Anthony Maida Consulting International

Bridges to Conquering Cross Border BioPharmaceutical Challenges

May 2010

Anthony E. Maida III, Ph.D., MA, MBA828 Eastbrook Court

Danville, CA 94506-1206

925/736.1863 Direct Line

925/736.5910 Facsimile

925/209.9626 Mobile

SKYPE: anthony.e.maida.iii

http:/www.linkedin.com/in/anthonymaida

www.anthonymaidaconsulting.com

 

Anthony E. Maida, III, Ph.D., MA, MBA

Formal Education

Ph.D. – Immunology (Tumor Immunology)BA – History, BA – Biology, MA – Toxicology, MBA

Professional Positions/Background

Chairman – BioConsul Drug Development CorporationPrincipal – Anthony E. Maida, III Consulting International (www.anthonymaidaconsulting.com)

VCs. Hedge Funds, Pharma, Investment BanksExecutive positions (CEO/CFO/CSO/Chairman) for a number of start-up and emerging biotechnology companiesRecognized as an expert in the virtual commercial development of ImmunotherapyExperience in ‘Cross Boarder’ commercial and clinical development

Recent NDA for Product In-Licensed

Professional Memberships

ASCO, AACR, ASI, ACS, SNO, iSBTc

Public Board SeatsSpectrum Pharmaceuticals, Inc. (SPPI)Sirion Therapeutics, Inc.

Private Company Board Seats

The Lam Lab

– Kit Lam, M.D., Ph.D. Professor of Medicine, Chief, Division of Hematology and Oncology, University of California, Davis Cancer Center

• World Renowned Inventor of the ‘One Bead One Compound’ Combinatorial Method

– A culturally diverse group of scientists composed mostly of doctoral and post doctoral students from China and the Pacific Rim

– Research is focused on medicinal proteomic combinatorial chemistry to discover novel therapies for patients with cancer.

– Offers the opportunity to understand, motivate, communicate and lead in a cross culture environment.

The Lam LaboratoryUniversity of California Medical Center

Davis, California

Key Competencies and Potential Services

I. Commercial

II. Financial Management

III. Strategic

IV. Scientific and Clinical Development

V. Technical

VI. Networking Across the World

Main Scientific Advisor to EndPoint BioCapital

Scientific ClinicalReview of Technology

• Later Stage BioPharmaceutical and Emerging Companies

– Scientific/Clinical Review of the Technologies/Approach» Mechanism of Action

» Scientific/Clinical Advantages – Data Validation

» Operational Advantages

» Manufacturing/Scale-Up Issues

» FDA Interactions “On Hands Review” -

» Commercial Considerations

» Familiarity with Scientific and International Markets -Asia (refer Lam Lab)/Europe/Israel)

» Cross Border Transfer of technology to US from foreign entities and Centers of Excellence for addition commercial clinical development (understanding the regulatory process)

» Cross border countries include China, Israel, Europe, Australia and Japan

Main Scientific Advisor to EndPoint BioCapital

Commercial

Review of Commercial Opportunities– Financial and Operational Strategy (Former CFO)

– Public listings Chinese Exchange as well as NASDAQ/AIM/NYSE listings

– Financial Structure of various collaborations (licensing/mergers/acquisitions/Joint Ventures, etc.)

– Recommendations on Investments/Divestment s• Including Venture Capital, Hedge Funds, Investment Banks, Angels, etc.

• Public Stocks – Private Stocks – PIPES – Various Financial Vehicles

• Significant Profits Realized – detail available up request

Services Provided (Financial)

• Financial – Fund Raising (over $200 million US)

• Business Development

• Mergers and Acquisitions

• Joint Ventures

• Collaborative Agreements

• Familiarity with Major Pharmaceutical Firms as well as ‘Centers of Excellence’

• Budgets and Forecasts

• Due Diligence (investment/acquisition/mergers)

• Financial and Operational Measurement

• Virtualization (cost cutting)

• Board Selection and Management

Services Provided (Technical)

• A ‘Rolodex’ of scientific, clinical and financial/business competent consultants/FTEs capable of delivering a well-designed and successful commercial clinical and business strategies.

• Scientific

• Preclinical

• Clinical

• Regulatory

• QA/QC

• Manufacturing– Process development

– Assay/Method Development

– Scale up

Services Provided (Clinical)

Preclinical Support

• Protocol Design of GLP Supporting Studies

• Selection of Contract Research Organization

• Animal Models 

Clinical Trial Support

• IND Submission

• Interface and Dialogue with the FDA

• Technical/Pre IND Meeting

• Package preparation and FDA & IRB Submission

• Data Collection and Analysis

• Conduct of Clinical Studies (Oversight)

• Protocol Design

• Design of Case Report Forms and Informed Consents

• Site Identification

• Site Qualification

• Site Initiation

Companies/Indications/Countries

• Companies/Foundations– Novartis - Abraxis Bioscience, Inc - Bearing Circle Capital

– Pfizer Corporation - North Sound Capital - Spectrum Pharmaceuticals, Inc.

– Takeda Pharmaceuticals - End Point Capital - Sirion Therapeutics, Inc.

– Bristol Myers - Roaring Fork Capital - Toucan Capital, Inc.

– Astra Zeneca - CMX Capital - Northwest Biotherapeutics, Inc.

– Eli Lilly - Sagamore Ventures - CancerVax Corporation

– RCT Corporation - Novel Bioventures - Clinical ‘Centers of Excellence’

– The Bonnie J. Addario Lung Cancer Foundation

– Numerous start-up and emerging biotechnology companies

• Disease Selection– Oncology

– Cardiovascular

– Inflammatory

– Autoimmune

– Metabolic

• Countries– US - Canada

– Switzerland - China

– Spain - France

– Israel - Italy

– Japan

Anthony Maida Consulting International

Bridges to Conquering Cross Border BioPharmaceutical Challenges

May 2010

Anthony E. Maida III, Ph.D., MA, MBA828 Eastbrook Court

Danville, CA 94506-1206

925/736.1863 Direct Line

925/736.5910 Facsimile

925/209.9626 Mobile

SKYPE: anthony.e.maida.iii

http:/www.linkedin.com/in/anthonymaida

www.anthonymaidaconsulting.com