The Evolving Role of Scientific Affairs in Drug Development
Developing New Chemical Entities (NCEs) and Investigational Medicinal Products (IMPs) is a complex and challenging task. It requires the collaborative efforts of professionals with different areas of expertise, including pharmacologists, physicians, pharmacokinetic scientists, bioanalytical scientists, and regulatory experts. Scientific affairs professionals play an important role in coordinating these collaborative efforts and bringing scientific and regulatory expertise to the clinical drug development process.
Traditionally, medical and scientific affairs teams have served as a bridge between the research and development (R&D) and commercial teams within an organization and as a link between the organization as a whole and external stakeholders.
However, as the complexity of clinical trial design and conduct increases, the role of medical and scientific affairs has also evolved. Scientific affairs teams are no longer just playing a supportive role within pharmaceutical companies or clinical research organizations (CROs). They have transformed into a valuable partner to other groups within organizations and, in some instances, have taken on the function of strategic leadership.
One of the crucial goals of scientific affairs teams is the generation of Data to support the regulatory goals of clinical drug development programs. However, they may also initiate and conduct scientifically and medically driven initiatives. Several areas in which scientific affairs have gained particular significance include promoting innovation and patient-focused healthcare, and demonstrating value for novel treatment options.
In addition, scientific and medical affairs teams thoroughly understand the science involved in clinical drug development and the data capabilities of their organizations. These may lead the dialogue with key internal and external stakeholders. Thus, scientific affairs professionals are in an optimal position to promote the generation of evidence to support the entire product lifecycle and to improve patient outcomes.
In-House Scientific Affairs Expertise
BioPharma Services, Inc. (BioPharma) is a full-service CRO with niche expertise in early-phase clinical trials and human abuse potential studies. Considering the critical and evolving role of scientific affairs in clinical drug development, BioPharma has established in-house expertise in this area. Our scientific affairs team contributes scientific and regulatory know-how to our clients’ clinical drug development programs.
Extensive Scientific Expertise
BioPharma’s team has multidisciplinary scientific competency, encompassing clinical pharmacology, clinical safety, pharmacokinetics, pharmacodynamics, bioanalysis, and bioequivalence. Executive Vice President of Scientific Affairs, Dr. John Oldenhof, oversees all of BioPharma’s scientific activities. Dr. Oldenhof is a widely recognized expert with more than 25 years of experience in clinical pharmacology and drug development.
The BioPharma Services scientific affairs team contributes scientific expertise to other teams within our company and directly to our clients. Moreover, our scientific affairs experts can advise on creative methodologies and innovative early-phase clinical development plans for all clinical drug development programs, ranging from generic equivalents to NCEs.
Proficient Regulatory Scientists
BioPharma’s in-house regulatory experts ensure that all aspects of our clients’ clinical drug development programs comply with the relevant regulatory requirements. They become involved in the clinical trials we conduct as early as possible to ensure that applicable regulatory requirements are already implemented at the stage of clinical trial design.
The regulatory expertise of our team is extensive. Over 30 successful inspections by a number of regulatory agencies have confirmed this expertise, including the United States Food and Drug Administration (FDA), Health Canada, World Health Organization, United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), French National Agency for the Safety of Medicines and Health Products (ANSM), Danish Medicines Agency (DKMA), and Brazilian National Health Surveillance Agency (ANVISA).
How Scientific Affairs Advance Drug Development Programs
The BioPharma Services scientific affairs team provides the know-how to all stages and aspects of our clients’ drug development programs. This includes, but is not limited to, the following:
Contributing to Clinical Trial Design
Designing a clinical trial is a complex process that should consider the scientific aspects of the study and the relevant regulatory requirements. Further, BioPharma has niche expertise in early-phase clinical trials, characterized by extensive safety monitoring and a high rate of drug candidate failure. Our scientific affairs experts play an essential role in clinical trial design. They provide scientific and regulatory know-how and collaborate with other team members to generate efficient and safe study designs.
Providing Scientific Feedback Based on Clinical Data
– Clinical trial complexity requires systematic and adaptive study designs. Our scientific affairs experts support our clients and internal teams throughout the complete course of a clinical trial. Their scientific and regulatory know-how enables them to provide feedback and suggest relevant modifications based on the incoming clinical data.
Participation in Regulatory Meetings
BioPharma’s scientific affairs team has experience working with a number of regulatory agencies around the world. If our clients’ clinical drug development programs require it, scientific affairs experts may help organize and conduct meetings with the relevant regulatory authorities.
Leading Communication With Internal & External Stakeholders
Aligning the needs and activities of internal and external stakeholders is an important prerequisite for the efficient and timely completion of clinical trial programs. Our scientific affairs team leads the continuous communication with internal and external stakeholders to streamline the process of clinical drug development.
The Scientific team at BioPharma includes a subset of seasoned Pharmacokinetic Scientists and Clinical Research Scientists responsible for drug development and protocol design across multiple regulatory markets. Together, this team can advise on creative methodologies and innovative early-stage clinical development plans for all drug programs, from generic equivalents to novel chemical entities. Designs include:
- First in Human (FIH)
- Single Ascending Dose (SAD)/Multiple Ascending Dose (MAD)
- Absolute bioavailability
- Safety and Tolerability
- Food Effect study
- Age and gender
- Dose proportionality
- Drug-Drug and Alcohol interaction studies
- Human Abuse Potential/Abuse Deterrent Assessment
- Medical Cannabis
- Pharmacokinetics/Pharmacodynamics (PK/PD)
- Exploratory clinical models for Proof-of-Concept decision making
- BA/BE for all dosage forms (including solid oral formulations, transdermal patches, inhalation products and deport injections)
The Strengths of the BioPharma Team
Our scientific affairs experts collaborate closely with other members of our multidisciplinary team to offer comprehensive solutions for our clients’ clinical drug development programs. Our strengths include, but are not limited to, the following:
Expertise in various therapeutic areas
As a full-service CRO, BioPharma Services has experience across a wide range of therapeutic areas. In addition, the proficiency of our internal team and external network of collaborators enables us to conduct studies with various, even very challenging, routes of administration. Finally, we can work with numerous formulations and dosage forms.
Successful completion of 2,000+ trials
BioPharma’s experienced scientists and physicians have already completed more than 2,000 early-phase clinical trials. Moreover, the expertise of our team has been recognized with more than 20 awards. In addition, the professionalism of our organization is supported by the impressive combined experience of our Principal Investigators (PIs), which exceeds 50 years.
Expertise with various study designs
Our team has successfully designed and completed various types of studies. Thus, we have conducted numerous first-in-human (FIH), single ascending dose (SAD), multiple ascending dose (MAD), and safety and tolerability trials. In addition, we are proficient in absolute bioavailability and bioavailability/bioequivalence studies. Our skill set also involves designing and performing pharmacokinetic/ pharmacodynamic (PK/PD), food effect, age and gender, and dose proportionality studies.
Further, we can design exploratory clinical models for proof-of-concept decision-making and investigate drug-drug and alcohol interactions. Finally, our team has niche expertise in human abuse potential/abuse deterrent assessments.
Experience working with numerous regulatory agencies
BioPharma’s regulatory and scientific affairs professionals have experience working with various regulatory agencies worldwide. This enables us to implement all applicable regulatory requirements in the clinical trial designs for our clients’ drug development programs and competently support them regardless of geographic location.
A multidisciplinary team that collaborates closely to optimize study outcomes
Our scientific affairs professionals collaborate with BioPharma’s experts from other scientific and clinical areas. For example, they work closely with our proficient medical physicians to ensure that clinical trial design and conduct prioritize the safety and well-being of our study volunteers.
BioPharma’s many multidisciplinary teams combined efforts enable us to understand the pharmacokinetics, pharmacodynamics, mechanism of action, and potential for adverse events of the drug candidates we develop clinically. Our experts can provide safe, reliable, data-driven solutions to the clinical development programs of our clients.
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