Scientific and regulatory consulting overview presentation jan 2013

Intelligent Actions.
Smarter Solutions.
S t S l ti
Beckloff Associates
Scientific and Regulatory Consulting

© Copyright 2012, Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are
trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

Cardinal Health Business Segments

Cardinal Health

$102.6B
$102 6B FY11 R Revenue
$ 1.58B FY11 Non-GAAP Operating Earnings
Approximately 30,000 worldwide employees

Operations

Pharmaceutical Medical
• $93.7B FY11 revenue • $8.9B FY11 revenue
• Serves pharmaceutical manufacturers, • Distributes products to ambulatory
retail pharmacies, hospital and mail-order
mail order care centers, physician offices,
facilities, physician offices, surgery clinical laboratories, and hospitals
centers, and alternate care facilities. across the U.S. and Canada.

2 © Copyright 2012, Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are

Cardinal Health
Pharmaceutical Segment
Pharmaceutical Nuclear and Pharmacy
Specialty Solutions
Distribution Services

 Beckloff Associates
 Pharmaceutical Distribution Scientific and Regulatory  Nuclear Pharmacy Services
 Pharmacy Solutions Consulting
 Borschow (Puerto Rico)  Healthcare Analytics and Marketing
 p g g
Pharmaceutical Repackaging Communications
 ParMed  Third Party Logistics Services
 Kinray  Specialty Pharmaceutical Distribution
 Yong Yu  GPO Contracts and Services
 Access Services (Health Connections)


Scientific and Regulatory Consulting –
Who are we?
• A specialized pharmaceutical research and development
consulting and services group
• Integrated scientific, strategic
regulatory, and business focus
• Established in 1976
• Beckloff Associates acquired
by Cardinal Health in 2004
• Also known as CHSS Scientific and Regulatory Consulting
• Headquarters in Overland Park KS with satellite and
Park, KS,
remote offices around the United States

“Celebrating 36 years of Client Success”

Beckloff Associates - Locations

Headquarters San Diego Regional Office
Commerce Plaza II, Suite 300 Regents Square I
7400 W. 110th Street 4275 Executive Square, Suite 300
Overland Park, KS 66210 La Jolla, CA 92037


Beckloff Associates – the People

• 106 Total Beckloff Associates
• 75 Regulatory Scientists: >70% with advanced
g y
scientific, technical, professional degree/certifications and
an average of more than 20 years experience
• Regulatory Affairs • Pharmaceutics
• Analytical Chemistry • Pharmacokinetics
• Organic Chemistry • Pharmacology
• Medicinal Chemistry • Toxicology
• Biochemistry • Veterinary Medicine
• Microbiology • Medical Writing
• Nursing • Project Management
• Neurology/Psychology • Business Administration


Therapeutic Areas of Experience
• Analgesia • Inflammation
• Anesthesia • Metabolism
• Anti Infective
Anti-Infective • Neurology
• Cardiology • Oncology
• Dermatology • Ophthalmology
• Endocrinology
E d i l • Rheumatology
Rh t l
• Gastroenterology • Psychiatry
• Hematology • Pulmonary
• Health (Men’s and • Special Pathogens
Women’s) • Urology
• Immunology • Vaccine
• Infectious Disease

Extensive C C e pe e ce with s a molecules,
te s e CMC experience t small o ecu es,
biologics, and combination products

Integrated Consulting Units

Regulatory Affairs & Medical Scientific
Product D
P d t Development
l t Writing Communications
(nonclinical and clinical)

Chemistry, Regulatory Compliance and
Manufacturing, and Publishing Services Quality Service
Controls
C t l (paper and electronic) (GLP, GMP GCP
(GLP GMP, GCP, QSR)

Regulatory Services

Continuity of services from laboratory bench to pharmacy shelf and beyond


Scientific Design, Regulatory Affairs, and
Strategic Planning
• Expertise from Discovery to Post-Approval
• Support Product Development, Dossier Life-cycle
Management,
Management and Market Expansion
• Design and Implement Domestic & Global Scientific
Regulatory Strategies and Objectives
• Understanding of FDA and Worldwide Regulatory
Agencies Requirements
• Author U.S., E.U., and ROW Regulatory Documentation
US EU
• Use an Integrated Regulatory, Nonclinical, Clinical, and
CMC Approach
• P id C
Provide Consulting and S i tifi and M di l W iti
lti d Scientific d Medical Writing
• Provide Ad-Hoc, Project-Based, and FTE Models


Global Regulatory Documentation
Prepare, Review, Publish, Submit, and Maintain
• DMFs • Clinical & Nonclinical Study Protocols and Reports
• INDs • Agency Meeting Requests & Information Packages
• NDAs • Response to Agency Questions

• 505(b)(2)s • Expedited Safety Reports, PSURs & DSURs
Reports PSURs,
• Integrated Summaries of Safety & Efficacy
• ANDAs
• Risk Evaluation and Mitigation Strategy (
g gy (REMS)
)
• BLA
BLAs
• Orphan Drug Applications (U.S. and Europe)
• 510(k)s
• Annual Reports, Amendments, Supplements
• IDEs
• European & Canadian Submissions (CDMF, CTA,
• PMAs IMPD, ASMF, NDS, MAA, Certificate of Suitability)


Service Offerings
g


Beckloff Associates Service Offerings
• Clinical and Nonclinical Consulting
• Medical and Scientific Writing
• Regulatory CMC P and P t
R l t Pre d Postapproval Sl Support
t
• Quality and Compliance
• Scientific Communications
• Global Regulatory Documentation (prepare and publish)
• Strategic Labeling and Promotional Materials
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• Risk Evaluation and Mitigation Strategy (REMS)
• State Licensing for Drugs and Devices
• Training Programs


Clinical and Nonclinical Consulting
• Program Management
• Pharmaceuticals
• Regulatory Dossier
• Biologics New Product Regulatory Maintenance
• Devices Development Affairs • R
Regulatory A
l t Agency
• Line Extensions Interactions & Meetings
• Expanded Label Claims • Briefing Documents

Clinical &
Strategic Regulatory Nonclinical
Consultation Operations
Management
• Strategic Development Plans
• Pre- & Post-Approval Studies
• Development Program Outlines & Timelines
• Due Diligence Evaluations • Study Planning

• Evaluation of Safety & Efficacy Data
Compliance • Study & Vendor Management
y g
• Risk Evaluation & Mitigation Strategy • Clinical Data for Post-Marketing
• Strategic Labeling Support
& Business Objectives
• Nonclinical & Clinical Program Integration
 GLP and GCP Auditing


Scientific and Medical Writing

• NC Study Designs • Clinical Study Designs

• NC Study Protocols Nonclinical Clinical • Clinical Study Protocols

• NC St d R
Study Reports
t Studies Studies • Clinical Study Reports

• Scientific & QC Review • Scientific & QC Review

Investigational New Market Applications
Drug Applications

• P ti t Narratives
Patient N ti
• Investigator’s Brochures • Integrated Summary of Safety
• Briefing Documents Safety • Integrated Summary of Efficacy
• Special Protocol Assessments Reports • Clinical & Nonclinical Summaries
• Orphan Drug Applications • NDA, BLA, MAA, NDS, PMA
• Fast Track Designation Requests • Expedited Safety Reports • Supplements
• Annual Reports and Amendments • DSURs & PSURs


CMC – Integrated Support

• Pre-approval CMC Support
– Product development and regulatory strategies
p g y g
– Due diligence (companies, submissions, and sites)
– Agency pre-meeting preparation and meeting
participation
– Vendor identification, qualification and management
• API development activities (synthesis and analytical)
• Product development activities (formulation and
analytical)
• Technical transfers and scale-up
• Clinical manufacturing and packaging
• Clinical drug supply import/export



• Pre-approval CMC Support (continued)
– Preparation, review and submission of applications (DMF, IND,
CTA, IMPD, ANDA, 505(b)(2) NDA, NDA, BLA and MAA)
– Submission maintenance
• Responses to agency questions
• Amendments
– Preparation for launch
• Scale
S l up and process validation
d lid ti

Extensive CMC experience with small molecules,
biologics, and combination products



• Post-approval CMC Support (continued)
– Assessment of manufacturing changes and process/product
deviations
– Post-approval strategy and communication
– Annual reports and annual product reviews
– Supplements, Variations and Notifications
• Prior Approval and Changes Being Effected
• Type I and Type II


Device Development
Medical Device, In Vitro Diagnostic Products,
and Laboratory-Developed Tests
• Product Development Planning
– Manufacturing and Controls
– Nonclinical and Clinical
• Drug/Device Combination Products
– Request for Designation
• Identification of Predicate Devices
f f
• Demonstration of Substantial Equivalence


Device Development
Medical Device, In Vitro Diagnostic Products,
and Laboratory-Developed Tests
• P
Preparation and M i t
ti d Maintenance of A li ti
f Applications
– Investigational Device Exemption (IDE)
– 510(k) Premarket Notification
– Premarket Approval (PMA)
– Humanitarian Device Exemption (HDE)
• Medical Device Reporting
– Adverse Events
– Product Complaints
• Product Recalls, Corrections, Removals


Compliance Services
• Good Manufacturing Practices (GMP) audits in accordance with
FDA and EU requirements, Good Laboratory Practices (GLP)
audits, and Good Clinical Practices (GCP) audits
• Quality Systems Regulatory (QSR) audits
• Pre-Approval Inspection (PAI) Readiness programs
• Compliance remediation support
• Global compliance auditing experience:
– North and South America
• U.S., Canada, Mexico, Argentine, Brazil
– Europe
• UK, Scotland, Switzerland, France, Germany, Spain, Portugal,
Netherlands, Italy, Sweden,
Netherlands Italy Sweden Greece
– Asia/Pacific Rim
• Australia, India, China, Japan, Taiwan, Korea,
Thailand


Compliance Services

• Ability to serve as a remote Quality Unit
– Product development through post approval quality programs
post-approval
– On-site or remote support
• Preparation of Standard Operating Procedures (SOPs)
– Product development through post-approval SOP support
– SOP authoring, maintenance and administration
g,
• 21 CFR Part 11 audits and consultation services
• Customized training programs


Scientific Communications Services


Regulatory Publishing Services

eCTD, NeeS and paper submissions,
SPL / DL preparation and consulting
• Focused on quality and on successful submission outcomes
• Backed by extensive scientific and regulatory expertise
• Proven through a long track record of successful filings
• Delivered via a collaborative partnership approach
• Facilitated by a document management and publishing
system built from industry-proven components and validated
to meet 21 CFR Part 11 requirements


Regulatory Publishing Platform

ISI Toolbox Pharma and Professional

Liquent Core Dossier/Submission Accelerator
Liquent Insight Publisher
Platform
i4i A4L – labeling and drug listing SPL files
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Components
C t
ESG Connectivity

MasterControl D
M t C t l Document M
t Management System
tS t

ePublishing System FDA pilot: February 2007
First eCTD submission: April 2007


BAI Publishing – Process Steps

Planning Pre-publishing Publishing Publishing QC Review

 schedule
h d l  organize  prepare  review publish  BAI or client
submission
 submission  assess docs  examine file /  ensure all
outline
map folder structure content present
 style/format
 add metadata
 styles / formats
y Word docs  examine  examine leaf
 attach lifecycle titles
 document  adjust / correct
documents
templates PDF docs  examine  examine
 transform / system reports lifecycle
 attachments  add bookmarks
render PDFs
& links  assess quality  check
 nonclin reports
 add inter- and bookmark / link
 CSRs / document links consistency destinations
protocols
 publish:
 literature produce output
references files / folders / Dispatch
index
 self-review


Beckloff Associates’ Publishing Experience

eCTDs published in the last 5 years
– INDs in eCTD: 23
– NDAs/BLAs in eCTD: 12
– ANDAs in eCTD: 35 85 eCTD originals
– DMFs/ASMFs in eCTD: 12
– MAAs in eCTD: 3
– CSRs (eCTD / ICH / custom): 70+
– Amendments / annual reports: 1000+

Paper submissions in the last 5 years
– Originals/ Amendments / annual reports: 1000+

ESG submissions in the last 2 years
– eCTDs, eLCRs, eDRs, eLCRs : 1000+


Strategic Labeling and
Promotional Materials Support
Strategic Labeling
• Target Product Profile (TPP) strategic labeling to support
pre-IND stages th
IND t through NDA submission
h b i i
• Prescribing Information
• Physician Labeling Rule (PLR)
development and conversion
• Competitive Analysis labeling
• sNDA updates to comply with
new guidance documents
• Consulting support to identify advantages that can
g pp y g
maximize the potential differentiation of the product at any
stage of development


Strategic Labeling and
Promotional Materials Support
Promotional Materials (OPDP) Support
• Pre- and post-launch Office of Prescription Drug
Promotion (OPDP) regulatory strategies
• Copy Approval Training
• For clients and client’s advertising agencies that focus on
efficiency and cutting edge compliance
• Full service Copy Approval administration
• Tracking and Auditing
• Submissions to FDA
• OPDP consultation includes competitor complaints,
notices of violation and warning letters


Risk Evaluation and Mitigation Strategy
(REMS)
REMS Support
• Strategic consulting and REMS strategies
• P
Preparation and submission of REMS d
i d b i i f documents tailored to
il d
client drug products
• Preparation of tasks and timelines for successful
p
implementation of REMS in partnership with client
• Pharmacovigilance oversight and postmarketing REMS
element management
• Web portal, database collection and call center services and
management
• Registry design and management
• REMS assessments, compliance and monitoring


State Licensing for Drugs and Devices

Pharmaceutical Drug and Device State Registration
• Services to obtain complete and submit state licensing
obtain,
forms for agreed-upon states (each state has its own
forms and requirements)
• M i t i client d t b
Maintain li t database and update state registrations
d d t t t i t ti
on ongoing basis (each state has different requirements
for renewal)


Training Programs
Training Courses
• U.S. Pharmaceutical Development and
Regulatory Systems Workshop
(4 week workshops)
• U.S. Regulatory Submissions Courses
• Clinical and Nonclinical Development
Programs
• GMP GLP, GCP Short Courses
GMP, GLP
• Pre-Approval and System Inspection Courses
• 21 CFR Part 11 Compliance Courses
p
• Customized Training Programs


The Right Team

• Strategic Global Approach that integrates Scientific,
Regulatory and Business Objectives
g y j
• Diverse Base of Experience
• Diverse Drug Development Network
g p
• Knowledge and Information Resource
• Significant International Relationships and Experience
g p p
• Fully integrated consulting firm — regulatory,
nonclinical, clinical, CMC,
compliance, and publishing
within one organization


Thank you
a you!


Scientific and regulatory consulting overview presentation jan 2013

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