Ingrid Hochmayer, Managing Director of ZAK-Pharma Dienstleistung Ges.m.b.H., plays a crucial role in overseeing all organizational processes, including employee management, resource management, business development, quality management, and financial status. Founded in 1997, ZAK-Pharma is a leading provider of clinical research and regulatory affairs services, known for its expertise in clinical trials, regulatory support, medical writing, and pharmacovigilance.
Ingrid’s unexpected journey into the pharmaceutical industry began during her psychology studies in Vienna, where an internship sparked her interest in clinical studies. After starting as a Clinical Research Associate (CRA), she held various positions in the industry before founding ZAK-Pharma. With over two decades of experience, Ingrid has guided ZAK-Pharma through the evolving domain of clinical research, embracing digital innovations, fostering international collaborations, and adapting to regulatory changes. Her leadership and strategic vision continue to drive the company’s success and innovation in the field.
Let’s explore Ingrid Hochmayer’s leadership at ZAK-Pharma and the company’s evolution in clinical research and regulatory affairs!
ZAK-Pharma has over 20 years of experience in clinical research and regulatory affairs. How has the industry evolved during this time?
The biggest changes are:
- Digital Development: Digital innovations have introduced complex systems requiring extensive training and certification for staff. Technical issues demand problem-solving skills and understanding. Systems must meet validation standards, address data protection, and cyber risks. Digital tools have shifted communication to platforms like MS Teams, enhancing speed and transparency but increasing documentation efforts.
- Increased Need for International Networking: SMEs struggle to meet sponsor requirements independently, necessitating collaboration with vendors. This increases organizational complexity and complicates service offers and billing.
- Centralization: Clinical trial submissions have been centralized to distribute tasks among Member States. However, national exceptions require staying updated with both European and national regulations.
- Speed and Time Pressure: Centralized submissions and shorter data gathering periods increase pressure on sponsors and CROs to achieve accuracy on the first attempt and conduct trials quickly.
- Remote/Centralized Monitoring: Sponsors prefer remote monitoring to reduce costs, shifting away from face-to-face visits.
- Complexity of Studies: Increasing complexity in studies necessitates specialized sites, limiting eligibility and increasing reliance on specialist sites for feasibility assessments.
- Lack of Consistency in Sponsor Strategy: Sponsors frequently change strategies, fluctuating between staying with satisfied companies and opting for the cheapest offers.
What are some of the key services that ZAK-Pharma offers in the area of clinical research development in Europe?
Management of Clinical trials, regulatory affairs services, medical writing and pharmacovigilance support. Since we have vast experience in mainly all therapeutic areas, a long-term relationship with Clinical Investigators and other clinical experts, we are also offering country and site feasibility, especially in rare indications.
How does ZAK-Pharma approach the challenge of patient recruitment and retention in clinical trials?
We have gained experience over the past years, having conducted clinical trials with various strategies already. Therefore, we have an insight into what is allowed from a regulatory perspective and what can work well under certain circumstances and can counsel our customers accordingly. Patient recruitment may be enhanced by advertisement, stressing the increased medical care due to more frequent visits to the investigator’s site during a clinical trial, patient compensation or considering satellite sites or referring physicians, respectively. Also, the involvement of a Site Management Organization may boost recruitment.
Can you discuss the importance of strategic partnerships in the pharmaceutical industry, especially for small and medium enterprises?
Strategic partnerships are very important; for an SME it’s crucial to have these partnerships. Even though it takes a lot of effort (e.g., audit and quality requirements) it’s the best way to offer a full service to the industry.
We need to act flexible to the (changing) Sponsor strategies and the required type of patients and preconditions; investments in being-up-to-date in all potentially required sectors would be too expensive to maintain; also, if you are connected and one of the partners is getting an offer, the partners can offer the other partner’s services vice versa which provides better chances on the market (cooperation rather than competition).
How does ZAK-Pharma balance the need for innovation in R&D processes with increasing regulatory requirements?
Basically, the Sponsor specifies what kind of innovation he imagines for a project. As a service provider we can give our advice based on our experience and do our best to realize those wishes. Of course, regulatory requirements are prerequisites that need to be met and considered when providing advice.
What advice would you give to pharmaceutical companies looking to conduct clinical trials in Europe?
We recommend sponsors familiarize themselves with the specifics of each country involved in their trial, as European countries vary significantly.
Choosing a CRO should be based on clinical indication and patient number requirements. Big CROs may handle large, multi-country studies well, while small CROs excel in rare disease trials due to their detailed feasibility and site selection efforts. However, CRO size doesn’t guarantee quality or outreach. Smaller CROs can offer high engagement and effort to meet customer needs, often through collaborations.
It’s crucial to select a well-established CRO. Maintaining good relationships and clear communication standards between the Investigator, Sponsor, and CRO is essential. A low staff turnover rate at the CRO is also beneficial.
In your opinion, what are the most promising new strategies in healthcare that CROs should be focusing on?
Our fields of activity are defined by the Sponsor’s requests. Nevertheless, we observe the developments, and the topics clinical trials are dealing with.
We consider hot topics:
- Personalized medicine
- 3D printing or bioprinting techniques (3D printing of dental implants, replacement joints, bioprinting of organ structures that behave like native tissues)
- Next generation pharmaceuticals
- Artificial intelligence in detecting, diagnosing and treating diseases
- Combined Medical Devices, allowing patients to act/apply medicinal products independently from their healthcare provider (long waiting periods, HCPs having less time per patient; greater self-determination and independency; targeted therapy; improved efficacy)
Overall, also Real-World Evidence Data should be used more frequently. They are cheaper and readily available, due to the enhancements for electronic recording (medical registers).
