Scientific and regulatory consulting overview presentation jan 2013

Intelligent Actions.S t S l tiSmarter Solutions.

Beckloff AssociatesScientific and Regulatory Consulting

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Cardinal Health Business Segments

Cardinal Health

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

Pharmaceutical Medical

Operations

• $93.7B FY11 revenue

• Serves pharmaceutical manufacturers, retail pharmacies, hospital and mail-order

• $8.9B FY11 revenue

• Distributes products to ambulatory care centers, physician offices,retail pharmacies, hospital and mail order

facilities, physician offices, surgery centers, and alternate care facilities.

care centers, physician offices, clinical laboratories, and hospitals across the U.S. and Canada.


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Cardinal Health

Pharmaceutical SegmentNuclear and Pharmacy

ServicesNuclear and Pharmacy

ServicesPharmaceutical

DistributionPharmaceutical

Distribution Specialty SolutionsSpecialty Solutions

Beckloff Associates Pharmaceutical Distribution Pharmacy Solutions Borschow (Puerto Rico) Pharmaceutical Repackaging

Nuclear Pharmacy Services Beckloff Associates

Scientific and Regulatory Consulting

Healthcare Analytics and Marketing Communicationsp g g

ParMed Kinray Yong Yu

Third Party Logistics Services Specialty Pharmaceutical Distribution GPO Contracts and Services Access Services (Health Connections)


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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 2004by Cardinal Health in 2004• Also known as CHSS Scientific and Regulatory Consulting• Headquarters in Overland Park KS with satellite and• Headquarters in Overland Park, KS, with satellite and

remote offices around the United States


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“Celebrating 36 years of Client Success”

Beckloff Associates - Locations

HeadquartersCommerce Plaza II, Suite 3007400 W. 110th StreetOverland Park, KS 66210

San Diego Regional OfficeRegents Square I4275 Executive Square, Suite 300La Jolla, CA 92037


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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• Regulatory Affairs • Pharmaceutics• Pharmaceutics• Regulatory Affairs• Analytical Chemistry• Organic Chemistry• Medicinal Chemistry

• Regulatory Affairs• Analytical Chemistry• Organic Chemistry• Medicinal Chemistry

• Pharmaceutics• Pharmacokinetics • Pharmacology• Toxicology

• Pharmaceutics• Pharmacokinetics • Pharmacology• Toxicology• Medicinal Chemistry

• Biochemistry• Microbiology

Nursing

• Medicinal Chemistry• Biochemistry• Microbiology

Nursing

• Toxicology • Veterinary Medicine• Medical Writing

Project Management

• Toxicology • Veterinary Medicine• Medical Writing

Project Management• Nursing• Neurology/Psychology• Nursing• Neurology/Psychology

• Project Management• Business Administration• Project Management• Business Administration


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Therapeutic Areas of Experience• Analgesia• Anesthesia• Anti-Infective

• Inflammation• Metabolism• NeurologyAnti Infective

• Cardiology• Dermatology

E d i l

Neurology• Oncology • Ophthalmology

Rh t l• Endocrinology• Gastroenterology • Hematology

• Rheumatology• Psychiatry• Pulmonary

• Health (Men’s and Women’s)

• Immunology

• Special Pathogens• Urology• VaccineImmunology

• Infectious Disease• Vaccine

Extensive CMC experience with small molecules,


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te s e C C e pe e ce t s a o ecu es,biologics, and combination products

Integrated Consulting Units

Regulatory Affairs & P d t D l t

Scientific MedicalProduct Development

(nonclinical and clinical)CommunicationsWriting

Chemistry, Manufacturing, and

C t l

Compliance and Quality Service

(GLP GMP GCP QSR)

Regulatory Publishing Services

(paper and electronic)Controls (GLP, GMP, GCP, QSR)(paper and electronic)

Regulatory Services

Continuity of services from laboratory bench to pharmacy shelf and beyond


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Scientific Design, Regulatory Affairs, and Strategic Planning

• Expertise from Discovery to Post-Approval• Support Product Development, Dossier Life-cycle

Management and Market ExpansionManagement, 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 DocumentationAuthor U.S., E.U., and ROW Regulatory Documentation• Use an Integrated Regulatory, Nonclinical, Clinical, and

CMC Approach P id C lti d S i tifi d M di l W iti• Provide Consulting and Scientific and Medical Writing

• Provide Ad-Hoc, Project-Based, and FTE Models


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Global Regulatory Documentation

Prepare, Review, Publish, Submit, and Maintain

• DMFs • Clinical & Nonclinical Study Protocols and Reports

• INDs

• NDAs

• Agency Meeting Requests & Information Packages• Response to Agency Questions• Expedited Safety Reports PSURs & DSURs• 505(b)(2)s

• ANDAs

BLA

• Expedited Safety Reports, PSURs, & DSURs• Integrated Summaries of Safety & Efficacy• Risk Evaluation and Mitigation Strategy (REMS)

• BLAs

• 510(k)s

• IDEs

g gy ( )• Orphan Drug Applications (U.S. and Europe)• Annual Reports, Amendments, Supplements

• IDEs

• PMAs• European & Canadian Submissions (CDMF, CTA,

IMPD, ASMF, NDS, MAA, Certificate of Suitability)


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Service Offeringsg


Beckloff Associates Service Offerings• Clinical and Nonclinical Consulting • Medical and Scientific Writing

R l t CMC P d P t l S t• Regulatory CMC Pre and Postapproval Support• Quality and Compliance• Scientific Communications• Scientific Communications• Global Regulatory Documentation (prepare and publish)• Strategic Labeling and Promotional Materialsg g• Risk Evaluation and Mitigation Strategy (REMS)• State Licensing for Drugs and Devices• Training Programs


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Clinical and Nonclinical Consulting

Regulatory Affairs

New Product Development

• Pharmaceuticals• Biologics• Devices

• Program Management• Regulatory Dossier

MaintenanceR l t AAffairsDevelopmentDevices

• Line Extensions• Expanded Label Claims

• Regulatory Agency Interactions & Meetings

• Briefing Documents

Clinical & Nonclinical Operations

Management

Strategic Regulatory Consultation

• Pre- & Post-Approval Studies• Study Planning • Study & Vendor ManagementCompliance

• Strategic Development Plans• Development Program Outlines & Timelines• Due Diligence Evaluations• Evaluation of Safety & Efficacy Data y g

• Clinical Data for Post-Marketing & Business Objectives

• Evaluation of Safety & Efficacy Data• Risk Evaluation & Mitigation Strategy• Strategic Labeling Support • Nonclinical & Clinical Program Integration GLP and GCP Auditing


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Scientific and Medical Writing

Clinical Studies

NonclinicalStudies

• NC Study Designs• NC Study Protocols

NC St d R t

• Clinical Study Designs• Clinical Study Protocols• Clinical Study ReportsStudiesStudies• NC Study Reports

• Scientific & QC Review

Clinical Study Reports• Scientific & QC Review

Market Applications Investigational New Drug Applications

P ti t N ti• Patient Narratives• Integrated Summary of Safety• Integrated Summary of Efficacy• Clinical & Nonclinical Summaries

Safety Reports

• Investigator’s Brochures• Briefing Documents• Special Protocol Assessments

• NDA, BLA, MAA, NDS, PMA• Supplements

• Orphan Drug Applications• Fast Track Designation Requests • Annual Reports and Amendments

• Expedited Safety Reports• DSURs & PSURs


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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

participationparticipation– 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


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• 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 questionsResponses to agency questions• Amendments

– Preparation for launchS l d lid ti• Scale up and process validation

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


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• Post-approval CMC Support (continued)

– Assessment of manufacturing changes and process/productAssessment of manufacturing changes and process/product deviations

– Post-approval strategy and communicationAnnual reports and annual product reviews– Annual reports and annual product reviews

– Supplements, Variations and Notifications• Prior Approval and Changes Being Effected• Type I and Type II


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Device Development

• Product Development Planning

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

f f• Identification of Predicate Devices • Demonstration of Substantial Equivalence


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Device Development

P ti d M i t f A li ti

Medical Device, In Vitro Diagnostic Products, and Laboratory-Developed Tests• Preparation and Maintenance of Applications

– Investigational Device Exemption (IDE)– 510(k) Premarket Notification510(k) Premarket Notification– Premarket Approval (PMA) – Humanitarian Device Exemption (HDE)

• Medical Device Reporting – Adverse Events – Product ComplaintsProduct Complaints

• Product Recalls, Corrections, Removals


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Compliance Services

• Good Manufacturing Practices (GMP) audits in accordance with FDA and EU requirements, Good Laboratory Practices (GLP) audits, and Good Clinical Practices (GCP) auditsaudits, 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 GreeceNetherlands, Italy, Sweden, Greece– Asia/Pacific Rim

• Australia, India, China, Japan, Taiwan, Korea, Thailand


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Compliance Services

• Ability to serve as a remote Quality UnitProduct development through post approval quality programs– Product development through post-approval quality programs

– On-site or remote support

• Preparation of Standard Operating Procedures (SOPs)Preparation of Standard Operating Procedures (SOPs)– Product development through post-approval SOP support

– SOP authoring, maintenance and administrationg,

• 21 CFR Part 11 audits and consultation services

• Customized training programsCustomized training programs


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Scientific Communications Services


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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

SPL / DL preparation and consulting

Backed by extensive scientific and regulatory expertise

• Proven through a long track record of successful filings

• Delivered via a collaborative partnership approach• 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


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Regulatory Publishing Platform

ISI Toolbox Pharma and Professional

Liquent Core Dossier/Submission AcceleratorLiquent Insight Publisher

i4i A4L – labeling and drug listing SPL filesPlatform

C t

M t C t l D t M t S t

g g g

ESG Connectivity

Components

MasterControl Document Management System

ePublishing System FDA pilot: February 2007

First eCTD submission: April 2007


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BAI Publishing – Process Steps

Planning Pre-publishing Publishing Publishing QC Review

h d l organize

assess docs

style/format Word docs

prepare submission outline

add metadata

review publish

examine file / folder structure

examine

BAI or client

ensure all content present

examine leaf

schedule

submission map

styles / formats Word docs

adjust / correct PDF docs

add bookmarks & links

attach documents

transform / render PDFs

examine lifecycle

examine system reports

assess quality

examine leaf titles

examine lifecycle

check

y

document templates

attachments& links

add inter-document links

publish: produce output

assess quality and consistency

check bookmark / link destinations

nonclin reports

CSRs / protocols

literatureDispatch

produce output files / folders / index

self-review

literature references


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Beckloff Associates’ Publishing Experience

eCTDs published in the last 5 years– INDs in eCTD: 23– NDAs/BLAs in eCTD: 12– NDAs/BLAs in eCTD: 12– ANDAs in eCTD: 35– DMFs/ASMFs in eCTD: 12– MAAs in eCTD: 3

85 eCTD originals

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+


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Strategic Labeling and Promotional Materials Support

• Target Product Profile (TPP) strategic labeling to support IND t th h NDA b i i

Strategic Labeling

pre-IND stages through NDA submission• Prescribing Information• Physician Labeling Rule (PLR)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


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Strategic Labeling and Promotional Materials Support

• Pre- and post-launch Office of Prescription Drug

Promotional Materials (OPDP) Support

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 administrationFull service Copy Approval administration• Tracking and Auditing

• Submissions to FDA

• OPDP consultation includes competitor complaints, notices of violation and warning letters


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Risk Evaluation and Mitigation Strategy (REMS)

• Strategic consulting and REMS strategiesP i d b i i f REMS d il d

REMS Support

• Preparation and submission of REMS documents tailored to client drug products

• Preparation of tasks and timelines for successful pimplementation of REMS in partnership with client

• Pharmacovigilance oversight and postmarketing REMS element managementelement management

• Web portal, database collection and call center services and management

• Registry design and management• REMS assessments, compliance and monitoring


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State Licensing for Drugs and Devices

• Services to obtain complete and submit state licensingPharmaceutical Drug and Device State Registration

Services to obtain, complete and submit state licensing forms for agreed-upon states (each state has its own forms and requirements)

M i t i li t d t b d d t t t i t ti• Maintain client database and update state registrations on ongoing basis (each state has different requirements for renewal)


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Training Programs

• U.S. Pharmaceutical Development and Regulatory Systems Workshop

Training Courses

Regulatory Systems Workshop (4 week workshops)

• U.S. Regulatory Submissions Courses• Clinical and Nonclinical Development

Programs • GMP GLP GCP Short Courses• GMP, GLP, GCP Short Courses• Pre-Approval and System Inspection Courses• 21 CFR Part 11 Compliance Coursesp• Customized Training Programs


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The Right Team

• Strategic Global Approach that integrates Scientific, Regulatory and Business Objectivesg y j

• Diverse Base of Experience• Diverse Drug Development Networkg p• Knowledge and Information Resource• Significant International Relationships and Experienceg p p• Fully integrated consulting firm — regulatory,

nonclinical, clinical, CMC, compliance, and publishing within one organization


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Thank you!a you
