Knipper Health - Providing Solutions Brochure 2023

Whether you are in the process of commercializing a brand or have a well established brand Knipper Health can provide a full range of solutions for every phase of the product life cycle.

A Solution for Every Phase Of Product Life Cycle

KnippeRx Custom Pharmacy Solutions

Pre-Approval

Product

Pre-Launch/ Launch

Clinical Trial Support Rx Network Planning

COMMERCIAL

Specialty Lite

Hub Lite

Direct to Patient - Cash

NON-COMMERCIAL

Free Trial

QS/Bridge

COMMERCIAL Specialty Lite

Hub Lite

Growth Stage

Loss of Exclusivity/ End of Life

NON-COMMERCIAL

PAP, PRP

QS/Bridge, Clinical Study

COMMERCIAL Specialty Lite

White Label Pharmacy

Direct to Patient - Cash

NON-COMMERCIAL

Free Trial Voucher

Knipper Third Party Logistics

Distribution Planning & Clinical Site

Stocking

3PL Distribution/ Stocking Kitting

Trade Warehousing, Distribution

Inventory Management

Knipper Marketing & Sample Management

Clinical Trial Support

Contact Center

Marketing Material

End-to-End Sample Management

Warehouse & Logistics

Contact Center Solutions

Marketing Material

White Space Support

Order to Cash

End-to-End Solutions

Reverse Logistics

Repackaging

Relabeling

Trade Warehousing, Distribution

Inventory Management

Order to Cash

End-to-End Solutions

Reverse Logistics

Repackaging

Relabeling

End-to-End Sample Management

Warehouse & Logistics

Contact Center Solutions

Marketing Material

White Space Support

End-to-End Sample Management

Warehouse & Logistics

Contact Center Solutions

Marketing Material

White Space Support

The Most Expansive Reach in the Industry

For over 35 years, Knipper Health has earned the distinction of being a well-recognized leader in healthcare solutions serving the pharmaceutical, biotechnology, and medical device industries. Through three distinct service offerings: Knipper3PL Third Party Logistics, KnippeRx Custom Pharmacy Solutions, and Knipper Marketing and Sample Management (MSM), we provide solutions for your brand, throughout the entire product life cycle.

Patient Access

Ensuring patient access to your product from launch – and throughout the product’s life cycle.

KnippeRx Custom Pharmacy Solutions help your brand overcome patient access obstacles throughout the product life cycle from launch to end-of life.

We provide commercial solutions that offer patients non-traditional direct access to their therapies by delivering a more convenient and personalized patient experience while strengthening your market position.

COMMERCIAL SOLUTIONS

Specialty Lite Services

Through state-of-the-art technology, KnippeRx has automated specialty pharmacy solutions, enabling lower WAC brands to benefit from traditional specialty pharmacy services.

> Highly Personalized Patient Service

> Integrated BV, PA, and Appeals Support

> Experts in Removing Barriers to Access

> Exceptional Clinical Expertise

> Flexible Program Models

Healthcare Provider

Direct to Patient Cash Programs

Many mature products enjoy considerable brand loyalty but struggle to maintain market share in highly competitive categories with shrinking formulary coverage.

> Serving the needs of small, medium, and large pharma-solutions built to scale with manufacturer’s needs

> From single brand initiatives to multi-brand solutions for mature product groups

> Highly automated solutions designed to fit the objectives of your brand while keeping the focus on the patient experience

White Labeled Pharmacy

> Highly Scalable Infrastructure

> Robust Data and Analytics

> Experienced, Knowledgeable and Trusted Partner

> Affordable Programs Customized to the Needs of Your Brand

Increase Greater Access to Therapy

Concierge Service

Home Delivery

Rx Management Tools

Manufacturers

Offer a one-stop solution to ensure patients receive the therapies they choose to take at a price they can afford.

Providers

Lowers the administrative burden on office staff by providing a hassle-free and exceptional experience, to ensure the patients receive the brands prescribed.

Patients

Patient-centric assistance with access to therapy, highly knowledgeable clinical staff, convenient home delivery and assistance with medication adherence.

Deliver white labeled pharmacy services under your brand to better serve your patients. When you partner with KnippeRx for your white labeled pharmacy needs, you get access to:

> Full-service mail-order pharmacy services

> Robust APIs that support telehealth integration

> Patient access support capabilities

> Central fill capabilities

> Call center service

> Clinical support

NON-COMMERCIAL SOLUTIONS

At KnippeRx, our Non-Commercial Pharmacy Services provide a range of access channels that help patients get their prescribed medication, regardless of their circumstances

Patient Assistance Programs

> Challenges with scalability and affordability of PAP programs is driving the need for more efficient, innovative solutions that reduce cost and improve the patient and HCP experience.

> KnippeRx has developed the “Rx Cares Technology Ecosystem” a comprehensive end-to-end platform based on the latest technologies and industry insights.

> Eliminating complex integrations across multiple providers

> Streamlining and automating application processing

> Aligning business rules with industry norms

> Maximizing scalability to better manage intake spikes

> Addressing higher than anticipated annual enrollments

> Ensuring compliance with state and federal regulations providing clear visibility to impactors and metrics which effect overall cost to the business

> API Based 3rd Party Integration Capability

> Advanced Reporting and Analytics Dashboards

> HCP Stock Replenishment via Knipper 3PL

NON-COMMERCIAL SOLUTIONS

Product Replacement Programs

A patient may need an urgent replacement drug or medical device, however, manufacturers often find the replacement process costly and time-consuming.

At KnippeRx, we provide small- and large-scale Patient Product Replacement services with a purpose-built CRM solution that integrates with manufacturers’ Medical Information team to:

> Receive approved patient requests

> Quickly deliver the replacement to the patient or provider

> Patient-labeled dispensing via the KnippeRx pharmacy

> Prescriber stock replenishment via Knipper’s integrated 3PL

Quick Start Program:

When prior authorizations or pre-approvals are required, patients may experience coverage decision delays. When an insurance coverage delay occurs and the Program eligibility requirements are met, the Quick Start Program can provide a one-time supply of their medication to the patient.

Bridge Program:

The Bridge Program provides continuity of care for patients who experience an unexpected gap or loss of insurance coverage. Patients can be provided with a supply of their medication until they obtain insurance coverage.

Clinical Trial Dispensing:

Licensed to dispense in all 50 states, we can help you;

> Manage the distribution and dispensing of clinical trial or study medication

> Process requests for double-blind, placebo-controlled trials

> Design and manage clinical trial transition programs

> Support uninterrupted treatment as patients transition to commercial dispensing

With our Knipper Integrated 3PL Services, we also offer inventory management, site stocking, secondary repackaging & relabeling, and product serialization.

Product Availability

Your partner in secure management and distribution, commercialization and special processing needs in life sciences.

COMPREHENSIVE 3PL SERVICES

Knipper 3PL offers a complete range of safe, scalable, compliant and cost-effective services and solutions that deliver unsurpassed performance, value and results. Most importantly, our 3PL services are purpose-built to achieve your specific goals and needs.

Expert 3PL Distribution & Logistics

• Inventory, storage management

• Automated pick and pack (Perfect Pick®), Pick to Light

Comprehensive 3PL Services

• Product launch commercialization, advanced data and analytics

• EDI comprehensive reporting

• 3PL Consignment and Flash Title models

3PL Customer and Financial Services

• Account set-up and management

• Full order-to-cash

The flexible, tailored solutions of Knipper 3PL integrate an agile, responsive business model with trusted, proven distribution services and an innovative suite of combined technology capabilities to drive performance, efficiencies and cost-controls.

• DSCSA full end-to-end serialization solutions

• DEA Controlled

• Cold chain

• Repacking/kitting/relabeling

• Reverse logistics

• Tamper seals

• Contract management

• DSCSA Buyer support

Dedicated solely to the Life Sciences industry for more than 35 years, Knipper is an industry leader in trade distribution, free goods distribution, dispensing and sampling.

We work closely with your team providing a holistic, consultative approach to address brand challenges and build advocacy, while providing value-added insights and actionable data in a timely, results-driven manner.

PRODUCT AVAILABLILTY

Operations Control Systems

• Integrated order management (OMS)

• Integrated logistics systems (WMS, TMS, labor, billing, cost accounting)

• Light-directed picking, Perfect Pick

• Trade partner management for rapid dock-to-stock times

• Robust and configurable ERP systems that support higher-than-industry standard focus on collecting and reporting quality assurance statistics

• Advanced, fully transparent reporting platform

Warehousing Facilities

• 850,000 square feet overall in multiple facilities

• 36,200 square feet of dedicated refrigerated warehouse space

• 27,500 square feet of dedicated space for DEA controlled substances Schedule III, IIIN, IV, & V

• Security: Onsite security guards, Card access control systems, Biometric access for DEA cages, Video Surveillance

• Warehousing and inventory management support for ambient, cold-chain, and frozen products, including quarantine

• Automated temperature and humidity control

Distribution Support Services

• Traditional 3PL order-to-cash and fulfillment

• State Licensing Support

• Alternative Distribution Models and Direct to Patient Models Integrated with our Specialty Pharmacy KnippeRx

• Government Pricing Support

• Repackaging/ Kitting/ Relabeling

• Reverse Logistics

• DSCSA Full End-to-End Serialization Services

Solid Regulatory Compliance

• FDA Audits covering cGMP, medical device quality systems, PDMA, and 21 CFR Part 11 systems compliance

• Licensed wholesaler/third-party logistics provider in all 50 states, DC, Puerto Rico and Guam

• FDA-registered Repackager/Relabeler facilities, cGMP-compliant for medical foods, drugs, and devices

• Registered with the DEA as an Importer and Exporter of Schedules III, IIIN, IV, and V controlled substances

• Registered with the DEA as a Distributor of Schedules III, IIIN, IV, and V controlled substances

• AICPA SOC certified

• NABP-accredited Drug Distributor (wholesaler/3PL, formerly VAWD)

KNIPPER SEAL™

Secure Exchange of Authentic Logistics

Knipper Secure Exchange of Authentic Logistics (SEAL) includes an array of overlapping systems and processes to ensure the secure handling of your products from receiving through distribution and after delivery to your buyer.

• Tightly Controlled and Validated Handling

• Process Focused on Serialization

• Encrypted Data Exchange

• GxP Processes

• Authentication at Receiving

• Layers of Physical Security

• Enhanced DEA Cage Security

• Cyber Security

• Controlled and Recorded Environment

End to End Secure Exchange of Authentic Logistics in Life Sciences

SERIALIZATION OFFERINGS

Multiple Serialization Offerings from basic serialization support to where Knipper 3PL can manage All DSCSA needs.

KNIPPER EASI™

Exchange of Aggregated Serialized Items

Service to aggregate your unaggregated products for DSCSA

KNIPPER TRAC™

Transit Refrigeration Assurance Controls

KNIPPER PAL™

Portal for Authentic Logistics

Web Browser Access for Your Buyers to DSCSA Transaction Documents

Patient Initiation

PATIENT INITIATION SOLUTION

A Patient Initiation Solution for Every Phase of Your Brand’s Life Cycle

Pre-Approval Product Pre-Launch/ Launch Growth Stage Loss of Exclusivity/ End of Life

Reach HCPs and patients as soon as possible after approval

Develop and implement a successful sampling program (Direct To Practitioner, Direct To Representative Hand Carry, Direct To Patient)

Ensure entire sampling program is always PDMA compliant (HCP compliance, sales representative compliance)

Sample inventory management

Field sales support

Ensure sampling program is achieving your desired ROI (real-time, advanced data visibility and analytics into entire sampling program)

Reach white space territories with product messaging, marketing material, and samples for no access practitioners

Augment commercialization efforts with additional marketing programs (print literature programs and product and collateral kitting)

Protect brand profitability and market share at product maturity and loss of exclusivity

Flexibility and adaptability to react to market changes

The Industry’s Only Fully Integrated End-to-End Sample Management Program

Direct To Practitioner (DTP)

An E-sampling portal for practitioners to request product samples, support materials, and literature.

Direct To Representative (DTR)

An intuitive business rules-based sales rep portal for ordering of samples and product literature.

Direct To Consumer (DTC)

Integrated patient portal whereby consumers can order OTC medications direct from the manufacturer.

Direct To Hospital (DTH)

An integrated platform for Hospitals that don’t dispense PDMA regulated samples to enroll and request Free Trial product.

Client Reporting Portal

One overarching, real-time view of all program data, inventory, and activity through a single integrated reporting portal.

Knipper Contact Center Interface

Integration with Knipper Health’s Contact Center that performs practitioner and sales rep outreach.

Advanced Data and Analytics

An onboard reporting dashboard providing real-time access to your sample-related data in an easy-to-use interface.

Sample Accountability (SA)

A built-in, rock-solid sample accountability module for ensuring compliance with PDMA guidelines.

Clinical Studies

Pre-Launch

Create Demand

Introduce Product to Market

Educate and Influence

Providers and Patients |

Generate and Reinforce

Contact Center

Direct Marketing

› Print Services

For Sponsors, CROs, and Recruitment Agencies

Phase II, III, IV

› Patient Screening

› Investigator Recruitment

› Candidate Recapture

› Direct Mail & Literature

Fulfillment

› Product/Supply Distribution

› Appointment Reminders

Contact Center

HCP Connect

› Territory Warming

› Inside Sales

› Telemarketing

› Teledetailing

HCP Office Sample Readiness Program

End-to-End Sample Management and Literature

Warehousing, Distribution, and Fulfillment

Assure HCP

› HCP Validation Program

Knipper

Market Penetration

Establish Loyalty

Patent Expiration Maturity

Capitalize on Market Potential

Expand Brand Reach and Increase Targets

Extend and Reposition

Market Demand | Cover Vacant Territories and White Space | Maximize Marketing and Promotional Spend

Exploit Switch Potential

Defend Brand Position

HCP Connect/HCP ReConnect

White Space Coverage › Inside Sales › Telesampling › Teledetailing

› Direct Mail and Literature Fulfillment › Product and Collateral Kitting

› Fully Integrated Sample Management Program

Sample Accountability

› PDMA Compliance

› Direct To Physician (DTP)

› Direct to Hospital (DTH)

› Direct To Rep (DTR)

› Rep Hand Carry Services

Audit Inventory Management System (AIMS)

› Field Audits

› Field Inventory

› Sample Reconciliations

› Field Close-outs

› National Rep Storage Facility Program

Knipper Advanced Data Analytics and Business Reporting Architecture (KADABRA)

› Unique Data Reporting Environment to Create Visual Analytics

›

SYNERGY WITH KNIPPER SERVICES TO MAXIMIZE SUCCESS

Product Sampling

DRIVING PRODUCT DEMAND

•Maximize HCP experience, awareness and trust

•Maximize patient experience and positive feedback through expanded usage

OVERCOMING BARRIERS TO ACCESS

•Initial MC coverage gaps

•Unique patient education on product usage instructions

•Ensuring patient compliance

•HCP confidence patient will get therapy

•Seamless office staff admin to ensure patient gets therapy

•Deamless patient experience in obtaining Rx

•Initial product retail availablilty

•Exceptions: Patient Assistance Programs; Affordability

LOGISTICS SOLUTION

•Launch solution experience

•End-to-end solution which optimizes efficiencies

•Centralized full service 3PL logistics capability

•Ability to service emerging to large manufacturers, specialty products, branded-generics and devices

• Cost efficiency/control

BENEFITS OF CHOOSING KNIPPER HEALTH

As your single source provider

• One Company

• One Warehouse

• One Contract

• One Quality Agreement

• One Audit

• One Primary Point of Contact

• One supplier from pre-approval through LOE

• Extensive therapeutic areas of expertise

• Extensive KPIs

• Extensive offerings for emerging to Fortune 500 Companies

• Extensive access to offering based SMEs for best practices

• Extensive efficiencies resulting in real savings

• Extensive rebate programs

• Extensive, real-time reporting and analysis for data transparency BONUS

• Access to the UPS Worldport

• Tailored Programs to meet the manufacturer’s needs

• Access to a flex force of workers for acute urgent needs

• Ease of Integration

• Proactive compliance coverage

• Scalability to meet your increasing business needs

• Flexibility to adapt to your changing environment