Make early decisions and do more processes in parallel

ANSWERED BY STEVEN GLAZER, VP CLINICAL AND REGULATORY AFFAIRS & ROLAND CARLSSON, VP PRECLINICAL RESEARCH, BIOINVENT INTERNATIONAL AB

Published in Medicon Valley Drug and Device Development Guide, June 2005

 

COMPANY BioInvent International AB

FOUNDED 1997

LOCATION Lund, Sweden
NUMBER OF EMPLOYEES 95

 

BioInvent develops antibody-based drugs against diseases where there is a significant unmet medical need. The company recently filed its first IND on an antibody-based therapeutic anti-HIV agent. The development of this antibody from discovery and characterisation of CD, via cell line development, manufacturing and regulatory toxicology testing has been achieved rapidly in approximately 2 1/2 years. In this article, people at BioInvent give their view on the background to this achievement.

 

1) How many products does BioInvent have in preclinical and clinical development?
We have four of our own compounds in preclinical development. Our HIV antibody will enter the clinic in the near future. In addition, we have two more compounds in preclinical development together with Thrombogenics, a Belgian company.

 

2) Good advice on how to prepare non-clinical and clinical trials
Our initial focus is to design clinical and preclinical programmes to cover activities until the end of phase II.

Define the intended use of the compound and design a clinical and pre-clinical programme accordingly. The same type of specificity and cross-reactivity pattern as to the human target antigen and tissues is preferred in the experimental model animals. The biology of the target antigen in the model should be similar to the human target. If immunological effector functions are to be used for therapeutic activity mouse Fc may be needed in e.g. a human mouse chimeric variant of the antibody. Preferably, the therapeutic antibody works in IHC both on human tissue and on animal tissue used in the tox and efficacy experiments.

 

3) In what processes did you seek external expert assistance (consultancy)?
Screening and testing of antibodies in in vitro and in vivo efficacy tests are performed in-house and in collaboration with partners.We have in-house expertise in process development and manufacturing, preclinical, regulatory and clinical affairs. When we develop project plans we identify potential issues as early as possible and discuss them with the regulatory agencies and in some cases consultants.

 

4) Based on your experience, can you recommend particular criteria for selecting external expert assistance?
Personal contacts and recommendations. It has been important that the experts have experience in developing biologics and if possible therapeutic antibodies from both a European and US perspective.

 

5) Please mention processes or events that were more demanding in terms of time and money than you initially expected
Technology transfer to CROs for them to set up and perform preclinical experiments. Negotiating and establishing a co-operation with academic institutions, having full control of the activities, and getting proper reports from them. And also setting up reporting systems.

 

6) If you were able to repeat the process (with your existing experience), what would you do differently?
We have learned from the tat project that it is possible to enter the clinic within less than 3 years from the start of the project. In order to do this it is imperative to create a focused project development plan and manage it tightly. It is important to do several processes in parallel and make early decisions and be willing to run a financial risk. It may be possible to run future projects even quicker if we learn from our experience with collaborators concerning model systems and set up more biology in-house thereby building further competence.

 

7) Consequently, what is your advice to companies confronting preclinical/clinical development for the first time?
Get a full picture of what is required as early as possible in the development. Obtain sufficient in-house expertise to scrutinize the advice from consultants. Not all suggested activities are needed and consultants are usually risk-averse. Understand the risks, identify the critical activities and be decisive.

 

8) Based on your experience: Where are the cost saving opportunities?
An integrated process with as many in-house steps as possible leading to less technology transfer between organisations. Standardised procedures for CMC activities whenever possible.
- And where are the time saving opportunities?
A well-defined project plan with effective project management and as many processes in parallel as possible.

 

9) How far will you go with your lead compound/product?
Depending on the indication and the complexity of regulatory preclinical and clinical proof-of-concept tests, the company may decide to outlicence the project at different levels of documentation. In the end, it will depend on the business opportunity. From a strategic point of view, BioInvent does not in general intend to develop any project further than the clinical phase II.