Greg A. Johnson
A Senior Executive with over 30 years of progressive experience in Biotech and
Clinical Research, with recognized expertise in strategic planning, project
management and operations management, as well as in electronic data capture and
the implementation and use of computerized systems in a clinical research
setting.
An effective leader, communicator, and decision-maker with significant international experience.
Cagley Johnson Consulting Inc.
2011 — Present
Canada
Principal Consultant
Jun 2011 - Present
Victoria BC, Canada
Support pharma, biotech, and CRO clients with:
- Program Management
- Vendor Management
- Portfolio Review
- Project Rescue Support
- Due Diligence for M&A Activities
- System Implementation
- Project Management Maturity Review
Current engagements include:
Kintara Therapeutics is dedicated to the development of novel cancer
therapies for patients who are failing or resistant to current treatment
regimens.
Kintara's second-generation photodynamic therapy (PDT) photosensitizer agent (REM-001) has undergone late stage clinical development in previous clinical trials showing a complete response in approximately 80% of evaluable tumor sites. The lead indication for REM-001 Therapy is unresectable cutaneous metastatic breast cancer (CMBC).
CJC provides consulting services with Greg functioning as (Acting) Head of Operations for the company.
Bioforum is an innovative, data-oriented Clinical Research Organization (CRO)
providing unique, high-quality, tailored solutions for efficient collection,
standardization, and reporting of clinical data.
Greg provides consulting and business development support to the company.
MedaSystems provides an easy to use, intuitive software solution for Expanded Access management that enables collaboration between life sciences teams and physicians. CJC provides related consultative expertise and services through a non-exclusive partnership with MedaSystems.
Previous engagements:
Rediscovery Life Sciences AKI LLC
CJC provided program management for the RLS-003 drug development program in
Acute Kidney Injury from manufacturing through completion of a Phase 2
proof-of-concept study and the eventual transfer of the asset.
MedGenesis Therapeutix Inc.
CJC provided program management support, and website and IT support.
Greg servec on the MedGenesis Board of Directors from Apr 2019 to Aug 2024.
MedGenesis Therapeutix Inc.
2007 — 2017
Canada
Member Board of Directors
Apr 2019 - Aug 2024
Victoria BC, Canada
President and Chief Financial Officer
Oct 2012 - Mar 2017
Victoria BC, Canada
Responsibilities
- Serve as chair of the Executive Committee, participating in setting corporate
strategy
- Develop operational plan, in conjunction with COO, and submit for board
approval on an annual basis
- Manage the financial operations of the company
- Direction and oversight for Accounting and Financial Management activities
performed by Controller; including budgeting, short and long-term financial
forecasting, management reporting, audit, tax, investment strategies, cash flow
management, accounting and related activities
- Operational accountability for risk management and information systems
- Responsible for liaising with shareholders, external advisors, and management
- Responsible with CEO for raising capital as needed
- Manage interactions with Board, Audit Committee, and Compensation Committee
- Contract negotiation and contract management with licensors and licensees,
vendors, professional advisors and consultants
Key Accomplishments
- Negotiated Option and License Agreement for MedGenesis' lead molecule
with Pfizer
- Served as Alliance Manager for MedGenesis/Pfizer Joint Steering
Committee
Chief Operating Officer
Senior Vice President, Operations Victoria BC
Mar 2007 - Sep 2012
Canada
Responsibilities
- Serve as member of Executive Committee, participating in setting
corporate strategy
- Develop operational plan, in conjunction with CFO, and submit for board
approval on annual basis
- Provide program leadership and project management for product
development including non-clinical, technical operations, clinical
operations, quality assurance, and alliance management
- Report on status of programs in quarterly Board meetings and institute
metrics to assess performance against plan
- Manage relationships with in-licensing partners (UCSF, NIH and Amgen)
including ensuring contractual obligations are met and negotiating any
contract amendments, and monitor milestones and identify opportunities for
enhancing these relationships
- Lead selection of and negotiations with CROs contracted for clinical trial
management, and provide oversight for management of CRO performance against
expectations and negotiate all changes in scope
Key Accomplishments
- Negotiated three-way License Agreement with Amgen and Biovail to acquire
MedGenesis' lead molecule
- Negotiated termination of agreement with Biovail after their acquisition by
Valeant
- Negotiated collaboration agreement with North Bristol Trust for
investigator initiated study for lead molecule
PRA International
1992 - 2007
Germany, UK, USA, Canada
Vice President, Operations, Americas
Jan 2007 - Feb 2007
Reston VA, USA
Responsibilities
- P&L responsibility for Trials Management Centers in USA, Canada, and Latin
America
- Served on Corporate Leadership Team
Vice President of Global Data Management
May 2006 - Dec 2006
Reston VA, USA
Jun 2004 - Apr 2006
Victoria BC, Canada
Responsibilities
- P&L responsibility for 300-person worldwide data management operations
- Served on Corporate Leadership Team
Key Accomplishments
- Oversaw successful implementation of new EDC-based data management system and
retirement of legacy system
- Led successful centralization of global data management services to four
offices
- Established a data management center in Pune, India
- President's Award winner in 2004
Vice President of Operations, Canada
Jul 2002 - May 2004
Victoria BC, Canada
Responsibilities
- P&L responsibility for Trials Management Centers in Victoria, BC and Ottawa,
ON
- Served on Corporate Leadership Team
Key Accomplishments
- Led successful operations integration of CroMedica acquisition
- President's Award winner in 2002
Director of Product Management
Product Director, Data Management
Senior Systems Program Manager
Feb 1998 - Jun 2002
Charlottesville VA, USA
Responsibilities
- Responsible for developing product methodologies, process documents, reports,
and other standard infrastructure for functional operating groups
- Responsible for implementing, maintaining, upgrading and retiring computerized
systems for functional operating groups
- Involved in due diligence and integration activities for multiple
acquisitions
- Served on Corporate Leadership Team
Key Accomplishments
- Successfully implemented global data management system and retired multiple
legacy data management systems
- Oversaw Y2K mitigation efforts for data management systems
- Oversaw successful implementation of global system for document imaging
- Led Product Management group in laying groundwork for company to eventually
establish ISO 9000 Quality Management certification
- Participated in due diligence and integration activities for multiple
international acquisitions
- President's Award winner in 2001
Manager, International Data Centre Dec 1996 - Jan 1998
Swansea, South Wales, UK
Responsibilities
- Responsible for establishment and management of European Data Management
Centre
Key Accomplishments
- Established a data management centre in Wales and achieved profitability in
first year of operation
Supervisor Information Technology
Supervisor Clinical Data Services
Apr 1994 - Nov 1996
Mannheim, Germany
Supervisor Information Technology
Nov 1992 - Mar 1994
Mannheim, Germany
Qualifications
- Master of Science, Clinical Research (with distinction)
Jul 2000, Liverpool John Moores University
- Project Management Professional (PMP) Certification
May 2001
- Current
Certification Number: 33205
Project Management Institute
- Fellow, Institute of Clinical Research (FICR)
Jun 2006 - Current
Institute of Clinical Research
- MBTI® Certified Practitioner
May 2011 - Current
- Corporate Governance: Maximize Your Effectiveness in the Boardroom Certification
The Wharton School, University of Pennsylvania
Oct 2022
- Guo, C, Yang, Q, Li, J, Wu, S, Deng, M, Du, X, Ke Sai, K, Jiang, X, Chen, Z,
Zhang, J, Lin, F, Wang, J, Chen, Y, Ke, C, Zhang, X, Ju, X, Mou, Y, Bacha, J,
Steino, A, Kanekal, S, Kwan, C, Johnson, GA, Schwartz, R, Langlands, J, Brown,
D, Chen, Z-p. "Phase 2 clinical trial of VAL 083 as first line treatment in
newly-diagnosed MGMT unmethylated glioblastoma multiforme (GBM): Halfway
report." Glioma 2020; 2:167-73.
- Whone, AL, Boca, M, Luz, M, Woolley, M, Mooney, L, Dharia, S, Broadfoot, J,
Cronin, D, Schroers, C, Barua, NU, Longpre, L, Barclay, CL, Boiko, C, Johnson,
GA, Fibiger, HC, Harrison, R, Lewis, O, Pritchard, G, Howell, M, Irving, C,
Johnson, D, Kinch, S, Marshall, C, Lawrence, AD, Blinder, S, Sossi, V, Stoessl,
AJ, Skinner, P, Mohr, E, Gill, SS. "Extended Treatment with Glial Cell
Line-Derived Neurotrophic Factor in Parkinson's Disease." Journal of Parkinson's
Disease 2019; 1-13.
- Whone, A, Luz, M, Boca, M, Woolley, M, Mooney, L, Dharia, S, Broadfoot, J,
Cronin, D, Schroers, C, Barua, NU, Longpre, L, Barclay, CL, Boiko, C, Johnson,
GA, Fibiger, HC, Harrison, R, Lewis, O, Pritchard, G, Howell, M, Irving, C,
Johnson, D, Kinch, S, Marshall, C, Lawrence, AD, Blinder, S, Sossi, V, Stoessl,
AJ, Skinner, P, Mohr, E, Gill, SS. "Randomized trial of intermittent intraputamenal glial cell line-derived neurotrophic factor in Parkinson's
disease." Brain 2019; 142:512-525.
- Grahn, AY, Bankiewicz, KS, Dugich-Djordjevic, M, Bringas, JR, Hadaczek, P,
Johnson, GA, Eastman, S and Luz, M. "Non-PEGylated liposomes for
convection-enhanced delivery of topotecan and gadodiamide in malignant glioma:
initial experience." J Neurooncol 2009; 95:185-197.
- Walsh, WM, and Johnson, GA. "Validation: Never an Endpoint – A Systems
Development Life Cycle Approach to Good Clinical Practice." Drug Information
Journal 2001; 35:809-817.
Posters
- Guo, C-c, Yang, Q-y, Li, J-w, Wu, S-x, Deng, M, Xi, S, Liao, Y, Chen, J-G,
Wang, H-r, Bacha, J, Kanekal, S, Kwan, C, Johnson, GA, Schwartz, R,
Langlands, J, Brown, D, Chen, Z-p. "Phase 2 Study of VAL-083 and Radiotherapy in
Newly Diagnosed MGMT-unmethylated GBM: Case Study Reports" presented at the
European Association of Neuro-Oncology (EANO 2023), September 2023.
- Guo, C-c, Yang, Q-y, Li, J-w, Wu, S-x, Chen, J-G, Wang, H-r, Bacha, J, Kanekal, S, Kwan, C, Johnson, GA, Schwartz, R, Langlands, J, Brown, D, Chen, Z-p. "Phase 2 Study of VAL-083 and Radiotherapy in Newly Diagnosed MGMT-unmethylated GBM" presented at the Society for Neuro-Oncology Annual Meeting, November 2022.
- Chen, Z-p, Guo, C-c, Yang, Q-y, Li, J-w, Wu, S-x, Johnson, GA, Langlands,
J, Kwan, C, Kanekal, S, Schwartz, R, Bacha, J, Steino, A, Brown, D. "Phase 2
clinical trial of dianhydrogalactitol (VAL-083) in patients with newly
diagnosed MGMT-unmethylated GBM" presented at the Society for Neuro-Oncology
Annual Meeting, November 2021.
- O'Brien, B, Penas-Prado, M, Kamiya-Matsuoka, C, Weathers, S-P, Yung, A,
Loghin, M, Harrison, R, Majd, N, Knight, S, Bacha, J, Brown, D, Johnson, GA, Langlands, J, Schwartz, R, Kanekal, S, Steino, A, Lopez, L, DeGroot, J. "
Phase 2 study of dianhydrogalactitol (VAL-083) in patients with MGMT-unmethylated,
bevacizumab-naïve glioblastoma in the adjuvant or recurrent setting"
presented at the Society for Neuro-Oncology Annual Meeting, November 2021.
- O'Brien, BJ, Kamiya-Matsuoka, C, Weathers, S-P, Yung, WKA, Loghin, M, Harrison,
R, Majd, N, Knight, S, Liu, D, Bacha, JA, Brown, DM, Steino, A, Johnson, GA, Kanekal, S, Langlands, J, Lopez, LM, Schwartz, R, Penas-Prado, M, De Groot, J.
"Phase 2 study of dianhydrogalactitol (VAL-083) in patients with MGMT-unmethylated,
bevacizumab-naïve glioblastoma in the adjuvant or recurrent setting" presented
at the AACR Annual Meeting 2021, Virtual Meeting, April 2021.
- Chen, Z-p, Guo, C, Yang, Q-y, Li, J-w, Wu, S-x, Johnson, GA, Langlands, J, Kwan,
C, Kanekal, S, Schwartz, R, Bacha, J, Steino, A, Brown, D. "Phase 2 clinical
trial of dianhydrogalactitol (VAL-083) in patients with newly diagnosed MGMT-unmethylated
GBM" presented at the AACR Annual Meeting 2021, Virtual Meeting, April 2021.
- Chen, Z-p, Guo, C-c, Yang, Q-y, Li, J-w, Wu, S-x, Bacha, J, Johnson, GA, Langlands, J, Kwan, C, Kanekal, S, Schwartz, R, Steino, A, Lopez, LM, Brown, D.
"Phase 2 Clinical Trial of VAL-083 in Newly Diagnosed MGMT-unmethylated GBM"
presented at the Society for Neuro-Oncology Virtual Conference, November 2020.
- O'Brien, B, Penas-Prado, M, Kamiya-Matsuoka, C, Weathers, S-P, Yung, A, Loghin,
M, Harrison, R, Majd, N, Knight, S, Bacha, J, Brown, D, Johnson, GA, Langlands,
J, Schwartz, R, Kanekal, S, Steino, A, Lopez, L, DeGroot, J. "Phase 2 study of
dianhydrogalactitol (VAL-083) in patients with MGMT unmethylated, bevacizumab-naïve
glioblastoma in the recurrent and adjuvant setting" presented at the Society for Neuro-Oncology Virtual Conference, November 2020.
- Chen, Z-p, Guo, C, Yang, Q-y, Li, J-w, Wu, S-x, Johnson, GA, Langlands, J, Kwan,
C, Kanekal, S, Schwartz, R, Bacha, J, Steino, A, Brown, D. "Phase 2 study of
dianhydrogalactitol (VAL-083) in patients with newly diagnosed, MGMT-unmethylated
glioblastoma" presented at the American Association for Cancer Research Annual
Meeting 2020, Virtual Annual Meeting II.
- O'Brien, BJ, Kamiya-Matsuoka, C, Weathers, S-P, Yung, A, Loghin, M, Harrison, R,
Majd, N, Bacha, JA, Brown, DM, Steino, A, Johnson, GA, Kanekal, S, Langlands, J,
Lopez, LM, Schwartz, R, Penas-Prado, M, De Groot, J. "Phase 2 study of
dianhydrogalactitol (VAL083) in patients with MGMT-unmethylated, bevacizumab-naïve
glioblastoma in the adjuvant or recurrent setting" presented at the American
Association for Cancer Research Annual Meeting 2020, Virtual Annual Meeting II.
- O'Brien, B, Penas-Prado, M, Kamiya, C, Weathers, S-P, Yung, A, Loghin, M,
Harrison, R, Bacha, J, Brown, D, Johnson, GA, Langlands, J, Schwartz, R, Kanekal,
S, Lopez, L, deGroot, J. "Phase 2 Study of Dianhydrogalactitol (Val-083) In
Patients with MGMT-Unmethylated, Bevacizumab-Naïve Glioblastoma in the Recurrent
and Adjuvant Setting" presented at the Society of Neuro-Oncology Annual Meeting,
Phoenix, November 2019.
- Chen, Z-p, Guo, C, Yang, Q-y, Li, J-w, Wu, S-x, Bacha, J, Johnson, GA, Langlands,
J, Kwan, C, Kanekal, S, Schwartz, R, Lopez, L, Brown, D. "Clinical Trial of
Val-083 in Newly Diagnosed MGMT-Unmethylated GBM: Half-Way Report" presented at
the Society of Neuro-Oncology Annual Meeting, Phoenix, November 2019.
- O'Brien, BJ, De Groot, J, Kamiya-Matsuoka, C, Weathers, S-P, Bacha, JA, Brown,
DM, Steino, A, Langlands, J, Johnson, GA, Schwartz, R, Kanekal, S, Lopez, LM,
and Penas-Prado, M. "Phase 2 study of dianhydrogalactitol (VAL-083) in patients
with MGMT-unmethylated, bevacizumab-naïve glioblastoma in the adjuvant or
recurrent setting" presented at the American Association for Cancer Research
Annual Meeting, Atlanta, April 2019.
- Chen, Z-p, Guo, C, Bacha, J, Langlands, J, Steino, A, Kwan, C, Kanekal, S,
Johnson, GA, Schwartz, R, Lopez, LM, Brown, D. "Phase 2 study of dianhydrogalactitol (VAL-083) with radiation therapy in patients with newly
diagnosed, MGMT-unmethylated glioblastoma" presented at the American Association
for Cancer Research Annual Meeting, Atlanta, April 2019.
- The GDNF Study Group. "Glial Cell Line-Derived Neurotrophic Factor (GDNF):
Indication of Biologically Mediated Clinical Benefit in Parkinson's Disease
After 80 Weeks of Treatment via Intermittent Intraputamenal Convection-Enhanced
Delivery (CED)". [abstract]. Mov Disord. 2017.
- The GDNF Study Group. "Randomized Parkinson's Trial of GDNF Administered via
Intermittent Intraputamenal Convection-Enhanced Delivery". [abstract]. Mov
Disord. 2017.
- Luz, M, Dugich-Djordjevic, M, Bringas, JR, Hadaczek, P, Johnson, GA, Grahn, AY,
Eastman, S, and Bankiewicz, KS. "Convection-enhanced Delivery of Nanoliposomal
Topotecan and Gadodiamide in Rodent Intracranial Brain Tumor Xenografts and
Normal Brain" presented at the Society of Neuro-Oncology Annual Meeting, Las
Vegas, November 2008.
Presentations
- Johnson, GA, and Brown, D. "VAL-083 Development Update,"
presented at 4th Glioblastoma Drug Development Summit, Boston, 2023.
- Johnson, GA. "Global Clinical Data Management and Electronic Data Capture,"
presented at Mahratta Chamber of Commerce Industries and Agriculture (MCCIA),
Pune, India, 2006.
- Johnson, GA. "Deployment of a Hybrid Data Management System," presented at the DIA Annual Meeting, Philadelphia, 2006.
- Richards, N, and Johnson, GA. "Conducting True Hybrid Studies Using EDC and
Paper Data Entry Together in the Same Trial," presented at EDC and Beyond:
Leveraging Electronic Applications to Improve Data Accessibility for Rapid
Decision Making, Las Vegas, 2006.
- Johnson, GA. "Segways, TiVos, and Electronic Data Capture: new technology is
always cool, but does it always add value?" keynote presentation at the
Pharmaceutical Technology Congress, Philadelphia, 2005.
- Johnson, GA. "Novel Processes in Support of CDM," session chair at the Annual
Fall Conference of the Society for Clinical Data Management, Arlington VA, 2000.
- Walsh, WM, and Johnson, GA. "Validation: Never an Endpoint – Implementing a
Systems Development Life Cycle," presented at the DIA Workshop for Clinical Data
Management, Philadelphia, 2000.
- Johnson, GA, and Hanson, M. "Complying with New Industry Guidance on
Computerized Systems Used in Clinical Trials," presented at the Annual Fall
Conference of the Society for Clinical Data Management, Chicago, 1999.
- Johnson, GA, and Hanson, M. "Conducting Vendor Audits," presented at North
American Recorder Users Group, Chicago, 1999.
- Newman, ML, and Johnson, GA. "Implementing New Technology (The Training Aspects
of a New Global Data Management System)," presented at the Annual Fall
Conference of the Society for Clinical Data Management, Washington, 1998.
- Johnson, GA. "Experience with Recorder V3.1," presented at North American
Recorder Users Group, Philadelphia, 1998.
- Thier, E, (chair), Bridgman, A, Cummings, S, Johnson, GA, O'Donoghue, P, Tebbs,
P, and Thomas, S. "Build versus Buy - The Challenge of New Software," panel
discussion at the DIA Workshop for Clinical Data Management, Paris, 1997.
- Johnson, GA, and Handelsman, D. "Combining Global Clinical Databases," presented
at the DIA Workshop for Clinical Data Management, London, 1996.