Professional Work ExamplesField Based Medical Affairs

and MSL Programs

John H. Carver, MSc. MBA.Managing Director MedSci

For presentation to:Dr. Robin Winter-Sperry7-29-14

Therapeutic Space and Related Pharmaceutical Compounds/Medical Devices/Biologics Experience

• Central Nervous System Disorders: Upjohn’s Xanax® (alprazolam), Solvay’s Luvox® (fluvoxamine maleate), Lithobid® (lithium carbonate), Flesinoxan (the 5-HT1A receptor agonist - (DU-29,373) investigational research only), Forest Labs Celexa® (Citalopram HBr), Lexapro® (escitalopram oxalate), Campral® (acamprosate calcium), Namenda® (memantine hydrochloride), Viibryd® (vilazodone HCl), H. Lundbeck A/S Serdolect® (sertindole), and early pre-marketing engagement on Arena’s 5Ht2c modulator Belviq® (lorcaserin HCI) for obesity management, marketed by Vivus Inc., *Neuraceq™ (florbetaben F -18 injection) Neuraceq™ is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline and is marketed by Piramal Imaging, a division of Piramal Life Sciences.

• CNS Medical Device: Cyberonics Vagus Nerve Stimulation (VNS Therapy®), the surgically implantable neurostimulator FDA class- III medical device indicated for treatment of refractory epilepsy and treatment-resistant depression.

• * Neuraceq™ (florbetaben F -18 injection) is also listed under Biologics

Therapeutic Space and Related Pharmaceutical Compounds/Medical Devices/Biologics Experience

• Gastrointestinal Disorders: Solvay’s Creon (pancrelipase), ROWASA® (Mesalamine) Rectal Suspension Enema and Suppository, Asacol® (mesalamine) Delayed-Release Tablets, Novartis Consumer Health’s Prevacid®24HR (lansoprazole delayed-release capsules 15 mg/acid reducer Proton Pump Inhibitor (PPI)).

– GI Medical Device: Olympus Surgical Technologies Global: CW-II PCNL Intracorporeal Lithotripsy.

• Women’s Health and Reproductive Endocrinology: Solvay’s Estratest® (esterified estrogens and methyltestosterone), Estratab® (esterified estrogens), Curatab® (medroxyprogesteroneacetate(MPA)), Zenate® Pre-natal Vitamin Tablets, Columbia Labs Crinone® (progesterone gel).

• Cardiovascular and Pulmonary: Forest Labs Tiazac® (diltiazem hydrochloride) Extended-Release Capsules, Aerobid® (flunisolide) and Aerobid®-M Inhaler System, Boehringer Ingelheim Aggrenox® (aspirin/extended-release dipyridamole) Capsules, BROVANA® (arformoterol tartrate) Inhalation Solution.

• Medical Devices: Cybersonics OmniWave™ Ultrasonic Endovascular Thrombectomy Device, C.R. Bard Peripheral Vascular’s FlowCardia™ CTO Crosser.

Therapeutic Space and Related Pharmaceutical Compounds/Medical Devices/Biologics Experience

• Biologics: Alexion Pharmaceuticals infused biologic, Soliris® (eculizumab), in the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy and paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. Savient Pharmaceuticals Krystexxa® (pegloticase), a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy, Novartis Vaccines and Diagnostics (NV&D) Menveo® [Meningococcal (Groups ACY and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine] solution for intramuscular injection. Neuraceq™ (florbetaben F -18 injection) Neuraceq™ is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline and is marketed by Piramal Imaging, a division of Piramal Life Sciences.

US Field Based Medical Affairs - MSL Team

Presentation Made to ClientMSL Program Update – State of the Team Report

Tuesday, 5/13/2014

CLIENT 1 EXAMPLE

State of the Team Report• MSLs Currently

– Training – Exposure to KOLs – Time in the field

• Next steps in training– Gap analysis– Individual or group Remediation

• Next steps for outreach– CMS-CED– Neurologists– Imaging Centers

• Current needs– Ratification of CED Process

• Future needs– TBD

HC

AD

Florbetaben Images for the 5-, 10-, and 20-min Scan Duration

Groups

Please note that the visual assessment method for florbetaben

teaches the use of grayscale and inverse grayscale, not color

CMS-CED Process

MSL Locations

NortheastV. Nassiri

SoutheastJ Acosta

WestD. Tapp

J Carver

x3 USA FBM-MSL REGIONSN

Policy Number

Policy Name

PIR-0001 Scientific Information Exchange

PIR-0002 Unsolicited Request for Medical Information

PIR-0003 Adverse Event Reporting

Thought Leader and Key Opinion Leader DevelopmentThought Leader and Key Opinion Leader Identification & SupportMedical Conferences and Conventions

Procedures for Medical Information Booths

Travel and Expenses

Business Meals and Items of Value

PIR-0004 State Restrictions on Interactions with Healthcare Professionals Commercial Collaboration

Investigator Initiated Studies (IIS, IIT)

Grants

Speaker Training

Promotional Speakers Program

Advisory Board and Consulting Agreements

Pharmacy and Therapeutics Committee MeetingsProviding Reimbursement Information to Customers and PatientsPatient Privacy

Medical Information Working GuidelinesRoles and Responsibilities of Medical Information DepartmentDeveloping Medical Information Responses

Fair Market Value

PIR-0005 OIG, AdvaMed and PhRMA Guidance

Medical Meeting Process

• SOP’s govern Field Based MSL activities providing the proper operational framework to ensure Client and MSL safe-harbor.

• In the absence of an official client provided Field Based Medical Affairs MSL SOP, MSLs will operate under and functionally within the domain of CMO SOP’s.

• MSL SOP’s are written in a manner which comply with all industry and regulatory guidance, and provide compliant direction and broad stroke control over MSL related activities.

First 5 MSL SOP’s

Task Assigned To Start End % Complete

TMAC / Piramal US FBM-MSL Program John Carver 12/1/13 6/11/14 94

1 Coordinate Veeva CRM / Now MSL-Connect InterimAK/ JC / ST / CP / BS 12/1/13 2/15/14 100

2 Manage x3 MSL Recruiting Effort JC / BS / JK /JM 12/15/13 3/1/14 100

3Develop project GANTT chart which will establishtimelines, deliverables, critical dates, andTMAC/Piramal stakeholder responsibilities

JC 12/1/13 2/15/14 100

3.1 Develop 2014 6 mo Key Milestone Linear Timeline JC 12/1/13 2/15/14 100

4 Develop x3 MSL Map w/ key IBA Regions JC 12/1/13 2/1/14 100

4.1 Align and Map IBA Regions to MSL Geographies JC / CR / CP 12/1/13 2/1/14 100

5 Finalize MSL JD and Client Profile: send to CP and BSJC / CP / BS / JK 12/6/13 12/23/13 100

6 Develop MSL Candidate Educational Primer JC 12/6/13 1/24/14 100

7Assemble key contacts roster: Medical Affairs,Clinical Development, Marketing, Sales,Legal-Regulatory (US and Global)

JC / CP / BS 12/13/13 1/7/14 100

8Gather list of initialSOPs upon which Piramal wouldlike for TMAC to focus

JC / CP / BS 12/9/13 1/29/14 85

9Assemble 2014 congresses and medical meetingsrequiring MSL attendance (US and Global)

JC / CP / BS 12/9/13 4/15/14 85

10Develop KOL Target Resource Dossier"Great Minds DB"

JC / CP / RS / SS 12/9/13 5/1/14 100

11 GatherPower Point slide decks (on-label / off-label) JC 12/9/13 5/1/14 95

12 key publications (PDF reprints)(on-label / off-label) JC / CP / BS / AS 12/9/13 5/1/14 95

13 Assemble Home Study Training Dossier JC 2/1/14 2/15/14 100

13.1 Coordinate ACP FBB TrainingCurriculum build JC / RW 2/1/14 2/15/14 100

13.2 Coordinate SharePoint portal for Flash Modules JC / AK 2/1/14 2/15/14 100

14 Harmonize CED Protocol and MSL Process Steps JC 12/13/13 4/15/14 80

15 Finalize the MSL Program Start Up Q&A JC / JK 12/15/13 1/15/14 100

16Regulatory Milestone: US-FDA PDUFA Date

(EMA Approved 2/24/14)FDA Approval Window 3/10/14 3/20/14 100

17 Assemble Global Medical Affairs Training Assets JC / BS / AS 12/15/13 3/15/14 100

18 Berlin GMA Meeting GMA / CP / JC 12/16/13 12/20/13 100

19 Capstone Didactic and launch Berlin GMA BS / AS / JC / MSLs 4/7/14 6/1/14 100

20Conduct Gap Analysis and execute remote / virtualGMA and TMAC remedial training where necessary

JC / AS / BS / MSLs 4/1/14 6/11/14 75

2013 2014

Dec Jan Feb Mar Apr May Jun

CP = Christian Planck US CMODH = David HahnBS = Bbarbara Schaeuble GMA BP = Beth PriceAS = Andrew Stephens GMA KK = Kyle KennedyRS = Robert Sgroi Product Lead JK =Jen KingCR = Colleen Ruby IBA SS = StephanieSaboda (Hospicom) Med EdJC = John Carver CRO = Popsicube /inVentiv Health ClinicalST = SusanThomason (Veeva) RW = RalphWeedonAK =Amit Kumar Piramal IT JM =Joi Maxey (Lead Recruiter)

2013Dec 2014Jan 2014Feb 2014March 2014April 2014May 2014June

MSL Program- :Kick Off Call

12/2

1 st MSL Hired. Dr D Tapp

1/13Start Date

( ) HAI HumanAmyloid

.Imaging Mtg

1/14/ - 1/17

:Boston Meeting, Barbara John

, Christian Rob

1/27 - 1/30

Berlin Germany GMA

Meeting

12/17 - 12/20

SNMMI Annual Meeting

. St Louis

6/7 - 6/11

MSL Home Study and

TMAC-On Boarding

2/3 - 3/15

MSL Capstone Piramal Training

Didactic Berlin

4/7 - 4/11

MSL HiringWindow

MSL FieldDeployment

4/15

AAN Annual Meeting

Philadelphia

4/26 - 5/3

3 X DayTrainingBoston

4/24 - 4/26

2 nd MSL Hired. Dr J Acosta

3/17Start Date

-On boarding . of Dr Susan

De Santi

FBB MSL Home Study Training Compendium

Enter Name Below

By my signature I certify and state that I have completed section one of thePiramal TMAC General Overview Training on Florbetaben

18-f-labeled ß-amyloid-targeted PET tracer

John H. Carver

Signature

This Day of

TMAC Piramal FlorbetabenScientific Training Curriculum

US Field Based Medical Affairs - MSL Team

Presentation Made to ClientMSL Program Update – State of the Team Report

Brovana Launch MeetingThursday, 5/29/2014

MSL Deployment Analytics and Process US Population Densities 2012

Aligning MSLs to Client Need is a Science.In order to best map FBM-MSL Geographies, Knowledge of Population Densities and COE must be part of the process.

MSL Deployment Analytics and Process US Population Densities 2012

Client Provided IST-Overlay MSL Deployment Analytics and Process

Tim Murphy, Hartford

Sara Harris Nashville

Ken GreenwaldColumbus

Harry YesilevichChicago

Robbin Honbo Los Angeles

Randy Richard Dallas

Paul Klees Seattle

Stacey GraningerPhoenix

Brian Maas Minneapolis

Chuck DrakslerPhiladelphia

As of 1-6-14

Bobby Cabaniss Orlando

Neil BoyceIndianapolis

Jonas LichtyCharlotte

Erica MannBuffalo

Pete AltieriBaltimore

VinnyDiRosa

Kansas City

Craig CounsellerDetroit

Kevin DunnMiami

Steve WondraschLong Island

Steven WeeksNewark

Dusty Menser Louisville

Greg IrvinAtlanta

Chip BleibergHouston

Troy HaubTulsa

Monija AfzalSan Diego

IST-Overlay + PDM = Alignment x3 FBM-MSLs MSL Deployment Analytics and Process Confirms Vertical

Boarder to Boarder Stratification Mapping

Tim Murphy, Hartford

Sara Harris Nashville

Ken GreenwaldColumbus

Harry YesilevichChicago

Robbin Honbo Los Angeles

Randy Richard Dallas

Paul Klees Seattle

Stacey GraningerPhoenix

Brian Maas Minneapolis

Chuck DrakslerPhiladelphia

Bobby Cabaniss Orlando

Neil BoyceIndianapolis

Jonas LichtyCharlotte

Erica MannBuffalo

Pete AltieriBaltimore

VinnyDiRosa

Kansas City

Craig CounsellerDetroit

Kevin DunnMiami

Steve WondraschLong Island

Steven WeeksNewark

Dusty Menser Louisville

Greg IrvinAtlanta

Chip BleibergHouston

Troy HaubTulsa

Monija AfzalSan Diego

LEGEND

Western Region

Central Region

Eastern Region

MSL REGIONS

Potential Locationsfor MSL Placement

Headcount Mitigation Action Plan

• Phase-I: In an effort to deliver near-term strategic and tactical MSL support and ensure stakeholder value recognition, we will respond to and facilitate High Value requests for CDMA commercial collaboration and support on a limited national level, until such time we are able to hire, train, onboard, and deploy the phased placement of the full x3 MSL Team.

04/10/2023 Scientific Advantage 25

Phase-I: In an effort todeliver near-term strategicand tactical MSL supportand ensure stakeholder

value recognition, we willrespond to and facilitateHigh Value requests for

CDMA commercialcollaboration and supporton a limited national leveluntil such time we are ableto hire, train, onboard, and

deploy the phasedplacement of the x3 MSL

Team.

National Coverage Plan

Phase-II: As the number twoMSL comes on-line, we will

issue revised direction to thefield a realignment

deployment action, andre-map the nation reflecting a

x2 MSL structure with theintention of partnering

internal customer commercialconstituents to the

appropriate MSL based on ageographic assignmentswhich best provides for a

logistically wise operationalstratification.

Phase-III: As the number threeMSL comes on-line, we will

issue final direction to the fielda realignment deployment

action, and re-map the nationreflecting the final x3 MSL

structure with the intention ofpartnering internal customer

commercial constituents to theappropriate MSL based on a

geographic assignments whichbest provides for a logisticallywise operational stratification.

MSL #1 Phase-IKristen S. Kau MBA. PhD.Sr. MSL (Midwest) CDMA

84 Waterford DriveMarlborough, MA 01752

Kristen.Kau@sunovion.com262-247-6579 Cell

MSL #2 Phase-II

National Coverage Plan

MSL #3 Phase-III

x2 East West Coverage Planx2 North South Coverage Plan x3 Coverage Plan x3 Coverage Plan

Phased Headcount Mitigation Coverage Plan

Key Milestone Timeline

Task Assigned To Start End % Complete

/ - TMAC Sunovion US FBM MSL Program John Carver TMAC 1/21/14 7/1/14 60

1 Prepare project GANTT chart which will establish

, , , timelines deliverables critical dates and/ TMAC Sunovion stakeholder responsibilities

JC 1/21/14 1/30/14 100

1.1 - Conduct Client Kick off Meeting / /JC SG KK / BP 1/21/14 1/23/14 100

1.2 2014 6 Develop mo Key Milestone Linear Timeline JC 1/23/14 1/30/14 100

1.3 3 Develop x MSL Map / JC SG 1/29/14 1/30/14 100

2 , , - Finalize MSL JD Client Profile Start up Q&A / JC SG 1/30/14 2/7/14 100

2.1 Communicate Client Ratified MSL Documents to TMAC Recruiting Team

JC 2/3/14 2/7/14 100

2.2 , . .Customize TMAC Sunovion Training Decks e g, , Admin Compliance T&E Spend Guidelines

JC 1/30/14 2/3/14 100

3 Initiate MSLRecruitment / / Hiring Training TMAC Recruiting 2/3/14 7/1/14 45

4 : , Assemble key contacts roster Medical Affairs Clinical

, , ,Development Marketing Commercial- ,Legal RegulatoryManaged , , Markets IT Compliance

/ JC SG 1/23/14 2/3/14 100

5 Obtain Critical SunovionSOPs Med Affairs Interaction

HCPs, , , ,Aggregate Spend Unsolicited Requests Travel, ..T&E etc

/JC SG 1/23/14 2/15/14 100

6 2014 Assemble congresses and medical meetings ( )requiring MSL attendance US and Global

/ JC SG 2/16/14 2/25/14 100

7 ( ' , ' )Seek KOL Target List KOL s to see KOL s not to see / JC SG 2/15/14 6/15/14 75

8 Develop MSL Candidate Educational Primer JC 2/3/14 2/20/14 100

9 Deploy MSL On boarding and Home Study Curriculum / / JC SG BP 2/3/14 4/1/14 85

9.1 Client Power Point ( / - )slide decks on off label / / JC SG BP 2/3/14 4/1/14 85

9.2 ( )( / - )Client key publications PDF on off label / JC SG 2/3/14 4/1/14 85

9.3 ( )Client Specified Training Elements Other / / JC SG BP 2/3/14 4/1/14 85

10 ( ) Capstone Didactic Training All MSLs Marlborough All Sunovion and TMAC Leadership4/7/14 7/1/14 33

11 Milestone MSLs are Field Deployed 4/7/14 7/1/14 33

12 POA andPreceptorship Houston / / JC SG All MSLs 3/2/14 3/7/14 100

13 Respiratory National POA Orlando Meeting Director and All MSLs 6/2/14 6/5/14 75

2014

Jan Feb Mar Apr May Jun Jul

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