ROBERT J. TOWARNICKI
1590 Bunker Court
Chambersburg, PA 17202-8040
Mobile: 215-630-1110
e-mail: rtowarnicki@comcast.net
PROFILE
Energetic hands-on executive with a track record of growing and developing business. A strategic leader who has
worked in Multinational Pharmaceutical Firms as well as guided early stage Medical Device and Biotechnology
companies. Specific Corporate experience includes:
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Strategic Planning and Evaluation
Business Plan Development
Executive Recruitment & Team Building
Venture, Mezzanine & Public Financings
Mergers, Divestitures & Acquisitions
Transaction Negotiations
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Technology In-Licensing & Out-Licensing
Initial Public Offerings
Operations Improvement
Project Management
Development & Defense of Intellectual
Property Portfolios
PROFESSIONAL EXPERIENCE
New Hope BioConsulting LLC – New Hope, PA & Chambersburg, PA
Managing Partner
1/2013 - Present
New Hope BioConsulting provides strategic services to Venture Capital, Angel Investors and others considering
investments in Biotechnology, Pharmaceutical, and Medical Device companies and also assists entrepreneurs and
established businesses in strategic evaluation, business plan development and implementation, project management
and operational improvement.
Robert J. Towarnicki, Managing Partner, has over 40 years’ experience in the pharmaceutical and biotechnology
industry, served as President of four biotech companies and raised over $200 Million USD for those companies to
further the development and commercialization of novel technologies including: small molecule pharmaceuticals;
biologicals, PMA and 510k medical devices; diagnostic assays; and laboratory services. In addition, Mr. Towarnicki
has served on the Board of Directors of multiple public and private companies as well as the Biotechnology Industry
Organization (BIO) and Pennsylvania BIO.
Royer Biomedical Corporation – Frederick, MD
Interim President
5/2014 - Present
Royer Biomedical, Inc. is a privately held company based outside Washington DC in Frederick, Maryland. Royer
has a strong research background in polymer chemistry and localized therapeutic systems, and holds numerous US
and international patents on calcium and hydrogel matrices capable of delivering a broad array of anti-infective, antineoplastic, and analgesic pharmaceuticals. Royer utilizes proprietary polymer platform technologies to deliver
existing pharmaceutical compounds in novel formulations. These synthetic (no animal products or collagen)
proprietary platforms allow for sterile delivery, controlled elution rates without any immunogenic response, and
controlled rates of bioresorption, without acid production during resorption or susceptibility to proteolytic enzyme
attack.
Mr. Towarnicki has completed a review of Royer’s lead clinical candidate including: performance characteristics;
target clinical indications; regulatory strategy; and market needs. As a result of this evaluation, the Company paused
a Phase II clinical trial in mild to moderately infected diabetic foot ulcers while initiating a new open label study in
moderate to severe chronic wounds where the product characteristics can be used to their full effect. In parallel, he is
developing an offering memorandum for another round of private financing.
Robert Towarnicki
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ExSAR Corporation – Monmouth Junction, NJ
Board Member serving as interim President
1/2013 – 6/2013
ExSAR is dedicated to advancing the identification and development of therapeutic agents through
hydrogen/deuterium exchange mass spectrometry technology. The Company uses this technology to screen
compounds for their ability to prevent protein misfolding and restore protein function in its quest to identify, develop
and commercialize small molecule therapeutics for protein misfolding diseases like Gaucher, Late-Onset Tay Sachs,
Sandhoff, ALS and Parkinson’s.
In addition to internal drug discovery and development efforts, ExSAR had provided H/D-Exchange analysis on a
contract basis to the Pharmaceutical and Biotechnology Industry. Clients turned to ExSAR for epitope mapping
services in support of therapeutic monoclonal antibody development, and utilize our H/D-Exchange technology to
characterize proteins and to identify ligand-binding sites.
Mr. Towarnicki served as an independent board member for three years and was asked to serve as interim President
to evaluate and recommend a course of action going forward. After careful evaluation, several alternatives were
presented. The Chairman decided to adopt one of the suggested options and Mr. Towarnicki shut down the service
side of the business and sold the lab assets at very favorable valuations, while re-writing the business plan and
investment premise for the drug development effort. The company continues as a virtual company under the
leadership of the Chairman/owner.
MAKEFIELD THERAPEUTICS, INC. – Newtown, PA
Founder, President & CEO
2009 – 2012
Makefield Therapeutics, Inc., founded in 2009, was a privately held virtual therapeutics company with two
development programs addressed to very large market opportunities in anti-infectives and the treatment of erectile
dysfunction, both based on an innovative nanoparticle drug delivery platform with the potential to generate a
pipeline of additional novel therapeutics.
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Negotiated an exclusive license to a novel “Hybrid Nanoparticle” Drug Delivery Platform
Raised Seed Capital in a difficult funding environment
Advanced technology platform through sponsored research
Pursuing Venture Capital, Government Grants and Corporate Alliances
At the end of 2012 I chose to discontinue my efforts with Makefield Therapeutics, finding capital very hard to raise
for a drug delivery technology not perceived as revolutionary or paradigm shifting. The experience gives me a good
sense of what types of technologies and programs can achieve funding in our current economic climate.
NUCLEONICS, INC. – Horsham, PA
Director, President & CEO
2003 - 2008
Nucleonics, Inc. was a privately held, emerging Biotechnology Company focused on the development of novel RNA
interference-based (RNAi) therapeutics for viral and other diseases.
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Working with the scientific founders and the seed venture financers, developed a new strategic vision,
redirecting the Company’s efforts from service provider to therapeutic discovery and development.
Solicited an offer from a public company to purchase Nucleonics from the original Series A investors at a 5X
return in Q4, 2003.
Wrote a new Business Plan and presented it to the venture community, closing a $49 million USD Series B
financing in Q1, 2004.
Successfully fought a patent infringement suit brought against the Company, resulting in the patent holder
withdrawing their suit, invalidating an issued patent and maintaining freedom to operate.
Led the team to a successful IND and initiation of a Phase 1 Clinical Trial for the company’s lead program, a
hepatitis B therapeutic.
Robert Towarnicki
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Led a strategic initiative to sell the Company, after terminating the CSO for falsification of scientific data,
resulting in December 2008 sale of the IP portfolio to Alnylam Pharmaceuticals (NASDAQ:ALNY).
CELL PATHWAYS, INC. (NASDAQ:CLPA) – Horsham, PA
Chairman, President & CEO 2000 – 2003
Chief Executive Officer 1996 - 2000
1996 – 2003
An emerging pharmaceutical company focused on the discovery, development and commercialization of novel small
molecule pharmaceuticals to treat cancer and certain autoimmune diseases.
Responsible for the development of the Company from a 10 person group focused on the development of a lead
compound for an orphan indication into an emerging pharmaceutical company with a platform technology, two drugs
in clinical development, and over 7000 proprietary compounds in a library focused on the treatment and prevention
of cancer.
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Working with the scientific founder and the Board of Directors, developed the strategic direction for the
Company and recruited a world class scientific team to accomplish our objectives.
Raised over $150 million through successive private placements with world class investors (including Goldman
Sachs Partners Fund, New York Life, and others), took the Company public through acquisition of a public shell
in a difficult market (1998) raising $28 million in the transaction and returning 7X for the venture investors,
executed several PIPES, and entered a definitive merger agreement with OSI Pharmaceuticals.
Established outside commercial and scientific collaborations, alliances, licensing agreements and marketing and
sales agreements to fund continuing research and development of the Company’s platform technology, while
establishing a commercial presence in the oncology community.
Established a dominant Intellectual Property position protecting the platform technology and the resultant drug
candidates. Company included in “The Innovation 50” most inventive small companies, August 2002, Inc
Magazine.
Filed two INDs and conducted clinical trials in 3 indications utilizing an internal clinical development group led
by a leading oncology CMO recruited from Aventis.
Led a strategic initiative to sell the Company resulting in the 2003 sale to OSI Pharmaceuticals
(NASDAQ:OSIP).
INTEGRA LIFESCIENCES CORPORATION (NASDAQ:IART) - Plainsboro, NJ
Director, President & COO
1992 - 1996
A medical device company focused on tissue engineering and regenerative medicine.
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Responsible for the development of a strategic plan for ILC, focusing the company's R&D efforts in the area of
regenerative medicine and tissue engineering.
Grew the Company from an initial 12 employees to over 75, hiring appropriate personnel to accomplish the
newly established strategic objectives.
Acquired companies in New Jersey, Kansas and California consolidating collagen based regenerative medicine
technologies.
Maximized the sales of existing products through selective licensing of marketing rights to leaders in various
medical markets. Partners included: Alcon Laboratories, Boston Scientific Corporation, Genetics Institute,
Marion Laboratories, and Union Carbide Corporation. Tripled product revenues from $1 Million in 1992 to $3
Million in 1993, and $9 Million in 1994. My last full year at Integra we achieved $15 Million in Revenue.
Raised $11M in equity capital through private placements with key corporate marketing partners.
Filed multiple PMAAs and 510ks.
Took the company public through the acquisition of Telios Pharmaceuticals and raised an additional $46 M
through private placements and a secondary offering.
Led the design, construction, validation and operation of a sterile implantable device manufacturing facility.
Robert Towarnicki
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MEDIREL, INC. - Cranbury, NJ
Founder, President & CEO
1991 – 1992
MediRel, Inc. was founded to license and develop proprietary technology in the field of controlled drug delivery.
Efforts were merged with Integra LifeSciences Corporation.
FOCUS/MRL - Cypress, CA
General Manager
1989 – 1991
A privately held health care corporation with three subsidiaries: Microbiology Reference Laboratory (an Esoteric
Infectious Disease Reference Laboratory); Hillcrest Biologicals (an In-vitro Diagnostics Manufacturer); and Hillcrest
Rare Antigens (a Biotech Company supplying rare retroviral antigens, recombinant proteins and the manufacturer of
AIDS Vaccine for the Immune Response Corporation/Rhone Poulenc Rorer clinical program.
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P&L responsibility for three businesses.
Acquired and integrated a competing reference laboratory in the west coast market.
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Introduced Hillcrest products to the European diagnostic market.
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Led the development and regulatory approval for the first Lyme’s Disease Elisa approved for commercialization
by the US FDA.
The combined businesses ended fiscal year 1990 at 13 Million in revenue, an increase of 65% over FY-89.
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COLLAGEN CORPORATION (NASDAQ:CGEN) - Palo Alto, CA
Vice President of Development and Operations
1985 – 1989
A medical device company manufacturing collagen based products for the dermatology/plastic surgery market,
dental markets and drug delivery. Researching tissue regeneration in dermal wound healing and bone regeneration.
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Responsible for day-to-day operations, including manufacturing, quality assurance and control, analytical
development, technical services, new product development and scale-up, facilities and engineering, and
materials management and distribution.
Led the commercial scale up of 3 sterile injectable products and the design, construction, validation and
operation of a state of the art sterile injectable manufacturing facility.
Assisted in developing corporate strategy, new market analysis, acquisition evaluation, and new business
development and funding recommendations and review.
Spent significant time with dermatologists and plastic surgeons understanding market dynamics to assist me in
leading product development efforts.
PFIZER, INC. - Terre Haute, IN
Operations Manager
1984 - 1985
A leading global pharmaceutical company.
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Managed a team of 60 employees and a budget in excess of $7 million.
Responsible for the redesign and construction and validation of a computer process controlled sterile bulk
cephalosporin facility, obtaining licensing, and ultimately hiring a management team and manufacturing Pfizer's
second largest selling product at the time, CEFOBID.
MERCK & CO., INC. - West Point, PA
A leading global pharmaceutical company.
1975 – 1984
Robert Towarnicki
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Sterile Operations Manager
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1982 - 1984
Managed a team of 70 employees and a budget in excess of $6 million.
Responsibility included manufacture of all bulk sterile pharmaceuticals produced by Merck, Sharp & Dohme in
this computer-integrated batch manufacturing facility.
Quality Control
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1975 - 1982
Held five positions, each with increasing responsibility. These responsibilities included managing QC
Laboratories, performing biological testing and process validation. I created and was the first manager
responsible for the validation and monitoring of sterile products and the manufacturing environment. Played a
leadership role in the design, construction, and validation of a new Small Volume Parenteral (SVP)
manufacturing facility including the first computer process control system in the pharmaceutical industry.
Close interaction with FDA was an integral part of the responsibilities.
PAOLI MEMORIAL HOSPITAL - Paoli, PA
Medical Technologist
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Worked independently in all areas of the clinical laboratory as a Stat Technician.
VILLANOVA UNIVERSITY - Villanova, PA
Graduate Teaching Assistant
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1972 - 1975
1973
Taught undergraduate labs in Microbiology and Parasitology.
EXTERNAL BOARD SEATS & COMMITTEES
PENN STATE HERSHEY MEDICAL SCHOOL
Commercialization Advisory Board
2013 - Present
ExSAR
2009 - 2013
ExSAR Corporation is a development stage company dedicated to identifying, developing and commercializing
small molecule therapeutics for protein misfolding diseases.
BIOTECHNOLOGY INDUSTRY ORGANIZATION
Serving on:
Board of Directors
Emerging Company Governing Body
Healthcare Section Governing Body
2005 – 2009
PENNSYLVANIA BIOTECHNOLOGY ASSOCIATION
1999 – 2004
VECTRAMED, INC.
Privately Held Drug Delivery Company
1998 – 2005
BATTELLE PHARMA INC.
Privately Held Drug Delivery Company
2000 – 2003
Robert Towarnicki
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EDUCATION
Ph.D. Candidate - Pharmaceutical Chemistry, Temple University, 1984
MS, Biology, Villanova University, 1974
BS, Biology, Villanova University, 1973
HONORS
The Rho Chi Society
(Pharmaceutical Honor Society)
Beta Lambda Chapter at Temple University