Welcome to KVC Biopharma, LLC
Early and Late Phase Drug Development
Kathleen V. Courtemanche
BIOPHARMA SERVICES
Over 30 years industry experience driving the advancement of therapeutic drugs from early pre-clinical assessment to late phase commercial licensure:
-Program leadership, management, and project team support
- Serve as development program lead for virtual and/or growing teams
- Develop and manage program plans including project scope, timelines and budgets to achieve development milestones, including first in man (FIM), proof of concept (PoC), and registration enabling objectives
- Provide program management leadership to development functions to achieve on-time dossier submission and approval/launch (BLA/NDA/JNDA/MAA)
- Manage product development and manufacturing, management of studies supporting product pharmacology and safety, clinical study design and operational execution
- Extensive network of experienced drug development consultants
- Provide regulatory writing and support, including drafting IND and IMPD eCTD submission documentation
-CMC technical oversight for biologics development and manufacturing at CDMOs
- Broad experience with establishing and managing contract organizations
- Procurement through proposal selection process and contract negotiations (MSAs/SOWs/QTA)
- End to end supply chain oversight including drug substance, drug product, and label/pack operations
- CMC regulatory experience (preparing/managing Module 3 / IMPD)
-Non-clinical study management
-Bioanalytical development and early-stage clinical support
- Sourcing and oversight of bioanalytical laboratories and contract research organizations to enable early-phase clinical development
-Diligence support for licensing and M&A
- Data room development, management, and related diligence support activities
EXAMPLE ASSIGNMENTS
Typically, a general consulting agreement with flexible terms depending on the scope and duration:
- Support early-stage company with asset development to achieve IND submission. Serve as the overall development lead, handling all aspects of execution and management (CMC, Pre-clinical, Clinical, Regulatory). The objective is typically to achieve a key inflection point for the company. This scope of work tends to be 25-75% of my time for 12-18 months depending on the development stage. This is an attractive model for companies planning a sale or out-license, or who wish to minimize the costs of full-time employees prior to achievement of a key value-creating inflection point. Typically, this assignment is accountable to a senior executive, C-level or board member.
- Provide early and late phase CMC support for biologic product candidates, including analytical, formulation, and process development, manufacturing and scale-up, and cGMP clinical trial material production. These assignments include CMC manufacturing support for drug substance and drug product and other supply chain sourcing activities. This scope of work tends to be 25-75% of my time for 6-18 months depending on stage and status of the program.
- Provide early phase pre-clinical and clinical support with procurement and management of contract bioanalytical laboratories and development of critical reagents for key assays, support of CRO selection with development of RFPs and management of bid-defense processes, as well as CRO oversight. This scope of work tends to be 25-50% of my time for 3-12 months depending on stage and status of the program.
- Provide early phase non-clinical safety program management support of contract laboratories for safety studies in partnership with Toxicologist. This scope of work tends to be 10% of my time for 6-12 months depending on stage and status of the program.
- Support for a late-stage company, specifically either the head of regulatory or CMO providing integrated program management to achieve a license application (BLA/NDA/MAA). My role would be to lead, direct and manage the organization through the development of an integrated plan then provide support for the management of plan with the team to the submission. This type of project tends to be 50-75% of my time for 6-18 months depending on when the planning is initiated.
- Integrated launch planning support for a late-stage company, providing operations or commercial overall program management support. This type of project tends to be 50-75% of my time for 6-18 months depending on when the planning is initiated.
- Support due diligence efforts with review of data and documents, usually early-stage assessment of IND readiness, with an emphasis on CMC and toxicology. Provide overall evaluation including feedback on development plans, including timelines and budgets. This scope of work is typically intensive effort over a short time period, depending on the quantity and accessibility of the information.
- Support CDMO business development with technical feedback and development of SOWs, advice on operations, current industry trends and best practices. This type of support is typically ad hoc and less than 10% of time depending on request.
- Fill resource need for CMC leadership, serving as head of CMC overseeing manufacturing, quality control, supply chain and CMC regulatory activities. (Primarily biologics)
- Fill resource gap for Product and Program Leadership, driving cross functional integration and advancement of development plans.
ABOUT ME
AREAS OF PRODUCT AND THERAPEUTIC AREA EXPERTISE
- Recombinant proteins (therapeutic, antibodies, fusions), vaccines, virus vectors (lentiviral and adeno-associated), and oligonucleotides, small molecules
- Common, orphan, and rare disease experience spanning oncology, autoimmune, neurology, ophthalmology, infectious disease, stem cell therapy, gene therapy and hemophilia
EXPERIENCE
- Thirty-one (31) years in large pharma, small biotech and CMO settings
- Twenty plus (20+) years directing early drug development and commercial product programs including managing virtual global cross functional product development teams
- Twenty plus (20+) years GMP operations (7 years within CMOs; 9 years within big pharma)
- Twenty-nine (29) years CMC development experience
- Ten (10) years independent drug development consultant
- Two years (2) years with CDC focused on pre-clinical studies in cardiovascular disease
KEY REGULATORY ACCOMPLISHMENTS
- Direct contributor to >25 INDs, 2 NDAs; 1 JNDA
- 4 product approvals (BLA/MAA) 2 Vaccines: Prevnar 13; Trumemba; 2 proteins Obizur; Ixinity
PROFESSIONAL HISTORY
2013- Present KVC Biopharma LLC, Early & Late-Stage Drug Development, USA, NC, President
- Abcuro, Inc., USA, MA
- Akebia Therapeutics, USA, MA
- Archetype Therapeutics, USA, MA
- Avaxia Biologics, USA, MA
- Ayala Pharmaceuticals, USA, DE
- Bamboo Therapeutics, USA, NC
- CatalYm GmbH, DE, Munich
- Deerfield Discovery & Development, USA, NY
- DJS Antibodies, UK, Upper Heyford
- Eleven Biotherapeutics, USA, MA
- F-star Biotechnology, UK, Cambridge
- Geron Corporation, USA, CA
- Immuntrin, UK, Cambridge
- ImmuneXcite, USA, MA
- Helios Cardio Inc., USA, MA
- Intercept Pharmaceuticals, USA, NY
- Macomics Ltd, Scotland, Edinburgh
- Matrivax, USA, MA
- Omni Health Bioscience Corp., USA, MA
- Other non-disclosed USA, CA
- Rheos Medicine, USA, MA
- Rocket Pharma, USA, NY
- Shattuck Labs, USA, TX
- Synklino, DK, Charlottenlund
- Tesaro, USA, MA
- Theia Therapeutics, USA, CA
- Tizona Therapeutics, USA, CA
- Tivorsan Pharmaceuticals, USA, RI
- Vigil Neuro, USA, MA
- ZWI Therapeutics, USA, MA
2022- Abcuro Inc., Newton MA, Chief Development Officer
2016- Bamboo Therapeutics Chapel Hill, NC, Chief Operating Officer
2011-2013- Inspiration Biopharmaceuticals, Cambridge MA, Program Director
2010-2011- KBI Biopharma, Durham NC, Director Program Management
2001-2010- Wyeth/Pfizer Sanford, NC, Associate Director II CMC Program Management
2000-2001- Biomeasure, Milford, MA, Sr. Program Manager
1996-2000- Covance Biotechnology, RTP, NC Sr. Scientist & Program Manager
1995-1996- Apex Bioscience, Durham, NC Sr. Senior Research Associate
1993-1995- Genetics Institute, Andover, MA, Research Associate
1991-1993- Center for Disease Control, Lowell, MA. Research Associate
EDUCATION AND CERTIFICATION
- 2006 MBA, Supply Chain Operations NC State University, Raleigh NC
- 2002 Project Management Professional #50138, PMI, Newton Square PA
- 1993 BS, Clinical Laboratory Sciences, University Massachusetts, Lowell MA