DarshanTalks Podcast

Send us Fan Mail Recently, Celia Sandhya Daniels was announced to be one of the top 20 LGBTQ leaders in Bio Pharma by Endpoints News. In this episode, We're venturing into the captivating world of Diversity, Equity, and Inclusion (DEI) in the realm of pharmaceuticals and healthcare. Get ready for a journey that will unravel the mysteries and intricacies of DEI! We’re joined by Celia Sunday Da...

Send us Fan Mail The case study on academic research center misconduct highlights the urgency to address and prevent such issues in the field. Instances of research misconduct, as exemplified by the Miami case, have drawn the attention of regulatory agencies like the Department of Justice, emphasizing the need for stringent oversight and ethical conduct. Examining the fictional case of Padre Pio H...

Send us Fan Mail Planning to incorporate artificial intelligence into your business in 2024? Stay informed about the Federal Trade Commission's (FTC) expectations. In his discussion, Darshan Kulkarni highlights the FTC's recommendations for AI: FTC expects that AI will foster fair, open and competitive markets, FTC intends to use its tools to challenge unfair and deceptive practices invo...

Send us Fan Mail Jessica Thompson discusses how project management can be a game-changer in clinical research.  We talk about how poor project management can lead to delays, cost overruns, and regulatory violations, and that lawyers can play a role in ensuring that clinical research projects are managed effectively. Thompson emphasized the need for early planning and communication between all stak...

Send us Fan Mail Virginia Tech recently received a $50 million gift from the Red Gates Foundation for Health Sciences research expansion. In light of recent news about research fraud prosecuted by the Department of Justice, it is crucial for the Fralin Biomedical Research Institute to implement robust research integrity policies. Here are five key steps that the institute can take to address resea...

Send us Fan Mail We discuss the 7 things to do before closing your pharmacy: 1. Return your DEA registration, 2. Notify the Board of Pharmacy, 3. Dispose of controlled substances appropriately, 4. Inventory your pharmacy and create a clear inventory list, 5. Keep all documentation, especially for controlled substances, for at least 2 years, 6. Know where your records are stored, as the DEA may req...

Send us Fan Mail The FDA's recent decision to cease its enforcement discretion for lab-developed tests (LDTs) has significant implications for developers. To ensure compliance, developers must adhere to a rigorous process.   Key steps include: 1) Develop a risk-based framework- 0:39 - 1:03 2) Get pre-market clearance or approval- 1:04 - 1:37 3) Quality control and quality assurance- 1:38 - 2:...

Send us Fan Mail On September 5th, 2023, a Miami jury found a medical clinic owner and pharmacist guilty of falsifying and fabricating clinical trial data.   We highlight the significance of pharmacists recognizing red flags indicating potential fraud, including patients unknowingly or involuntarily enrolled in clinical trials.   Beyond the broader impact on public trust, pharmacists could face sp...

Send us Fan Mail In this episode, guest Dave Bulger delves into the intricate role of AI, questioning whether it functions as a creator, a copycat, or perhaps both. Dave Bulger, delves into the world of #AI , highlighting the distinction between AI and large language models (LLMs). He exposes the limitations of generative AI, raises concerns about copyright in content generation, and explores AI&a...

Send us Fan Mail The FDA has taken action by sending warning letters to eight companies that have been marketing unapproved eye products, potentially violating federal laws and risking consumer health.  These companies include Boiron Inc, CVS Health, Dr. Vitamin Solutions, Natural Ophthalmics Inc., OcluMed LLC, Similasan USA or Similasan AG, TRP Company Inc., and Walgreens Boots Alliance Inc.  The...

Send us Fan Mail FDA is suggesting the use of one-pagers to provide essential drug information to patients. Past attempts faced challenges, such as one-size-fits-all content and patient trust issues.    Darshan emphasizes that while the FDA's proposal is a step in the right direction, it must ensure that these one-pagers are comprehensive, accurate, and transparent. Patients often rely on hea...

Send us Fan Mail  In this episode, we’ll discuss how to speed up your marketing approval process with these must know concept review tips. We will talk to Heather McFalls, Director of AD Promo at Organon. In this interview we will address the following questions:  1.    How often do people do concept reviews?  2.    Is it useful to have an attorney at the concept review stage?  3.    Is the role o...

Send us Fan Mail  We explore the world of biohacking, with a particular focus on the emerging trend of "testosterone parties." These biohacking practices raise concerns regarding safety, efficacy, and misleading promotion, as many unapproved applications lack scientific support. It's worth noting that the FBI oversees biohacking, despite its primary purpose not being generalized res...

Send us Fan Mail  AI expert Dave Bulger, delves into the world of #AI, highlighting the distinction between AI and large language models (LLMs). He exposes the limitations of generative AI, raises concerns about copyright in content generation, and explores AI's potential impact across industries. Dave underscores that while LLMs can generate text, they lack true understanding. The conversati...

Send us Fan Mail  We explore the world of biohacking, with a particular focus on the emerging trend of "testosterone parties." These biohacking practices raise concerns regarding safety, efficacy, and misleading promotion, as many unapproved applications lack scientific support. It's worth noting that the FBI oversees biohacking, despite its primary purpose not being generalized res...

Send us Fan Mail  Mayya Tatsene has been issued a final debarment order by the FDA. The reason for the debarment stems from violating FDA regulations concerning clinical trials. Specifically, Tatsene failed to test on the appropriate number of subjects, thus compromising the integrity and reliability of the trial data. How to Avoid this Fate: To sidestep such consequences, individuals and organiza...

Send us Fan Mail  The FDA's Center for Tobacco Products (CTP) was created in 2009 to regulate tobacco products. Micah Berman worked at CTP from 2011-2012. He discusses the CTP's evolution in the past decade and shares insights from his recent article published in the New England Journal of Medicine. We discussed the following:  When was Micah a part of CTP? - 0:58 - 1:27  What was the vi...

Send us Fan Mail  Darshan Kulkarni emphasizes that companies considering #acquisitions must be ready for scrutiny from multiple agencies: FDA, FTC, DOJ, and OIG. FDA examines various aspects like manufacturing, clinical research, pharmacovigilance, advertising, and distribution. FTC now addresses advertising and antitrust concerns. DOJ concentrates on corporate compliance. Is your organization wel...

Send us Fan Mail  In this episode, the focus is on planning #FDA meetings and the significance of pre-IND meetings. We discuss how pre-IND meetings are crucial for identifying and addressing any roadblocks or gaps in the preclinical program before the actual filing. By doing so, potential delays or complications during the clinical trial phase can be mitigated. The discussion also includes insight...

Send us Fan Mail  Isaac Rodriguez-Chavez discusses the role and the significance of the Decentralized Clinical Trials guidance.  We discuss the following:  What are decentralized clinical trials? - 2:05- 4:25  What factors led to the rise of decentralized trials? – 4:26- 10:58  What is the role of decentralized clinical trials?- 10:59- 14:36  What is the process of FDA to develop a guidance?- 14:4...

Send us Fan Mail  Istvan Fekete and Darshan Kulkarni discuss the 7 types of clinical trial agreements (CTAs). CTAs Explored Include:   Industry-Sponsored Trials,  Phase Four and Post-Market Studies,  Registry Studies,  Federally Funded Studies,  Drug and Device Studies,  Consortium Studies,  Investigator-Initiated Studies:  We discuss the potential risks of seeding trials, and the need for both sp...