Pivotal Clinical Trial Podcast

Mpox virus (MPXV) is evolving. So is the science. In this presentation, I'll discuss the current mpox vaccine landscape and next-generation vaccines being developed to improve large-scale production and long-term efficacy. If successful, these next-gen vaccines will help the scientific community stay ahead of the curve. ****** Hi, my name is Dr. Amos Ndhere! I am a medical doctor, Clinical Investigator, and Regulatory affairs specialist. My goal is simple: To provide pharmaceutical R&D leaders with clinical trial strategies that optimize outcomes and allow them to access emerging markets. Let's talk: https://www.aceresearchafrica.com/com ****** PS - Join the conversation on social! https://www.linkedin.com/in/amosndhere https://twitter.com/amosndhere https://facebook.com/amosndhere https://www.instagram.com/amos.ndhere/Clinical Research #mpox #vaccine #clinicaltrials #clinicalresearch #publichealth

Mpox Virus has evolved into two distinct clades I and II, each with differing transmission rates and virulence. These clades raises new concerns about transmissibility and what it means for the future of Mpox control and vaccine efficacy. This episode highlights evolutionary dynamics of Mpox Virus clades and their implications for public health! References:

Outsourcing offers potential relief for pharmaceutical and biotechnology firms engaged in clinical trials. However, determining the most appropriate outsourcing approach presents challenges, consumes time, and carries inherent risks that could result in project failure.Reevaluating one's strategy is imperative to ensure alignment with organizational goals and capacities. Furthermore, the selection of the optimal operational delivery model plays a pivotal role in achieving success.This episode discusses the merits and demerits of each approach and aids pharmaceutical industry leaders in making informed decisions tailored to the needs of biotechnology or pharmaceutical enterprises.✅ In-House Management✅ Full Outsourcing✅ Hybrid ModelThanks for watching and see you at the next one.

The pharmaceutical industry suffers significant financial losses and delays market entry due to the overwhelming maze of clinical research regulatory requirements.Here is a 3-step roadmap to perfect the timing of regulatory submission for success:STEP 1. Identify Regulatory Authority.STEP 2: Collect Regulatory Intelligence.STEP 3: Strategize Submission.Timing is everything! Submitting your regulatory documents on the most opportune dates can increase approval odds with aligned regulatory schedules.

Clinical trials play a crucial role in developing new medical treatments and vaccines for public health. They are the stepping stones that bring hope to patients. Regulatory delays have significant consequences for the pharmaceutical industry and patients and their families who rely on timely R&D of new treatments for better outcomes and quality of life. In this episode, I will explain the consequences and impact of clinical research regulatory delays. DOWNLOAD FREE Regulatory Case Study to learn how to navigate the process efficiently. https://aceresearchafrica-3272060.hs-sites.com/regulatorycasestudy

Clinical Trials in Africa: Opportunities & Benefits for Pharmaceutical Industry - PART 2 VIDEOIn this two-part episode series, I will examine the trends, drivers, and opportunity windows that shape the African clinical industry market dynamics and why industry sponsors should consider Africa in their product development plan and strategy.Download a FREE report using this link. https://lnkd.in/ecaMvj-V

International Conference on Harmonization (ICH) Good Clinical Practice (E-6) requires investigators and sponsors to retain specific study records associated with the conduct of clinical research. These documents are often referred to as Essential Documents.

Clinical trials play a crucial role in developing new medical treatments and vaccines. They are the stepping stones that bring hope to patients. Regulatory delays have significant consequences for the pharmaceutical industry and patients and their families who rely on timely R&D of new treatments for better outcomes and quality of life. In this video, I will explain the consequences and impact of clinical research regulatory delays. Get a FREE Regulatory Case Study and Discover How You Can Accelerate Your Start-up in Africa Download Now ****** Hi, I'm Dr. Amos Ndhere! I am a medical doctor, Clinical Investigator, and Regulatory affairs specialist. My goal is simple: Reduce the pain of clinical research and help biopharma industry leaders get new treatments to market faster, at a reasonable cost, while adhering to safety concerns. Do you want to deliver your clinical trial in Africa safely? Let's talk ***** PS - Join the conversation on social! ⁠LinkedIn⁠ ⁠Twitter⁠ ⁠YouTube

As a pharmaceutical sponsor of clinical research, you want a seamless, efficient, and prompt regulatory submission, review, and approval for your next clinical trial. The challenge lies in the fact that the regulatory process may have its own pace. But what if you strategically aligned your team's objectives with the regulatory agency's course to accelerate clinical trial regulatory approval for your next vaccine or drug trial?   In this video, I will explain 7 simple strategies pharmaceutical sponsor teams can take to achieve their timeline objective and overcome regulatory obstacles. Listen now! ***** Hi, I'm Dr. Amos Ndhere! I am a medical doctor, Clinical Investigator, and Regulatory affairs specialist. My goal is simple: Reduce the pain of clinical research and help biopharma industry leaders get new treatments to market faster at reasonable costs while adhering to safety standards. Get Your FREE Regulatory FAQ To Build A Robust Regulatory Strategy: Download Now ***** PS - Join the conversation on social! LinkedIn Twitter YouTube

This two-part episode reveals 12 common non-sponsor-related causes and reasons for clinical regulatory delays and offers expert insights and guidance on navigating them. Understanding these causes helps Sponsor teams to: Plan Regulatory Submission, Make informed GO/No-Go Decisions, Mitigate Risks, and Hedge Clinical Development Plan.  Listen now! ***** Hi, I'm Dr. Amos Ndhere! I am a medical doctor, Clinical Investigator, and Regulatory affairs specialist. My goal is simple: Reduce the pain of clinical research and help biopharma industry leaders get new treatments to market faster at reasonable costs while adhering to safety standards. Do you want to deliver your next clinical trial in Africa safely? Let's talk ****** PS - Join the conversation on social! ⁠LinkedIn⁠ ⁠Twitter⁠ ⁠YouTube

The R&D window during an outbreak is very short; in some cases, there is only a limited number of patients for experimental treatment. Pharmaceutical sponsors will struggle to complete the R&D of vaccines and treatments against global health biothreats in outbreak settings until they leverage lessons learned and decisive actions to overcome practical difficulties of R&D in an outbreak setting. In this part-2 episode, I'll explain additional key factors that led to R&D successes during the 2014-15 Ebola virus outbreak in West Africa. If you haven't watched the part-1 video, I've included the link in the description below. Watch PART 1 Video Now ***** Hi, I'm Dr. Amos Ndhere! I am a medical doctor, Clinical Investigator, and Regulatory Affairs Specialist. My goal is simple: Help Pharma industry leaders understand key trends, top strategies, and tools to conduct R&D in emerging markets and deliver life-changing treatments to patients faster. Do you want to deliver your clinical trial in sub-Saharan Africa safely? Let's talk ***** PS - Join the conversation on social! ⁠LinkedIn⁠ ⁠Twitter⁠ ⁠YouTube

Conducting vaccine, drug, and biologics R&D during disease outbreaks can be a drag. Sponsors will struggle to deliver new products against global health biothreats unless they leverage lessons learned during previous studies to influence clinical research development plans during future outbreaks. In this Episode #03, I will explain how lessons learned during the 2014-15 West Africa Ebola virus outbreak can supercharge R&D during future outbreaks and deliver life-saving clinical products to patients and families faster. **** Hi, I'm Dr. Amos Ndhere! I am a medical doctor, Clinical Investigator, and Regulatory Affairs Specialist. My goal is simple: Help Pharma industry leaders to gain a sound understanding of key trends, top strategies, and tools to conduct R&D in emerging markets and deliver life-changing treatments to patients faster. Do you want to safely deliver your clinical trial in sub-Saharan Africa? Let's talk: https://lnkd.in/g_H5UfqD... **** Please like, share and give me a 5-star, that'd be appreciated!

Regulatory authorities in Sub-Saharan Africa are scrutinizing pharmaceutical companies' risk management and control practices with more rigor than ever before. Choosing the right insurance for human clinical trials can be a drag, especially in sub-Saharan Africa. Clinical trial sponsors must procure appropriate insurance coverage which must fulfill country-specific statutory requirements and provide adequate risk management and control during the life of a clinical trial. In this episode, I will discuss the following: What is Clinical trial insurance? Forms of insurance policies Types of insurance covers required in Sub-Saharan Africa Who should be indemnified? Risks covered under Insurance Policy limit requirements Term of Insurance policy *** Hi, I'm Dr. Amos Ndhere! I am a Medical doctor, Clinical Investigator, and Regulatory affairs specialist. My goal is simple: Help YOU with the right tools, tips, and framework to deliver life-changing treatments to patients faster through clinical research and emerging market access. Do you want to safely deliver your clinical trial in sub-Saharan Africa? Let's talk: https://www.linkedin.com/in/amosndhere *** Please subscribe, that'd be appreciated!

Africa's pharmaceutical market is $60B and CAGR is about 10%. Global pharmaceutical companies will struggle to break into the growing African market until they position pharmaceutical products correctly. In this video, I will explain how Medical Affairs can position products for the growing African market and WIN a piece of the $60B market share. **** Hi, I'm Dr. Amos Ndhere! I am a medical doctor, Clinical Investigator, and Regulatory affairs specialist. My goal is simple: Help YOU with the right tools, tips, and framework to deliver life-changing treatments to patients faster through clinical research and emerging market access. Do you want to safely deliver your clinical trial in sub-Saharan Africa? Let's talk: https://www.aceresearchafrica.com/con... **** Please subscribe, that'd be appreciated!

Did you know more clinical studies happen in Africa compared to South Asia and Australia? In this two-part podcast series, Dr. Amos Ndhere offers insights on the evolution of the clinical research landscape, drivers, key opportunities and benefits, and how pharmaceutical industry can maximize R&D ROI in Africa. You can also download a FREE report using this link. https://lnkd.in/ecaMvj-V

Africa is one of the fastest-growing and emerging pharmaceutical markets. The African pharmaceutical industry is experiencing 9-12% CARG. In this episode, host Dr. Amos Ndhere shares insights and strategies to help industry leaders to win the growing $60B market share. Specifically, we uncover: How to position final pharmaceutical products such as vaccines, drugs, and medical devices for the African market Who are the key stakeholders in Africa? Actionable strategies for medical affairs leaders And SO much more... Links from the Show