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HIGHLIGHTS FROM THE DIA ANNUAL MEETING, 2024 from BioPharma Services

HIGHLIGHTS FROM THE DIA ANNUAL MEETING, 2024 from BioPharma Services blog image.

At the 2024 DIA Annual Meeting in San Diego, the pharmaceutical and healthcare industries converged on several pivotal reflecting ongoing transformations within the sector. Here are some key themes that dominated discussions:

  • AI in Drug Development: Discussions centered around the integration of artificial intelligence (AI) in drug discovery, clinical trials, and personalized medicine. Topics included predictive analytics, biomarker identification, and optimizing trial designs.
  • Patient-Centricity and Engagement: Emphasis was placed on strategies to enhance patient recruitment, retention in clinical trials, and improvement on patient-reported outcomes, and ensuring inclusivity and diversity in research.
  • Regulatory Challenges and Innovations: Updates on regulatory frameworks globally highlighted efforts in regulatory harmonization, expedited pathways for drug approvals, and adapting regulations to accommodate technological and therapeutic advancements.
  • Data Privacy and Security: Given the increasing reliance on digital platforms and data-driven approaches, sessions addressed concerns surrounding data privacy, cybersecurity, and regulatory compliance in handling patient and clinical trial data.
  • Health Equity and Access: There was a strong focus on addressing healthcare disparities and improving access to innovative therapies globally. Discussions covered strategies for reducing barriers to healthcare access, ensuring equitable participation in clinical trials, and fostering partnerships to enhance healthcare delivery in underserved communities.
  • Emerging Therapeutic Areas: Sessions highlighted advancements in specific therapeutic areas such as oncology, neurology and rare diseases. Discussions included new treatment modalities, biomarkers, and challenges in clinical development for these areas.

Overall, the 2024 DIA Annual Meeting in San Diego provided a platform for industry leaders, regulators, and researchers to explore these critical topics, share insights, and collaborate on shaping the future of healthcare and pharmaceutical innovation.

BioPharma’s Poster Presentation at DIA 2024

BioPharma Services Inc. (BPSI) also contributed to this year’s annual meeting by presenting the poster assess the regulatory requirements and procedures mandated by Health Canada for conducting clinical trials involving cannabis and psychedelic-assisted psychotherapy. You can access this full-resolution poster here.

Negar Gharavi, Senior Director of Medical Writing & Regulatory Affairs at BioPharma Services, highlighted the company’s contributions at the event, particularly their poster presentation:

“Our poster at DIA 2024 explores Health Canada’s intricate regulatory landscape for clinical trials involving cannabis and psychedelic-assisted psychotherapy,” said Negar Gharavi. “Understanding these guidelines is pivotal for navigating Canada’s evolving regulatory framework.”

Health Canada Regulatory Requirements for Therapeutic Clinical Trials with Cannabis and Psychedelic-Assisted Psychotherapy

The study categorizes therapeutic clinical trials under the Food and Drugs Regulations (FDR) for both cannabis and psychedelic-assisted psychotherapy. Additional regulations under the Cannabis Act apply to cannabis-related trials. Non-Therapeutic Research Cannabis (NTRC) studies explore non-therapeutic effects and follow specific guidelines under the Cannabis Act.

The fields of cannabis and psychedelic-assisted psychotherapy have garnered significant attention within the realm of clinical research. In Canada, where regulatory frameworks play a crucial role in shaping such investigations, understanding the requirements set forth by Health Canada is very important. This study offers a comprehensive review of Health Canada’s regulations governing clinical trials involving cannabis and psychedelic-assisted psychotherapy. It delves into the specific mandates that researchers must navigate to conduct trials in compliance with federal regulations.

Results:

Therapeutics clinical trials of both cannabis and psychedelic–assisted psychotherapy fall under the Food and Drugs Regulations (FDR), specifically under the scope of interventional clinical trials, regardless of data usage intentions. For cannabis-related trials, sponsors must also comply with regulations outlined in the Cannabis Act and its associated regulations. The below tables summarize Health Canada’s requirements for conducting therapeutics clinical trials using Cannabis and Psychedelic Drugs.

There are also studies categorized as NTRC (Non-Therapeutic Research Cannabis) where cannabis is administered to participants. NTRC studies focus solely on exploring non-therapeutic effects of cannabis and regulated under the Cannabis Act and its Regulations. For these studies, Clinical Trial application (CTA) and No Objection Letter (NOL) are not required and GPP compliant is sufficient. The below tables summarize Health Canada’s requirements for conducting therapeutic clinical trials using Cannabis and Psychedelic Drugs.

Specific Requirements for Cannabis Therapeutics Clinical Trials* Specific Requirements for Psychedelic Drugs Therapeutics Clinical Trials 
  • May waive the need for a full set of product-specific pre-clinical studies in the Investigator’s Brochure (IB) if the cannabis product is GMP-compliant and deemed safe per existing evidence.
  • The IB must be updated with new information to align with ICH M3(R2) for assessing efficacy and safety.
  • Market-authorized cannabis products may grant flexibility, permitting the IB for early trials without a full set of pre-clinical studies.
  • Synthetic products or those lacking market authorization necessitate specific pre-clinical studies.
  • Psilocybin (from “magic mushrooms”) and MDMA (“ecstasy”) increase psychological risks for participants undergoing psychedelic-assisted psychotherapy.
  • CTAs for these drugs must include detailed risk-management measures.
  • Health Canada mandates therapists to have proper training and license for psychedelic drugs. Unlicensed team members must be supervised by a licensed therapist.
  • Detailed descriptions of therapists’ qualifications, including credentials, licensing status, and previous experience with psychedelic-assisted psychotherapy, must be submitted in CTA and documented in the trial master file.
  • The overseeing physician must be authorized to administer restricted drugs and be present on-site during the drug’s effects

 

Requirements for Therapeutic Clinical Trial (continued) Cannabis Psychedelic Drugs
Interventional Research X X
A federal research licence from the Office of Controlled Substances X X
A federal research licence from the Cannabis Branch of Health Canada X NA
Research Ethics Board (REB) Approval X X
No Objection letter (NOL) from Health Canada in results of Clinical Trial Application (CTA) Submission X X
GCP X X
GMP X X
Risk Management Measures NA X

 

Type of Cannabis Product Type of Clinical Trial Eligibility for Non-product Specific IB*
Cannabis products of botanical origin & synthetics that are duplicates of naturally occurring cannabinoid Early Phase Clinical Trial X
Confirmatory Clinical Trial NA
Synthetics that are not duplicates of naturally occurring cannabinoids Early Phase Clinical Trial NA
Confirmatory Clinical Trial NA
Cannabis products where a similar product has received market authorization either in Canada or in an ICH member state Early Phase Clinical Trial X
Confirmatory Clinical Trial NA

Our Conclusions:

Our assessment of Health Canada’s regulatory requirements for therapeutic clinical trials involving cannabis and psychedelic-assisted psychotherapy reveals a comprehensive framework governing research in these areas. For both cannabis and psychedelic drugs, Health Canada has similar requirements regarding licensing for Controlled substances, REB approval, NOL and compliance with GCP and GMP standards.

However, specific risk-management measures are required for psychedelic drugs due to their potential psychological impacts. Moreover, therapists involved in psychedelic-assisted psychotherapy trials must undergo specialized training and be licensed, with detailed qualifications documented. Despite challenges in creating product-specific Investigator’s Brochures for cannabis, Health Canada emphasizes the importance of aligning with international guidelines and updating information regularly. Overall, these requirements for therapeutic clinical trials aim to ensure the safety and efficacy of clinical trials while advancing research in these areas.

Written By:

Negar Gharavi

Senior Director, Medical Writing & Regulatory Affairs

BioPharma Services, Inc., a HEALWELL AI and clinical trial services company, is a full-service Contract Clinical Research Organization (CRO) based in Toronto, Canada, specializing in Phase 1 clinical trials 1/2a, Human Abuse Liability(HAL) and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma Services conducts clinical research operations from its Canadian facility, with access to healthy volunteers and special populations.

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