Camargo

Developmental and Reproductive Toxicology (DART) Studies: What Are They, and How Do They Fit into Your Program?

Camargo

Development and Reproductive Toxicology studies, or DART studies, are required for most non-oncology programs between IND and NDA filings.

Gene Therapy and Pharmacokinetics

Camargo

How and When to Incorporate PK Design into Your Gene Therapy Development Plan. Gene therapy, which was in its infancy around 30 years ago, is now becoming a more prominent treatment method in many therapeutic areas, from personalized therapy to mass vaccinations against COVID-19.

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In the News: July 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: Repurposed Transplant Drug Approved Based Only on Real-World Evidence.

Regulatory Strategy Considerations for Working with the FDA vs the EMA, Part 1

Camargo

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined.

2022 Research: The Rapid Rise of Ocean Freight Visibility

Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.

Equal Parts Caregiver and Advocate: Clinical Trials from the Caregiver’s Point of View

Camargo

“There are only four kinds of people in the world: Those who have been caregivers, those who are currently caregivers, those who will be caregivers, and those who will need caregivers.”. Roslyn Carter.

Regulatory Strategy for Combination Devices: Working with the FDA for Program Success

Camargo

As pharmaceutical science and innovation advance, breakthrough combination products frequently emerge that provide patients with therapeutics comprised of two or more constituents.

PDUFA VII: Implications for Developers of Cell and Gene Therapies

Camargo

One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA VII , as the reauthorization is commonly known, will cover the fiscal years 2023-2027.

Advancing from Research to Development: What Can Go Wrong?

Camargo

The drug development process is a long journey, beginning with drug discovery, moving through nonclinical and clinical studies, and ultimately culminating in regulatory approval.

In the News: October 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 Guidance Addresses Real-World Evidence Data Standards.

PDUFA VII: More Changes Coming in the Latest Reauthorization

Camargo

As we noted in a separate blog post , the forthcoming reauthorization of the FDA’s Prescription Drug User Fee Act (PDUFA VII) includes several provisions that are expected to help advance cell and gene therapy products, as well as therapies designed to treat rare diseases.

An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.

Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available.

In the News: November 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. Voxzogo Approved as a Growth-Improvement Therapy for Children with Dwarfism.

In the News: September 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 Discusses Focus Areas for PDUFA VII During Public Meeting.

The Composition and Value of a Portfolio Analysis

Camargo

One of Camargo’s differentiating offerings is the portfolio analysis, a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio.

In the News: August 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. Some Drugs May Require Reclassification to Devices.

Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Camargo

When a submission is sent through the FDA’s Electronic Submissions Gateway (ESG), it goes through an automated check of many validation rules, as specified in the Electronic Common Technical Document (eCTD) submission standards guidance.

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available.

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.

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.

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.

2020 505(b)(2) NDA Approvals: A Year in Review, and What a Year It Was!

Camargo

In 2020, CDER approved 68 NDAs that used the 505(b)(2) pathway, representing important advances in patient care across a wide range of therapeutic areas. 505(b)(2) Drug Improvement Approvals by Year.

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

Regulatory Strategy Considerations for Working with the FDA vs the EMA, Part 2

Camargo

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined.

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.

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.

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 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.

Improving the Pediatric Patient Journey with Decentralized Clinical Trials

Camargo

While the COVID-19 pandemic has accelerated innovation in many areas, including clinical trial design, many recent advancements were already in motion before 2020 as sponsors and CROs sought to improve the patient journey and encourage trial participation.

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.

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.

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: June 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. Old Antidepressants Being Repurposed to Treat Cancer .

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.

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.

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.

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: 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.

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

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.

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.