Expert Details
Biopharmaceutical industry expert
ID: 739966
Maryland, USA
Expert has uniquely broad and deep experience both as a hands-on manager and consultant, in drug discovery, preclinical and clinical development (including IND filings and clinical trial management), biologics manufacturing and CMC, business and corporate development (licensing and M&A deals), strategic planning (up to division level), portfolio management, product and therapeutic area strategies, major new product launches and commercial development planning, startup management and financing. He is an experienced negotiator with large business development deals and vendor management. As consultant, he has been retained as personal advisor to a large pharmaceutical company CEO and as acting COO/CEO for several biotech companies. He also has experience teaching academics at the graduate level (MIT).
Experience in:
• Therapeutic modalities, including small molecules, peptides, biologics (especially monoclonal antibodies), gene therapies (especially AAV) and RNA therapeutics (especially siRNA).
• Therapeutic areas, including oncology, gastrointestinal (functional and IBD), infectious disease (including HCV and HBV), CNS & pain, ophthalmology, immunology including allergy & RA, cardiovascular and respiratory (including asthma).
• hands on management of projects in discovery, pre-clinical development and IND filings, phase 1 and 2 clinical trials, BLA and NDA filings, marketing strategies and launch planning.
• biologics manufacturing, including therapeutic proteins and monoclonal antibodies, gene therapies (adherent and suspension cultures), cell therapies, peptides and oligonucleotides.
• most parts of the production chain, from process development to fill finish, including both processes and production equipment, as well as building and managing gene therapy and manufacturing organization.
Example work experiences:
• Discovery of diagnostic and therapeutic monoclonal antibodies
• Large scale manufacturing of monoclonal antibodies
• Artificial intelligence system for control of bioreactors
• Large analysis of US Pharmaceutical Industry for PhRMA
• Large corporate pharmaceutical strategy project for Proctor & Gamble
• Re-design of the business development function for Pfizer
• EU corporate strategy for Pharmacia
• Divisional strategy, Pharmacia diagnostic division
• Organizational plan for re-organization of Pharmacia
• Several large therapeutic area strategies for Pharmacia, Merck, Seneca and AstraMerck
• Manager of the post-merger integration office for the Pharmacia-UpJohn merger Retained as advisor to CEO of BASF Pharma US division
• Restructured the strategic planning system for BASF Pharma, including the financial reporting system
• Develop a portfolio planning system for BASFs Pharma
• Strategic assessment and early clinical development plans for adalimumab (Humira)
• Managing the sale of a $300 M wound care product
• Commercial launch planning for a metabolic drug in Phase III development
• Updated marketing strategy and re-launch plan for an obesity drug
• Commercial launch planning for a stroke drug in Phase III development
• Discovery strategies for a novel drug screening technology using gene expression arrays
• Several large technology platform partnering campaigns, with deal values up to $600 M
• Deal scouting and closing of a $500 M discover partnership with Aventis
• Development strategies and clinical trial planning for a novel pain drug adjuvant (Superoxide Dismutase mimetic)
• Indication strategy and development plan for an oncology drug in phase I development
• Development strategy for an ophthalmic drug in pre-clinical development
• Development plans, pre-clinal development and IND filing for a peptide drug in GI
• Indication strategies and clinical development plans for an antisense drug
• Launch planning, sales force sizing and marketing strategy for a cancer drug
• Large deal scouting for a cancer drug in Phase III, $500 M contract
• Consultant COO for a peptide drug company. Managed VC financing, development strategy and IND enabling studies and filing
• Head of marketing for Easton Associates, a boutique biopharma management consultancy
• Practice leader, IBM Global services. Develop a management consulting strategy practice
• Consultant COO for Benitec; Merger management, pre-clinical development, IND filing, clinical trial design and clinical trial management for a gene therapy product for hepatitis C.
• Discovery strategy, discovery and pre-clinical development for a gene therapy product in age related macular degeneration
• Management of AAV manufacturing for Benitec, including production system selection, CDMO selection, organization design, operations management
• Design and establishment of AAV vector design partnership with 4D therapeutics
• Strategy and plan for introduction of Benitec to NASDAQ
• Over 20 consulting projects in bioprocessing for Danaher
• Due diligence for radiopharmaceutical equipment company
• Future state design of PharmSci function for top 10 pharma company
• Customer experience and interaction strategy for top 5 pharma company
• Expert witness for lawsuit on Lentivirus gene therapy
• Expert witness for lawsuit in DNA plasmid manufacturing
• Pre-clinical and clinical development plans for four siRNA drugs in ocular diseases
• Pre-clinical development strategies for gene therapy product for Alzheimer’s and Parkinson’s disease
Countries worked in: USA, Sweden, UK, Germany, Netherlands, Belgium, France, Australia. Qualified to work on-site in US and EU.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1992 | Degree: Sc.D. | Subject: Biochemical Engineering | Institution: Massachusetts Institute of Technology |
| Year: 1981 | Degree: MSc | Subject: Chemical Engineering | Institution: Royal Institute of Technology, Sweden |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2011 to Present | Employer: Undisclosed | Title: Managing Director | Department: |
Responsibilities:Boutique consulting firm providing a broad set of services to pharmaceutical and biotechnology companies, including operational management (discovery, drug design, pre-clinical and clinical development, and biologics manufacturing), business and corporate development (deal scouting, negotiating, and M&A), market assessments, strategic planning and financing (venture capital and public markets).Engagement for biopharma companies in antibodies, immune checkpoint inhibitors, gene therapy and RNA therapeutics, including operations, deal scouting and negotiating, acquisition searches, drug discovery (targets strategy and drug design), pre-clinical and clinical development, IPO financing and gene therapy vector and biologics manufacturing (set up pilot and large-scale clinical supply manufacturing). Engagement covered several therapeutic areas. Acting COO/CEO for peptide, gene therapy and gene silencing companies. Instrumental in taking a gene therapy company from market cap of a $15 M to $150 M and Nasdaq listing. Engagement for Fortune 500 companies in strategic planning, bioprocessing, business development and analytics development. |
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| Years | Employer | Title | Department |
| Years: 2010 to 2011 | Employer: IBM Global Business Services | Title: Practice Leader | Department: Pharmaceutical Industry Management Consulting Practice |
Responsibilities:Pharmaceutical management consulting for large pharmaceutical companies in IT, business development, strategic and portfolio planning and R&D management. Developed novel consulting methods and deal valuation methodologies. |
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| Years | Employer | Title | Department |
| Years: 2008 to 2009 | Employer: Easton Associates | Title: Director (part-time) | Department: Biotechnology Management Consulting Practice |
Responsibilities:Managed Easton Associates marketing activities as well as client engagements and practice methodology development (in parallel with independent management consulting practice). Easton Associates is a biopharmaceutical management consulting firm founded from the former Wilkerson Group (now part of Navigant). |
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| Years | Employer | Title | Department |
| Years: 2007 to 2010 | Employer: Independent | Title: Management Consultant | Department: |
Responsibilities:Provided management consulting services to biotechnology companies in operations, business development, strategic planning, clinical development strategies and management, CMC management, technology strategies and corporate financing. Consultant COO to public biotech company in peptide therapeutics. Therapeutic areas included gastrointestinal, oncology, rheumatoid arthritis and autoimmunity, obesity and pain. Modalities included small molecules, peptides, antibodies, siRNA and antisense drugs. |
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| Years | Employer | Title | Department |
| Years: 2005 to 2007 | Employer: Genta Inc. | Title: Vice President, Corporate Development | Department: |
Responsibilities:Responsible for strategy and corporate development in a 100+ person public biotechnology company (Nasdaq GNTA). Several large license and M&A negotiations. Reported to the CEO. |
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| Years | Employer | Title | Department |
| Years: 2003 to 2005 | Employer: Metaphore Pharmaceuticals | Title: Vice President, Corporate Development | Department: |
Responsibilities:Responsible for strategy, business and corporate development, and CMC in a well funded ($40 M series D financing) 40+ person biotechnology company. Wrote S1 filing for IPO. Managed CMC operations and new indications development. Reported to the CEO. |
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| Years | Employer | Title | Department |
| Years: 2001 to 2003 | Employer: Avalon Pharmaceuticals | Title: Vice President, Business Development | Department: |
Responsibilities:Responsible for business development in a well funded ($70 M series B financing) 65+ person biotechnology company focused on small molecule discovery using genomics information. Negotiated several large partnerships and deals. Received special bonuses. Reported to the CEO. |
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| Years | Employer | Title | Department |
| Years: 1998 to 2001 | Employer: BASF Pharma Company | Title: Senior Director | Department: Knoll, division of BASF |
Responsibilities:- Business Development: Projects included a $225 M divestiture, co-promotion arrangements valued up to $1 Bn, acquisition opportunities up to $1.3 Bn and new product investments.- Product development launches and marketing: Managed several very large product development, launch and repositioning projects, including the Humira development strategy. - Strategic Planning: Managed strategic planning department. Restructured the corporate strategic planning and portfolio management process. Member of several boards. - Reported to SVP finance and CEO. |
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| Years | Employer | Title | Department |
| Years: 1994 to 1998 | Employer: Arthur D. Little | Title: Senior Engagement Manager | Department: |
Responsibilities:Member of the Pharmaceutical Industry and Technology & Innovation Management practices. Managed key accounts and served as personal counsel to CEO. Awarded the Presidents Medal for outstanding casework and several Star Case awards. |
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| Years | Employer | Title | Department |
| Years: 1992 to 1994 | Employer: The Boston Consulting Group | Title: Management Consultant | Department: |
Responsibilities:Management consultant. Member of Pharmaceutical Industry and Finance practices. Broad experience in U.S. business issues. Wrote large well published pharmaceutical industry report. |
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| Years | Employer | Title | Department |
| Years: 1981 to 1985 | Employer: Pharmacia AB | Title: Research Engineer | Department: |
Responsibilities:Research Engineer. Managed biotechnology discovery projects focusing on monoclonal antibody development. Awarded Pharmacia full salary Ph.D. scholarship and special bonuses. |
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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 1981 to 1985 | Country / Region: Sweden | Summary: |
| Years: 1997 to 1997 | Country / Region: United Kingdom | Summary: |
| Years: 2012 to 2016 | Country / Region: Australia | Summary: |
| Years: 1992 to 1996 | Country / Region: Germany | Summary: |
Career Accomplishments
| Associations / Societies |
|---|
| American Institute of Chemical Engineers American Society of Gene & Cell Therapy European Society of Gene and Cell Therapy Fulbright Alumni International Complement Society International Society for BioProcess Technology Licensing Executives Society Oligonucleotide Therapeutics Society Parenteral Drug Association |
| Awards / Recognition |
|---|
| Fulbright Scholar |
Additional Experience
| Expert Witness Experience |
|---|
| Served as an expert witness in two cases involving drug development. |
| Training / Seminars |
|---|
| 1987 to 1989. Massachusetts Institute of Technology, MA, USA. Head Teaching Assistant for graduate course "Biochemical Engineering Laboratory". Responsibilities involved course development, lecturing, student support and testing. 1991 to 1992. Sloan School of Management, Massachusetts Institute of Technology, MA, USA. Research Associate, Program on the Pharmaceutical Industry. Research and teaching focused on the enabling and cost-driving role of biotechnology manufacturing technologies. |
| Marketing Experience |
|---|
| Expert has developed drug launch strategies for three large drugs. |
Language Skills
| Language | Proficiency |
|---|---|
| Swedish | Native |
| English | Fluent |
| German | Proficient |
Fields of Expertise
bioprocess engineering, bioprocessing, antisense oligonucleotide, oligonucleotide, combination drug therapy, drug development, drug discovery, preclinical research, monoclonal antibody, monoclonal antibody production, gene therapy, biopharmaceutical, biopharmaceutical product development, business development, peptide, biologic (product)