Altasciences invites you to an exclusive symposium taking place on April 30th, from 1 p.m. to 5 p.m., at the MassBioHub, in Cambridge, MA.
This complimentary event is by invitation only and registration is mandatory by filling out the form on your right.
Join our panel of experts as we explore a spectrum of topics, including the latest regulatory updates and effective strategies to navigate them. We'll discuss the impact of the current financial landscape on various biotech companies, the optimal pathway for nonclinical gene therapy development, and how ethnobridging can significantly accelerate project timelines.
1:00 p.m. to 1:15 p.m.: Introduction, Lisa Sanford, Vice President Business Development, Altasciences
1:15 p.m. to 2:00 p.m.: Nonclinical Adeno-Associated Virus (AAV) Gene Therapy Development–Key Considerations for Study Design, Laboratory Endpoints, and Regulatory Guidance. Julie Forget, DESS Tox, DABT, Senior Director, Safety Assessment, Altasciences and Pierre Jolicoeur, PhD, Scientific Director, Laboratory Sciences, Altasciences.
2:00 p.m. to 2:45 p.m.: Conducting Clinical Trial in Canada–A Strategic Regulatory Pathway? Eryn Corriveau, MSc, BSc, Senior Director, Drug Development and Regulatory Strategy, Altasciences.
2:45 p.m. to 3:30 p.m.: Navigating Critical Crossroads in Early Clinical Development. Dr. Mel Affrime, PharmD, Executive Vice President, Translational Medicine, Altasciences, Dr. David Nguyen, MD, MBA, General Manager and Medical Director, Altasciences, Dr. Christopher Banfield, PhD, CB Pharma Consulting Services, Dr. Shivraj Sohur, MD, PhD, Vice President, Neurology Clinical Development, Ono Pharma USA INC.
3:30 p.m. to 4:15 p.m.: Collaborative Innovation: The Role of CROs and CDMOs in Shaping the Future of Drug Development. Kurt Nielsen, PhD Managing Director, Drug Development, Expert Insights
4:15 p.m. to 4:30 p.m.: Closing Remarks, Lisa Sanford, Vice President Business Development, Altasciences
4:30 p.m.: Networking and cocktails
1:45 p.m. to 2:15 p.m.
Julie Forget, DESS Tox, DABT, Senior Director, Safety Assessment, Altasciences and Pierre Jolicoeur, PhD, Scientific Director, Laboratory Sciences, Altasciences
Abstract: This presentation provides detailed insights into preclinical gene therapies, immunity challenges, vector targets and biodistribution, and required analytical laboratory endpoints. Introductory paragraph AAV gene therapy is a groundbreaking advance in genetic medicine, offering a promising vector solution for various diseases. AAV, a non-pathogenic virus, efficiently delivers therapeutic genes, aiming to correct genetic abnormalities. This innovative approach addresses the root causes of genetic diseases, ushering in a new era of personalized interventions.
While AAV vectors are generally well tolerated, factors influencing immune reactions require careful assessment. Screening for pre-existing antibodies against AAV is crucial, as they can diminish the therapy's effectiveness. Quantifying AAV through qPCR is pivotal for assessing therapy efficacy and safety, providing insights into vector biodistribution. In this presentation, we explore the evolving gene therapy landscape through case studies emphasising the need to balance innovation with a meticulous commitment to safety and regulatory compliance.
2:15 p.m. to 3:00 p.m.:
Eryn Corriveau, MSc, BSc, Senior Director, Drug Development and Regulatory Strategy, Altasciences
Early-phase trials play a pivotal role in drug development, with sponsors continuously seeking accelerated, cost-effective, and efficient approaches to maximize the value of their molecule. Sponsors face an array of decisions, such as timelines, trial design and duration, dosing regimens, patient populations, and location. Certain countries offer strategic advantages that safely accelerate Phase I program initiation, streamline processes, and help reduce overall costs. In fact, distinct and tangible benefits exist to conducting early-phase studies in Canada that merit exploration and consideration in drug development planning. Join our panel of experts as they delve into the numerous advantages of conducting clinical trials in Canada, including convenient access to trial sites, availability of high-quality research subjects, potential cost savings, and an expedited and streamlined regulatory process, leading to a meaningful reduction in timelines
3:00 p.m. to 3:45 p.m.:
Dr. Mel Affrime, PharmD, Executive Vice President, Translational Medicine, Altasciences, Dr. David Nguyen, MD, MBA, General Manager and Medical Director, Altasciences, Dr. Christopher Banfield, PhD, CB Pharma Consulting Services, Dr. Shivraj Sohur, MD, PhD, Vice President, Neurology Clinical Development, Ono Pharma USA INC.
Abstract: The transition from preclinical studies to Phase I clinical trials marks a pivotal juncture in drug development. Our panel of key opinion leaders will delve into intricate aspects of Phase I, ranging from the nuanced comparison between small molecule and biologic early clinical development to in-depth assessments of QT intervals, drug-drug interactions, and a translational medicine approach for informed 'go/no-go' decisions. Further discussions will unravel the strategic groundwork for Phase I in preparation for the subsequent multi-regional Phase II and Phase III launch. This interactive session will provide a comprehensive exploration of the intricate facets shaping Phase I clinical development.
3:45 p.m. to 4:15 p.m.:
Kurt Nielsen, PhD Managing Director, Drug Development, Expert Insights
This discussion highlights the transformative impact of CRO and CDMO collaborations (with each other and their clients) on the pharmaceutical industry, especially in the context of NCEs, NBEs, and ADCs. It examines how these partnerships foster innovation, from discovery through to commercialization, and how they can be strategically utilized to overcome common bottlenecks in drug development. The session will also delve into the integration of new technologies and methodologies within these collaborations, showcasing how they contribute to streamlined processes, reduced time to market, and ultimately, a more efficient pathway to deliver breakthrough therapies to patients.
Julie Forget joined Altasciences in 2018 as Director, Safety Assessment, and became Senior Director in 2022. With over 15 years of experience in the preclinical industry, Julie brings scientific depth and expertise to the study director team, with a focus on delivering quality science to clients, from protocol development to report delivery. Before joining Altasciences, Julie’s expertise as a study director covered a large spectrum of study designs, from discovery to IND/NDA-enabling studies.
Dr. Pierre Jolicoeur joined Altasciences as Scientific Director after a tenure at Immunologix Laboratories as COO. Passionate for Public Health, Pierre holds a PhD in microbiology and immunology from the Universite de Montreal. He brings over 25 years of CRO experience, including ground-up laboratory operations management in the fields of large molecule bioanalysis, vaccines and gene therapy. After spending over a decade in the laboratory working on projects related to Gene Therapy and high-throughput therapeutic antibody productions, Pierre transitioned to the industry overseeing operations at Qbiogene, a small gene therapy company located in Montreal. He then joined MDS Pharma Services, supervising the Ligand Binding team and developing cell-based assay capabilities. In 2006, Pierre joined PPD in Richmond, Virginia, where he spent 15 years overseeing operational activities aimed at developing new business segments related to cell-based assay support for IM studies and vaccine development. In his role, Pierre oversees the operational and scientific activities of the Laboratory Sciences team in Seattle, WA.
Eryn Corriveau joined Altasciences in 2023, bringing with her a wealth of expertise in diverse therapeutic areas. With an M.Sc. in Human Physiology, and a B.Sc. in Biology, Eryn is currently working towards a Ph.D at Quantum University; her research focusing on the impact of supramental awareness on disease prevention, healing, and health. In her current role, Eryn guides regulatory strategies during early drug development, conducting gap analyses and leading interactions with regulatory agencies. Eryn’s past positions and extensive background in Regulatory Affairs from companies such as Cencora, KYE Pharmceuticals, and Verity Pharmaceuticals, showcases her commitment to advancing pharmaceutical development.
Mel Affrime has an extensive background in Global Clinical R&D. Following completion of PharmD training at PCP&S in Philadelphia, he completed a Clinical Pharmacology Fellowship with Marcus Reidenberg, MD, at Temple University College of Medicine. He then co-founded the Clinical Pharmacology research unit at Hahnemann Hospital, Philadelphia, PA with David Lowenthal, MD, PhD, in 1976. He remained on the faculty at Hahnemann until 1982 when he joined Hoechst-Roussel Pharmaceuticals as Associate Director, Clinical Pharmacology. Prior to joining WCCT Global in 2011 as the Senior Vice President of Translational Medicine, Mel managed the medical staff at ICON Development Solutions’ three CPUs, the Population PK software business, and the R&D department from 2006 to 2011. His experience also includes heading Global Profiling Clinical Pharmacology at Novartis Pharmaceuticals and 16 years at Schering-Plough Research Institute where he managed the early development programs for the entire Schering pipeline.
Dr. David Nguyen is an anesthesiology-trained General Manager and Medical Director with experience in all major inpatient surgical specialties including neurosurgery, cardiothoracic, and obstetrics, as well as outpatient procedures and GI services. He is intimately familiar with transfusion medicine, fluid management, infusion reactions, and emergency anaphylactic airway response. While treating chronic pain patients, Dr. Nguyen received a first-hand account of both the opioid crisis as well as the frustrations and poor quality of life for a patient suffering from chronic pain, which was the impetus that drove him to become a patient advocate for responsible medical cannabis use. At Altasciences, his goal is to push forward high-quality pharmaceutical therapies for patients, and to ensure subject safety on all trials. Prior to joining Altasciences in 2017, he expanded his clinical knowledge to include dermatology and regenerative medicine, prompting the launch of his medical aesthetic practice, Dr. Dave’s Dermal Institute, where he functioned as both medical director and primary practitioner. He brings the same customer-focused approach from this practice to volunteers in clinical trials, ensuring subject satisfaction at all levels.
Dr. Chris Banfield is an accomplished Clinical Pharmacology leader, with over 25 years of pharmaceutical industry experience. His primary goal has been the maximization of the efficiency and effectiveness of the conduct and design of clinical pharmacology Research and Development programs within the pharmaceutical industry. Chris has demonstrated the ability to deliver mission critical results as a high-performing individual, with in-depth knowledge of drug development at all levels (discovery, pharmacokinetics, pharmacodynamics, bioanalysis and regulatory). Chis’ most recent role was as Vice President, Clinical Pharmacology, at Pfizer Inc., where he was responsible for the early clinical development portfolio in inflammation and immunology. Chris’ areas of interest include designing Phase I development strategies for both small molecules and biological products. His approach integrates a comprehensive understanding of target engagement, pharmacokinetics, and safety and tolerability assessments. This holistic perspective informs the quantitative design of Phase II and III clinical studies, encompassing critical aspects such as patient selection and dose determination. Chris is a strong promoter of the value of using model informed drug development to aid in rational decision making in drug development.
Dr. Shivraj Sohur joined ONO PHARMA USA, INC. in June 2021, serving as the Vice President, Neurology Clinical Development. He leads neurology clinical development activities in the U.S. and globally while providing medical and strategy input on ONO PHARMA USA, INC.’s various clinical development Dr. Shivraj Sohur joined ONO PHARMA USA, INC. in June 2021, serving as the Vice President, Neurology Clinical Development. He leads neurology clinical development activities in the U.S. and globally while providing medical and strategy input on ONO PHARMA USA, INC.’s various clinical development projects. With a two-decade career focused on the treatment of neuropsychiatric disorders, Shiv has held a variety of leadership positions, most recently with Alexion Pharmaceuticals, where he was a clinical lead in a Guillain Barré Syndrome III Study in Japan, culminating in Sakigake fast-track and Orphan Drug designations. Prior to joining Alexion, Shiv worked for Alkermes and Pfizer, where he served in a variety of roles, each leading to significant accomplishments in neuroscience programs. Shiv earned his M.D. and Ph.D. from Vanderbilt University in Nashville, TN, and holds a B.S. in Biology and Chemistry from Angelo State University in San Angelo, Texas. In addition to his academic credentials, Shiv is on the faculty at Harvard Medical School and continues to be a part-time faculty in Neurology with a sub-specialization in Movement Disorders, practicing at Massachusetts General Hospital in Boston, MA.
Dr. Kurt Nielsen, a veteran industry executive and currently a Managing Partner at Expert Insights Consulting, a top advisory firm for Pharma Services firms and investors. Over the past 30 years, Kurt has served in a variety of product development and executive leadership roles, including CEO at Pii, CTO at Catalent, President at Lupin Somerset, a division of Lupin Inc., as well as SVP of Launch Management and Commercialization at Sandoz, Inc, and EVP of Pharmaceuticals at URL Pharma. His experiences also include business development roles at Teva Pharmaceuticals and Johnson & Johnson. Kurt has a BS in Chemistry from the University of Delaware and a PhD in Chemistry from Villanova University.
The event will be held at the MassBioHub, in Cambridge, MA.
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Altasciences has been recognised as a 2023 CRO Leadership Award Champion in the Capabilities category, as voted by you in ISR’s annual CRO Quality Benchmarking survey. |
