© 2019 by Georgia Bio. Proudly created with Wix.com

#GaBioSummit

TRACK B- Business Growth:

Advancing from ‘R’ to ‘D’ to ‘C’: Various Routes to Building Successful Clinical Stage Companies

Atlanta is a hub for startup creation for biotech, but it's not always easy to go from research to commercialization. Come hear founders and industry leaders offer lessons learned on intelligently scaling your company amid rapid growth including when to partner, sell or IPO, or when to build or buy preclinical, manufacturing, and clinical development capabilities.

 

Steve Damon
VP of Business & Commercial Development, Femasys
Moderator

Mr. Damon has over 30 years of experience with various business roles in the medical device and pharmaceutical industries. Prior to his current role at Femasys he served as the President and CEO of 4P Therapeutics, a company he founded in 2011 and sold to Nutriband Inc. in 2018. Before founding 4P Therapeutics, Steve led partnership and funding efforts at Altea Therapeutics as the company’s Senior Vice President of Business and Corporate Development. Prior to joining Altea Therapeutics, Steven Damon was a member of the executive management team at Durect Corporation in Cupertino, Ca, where he served as Executive Director for Business and Corporate Development in addition was founder and President of Absorbable Polymers International a Birmingham, Alabama company. He was previously a senior management member of the Professional Health Care team at Kimberly-Clark Corporation, with lead responsibilities for commercial development of the healthcare business in Europe and key responsibilities for a number of major acquisition deals.

Steve serves on the Board of Directors for Temple Therapeutics, Nutriband Inc., Micron BioMedical and Georgia BIO.  He also serves as a mentor for the Georgia Tech and Emory TiGER program.  Steve has maintained Business and Corporate Development consultant roles throughout his career including supporting the sale of Map Pharmaceuticals to Allergan.   

Femasys is an Atlanta based women’s health care company.

Sharon Ayd, PhD, MBA
CEO, Ayd BioPharma Consulting Group

Dr. Sharon Ayd is a biopharmaceutical industry veteran with  greater than 30-years’ experience in commercializing Branded/Novel, Specialty, Rare/Orphan and Complex Generic drugs. Drug product types include small molecules as well as biologics. She has a record of value creation for companies as demonstrated by having led numerous international drug development programs from translation/discovery through clinical evaluation, the regulatory review and approval process, product launch and lifecycle management. 

During her career, Dr. Ayd has worked in several multi-national companies including, Baxter International (BAX:NYSE), Apotex Inc., Hospira (now Pfizer)(HSP:NYSE)and Fresenius-Kabi (FRE:DAX). She has also been a founding/C-level executive in start-ups; Transcend Therapeutics, (TSND:NASDAQ),Advanced Life Sciences,(ADLS:NASDAQ)and Pinnacle Biologics.  Under her leadership,  ~100 drug application approvals (NDA, 505(b)(2), ANDA and biosimilar and supplements) have been obtained. She has also been a key player in many M&A transactions up to $1b.

In 2015, Dr. Ayd formed Ayd BioPharma Consulting Group LLC, a consultancy that serves start up to big Pharma clients in Life Sciences, Pharmaceuticals, Biologics and Combination Products.  She received a Ph.D. in Biopharmaceutical sciences from University of Illinois at Chicago. Dr. Ayd received is also an Adjunct Professor at Northwestern University, Pritzker School of Law and is on the Board of Reglagene Inc., a startup involved in the variable control of individual gene expression in various forms of cancer.

Leslie Lemke-Boutcher, PhD, DABT
Drug Development Leader, North American Lead, Covance Drug Development

Dr. Leslie Lemke-Boutcher is a drug development professional with over 20 years’ experience bringing new small molecule and biopharmaceutical therapies to market. Leslie has been directly engaged in programs running through all phases of drug development; initial target identification, candidate screening/nomination, IND and NDA/BLA safety assessment, as well as, through the Regulatory Approval process and into post-marketing support. While experienced in all aspects of general toxicology, Leslie’s particular areas of specialization include toxicology of the special senses (both ocular and otic) and drug/device combination development. Prior to joining Covance, Leslie gained her industry experience while working on research and development programs at Eli Lilly, Alcon Laboratories and Novartis. Leslie’s current role with Covance allows her to bring the benefit of her real world experience to start-up and mid-sized companies looking to bring innovative medicines to market while maintaining a small and agile company profile.

Leslie has a Bachelor’s degree in Biotechnology from the Rochester Institute of Technology (NY), and both a Master’s degree in Toxicology, and a PhD in Pharmacology and Toxicology from the University of Arizona. She is also a Diplomate of the American Board of Toxicology.

Wayne Wiley
VP of Regulatory Affairs and Pharmacovigilance, Recro Gainesville 

R. Wayne Wiley brings more than 30 years of experience in pharmaceutical regulatory affairs to Recro Gainesville, serving as the site’s vice president of regulatory affairs and pharmacovigilance. Wiley is an experienced manager with broad experience and success providing support for regulatory agency meetings in addition to IND, NDA, ANDA, DMF, and ROW filings and approvals. Wiley has a strong understanding of regulatory, clinical, development, and life cycle management filing requirements, including post approval support for phase IV, pharmacovigilance, and supplemental approvals.

Prior to joining Recro, Wiley held various positions of increasing responsibility at Alkermes, Elan Drug Technologies, and Solvay Pharmaceuticals.

Wiley is a registered pharmacist, graduating from the Mercer University School of Pharmacy. He has delivered lectures in regulatory affairs and pharmacovigilance for the University of Georgia School of Pharmacy: Master of Science in Regulatory Affairs program and serves on the curriculum and admissions committees. He has also provided support for the Mercer School of Pharmacy: Doctor of Pharmacy Preceptor training program. He is a member of RAPS, DIA, and AAPS.

Tiffany Wilson, MBA
CEO, Global Center for Medical Innovation (GCMI)

Tiffany has spent more than 15 years bringing innovative medical technology from benchtop to bedside. She joined GCMI in 2011 to lead its startup phase, establishing overall strategic vision, building strategic relationships and bringing together key stakeholders of the medical device ecosystem. Her strong background in medical devices, commitment to fostering innovation and understanding of business strategies have propelled her into a leadership role in the Southeast and brought her into the national spotlight. Tiffany earned a BBA in International Business from Loyola University and an MBA from Georgetown University McDonough School of Business.

 

Wilson joined GCMI from Scientific Intake, where she served as the Vice President of Business Development and Strategy, evaluating marketing and distribution opportunities and driving product development projects for the global obesity market. Prior to Scientific Intake, she was Vice President of Corporate Strategy and Finance at ACell, Inc., a regenerative medicine and tissue engineering company based in Columbia, Maryland. At ACell, she led a broad range of initiatives including corporate finance, investor relations, strategic and operational planning, business development, regulatory, and reimbursement.

 

Tiffany serves as Past-President of the Board of the Southeast Medical Device Association (SEMDA), Founding Member of Medtech Women @ SEMDA, Chair of the Advisory Board for GCMI’s preclinical testing facility, and the Georgia Bio Board of Directors. She is a Member of the National Advisory Council on Innovation and Entrepreneurship (NACIE) at the U.S. Department of Commerce. She led the Sponsorship Committee of the 2013 SEMDA Conference and has served as the Co-Chair of the Medical Device Subcommittee of the Metro Atlanta Chamber Bioscience Leadership Council.

 

In 2015 Tiffany received the prestigious Georgia Bio Community Award and in 2017 was presented with the Industry Growth Award, the highest honor bestowed each year by Georgia Bio.  She was recently recognized by Inc. Magazine as one of “17 Inspiring Women to Watch in 2017” and one of Becker Hospital Review’s “110 Women in Medtech to Know in 2017."