Camargo

Patient-Centric Approach and FDA Expertise Lead to Orphan Approval

Camargo

Challenge. An international company developing an orphan drug product needed support navigating the US regulatory process from beginning formulation to NDA approval from a partner with experience in FDA interactions and a deep understanding of the Agency’s evolving thinking. Background.

Niche Nonclinical Studies: Uncommon Routes of Administration and Animal Models

Camargo

Camargo Research Group , Camargo’s managed nonclinical solution, has worked on more than 200 nonclinical programs since its inception in 2005, many of which include rare routes of administrations (ROAs) and use of uncommon animal species.

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In the News: May 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Approval of the Month: Non-Opioid for Post-Surgical Pain Gets FDA Nod.

FDA Designations for Rare Disease Products, Part 4: Humanitarian Use Device

Camargo

The Camargo Blog has published a four-part blog series highlighting those designation programs available specifically for products with rare disease indications. This final installment will explain the criteria, timeline, and benefits of Humanitarian Use Device (HUD) designation.

In the News: April 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA’s Accelerated Approval Program Comes Under Fire.

FDA INTERACT Meetings: Early Interactions for Cell and Gene Therapy Sponsors

Camargo

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers.

Development of Oncology Therapies – Tips from the FDA to Drive Success

Camargo

Cancer is not a single disease, but rather hundreds of different diseases. Thus, there will never be a single cure to cancer.

In the News: March 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Rare Disease Clinical Trials Most Often Terminated Due to Regulatory and Recruitment Issues.

Technology Transfer: What Is It, and How Is It Done?

Camargo

Technology transfer is a critical step in any drug development program, occurring for various reasons and at different development stages.

In the News: February 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA: Sponsors Seldom Disclose RTF Letters’ Existence or Contents and Often Ignore Agency Advice.

Using PK Modeling and Simulation to Plan Studies for Pediatric Patient Populations

Camargo

Conducting a clinical study in a pediatric patient population requires careful planning, as providing a benefit to a child without causing harm is a weighty responsibility.

FDA Designations for Rare Disease Products, Part 3: Rare Pediatric Disease Designation

Camargo

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications : Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation.

How PK Modeling Can Inform Sample Size Estimation and Dose Selection for Your Product

Camargo

Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug attrition rates are very high.

Top 5 Common Misconceptions About Meeting with the FDA

Camargo

Preparing to meet with the FDA can be challenging and stressful for sponsors, especially when they do not know what to expect. Many have misunderstandings about how meetings should be conducted and what constitutes success.

Your NDA Preparation Should Have Started by Now: Planning and Managing Your NDA Submission

Camargo

Throughout our years of preparing and filing FDA submissions, Camargo has often encountered sponsors who cannot file an NDA or BLA within expected timeframes, most commonly due to a failure to start and complete prerequisite activities before the targeted filing date.

In the News: December 2020 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Issues Advice on Combination Products.

In the News: October Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning.

FDA Designations for Rare Disease Products, Part 2: Orphan Drug Designation

Camargo

The Camargo Blog is publishing a four-part blog series highlighting those designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation.

Accelerated Authorizations Using Surrogate Endpoints: Takeaways from DIA 2020

Camargo

Sponsors and regulators use surrogate endpoints to predict the long-term benefits of drug products that. The post Accelerated Authorizations Using Surrogate Endpoints: Takeaways from DIA 2020 appeared first on Camargo. Blog Clinical Studies, Phases I-IV

In the News: January 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Approval of the Month: Previously Approved Oncology Drug Cleared for Rare Pediatric Indication.

What to Expect from the FDA During COVID-19 Product Development

Camargo

As the COVID-19 national emergency stretches on in the United States, the eyes of the. The post What to Expect from the FDA During COVID-19 Product Development appeared first on Camargo. Blog Regulatory Strategy & Submissions

How to Position Your Program to Investors: Leveraging FDA Feedback to Communicate Risk and Boost Confidence

Camargo

When pitching to investors, a sponsor is not just selling them on the product; it is also selling them on its own ability to develop that product. Investors want to know the risks involved with the program, but they are also evaluating the sponsor as a risk factor of its own.

Single-Arm Trials Using Real-World Evidence for Rare Disease Product Development

Camargo

As a sponsor designs clinical studies, the respective comparison control groups become a critical factor to consider.

FDA Designations for Rare Disease Products, Part 1

Camargo

Comparing Orphan Drug, Rare Pediatric Disease, and Humanitarian Use Device Designations.

Prescription Digital Therapeutics: When Software Is the Active Ingredient

Camargo

With smartphones now ubiquitous, interest has increased in digital health solutions such as telemedicine platforms. The post Prescription Digital Therapeutics: When Software Is the Active Ingredient appeared first on Camargo. Blog Combination Products Device

In the News: November Regulatory and Development Updates

Camargo

Remote Document Review Leads to CRL: Be Careful What You Wish for? The FDA’s halt of onsite inspections has created a wealth of problems.

In the News: September Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Establishes Digital Health Center of Excellence.

Repurposing Drugs As an Answer to the COVID-19 Crisis

Camargo

Hydroxychloroquine. The world rallied around this old drug as a potential treatment of COVID-19 patients. The post Repurposing Drugs As an Answer to the COVID-19 Crisis appeared first on Camargo. 505(b)(2) Development Blog

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You Have a Product – Now What? Key Considerations for an Effective Commercial Strategy

Camargo

Whether a sponsor develops a new product or plans to license an exciting new asset developed somewhere else, commercial success or failure will depend on its understanding of the market and ability to develop an effective commercial strategy.

Developing Drug Products with the Label’s Commercial Value in Mind

Camargo

Whether you plan to out-license or commercialize your product, getting the label right matters. The post Developing Drug Products with the Label’s Commercial Value in Mind appeared first on Camargo. Blog Commercialization

Emergency Use Authorizations: What Is an EUA, and Does Your Product Qualify?

Camargo

On January 31, 2020, the Secretary of Health and Human Services (HHS) declared a national. The post Emergency Use Authorizations: What Is an EUA, and Does Your Product Qualify? appeared first on Camargo. Blog Regulatory Strategy & Submissions

Nonclinical Pulmonary Drug Delivery: Setting Up Your Inhalation Drug Study for Success

Camargo

Most are familiar with, know someone who uses, or take “pumps” themselves to prevent or relieve shortness of breath after an effort or during allergy season.

In the News: July Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series will highlight important changes and advancements in the. The post In the News: July Regulatory and Development Updates appeared first on Camargo. 505(b)(2) Development Blog DESI Drug Regulatory Strategy & Submissions

Juvenile Nonclinical Studies: What’s Involved, and How do I Proceed?

Camargo

So you’ve determined that you need to perform juvenile animal toxicity studies as part of your nonclinical program. The next step is understanding why these studies are required and how they should be designed. Why Are Juvenile Nonclinical Studies Needed?

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A 505(b)(2) Primer: Building the Bridge Between an Approved Drug and Your Novel Therapy

Camargo

This blog features considerations and recommendations for sponsors exploring a 505(b)(2) pathway to drug approval. The post A 505(b)(2) Primer: Building the Bridge Between an Approved Drug and Your Novel Therapy appeared first on Camargo. 505(b)(2) Development Blog Clinical Studies, Phases I-IV

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How Are Biopharma Companies Evaluating Partnerships in the Rare Disease Space?

Camargo

Panel Summary from the World Orphan Drug Congress 2020. Last month, executives from leading international biopharma companies came together at the World Orphan Drug Congress 2020 to discuss how they are evaluating new opportunities in the rare disease space.

Navigating the Global NHP Shortage: How to Keep Your Development Program on Track

Camargo

In the first half of 2020 and as a direct consequence of the ongoing pandemic, China issued a ban on the export of non-human primates (NHPs) , including those used for pharmaceutical research.

Preclinical and Nonclinical Studies— What Is the Difference, and Where in Your Program Should They Fall?

Camargo

Have you ever wondered about the difference between preclinical and nonclinical studies? While those in. The post Preclinical and Nonclinical Studies— What Is the Difference, and Where in Your Program Should They Fall? appeared first on Camargo. Blog Nonclinical Testing Services

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“Get the First Inch Right”: Oncology Combination Product First-in-class Treatment Success Story

Camargo

Throughout the life-cycle of a drug development program, sponsors are confronted with a range of key questions. They must decide on the correct….

In the News: August Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explore how those changes could impact your program. Fitbit developing algorithm COVID-19 early detection.

Patient-Centered Drug Development for Oncology Products

Camargo

Oncology patients face a difficult journey — a frightening diagnosis followed by intricate and oftentimes. The post Patient-Centered Drug Development for Oncology Products appeared first on Camargo.

CARES Act Introduces OTC Administrative Order Process

Camargo

In a previous blog post, we discussed some significant changes to over-the-counter (OTC) product regulations. The post CARES Act Introduces OTC Administrative Order Process appeared first on Camargo. Blog Commercialization

Choosing the Right Animal Model for COVID-19 Nonclinical Research

Camargo

Research into drugs and vaccines to combat the ongoing COVID-19 pandemic caused by the SARS-CoV-2. The post Choosing the Right Animal Model for COVID-19 Nonclinical Research appeared first on Camargo. Blog Nonclinical Testing