Name: Understanding SEND Requirements
Start: 2017-05-31T18:00:00Z
End: 2017-05-31T18:25:33.000Z
Location: BrightTALK
Rating: 3.5

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Gene and Cell Therapy – An Overview of the Current and Changing Regulatory Requirements and Study Design for Nonclinical Safety Evaluation

Nonclinical development of gene and cell therapies has been ongoing for more than three decades, and has been increasing in recent years. In the early days of these efforts, these therapies shared the fate of many novel experimental medicine approaches with progress impeded by severe side effects in treated patients or a failure to demonstrate efficacy in the target patient population. Research over the past decade has resulted in the development of highly sophisticated gene transfer tools with improved safety and therapeutic efficacy.  As these tools have been developed, regulatory agencies worldwide have adapted new review processes and developed a wide range of guidance documents to aide researchers in designing rigorous nonclinical studies to ensure the safety, biodistribution and potential benefit of these advanced therapeutics.  This presentation will provide an overview of the regulatory guidelines, provide some key considerations in the nonclinical development and testing of cellular and gene therapies, and detail several case studies of these therapeutics.

Gene and Cell Therapy – An Overview of the Current and Changing Regulatory

Developments for new therapeutics to target various aspects of auditory system dysfunction is on the rise within the drug development industry. Join Rachel as she reviews nonclinical auditory safety programs, including standard and non-standard endpoints. She will also share in-depth answers to common questions regarding species selection and study timelines.

The Otic Chronicle │ A Guide to Conducting Nonclinical Auditory Studies

A poor animal welfare program can derail your preclinical research. Join Chris Dillon as he examines the importance of animal welfare as it relates to drug development costs, compliance, and factors for considerations when outsourcing preclinical programs.

The Good, The Bad & The Ugly | Choosing a CRO Based on Animal Welfare Compliance

According to the ICH Harmonised Tripartite Guideline: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3(R2), both men and women of child bearing potential (WoCBP) can be included in Phase I and II trials before the conduct of the male and female nonclinical fertility studies, since an evaluation of the male and female reproductive organs is performed in the repeat-dose toxicity studies.  As such, much of the early assessment of potential test article-related effects on the reproductive system falls on the nonclinical toxicologic pathologist.  This requires the pathologist to have a have a sound understanding of spermatogenesis, stage-aware evaluation of the testis, estrous and menstrual cyclicity, and normal physiology and endocrinology in order to carefully and thoroughly evaluate potential xenobiotic-related effects on the reproductive system.  However, even with the most thorough pathology assessment, the design and conduct of nonclinical general toxicity studies can greatly impact the pathologist’s evaluation of the reproductive system.  Commonly encountered challenges include age (onset of puberty and reproductive senescence), body weight changes and systemic toxicity, husbandry practices, strain differences, small sample size (non-rodents), and even histologic sectioning patterns.

Common Challenges in Evaluating the Reproductive System in Nonclinical

Preclinical laboratories face several challenges when conducting animal studies requiring Biosafety Level (BSL) 2 level containment. Some of these challenges include informed study design (including knowledge of associated regulatory guidelines), proper preparation of the vivarium, species isolation, traffic control between containment areas, training of personnel, veterinarian care, and proper decontamination of equipment/waste/bedding prior to disposal. In addition, proper post-life handling of animals and samples, with focused attention on tissue sampling and specialized evaluation is a vital element in ensuring personnel safety and high scientific quality. Overcoming these hurdles will generate high quality data and allow for a safe and productive environment.

Common Challenges to Overcome While Conducting BSL2 Studies

Careful assessment of the relationship between efficacy and toxicity is vital to drug developers as they seek advancement of their compounds. Nonclinical testing is required to establish a safe starting dose for the initial human clinical trials. In partnering with our pharmaceutical and biotechnology Sponsors, our goal is to improve the odds of selecting the right lead candidates, and to conduct the right studies in the right way, taking all factors into consideration to ensure a successful IND submission.
As part of this webinar we will outline the nonclinical studies needed to progress a therapeutic into a Phase I clinical trial. We will cover small molecules to vaccines to biopharmaceuticals as well as standard indications to life-threatening and rare/orphan indications.

How Do I Get My Compound Into Phase I?

A primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity before entering into human clinical trials. Nonclinical testing is required to evaluate the potential efficacy of a new therapeutic and establish a safe starting dose for initial human clinical trials. Knowing when and where to invest your time and effort in preparing for these nonclinical studies is a critical component of a company’s drug development strategy. Many companies outsource their nonclinical testing to contract research organizations (CROs) and have little to no prior experience in working with a CRO. There are a number of technical challenges involved in the process of outsourcing, which if not taken under consideration, can cause delays and unexpected expenses in developing a compound. These challenges range from determining which species is appropriate for your project to basic formulation and dosing aspects. Being aware of and mitigating as many of these challenges early in the process as possible reduces the potential for delays and allows a company to proceed with increased confidence. This webinar will describe some common technical challenges that we have encountered while working with our Sponsors.

Common Technical Challenges with Outsourcing Nonclinical Studies

The CRO+Consultant+Sponsor Relationship: Collaborating to Ensure Sponsor and Client Success.Collaboration is the key to a successful consulting partnership. This webinar will focus on the responsibilities and perspectives of key stakeholders (Sponsor, consultant and CRO), how to make the most out of the Sponsor/consultant relationship, and key considerations when partnering with a contract research organization.  Explore ways to optimize your consultant relationships to ensure success!

The CRO+Consultant+Sponsor Relationship

SEND requirements are now in effect and many companies have implementation questions: Is SEND required for this study?  What are the components of a complete SEND dataset package?  What should be done with endpoints not modeled in SEND?  This webinar will provide answers to those questions and provide best practices for determining how SEND requirements should be applied.

Understanding SEND Requirements

SEND

Preclinical

Drug

Development

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Understanding SEND Requirements

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