Adriana Andrić, Senior Consultant at NDA, is an MD and MPH with over a decade of regulatory experience. Adriana previously worked for the Croatian Medicines Agency (HALMED) and served as a delegate on several EMA committees/working parties, namely the COMP, PDCO and SAWP.

Adriana was born and raised in Zagreb, and from an early age, was curious by nature and interested in different disciplines.

“It was not a straightforward decision to study medicine, because although I was more interested in subjects like IT, maths, physics, and biology, I also performed well in social sciences and languages. I wanted to help people live better, healthier lives so I decided to study medicine. After graduating from Zagreb Medical School, I started a master’s program in Public Health at the Andrija Štampar School of Public Health. Doing a master’s program, at that time and in that environment, was a great way to get introduced to a number of disciplines that deal with people's health in different ways. And it proved to be a great step to further broaden my horizons.”

After her master’s program, Adriana started her career as a regulator at the Croatian Medicines Agency (HALMED), and the opportunity opened other doors. For nearly 10 years, Adriana was a Croatian delegate on several different EMA committees and working parties – the Committee for Orphan Medicinal Products (COMP), Paediatric Committee (PDCO), and Scientific Advice Working Party (SAWP).

“Becoming a regulator was new, challenging, and exciting at the same time. I wore very many regulatory hats, including pharmacovigilance assessment, quality assurance and international project collaborations. But it was being a representative at the COMP, PDCO and SAWP that gave me the opportunity to discuss, and directly contribute to the development of new medicines in the EU. Working at the core of the European regulatory network that is the EMA and collaborating with numerous experts across the EU to help bring medicines to European patients, was an extremely rewarding and humbling experience.”

In August 2022, Adriana joined NDA’s EU Regulatory & Strategy Team as a Senior Consultant. Her role involves supporting clients with various regulatory processes, such as orphan drug designations, paediatric investigation plans and scientific advice.

“Joining NDA was a no-brainer. I was already aware that NDA has supported the approval of a quarter of all new medicines in the EU and US in the last three years. But it was only when I started working and met the entire team that I saw just how committed and passionate they are about helping their clients develop new medicines. It is this dedication of a team of profoundly skilled experts that make these results happen for the patient, and our clients at NDA.”

When asked what she enjoys about her role at NDA, she had this to say:

“I thoroughly enjoy the variability in the types of medicines, therapeutic areas, and regulatory processes that we support our clients with. Working at NDA invites me to stretch my intellectual muscles a bit more every day – every project is different with its own unique challenges. Guiding clients through various regulatory processes and helping them define the path to bring their medicines to patients is exceptionally rewarding. NDA is a dynamic and stimulating environment with a great collaborative culture. These values align with my personal values. I feel privileged to be working with colleagues with such broad expertise and past experience as ex-regulators, in industry, or within regulatory consultancies.”

• The biological activity of ATMPs can be mediated by numerous factors meaning one single marker or assay may not fully reflect the functionality of the product.
• Functional potency assays can be difficult to validate due to the cellular components and inherent variability related to the material and manufacturing process.
• Limited number of cells available in autologous therapies and needs for rapid patient administration (fresh products) may restrict potency testing possibilities at release

Drawing on over a decade of experience in regulatory affairs, Adriana offers a unique perspective on the essence and audience of regulatory affairs. Her perspective can be summed up as:

“In the past, regulatory affairs was perceived as something dull or administrative. That perspective has shifted greatly over recent years, especially given the increasing challenges and technical knowledge required to support the increasing numbers of advanced therapies in development. I think there's now a great understanding that what often makes or breaks a medicine, their approval, and access to the market and patients is a clearly defined regulatory path and development plans that are informed by the expectations of regulators. I would say that regulatory affairs is a key element in developing medicines. The great strength of regulatory affairs is that it is multidisciplinary in nature. The challenges of regulatory affairs are varied and complex and require a mix of professionals with various scientific and technical backgrounds, training, and past experiences. It's the diversity that makes the entire system work.”

Based on her extensive experience, Adriana emphasizes that effective communication, meticulous attention to detail, and unwavering resilience are essential ingredients for achieving success.

“It is all about communication – first and foremost listening, to ensure you understand the perspectives and expectations of all parties involved, from the client to the regulatory authority that will ultimately approve the medicine. Drug regulation constantly throws new challenges, be they new or changing guidelines, or new technologies that challenge the regulatory paradigm. At NDA, we aim to help our clients reach a consensus with the regulators on the steps they need to take to reach regulatory milestones. No client likes unexpected challenges. NDA’s extensive experience allows us to provide evidence-based solutions for success. NDA’s goal is always aligned with the client’s goal to bring new medicines to patients.”