MarketsandMarkets recently interviewed Ester Lovsin Barle, Corporate Toxicologist, Lonza regarding 3rd Annual MarketsandMarkets High Potent Medicines Conference taking place on 28th – 29th May 2019 in Milan, Italy.
When asked about recent advances in the high potent medicines area and current challenges, and this is what she had to say.
1.What are the recent advances in the high potent medicines area and current challenges that need immediate attention?
A – It is acknowledged that the hazards, as qualitative aspects are much easier to assess, communicate and perceive by the general public, but hazards alone are insufficient to assess the risks for populations and define the risk mitigation strategies that should follow. Scales that include the qualitative and quantitative aspects of hazards and potency that can be used in setting priorities of concern have been proposed for decades. We will be discussing when simple solutions can be applied and how to identify if they are applied in an incorrect way.
2.What are the new opportunities emerging in your field of work?
A. Regulatory agencies are setting stricter limits for the chemicals, new tests are identifying previously undetected adverse effects that they cause and new therapies are getting increasingly more active in lower doses. In this era it is a challenge to manage risks at the workplace, as well as risk for patients safety in a way that it is not over conservative. The key challenge is to keep the balance between the “risks and the benefits” during manufacturing, so that innovation and drug supply are stimulated
3.What are the key take away points from your presentation topic which will help in building the knowledge base of attendees?
A- The terms highly hazardous, highly active and highly potent are often used in mixed or inconsistent contexts regarding good manufacturing practice and worker safety. It is important to understand when and how to use these terms to assure the safety while not compromising the business activities. While competent toxicological evaluation is required to identify and characterize the health hazards for each drug substance and then calculate a health based exposure limit, other criteria that comprehensively round up risk assessment need to be taken into account. The bottom line is that risks presented by drug substances should not be managed by simple classification into highly potent and highly hazardous categories, but instead integrate flexibility.
4.Hope you had a chance to go through the agenda, what are your views on it and how helpful it is to the targeted audience?
A- In our filed od activities that are associated with manufacturing innovative medicines it is important to keep up with the science and technological accomplishments. The agenda provides a comprehensive overview of the activities associated with manufacturing highly potent innovative medicines for the new era.
