Hal Siegel of Siegel Consultancy LLC

EXPERIENCED REGULATORY AFFAIRS AND

SCIENTIFIC RESOURCE

HAL@SI EGELCON SU LTAN CY.COM480 .229 .1870

H TT P: / / W W W. L I N K E D I N. C O M / I N / H A L N S I E G E L@ H S I E G E L

Hal Siegel, Ph.D.

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

[email protected] 480.229.1870

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What Can I Do For You?

Provide ad hoc augmentation of targeted programs, leveraging corporate strengths while taking advantage of strategic opportunities. Minimizing overhead with a dedicated regulatory and scientific resource ensures your programs advance cost-effectively.

Deliver timely program feedback, clearly communicated.Keep you informed of strategic external information key

to the business and work with other resources (technical, financial, human) to formulate contingency planning.

Reach developmental or financial milestones faster with lower total cost. Effective resource allocation makes for happier partners, Boards and investors.


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What Have I Done?

Consultant to FDA-regulated industry on medical product development, regulatory affairs, quality systems, clinical affairs and related matters.

Successfully transitioned from research scientist to regulatory affairs resource and senior management positions in medical product development and information technology industries.

Scientific mindset with broad technological and medical knowledgebase.

Strong social skills to support C-level executive strategic and tactical operations as well as outward directed communications

Specialties: Regulatory affairs experience in drugs, devices, biologics.

Pharmacology-educated, business-trained for realistic operational insights and action.

Medical product development processes; business and regulatory strategy development; scientific documentation preparation and review; auditing of manufacturing, clinical and preclinical facilities; FDA liaison.


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VP and Chief Scientific Officer ImmuneRegen Biosciences, Inc.

Started March 2005 as a consulting resource, joined full time in October 2006 as Senior Director, Product Development and Regulatory Affairs. Business development liaison.

Promoted to Chief Scientific Officer and Vice President (and member, Science Advisory Board and Board of Directors). Led team that defined, performed or managed all drug development and US FDA regulatory-related activities.

The product, a stem cell active immunomodulatory peptide, has pleiotropic activities that may treat cancers, potentially pandemic infections and provide Chemical-Biological-Radiological mitigation. Orphan designation for Idiopathic Pulmonary Fibrosis obtained March 2011.


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VP Regulatory and Scientific Affairs, General Manager; Zila Inc.

Starting as a consultant to the firm in early 2004, joined full time in March 2005 as General Manager of Zila Biotechnology Inc., and then from March 2006 as VP at parent company Zila, Inc., I was responsible for managing the research and development budget and activities of this preventative oral health care products firm, in-licensing evaluations, and provided regulatory and strategic business development input to Senior Management.

Departed in October 2006 for full time position at ongoing consulting client, ImmuneRegen BioSciences


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Founder and Principal Siegel Consultancy LLC

Performs ad hoc scientific, regulatory, business and compliance consulting for FDA regulated industry.

Perform due diligence and freedom to operate evaluations, assisted in management reviews and strategic operational change implementation, prepared technical scientific, clinical and regulatory position papers, process and system audits and data reviews.

Leader and participant in real and virtual teams to perform and deliver risk analyses and formulate/implement corrective action plans for corporate risk management.

Since June, 2001 offered two full-time VP/C-level positions resulting from successful consulting engagements.


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Life Science Market Segment Specialist and Business Development Manager; Sun Microsystems

Life Science subject matter expert for Global Life Sciences (GLS) team at international IT systems firm; participated in formulation and internal communication of business plans and strategies (including 21 CFR 11 and HIPAA responsibilities), forged consultative relationships with industry partners (in hardware, software and services), initiated GLS-industry outreach programming, provided marketing review and sales training.


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VP ContentBioQ

Founding member of entrepreneurial software product/service startup enabling rapid and compliant Life Science Industry product development, electronic submission and collaborative review.

Executive management role in business plan and product development, and ongoing corporate strategic planning.

Led team providing scientific, regulatory and compliance content input.

Defined, developed and maintained product content; managed budget, scope and priorities of department; partnered with software development, including Part 11 training and validation activities.


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Executive Director, Regulatory Affairs Paragon Biomedical

Provided cGXP-compliant support of clinical, scientific and regulatory functions for clinical research organization (CRO) delivering Phase 2 through Phase 4 clinical study services.

Developed and supported compliance requirements and business development activities while delivering integrated clinical and regulatory consulting services to pharmaceutical and medical device clients.


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Associate Vice PresidentAdvanced Bioresearch Associates

Principal contributor for scientific research and reporting, contract manufacturing evaluation and auditing, safety and analytical testing and clinical activities, cGMP and cGLP auditing and evaluations for partnering, advertising and promotional activities and FDA meetings as clients’ regulatory and scientific liaison. Technical liaison to law firm in national litigation activity.

Directed multi-year dietary supplement product development program billing over $2,000,000; directed and performed scientific and regulatory consulting and managed from pre-funding through FDA clinical study authorization. Licensed to Wyeth, first year retail sales over $15MM.


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Director and Manager, Regulatory Affairs

Advanced Bioresearch Associates

Project management in multiple programs involving internal/external teams performing technical research and review, writing, assembly and submission of CDER, CBER and CDRH submissions including INDs, 510(k)s, PMAs and drug and device Master Files.

Performed technical and regulatory assessments regarding GMPs, clinical trial design and audit requirements, and prepared and delivered reports to corporate executives and venture firms.


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Manager, Regulatory AffairsHybritech, Inc.

Managed the writing, editing and submission of regulatory documentation (NDA/PLA/ELA) for company's first CDER/CBER regulated product.

Representative to change control team, clinical data management system team, multiple product teams, and Product Feasibility Teams for in/out-licensing assessment.

Offered position in biologics regulatory affairs at parent company following divestment.


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Technical Operations Manager Iatric Corporation

Responsible for regulatory affairs, QA management, and all R&D management (over 20 people) for human and animal biologics (allergenic extracts) and in-vitro diagnostic device manufacturer.


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Education

State University of New York at BuffaloPh.D., Biochemical Pharmacology, 1975

- 1982Rensselaer Polytechnic Institute

B.S., Biology (sociology minor), 1971 – 1975

Attended George Washington University National Law Center (1976)


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Recommendations

"Since 2006 I have worked closely with Hal at ImmuneRegen BioSciences, and have been impressed by the scope of his knowledge and his commitment to the people and goals of the company. Although very lightly staffed, our company needed to converse with scientists, doctors, business people and financial experts, and Hal was always bringing the technical details and strategic insights to the discussions. The complexities of the science and the shifting business plans at ImmuneRegen were ALWAYS handled with enthusiasm and flexibility, and no options were off limits for internal discussion and evaluation. I would relish the opportunity to work with Hal again, as a colleague or subordinate, being confident in his fairness, accessibility, intellect and capabilities."

— Chris Romano, Scientific Director / Business Development Analyst, ImmuneRegen BioSciences, reported to Hal at ImmuneRegen Biosciences, Inc.

"My company, MDx BioAnalytical Laboratory, Inc., has provided product characterization, purity analyses, developed methodology for PK studies and performed PK studies for Hal on an ImmuneRegen BioSciences, Inc., drug product . Hal and ImmuneRegen have been one of our best sponsors and it is always a pleasure to work with him. He is a seasoned manager that is very knowledgable in the biopharmaceutical/drug development industry who pays very close attention to details. Hal and I co-authored a poster describing PK of an ImmuneRegen product that was presented at the American Society of Mass Spectrometry Conference in 2009 which was very well received. MDx and I eagerly look forward to a continued working relationship with Hal."

— Earl White, President & CEO, MDx BioAnalytical, Inc., was with another company when working with Hal at ImmuneRegen Biosciences, Inc.


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Recommendations (continued)

"As this rec relates to the ”Basis of recommendation" I was unable to select one category. Hal reported to me directly, Hal works for me, I am senior to Hal, we worked in the same groups and in different groups, Hal reports to our board as well. What I am saying is, "I report to him too and I work for him as well and together we report to many." Hal is and has been a tremendous friend and partner that is hugely experienced in his field and always learning. He is an incredible partner and asset to me and our company. Together we will make great things happen, but in biotech it just doesn't happen overnight. Together with our team we will succeed. Not only could I not make IR successful without Hal I wouldn't want to try. Very loyal, responsible, funny and diligent. We are proud to work with him."

— Michael Wilhelm, CEO, ImmuneRegen BioSciences, Inc, worked directly with Hal at ImmuneRegen Biosciences, Inc.


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Recommendations (continued)

"Hal has an ability to grasp not only the technical aspects of small life science company R&Defforts, but to integrate broader financial and strategic issues into a cogent overarching vision. Hecommunicates effectively up and down the organization and brings great vision to projects."— Granger Whitelaw, was Hal's client

"Hal knows his stuff, including regulations, healthcare, and technology. For our start-up, he usedthis knowledge to help us create a business plan that is simultaneously bold, achievable, andregulation-compliant."— Byron Davies, was Hal's client

"I found Hal to be highly knowledgeable about 21 CFR Part 11 regulations and how the industry hasresponded to meeting them. He was very personable and easy to work with."— Ron Paul, was Hal's client

"Hal's knowledge of the life sciences industry is extensive. He demonstrated an amazing ability tobridge disciplines, technologies and strategies. He was effective interacting with horizontally andvertically diverse groups. Hal has a truly astonishing ability to keep abreast of contemporaryissues/concepts. He is sorely missed."— Marci Tarvin, Industry Strategy & Development, Life Sciences, Sun Microsystems, Inc., worked

directly with Hal at Sun Microsystems