Development Research

STEPHEN S. PALMER

** ****** **** ******, ************* 01450

339-***-**** aczwin@r.postjobfree.com

Executive Director, Pharmaceutical Research

An accomplished pharmaceutical research director with extensive experience and success in large pharma and start-up biotech developing innovative therapeutics and diagnostics from early discovery to phase 2 clinical trials. PhD executive with good patent [18 patents] and publication track record [45 publications].

Employment Objective: Director/Senior Director of biotech R&D organization capable of leading operations, pharmacology, alliance management, translational research, early clinical development. Experience developing innovative medicines for treatment of life altering diseases and building scientific teams to become successful drug developers.

Overview of Professional Experience

TOCOPHERX, INC. Innovative Biotech Entrepreneur, Burlington MA, (2013 – 2016)

Founder, Scientific Director of biotech company, served on Board of Directors

Experience: Preclinical Pharmacology, DMPK, Toxicology, Safety pharmacology, early clinical development

Key Achievements

Secured seed series $4.2M from venture capital investors; founded C corporation

Built company infrastructure and operations (Legal, Financial, Payroll, Liability Insurance, Research & Development; Clinical Development with consultants & CROs).

Established public funding capability, SBA, SAM, ERA registrations for NIH, SBIR, R21 proposal submissions,

Completed Lead Optimization, Exploratory Development, to advance small molecule GPCR agonist to IND stage within 20 months.

Identified, outsourced, and managed multiple CROs in US & China to complete preclinical package; effectively utilized consultants for toxicology, DMPK, Med Chem, and advisory boards for Clinical Development, Regulatory Affairs.

Seminars presented at multiple international meetings; coordinated clinical advisory boards

Data package reviewed among top 10% by worldwide preclinical & clinical CROs & investors

Clinical candidate portfolio >$2B commercial value assessments in field of women’s health; led team to complete preclinical stage in 20 months.

Prepared & presented scientific & budget updates to board, clinical development and early regulatory drafts with consultants, investor presentations at JP Morgan conference, and hosted multiple due diligence reviews.

Scientific Advisor for MIT - Gynepathology, Baylor College - Oncology program, Rutgers University – Genomic screening

Consultant for Auxogyn, Nerre Therapeutics, Forrendo Therapeutics, Merck-Ventures

EMD SERONO RESEARCH & DEVELOPMENT INSTITUTE, MA (1999 – 2013)

Global pharmaceutical and Biotechnology Company.

Executive Director, Global Head of Reproductive Health Research (2009 – 2013)

Develop and lead strategic R & D plans for small molecule and biotherapeutic drug discovery and early drug development ($8M/year). Propose and defend parallel, strategic basic science research program ($3.5M/yr over 5 years) to identify biomarker & companion diagnostic programs. Managed preclinical budget, resource, and collaborations with internal technology platforms (antibody, biotherapeutics, small molecules, chemi-informatics, bioinformatics, non-clinical development). Establish and managed funded collaborations with external academic groups to validate clinical concepts before phase 1 ($2M/yr).

Proven Pharmaceutical R & D manager - program leader for kinase inhibitor to be used in autoimmune disorders & inflammatory disease; clinical biomarker program engaging 90 trial sites, 1500 patients through CRO. Multiple small molecule (NCE) and biologics (NBE) drug discovery programs, including collaborations with neurodegenerative, immunology and oncology drug discovery programs. Identified academic collaborators to outsource key R&D preclinical experiments for proof of concept and corporate CROs for key development milestones.

Executive Management Skills - Demonstrated skill in building, developing, and leading executive teams to capitalize on R & D strengths that help teams achieve strategic plans. Work with academic collaborators to augment corporate portfolio, and build credibility of portfolio through academic collaborations (MIT, Harvard, Baylor, Vanderbilt, Oxford) and clinical collaborators (MA, NJ, CA). Recognized for ability to build collaborative relationships among Research [small molecule and bio-pharmaceutical programs] and Development [internal & external] experts to build independent leaders skilled in delivering new medical entities and new medical diagnostics for unmet medical needs.

Key Achievements:

Expanded preclinical research program to develop both new molecular entities and new laboratory diagnostic tests; trained 3 postdoctoral fellows

Increased external value by developing technologies incorporated into private clinics through our internal research; trained 2 postdoctoral fellows

Developed new and improved existing in vivo pharmacology translational models to better predict efficacy in clinical trials

2 small molecule screening programs including kinases, GPCRs, advanced to phase 2 with efficacy on target

2 biologics screening programs including GPCR ligands, soluble receptor domains advanced to phase 2 with efficacy on target

Embryo biomarker research program laid foundation for laboratory diagnostic technology business

Completed opportunity evaluation, due diligence for Merck Serono.

Conducted strategic sourcing of R&D & clinical development through outsourcing with qualified academic and private CRO investigators

Managed alliances among external collaborating companies

Assistant Head of Research (2004 – 2008)

Led execution of US site research objectives for franchise strategy. Provided management oversight on preclinical and clinical development projects, management progress reviews. Implemented technical solutions for complex R&D teams (drug & device business units)

Key Achievements: Neurodegeneration & Reproductive Health

JNK inhibitor, developed for multiple sclerosis, repurposed for treatment of endometriosis, out-licensed after 2009

5 bio-therapeutics successfully developed through Exploratory Development; 3 held for strategic development priorities

1 GPCR program (EP2/EP4 agonist) and 1 enzyme inhibitor program (PDE4 inhibitor); reached decision to stop; did not meet TPP

Business unit increased revenues >5% year over year during collaboration with academic and clinical KOLs.

Trained and mentored 5 postdoctoral fellows in academic and clinical KOL collaborations;

4 fellows obtained major positions outside industry in academic positions (1 young investigator award; 1 NIH young investigator award; 1 oncology non-profit organization founder; 1 NIH mentored research award) and 2 remain in industry; clinical development)

Key Achievements: Oncology & autoimmune disease

Establish institutional policies and procedure for use of lentivirus research tools

Implemented oncology research program centered around c-kit with key scientists

Explored use of autoimmune kinase inhibitors across multiple therapeutic areas; identified use for PI3K inhibitors, IKKb inhibitors

Previous Employment

J & J RESEARCH & DEVELOPMENT INSTITUTE

Principal Scientist, Research Scientist, and Senior Research Scientist

NORTH CAROLINA STATE UNIVERSITY

NRSA – Postdoctoral Fellow – Department of Biochemistry,

Education & Professional Development

PhD in Animal Science, Physiology

University of Illinois, Urbana, Illinois

MS in Nutritional Biochemistry

BS in Animal Science

University of Illinois, Urbana, Illinois

Entrepreneur Preparations towards MBA

CEO Roundtable; JP Morgan presentations

Entrepreneurs’ Boot Camp, Babson College

Mastering Science of Biotechnology, Babson College

Biotech Seasoned Leader Program, Babson College

Scientific Publications; (attached below)

Pharma Drug Discovery & Development Experience; Appendix 1

Pharmacology small molecules, biologics Management Drug Discovery organization

Strategic Preclinical & Clinical Outsourcing Multiple therapeutic areas

Medical Device & Diagnostic Development Experience; Appendix 2

Strategic Business & Scientific Planning Innovative R&D Business Models Management Budget Resource Operations Publications & Presentations support strengths

Scientific Publications (arranged by drug target)

1.Development of novel orally active FSH receptor agonists

a.Nataraja SG, Yu HN, Palmer SS, 2015. Discovery and Development of Small Molecule Allosteric Modulators of Glycoprotein Hormone Receptors. Front Endocrinol (Lausanne). 14; 6:142.

b.Yu HN, Richardson TE, Nataraja S, Fischer DJ, Sriraman V, Jiang X, Bharathi P, Foglesong RJ, Haxell TF, Heasley BH, Jenks M, Li J, Dugas MS, Collis R, Tian H, Palmer S, Goutopoulos A, 2014. Discovery of substituted benzamides as follicle stimulating hormone receptor allosteric modulators. Bioorg Med Chem Lett. 24(9):2168-72.

c.Sriraman V, Denis D, de Matos D, Yu H, Palmer S, Nataraja S, 2014. Investigation of a thiazolidinone derivative as an allosteric modulator of follicle stimulating hormone receptor: evidence for its ability to support follicular development and ovulation. Biochem Pharmacol. 89(2):266-75

d.Thomas RM, Nechamen CA, Mazurkiewicz JE, Muda M, Palmer S, Dias JA, 2007. Follicle-stimulating hormone receptor forms oligomers and shows evidence carboxyl-terminal proteolytic processing. Endocrinology. 148(5):1987-95.

e.Palmer SS, McKenna S, Arkinstall S, 2005. Discovery of new molecules for future treatment of infertility. Reprod Biomed Online. 10 Suppl 3:45-54.

f.Weenen C, Peña JE, Pollak SV, Klein J, Lobel L, Trousdale RK, Palmer S, Lustbader EG, Ogden RT, Lustbader JW, 2004. Long-acting follicle-stimulating hormone analogs containing N-linked glycosylation exhibited increased bioactivity compared with o-linked analogs in female rats. J Clin Endocrinol Metab. 89(10):5204-12.

g.Cottom J, Salvador LM, Maizels ET, Reierstad S, Park Y, Carr DW, Davare MA, Hell JW, Palmer SS, Dent P, Kawakatsu H, Ogata M, Hunzicker-Dunn M, 2003. Follicle-stimulating hormone activates extracellular signal-regulated kinase but not extracellular signal-regulated kinase kinase through a 100-kDa phosphotyrosine phosphatase. J Biol Chem. 278(9):7167-79.

h.Haynes-Johnson D, Lai MT, Campen C, Palmer S,1999. Diverse effects of tyrosine kinase inhibitors on follicle-stimulating hormone-stimulated estradiol and progesterone production from rat granulosa cells in serum-containing medium and serum-free medium containing epidermal growth factor. Biol Reprod. 61(1):147-53.

i.Palmer SS, Bahr JM, 1992. Follicle stimulating hormone increases serum oestradiol-17 beta concentrations, number of growing follicles and yolk deposition in aging hens (Gallus gallus domesticus) with decreased egg production. Br Poult Sci. 33(2):403-14.

j.Johnson PA, Palmer SS, Bahr JM, 1985. Hormone-stimulable adenylyl cyclase and steroid concentration of follicles of the pregnant mare's serum gonadotropin-treated hen. Biol Reprod. 32(4):828-33.

2.Development of non-steroidal progesterone agonists and antagonists

(RWJ26819, RWJ47626, RWJ66826, JNJ1250132; Allan et al;, Palmer, et al); asoprisnil; ulipristal telopristal

a.Allan, G.F., Palmer, E., Musto, A., Lai, M.T., Clancy, J., and Palmer, S. (2006) Molecular properties and preclinical pharmacology of JNJ-1250132, a steroidal progesterone receptor modulator that inhibits binding of the receptor to DNA in vitro. Steroids, 71:578–584.

b.Palmer, S., Campen, C.A., Allen, G.F., Rybczynski, P., Haynes-Johnson, D., Hutchins, A., Kraft, P., Kiddoe, M., Lai, M.-T., Lombardi, E., Pedersen, P., Hodgen, G., and Combs, D.W. (2000) Nonsteroidal progesterone receptor ligands with unprecedented receptor selectivity. J Steroid Biochemistry & Molecular Biology, 75:33–42.

3.Development of PDE4 inhibitors, EP2/EP4 agonists for follicular development and ovulation

During 2000–2007, my research at EMD Serono led to development of phosphodiesterase inhibitors for ovulation and selective EP2/EP4 agonists for follicular development and ovulation.

c.Stephen S. Palmer, Sean D. Mckenna, Stephen J. Arkinstall, Aliza Eshkol, and Michael C. Macnamee

WO-200-***-**** - 14-Oct-2004 (01-Apr-2003)

Inhibitors of phosphodiesterases in infertility

Applied Research Systems ARS Holding NV [Serono SA] (Patent Assignee/Owner)

d.Brugger, N., Kim, N.N., Araldi, G.L., Traish, A.M., and Palmer, S.S. (2007) Pharmacological and functional characterization of novel EP and DP receptor agonists: DP1 receptor mediates penile erection in multiple species. J Sex Med, 5:344–356.

4.Molecules to support oocyte maturation in vitro

Treatments that could be applied in culture, following retrieval of oocytes from patients, including IL-6 family members (LIF, IL-6, IL-17) as agents that were capable of improving cumulus-oocyte maturation in vitro, as a means to treat oocytes from women with polycystic ovarian disease who would need to avoid injection of hCG to prevent ovarian hyperstimulation syndrome (OHSS).

e.Ann Clark, David Kagan, and Stephen Palmer

WO-200-***-****. Use of IL-17 in the treatment of fertility-related disorders.

EP1794287 B1 A61K 20090722 Merck Serono SA

Use of IL-17 for maturation of oocytes

f.Liu, Z., de Matos, D.G., Fan, H.Y., Shimada, M., Palmer, S., and Richards, J.S. (2009). Interleukin-6: an autocrine regulator of the mouse cumulus cell-oocyte complex expansion process. Endocrinology, 150:3360–3368.

g.De Matos, D.G., Miller, K., Scott, R., Tran, C.A., Kagan, D., Nataraja, S.G., Clark, A., and Palmer, S. (2008) Leukemia inhibitory factor induces cumulus expansion in immature human and mouse oocytes and improves mouse two-cell rate and delivery rates when it is present during mouse in vitro oocyte maturation. Fertil Steril, 90:2367–2375.

5.A family of patents and manuscripts for inflammatory disease

TNF-binding proteins and JNK inhibitors are highly effective immune modulators for treatment of endometriosis with minimal impact on reproductive hormones (Onercept; TBP-SHARC; AS602801, Bentamipimod - licensed to PreGlem, phase 2 clinical trial reported on Clinicaltrials.gov [NCT01630252; PGL5001 Proof of Concept Study in Inflammatory Endometriosis (JADE)]

h.Stephen S. Palmer and Selvaraj Nataraja

Kinase inhibitors for treatment of endometriosis.

EP1904181 A2 A61P 20080402 Merck Serono SA; USPTO #201********

i.Hussein M, Chai DC, Kyama CM, Mwenda JM, Palmer SS, Gotteland JP, D'Hooghe TM, 2016. c-Jun NH2-terminal kinase inhibitor bentamapimod reduces induced endometriosis in

baboons: an assessor-blind placebo-controlled randomized study. Fertil Steril. 105:815-24.

j.Palmer, S.S., Altan, M., Denis, D., Tos, E.G., Gotteland, J.-P., Osteen, K.G., Bruner-Tran, K.L., and Nataraja, S.G. (2016) Bentamapimod (JNK-inhibitor AS602801) induces regression of endometriotic lesions in animal models. Reproductive Science 23:11-23.

k.Altan, A.M., Denis, D., Kagan, D., Grund, E.M., Palmer, S.S., and Nataraja, S.G. (2010) A long-acting tumor necrosis factor alpha-binding protein demonstrates activity in both in vitro and in vivo models of endometriosis. J Pharmacol Exp Ther, 334:460–466.

l.Grund EM, Kagan D, Tran CA, Zeitvogel A, Starzinski-Powitz A, Nataraja S, Palmer SS, 2008. Tumor necrosis factor-alpha regulates inflammatory and mesenchymal responses via mitogen-activated protein kinase kinase, p38, and nuclear factor kappaB in human endometriotic epithelial cells. Mol Pharmacol. 73(5):1394-404.

m.Allan GF, Palmer E, Musto A, Lai MT, Clancy J, Palmer S, 2006. Molecular properties and preclinical pharmacology of JNJ-1250132, a steroidal progesterone receptor modulator that inhibits binding of the receptor to DNA in vitro. Steroids 71(7):578-84.

n.Allan G, Campen C, Hodgen G, Williams R, Charnock-Jones DS, Wan J, Erlander M, Palmer S, 2003. Identification of genes with differential regulation in primate endometrium during the proliferative and secretory phases of the cycle. Endocr Res. 29(1):53-65.

6.Detection and validation of totipotency and pluripotency markers of embryo viability

A critical success factor in treatment of infertility is to distinguish viable embryos from non-viable embryos. My group identified potential markers of embryo viability through research conducted with mice embryos.

o.Kidder, B.L., Yang, J., and Palmer, S.S. (2008) Stat-3 and c-Myc genome-wide promoter occupancy in embryonic stem cells. PLoS One, 3:e3932.

p.Kidder, B.L., Palmer, S., and Knott, J.G. (2009) SWI/SNF-Brg-1 regulates self-renewal and occupies core pluripotency-related genes in embryonic stem cells. Stem Cells, 27:317–328.

q.Kidder, B.L. and Palmer, S.S. (2010) Examination of transcriptional networks reveals an important role for TCFAP2C, SMARCA4, and EOMES in trophoblast stem cell maintenance. Genome Research, 20:458–472.

r.Kidder, B.L. and Palmer, S. (2012) HDAC1 regulates pluripotency and lineage specific transcriptional networks in embryonic and trophoblast stem cells. Nucleic Acids Res, 40(7):2925–39. doi: 10.1093/nar/gkr1151.

Complete List of Published Work in MyBibliography: http://www.ncbi.nlm.nih.gov/myncbi/browse/collection/48011606/?sort=date&direction=ascending

PROFESSIONAL MEMBERSHIP

Society for the Study of Reproduction – Industry Liaison

Society for Gynecology Investigation – Corporate Advisory Board

American Society of Reproductive Medicine

European Society for Human Reproduction and Embryology

Endocrine Society

Industrial – Professional Society Partnerships

Program Committee, Clinical Subteam, Society Study of Reproduction, Development Committee

Development Committee, Society Study of Reproduction

Society for the Study of Reproduction, Public Affairs Committee

COSAT Focus Giving Program, Strategic Entry into Oncology Franchise for JNJ, Scientific Liaison

RWJPRI Task Force on Performance Evaluation and Promotion Criteria

RWJPRI Drug Discovery Journal Club, Organizer

Rutgers University, Doctoral Committee

Society for the Study of Reproduction, Development Committee

Society for the Study of Reproduction, Trainee Representative

AWARDS & HONORS

National Research Service Award, Postdoctoral Fellowship

University of Illinois, Carle Foundation Hospital, Research Grant Award

Computer System Grant for Teaching

University of Illinois, Department of Animal Science, Outstanding Graduate Student Award

Carle Foundation Hospital, Research Grant Award

COMPUTER SKILLS

Microsoft Project, Word, PowerPoint, Excel, Quick Books, ChemAxon JChem

PC and Mac, NIH/NCBI databases, FDA databases, SBIR/STTR applications;

Website development, Venture capital presentations

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Providers of Recommendation Letters on request

Veronica Alam, MD (Merck Serono)

Steve Arkinstall, PhD (Kymab Laboratories, UK)

Hakan Goker, PhD (Merck Ventures)

Martin Matzuk, MD, PhD (Baylor)

Linda Griffith, PhD (MIT)

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