Our Vision
Enabling life sciences companies to advance breakthrough treatments through excellence in clinical development
Joachim is passionate about Clinical Research and is the Managing director and co-founder of BioLink.
He is an experienced Senior Executive in Pharmaceutical Research and Development with extensive knowledge of clinical development processes, digital technologies, and a track record of operational over delivery. During his more than 20 years of experience he has gained hands-on experience in Research, Strategic Planning, Project Management and Clinical Operations in a plethora of indications and though all phases of development. He led modernization of clinical trial conduct to transform patient health at Bayer as Senior Vice President of Clinical Operations an organization active in 45 countries.
Joachim develops future leaders and creates a high-performance culture based on psychological safety, trust, autonomy, and recognition. He was inspiring and driving a global team of 1800+ to achieve clinical operational excellence. He shaped an organizational culture that puts employees and patients’ needs first by strengthening data science and technology platforms to improve future healthcare.
Christina, a hands-on and passionate clinical developer with 20 years of experience in the pharmaceutical industry, serves as the Medical Director and co-founder of BioLink.
She brings profound knowledge of clinical and operational processes across various functions in R&D. With finerenone becoming Kerendia® in July 2021, Christina completed the successful development of an investigational compound for which she was responsible as Clinical Lead from the proof-of-concept phase to the multinational Phase III program. By introducing a newly accepted endpoint, the innovative design of FIGARO and FIDELIO led to worldwide approval of finerenone with a very broad label.
During her career in pharma, Christina led several initiatives aiming for modernizing clinical trials, optimization of operational structures, processes and costs. She is convinced that patient centricity is crucial for successfully developing drugs and that “culture eats strategy for breakfast”.
Christina was involved in many Due Diligences across a wide spectrum of indications representing Clinical but also Operations. Christina is winner of the Otto-Bayer-Medal for excellence in Research and Development.
Our Consultant Network
At BioLink Intelligence, we excel in working closely with highly skilled professionals from various disciplines, enabling us to offer comprehensive services to our clients in one place. We ensure that all aspects are carefully considered in line with a coordinated project plan, aiming to deliver customized and optimal solutions tailored to each client's needs. Our network includes distinguished experts known for their unparalleled insights and expertise.
Regulatory
The regulatory function is pivotal in guaranteeing adherence to international regulatory frameworks and directives. This entails the thorough preparation and submission of required documentation to secure authorization for clinical investigations and market authorizations, while ensuring that investigational and commercial products conform to established safety and efficacy criteria. Moreover, regulatory experts continuously monitor the evolving regulatory landscape to develop and implement strategic pathways that facilitate expedited regulatory approvals and sustained compliance.
Toxicology
Toxicology is vital for assessing the safety of pharmaceutical compounds. Our consultant advises our clients which preclinical assessment and studies are required to determine toxicity levels, identify organ-specific effects, and understand mechanisms of adverse reactions. The strategic analyses help define safe dosage guidelines, inform clinical trial protocols, and support regulatory submissions, ensuring that drug development processes meet stringent safety standards.
CMC
Our CMC expert supports our clients in ensuring the quality, safety, and efficacy of pharmaceutical products. The focus lays on comprehensive characterization of drug substances and products, development of robust manufacturing processes, and establishment of stringent quality control measures. The strategic oversight ensures that all aspects of drug formulation, production, and packaging meet regulatory standards, facilitating successful regulatory submissions. This role is essential for guaranteeing that pharmaceutical products are consistently produced and controlled to meet the quality standards appropriate for their intended use.
Pharmacokinetics
Our pharmacokinetics expert plays a key role in characterizing the absorption, distribution, metabolism, and excretion (ADME) properties of pharmaceutical compounds. Through strategic evaluation of pharmacokinetic profiles, our expert identifies optimal dosing regimens, investigates, and predicts drug interactions, and assesses bioavailability and elimination pathways. This expertise is vital for designing effective and safe clinical trials, guiding dose adjustments, and supporting regulatory submissions, ensuring that therapeutic agents are both efficacious and safe for patient use.
Medical Writing
Medical Writing plays a pivotal role in the clear, concise, and accurate dissemination of scientific and clinical data. Our very experienced Medical Writer develops regulatory documents, clinical trial protocols, study reports, and submissions for regulatory authorities, ensuring that these documents meet stringent regulatory guidelines and standards. Strategic communication skills are essential for bridging the gap between complex scientific data and the regulatory requirements, facilitating the approval process for new drugs and therapies. This expertise is crucial for advancing pharmaceutical products through the development pipeline and into the market, while ensuring transparency and compliance with global regulatory demands.