Home Medexpansion 2017 2017-10-17T09:05:11+00:00
Building on a 30+ year broad-based career and a wealth of expertise in all the medical fields of orphan drug development, we help solve the critical medical challenges of orphan drug development.
Our solutions are aimed at speeding up orphan drug development to provide measurable benefits for your company, at all the phases of orphan drug development.

PRECLINICAL PHASES

Which orphan disease is the best option?

...

TO FINE-TUNE ANIMAL STUDIES

you need medical advice to help you make optimal choices.

HOW YOU BENEFIT:

Our global assessment of the current and future medical environment of the orphan disease will help you to make the right choices.

You can launch your orphan disease animal model studies on the right track.

PRECLINICAL FINALIZED / IND

How best to achieve the demonstration of proof-of-concept?

...

TO PREPARE THE PHASE 2 STUDY

you need to translate the full capabilities of the molecule into a clinical study protocol and provide first evidence of orphan drug safety/efficacy.

HOW YOU BENEFIT:

We determine the critical elements of the study protocol to demonstrate the full extent of clinical benefits for patients. You are fully involved in dynamic exchanges with all sources of value: literature, experts, patients, EMA/FDA protocol assistance … This secures effective bridging between your expertise on the molecule and the expectations of patients, HCPs and regulatory authorities.

PHASE 2

How to enrol more orphan disease patients for phase 3 in CEE countries?

...

TO ANTICIPATE PHASE 3

you need to expand the number of investigator sites to meet the increased target number of patients.

HOW YOU BENEFIT:

You reach out quickly to the right experts motivated by studies. Our peer-to-peer discussions with experts allow us to develop trusting relationships with your company and identify eligible patients who meet the protocol criteria of your study.

Thus, patient enrolment by the CRO is sped up within the time target and the opening of inactive time- and budget-consuming centres is limited.

We have extensive experience in Azerbaijan, Bulgaria, the Czech Republic, Estonia, Georgia, Hungary, Lithuania, Poland, Romania, Serbia, Slovakia, Slovenia, … in addition to Switzerland and France.

COMMERCIALIZATION

How to improve the identification of patients?

...

ORPHAN DISEASE PATIENT SCARCITY 

imposes the need for costly geographically extensive searches for patients in hospitals where no or very few patients have the orphan disease.

HOW YOU BENEFIT:

We help you to design bespoke disease-specific medical strategies that increase the efficiency of patient identification by sales forces and by physicians.

Misdiagnosed patients are thus offered long-awaited access to properly effective treatments like yours.

THE COMMON DENOMINATORS OF OUR CHALLENGE-SOLVING APPROACH ARE:

our analytical capabilities and our out-of-the-box thinking, which allow us to work out inventive solutions from literature review combined with the input of European experts and of patients, in order to meet the challenges of protocol elaboration and EMA/FDA protocol assistance

our talent for developing ethical and trusting relationships with experts and organizing fruitful collaborations with your company

our extensive networks of experts particularly in Central & Eastern Europe and our partners with shared values and complementary expertise.

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.

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