Bringing 30 years of experience to the forefront of medical affairs, particularly for orphan diseases, Dr. Alain Rinaldi is the founder and executor of services at MedExpansion.
At MedExpansion, we’re able to oversee requirements of rare diseases from strategy elaboration to implementation at an international European level, empowering drug companies to better understand the ever-evolving field of orphan diseases.

OUR WIDE SPECTRUM OF MEDICAL SERVICES INCLUDES:

Elaboration of clinical protocols to maximize drug value and emphasize benefits for patients

Improvement of the identification of the patients to facilitate business development or enrolment in clinical trials

In-depth organization of medical activities and interactions with experts to support the different phases of the drug development process

Elaboration of clinical protocols

to maximize drug value and emphasize benefits for patients

Uncertainty is a ubiquitous hurdle to overcome when designing clinical development plans of orphan drugs.
As medical research and disease knowledge continually evolve, creating an ever-changing environment, we need to conduct thorough investigations in up-to-date literature and intensive two-way interactions to identify validated and consensual information from the community of international experts. We also need to capture information from a wide range of other sources, potentially providers of meaningful information such as patients, nurses, caregivers, other healthcare professionals and payers.

This 360-degree harvesting of information is critical to designing innovative and smart protocols that demonstrate the full efficacy of the drug and the largest range of benefits for the patients: 

  • Optimal inclusion criteria and patient profiles
  • Factors best contributing to drug value
  • Identification of the real needs of physicians and patients
  • State-of-the-art measuring instruments to optimally translate the variations of clinical or biological markers under treatment, including Quality of Life Scales
  • Identified yardsticks of payers and factors of medico-economic analysis (HTA)

Patient identification: a structured medical methodology 

In the realm of orphan diseases, properly diagnosed patients often represent only the tip of an iceberg. Most patients, misdiagnosed or not diagnosed at all, follow an odyssey, frequently lasting several years after the first signs of the disease onset.

For this purpose, based on our experience of ultra-rare diseases, we have developed a structured medical methodology to locate misdiagnosed or undiagnosed patients in the real life and improve clinical trials, early access programs, or business development.

Our methodology is the result of our experience of both clinical practice and elaboration of strategies of patient identification in several ultra-rare diseases. This experience serves us as a prism to filter and analyze data and processes.

It starts with an in-depth assemblage of whatever pieces of information we can find from the medical literature, the reality of patient management and environment, to generate practical knowledge.
This drives us to an enhanced understanding of disease history and patient journey, and of the reasons why patients with a masquerading disease get lost in the medical shuffle. Reservoirs of potential patients and the diagnosis pathway are then identified for targeted strategies and medical activities to leverage the process of patient identification.

Improvement of the identification of patients

to facilitate business development or enrolment in clinical trials

In-depth organization of medical activities and interactions with experts

to support the different phases of the drug development process

Organization of Medical Activities with Physicians 

Organizing medical activities and intensively interacting with the different stakeholders are critical in rare diseases, with all their specificities of objectives.

Depending on your company’s phase of drug development, we can organize specific activities at any stage independently of the others to fulfill your individual requirements:

  • In the very early phases of drug development, the company has to develop interactions with all stakeholders to increase their knowledge of the disease and its environment: identify the right unmet medical needs, assess the expectations of patients, caregivers, and payers to elaborate smart clinical development plans.
  • Further along its development, drug information has to be disseminated in the medical community through targeted educational or informative activities
  • At a later stage, business development relies on the elaboration of strategies to improve the diagnosis pathway and leverage the process of patient identification.

Our experience and understanding of the drug development process allows us to elaborate medical strategies specific to those different frameworks and implement medical activities at the international European level to adequately match your needs:

  • Face-to face in-depth discussions with experts
  • Thorough review and analysis of literature
  • KOL mapping and identification of influencers
  • Qualification of centres for clinical trials with realistic assessment of eligible patient numbers
  • Advisory boards and expert committees
  • Symposia and educational meetings
  • Follow-up of patient treatment
  • Development of relationships with patient associations

OUR MISSION BEGINS WITH EXPERTISE AND FLEXIBILITY

The future of the clinical development of orphan drugs has everything to do with flexibility and expertise, a foundation reflected strongly in Dr. Rinaldi’s competencies.

His combined broad range of expertise and flexibility means that, depending on your needs, he has the ability to:

  • Perform focused assignments in complement to existing in-house capabilities, on specific issues derived from his experience:
  • Take full charge of all the Medical Affairs activities, e.g. for small companies who have not yet established an in-house medical position.

At MedExpansion, our medical flexibility allows us to intervene in any therapeutic area, and we can also share our background experience in:

  • Onco-haematology, nephrology, and transplantation
  • Complement-related orphan diseases (PNH, aHUS) with the associated European networks of experts.

WHO WE ARE

Foremost a paediatrician with clinical practice, Dr. Alain Rinaldi has gained 360-degree experience in the pharma industry since 1991, including Alexion Europe where he has directed Medical Affairs in Europe for more than 8 years. In this position, he has been instrumental in constructing medical foundations, developing medical networks, supporting new clinical developments, and preparing commercial development in France, Switzerland, and several major Central and Eastern European countries for eculizumab (Soliris®) in complement-related diseases.

MEDEXPANSION

AVENUE FLOREAL 3

1006 LAUSANNE

 

PHONE: +41 (0)79 624 79 55