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.

• greg@cagleyjohnson.com
• www.twitter.com/cagleyjohnson
• www.cagleyjohnson.com
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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 (https.kintara.com)

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.

MedaSystems (https://medasystems.com)

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.

Past engagements:

Rediscovery Life Sciences AKI LLC

CJC provided program management for the RLS-003 drug development program in AKI 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 continues to serve on the MedGenesis Board of Directors.

MedGenesis Therapeutix Inc.
2007 — 2017
Canada

Member Board of Directors Apr 2019 - Present

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

Publications

• 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, 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.
• 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.
• 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.