Q&A with Roberto Darienzo, Halo Pharmaceutical

Q&A with

Roberto Darienzo,

Chief Operating Officer, Halo Pharmaceutical

PharmTech:

What strategies are you planning to employ to remain competitive in the contract pharmaceutical development and commercial manufacturing industry?

Darienzo:

Clients expect us to be flexible, fast, and obviously to have competitive costs. We will achieve that by implementing best practices in operational excellence initiatives so that we have highly performing equipment, greatly trained and motivated teams, and that we are creative enough to find solutions to the most diverse problems our clients may face with their products. We believe we can generate ideas for development solutions, bringing those solutions to them better than our competition.

PharmTech:

Do you see a new industry trend emerging?

Darienzo:

There are several companies working not only in the discovery of new molecules, but also in taking known molecules or products and developing new ways of formulating them, new ways to release or deliver them to patients, reducing their abuse potential, improving their safety, efficacy, absorption, reducing side effects or effective dosage, etc. Obviously reducing the abuse potential of narcotic analgesic formulations (as well as other frequently abused drugs) is an active area at the moment, and an area in which Halo is currently working on numerous controlled substances.

PharmTech:

How is your company responding to regulators' intensifying emphasis on inspections and product quality?

Darienzo:

We are obliged to be absolutely perfect in our quality and compliance. So far, as a CDMO that started in 2008 that has had annual general and preapproval inspections because of our sterile area and the introduction of new products, we have yet to receive a 483 observation. This is very difficult, and never to be taken for granted, but it's a record we are determined to continue. Because of the number of clients we are now dealing with, we have an average of one audit per week, and have a tremendous source of GMP consulting advice. This gives us the opportunity to learn fast, to be fully updated on trends and new concepts, and to improve continuously every week.