About Us
Leadership
Kamal Egodage
Kamal Egodage, Ph.D., MBA is the Founder and CEO of Lasanth Consulting and Canopy Biopharma, LLC. He is a results-oriented biopharmaceutical executive with over 25 years of experience in pharmaceutical, biotechnology and biotech start-up, incubator and accelerator environments in the US and Europe. Prior to starting Lasanth Consulting, Kamal held positions with Symic bio, Novartis, Eli Lilly, Pharmacia and Monsanto.
Kamal is an expert in biologics full CMC development, regulatory strategy and health authority interactions from discovery to commercialization including due diligence. He has successfully supported more than 75 biotech therapeutics in different stages of development through commercialization and life cycle management. Kamal had many successful health authority submissions/interactions (preIND, IND, IMPD, BLA, Q&A’s). He has established and managed functional areas including Analytical and Formulation Development, Drug Substance (DS) and Drug Product (DP) Process Development, Quality Control, Bioanalysis, and Clinical Production of DS and DP. Kamal is a Scientific Advisory Board Member for Cairn Therapeutics.
Additionally, he has extensive experience in business development, corporate strategies, program timelines, investor presentations and fundraising activities for biotech start-ups. Kamal has been an Angel investor for biotech and tech start-ups for the past 10 years.
Kamal earned an Executive MBA from the Kellogg School of Management at Northwestern University, Illinois, USA and Otto Beisheim School of Management, WHU, Germany. He received a Ph.D. with honors in Bioanalytical Chemistry from University of Kansas, USA and a B.Sc. with honors in Chemistry from University of Colombo, Sri Lanka.
Pam De Moor
Pam De Moor, PhD., is the Senior Director of CMC and Device Development for Lasanth Consulting. Pam is focused on CMC and Device Development for early and late-stage products. Prior to Lasanth Consulting, Pam held positions at Canopy Biopharma, Novartis AG Basel, Switzerland and Medimmune, LLC, Alza Corporation (Johnson & Johnson), and Nektar Therapeutics (formerly Inhale) United States. She has extensive professional experience in formulation development and regulatory strategy, optimization and GMP manufacturing of the drug product, device selection and in-use studies, writing of IND’s and IMPDs, BLA’s, regulatory authority interaction, statistical data analysis and analytical method development.
Pam brings over 25 years of experience in the fields of biomedical, pharmaceutical, diagnostic, chemical and environmental engineering. With strong hands-on problem-solving, theoretical, analytical and design skills, Pam has held global positions including aligning four international Drug Product development groups at Novartis Biologics for process and product development. She was instrumental in developing the late phase process group for Novartis biologic drug product development to facilitate product development from phase II to commercial. She has also built and led a strong, high-performing team focused on characterization and formulation development of live attenuated and subunit vaccines and adjuvants. Pam brings expert knowledge in Design of Experiments, Six Sigma tests, QbD principles and advanced statistical methods as well as formulation, materials science and physical characterization.
Pam earned her Ph.D. in Bioengineering, specializing in Mass Transport and Drug Delivery Systems from University of California, at Berkeley and San Francisco. Her M. S. in Bioengineering, specializing in Hydrogels in Drug Delivery Systems from the School of Pharmacy, University of California, San Francisco and her B. S. with honors in Chemical Engineering at California Institute of Technology, Pasadena, CA.
Our Difference
Our team has supported more than 100 biologics in different stages of development from discovery to commercialization.
Expertise in biologics full CMC development, regulatory strategy and health authority interaction, communications and writing of the health authority submission documentation.
Professionals with experience in the fields of biologics, cell and gene therapy, combination products and devices.
Personalized service and direct access to consultants.
Our Clients
We support pharma and biotech companies based around the world to develop and obtain regulatory approval for their biotherapeutic development programs. Our clients are privately held or public companies. We work with our worldwide preferred or client designated CDMO’s and CRO’s to achieve successful regulatory submission for our clients.
Following are a few recent clients for our technical development engagements.
Management and Support of a Drug Product Development Organization
Lasanth Consulting (previously Canopy Biopharma) supported the fully operational drug product organization for a publicly traded company of multiple therapeutics modalities. All subject matter expertise and work packages within the company for the drug product development organization were supported by Lasanth consultants.
We are currently supporting six biologics molecules from pre-IND tox to phase I/II and III including formulation development, clinical DP manufacturing and regulatory submission support (CMC submission strategy, writing of CMC submission documents, and answering health authority questions).
We are working to identify and select phase III development partners/CDMOs for their late phase and accelerated programs.
Management and Support of the Full CMC Package with Novel Delivery Device for Brain Delivery
Our client, a privately held company, is developing a biologic with a novel delivery device for direct infusion of therapeutics to the brain. We managed the full CMC package for the phase I development and clinical submission with technical and operational support.
Our internal consultant's supported drug substance, drug product, analytical development, and quality control activities working with the partnered CDMO in Europe. We wrote all technical documents for the submission (CMC submission strategy, writing of CMC submission documents, answering health authority questions). Lasanth consulting, through their partner network, supported the client’s Toxicology, IND/IMPD publishing and submission teams as well.
Management and Support of the Full CMC Package for Intravitreally administered biologic
Our client is a fully owned subsidiary of a medium sized biotech company focused on developing a novel biologic for intravitreal administration. Lasanth consultants manage the full CMC package for the phase I development and clinical submission with technical and operational support.
Our internal consultant's support drug substance, drug product, analytical development, quality control and quality assurance activities including the clinical manufacturing support of DS (Drug Substance) and DP (Drug Product) working with client’s preferred CDMO based in Asia.