Putting science on a development and regulatory track

Contact:

Costas C. Loullis, Ph.D.

President & CEO

Phone: 919.475.1876

cloullis@anixisbiomed.com

To provide value added services at reasonable cost to biotechnology companies involved in drug development by:

Delineating the best route to market

Facilitating strategic alliances

Providing rigorous project management

for on time and on budget results

Anixis Biomedical Consulting

To help you generate reliable information that

can lead to business decisions, which will

increase the value of your products

Anixis Biomedical Consulting

Experience in putting science on a development and regulatory track

Optimizing product development in terms of time and cost

Anixis Biomedical Consulting

Define client’s needs to provide the right amount of assistance in order to maintain quality standards and minimize costs

Provide access to a network of experts associated with Anixis, in the drug, biologic and dietary supplement arenas

Manage scope and quality to make sure that changes in scope are agreed to by all, reinforcing accountability

Anixis Biomedical Consulting

Anixis Biomedical Consulting

Examples of Anixis’ Consulting Services: Drug and DS*

FDA/Regulatory interactions

Formulate/assess business plans Assess products/platforms/assets Pharmacology/Pharmacokinetics/Toxicology Product Development Plans Intellectual Property Assess Dietary Supplement claims Clinical trial protocols Dietary Supplement product differentiation Manufacturing/Formulation Regulatory and Publication writing DS* expertise in USA/European/Ayurveda/TCM

*Dietary supplements

An increasingly competitive funding environment and long product development timelines in a demanding regulatory environment means that young companies often get only one shot at the goal

• Specific programs or products competing within established companies face the same constraints

Missed market opportunities due to poor product positioning and/or failure to formulate and execute a program plan can be very costly because of:

• Missed revenue by not getting to the market at all

• Missed revenue opportunity by getting to market late

• Costs incurred due to poor plan execution

Anixis Biomedical Consulting

Failure of product development programs is often in part due to:

Expectations incongruent with strategic planning

Resources, tasks and timeline are not clearly defined or committed to, including funding allocation

Failure to execute project plan

Failure to fully formulate and articulate risk factors

Lack of alternative and contingency planning in case of funding and market changes

Anixis Biomedical Consulting

Transform company’s vision into a strategic plan that results in a realistic project plan

Bring to bear expertise and experience with a proven track record of success

Provide flexible project plans that incorporate and anticipate changes in the market and funding arena

• Project plans are living documents and modular

• Anticipate and resolve issues proactively

• Clearly articulate potential risk areas upfront and develop strategies to mitigate risk, where possible, and incorporate into project plan

• Assess plan and critical path at frequent intervals with flags build in for deviations

Anixis Biomedical Consulting

Anixis Biomedical Consulting

Anixis Biomedical Consulting

Costas C. Loullis, Ph.D.

I am presently the founder and president of ANIXIS Biomedical Consulting, providing the pharmaceutical industry with strategic

planning, drug and business development services. These include a wide range of Research, Preclinical and Clinical drug development

services, formulating and assessing business plans, and assessing technology platforms, product candidates and other assets, with

respect to business and business development goals. I have experience in the Drug, Biologic, Botanical drug and Dietary Supplement

arenas.

I have served as a company officer and a key member of a number of executive management teams, where I headed R&D and was fully

engaged in strategic planning, operations, fund raising and business development as well as budget generation and oversight. I have

over thirty years of broad experience in all aspects of Product Selection, Research and Development in many therapeutic areas and a

keen sense for product positioning in the marketplace. I have focused my efforts on streamlining these processes, to reduce cost and

time, using a combination of internal and external contract resources. I have successfully shepherded drug products from research into

preclinical development and clinical trials many times, the proof of concept cycle, and have fostered translational medicine and project

management principles. I have been responsible for submitting many INDs in a wide range of indications.

I have established and led a number of research, preclinical, development, clinical, and regulatory groups in the US and overseas and I

was in charge of all FDA interactions and filings. These groups included technology assessment, biology and pharmacology, toxicology,

pharmacokinetic, pharmaceutical and manufacturing and QA/QC and project management. My regulatory work has included difficult

new areas at the FDA, which required unconventional strategic and tactical thinking, extensive interactions with the FDA and successful

submission of regulatory documents without the benefit of clear guidelines or paved pathways. As a result I have dealt with complex

regulatory issues with respect to submissions in the areas of CMC, preclinical and clinical and their interplay.

I have assembled and led scientific advisory boards and have represented companies at scientific and regulatory environments in

national and international forums. I have also been responsible for overseeing, contributing and securing intellectual property emanating

from R&D. I have submitted as PI and oversaw the submission of SBIR grants.

Selected accomplishments in previous positions

• I was Co-founder and General partner of BioPontis Alliance, a transformative model dedicated to unleashing innovative science from

universities toward the development of important medical products. There he worked to lay the foundation of our university alliance

partners: Columbia, Memorial Sloan Kettering, New York, Florida, North Carolina, Virginia and Pennsylvania, assess over 250

technologies and select promising assets for further development. In 2014-15 the company evolved to BioPontis Alliance for Rare

Diseases.

Anixis Biomedical Consulting

Costas C. Loullis, Ph.D.

• I Build and managed a multifaceted research a development team from 20 to 80 staff members and lead the effort to an allowed IND

in a cancer gene therapy indication.

• I was the CO-inventor of a family of small peptide anti-inflammatory compounds based on cytokine restrain and I directed the

development of the lead compound from preclinical through to the end of phase 2 for Pain management and Cancer, using a

combination of in-house resources and Contract Service Organizations. I also lead the effort to use the above compound for Asthma,

via topical administration to the lungs.

• I have clinical and regulatory experience in a number of therapeutic areas including Allergy/Immunology, CNS, CV, Diabetes,

Infectious Diseases, Inflammation/Pain, Oncology and Urology. I designed and oversaw many clinical trials and filed many INDs

• I was a key member of the R&D team at American Cyanamid (now Pfizer), which focused on the use of Monoclonal Antibodies and

their radioactive or toxin conjugates in cancer imaging and therapy. These conjugates included Mylotarg (TM) - a MoAb/toxin

conjugate approved in 2000 and indicated for the treatment of patients with CD33 positive acute myeloid leukemia.

• I was responsible for 7 OTC/phytoceutical products marketed by American Home Products under their Centrum line in a deal worth

over $40,000,000.

• I was a member of the International Pharmaceutical Aerosol Consortia for Toxicology Testing (IPACT I & II). These panels oversaw

the studies and filing of the Drug Master Files (DMF) to the FDA for introduction of these alternative aerosol propellants HFA-134a

and 227 Hydrofluorocarbons (HFC), consistent with the protection of the earth’s ozone layer.

Specific Dietary Supplement and Botanical Drug Experience

• Prior to founding Anixis Biomedical Consulting I served as a company officer, senior vice president and executive vice president in

two dietary supplement companies, where I was in charge of research, product development, formulation, clinical & regulatory,

manufacturing and intellectual property for European, Traditional Chinese Medicine and Ayurveda botanicals.

• I was critically involved in the early and subsequent stages of product standardization and Good Manufacturing Practices (GMP) for

Dietary Supplements and oversaw related research and patent development. As mentioned above, I was responsible for 7 botanical

products marketed by American Home Products (now Pfizer) under their Centrum line in a deal worth over $40,000,000, using this

patented technology.

Anixis Biomedical Consulting

Costas C. Loullis, Ph.D.

• I continue to be very much involved in the dietary supplement field in a consulting capacity, as the DS industry progresses beyond

product standardization to clinical substantiation of product claims via well designed and controlled clinical trials. These trials are

rapidly recognized by DS companies not only as a scientific validation of their products but also as a necessary marketing investment

in order to compete in the marketplace.

• In addition to the dietary supplement path I was also responsible for submitting the first botanical drug IND to FDA by a biotech

company, followed by five additional botanical drug IND submissions.