Myths and Urban Legends in Drug Development: Lessons Learned for Small Biotech Companies
Regis Technologies invites you for a seminar on "Myths and Urban Legends in Drug Development: Lessons Learned for Small Biotech Companies" delivered by guest speakers, Dr. Michelle Higgin and Dr. Lisa Lallos of PharmaDirections. Read the abstract below for more details. A continental breakfast will be served.
Who should attend? Small Biotech, VCs, CEOs, COOs, VP of Operations, CSOs and Academics.
Join us for coffee and chemistry on Tuesday, October 11th, 8-9:30AM.
Coffee served at 8:00am; presentation begins at 8:30am; Q&A at 9:30am.
Myths and Urban Legends in Drug Development:Lessons Learned for Small Biotech Companies
Michelle Higgin, Ph.D., & Lisa Lallos, Ph.D., PharmaDirections
Can you spot the drug development urban legend?
- Clinical studies in Australia are cheaper due to tax rebate
- No CMC or preclinical studies are required for an investigator-sponsored IND
- My drug is completely safe; all the mice are active at the end of the study
- There are no Asian suppliers that can manufacture API or drug product per cGMP
Drs. Michelle Higgin and Lisa Lallos have heard them all many times! They talk to hundreds of newly formed biotech companies every year and have the opportunity to hear their creative strategies for building value on extremely lean budgets. Many of those ideas are ground breaking, but some are based on misconceptions that lead to costly delays and missed investment opportunities. Knowing how to side step these landmines will help streamline the development path but also offer some new strategies. During the presentation, they will share some truths, myths and legends spanning drug development – preclinical, CMC, clinical, regulatory and program management. This meeting will help early biotech companies avoid these potential pitfalls while providing alternatives paths to IND and clinical studies.
Michelle Higgin, Ph.D., has worked with 50+ small biotech companies over the last 10 years as managing principal at PharmaDirections in both strategic and operational roles. Supported by her 20+ years of experience in CMC and project management, Michelle’s efforts have ranged from performing due diligence on start-up technologies, developing strategic plans, and leading drug development teams as the director of operations. At PharmaDirections, she helped several ‘two men and a molecule’ type companies take off the ground and mature into publically traded companies. She has had the opportunity to work pre-clinically and clinically in a variety of indications from endocrinology to oncology to kidney disease and a myriad of orphan indications from Pre-IND to Phase 3. She routinely leads and manages R&D programs for small molecules, large molecules and biologicals with budgets in excess of $30M. Dr. Higgin received her Ph.D. in Biochemistry from University of Wisconsin-Madison and a postdoctoral training at National Institutes of Health.
Lisa Bastiani Lallos, Ph.D., has 20 years of drug discovery and development expertise for emerging and growth stage biotech companies with a focus on infectious disease, antiviral and oncology research from discovery through Phase I clinical trials. As Project Leader for PharmaDirections, Inc., Dr. Lallos is responsible for client development and project management for the firm’s emerging biotech clients. She is responsible for the execution of client development plans, developing strategic plans, managing vendor relationships, and assisting her clients’ obtaining SBIR/STTR, venture capital and other forms of financing. Prior to working with PharmaDirections, Lisa was a Senior Scientist at Idenix Pharmaceuticals where she was part of the team that successfully characterized anti-HCV compounds for single and combination resistance. She also led the Biology Protease Inhibitor Team, contributed to eight anti-HCV IND applications, and designed and implemented new experimental methods that increased sensitivity and reduced both time and cost. Earlier in her career, in addition to managing the virology department at Aphios Corporation, she was responsible for procuring HIV and influenza antiviral NIH SBIR grants, as well as designing innovative approaches to extend the firm’s core viral research into new areas including influenza, smallpox and parvovirus. She has also served on the Boston Chapter board of the Healthcare Businesswomen’s Association as programming director and secretary. Dr. Lallos has a BA in Biology from Oberlin College, received her MS and PhD in Viral Immunology from New York University, and completed her postdoctoral training at Harvard University. Dr. Lallos has over ten peer-reviewed publications and holds two patents.
Join us to learn more about the JumpStart Grant for Massachussetts!
About PharmaDirections: PharmaDirections Inc. offers the highest level of scientific and management expertise in virtual drug development to help transform your new technologies into successful drug products. At PharmaDirections, we roll up our sleeves to go through the development process with you. We have pioneered the virtual biotech model since 2003, and have established relationships with all major preclinical and manufacturing CROs and CMOs. Our primary focus is early development, with core competencies in designing and managing formulation, CMC, and preclinical programs with regulatory affairs and project management oversight.