. J. Shelon, Vce Preden, Academc Collaboraon, CSCMP San Francco Suanne Somervlle, Former Vce Preden, Supply Chan Norh Amerca, Genenech Prahan Yadav, Senor Reearch Fellow and Drecor of he Healh Care Reearch Inave, Wllam Davdon Repreenave from ISM 2:00-5:30pm TRACK 3: GLOBAL SUPPLY CHAIN INTEGRITY (TEMPERATURE-CONTROLLED DISTRIBUTION) 2:00-2:30pm Pan n he Supply Chan of Pharma, Boech and Medcal Devce: Sraegc and Taccal Iue n he Global Marke Preenaon of he key fndng on he bune landcape of healhcare logc around he world, a well a healhcare logc execuve op concern and raege for expanon. In collaboraon wh TNS Global, over 440 execuve were nervewed n he pharma, boech and medcal devce ndure world-wde. Subjec have been elevaed whch are of val mporance o mall and large compane alke. Conderable concern ha been hghlghed n emperaureconrolled drbuon and cold chan, for example. Robn Hooker, Drecor of Global Sraegy Healhcare Logc, UPS 2:30-3:00pm A Proce Valdaon Gude for Cold Chan Logc: Enurng Complance Globally Sraege focued on he packagng qualfcaon, whou conderaon for valdaon of he proce of drug produc ranpor and he poenal mpac on he poency, effcacy, or pury of he drug produc a compared o he pecfcaon, wll be challenged by regulaory agence around he world. Proce valdaon for cold chan logc (packagng, orage, and drbuon) a requred par of he Common Techncal Documen (CTD) for any Bologc Lcene Applcaon (BLA) for monoclonal anbode. Any revew of he ubmed doer and ubequen pre-approval npecon one wll mo lkely revew he area of 1.Sably eng, 2. Thermal packagng qualfcaon, 3. Proce valdaon, and 4. Valdaon maer plannng. The be pracce wll be denfed and curren expecaon of drug qualy from regulaory agence globally wll be confrmed afer ranpor. Gary M. Huchnon, Preden, Modaly Soluon 3:00-3:30pm Wrng he Boech Supply Chan for Aconable Inellgence, Accounably & Overall Proce Improvemen The preenaon wll demonrae how a yemac deploymen of enor a he crcal node of he upply chan, gaherng daa wrelely and near real-me compung can produce aconable nellgence o acheve co reducon, ae ulzaon, afey, rk mgaon and paen care. The Inerne of hng ha been uccefully deployed o negrae all akeholder for overall good and complance. Rch Klmer, CEO, CargoSene 3:30-4:00pm Nework Break 4:00-4:30 m Takng a Rk-Managemen Approach o Enure Supply Chan Inegry Preenaon of he hghe level of underandng of a complex logc nework o ha effcence can be realzed acro a mul-ervce channel bune by mnng qualy daa hrough he creaon of afey zone for produc qualy. Tool and applcaon o creae upply chan vbly any me wll be dcued along wh be pracce o apply acve echnologe acro your global plaform for reul. Bran Cooper, Head of Healhcare Sale, Envroaner 4:30-5:30pm PANEL: Temperaure-Conrolled and Cold Chan Supply Chan: Proven Technologe and Pracce for Complance Deploymen of he emergng emperaure-conrolled logc and cold chan echnology, manfeng from end-o-end of he upply chan, requre packagng engneerng andard, bune procee, nformaon yem and monorng mechanm. The akeholder wll dcu he pfall and preen a blueprn for he manufacurng, logc and drbuon of emperaure-enve maeral and fnhed produc globally. PANELISTS: Gary Huchnon, Preden, Modaly Soluon Jm Peyon, Aocae Drecor, Supply Chan, Glead Scence Sopha Sharp-Donaldon, Sr. Drecor and Head of Global Sourcng & Procuremen, Baxala US Inc. Doug Weegren, Bune Area Key Accoun - The Amerca, Envroaner Moderaor: Vhal Sngal, Vce Preden, Cold Chan & Emergng Marke, BSMA, Drecor Healhcare Advory, Double Helx 5:30-7:00pm SUPPLY CHAIN EXCELLENCE AWARD & COCKTAIL RECEPTION /PAGE 7 / bo upply ManaGeMen allance

8 Prevew: PUTTING VOLUNTEERS FIRST Wha Every Clncal Team Should Conder Before Developng he Nex Proocol Some call a buzz phrae, oher a movemen. Regardle of wha, momenum connue o buld around paen cenrcy, a concep ha capvang he bopharmaceucal ndury and pawnng everyhng from arcle and conference o urvey, webnar and lvely LnkedIn exchange. And whle everyone applaud he renewed focu on paen a a pove developmen, ome ay me for bopharma compane o urn her aenon o anoher audence whou whom drug developmen would be mpoble clncal ral parcpan. For one hng, here an mporan dncon beween he wo audence, accordng o repreenave of nvegaor e, who operae on he fron lne of clncal reearch. Alhough ndvdual who parcpae n clncal ral are ofen referred o a paen, hey really aren paen hey re acually voluneer, ad Theree Dayon, RN, CCRC, Drecor of Nurng and Operaon a Rocheer Clncal Reearch (RCR) n Rocheer, NY. They voluneer her me and medcal reamen durng a ral no guaraneed, he added, explanng, Voluneer could receve a placebo oran unproven or neffecve reamen. Tha he whole pon of reearch. A a reul, nvegaor e echew he phrae paen cenrcy n favor of voluneer cenrcy. Semanc ade, an examnaon of he ue urroundng clncal ral appear o be long overdue. Only abou 5 percen of hoe elgble o parcpae n ral acually do o, even hough he number and ze of ude have been ecalang. Thoe who do voluneer o parcpae n ral can face ome frurang experence, hank o wha could be characerzed a a combnaon of fauly communcaon and proocol mep. Among hem: hard-o-open drug packagng, unclear drecon abou followng complex regmen, an ecalang number of requred medcal procedure, malfunconng echnology, and clnc apponmen ha mu be cancelled agan when upple fal o arrve. The ue may be a conequence of a falure o conder he need of voluneer durng he proocol developmen proce. Beyond engenderng fruraon among voluneer and he e aff who nerac wh hem, uch ue poenally endanger drug developmen by erodng he hree cornerone of clncal reearch adherence, reenon and recrumen. A a me when compane are readly embracng new opporune o engage paen, hey would do well o dmanle barrer o clncal ral parcpaon by makng ubjec he cenerpece of he proocol plannng proce. Voluneer-cenrc ral engage ubjec a parner n clncal reearch by makng parcpaon eay, pove and comforable experence for hem. Dong o ha he poenal o launch a new era of voluneer-cenrc clncal ral ha, ade from beng effcen and co-effecve, eablh a cadre of reearch ambaador voluneer whoe experence are o fulfllng ha hey jon addonal ude and encourage frend and famly o do he ame. The full paper wa developed by Parca S. Larrabee, RNNP, CCRC, who Se Drecor, Founder and CEO of Rocheer Clncal Reearch and Amy Muolno, New Servce Developmen Program Drecor a Fher Clncal Servce. M. Larrabee and M. Muolno erve on he Invegaor Se Panel on Clncal Supple, a voluneer organzaon ha ha repreened clncal e n Norh Amerca, Europe and Souh Amerca and oher nvolved n he mplemenaon of clncal ral nce The 11-member panel nclude wo repreenave of Fher Clncal Servce, a global leader n upply chan managemen ha commed o parcpang n ongong dalogue and mprovng clncal reearch. You can vew he full whepaper a fherclncalervce.com/paen-cenrcy-whe-paper/

9 We Supply Hope SM Helpng our cuomer delver an effcen and rk conrolled clncal upply chan o nvegaor and paen worldwde. fherclncalervce.com

10 BIO SUPPLY MANAGEMENT ALLIANCE Becaue lfe depend on u Bo Supply Managemen Allance memberhp open o hoe who belong or have an nere n he operaon and upply chan acve n he bo lfe cence. The member due cover all ubdare of he eny. BSMA dedcaed o ncreang he capable and knowledge of bo lfe cence upply chan managemen profeonal worldwde. MEMBERSHIP APPLICATION COMPANY NAME WEBSITE HEADQUARTERS ADDRESS LATEST Y/E REVENUES TICKER SYMBOL CITY STATE/PROVINCE COUNTRY POSTAL CODE PRIMARY CONTACT NAME WORK PHONE FAX TITLE MOBILE PHONE ADDRESS CITY STATE/PROVINCE COUNTRY POSTAL CODE MEMBERSHIP CATEGORY (CHECK ONE) Member Caegory Member Decrpon Annual Due (elec one) Execuve Memberhp Level 1 Annual Revenue Greaer han $1 Bllon $12,500 Execuve Memberhp Level 2 Annual Revenue Le Than or Equal o $1 Bllon $6,500 Execuve Memberhp Level 3 Emergng and Sarup Drug Compane $2,000 whou a commercal produc Afflae Memberhp 1 Annual Revenue Greaer han $250 mllon $6,500 Afflae Memberhp 2 Annual Revenue Le han or Equal o $250 mllon $2,500 Academa Memberhp Any accreded academc nuon ha work n $500 uppor of he bo lfe cence. Indvdual Memberhp Annual Revenue Greaer han $1 Bllon $500 PAYMENT Memberhp effecve upon recep of due paymen and acve for welve (12) monh hereafer. If payng by check, make payable o BIO SUPPLY MANAGEMENT ALLIANCE. Send compleed applcaon o Devendra Mhra, Park Andorra, Calabaa, CA or fax o CREDIT CARD NUMBER or CHECK NUMBER EXPIRATION DATE CDC NAME ON CREDIT CARD SIGNATURE DATE

11 JOIN THE BIO SUPPLY MANAGEMENT ALLIANCE Supply Chan Leaderhp & Excellence Become a member of he world leadng organzaon for operaon and upply chan managemen profeonal n he bo lfe cence ndury. Becaue lfe depend on u, he Bo Supply Managemen Allance uppor connuou learnng and developmen of bo upply managemen profeonal and he enhancemen and effcacy of he upply chan n he ndury hrough collaboraon. MemberhpBenef Advory board memberhp Parcpaon n ndury-pecfc eerng commee Pae o BSMA parner even Markeng and adverng n quarerly ndury journal Upgrade on ponorhp and group regraon package o parner even Excluve banner ad on newleer and op roaon on Allance webe Company logo on organzaon communcaon Excluve acce o Allance onlne communy Dcoun o Allance even Excluve acce o onlne preenaon from BSMA ponored even FIND OUT MORE: Becaue lfe depend on u

12 You ar by lenng In me lke hee, knowng where o ar he converaon n helpng o addre complex ue val. So, here a proce o everyhng we do and ar wh lenng and denfyng he rgh queon. Knowng where o ar and wha o ak come from experence and dcplne of hough. Th ju he begnnng of wha we provde o our clen. Through our global nework of frm wh more han 195,000 people n 157 counre, we provde qualy aurance, ax and advory ervce o many of he world mo ucceful compane. Tell u wha challenge you face or fnd ou more by vng u a Wayne McDonnell [email protected] (949) Jennfer Parkhur [email protected] (650) PwC. All rgh reerved. PwC refer o he PwC nework and/or one or more of member frm, each of whch a eparae legal eny. Pleae ee for furher deal. Th conen for general nformaon purpoe only, and hould no be ued a a ubue for conulaon wh profeonal advor BSMA Ad.ndd 1 9/29/2015 5:55:07 PM

13 JOIN THE BIO SUPPLY MANAGEMENT ALLIANCE STEERING COMMITTEES PROMOTING INDUSTRY SUPPLY CHAIN INITIATIVES! SUPPLY CHAIN INFORMATION MANAGEMENT (SCIM) STEERING COMMITTEE Idenfyng he be nformaon and yem echnology requred o mee he complex echnology need of he boech and pharma upply chan. CHAIRPERSON: Gran Hodgkn, Sraegy Sandard & Proce Manager, Global Supply Chan, Alcon Laboraore Commee Member: R. Arun Kumar, VP, Global Sale, Capgemn Coln Fnn, Founder and VP, Markeng, Pelyco Syem Kevn Rccobon, IT Leader, Global Operaon, Lfe Technologe Lou Kllan, Enerpre Syem for Techncal Operaon, BoMarn Tm Kvanvg, Bune Un Lfe Scence, Oracle SUPPLY CHAIN STRATEGIC SOURCING (SCSS) STEERING COMMITTEE Idenfyng and enablng he harng of be pracce n common area of nere relang o raegc ourcng. CHAIRPERSON: Jm Lamer, Senor Drecor, Purchang and Supply Managemen, Elan Pharmaceucal Commee Member: Dan Ambroe, Drecor cuomer Logc, VWr nernaonal Paul Anderon, VP, Global Procuremen, Lfe echnologe Mark Buck, Global Procuremen and upply Leader, bo-rad Laboraore Tm Doran, Sr Drecor, Global Sraegc Sourcng & Procuremen, Jazz Pharmaceucal Ken Duval, Aocae Drecor, upply chan, hre Pharmaceucal Dale Dwer, Manager, Procuremen-Drec Maeral, Bayer Healhcare Jennfer Fore, Aocae Conrac Drecor, Purchang Group, BIOCOM Rck Fulz, Drecor of Purchang Group, BIOCOM Tom Heebnk, Bune Developmen & Sraegc Allance, Weern Regon, BIO Joeph Hopkn, Sr Sraegc Sourcng & Procuremen Conulan Tm Jordan, Aocae Drecor upply chan, MAP Pharmaceucal Mary Kachnky, enor Drecor, raegc ourcng, cub Pharmaceucal Marna Kreculj, Drecor of Corporae Admn & Sourcng, Ke Pharma Marc Lampron, enor Drecor, Procuremen, Genenech Mke Mayo, Drecor, Maeral and Procuremen, Olympu boech Mke Mchell, Drecor, upply chan Managemen, Afc bocence Sopha Sharp-Donaldon, head of Sraegc Sourcng & Global Logc, Baxer Healhcare Iaac Young, r. Dr., upply chan Operaon, bomarn Pharmaceucal, nc. Yngmng Yue, Aocae Drecor, Nekar Therapeuc Pharmaceucal SUPPLY CHAIN TALENT MANAGEMENT (SCTM) STEERING COMMITTEE Developng leader and program ha ncreae he capable and kll n he boech and pharma upply chan communy. CHAIRPERSON: Muffe Dalon, Aocae Drecor, Operaon Plannng Genenech Commee Member: Don Wlon, Aocae Manager, Amgen Keh Launchbury, cfpm, Preden, Keh Launchbury and Aocae, Vce char, bma alen Developmen commee Devendra Mhra, founder & execuve Drecor, bo upply Managemen Allance Nancy Nx, Ph.D., Execuve Drecor, Execuve MBA Program; Supply Chan Profeor, Neeley School of Bune, Texa Chran Unvery Dave Malenfan, VP, Global Supply Chan, Alcon Laboraore Inc. Phl Kamnky, Ph.D., Profeor, School of Indural Engneerng, Unvery of Calforna, Berkeley, Se Drecor, Cener for Excellence n Logc and Drbuon Rchard Dawe, Ph.D., Profeor, Ageno School of Bune, Golden Gae Unvery Kevn Pegel, VP, Supply Chan Managemen, Bayer Healhcare Adam Zak, CEO, Adam Zak Execuve Search SUPPLY CHAIN RISK MANAGEMENT (SCRM) STEERING COMMITTEE Idenfyng he be pracce for he denfcaon, meauremen, and execuon of managng rk n he end-o-end upply chan of he boech and pharma ndury. CHAIRPERSON, Vjay Chruvolu, Drecor, Operaon Rk Managemen, Amgen Commee Member: Adam Zak, founder and ceo, Adam Zak execuve recruer Laboraore Arun Cavale, Prncpal, NexInfo Carla Reed, Prncpal, Tunnell Conulng Chr Sam, Execuve Drecor, Craghannock Dave Malenfan, SVP, Global Supply Chan, Alcon Jane Lavne, Inurance Execuve Lew Konnk, Drecor of Brand Proecon, Amgen Mchael Mooney, Dr., Rk Managemen & Inurance - The Amerca, Expedor Mohnder Skka, CEO, Senel Ron Bone, SVP, Drbuon, McKeon Pharmaceucal Thoma Smh, Drecor, Supply Chan, Shre Pharmaceucal Yngmng Yue, Aocae Drecor, Nekar herapeuc page 13 / bo upply ManaGeMen allance

14 STEERING COMMITTEES PROMOTING INDUSTRY SUPPLY CHAIN INITIATIVES! ENVIRONMENTALLY CONTROLLED LOGISTICS (BIOTECH COLD CHAIN MANAGEMENT) STEERING COMMITTEE denfyng he be pracce for conrolled envronmenal logc o maxmze paen afey and enhance value chan. CHAIRPERSON: Vhal Sngal, VP, Cold Chan Emergng Marke, BSMA Commee Member: Chr Amberg, EVP, Unran Inernaonal Jm Cox, All QA Conulng, All QA Produc Carl Derfeld, CTO, Pharmour Rod Derfeld, CEO, Pharmour Chr Fore, Complance Manager, Envroaner Alex Gullen, Global Cold Chan Drecor, Fher Clncal Servce Wahba Hall, Sr Mgr Global Tranporaon & Cold Chan, Baxer Healhcare Darold Hll, Drecor of Manufacurng & Valdaon, Glead Servce La Howard, Temperaure True Produc Manager, UPS Gary M. Huchnon, CEO, Modaly Soluon Mara Johnon, Temperaure Managemen Soluon, Thermone, LfeConex (DHL Forwardng) Chrelle Lao, Techncal Fellow, Cold Chan Mgm Lfe Scence, FedEx Dave Malenfan, EVP, Indury Laon & Talen Developmen, BSMA Jm Peyon, Aocae Drecor of Supply Chan, Glead Scence Karl Schlenker, Vce Preden, va-q-ec USA Sopha Sharp-Donaldon, Sr Drecor, Global Supply Chan, Baxer Healhcare Don Wlon, Aocae Manager, Amgen Dougla Weegren, regonal ale Manager, Weern Norh Amerca, envroaner HEALTHCARE POLICY COMMITTEE nformng and educang he member abou governmenal regulaon relaed o he bopharma ndury and erve a a reource for he governmenal agence a develop and mplemen regulaon. CHAIRPERSON: Ron Bone, VP, Drbuon, McKeon Pharmaceucal Commee Member: Karen Conway, Drecor, Healhcare, Global Healh exchange Lou Konnk, Drecor of brand Proecon, Amgen Mke Wallace, Drecor, Global Sandard and Seralzaon, Maer Daa, Abbo Laboraore Wayne McDonnell, Pharma & Lfe cence Advory, Prcewaerhouecooper MOLECULAR DIAGNOSTICS TESTING STEERING COMMITTEE eablh a nework and faclae he harng and buldng be pracce, advancng he adopon of nformaon yem and ool, and meeng he challenge of logc n emergng marke of he Molecular Dagnoc eng egmen of he bopharma ndury. he broad area o be embraced are ale & Operaon Plannng, Maeral Managemen /raegc ourcng and Procuremen, Logc, nformaon echnologe, emergng Marke and cm n general. CHAIRPERSON: Mke Crowell, r. Drecor, upply chan Managemen, Vernaa Healh Commee Member: Andrea Fox, VP, Dagnoc Laboraory Operaon, Lfe Technologe Arb Haroooonan, Vce Preden, Bune Developmen, Therapak Karel Hurka Jr, Sr. Manager Supply Chan Managemen, Genomc Healh Suan Jang, Healh Supply Chan Supervor, Vernaa Healh Sco Krhoun, Supply Chan Operaon Manager, Tehy Bocence Rh Kacker, Vce Preden, Engneerng, Counyl Dagnoc Glen McHenry, Sr. Manager Supply Chan Managemen, Monogram Bocence Jordan Myer, Sale Aocae, VWR Healhcare Meerve Pla, Aocae Drecor Maeral / Facle, crecen-do Bocence Tom Schoenherr, Vce Preden, Bune Developmen, Counyl Dagnoc Wnne To, Supply Chan Manager, Naera Healh Alan Well, VP, Dagnoc Laboraory Operaon, Lfe Technologe SUPPLY CHAIN CLINICAL OPERATIONS (SCCO) STEERING COMMITTEE denfyng and enablng he harng of be pracce, knowledge and experence n clncal upply and negrae clncal operaon a a crcal egmane pf he overall upply chan. CHAIRPERSON: Bll Coakley, Drecor, Supply Chan Plannng, BoMarn Commee Member: Phlp Chou, Aocae Drecor,Clncal Supple, Elan Pharmaceucal Mchael Dallmann, Aocae Drecor, Clncal Supple, Cerexa Jaymn Eberhar, Prncpal, PRTM Rchard Horn, Aocae Drecor Suppler Mgm, Neckar Therapeuc Theodore Jame Maylah, Manager, clncal upply, Abbo Amy Pencoff, Aocae Drecor Pharmaceucal cence, NeurogeX, nc. Bo Supply Managemen Allance 2015 / Page 14

15 How can medcne perform mracle f can clear cuom? UPS for healhcare. To u, abou much more han package. Tha why we have dedcaed eam of healhcare pecal, rade complance exper, and facle around he world. All workng wh advanced cuom clearance procee o make nernaonal drbuon and hppng mooher for your bune. And wh our emperaure-enve packagng expere, acve monorng, and nervenon capable, we re helpng delver crcal produc afely o he people who need hem. From fgurng ou o geng done, we re here o help. up.com/olver up uned problem olver Copyrgh 2015 Uned Parcel Servce of Amerca, Inc.