SCOTT L. KLAKAMP
EXECUTIVE LEADER/BIOPHYSICAL/ANALYTICAL CHEMIST
SUMMARY OF QUALIFICATIONS
Ph.D. Executive Leader and Senior Research Fellow with more than 20 years experience in biophysical and analytical chemistry and analytical biochemistry in small to large biotechnology and pharmaceutical research environments. Also experienced in providing executive leadership and management in the development of biophysical tools for the biotechnology and pharmaceutical markets.
Distinguishing skills include:
- Nationally recognized expert in the biophysical characterization of antigen/monoclonal antibody (Ag/mAb) interactions by surface-based and solution-based biosensors
- Expertise in driving the science behind the development and biochemical application of biosensor instrumentation for the biotechnology and pharmaceutical industries
- Expertise in driving and leading the biophysical characterization of nine therapeutic monoclonal antibodies that have reached IND stage
- Expertise in many analytical chemistry/biochemistry platforms
- Led, motivated, and trained a team of scientists to execute biophysical characterization of a preclinical antibody portfolio
- Highly competent in antibody-drug conjugate technology
- Established track record for the ability to consistently produce the highest quality biophysical and analytical data, while motivating colleagues to reach this same goal
PROFESSIONAL EXPERIENCE
SKD Consulting LLC, Camarillo, CA 2024-present (50% time)
Founder and Principal Consultant
Provide consulting and hands-on training in the use of biosensors and the Kinetic Exclusion Assay (KinExA) technology platform. Theoretical calculations and practical considerations for general and competitive equilibrium scenarios and kinetic phenomenon of ligand/receptor binding interactions are also delivered to clients.
- Contract research services for surface plasmon resonance (SPR) analysis are provided for biotechnology and pharmaceutical clients.
Coherus Biosciences, Camarillo, CA 2020-present
Distinguished Research Fellow 2024-present (50% time)
Distinguished Research Fellow 2022-2024
Senior Scientific Research Fellow 2020-2022
Lead and manage the Molecular Interactions Group with two direct reports as well as hands-on performance of biophysical experiments. Other responsibilities include assignment and supervision of the quality of the data. Mentoring and teaching correct biophysical methodology and technique is also a significant part of my position.
- Led the kinetic and affinity characterization for biosimilarity and comparability for Yusimry® (Humira biosimilar) in addition to three other biosimilar programs.
- Led and contributed to the high-resolution KinExA and surface plasmon resonance (SPR) kinetic, affinity, and competitive screening for CHS-1000 (anti-ILT4 antibody).
- Conducted SPR kinetic, affinity, and competitive binding experiments for four Immuno-Oncology (I-O) programs in the pre-clinical stage.
- Co-leader of an undisclosed immuno-oncology program.
- Supervised one Ph.D. scientist and one Master-degreed scientist.
- Intermittently supervised a small biological functional assay group.
- Research resulted in one patent, two research publications, and one minireview.
Janssen R&D LLC, Spring House, PA 2018-2020
Senior Director and Head, Biophysics
Led and managed the Biophysics Group for biologic characterization using mass spectrometry, SPR biosensors, chromatography, and many other biophysical methodologies.
- Identified biophysical or developability problems with candidate molecules numbering in the hundreds from early discovery up to the selection of a new molecular entity for advancement to the development and manufacturing organization.
- Oversaw the strategic direction of the biophysical characterization performed by a group consisting of 24 scientists. Two Directors, one Associate Director, and one Senior Scientist reported directly to me.
- Managed and led three sub-teams in the Biophysics group consisting of a Structural Characterization group (MS and high-resolution HDX-MS epitope and paratope mapping), an Intrinsic Properties group (SPR, KinExA, AUC, SEC-MALS, DSF, DSC, and preformulation), and a Quality of Antibody Response and Epitope Binning group (SPRi of 384 antibodies and high-throughput HDX-MS epitope and paratope mapping).
- Developed personally in the laboratory a method with SPR to measure the Gibbs Free Energy of the bivalent binding (avidity) of a monoclonal antibody to an antigen-immobilized surface.
Biomolecular Interaction Technologies Center (BITC)
Member of Scientific Advisory Board 2018-2020
Chairman of Scientific Advisory Board 2019-2020
Represented the interests of Janssen Biotherapeutics in the BITC consortium to ensure that the research funded included a return on investment for Janssen.
SKD Consulting LLC, Broomfield, CO 2017-2018
Founder and Principal Consultant
Provided consulting and hands-on training in the use of biosensors and the Kinetic Exclusion Assay (KinExA) technology platform. Provided theoretical calculations and practical considerations for general and competitive equilibrium scenarios and kinetic phenomenon of ligand/receptor binding interactions.
BiOptix Inc, Boulder, CO 2015-2017
Vice President of Chemistry and Biochemistry
Led and managed the overall scientific direction and biochemical applications of the company. Provided outstanding customer support for scientific applications of the BiOptix 404pi biosensor.
- Developed and demonstrated new scientific applications that will drive the sales of the BiOptix 404pi biosensor in the pharmaceutical and biotechnology sector.
- Was the scientific lead in the company for customer-facing scientific presentations and internal scientific discussions
- Performed the research for and wrote numerous application notes ranging from how to measure high affinity interactions with a slow dissociation rate constant to the screening of hundreds of fragments to immunogenicity testing on the 404pi biosensor.
- Invented SimuljectTM, a method that allows the determination of binding kinetics for interactions in which no regeneration condition can be determined.
- Directly managed three Field Application Scientists or Specialists in their day to day research and customer-interfacing activities.
SKD Consulting LLC, Fremont, CA 2012-2014
Founder and Principal Consultant
Provide consulting and hands-on training in the use of biosensors and the Kinetic Exclusion Assay (KinExA) technology platform. Provide theoretical calculations and practical considerations for general and competitive equilibrium scenarios and kinetic phenomenon of ligand/receptor binding interactions.
Takeda San Francisco/California, South San Francisco, CA 2008-2012
Senior Research Fellow, Head of the Biophysical Chemistry and Research Informatics Department
Led the Biophysical and Research Informatics Department with five reports along with hands-on performance of biophysical experiments. Responsibilities included assignment and prioritization of experimental systems and supervision of the quality of data generated.
- Performed protein conjugation research towards development of bispecific and enhanced antibody drug conjugates by chemical innovation.
- Invented a proprietary antibody drug conjugate platform.
- Led and contributed to the high resolution Biacore and KinExA kinetic screening and FACS affinity characterization for the IND of TAK-079.
- Conducted Biacore® surface plasmon resonance (SPR) kinetic binding experiments and KinExA (Kinetic Exclusion Assay) binding experiments on fully human, humanized, and murine antibodies with ~10 target (antigen) molecules/year to provide pre-clinical biology crucial information to make “go or no go” decisions on development programs.
- Managed Biacore epitope binning experiments on various mAbs for intellectual property differentiation from competitor mAbs, and also for selection of mAb leads from unique epitope bins to advance into development.
- Led FACS cell-based equilibrium dissociation constant, KD, determinations on therapeutic mAb drugs for antigens in their native conformation on the cell surface.
- Supervised the small molecule SPR fragment screening effort against enzymatic targets to identify molecular scaffolds that could be built into lead small molecule compounds.
- Served as an internal company consultant on applying chemical principles to biological kinetic and thermodynamic problems encountered with therapeutic antibody/antigen, protein/protein and small molecule/protein interactions.
- Research resulted in three publications, one co-edited book, and one book chapter.
AstraZeneca Pharmaceuticals LP/Medimmune, Hayward, CA 2006-2008
Principal Scientist II, Head of the Biophysical Chemistry Group
Led the Biophysical Chemistry Group and personally performed Biacore and KinExA experiments in support of pre-clinical and clinical development of therapeutic antibodies.
- Conducted Biacore® surface plasmon resonance kinetic binding experiments on fully human antibodies with ~10-15 target (antigen) molecules/year, and also performed KinExA® (Kinetic Exclusion Assay) binding experiments on human monoclonal antibodies to target antigen molecules and other biologics for support of AstraZeneca/MedImmune mAb development programs in Boston, MA and Gaithersburg, MD.
- Led and contributed to the Biacore, KinExA, and FACS biophysical screening of three monoclonal antibody therapeutics that reached IND stage: MEDI-3617, MEDI-573, and MEDI-575.
- Led and analyzed FACS cell-based equilibrium dissociation constant, KD, determinations on therapeutic mAbs in support of AstraZeneca/MedImmune pre-clinical development programs
- Research resulted in one publication.
- Implemented and performed rigorous and advanced detection limit theory (like Hubaux-Vos theory) analyses for all immunogenicity assays run at MedImmune Hayward.
Amgen Fremont/Abgenix, Fremont,CA 2001-2006
Senior Scientist, Leader of the Biophysical Chemistry Group
Managed the Biophysical Group including the assignment and prioritization of experimental systems and supervision of the quality of the data generated. One other pivotal requirement of this position was to identify novel technologies to keep the biophysical group at the leading edge of antibody/antigen characterization.
- Conducted Biacore® surface plasmon resonance kinetic binding experiments and KinExA experiments on XenoMouse® and XenoMax® derived fully human antibodies with over 20-50 target (antigen) molecules/year to advance internal Abgenix mAb drug candidates as well as mAb therapeutics for partners into the pre-clinical and clinical pipeline.
- Led and contributed to the Biacore, KinExA, and FACS biophysical characterization of five therapeutic monoclonal antibodies that reached IND stage: ABX-IL8, ABX-PTH, ABX-MA1, CR002, and CR011.
- Led the development of a FACS cell-based equilibrium dissociation constant, KD, determination method specifically designed for the AstraZeneca Pharmaceuticals/Abgenix collaboration. This method was utilized to study the binding of mAbs to antigen presented on the cell membrane.
- Performed immunogenicity testing by Biacore® for anti-drug antibody studies against therapeutic mAbs.
- Research resulted in eight publications, two book chapters and eight patents or patent applications.
Chiron Corporation,Emeryville,CA 1999-2001
Research Scientist II, Adjuvants Group, Vaccines Research
Developed HPLC methods for quantitating small molecule adjuvants in vaccine formulations.
- Conjugated proprietary protein antigens to protein adjuvants to generate more immunogenic antigens.
- Conducted Biacore® surface plasmon resonance kinetic experiments of human antibody binding to a proprietary target.
- Research resulted in one publication.
GeneMedicine, Inc., The Woodlands, TX 1996-1999
Senior Scientist, Gene Delivery Sciences
Developed and investigated mechanisms of action for various polymeric gene delivery systems. Managed and coordinated experiments for one scientist.
- Performed Biacore® surface plasmon resonance, equilibrium dialysis, ultrafiltration, gel permeation chromatography, isothermal microtitration calorimetry, and fluorescence techniques for studying the binding interaction of polymeric gene delivery systems to plasmid DNA.
- Investigated particulate DNA delivery systems for gene therapy including cationic peptides, Starburst® dendrimers, chitosan, and Eu(III) ion.
- Examined PNA (peptide nucleic acid) clamp binding to plasmid DNA for utilization in receptor-mediated cell targeting.
- Research resulted in one publication and one book chapter.
OTHER PROFESSIONAL EXPERIENCE
Pennsylvania State Police Laboratory, Erie, PA
Forensic Scientist
Performed qualitative and/or quantitative analysis of items submitted in drug criminal cases using methods of identification including microscopy, spectroscopy, and chromatography.
Michigan Molecular Institute, Midland, MI
Laboratory of Dr. Donald Tomalia
Research Associate
Performed surface modifications and biomolecule conjugations of Starburst® dendrimers (spherical polymers) for gene therapy, diagnostic, and antisense applications. One US patent resulted from this work.
California Institute of Technology, Pasadena, CA
Laboratory of Professor Jacqueline K. Barton
Postdoctoral Fellow (National Research Service Award)
Conducted studies to develop the Rh(phi)2bpyC13 complex(phi = phenanthrenequinonediimine, bpy = bipyridyl) as an in vivo photofootprinting agent. One book chapter resulted from this work.
Pennsylvania State University, University Park, PA
Laboratory of William DeW. Horrocks, Jr.
Graduate Student
Initiated studies on the development of the Eu(III) ion as a probe of DNA structure. Utilized laser-induced lanthanide ion luminescence to probe the Eu(III)/DNA complex. This research resulted in four papers.
HONORS AND AWARDS
| 2015 | Interviewed for article on “Surface Resonance Sensing: Is all the Buzz” in Genetic Engineering & Biotechnology News, December (2015), vol. 35, in the Tools, Technologies, and Techniques section. |
| 2011 | Member of a project team recognized with a Takeda Pinnacle Award for advancing a therapeutic mAb to a clinical development stage gate |
| 1998 | Member of a team recognized for outstanding performance at GENEMEDICINE |
| 1990 – 1993 | National Institutes of Health Postdoctoral Fellow (National Cancer Institute) |
| 1991 | Interviewed by NASA for a Mission Specialist Astronaut position |
| 1985 | Gardner Scholarship, Houghton College |
| 1985 | Dean’s List, Houghton College |
AREAS OF ANALYTICAL AND BIOPHYSICAL EXPERTISE
- Biophysical characterization of small molecules and biomolecules using:
| a. BiOptix 404pi® SP-Enhanced Interferometry | i. Reverse-Phase, Ion-Exchange and Size-Exclusion HPLC with Multiple-Angle Light Scattering Detection (MALS) |
| b. Biacore® Surface Plasmon Resonance | j. Circular Dichroism Spectroscopy |
| c. KinExA® (Kinetic Exclusion Assay) | k. Dynamic Light Scattering |
| d. Fluorescence Activated Cell Sorting (FACS) | l. GC-MS |
| e. Fluorescence Spectroscopy | m. Atomic Absorption Spectroscopy |
| f. Ion Mobility Spectrometry | n. FT-IR |
| g. Isothermal Microtitration Calorimetry | |
| h. UV-visible Spectroscopy |
EDUCATION
Ph.D. in Inorganic Chemistry, Pennsylvania State University
B.A. in Chemistry, Houghton College
CONTINUING EDUCATION
- Attended and presented at SensorCon One in Salt Lake City, UT, August 10-13, 2015.
- Attended and lectured at an Advanced Level 2 Biosensor Tools workshop in Salt Lake City, UT, February 22-23, 2007.
- Attended a GLP training course sponsored by PERI in Philadelphia, PA, November 2-4, 2005.
- Attended a Biosensor Tools Level 1 workshop in Salt Lake City, UT, February 25-27, 2004.
- Attended an “Introductory Course in Immunology” sponsored by the American Association of Immunologists, Tufts University, Medford, MA, June 22 – 29, 2002.
- Attended a Biacore® Level II course in April 2000.
- Attended a Waters Corp. course entitled “Practical Method Development and Validation for Reverse-Phase HPLC” in July 1999.
- Attended two management courses in 1997 and 1998.
- Attended a Biacore® Basics course and Level I course in 1997 and 1998.
MEMBERSHIPS
American Chemical Society
REVIEWER, PEER REVIEWED JOURNALS AND GRANTING AGENCIES
- Analytical Biochemistry
- Nature Communications
- Communications Biology
- Journal of Pharmaceutical and Biomedical Analysis
- Journal of Molecular Recognition
- mAbs
- Ad hoc member, National Institutes of Health Study Review Group (Instrumentation and Systems Development), Washington, D.C., October 7-8, 2008.
