Peter Lutes

Vice-President

Peter Lutes has over ten years experience in finance, executive administration, and operations of early-stage biotech companies. He has played significant roles in the creation and launch of several start-up companies, including Immune Control, Anethon, LLTech and others. After evaluating technology potential, he has raised over $20 million from state resources and venture firms for early-stage companies. Peter writes business plans, presents at various industry events, has coordinated three INDs and is currently pursuing a 510k submission. Operational efforts include building teams of employees and consultants, recruiting principal investigators for clinical trials, and organizing patents and maintaining corporate documents. On the financing side, Peter was Senior Venture Officer at the New Jersey Economic Development Authority where he evaluated life sciences companies for nearly $30 million in investment and tax-based incentive programs. Earlier in his career, Mr. Lutes worked at Genentech for a short stint and at an former investment bank that brought over one dozen companies public (Ariad, Calgene, DNAP, Guilford Pharmaceuticals, Incyte, and La Jolla Pharmaceuticals). Peter has BA in Economics from the University of Massachusetts-Boston, and Master's degree in Biotechnology from the University of Pennsylvania.

CONSULTING

Assisting a prominent biotechnology venture capital firm select vaccine technologies for development
Conducting due diligence

• Forming preclinical and clinical development plans
• Structuring licensing deals

Furthered product development for French medical imaging company

• Arranging clinical testing (derma. and oncology) in pursuit of eventual 510k approval
• Presented at the OneMed conference; and orchestrated meetings with VCs, clinical partners

- Organized a CEO-Investor Forum for 10 European e-Health companies and 20+ attendees in NYC

- Business development for a protein-based stent bio-coating company

• Prepared and presented a strategic plan to potential investors and partners
• Helped fill a $2.5 million investment round for pre-IND efforts

- Created a strategic presentation for a Treg modulation spin-out; secured $50,000 in seed funding

• Coordinated with scientific founder and another consultant

- Analyzed un-blinded data to forecast drug supply in a phase 2 study being held in 10 countries
- Advised a University of Pennsylvania spinout on commercialization strategy and fund-raising
- Conducted due diligence on pre- and post-proof-of-concept companies, management and investors
- Evaluated Private Placement Memorandums for possible LP investment into State-centric VC funds
- Contributed to recommended changes to the Governor for the State's Net Operating Loss program
- Served as poster session judge and presentation coach various industry conferences
 

CONTRACT

Corporate:

- Directly involved with every aspect of a biotech startup company - grew from two to six people
- Raised $1.2 million from angel investors
- Satisfied due diligence inquiries and secured series A investment of $11.3 million
- Served as Corporate Secretary and Treasurer; assembled board packages and wrote investor updates
- Maintained corporate documents, including incorporation documents, stocks certificates, and ESOP
- Presented company data at the Bio-Life-Tech and Mid-Atlantic Bio Conferences

Operational:

- Secured office space and set up communications for a virtual team of employees and consultants
- Planned and executed efforts with R&D, regulatory, and monitoring personnel
- Negotiated contracts with consultants and vendors (pre-clinical, CROs, hospitals, legal, strategic)
- Project Management - established and monitored timelines and budgets; wrote RFPs
- Organized and hosted a scientific symposium featuring eight leading researchers
- Guest lectured at Drexel University and Wharton Biotech Group

Clinical (oncology and autoimmune):

- Participated in a pre-IND meeting with the FDA to discuss the repurposing of a drug for myeloma
- Coordinated construction and submission of our myeloma IND with a team of consultants
- Evaluated, selected and managed CROs in the US and India. 
- Secured IRB approval at three U.S. sites, and almost a dozen sites in India
- Started the phase 1 myeloma trial in the US, and extended it to India, reaching eight active sites
- Led the myeloma phase 1 trial Principal Investigator meeting in India
- Helped prepare the protocol, IB, and CRFs for two physician-initiated INDs in psoriasis
- Was primary contact with principal investigator in two psoriasis phase 1 studies, at two sites
- Assisted with development of new chemical entities for asthma and rheumatoid arthritis

Site management:

- Provided functional guidance and established internal processes for internal and clinical teams
- Created and maintained document status reports; updated department team members on a regular basis
- Reviewed proposals, contracts, and budgets for completeness and accuracy, and ensured that corrections      were appropriately made and documented