Mark G.

- Advise biotechnology executives, investors, and government stakeholders on development strategies for next-generation biologics, nucleic acid therapeutics, and vaccine platform technologies, including programs relevant to emerging infectious disease threats and medical countermeasures. - Conduct technical due diligence and scientific risk assessment across discovery, nonclinical development, clinical strategy, and CMC to inform high-impact investment and programmatic decisions. - Provide expert guidance on regulatory strategy, development pathways, and manufacturing readiness for innovative therapeutic platforms and advanced biologics. - Support strategic planning and cross-sector collaboration among biotechnology companies, investors, and research organizations to accelerate translation of novel therapeutic technologies into clinical development.

- Expertise in long-range strategic planning and financial modeling. - Key contributor to the launch and commercialization of clinical and commercial-stage programs. - Leadership in DNA technologies and customized enzyme development. - Proven experience in vendor and supplier selection, GMP compliance for internal and external facilities, tech transfer, change management, and process optimization. - Skilled facilitator in setting business strategies and driving Industry 4.0 advancements.

- Next gen CRISPR therapeutic development and production; - Guide RNA impurity profiling and off target/safety testing; - IND drafting and comparability studies; - Key decision maker in supplier/vendor evaluation & selection, auditor and leader in onboarding; - Key stakeholder in managing external manufacturing and contract lifecycles

- COVID vaccine development, testing, manufacturing & regulatory filing; - Early and late-stage development, production, and testing of mRNA/lipid based vaccine & therapeutic products; - Next gen mRNA/lipid product development, manufacturing, testing, and digital twin; - Inventor of three patents on mRNA continuous manufacturing: 1. Multicolumn chromatography mRNA purification: WO TW WO2023018923A1 2. Continuous precipitation for mRNA purification: WO WO2023150256A1 3. Preparation of highly concentrated mRNA: WO WO2023225524A1

- Modalities (solved technical challenges from early to late stage development): viral vector (oncolytic adenovirus), antibody (mAb, fusion), recombinant protein (relaxin/insulin family hormones), drug conjugate (pegylated IL-2/FGF-21), CAR-T cell therapy and interleukins; - Tech Dev: Lead processes intensification/scaling-up, continuous process; tech transfer & Gemba at internal & external GMP facilities; - Clinical trial major partner; - Regulatory: Support early and late staged clinical trials, CMC development & filing; - Research: High-throughput research on process characterization & improvement; - Support cell therapy development and operations. Built platforms for pegylated microbial proteins & viral vector based gene therapies based on chromatography and TFF; - People/CDMO/CRO management; Lead matrix campaign teams; PhD level coop projects. - D6

- Regulatory: PPQ/PAI campaigns, BLA filing, Annual Product Quality Report, & FDA inspections; - Manufacturing: 25,000L stainless steel and 2000L single-use facility GMP campaign tech transfer, MBR & PIP support; Satellite runs, deviation investigation, RCA, CAPA; - SME: Viral clearance, pharmacology, toxicology, & intermediate stability studies; Benzonase digestion & trypsin conversion; At-scale continuous centrifugation, depth filtration, chromatography, TFF, cryogenics, & primary packaging. - D5-2

- Negotiated & drafted statement of work and contract research agreements, worked with clients to resolve contractual issues; - As a core member of the study management, managed laboratory/plant operations and ensured all work & documentation comply with the FDA/EMEA regulations.

- Led tech transfer of therapeutic protein manufacturing processes at different scales; - As the single point of study control in non-clinical drug testing, planned & executed GLP studies to facilitate BLA submission for new drugs.

- Sought and obtained funding from NIH SBIR and Small Business Technology Transfer (STTR) Programs; - Led multidisciplinary research teams in antibody-drug conjugate engineering; - Led various drug delivery projects by rationally designing, expressing, and characterizing therapeutic drug leads; - Developed, optimized, and validated the manufacturing processes for multiple recombinant peptide-nucleic acid therapeutics and analyzed the cell internalization.

- Developed a new approach in antifungal drug discovery, which involved generating super short peptides to develop a complementation assay evaluating RNA-protein interaction in group I intron splicing inhibition; - Resolved scalability issues in characterizing a micron-scale DNA crystal as a solid enzyme vehicle for biocatalysis; - Developed a proof-of-concept for NMR protein backbone labeling using 1,2-13C2-pyruvate.

Advisors: Vitali Tugarinov (2008-10 on biomolecular NMR); Paul Paukstelis (2010-14 on RNA-binding protein biochemistry and nucleic acid nanotechnology)

HMX Pro Courses are 10-week online programs from Harvard Medical School.

YMC ChromaCon AG lab training