MAXIM KOTS MD
CLINICAL DEVELOMENT AND MEDICAL AFFAIRS EXPERT
I am a Clinical Development and Medical Affairs professional with two decades of experience in leadership positions in global pharmaceutical companies.
Being a medical doctor by training and entrepreneur by passion my ambition is to build long-term scientific value for medicines, leveraging theoretical knowledge and practical experience I have.
Throughout my career, I have created company medical governance, target product profiles, clinical development plans, evidence generation plans, clinical trials, patient-oriented programs, KOL development plans, and other projects always focused on patients’ needs and healthcare professionals’ support providing them with the best therapy options based on scientific research data.
Overall, thousands of patients have participated in the studies and programs I have developed. I am a co-author of the articles in peer-reviewed journals and scientific abstracts.
My experience is global. I have worked with different regulatory agencies (e.g., EMA, FDA), scientific societies (European, American, and at the country level), and geographies (EU, US, China, and Japan). I have also represented companies in different international bodies (e.g., EFPIA).
I build long-term relationships with opinion leaders, scientific societies, and healthcare organizations, which enable me to effectively support products and programs.
Today, I am serving as a freelance consultant, and I am happy to help you, your teams, and your projects.
AREAS OF EXPERTISE
THERAPEUTICAL AREAS
Respiratory | Allergic diseases | Diabetes | Gastroenterology | Thrombosis | Inflammation | Antimicrobial therapy | Surgery | Pediatrics | Rare disease | Anti-age therapy
BUSINESS AREAS
Biotech | Medtech | Rx products | Vaccines | Medical devices | Cosmeceutical
CLINICAL DEVELOPMENT SERVICES
Target product profile (TPP)
TPP is the main R&D document which identifies your future product profile. This document is written by a team of experts where clinical development and medical affairs parts are two cornerstones which have to deliver the data for future product positioning and commercialization. Usually, this document reflects different scenarios based on the probability of success.
Clinical development plan (CDP)
CDP — is the main clinical development document. It reflects all clinical development stages from Phase I to Phase IV trials which are needed to achieve product market authorisation and additional data collection which can serve different needs (e.g. market access). This document also reflects specific data collection according to different geographical requirements (e.g. FDA, EMA), pediatric plans, etc. Also, it gives a high-level overview of the registration strategy and interaction with regulators.
Clinical trials
- Phase I First-in-Human (FIH)- first introduction of the molecule in humans.
- Phase I PK/PD/Bioequivalence etc. — trials which can be run either in healthy volunteers or patients and focused on the different aspects of the pharmacological profile.
- Phase II Safety — trials which are performed in the target patient population and focused on safety signals.
- Phase II Proof-of-Concept (PoC)/-Mechanism (PoM) — trials performed in the target patient population and focused on efficacy signals which facilitate GO/NOGO Phase III decision.
- Phase I / II Hybrid trials — currently becoming more and more used. Usually combine FIH and PoC/PoM phases, facilitating the timelines and GO/NOGO decisions.
- Phase III Registration — classical registration trials which have to be run as two pivotals. However, during the interaction with regulators, it is feasible to negotiate some differences in the trial design to obtain additional data collection. Also, futility analysis can be helpful at this stage in high-risk projects.
- Phase III Market access — additional pre-authorisation data collection which will not be part of the Common technical document (CTD) submission for marketing authorisation, but will serve additional needs e.g. discussion with payors, direct comparison with the competitors in blinded and unblinded ways, etc.
- Phase IV — post-authorisation trials which help to answer additional questions and position the drug within the obtained indication, e.g. higher response rate in the specific group of patients within the product indication.
- Investigator Initiated Trials — trials where pharma companies sponsor the investigator hypothesis testing by different means, e.g. providing the product, service or financial support.
Data review and interpretation
One of the most important steps of any clinical trial. Data review is a consistent process which starts from the first day of data collection and consistently run even after the trial closuer. Collected data reflects the pre-specified analysis and can support many types of post-hoc analysis and additional hypothesis generation for future trials.
Correct and balanced data interpretation is a sensitive and important step. At this stage, we form the future marketing authorisation document like SmPC (Summary of the Product Characteristics). It is very important to interpret the data in an objective manner and different types of scientific advice can be used at this step.
Clinical development digital and AI tools
Today we have thousands of different digital tools which can facilitate data collection and provide us with insights about patients’ well-being outside of the site visits. These tools have to be thoroughly selected to provide the most qualitative result. New opportunities also comes with AI introduction in the clinical trials. This technology can help to complete many tasks, starting from routine overreading improvement and outliers signalling patients’ well-being or drug response prediction.
Interactions with regulators
Interaction with regulators is a complex process which starts with the Briefing Book (BB) development where the company present the project and already existing data, ask questions to regulators and clarify the company’s position regarding the raised questions. When the BB is ready and submitted the regulator’s meeting can happen where the company has an opportunity to present the position in more detail and discuss with regulators. Usually, the company has an obligation to write the meeting minutes draft and submit it to regulators in a timely manner for further formal answer development.
Regulators have clearly defined timelines for the interaction process starting from the meeting request moment, however, there can be official clock-stop periods. In practice, the company starts the BB preparation before the meeting request and in many cases the overall timeline from Day 0 when the decision to have an interaction with regulators is made and the team is nominated to the final regulator’s answer received can take significant time like 1 year or so. That is why it is crucial to plan interactions with regulators upfront in the CDP and other relevant plans.
Clinical assessment of the operations
The operations department is a technical driver of the clinical development programs, however, it is very important to plan the programs from the scientific and medical need standpoint. That can happen that sometimes vendors or internal operations department can propose the company a project without a thorough clinical assessment. These kinds of initiatives can be ineffective or even harm the project. So it is essential to plan the activities with scientific and medical input from the beginning or ensure appropriate evaluation before the program starts in the planning phase.
Data and safety monitoring boards (DSMB)
Very formalized type of activity which helps the company to have live control or asses collected data or make judgements with the help of an independent group of experts. DSMBs can be incorporated into the clinical trial protocols to perform certain activities through the trial course.
Advisory boards
Less formalized type of interaction with experts for obtaining advice. Usually used outside of the clinical trials. Can be effective at different project levels from hypothesis identification or trial results data interpretation to project TPP identification or new indications and applications assessment.
MEDICAL AFFAIRS SERVICES
Launch readiness review (LRR)
One of the most crucial steps for a successful launch. LRR gives an overview of the medical affairs launch strategy and tactical actions. It provide’s deep understanding of connected elements like timeline, resources, budget etc.
Evidence generation plan (EGP)
EGP is the strategic document which peers CDP from the clinical development side. The main task of the EGP is to build a roadmap for data generation regarding company projects. EGP can be product- or disease-specific.
Real-world evidence trials (RWE)
RWE trials are usually classified by the type of data they use.
Primary data collection RWE — the trials where data is generated and collected based on the trial protocol. This kind of RWE is a classical clinical trial.
Secondary data analysis RWE — this type of trial usually utilises company in-house data from the previously run RWE trials.
Tertietary RWE — this is the most widespread type of trial. It derives data from electronic health records, medical claims data, data from product or disease registries, etc.
Medical affairs strategy
Medical affairs strategy has to be created and further regularly updated based on the product profile, disease knowledge, scientific activity in the area, etc. It is important to start building it and implement activities as soon as medical affairs is present in the project. A medical affairs strategy is a complex and comprehensive plan which guides the company through the needed activities to succeed the project.
OMNI chanel dissemination of data
Today there are thousands of ways how the information can reach healthcare professionals (HPCs) and healthcare organisations (HCOs). Apart from the official and classical communication modes like congresses, articles or visits, HPCs/HCOs use social media platforms, specialized information tracking tools or other sources of data. It is important to be sure that information about your drugs or projects is disseminated in an appropriate way and platforms.
Medical affairs AI tools
Medical affairs AI tools are a very dynamic and rapidly growing area. They can help a lot in the day-to-day activities to generate insights, track progress, analyse the unmet need, etc. It is important to be sure that available technology supports medical affairs strategy and daily activities.
Healthcare professionals (HCPs) / organizations (HCOs) interactions
Interaction with HCPs/HCOs is an important element of medical affairs tasks. Leveraging scientific data a scientific dialogue is built between the company and HCPs/HCOs. It is a very specific and delicate type of interaction because HCPs/HCOs have different metrics to measure the value and applicability of your product. It is always important to be honest and transparent but appropriate in this interaction. The ultimate goal is to build trust and credibility in this interaction which will benefit everyone.
KOL management and development plans
One of the important tasks of medical affairs is to build a scientific dialogue with KOLs and create new KOLs in the area. Usually, companies start their projects leveraging already existing KOL networks and later HCPs become KOLs based on the scientific projects which they develop together with the company. These activities should not be accidental they have to be carefully planned and implemented.
Patient-oriented programs (POP)
POPs are a very powerful type of activity which can help all stakeholders to understand the diseases and project application better. It is a tool which can help to get a lot of practical insights about patients’ reality and support the company with invaluable information on how to develop the project further. It is important to mention that patient groups and their representation are more and more active each single day. Today we can see patient representation at all levels from governmental bodies (eg. EMA) to the company advisors on the clinical trial protocol. POPs and interaction with patients can help to improve the project and make it more useful and effective for patients.
Scientific societies interactions
Scientific society is another type of stakeholder that affects a lot of the scientific knowledge about the area and it is important to be connected with them. Apart from the classical congress activity scientific societies have numerous tools where productive collaboration between the company project and society can be built. Today societies cover many areas like CRCs (clinical research collaborations), educational (online and offline activities), data dissemination (eg. society journals, textbooks), guidelines creation, interdisciplinary workgroups, governmental interactions and many others. It is important to be in contact with scientific society to build collaborative projects in suitable areas.
Advisory boards
As in clinical development medical affairs activities can require appropriate independent evaluation and advice. Advisory boards are formed with independent professionals who can evaluate company projects and provide company with the advice. It is very important to prepare the advisory board appropriately and perform the event in a structured way with professional moderation. This can help to obtain the most effective and demanded advice.
Publication plans
Scientific publications are an important tool in medical affairs activity. It gives the company an opportunity to share scientific data and to involve different stakeholders in the scientific dialogue. Planning the publications gives the company an understanding of where, when and how scientific data will be shared and what can be the scientific coverage.
GENERAL BUSINESS SERVICES
Company medical governance
Company medical governance is an important management tool which regulates medical activities «per se» and boosts the company’s overall effectiveness.
Medical governance is the term which takes clinical development and medical affairs under the same umbrella within the principle that both functions perform medical activities in close connection with medical society (e.g. investigators, regulators, scientific society, doctors, KOLs, HCPs) and covers different aspects in addition to core activities (clinical development and medical affairs) like compliance, pharmacovigilance, regulatory, etc. Different models of medical governance exist e.g. collated clinical development, medical affairs and regulatory department, separated functions where even the pharmacovigilance and medical information are separate functions, etc. It is up to the company and to the project(s) specificity to build the most appropriate and effective one.
Medical governance is introduced with the clinical development activities planning, it starts when the molecule or project is in the translational phase and is preparing to be introduced for the first human use. At this time company builds the clinical development department and organises the department structure. Alongside the project’s growth medical affairs activities and needs become more prominent. At the time of Proof-of-X studies, the company initiates the creation of the medical affairs function.
Building the governance is not a «single shot» event. The project(s) growth to different stages and scales of activities requires regular governance update or revision.
Clinical development and medical affairs function management
Management of the clinical development and medical affairs department requires not only technical skills and industry experience but also strong scientific knowledge. These departments are formed with top-level professionals with clinical practice background (many of them) and scientific degrees like PhD or others. Managing this department is a complex task, it is important to build professional trust and respect in this environment to achieve the targets.
Pre-acquisition or pre-investment assessment
Pre-acquisition/pre-investment project assessment is a standard practice for every project. However, apart from the scientific value which can be assessed by KOLs, it is important to have clinical development and medical affairs assessment. Being the core industry functions, clinical development and medical affairs assessment can provide a more precise projection of the project’s probability of success, potential, timelines, resources and budget spending.
After-acquisition projects merge strategy
When the project is acquired and has to be transferred to the company it is important to shape and adapt company clinical development and medical affairs functions to proceed with the project in the most effective and suitable way. Many aspects like clinical development plan, regulatory strategy, scientific society dialogue, KOLs management, unmet medical need discussion, etc. have to be addressed. The new company project team have to inherit and implement the project into life. This requires appropriate guidance and leadership.
Clinical development and medical affairs advice
Apart from the full assessment which is usually done in a way of a comprehensive assessment of the project by a group of experts clinical development and medical affairs advice can be requested. The format of this kind of advice is very similar to the Advisory boards. This is a pretty slim and quick format which allows to jump into the project, provide an expert evaluation of the current state and propose further steps.
CONTACTS
- Phone: +39 346 303 0004
- E-Mail: maxim.kots@erinaco.it
- P.IVA: 03081090346
