F. Richard Christ, MSChE, MBA

SUMMARY

Proven executive in the surgical ophthalmic' field. Technical leader in biomedical/biotechnology industry. Invented more than 10 biomedical materials and designs, totaling over $100 million in revenues. Proven ability to develop new products from concept to regulatory approval and on to manufacturing transfer and scale-up. Technical leader in the start-up of two ophthalmic device firms which sold recently for a combined $700 million (Visiogen, Inc. and eyeonics, Inc.). Recognized international speaker/author. Areas of particular expertise include:

• Executive-Level Experience • FDA/CE Biocompatibility Testing Expert
• Materials Research and Development • University Research Agreements/Liaisons
• Project Management – Design to Approval

EXPERIENCE

2009-Present InVision Biomedical Group, Inc.
Principal
Offering consulting services in biomedical product development. Expertise in the development of new biomedical products from conception through regulatory approval and manufacturing scale-up.

2007-2009 Aaren Scientific, Inc. (formerly OII International, Inc.)
Chief Technology Officer/Chief Operating Officer
As CTO, brought the following products through the CE mark approval process:

• Identified source for and developed a hydrophobic acrylic IOL material – three-piece and single-piece IOL models were approved for CE mark
• Hydrophilic acrylic based lenses including (a) iris-fixated lens, (b) yellow single-piece lens, (c) three-piece lens with PVDF haptics
• Managed the full development and CE approval process for a novel multifocal IOL. Lens is currently launched in Europe.
• Set up and managed the FDA clinical evaluation of a three-piece hydrophobic acrylic IOL. This product is at the PMA stage.
• Prepared CE and IDE files for regulatory approvals.

As COO, accomplished the following:

• Managed the manufacturing and manufacturing engineering functions which consisted of 170 employees.
• Re-organized operations to achieve significant reductions in cost-of-goods for all product lines
• Introduced at least 5 new products to the manufacturing floor including a single-piece hydrophobic acrylic IOL. Scaled the hydrophobic product up to 150,000 units per year.
  Achieved through-put goals for all product lines of as many as 60,000 IOL units per month.

1996-2007 BioMediChem, Inc., Irvine, CA
Principal/Biomedical Consultant
Performed product development activities and project management for intraocular and refractive lens products, contact lens disinfection solutions, and cardiopulmonary devices. Representative projects include:

• Performed biocompatibility evaluation and contributed to materials development for a corneal inlay start-up technology. This technology is currently in advanced clinical evaluation.
• Performed silicone materials development and biocompatibility evaluations for two accommodating IOL start-up technologies. One has been approved and commercialized and the second is in advanced clinical evaluation.
• Managed a project on novel silicone-based light adjustable IOLs including relationships with Caltech inventors. This product is currently commercialized in Europe and in advanced clinical evaluations in US.
• Managed the in vivo/in vitro evaluation program and the identification of drug delivery modalities for anti-angiogenic protein and peptide targeted to retinal diseases. Included developing relationships and liaison with research groups at Harvard, University of California Berkeley, and Indiana University.
• Managed the development of two new intraocular lenses through entire pre-clinical development and ISO submission.
• Managed the initial development phases of a novel acrylic-based phakic IOL. Developed research relationship with Department of Ophthalmology, Medical University of South Carolina.
• Performed due diligence evaluations on an electronically-based artificial retina and on a retinal imaging technology for a Massachusetts venture capital group.
• Set up and conducted a complete evaluation program, including animal surgeries, for a phacoemulsification adjunctive product allowing a timely, well-informed decision to be made on the technology.

1984-1996 Allergan, Inc., Irvine, CA
Director of Surgical Research (1992-1996)
Directed five to ten Ph.D. and Masters level chemists and engineers in development of new ophthalmic devices. Served on strategic business teams for IOLs and surgical adjuncts responsible for planning and executing a multi-million dollar research project portfolio.

• Directed and guided the development of more than six patented new ophthalmic biomaterials and device designs.
• Selected to present technical papers to medical doctors in five different countries at United States and International Symposia. Authored a book chapter on Ophthalmic Biomaterials.
• Identified and established alliances with University and other research institutions for potential development of innovative technology to extend Allergan's base of technologies and competencies.

Manager of Surgical Polymer Research (1990-1992)
Guided project team leaders and team members in development projects spanning silicone materials, corneal onlays/inlays and injectable IOLs. Responsible for planning/scheduling, cost estimation, budgeting and resolution of scientific/engineering problems.

• Extended the capabilities of Surgical Research beyond cataract-related products into retina and glaucoma research.
• Championed in-house Project Management seminars resulting in improvements in specifications setting, project planning, and milestone tracking.

Section Manager, Surgical R&D (1987-1990)
Project leader responsible for the development of a sodium hyaluronate viscoelastic fluid. Managed relationships with international and domestic contractors and suppliers.

• Successfully managed a multidisciplinary team including members from quality assurance, clinical research and regulatory affairs in development of Allergan's first product in the viscoelastic category.
• Achieved successful completion of United States clinical trial in six months.
• Negotiated contracts with Japanese raw material supplier and a United States contract manufacturer obtaining targeted cost-of-goods.
• Invented two novel viscoelastic formulations.

Research Engineer (1984-1987)
Project leader responsible for developing a new intraocular lens for the small-incison surgery market. The project team included representatives of all functional areas.

• Invented and led the development of two generations of foldable intraocular lens products (currently generating $100+ million in product revenues).
• Developed manufacturing processes and material testing procedures that became industry standards.
• Researched additional materials such as urethanes, acrylics and hydrogels leading to a confimation that the silicones were the most suitable materials for the foldable lenses and to significant publications in the biomaterials literature.

1979-1981 SRI International, Menlo Park, CA
Research Analyst
Researched and authored technical marketing studies for the polymer materials section of the Chemical Industries Center that became part of a encyclopedia of industrial chemicals. Assessed technologies and recommended product development strategies for manufacturers of polymer-based products.

1978-1979 Nuclear Enterprises, Inc., San Carlos, CA
Research Scientist
Optimized process for fabrication of plastic scintillator material sheets used in high energy physics applications. Developed a plastic scintillation detector for HPLC.

MILITARY: 1972-1976 U.S. Navy

Nuclear Submarine Officer

EDUCATION

• 1993 M.B.A., University of California, Irvine. Beta Gamma Sigma Honor Society
• 1983 M.S. Chemical Engineering, University of California, Los Angeles
• Thesis: "Hydrodynamic adsorption effects in the flow of polyacrylamide solutions through porous media"
• 1977 M.A. Biophysical Chemistry, University of California, Irvine
• 1974 U.S. Navy, graduated Nuclear Power School, Vallejo, CA and Idaho Falls, ID
• 1972 B.S. Chemistry, University of California, Los Angeles. Cum laude graduate

AFFILIATIONS

• Society for Biomaterials
• ARVO

SUMMARY OF PUBLICATIONS, PATENTS, PRESENTATIONS

PUBLICATIONS

1. Christ, F.R., teal., Biomaterials Used for Intraocular Lenses, In Encyclopedic Handbook of Biomaterials and Bioengineering Part B: Applications (Vol 2); Wise, D.L., et al., Eds.; Marcel Dekker, Inc.: New York, 1995; pp1261-1313 (Ch. 46).
2. Francese, J. E., F.R. Christ., S.Y. Buchen, A. Gwon, and J.E. Robertson, Moisture droplet formation on the posterior surface of intraocular lenses during fluid/air exchange, J Cataract and Refract Surg 1995, 21, 685-689.
3. Yang, S., H. Makker, and F.R. Christ, Accelerated ultraviolet aging of intraocular lenses. Part I: A new photo-aging model, J Cataract and Refract Surg (in press).
4. Yang, S., H. Makker, and F.R. Christ, Accelerated ultraviolet aging of intraocular lenses. Part II: 50-year simulated aging of SI-18NB and SI-20NB silicone intraocular lenses, J Cataract and Refract Surg (in press).
5. Francese, J. E., L. Pham, F.R. Christ, Accelerated hydrolytic and ultraviolet aging studies on SI-18NB and SI-20NB silicone lenses, J Cataract and Refract Surg 1992, 18, 685-689.
6. Buchen S.Y.,S.C. Richards, K.D. Solomon, D.J. Apple, P.M. Knight, F.R. Christ, et al., Evaluation of the biocompatibility and fixation of a new silicone intraocular lens in the feline model, J Cataract Refract Surg 1989, 15, 545-553.
7. Christ, F.R., S.Y. Buchen, D.A. Fencil, P.M. Knight, K.D. Solomon, and D.J. Apple, A comparative evaluation of the biostability of a poly(ether urethane) in the intraocular, intramuscular, and subcutaneous environments, J Biomed Mater Res, 1992, 26, 607-629.
8. Yang, S., H. Makker, J. Kerkmeyer, and F.R. Christ, UV absorbing silicone compositions for IOL, Proceedings of the American Chemical Society, Division of Polymeric Materials: Science and Engineering, 1993, 69, 417-418.
9. Christ, F.R., D.A. Fencil, S. Van Gent, and P.M. Knight, Evaluation of the chemical, optical and mechanical properties of elastomeric intraocular lens materials and their clinical significance, J. Cataract Refract Surg, March 1989, 15, 176-184.
10. Christ, F.R., Polymer retention and adsorption in the flow of polymer solutions through porous media, Soc Petroleum Engineers Reservoir Engineering, March 1986, p113.

POSTERS

1. A Simple Animal Model for Screening New Intraocular Lens Materials, Presented at the Society for Biomaterials Annual Symposium, New York, 1987.
2. Stability Evaluation of a Poly (ether urethane) Considered for Use as an Intraocular Implant, Presented at the Society for Biomaterials Annual Symposium, Orlando, 1989.

SELECTED PODIUM PRESENTATIONS

1. "Biomaterials Used for Intraocular Lenses" Presented to Meeting of American Chemical Society, Orange County Chapter, February 1996.
2. "A Comparison of SI-30 and SI-40 Silicone IOLs" Presented to Foldable Academy, Zermatt, Switzerland, 1996.
3. "AMO® Vitrax® Viscoelastic Solution for Small Incision Surgery" Presented to Foldable Academy, Zermatt, Switzerland, 1996.
4. "A Comparative Overview of IOL Optic Materials: Laboratory Testing" Presented at the ASCRS, San Diego, CA, April 1995.
5. "How to Build a Foldable IOL: Insights into Materials Challenges" Presented at ESCRS, Amsterdam, the Netherlands, October 1995.
6. "AMO®PHACOFLEXII® SI-30NB and SI-40NB Foldable Silicone Intraocular Lenses" Presented at Academy of Ophthalmology (Booth Presentation), Atlanta, Georgia, October 1995.
7. "Design and Clinical Results of AMO®AcryFlex® IOLs" Presented to Foldable Academy, Zermatt, Switzerland, 1995.

SELECTED U.S. PATENTS

1. 6,793, 941 (2004): "Contact lens and ophthalmic solutions"
2. 5,843, 186 (1998): "Intraocular lens with antimicrobial activity"
3. 5.647,409 (1997): "On-site filling apparatus for viscoelastic materials and corresponding method for on-site syringe filling"
4. 5,494,946 (1996): "Optically clear reinforced silicone elastomers of high optical refractive index and improved mechanical properties for use in intraocular lenses"
5. 5,492.936 (1996): "Bimodal molecular weight hyaluronate formulations and methods for using same"
6. 5,411,553 (1995): "Cross-linked silicone polymers, fast curing silicone composition and injectable intraocular lenses"
7. 5,391,590 (1995): "Injectable IOL compositions and precursors thereof"
8. 5,359,021 (1994): "Polymeric compositions and intraocular lenses made from same" (acrylic material)
9. 5,344,449 (1994): "Intraocular lenses. fixation member assemblies and methods for making same"
10. 5,331,073 (1994): "Injectable IOL compositions and precursors thereof"
11. 5,278,258 (1994): "Cross-linked silicone polymers, fast curing silicone composition and injectable intraocular lenses"
12. 5,262,097 (1993): "Methods for attaching fixation members to optics of intraocular lenses"
13. 5,236,970 (1993): "Optically clear reinforced silicone elastomers of high optical refractive index and improved mechanical properties for use in intraocular lenses"
14. 5,147,397 (1992): "Intraocular lens and method for making same"
15. 4,897,079 (1990): "Polymeric sleeve for surgical instruments" (polyurethane)
16. 4,894,062 (1990): "Staking anchor for soft intraocular lens"
17. 4,888,013 (1989): "Haptic to optic attachment for a soft intraocular lens"
18. 4,868,251 (1989): "Ultraviolet light absorbing silicone compositions"
19. 4,834,751 (1989): "Staking ring for soft IOL"
20. 4,790,846 (1988): "Haptic to optic junction for soft intraocular lens"

AWARDS

1. Allergan Scientific Achievement Award, 1990 (silicone IOL project)
2. Allergan Applied Science Paper of the Year - 2 times
3. Allergan Impact Award, 1988 (viscoelastic fluid project)