Expertise | Hariz Hassan, MD

Hariz Hassan

Hariz has a high level of expertise in oncology, CNS, hematology, infectious diseases, immunology, internal medicine, spinal implants, and medical devices. Hariz has worked with various drug classes like mRNA‑encoded therapeutics (such as mRNA‑encoded cancer vaccines, cytokines, and antibodies), small molecules, antibodies including bispecifics, ADCs, dendritic cell and CAR T‑cell therapies. Hariz also has a niche expertise combining radiotherapy with novel drugs in both early and late phase trials.

Labelling Exercise

A solid clinical strategy begins by clearly defining the intended product label. This seemingly straightforward step is often overlooked by many companies, leading to a loss of focus during development. By establishing the end goal upfront, a robust strategy can be crafted, guiding the entire development process effectively.

Clinical Strategy

Conduct a comprehensive analysis of all preclinical data, including toxicology findings, along with clinical and safety data gathered to date, to inform indication selection.
Perform an in-depth examination of the existing treatment landscape, trial pipeline, and real-world data to craft a robust drug development strategy.
Develop Clinical Development Plan (CDP) and Target Product Profile (TPP).

Medical Monitoring

Develop study synopsis and protocol.
Provide medical oversight and input for protocol amendments.
Review safety data and adverse event reports throughout clinical trials.
Conduct regular safety calls or meetings to discuss safety issues and make dose adjustments if necessary.
Assess the overall benefit-risk profile of the investigational drug.
Interpret clinical trial results in collaboration with other stakeholders.
Implement risk mitigation strategies as needed.
Monitor and manage serious adverse events (SAEs) and adverse events of special interest (AESIs).
Establish a comprehensive medical monitoring plan.
Contribute to the development of safety-related documents, such as the Investigator's Brochure, Safety Management Plan, and Risk Evaluation and Mitigation Strategies (REMS).
Collaborate with regulatory authorities on safety-related matters.
Provide medical expertise during regulatory submissions and interactions.
Conduct medical review of clinical study reports and other regulatory documents.
Design electronic case report forms (eCRFs) for data collection.
Draft the charter for the independent data monitoring committee (IDMC), oversee member selection, and manage its operations.
Participate in Data Monitoring Committees (DMCs) or Independent Data Monitoring Committees (IDMCs) to assess safety and efficacy data.
Formulate a statistical analysis plan with biostatistician, encompassing tables, listings, and figures.
Facilitate site selection, feasibility assessments, site initiation visits, and site training and activation.
Address inquiries from ethics committees and institutional review boards.
Collaborate with contract research organizations (CROs) and clinical operations teams.
Undertake various trial management tasks pertinent to clinical operations.
Ensure compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements related to medical monitoring.
Train and provide support to clinical investigators and study site staff on safety-related matters.
Contribute to the development of safety-related sections of clinical study protocols and informed consent forms.

Early Phase Development

Analyze preclinical pharmacology, toxicology, drug metabolism, and pharmacokinetics reports to determine the starting dose, identify dose-limiting toxicities, and develop the overall clinical strategy for Phase I first-in-human trials.
Advise on clinical pharmacology aspects, including recommending optimal time points for pharmacokinetic blood samplings.
Conduct translational research encompassing metabolic, genetic, and immunological testing.
Assess anti-drug antibody responses and immunogenicity.
Explore early combinations with other investigational and approved drugs, as well as different modalities such as radiotherapy, transarterial chemoembolization (TACE), and surgery.
Facilitate safety calls and dose decision meetings.
Chair the safety review committee to ensure rigorous safety oversight.
Perform day-to-day review of trial data to ensure ongoing safety and efficacy evaluation.
Oversee the review and management of dose-limiting toxicities (DLTs) and serious adverse event (SAE) reports.
Establish and expand Phase 1 site networks across North America, Europe, and Asia to ensure broad access to clinical trial sites.

Late Phase Development

Patient-Centric Trial Design: Consider patient preferences, needs, and outcomes when designing late-phase clinical trials. Incorporate patient-reported outcomes (PROs) and quality of life assessments to capture the full impact of the investigational product on patients' lives.
Endpoint Selection: Select clinically meaningful and regulatory acceptable primary and secondary endpoints for Phase 3 trials. Ensure endpoints are aligned with regulatory guidance and capture the intended treatment effect of the investigational product.
Comparator Selection: Evaluate appropriate comparators for Phase 3 trials, considering current standard of care, regulatory requirements, and clinical relevance. Choose comparators that provide meaningful insights into the efficacy and safety of the investigational product.
Sample Size and Power Calculations: Conduct rigorous sample size and power calculations to ensure the Phase 3 trial is adequately powered to detect the hypothesized treatment effect. Consider variability in outcomes, anticipated dropout rates, and regulatory requirements for statistical significance.
Trial Protocol Development: Develop a comprehensive trial protocol that outlines study objectives, patient eligibility criteria, treatment regimens, dosing schedules, study procedures, and safety monitoring plans. Ensure the protocol adheres to regulatory requirements and ethical principles.
Site Selection and Feasibility Assessment: Identify and select appropriate clinical trial sites for Phase 3 trials based on patient population, investigator experience, infrastructure, and regulatory environment. Conduct feasibility assessments to evaluate site capabilities and ensure timely enrollment.
Regulatory Engagement: Proactively engage with regulatory authorities to discuss trial design, endpoints, and regulatory requirements for Phase 3 trials. Seek regulatory input and guidance to optimize study design and facilitate regulatory approval.
Risk Management and Mitigation: Develop a risk management plan to identify, assess, and mitigate potential risks associated with Phase 3 trials. Implement risk mitigation strategies to safeguard patient safety and trial integrity.
Data Management and Monitoring: Establish robust data management systems and procedures to ensure accurate and timely collection, processing, and analysis of clinical trial data. Implement comprehensive monitoring plans to oversee trial conduct and compliance with protocols.
Safety Reporting and Pharmacovigilance: Implement safety reporting mechanisms to capture and evaluate adverse events and serious adverse events occurring during Phase 3 trials. Adhere to pharmacovigilance requirements for safety surveillance and reporting.
Interim Analysis and Data Monitoring: Conduct planned interim analyses to assess trial progress, efficacy trends, and safety signals. Implement data monitoring committees (DMCs) or independent data monitoring boards (IDMBs) to provide independent oversight of trial data.
Publication Planning and Dissemination: Develop a publication plan to communicate trial results to the scientific community, healthcare professionals, and patients. Prepare manuscripts for publication in peer-reviewed journals and present findings at scientific conferences.
Commercialization Strategy: Align late-phase development activities with the broader commercialization strategy for the investigational product. Consider market access, pricing, reimbursement, and market positioning strategies to maximize product value and market potential.

Regulatory

Develop strategic briefing books for regulatory meetings with EU and FDA.
- Lead face-to-face interactions with regulators, ensuring productive discussions and decisions.
- Regulatory Designations:
Assess eligibility and benefits for designations (e.g., Breakthrough Therapy, ATMP, PRIME, Orphan Drug).
- Prepare and submit applications, manage interactions with regulators, and ensure compliance throughout the product lifecycle.

Scientific Advisory Board (SAB)

Strategic Planning:
- Define the objectives and goals of the SAB meeting.
- Determine the topics and areas of focus for discussion.
- Identify key opinion leaders (KOLs) and experts to invite to the SAB.
Meeting Logistics:
- Plan and coordinate the logistics of the SAB meeting, including scheduling, venue selection, and travel arrangements for participants.
- Arrange for audiovisual equipment, presentation materials, and other necessary resources.
Agenda Development:
- Develop a detailed agenda outlining the topics, presentations, and discussion points for the SAB meeting.
- Allocate time slots for each agenda item and ensure sufficient time for discussions and Q&A sessions.
Presentation Preparation:
- Work with internal teams to prepare presentations and materials for the SAB meeting.
- Ensure that presentations are clear, concise, and scientifically rigorous, with appropriate data and supporting evidence.
Pre-Meeting Briefings:
- Conduct pre-meeting briefings with presenters and key stakeholders to review agenda, objectives, and expectations for the SAB meeting.
- Provide guidance on presentation content, format, and messaging.
Participant Communication:
- Communicate with SAB members to confirm attendance, provide meeting details, and distribute pre-reading materials.
- Address any questions or concerns raised by SAB members prior to the meeting.
Logistical Support:
- Provide logistical support to SAB members, including travel arrangements, accommodations, and onsite assistance during the meeting.
Meeting Facilitation:
- Facilitate the SAB meeting, ensuring that discussions stay on track, agenda items are covered, and objectives are met.
- Manage time effectively, allowing for adequate discussion and input from SAB members on each agenda item.
Q&A and Discussion Management:
- Moderate Q&A sessions and discussions, facilitating dialogue between SAB members and presenters.
- Ensure that all questions are addressed and that diverse perspectives are heard and considered.
Decision-Making Support:
- Provide support to decision-makers based on feedback and recommendations from the SAB meeting.
- Assist in synthesizing key insights and action items arising from the meeting.
Follow-Up Activities:
- Follow up with SAB members after the meeting to thank them for their participation and provide any additional information or clarifications.
- Document meeting proceedings, action items, and decisions for reference and follow-up.
Evaluation and Feedback:
- Evaluate the effectiveness of the SAB meeting in achieving its objectives.
- Solicit feedback from SAB members and internal stakeholders to identify areas for improvement and inform future meetings.

KOL Engagement

KOL Identification:
- Identify key opinion leaders (KOLs) within relevant therapeutic areas and specialties.
- Consider expertise, influence, publication track record, and network connections when selecting KOLs.
Relationship Building:
- Develop and nurture relationships with KOLs through regular communication, networking events, and scientific exchanges.
- Engage KOLs in advisory boards, investigator meetings, and other collaborative activities to foster partnerships and knowledge sharing.
Strategic Collaboration:
- Collaborate with KOLs to gain insights into disease biology, treatment paradigms, and unmet medical needs.
- Seek input from KOLs on clinical trial design, protocol development, and study implementation to enhance study relevance and success.
Educational Initiatives:
- Support KOLs in educational initiatives, such as speaker programs, medical education events, and scientific symposia.
- Provide resources and materials to facilitate KOL-led educational activities aimed at healthcare professionals, patients, and other stakeholders.
Advocacy Support:
- Partner with KOLs to advocate for disease awareness, patient advocacy, and policy initiatives.
- Leverage KOL networks to amplify advocacy efforts and drive positive change in healthcare policy and practice.
Recognition and Appreciation:
- Recognize and appreciate the contributions of KOLs through awards, honors, and acknowledgments.
- Demonstrate appreciation for KOLs' expertise, time, and commitment to advancing medical science and patient care.

Site Network

Site Selection and Qualification:
- Identify and evaluate potential clinical trial sites based on patient population, investigator experience, infrastructure, and regulatory environment.
- Conduct site feasibility assessments to assess site capabilities, resources, and willingness to participate in clinical trials.
Site Initiation and Activation:
- Initiate and activate clinical trial sites through site initiation visits, investigator training, and regulatory approvals.
- Ensure compliance with regulatory requirements, institutional review board (IRB) approvals, and Good Clinical Practice (GCP) guidelines.
Site Support and Training:
- Provide ongoing support and training to clinical trial sites throughout the trial conduct.
- Offer resources, tools, and guidance to help sites with patient recruitment, data collection, and study procedures.
Site Performance Monitoring:
- Monitor site performance and compliance with study protocols, regulatory requirements, and quality standards.
- Conduct regular site visits, monitoring visits, and remote monitoring to assess site progress and address any issues or challenges.
Relationship Management:
- Build and maintain positive relationships with clinical trial sites, investigators, and site staff.
- Foster open communication, collaboration, and trust to ensure successful partnerships and site engagement.
Site Expansion and Optimization:
- Evaluate the need for site expansion based on enrollment targets, patient demographics, and study progress.
- Optimize site network by adding new sites, consolidating underperforming sites, or reallocating resources as needed to maximize efficiency and productivity.

Oncology

Immunology

CNS

Medical Devices

phone: +420 736 704 407

mail: hariz@harizhassan.com

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