Solutions Overview

Optimizing the path to

patients

2

Optimizing the path to

patients

Camargo Pharmaceutical Services partners with emerging biopharma companies to address unmet medical needs in rare and complex areas by optimizing the path to patients.

We challenge the conventional drug development process, applying a specialized approach to increase efficiency, reduce overall costs, and deliver safe and effective treatment to the right patients.

For nearly 20 years, we have successfully positioned high-science, creatively bold strategies to regulators, enabling our clients to accelerate development with confidence. Our Strategy, IND-enabling, Regulatory, and Commercial solutions meet the needs of clients from concept to commercialization.

Headquartered in the United States, we have offices in Cincinnati, Ohio; Durham, North Carolina; and Montreal, Québec. We are proud to partner with clients in more than 35 countries around the world.

3

Contents

Who We Serve 4

Value Proposition 5

Solutions 6

The Camargo Difference 12

Therapeutic and Special Population Expertise 13

Approach 14

Ways to Partner 16

Value

4

Emerging biopharma

Who We Serve

Leading the way forward in patient care

Scientific advances in the 21st century have transformed the practice of medicine. Emerging biopharma companies are leading the way forward, equipped with tools to address patient needs for even the most rare and complex conditions.

Novel Modalities

Real-world Data

Digital Therapeutics

Platform Technologies

Drug Improvement

Value

5

In this new era of medicine, the regulatory, development, and commercial landscape is constantly evolving. Product development is not linear. Regulatory approval does not guarantee commercial success. Addressing unmet patient needs in rare and complex areas requires a specialized approach:

• Patient centricity and inclusion in all aspects• Novel development strategies • Alternative data sources to establish safety

and efficacy• Close collaboration with regulators• Multidisciplinary expertise • Commercial insights at all stages of development

That’s where we come in. Management teams don’t partner with Camargo because they need conventional outsourced R&D services. They choose Camargo because they need a strategic partner equipped to navigate the changing the landscape they face and accelerate development with confidence.

We are built to serve the specialized needs of emerging biopharma companies, with a commitment to making drug development more sustainable.

We consistently help our clients deliver therapy to patients in need faster, smarter, with greater transparency compared to less specialized, conventional R&D vendors.

Addressing unmet patient needs in rare and complex areas requires a specialized development approach

Value Proposition

Our longitudinal solutions meet the needs of clients throughout development.

6

Continuity and breadth of solutions to optimize the path to patients

Solutions

7

Solutions

CommercialRegulatoryStrategy IND-enabling

Commercial Assessments

Commercial Strategy & Launch Planning

Corporate Advisory Services

FDA Regulatory Submissions

Special Designation Applications

Regulatory Agency Interactions

Strategic Assessments

Product Development Plan & Pre-IND Meeting

Camargo Research Group Managed Nonclinical CRO

Services

Nonclinical, CMC & PK Advisory

Services

Value

8

Understanding the development and commercial potential of your portfolio or lead compound is critical to inform early development decisions. Whether your needs are comprehensive or targeted, we offer solutions to evaluate regulatory, development, and commercial aspects of your program.

Solutions

Strategy

Strategic AssessmentsAssess optionality and development risk for your compound(s). Assessments are tailored to client needs and can address:

• Product Selection & Prioritization• Target Product Profile• Commercial Opportunity• Regulatory Strategy• Development Program• Estimated Time and Cost to Market

Product Development Plan & Pre-IND MeetingFor novel compounds: Prepare and present necessary safety and stability data to achieve regulatory alignment to advance to first-in-human studies.

For drug improvement: Prepare and present comprehensive development plan to achieve regulatory alignment on proposed CMC, nonclinical and clinical strategy.

Value

9

De-risking your early development program starts with building necessary safety and stability data to conduct first-in-human studies. Our multidisciplinary team and integrated solutions help you advance confidently, avoid unnecessary delays, and manage fixed costs.

IND-enabling

Managed Nonclinical CRO ServicesDelivered through Camargo Research Group • Study Design and Review• CRO Procurement• Nonclinical Program Management• Study Monitoring• Report Review and Finalization

Nonclinical & Clinical Strategy• Nonclinical Strategy & Study Design• Clinical Strategy & Study Design• Protocol Development

CMC Technical Advisory• Manufacturing and Quality• Analytical Method Development/Validation• Release and Stability Testing, Specifications• Process Development and Validation, QbD• Identification of CMO, Technology Transfer and Comparability

PK/PD Expertise• PK Analysis / Data Review• PK/PD Modeling & Simulations

Solutions

Value

10

Regulatory document preparation and agency interactions can accelerate momentum or create costly delays. Our experienced team provides comprehensive solutions to advance your program seamlessly through key regulatory milestones.

Solutions

Regulatory

Regulatory Preparation, Submissions & Maintenance• Clinical Trial Applications (INDs, CTAs, CTNs)• NDA, BLA, ANDAs• Investigator’s Brochure• Pediatric Study Plans (iPSPs) and Pediatric Investigation

Plans (PIPs), Deferrals & Waivers• IND Development Safety Update Report (DSUR)• PDUFA Fee Waiver• Investigational Medicinal Product Dossiers (IMPD) & other

international documents• eCTD Submissions• Maintenance, Amendments, Renewals, Supplements &

Annual Reports

Special Designation Applications• Request for expedited designations (Fast Track, Priority

Review, Accelerated Approval & Breakthrough Therapy)• Orphan Drug Designation (ODD)• Rare Pediatric Disease Designation (RPDD) & Voucher

(RPDV)• Qualified Infectious Disease Product (QIDP) Designation

Regulatory Agency Interactions• Pre-IND, EOP1, EOP2, Pre-NDA/BLA & Advisory Committee

Meetings• Type A, B and C & INTERACT Meetings

Value

11

Our commercial solutions expand on our industry-leading scientific and regulatory offerings to maximize the potential of your program throughout development and the commercial lifecycle.

Commercial

Commercial AssessmentsUnderstand the commercial market and how to best position your product for success. Assessments are tailored to client needs and can address:

• Target Product Profile• Commercial Opportunity • Patient & Provider Journey• Market Research & Sizing • Competitive Evaluations• Pricing & Access• SWOT Analysis

Commercial Strategy & Launch Planning • Market Access• Patient Support• Brand Strategy

Advisory Services• Due Diligence Support• Capital Sourcing• Licensing & Partnership Evaluation

Solutions

12

Drug development is the ultimate team sport

The Camargo Difference

Our multidisciplinary teams work collaboratively to solve complex challenges and optimize patient impact and product value.

We have the expertise to address unmet patient needs in rare and complex areas where no playbook exists through high-science strategies.

We are committed to delivering a world-class service experience built to meet the needs of emerging biopharma companies.

Our integrated capabilities drive program success from concept to commercial stages.

Here is how we help clients win:

13

Therapeutic and Special Population Expertise

Experts in rare and complex areas

Oncology

Navigating the evolving regulatory, clinical, and commercial landscape is especially complex in oncology. Our team can help navigate the optimal path to deliver better care to patients.

Pediatrics

For optimum safety and efficacy, pediatric clinical trials require specialized expertise. Our team understands how to meet the needs of children who respond to medical treatments differently.

Orphan Drugs

Niche and targeted patient populations come with increased complexity. Our team has the expertise to design and execute a product development plan that meets all stakeholder needs.

Drug Improvement

Whether its formulation changes, new delivery technologies, or combination products, our team has deep expertise successfully positioning drug improvement programs to regulators.

In a typical year, we partner with more than 100 clients across a wide range of therapeutic areas. Our team has the expertise to build scientifically credible, customized development solutions across a wide range of programs. Here are a few areas that we encounter most often:

14

Launch Planning and Execution

Approved Label

NDA

Clinical NonclinicalCMC Regulatory

Strategy & Product Development Plan

Market Intelligence and Commercial

Strategy

Connecting the right patients to your therapy

Our begin-with-the-end-in-mind approach drives program success

Approach

In rare and complex areas, no product development playbook exists. We begin with the end in mind considering the patient journey, physician prescribing practices, and the reimbursement landscape. These insights inform how clients will ultimately connect the right patients to therapy so that our multidisciplinary team can design and execute the right program from the start.

15

Client connectivity every step of the wayWe leverage people, process, and technology to create an industry-leading client experience.

A Strategy Lead and Program Success Manager partner with client management teams to shape and implement strategic vision.

A dedicated Project Manager supports day-to-day project deliverables, status updates, timelines, and scheduling.

Our Client Dashboard provides real-time project visibility to access and share the latest information across all stakeholders.

Approach

16

Our longitudinal solutions meet the needs of clients throughout development

Ways to Partner

We provide flexible solutions to fit the needs of each client. Here is one example of how we support clients as a full-service development partner:

17

Full-Service Development PartnerPartner with our team for a fully integrated

product development solution designed for optimal speed and efficiency.

Functional Service Provider

Access top multidisciplinary experts through our tailored workforce solutions designed to keep your fixed costs low.

Contact us to design a solution that’s right for you

Ways to Partner

Camargo Pharmaceutical Services Cincinnati | Durham | Montreal

+1 (513) 780-5195 | services@camargopharma.com | www.camargopharma.com