professional work examples carver 7 29-14
DESCRIPTION
Private: For Presentation to Dr. Robin Winter-SperryTRANSCRIPT
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
[email protected] 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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