Five Things to Know About Scientific Affairs
Successful early phase drug development studies are grounded in a strong scientific rationale, and a deep understanding of regulatory requirements. Altasciences’ Scientific Affairs (SA) team combines these critical knowledge bases to support sponsors in designing and conducting the most appropriate studies for their unique development program.
Catherine Dussault is the Director of Altasciences’ Scientific Affairs team. She has been with Altasciences since 2004; and is a senior scientific leader with a deep knowledge of regulatory framework for various drug development clinical research programs. Catherine has overseen over 2,000 clinical trials, including Phase I and II, FIH, bioequivalence, 505(b)(2), drug-drug interactions, QTc, and proof of concept, in both healthy normal and special patient populations. She has extensive experience in multiple therapeutic areas, such as central nervous system, GI tract and metabolism, cardiovascular, genito-urinary system and sex hormones, antineoplastic and immunomodulating, and anti-infective agents.
Q1: Can you describe the SA team’s roles and responsibilities?
Generally speaking, the SA team supports both sponsors and internal teams, especially for the development and review of study designs, and for any specific scientific or regulatory design expertise required throughout the study conduct.
The SA team is involved from the start of a program or study to the finish, ensuring we provide the best design to meet study objectives and regulatory requirements. We offer scientific insight and consultancy to support regulatory meetings, grant applications, and internal/external stakeholder communication.
We also provide knowledge and insight throughout the study design elaboration, the study conduct, and the data analysis, to ensure a solid scientific base for every study, and every client.
- Time is devoted to literature searches, review of available/applicable guidances, discussions with experts, feasibility analysis, and verification of safety monitoring considerations with the Principal investigator (e.g., inclusion/exclusion criteria, dose levels, vital signs, and ECGs.).
- We work closely with the medical writers and PK scientists to ensure thorough understanding of the design, including any specific requests from the sponsor; a collaboration that continues from protocol development through study conduct.
- We provide support to Altasciences’ bioanalytical laboratories for analytical range determination.
- We review the preliminary results of bioequivalence studies.
- We provide insight into result interpretation, and we prepare scientific documents to support productive and successful sponsor meetings with regulatory agencies.
Q2: Can you tell us about the individuals that are part of the SA team?
Our SA experts are open-minded, curious, customer-focused, science-driven, flexible, creative, and so much more. Specifically, they offer:
- Strong scientific skills
- Excellent teamwork and collaboration
- Diversity and complementary strengths
The team members are highly educated drug development scientists (Bachelor, Master, and PhD), with an average of 16 years’ experience supporting sponsor programs.
Q3: How does Altasciences’ unique and streamlined organizational structure benefit your team?
As you may know, Altasciences has two executives sharing the oversight of our operations. One is focused on scientific, bioanalytical, and research support services, and the other is dedicated to the research itself. The SA team falls under the first group, and is not directly involved in the day-to-day study deliverables. This allows for tremendous flexibility in supporting sponsors and internal stakeholders. Our deliverable is rapid turnaround and dedicated help, and we can quickly assign unscheduled or time-consuming work that may be required to respond to a request. The team is ideally placed to provide personalized, customized service – being distinct from, while closely collaborating with, operations, helps us deliver a customer-focused, scientifically appropriate and logistically feasible solution.
Q4: What references and resources does the SA team use to support stakeholders?
Altasciences has been involved in a multitude of different drug development programs over the last 25 years, so our firsthand experience is extremely useful. Over the decades, the team has gained significant knowledge and expertise in different drug development domains and study types:
- FIH (SAD/MAD/FE/POC)
- Complex generic
- 505(b)(2) or Hybrid
- Drug-drug interaction
- Hepatic/Renal impaired studies
- Abuse deterrence
- Human abuse potential
- Thorough or early QT
We have access to an impressive database built from the thousands of studies carried out at our sites over the years, and we work with a team of internal and external multidisciplinary experts. The team is always on the lookout for new guidances published by worldwide regulatory agencies, to ensure that our knowledge remains current and relevant.
Over the years, we have carried out thousands of literature reviews on different drugs.
Q5: Do you have any advice for sponsors on how they can help you to help them?
Of course, it helps when the sponsor provides a clear objective for the program. It’s also helpful to have access to the results of their development efforts to date, including any data or information that will affect the study design, such as safety data, PK, previous study results, previous agency communications, etc. That said, we are here to help every sponsor, and to consult with them on their objectives, even if they are not solidified. We will bring our decades of expertise and vast knowledge to the table and help the sponsor design, plan, and conduct the most appropriate studies for their unique situation.