1. Timothy M. Ruane
35 Tierra Verde Court
Walnut Creek, CA 94598
510-666-7113
truane@excite.com
OVERVIEW A balanced and dedicated pharmaceutical executive with over 30 years of increasing financial and management
responsibilities in large, medium, and small public pharmaceutical and biotechnology companies. My experience
includes extensive drug delivery and clinical drug development experience, and direct responsibility for leading
teams in launching and commercializing 7 new molecular entities, 5 new indications and 8 line extensions, with
clinical development, business development, and commercial experience covering multiple disease areas, medical
technologies and devices. Experience includes direct involvement and/or responsibility in 9 merger/acquisition
transactions, 12 major corporate restructuring or expansion activities, and partner management. Since early 2002, I
have gained significant experience and responsibility in working with Boards to lead companies, chart and execute
new business plans, solve complex business, intellectual property and legal issues, develop and file NDAs, create
substantial business development transactions, secure respect among the financial community, and to raise both
traditional and novel non-dilutive capital – all to extract and maximize shareholder value from corporate assets.
EXPERIENCE
INSITE VISION (December 2010 – February 2016) ALAMEDA, CA
Chief Executive Officer & Member of the Board of Directors
• Negotiated, signed and announced merger with QLT Inc. to combine InSite’s late stage ophthalmology pipeline
with QLT’s favorable balance sheet, favorable NASDAQ listing, and favorable Canadian tax status, to create a
powerful new pure play ophthalmic company. Managed the subsequent three round “bidding war” processes
whereby Sun Pharmaceuticals and QLT doubled the price of the eventual deal. Negotiated, signed and
announced InSite Vision’s acquisition by Sun Pharmaceuticals, which successfully closed in Q4 2015.
• Built one of the most cost-effective and productive ophthalmology regulatory and clinical development
operations in the world. During the 2012-2013 periods this 30 person company accrued over 1600 patients on
three pivotal Phase 3 programs, with BromSite™ NDA filed in Q1 2015, and one NDA scheduled for Q1 2017.
BromSite was successfully approved by US FDA on April 9th
, 2016, ahead of its scheduled PDUFA date.
• Negotiated and closed seven-party deal to extinguish $43.9 in liabilities and non-recourse debt from AzaSite
royalty Noteholders, using a single $6M payment, and returning AzaSite tiered royalties to InSite Vision.
• Negotiated and closed novel AzaSite®, AzaSite Xtra™, and BromSite licensing and 50% co-development deal
covering 105 countries in Europe, the Middle East and northern Africa with Nicox Pharmaceuticals.
• Negotiated and closed AzaSite® and AzaSite Xtra™ licensing deal in Japan with Senju Pharmaceuticals.
• Negotiated and closed $16M non-dilutive financing via three-party Besivance® royalty monetization deal.
• Renegotiated (twice) North American AzaSite® licensing agreement with Inspire Pharmaceuticals (Merck) to
restructure minimum vs. actual quarterly royalty payments, and the return of the North American development
rights to AzaSite Xtra™.
• Harmonized/aligned Key European Health Authority and FDA clinical endpoints and pivotal Phase 3 trial
designs allowing European MAA and FDA NDA filings to be made from the same U.S.-based trials, cutting by
50% the amount of Phase 3 trials required to support such filings – a substantial cost and time saving result.
2. • Resurrected hibernating 8-person ophthalmology-focused company, authored 3-year financial and clinical
development plan, secured $22M+ financing from a top slate of healthcare dedicated investors, and repositioned
company for growth as a late stage biopharmaceutical company with three parallel Phase 3 programs.
TEKMIRA (INEX) PHARMACEUTICALS CORPORATION (December 2004 – June 2008) BURNABY, BC
President & Chief Executive Officer & Member of the Board of Directors
• Negotiated and closed four-party transaction to purchase privately-held Protiva Biotherapeutics to create global
leader in emerging siRNA field, with partners Alnylam and Roche Pharmaceuticals. Multi-party transaction
expanded the Alnylam partnership, secured Roche to a new research and manufacturing funding commitment,
and included a $10.0M equity investment by Alnylam and Roche at a price of $2.40 – a 300% premium. In
early 2015, Tekmira acquired with privately held OnCore Biopharma to create Arbutus Pharmaceuticals.
• Completed novel spin-out transaction with Calgary investor group, monetizing $100M in INEX’s Canadian tax
losses for $5.8M, and creating Tekmira Pharmaceuticals from INEX Pharmaceuticals.
• Executed $16.0M straight equity financing following Alnylam announcement, significantly improving INEX’s
balance sheet to three years of cash, and providing funds for rebuilding its novel oligonucleotide-based pipeline.
• Negotiated and implemented landmark global exclusive licensing agreement with Alnylam Pharmaceuticals to
create global “operating system” to enable systemic RNAi-based therapies. Transaction provided INEX
$17.0M in committed funding, milestones and royalties for each and every lipid-encapsulated siRNA-based
therapeutic, global exclusive manufacturing rights, and commercial development rights for three INEX siRNA
pipeline products, and immunostimulatory RNA products, subject only to downstream royalty obligations.
• Gained 99.3% shareholder approval to INEX’s revised Plan of Arrangement #2 proposal to monetize its
Canadian tax losses, by way of spinning out all its assets, employees, and cash into Tekmira Pharmaceuticals.
• Successfully defended two bankruptcy petitions, two bankruptcy appeals, and then negotiated novel debt
settlement agreement with convertible debt holders, permanently extinguishing US$36.5M of convertible debt
from INEX’s balance sheet at a significant (66%) discount.
• Gained 98.3% shareholder approval to INEX’s Plan of Arrangement #1 proposal to spin-off its oligonucleotide
assets, employees, and cash into a new debt-free company – Tekmira Pharmaceuticals.
• Successfully partnered INEX’s three liposomal chemotherapy products in a landmark US$42M global licensing
agreement with Hana Biosciences, providing INEX US$11.5M in upfront consideration, US$30.5M in success-
based milestones, net sales royalty participation, and a US$250K/FTE services agreement.
• Developed integrated and novel business and legal strategy and plan to spin-off INEX’s oligonucleotide assets,
its employees, and its remaining cash into a new debt-free company – Tekmira Pharmaceuticals.
• Successfully defended two bankruptcy petitions, and two bankruptcy appeals (brought on by convertible debt
holders) seeking to have INEX declared bankrupt and insolvent, and placed into receivership for liquidation.
• Subleased two-thirds of INEX facility to Response Biomedical, significant lowering the INEX burn rate.
Senior Vice President, Corporate Development
Senior Executive and Corporate Officer responsible for all commercial and legal operations of the company,
including marketing, sales, marketing research, medical affairs, in-and out-licensing, and legal functions.
• Named President and CEO after securing unanimous Board approval of a 5-point strategic restructuring plan to
refocus the company on its novel oligonucleotide-based gene silencing platform.
• Developed integrated business and legal strategy to establish INEX’s position in emerging siRNA field.
3. • Identified key oligonucleotide and siRNA intellectual property positions for the company, and as a result,
developed and gained unanimous Board approval to pursue transformational opportunity for the company.
ILEX ONCOLOGY (February, 2002 – December, 2004) SAN ANTONIO, TX
Senior Vice-President, Business Management
Senior Executive and Corporate Officer responsible for all commercial operations of the company, including
marketing, sales, marketing research, medical affairs, and in-and out-licensing functions. At end-2004, Genzyme
Corporation purchased ILEX Oncology in a strategic merger transaction valued at $1 billion.
• Senior executive responsible for leading the Genzyme/ILEX integration activities in preparation for the
December 2004 launch of Clolar® (clofarabine), the first pediatric oncology drug approved in over a decade.
• Restructured and reorganized all commercial functions to address company’s new product-driven focus,
including development and implementation of the ILEX Medical Science Liaison field force.
• Negotiated out-licensing deal for Japan/Asia Pacific rights to CAMPATH® (alemtuzumab). Agreement
included significant upfront fee, performance-based milestones, manufacturing fees, and a net sales royalty.
• Identified, developed, and negotiated in-licensing of global CAMPATH®-related diagnostic rights, and out-
licensing deals with established diagnostic companies, in support of CD52 diagnostic strategic plan.
• Identified, developed, and negotiated out-licensing of novel cardiovascular assets to QUATRx Pharmaceuticals.
Agreement included significant upfront fee, performance-based milestones, and a net sales royalty.
• Senior Commercial Representative on ILEX Research and Development Management Committee responsible
for the CAMPATH development plan in relapsing/remitting multiple sclerosis.
PHARMACIA CORPORATION’S
PHARMACIA ONCOLOGY DIVISION (March, 2000 – February, 2002) PEAPACK, NJ
Director, Oncology North America & Latin America
Responsible for doubling North & Latin American volume and profits for Pharmacia’s global oncology franchise.
Year 2001 line responsibility for $750M+ in revenues and a $35M advertising, promotion, and education budget.
• Completely restructured commercial team operations and focus as Commercial leader representative on multi-
disciplinary oncology development team, interfacing with R&D, Regulatory, Medical Affairs and Finance
representatives to refine/implement cross-functional regulatory, clinical and commercial development plans.
• Led North American region to $725M in revenues, a 42% increase versus 2000 revenues of $511M.
• Led United States Ellence® (epirubicin) launch and adjuvant breast sales growth to $65M in revenues (+433%
vs. 2000).
• Led United States Aromasin® (exemestane) launch and adjuvant breast sales growth to $25M in revenues
(+200% vs. 2000).
• Launched United States approval of Camptosar® (irinotecan) for first-line colorectal cancer at ASCO 2000;
Achieved 61% patient share of 1st-line colorectal market, and $555M in revenues at year-end 2001.
• Responsible for launch and commercialization planning of Trelstar™ (triptorelin) for prostate and breast cancer.
SAATCHI & SAATCHI HEALTHCARE’S
ADVANCED THERAPEUTICS GROUP (September, 1998 – March, 2000) NEW YORK, NY
Managing Director and Founder
4. Responsible for start-up and operations, including volume and profit objectives, of oncology/hematology-focused
advertising and medical education group serving Pharmacia Corporation’s global oncology franchise.
• Led agency team in support of the successful United States full approval launch of Camptosar® (irinotecan) for
second-line colorectal cancer. Achieved 80% patient share of 2nd
-line colorectal market by year-end 1999.
• Led agency team in strategic product positioning, selling messages, and tactical executions in support of the
successful United States launch of Ellence® (epirubicin) for adjuvant therapy in early breast cancer. Identified
epirubicin Orphan Drug opportunity providing 7 years of United States exclusivity.
• Led agency team in developing strategic product positioning, core selling messages, and tactical executions in
support of the successful global launches of Aromasin® (exemestane) for advanced breast cancer.
IMMUNEX CORPORATION (July, 1993 – September, 1998) SEATTLE, WA
Director of Marketing – Leukine® & Flt3 Ligand
Responsible for volume and profit objectives for the Leukine® (rhuGM-CSF) franchise. Line responsibility for
$64.5M in revenues and a $4.2M advertising, promotion, and education budget.
• Developed and implemented September 1995 launch of new Leukine® approval: AML indication. One-year
post-launch, Leukine® was the market leader (vs. Neupogen®) in this indication.
• Developed and implemented January 1996 launch of new Leukine® approval: stem cell transplants indications.
Two years post launch, hospital-based revenues increased 40% as a result of this indication.
• Developed and implemented January 1997 launch of new Leukine® Liquid, eliminating a key impediment to
sales growth. One-year post-launch, offices/clinics-based revenues increased 24%.
• Commercial representative on Leukine®, Flt3 ligand, IL-15, and CD40 ligand project teams pursuing vaccine
adjuvancy, anti-tumor, stem cell, and dendritic cell biology clinical uses and indications.
Director of New Business Development
Responsible for identifying, evaluating, and recommending all North American in- and out-licensing opportunities,
in combination with global American Cyanamid/American Home Products personnel.
• Identified, developed, and negotiated the Immunex Cell Software™ - ESCCAT (Extracorporeal Stem Cell
Collection and Transplantation) out-licensing program with licensees, involving all Immunex cytokines, and
negotiated North American sub-license for generic Taxol® (paclitaxel) program and Project Team.
Group Product Manager – Cytotoxics Franchise
Responsible for North American volume and profit objectives for the Lederle Oncology/Bristol-Myers Squibb
franchise. Line responsibility for $142M in revenues and an $8.0M advertising, promotion, and education budget.
• Merged Lederle Oncology and Immunex marketing personnel into cohesive department, and integrated all
Lederle Oncology business and marketing plans and budgets into Immunex systems, and established Lederle
Oncology/Immunex manufacturing and inventory planning systems and procedures.
AMERICAN CYANAMID COMPANY
LEDERLE ONCOLOGY DIVISION WAYNE, NJ
Director of Marketing (September, 1992 – July, 1993)
Responsible for North American volume and profit objectives for the Lederle Oncology division. Line
responsibility for $96M in revenues and a $6.0M advertising, promotion, and education budget.
• Marketing representative on team evaluating Cyanamid’s $750M acquisition of a 53% ownership in Immunex.
5. • Identified key development opportunities, and then refined the Novantrone® (mitoxantrone) pricing, clinical
development, patent, regulatory, and line extension strategies and plans.
• Solved thiotepa’s chronic supply problem and then resurrected circa-1954 thiotepa franchise via patent and
reformulation strategies, thus creating Thioplex®.
ENZON, INC. (April, 1990 – October, 1992) PISCATAWAY, NJ
Assistant Director of Marketing & Sales Planning
Directed the operations of Marketing and Professional Services groups, and Sales department start-up staffing plans.
Line responsibility for $8.0M in Adagen® revenues and a $3.0M advertising, promotion, and education budget.
• Responsible for $4.0M Oncaspar® (PEG-asparaginase) pre-marketing and pre-launch preparations, developed
and implemented Sales Force establishment team, in support of Adagen® and Oncaspar® launch, and
marketing evaluation representative for Enzon’s $8.0M acquisition of Genex Corporation.
Marketing Manager
Developed and executed product and corporate marketing plans, coordinated and led development teams, and
instilled marketing focus in a young and emerging biotechnology company.
• Launched Enzon’s first product - Adagen® (PEG-adenosine deaminase) – the “bubble boy” therapy, achieving
95% payor reimbursement for the world’s most expensive pharmaceutical therapy.
PROCTER & GAMBLE PHARMACEUTICALS
NORWICH EATON DIVISION (July, 1986 – April 1990) NORWICH, NY
Brand Assistant – Nutritional Line
Developed and executed product marketing plans, selected advertising copy and media, analyzed market research,
and created selling materials for the Vivonex® nutritional line.
• Identified key issues impeding growth of line’s flagship product, developed and implemented Tolerex®
renaming and repositioning campaign to eliminate brand confusion and position for maximum revenue growth,
and balanced $287K deficit in $4.6M marketing budget, while leading the 20-year-old nutritional product line
to a record +23% brand and division growth.
Medical/Hospital Sales Representative ANNAPOLIS, MD
Sold the features and benefits of diverse product lines to physicians, pharmacists, and nurses in hospitals, nursing
homes, home healthcare agencies, and retail pharmacies.
• Led Eastern Region performance in first year, with +254% sales increase, launched first oncology product –
Didronel® IV (etidronate disodium) – for the treatment of hypercalcemia, and elected Speaker of Class –
Professional Sales Training I by peers.
BEECHAM LABORATORIES (Summers, 1983 & 1984) BRISTOL, TN
Pharmaceutical Intern
Comprehensive manufacturing and packaging lines experience in support of the Amoxil® antibiotic franchise, and
the 1984 launch of Augmentin®.
EDUCATION UNIVERSITY OF WASHINGTON SEATTLE, WA
Executive MBA (June, 1995 – June, 1997)
• Team Leader – Red Team Study Group.
• Co-founder, Class XIII Entrepreneur Club.
6. WAKE FOREST UNIVERSITY WINSTON-SALEM, NC
B.S., Business – Finance (August, 1982 – May 1986)
Concentrated additional course work in life sciences, especially Biology and Chemistry, and tailored studies toward
obtaining an entry-level position in pharmaceutical sales.
• Alumni Interface, Delta Kappa Epsilon’s Psi Delta Chapter.
• House Manager, Delta Kappa Epsilon.
AFFILIATIONS Volunteer, Rotary of Walnut Creek
Volunteer, City of Walnut Creek
Volunteer, The Seven Hills School
FAMILY Married to Jennifer A. Ruane (21 years)
Father to daughter Peyton (5 ½), and sons Brayden (5½) and Tristan (3 ½)
INTERESTS Cheering loudly for Lord Stanley’s Cup to stay in the United States where it belongs
Following the San Antonio Spurs basketball team as they win
Watching Wake Forest’s basketball team lose
Cheering against Duke and Kentucky winning anything
Continuing to fund private school tuition
Mono-skiing and alpine skiing
Exotic car racing, custom cars, motorcycles
Power Yachting
7. WAKE FOREST UNIVERSITY WINSTON-SALEM, NC
B.S., Business – Finance (August, 1982 – May 1986)
Concentrated additional course work in life sciences, especially Biology and Chemistry, and tailored studies toward
obtaining an entry-level position in pharmaceutical sales.
• Alumni Interface, Delta Kappa Epsilon’s Psi Delta Chapter.
• House Manager, Delta Kappa Epsilon.
AFFILIATIONS Volunteer, Rotary of Walnut Creek
Volunteer, City of Walnut Creek
Volunteer, The Seven Hills School
FAMILY Married to Jennifer A. Ruane (21 years)
Father to daughter Peyton (5 ½), and sons Brayden (5½) and Tristan (3 ½)
INTERESTS Cheering loudly for Lord Stanley’s Cup to stay in the United States where it belongs
Following the San Antonio Spurs basketball team as they win
Watching Wake Forest’s basketball team lose
Cheering against Duke and Kentucky winning anything
Continuing to fund private school tuition
Mono-skiing and alpine skiing
Exotic car racing, custom cars, motorcycles
Power Yachting